SKIN SENSOR PROBE, GENERAL PURPOSE PROBE, TYMPANIC PROBE

K101244 · Truer Medical, Inc. · FLL · Nov 18, 2010 · General Hospital

Device Facts

• Record ID: K101244
• Device Name: SKIN SENSOR PROBE, GENERAL PURPOSE PROBE, TYMPANIC PROBE
• Applicant: Truer Medical, Inc.
• Product Code: FLL · General Hospital
• Decision Date: Nov 18, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The intended use of the temperature probes is to measure temperature by a resistor that is sensitive to temperature changes. The probe is connected to the patient monitor by using an interconnect cable. These probes have skin or core contact with a patient. Skin probe (SSP 400 and SSP 700): The Skin Sensor Probe is indicated for use in the routine monitoring of skin temperature. It is individually packaged. The skin temperature probe is designed for use with Data Scope, Protocol and DeBusk monitoring systems and other monitors capable with 400 Series temperature probes. The device is indicated for use by qualified medical personnel only. GP Probes (GP 9400, GP 9700 and GP 14400): The General Purpose Temperature Probe is intended for continuous temperature monitoring. The probe is inserted into the nasopharynx, mouth or the rectum. It is individually packaged. The temperature probe beneath the cuff at the distal tip is designed for use with Data Scope, Protocol and DeBusk monitoring systems and other monitors capable with 400 Series temperature probes. The device is indicated for use by qualified medical personnel only, Tympanic Probe (TP 400 and TP 700: The Tympanic Probe is intended for monitoring patient temperature through the outer auditory ear canal. It is individually packaged. The tympanic Probe is designed for use with Data Scope, Protocol and DeBusk monitoring systems and other monitors capable with 400 Series temperature probes. The device is indicated for use by qualified medical personnel only.

Device Story

General Purpose, Tympanic, and Skin Sensing Probes measure patient temperature via temperature-sensitive resistors. Probes connect to patient monitors (e.g., Data Scope, Protocol, DeBusk) via interconnect cables. Skin probes monitor skin surface; GP probes monitor core temperature via nasopharyngeal, oral, or rectal insertion; Tympanic probes monitor via outer auditory canal. Operated by qualified medical personnel in clinical settings. Output is continuous temperature data displayed on compatible monitors, facilitating clinical assessment of patient thermal status.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Temperature-sensitive resistor (thermistor) sensing principle. Compatible with 400 Series temperature monitoring systems. Form factor includes skin, general purpose (nasopharyngeal/oral/rectal), and tympanic probe configurations. Connectivity via interconnect cable to patient monitor.

Indications for Use

Indicated for routine skin temperature monitoring (SSP series), continuous nasopharyngeal, oral, or rectal temperature monitoring (GP series), and outer auditory ear canal temperature monitoring (TP series). For use by qualified medical personnel only with compatible 400 Series temperature monitoring systems.

Regulatory Classification

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.

Special Controls

(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.

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of what appears to be an abstract human form or symbol, composed of three curved lines.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Truer Medical Incorporated C/O Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25" Street, NW Buffalo, Minnesota 55313 .

NOV 1 8 2010

Re: K101244

Trade/Device Name: General Purpose Probes, Tympanic Probes, Skin Sensing Probes, Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: October 30, 2010 Received: November 3, 2010-

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. .

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Page 2- Mr.Job

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket-Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

h for

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

## Enclosure

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## Indications for Use Statement

510(k) Number (if known): not assigned

Device Name: General Purpose Probes, Tympanic Probes, Skin Sensing Probes

Indications for Use:

The intended use of the temperature probes is to measure temperature by a resistor that is sensitive to temperature changes. The probe is connected to the patient monitor by using an interconnect cable. These probes have skin or core contact with a patient.

Skin probe (SSP 400 and SSP 700): The Skin Sensor Probe is indicated for use in the routine monitoring of skin temperature. It is individually packaged. The skin temperature probe is designed for use with Data Scope, Protocol and DeBusk monitoring systems and other monitors capable with 400 Series temperature probes. The device is indicated for use by qualified medical personnel only.

GP Probes (GP 9400, GP 9700 and GP 14400): The General Purpose Temperature Probe is intended for continuous temperature monitoring. The probe is inserted into the nasopharynx, mouth or the rectum. It is individually packaged. The temperature probe beneath the cuff at the distal tip is designed for use with Data Scope, Protocol and DeBusk monitoring systems and other monitors capable with 400 Series temperature probes. The device is indicated for use by qualified medical personnel only,

Tympanic Probe (TP 400 and TP 700: The Tympanic Probe is intended for monitoring patient temperature through the outer auditory ear canal. It is individually packaged. The tympanic Probe is designed for use with Data Scope, Protocol and DeBusk monitoring systems and other monitors capable with 400 Series temperature probes. The device is indicated for use by qualified medical personnel only.

Prescription Use X (Per 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Austri for RZC

(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices Division of Anosthools - 33
Infection Control, Dental Devices

510(k) Number: k101244