VitalSense® can be used in any setting where physiological body core and skin temperature are used to further the understanding of body function. The device can be used for simultaneous assessment of core body temperature, dermal surface temperature, or ambient temperatures that require logging of data over time with subsequent conversion, display, and analysis of the aforementioned parameters. VitalSense® may be used in any instance where quantifiable analysis of temperature data is desirable.

Device Description

VitalSense® is a compact, ambulatory, physiological data logger. VitalSense® may be attached to the belt or worn in a shirt pocket. Up to ten telemetric sensors may be used with a single VitalSense® logger. The device senses and records physiological data and displays the data on its LCD screen. Recorded data may be transferred later to a PC for display and conversion for export to other programs.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the VitalSense® device based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Figure of Merit	Acceptance Criteria (Stated)	Reported Device Performance (VitalSense®)	Reported Predicate Performance (Mini-Logger® Series 2000)
Temperature Stability	Must not drift more than +/- 0.1 °C over 10-12 hours	+/- 0.01 °C	+/- 0.03 °C
Temperature Linearity/Accuracy	Within +/- 0.1 °C of a standard, NIST-traceable digital RTD thermometer (over 25-50 °C range)	+/- 0.05 °C	+/- 0.08 °C

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state a "test set" in the context of clinical data or human subjects. The tests described are laboratory-based performance verification tests.

Sample Size: For the stability test, the image description mentions "Two Temperature Probes" (Sensor 24 and Sensor 26). For linearity, the image description also refers to "Sensor_24" and "Sensor_26". The total number of devices or sensors tested across the entire evaluation is not specified beyond these two examples for illustration.
Data Provenance: The data is generated from internal laboratory testing by Mini Mitter Co., Inc. (as indicated by "Mini Mitter Company has established criteria..." and "Mini Mitter has tested the accuracy..."). The country of origin is the USA, specifically Bend, Oregon, where the company is located. The study is prospective in nature, as it involves active testing of the device's performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

Not applicable. The ground truth for these performance tests is based on objective, quantifiable measurements against established standards and calibration, not expert consensus or interpretation of medical data. The "ground truth" for temperature linearity is a "standard, NIST-traceable digital RTD thermometer."

4. Adjudication Method for the Test Set:

Not applicable. There is no adjudication method used for these non-clinical performance tests, as the results are numerical comparisons against defined thresholds.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. The document describes engineering performance tests of the device itself (accuracy and stability of temperature measurement), not studies involving human readers or assessment of human interpretation with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Yes, the studies described are standalone performance evaluations of the device's ability to accurately and stably measure temperature. The device functions as a data logger, and the tests evaluate its fundamental measurement capabilities directly, without human intervention in the data acquisition or algorithmic processing during the test.

7. The Type of Ground Truth Used:

The ground truth used for these performance tests is based on:

Reference Standards: For temperature linearity, a "standard, NIST-traceable digital RTD thermometer" served as the reference for ground truth.
Defined Baseline/Stability: For temperature stability, the expectation of minimal drift over time (e.g., in a stable bath) serves as the ground truth.

8. The Sample Size for the Training Set:

Not applicable. This document describes the verification and validation of a finished device's performance, not the development or training of an algorithm using a dataset. The device is a physiological data logger, not an AI/ML algorithm that requires a training set in the typical sense.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for an AI/ML algorithm described.

Summary

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510(K) SUMMARY 11.0

Summary information 11.1

Submitter's name and address 11.1.1

Jack E. McKenzie, Ph.D. Mini-Mitter Co., Inc. 20300 Empire Ave., Bldg. B-3 Bend, Oregon 97701 541-322-7272 Fax 541-322-7277

November 4, 2003 Date summary was prepared:

Name of device 11.1.2

Trade Name:	VitalSense®
Common Name:	Physiological Data Logging Device
Classification Name:	Physiological Signal Conditioner
Product Code:	GWK

Identification of predicate device 11.1.3

Mini-Logger® Series 2000, Physiological Data Logging Device 510(k) Number : K991045

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Device description 11.1.4

Functions of the device 11.1.4.1

Basic scientific concepts 11.1.4.2

The device acquires and logs digital data whose values represent the amplitudes of physiological signals. Currently available wireless sensors (see Addendum 1) sense temperature as the physiological signal. The scientific concepts and technologies that are used to sense the signals are summarized in Table 13.

