K Number

Device Name

VITALSENSE

Manufacturer

MINI-MITTER CO., INC.

Date Cleared

2004-04-22

(164 days)

Product Code

FLL

Regulation Number

880.2910

Intended Use

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K991045

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a data logger for temperature measurements and does not mention any AI or ML capabilities for analysis or interpretation.

Therapeutic

No
The device is described as a physiological data logger used for monitoring and recording temperature data to further the understanding of body function, not for treating or diagnosing any condition.

Diagnostic

Explanation: The device is described as a "physiological data logger" that measures and records core body, skin, and ambient temperatures. Its purpose is to "further the understanding of body function" and provide "quantifiable analysis of temperature data." While it collects physiological data, there is no mention of it being used to diagnose diseases, conditions, or to guide treatment decisions. It simply provides data for understanding and analysis.

SaMD (Software as a Medical Device)

The device description explicitly states it is a "compact, ambulatory, physiological data logger" with an "LCD screen" and the ability to "sense and record physiological data," indicating it is a hardware device with integrated software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
VitalSense® Function: The description clearly states that VitalSense® measures and logs physiological body core and skin temperature. This is a measurement of a physical parameter within or on the body, not an analysis of a sample taken from the body.
Intended Use: The intended use focuses on understanding body function through temperature measurement, not on diagnosing a disease or condition based on a biological sample.
Device Description: The device is described as a "physiological data logger" that uses telemetric sensors. This aligns with in-vivo measurement, not in-vitro analysis.

Therefore, VitalSense® is a physiological monitoring device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

GWK, FLL

Device Description

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.

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-IP52
NEMA250-5
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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Body core, dermal surface

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Any setting where physiological body core and skin temperature are used to further the understanding of body function.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Two non-clinical performance tests were conducted:

First test: stability of temperature measurement
- Study type: Temperature stability test.
- Key results: The measured temperature must not drift more than +/- 0.1 ℃ over a 10- to 12-hour period. The stability was +/- 0.01 ℃, which is ten times better than required.
- Description of graph: 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.
Second test: temperature linearity
- Study type: Temperature linearity test.
- Key results: Temperature checked within +/- 0.1 °C of a standard, NIST-traceable digital RTD thermometer. The performance of VitalSense® over the range 25 -50 Celsius is within +/- 0.1 °C.
- Description of graph: 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".

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Typical Accuracy: +/- 0.05 °C
Typical Stability: +/- 0.01 °C

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K991045

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

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

Device description 11.1.4

Functions of the device 11.1.4.1

Basic scientific concepts 11.1.4.2

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

Physiological Parameter	Sensor Used	Sensor Technology
Skin surface temperature	Surface dermal patch	Thermistor resistance
varies uniquely with
temperature.	Digital waveform whose
duty cycle represents
temperature.
Core body temperature	Ingestible capsule	Thermistor resistance
varies uniquely with
temperature.	Digital waveform whose
duty cycle represents
temperature.

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-IP52
NEMA250-5
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

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.

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.

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.

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

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.

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

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)