Mini Mitter Co, Inc.510(k) PremarketNotificationVitalSense APR 2 2 2004510(K) SUMMARY11.0Summary information11.111.1.1Submitter's name and addressJack E. McKenzie, Ph.D.Mini-Mitter Co., Inc.20300 Empire Ave., Bldg. B-3Bend, Oregon 97701541-322-7272Fax 541-322-7277Date summary was prepared:11.1.2November 4, 2003Name of deviceTrade Name:VitalSense Common Name:Physiological Data Logging DeviceClassification Name:Physiological Signal ConditionerProduct Code:GWK11.1.3Identification of predicate deviceMini-Logger Series 2000, Physiological Data Logging Device510(k) Number: K991045Page 28

510(k) Premarket NotificationVitalSense 0Mini Mitter Co, Inc.11.1.4Device description11.1.4.1 Functions of the deviceVitalSense is a compact, ambulatory, physiological data logger. VitalSense may beattached to the belt or worn in a shirt pocket. Up to ten telemetric sensors may be used with asingle VitalSense logger. The device senses and records physiological data and displays the dataon its LCD screen. Recorded data may be transferred later to a PC for display and conversion forexport to other programs. Basic scientific conceptsThe device acquires and logs digital data whose values represent the amplitudes ofphysiological signals. Currently available wireless sensors (see Addendum 1) sense temperatureas the physiological signal. The scientific concepts and technologies that are used to sense thesignals are summarized in Table 13.TABLE 13. BASIC TECHNOLOGIES USED FOR PHYSIOLOGICAL SIGNALRECORDING IN VITALSENSE" SENSORSPhysiological ParameterSensor UsedSensor TechnologySignal ObtainedSkin surface temperatureSurface dermal patchThermistor resistancevaries uniquely withDigital waveform whoseduty cycle representstemperature.temperature.Thermistor resistancevaries uniquely withDigital waveform whoseduty cycle representstemperature.temperature.Core body temperatureIngestible capsulePage 29

510(k) Premarket NotificationVitaiSense Mini Mitter Co, Inc. characteristicsin Table 14.Pertinent physical characteristics of the VitalSenseo data logger are shownTABLE 14. PHYSICAL CHARACTERISTICS OF VITALSENSE" LOGGERValueParameterSize120 x 90 x 25 mmWeightBattery typeCase materialMoisture protection200 grams3.6 volt lithium cell (1 ea)Polycarbonate/ABS plasticIEC529-IP52NEMA250-5-20 C to 50 C at 5-95% relative humidityStorage temperatureOperating temperatureInterface panel0 C to 40 CNon-permeable membrane switch panelMonochrome liquid-crystal with backlightDisplay11.1.5Statement of the intended use of the device.core and skinVitalSense can be used in any setting where physiological bodyThe devicetemperature are used to further the understanding of body function.dermalcan be used for simultaneous assessment of core body temperature,of data oversurface temperature, or ambient temperatures that require loggingtime with subsequent conversion, display, and analysis of the aforementionedanalysisparameters. VitalSense may be used in any instance where quantifiableof temperature data is desirable.11.1.6How the technological characteristics of the device compare tothose of the predicate deviceK991045) are eachVitalSenseo and the Mini-LoggeroSeries 2000 (FDA 5 10(k) Number:physiologicaldiagnostic test systems based upon the concept of an ambulatory, unattendedThe device communicateslogger that logs sensor-input physiological data to the logging device.Page 30

510(k) Premarket NotificationVitalSense Mini Mitter Co, Inc.of these devices is a solid-statethe data with an IBM compatible personal computer (PC). Eachtypes of channels, andlogger with data collection algorithms, definable numbers of channels,VitalSense and the Miniwith the ability to store data until it is downloaded into the PC.have an internal clock andLoggers Series 2000 are of similar size and weight. Both devicesVitalSenseo has the potentialevent marker to time-stamp and mark data for later interpretation.Series 2000 has theto input specific types of data on each of ten channels. The Mini-LoggerRpotential for five sensor inputs.Page 31

510(k) Premarket NotificationVitalSense Mini Mitter Co, Inc.Assessment of non-clinical performance data11.2data logger using aMini Mitter Company has verified the performance of the VitalSensein this verification, theDesign Inputs * Design Outputs methodology. Of the tests conductedperformancetemperature stability and temperature linearity are the two most importantstability of temperatureconsiderations. Mini Mitter Company has established criteria for thethe test results for those aremeasurements, based on ASTM-E 112-00, clause 4.2. A summary ofprovided below.First test: stability of temperature measurement11.2.1a 10- to 12-hour period.The measured temperature must not drift more than /- 0.1 C over0required.As the chart indicates, the stability is /- 0.01 C, ten times better thanTemperature Measurement Stability of Two Temperature ProbesRelative to Bath Temperature 37.00 CelsiusJul-31-2003/M in i Mitter Co.-*Sensor 24 Error -oSensor 26 Error0. 0.01o.o0.00E0.0.01- 22:00P'-0.05'I7/31/2003 0:007/31/2003 2:00'7/31/2003 4:00Time of Day(Total span 10 hours)Page 327/31/2003 6:007/31/2003 8:007/31/2003 10:00