TABLE 13. BASIC TECHNOLOGIES USED FOR PHYSIOLOGICAL SIGNAL RECORDING IN VITALSENSE®SENSORS

Physiological Parameter	Sensor Used	Sensor Technology	Signal Obtained
Skin surface temperature	Surface dermal patch	Thermistor resistancevaries uniquely withtemperature.	Digital waveform whoseduty cycle representstemperature.
Core body temperature	Ingestible capsule	Thermistor resistancevaries uniquely withtemperature.	Digital waveform whoseduty cycle representstemperature.

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Physical characteristics 11.1.4.3

11.1.4.5 - I hystear characteristics
Pertinent physical characteristics of the VitalSense® data logger are shown in Table 14.

Parameter	Value
Size	120 x 90 x 25 mm
Weight	200 grams
Battery type	3.6 volt lithium cell (1 ea)
Case material	Polycarbonate/ABS plastic
Moisture protection	IEC529-IP52NEMA250-5
Storage temperature	-20 C to 50 C at 5-95% relative humidity
Operating temperature	0 C to 40 C
Interface panel	Non-permeable membrane switch panel
Display	Monochrome liquid-crystal with backlight

TABLE 14. PHYSICAL CHARACTERISTICS OF VITALSENSE® LOGGER

Statement of the intended use of the device. 11.1.5

How the technological characteristics of the device compare to 11.1.6 those of the predicate device

VitalSense® and the Mini-Logger® Series 2000 (FDA 510(k) Number: K991045) are each diagnostic test systems based upon the concept of an ambulatory, unattended physiological logger that logs sensor-input physiological data to the logging device. The device communicates

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the data with an IBM compatible personal computer (PC). Each of these devices is a solid-state logger with data collection algorithms, definable numbers of channels, types of channels, and with the ability to store data until it is downloaded into the PC. VitalSense® and the Mini-Logger® Series 2000 are of similar size and weight. Both devices have an internal clock and event marker to time-stamp and mark data for later interpretation. VitalSense® has the potential to input specific types of data on each of ten channels. The Mini-Logger® Series 2000 has the potential for five sensor inputs.

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Assessment of non-clinical performance data 11.2

1.2 Design Inputs $\Leftrightarrow$ Design Outputs methodology. Of the tests conducted in this verification, the temperature stability and temperature linearity are the two most important performance considerations. Mini Mitter Company has established criteria for the stability of temperature measurements, based on ASTM-E1112-00, clause 4.2. A summary of the test results for those are provided below.

First test: stability of temperature measurement 11.2.1

The measured temperature must not drift more than +/- 0.1 ℃ over a 10- to 12-hour period. As the chart indicates, the stability is +/- 0.01 ℃, ten times better than required.

Image /page/4/Figure/6 description: The image is a graph titled "Temperature Measurement Stability of Two Temperature Probes Relative to Bath Temperature = 37.00 Celsius". The x-axis is labeled "Time of Day" and spans from 7/30/2003 22:00 to 7/31/2003 10:00, with a total span of 10 hours. The y-axis is labeled "Temperature" and ranges from -0.05 to 0.05. The graph plots two data series: "Sensor 24 Error" and "Sensor 26 Error", with Sensor 24 Error generally plotting around -0.02 and Sensor 26 Error generally plotting around 0.02.

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Second test: temperature linearity 11.2.2

I I.2.2 Second test. temperature checked within +/- 0.1 °C of a standard, NIST-traccable digital RTD thermometer. Mini Mitter has tested the accuracy of VitalSense® over the range 25 -50 Celsius, and its performance is within +/- 0.1 °C (see section 5.6). See following chart.

Image /page/5/Figure/4 description: The image shows a graph titled "Temperature Performance of VitalSense Logger Jul-30-2003/Mini Mitter Co., Inc." The graph plots "Displayed Temperature ('C)" on the y-axis versus "Water Bath Temperature ('C)" on the x-axis. The graph shows a linear relationship between the two variables for "Sensor_24" and "Sensor_26".

Comparison to predicate device performance 11.3

Comparable data for the predicate device appear in the 510(k) Premarket Notification for that device (submitted June 22, 1999, by Mini Mitter Co., Inc.). In that Notification, data were provided that demonstrate Mini-Logger® Series 2000 has a typical accuracy of +/- 0.08 °C and a stability of +/- 0.03 °C. Data provided in the present Premarket Notification for VitalSense demonstrate a typical accuracy of +/- 0.05 °C and a stability of +/- 0.01 °C. Thus, VitalSense® performance exceeds that of the currently-marketed predicate device. A summary of these results appears in Table 12.

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TABLE 12. VITALSENSE® AND MINI-LOGGER® SERIES 2000, TEMPERATURE MEASUREMENT CHARACTERISTICS

Figure of Merit	VitalSense ®	Mini-Logger ® Series 2000
Typical Accuracy	+/- 0.05 °C	+/- 0.08 °C
Typical Stability	+/- 0.01 °C	+/- 0.03 °C

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, overlaid on a circular seal. Encircling the caduceus are the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 2 2004

Mini Mitter Company, Inc. Jack E. McKenzie, Ph.D. 20300 Empire Avenues Building B-3 Bend, Oregon 97701

Re: K033534

Trade/Device Name: VitalSense Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: January 22, 2004 Received: February 11, 2004

Dear Dr. McKenzie:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 9 rotty pressession is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regally manat date of the Medical Device American be on the oddined. Dave comments that have been reclassified in accordance with the provisions of the Federal Food, Drug. devices that have been recuired in accercap.co in of a premarket approval application (PMA). and Cosment Act (Act) that to hot require appear al controls provisions of the Act. The You may, ulerelore, market the device, books of the mount registration, listing of general controls provisions of the tice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (sec above) and existing major regulations affecting your device can
may be subject to such additional controls. Existing major regal of edition may be subject to such additional controls. Extremy may in 1998 In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898, In addition, be found in the Code of Poderal Registering your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualles of a successfies with other requirements of the Act
that FDA has made a determination that your device of any also anaros. You must that FDA has made a decertimation that Jour at research agencies. You must or any Federal statutes and regulations dammistered of registration and listing (21 to comply with all the Act s requirements, me, good manufacturing practice requirements as set CFR Parl 807), labeling (21 CFR Party, good franch 820); and if applicable, the clectronic
forth in the quality systems (QS) regulation (21 CFR 1000); 11 CFR 1000 1050 forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 – Dr. Jack E. McKenzie

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin marketing your avine equivalence of your device to a legally premarket nothcation. The PDA mixing of basification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your do not all one and the regulation entitled, Contact the Office of Comphance at (301) = if (21CFR Part 807.97). You may obtain "Misbranding by reference to premaince notification of Sciffrom the Division of Small other gelleral information on your responses Assistance at its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-freel Manufacturers, International and Consailerry//www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

-miriam C. Provost

Colia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): ___K033534

Device Name:_ VitalSense® Integrated Physiological Monitoring System

Indications For Use:

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

Prescription Use _ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Regulation Number and Section

§ 880.2910 Clinical electronic thermometer.

(a)
Identification. A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(1) Device is not a clinical thermometer with telethermographic functions;
(2) Device is not a clinical thermometer with continuous temperature measurement functions; and
(3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.