510(k) PremarketNotificationVitalSense Mini Mitter Co, Inc.Second test: temperature linearity11.2.2The measured temperature must agree to within /- 0.1 C of a standard, NIST-traceable the range 25 digital RTD thermometer. Mini Mitter has tested the accuracy of VitalSense overchart.50 Celsius, and its performance is within /- 0.1 C (see section 5.6). See followingTemperature Performance of VitalSense LoggerJuI-30-2003/M ini Mitter Co., Inc.[.- Sensor 24 -.--- Se nsor 26]53.00- 48.00-43.00-38.0028.00 .--23.0023. Bath Temperature ('C)11.3Comparison to predicate device performancefor thatComparable data for the predicate device appear in the 5 10O(k) Premnarket Notificationdata weredevice (submitted June 22, 1999, by Mini Mitter Co., Inc.). In that Notifi[cation, /- 0.08 'C and aprovided that demonstrate Minii-Logger0 Series 2000 has a typical accuracy ofVitalSensestability of /- 0.03 'C. Data provided in the present Premarket Notification forVitalSenseodemonstrate a typical accuracy of /- 0.05 'C and a stability of /- 0.01 "'C. Thus,of these resultsperformance exceeds that of the currently-marketed predicate device. A summaryappears in Table 12.Page 33

510(k) Premarket NotificationVitalSense Mini Mitter CI, Inc. TEMPERATURETABLE 12. VITALSENSE& AND MINI-LOGGER SERIES 2000,MEASUREMENT CHARACTERISTICSFigure of MeritTypicalAccuracyTypicalStabilityMini-Loggers Series 2000 /-0.08 CVitalSense /- 0.05 C /-0.03 C /- 0.01 0CPage 34

4-DEPARTMENT OF HEALTH & HUMAN SERVICESAPR 2 2 2004Public Health ServiceFood and Drug Administration9200 Corporate BoulevardRockville MD 20850Mini Mitter Company, Inc.Jack E. McKenzie, Ph.D.20300 Empire AvenuesBuilding B-3Bend, Oregon 97701Re: K033534Trade/Device Name: VitalSenseRegulation Number: 21 CFR 880.2910Regulation Name: Clinical Electronic ThermometerRegulatory Class: IIProduct Code: FLLDated: January 22, 2004Received: February 11, 2004Dear Dr. McKenzie:to market the deviceWe have reviewed your Section 510(k) premarket notification of intent(for the indicationsequivalentreferenced above and have determined the device is substantiallymarketed in interstatefor use stated in the enclosure) to legally marketed predicate devicesDevice Amendments, or tocommerce prior to May 28, 1976, the enactment date of the Medicalof the Federal Food, Drug,devices that have been reclassified in accordance with the provisionsapproval application (PMA).and Cosmetic Act (Act) that do not require approval of a premarketprovisions of the Act. TheYou may, therefore, market the device, subject to the general controlsregistration, listing ofgeneral controls provisions of the Act include requirements for annualmisbranding anddevices, good manufacturing practice, labeling, and prohibitions againstadulteration.or class III (PMA), itIf your device is classified (see above) into either class II (Special Controls)affecting your device canmay be subject to such additional controls. Existing major regulations898. [n addition, FDA maybe found in the Code of Federal Regulations, Title 21, Parts 800 toRegister.publish further announcements concerning your device in the Federaldetermination does not meanPlease be advised that FDA's issuance of a substantial equivalenceother requirements of the Actthat FDA has made a determination that your device complies withagencies. You mustor any Federal statutes and regulations administered by other Federalregistration and listing (21comply with all the Act's requirements, including, but not limited to:requirements as setCFR Part 807); labeling (21 CFR Part 801); good manufacturing practiceif applicable, the electronicforth in the quality systems (QS) regulation (21 CFR Part 820); and21 CFR 1000-1050.product radiation control provisions (Sections 531-542 of the Act);

Page 2 - Dr. Jack E. McKenziein your Section 510(k)This letter will allow you to begin marketing your device as describedyour device to a legallypremarket notification. The FDA finding of substantial equivalence ofthus, permits your devicemarketed predicate device results in a classification for your device andto proceed to the market.(21 CFR Part 801), pleaseIf you desire specific advice for your device on our labeling regulationthe regulation entitled,contact the Office of Compliance at (301) 594-4659. Also, please noteYou may obtain"Misbranding by reference to premarket notification" (21CFR Part 807.97).Division of Smallother general information on your responsibilities under the Act from the(800) 638-2041 orManufacturers, International and Consumer Assistance at its toll-free 01) 443-6597 or at its Internet addressSincerely yours,&'Celia M. Witten, Ph.D., M.D.DirectorDivision of General, Restorativeand Neurological DevicesOffice of Device EvaluationCenter for Devices and Radiological HealthEnclosure

Indications for Use510(k) Number (if known):K033534Device Name: VitalSense Integrated Physioloqical Monitoring SystemIndications For Use:VitalSense can be used in any setting where physiological body core andskin temperature are used to further the understanding of body function.The device can be used for simultaneous assessment of core bodytemperature, dermal surface temperature, or ambient temperatures thatrequire logging of data over time with subsequent conversion, display, andanalysis of the aforementioned parameters. VitalSense may be used inany instance where quantifiable analysis of temperature data is desirable.(Division Sign-Off)Division of General, Restorative,and Neurological Devices510(k) Number /xPrescription Use(Part 21 CFR 801 Subpart D)AND/ORb 53Over-The-Counter Use(21 CFR 807 Subpart C)PAGE IF(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHERNEEDED)Concurrence of CDRH, Office of Device Evaluation (ODE)

Bend, Oregon 97701 541-322-7272 Fax 541-322-7277 Date summary was prepared: November 4, 2003 11.1.2 Name of device Trade Name: VitalSense Common Name: Physiological Data Logging Device Classification Name: Physiological Signal Conditioner Pr