TYMPANIC TEMPERATURE PROBE WITH FOAM, MODEL M1024233; WITHOUT FOAM MODEL M1024237

K061942 · GE Healthcare · FLL · Sep 29, 2006 · General Hospital

Device Facts

• Record ID: K061942
• Device Name: TYMPANIC TEMPERATURE PROBE WITH FOAM, MODEL M1024233; WITHOUT FOAM MODEL M1024237
• Applicant: GE Healthcare
• Product Code: FLL · General Hospital
• Decision Date: Sep 29, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2

Intended Use

The Tympanic Temperature Probe is intended for atraumatic placement in proximity of the tympanic membrane. The temperature probes are designed for use with Datex-Ohmeda and GE Medical Systems IT monitoring systems and other monitors compatible with 400 Series temperature probes. Please consult your monitoring system manual for information specific to the temperature probe usage. The device is indicated for use by qualified medical personnel only

Device Story

Disposable tympanic temperature probe; utilizes thermistor to measure temperature in outer auditory canal; connects to patient monitor via interconnect cable. Designed for use with 400-series compatible monitoring systems (e.g., GE Dash, Solar, TRAM, Datex-Ohmeda modules). Operated by qualified medical personnel in clinical settings. Provides continuous temperature data to monitor; assists clinicians in patient thermal management. Non-sterile, single-patient use.

Clinical Evidence

Bench testing only. Device verified against IEC 60601-1, IEC 60601-2-49, ISO 10993 (biocompatibility), and ISO 14971 (risk management). No clinical data presented.

Technological Characteristics

Disposable thermistor-based temperature probe. Compatible with 400-series monitoring systems. Materials and mechanical design equivalent to predicate. Non-sterile. Complies with IEC 60601-1, IEC 60601-2-49, ISO 10993, and ISO 14971.

Indications for Use

Indicated for atraumatic placement in proximity of the tympanic membrane for temperature measurement in patients. For use by qualified medical personnel only with 400-series compatible 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.

Predicate Devices

• DeRoyal temperature probes (K925792)

Reference Devices

• Dash 300/4000 (K033304)
• Solar (K012467)
• TRAM (K900540)
• M-PRESTN (K041772)
• Cardiocap 5 (K992323)
• Light (K981378)
• M-ESTPR (K953175)

Submission Summary (Full Text)

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K061942 Page 1 of 3

## Premarket Notification 510(k) Summary As required by section 807.92 Tympanic Temperature Probe with foam (M1024233) and Tympanic Temperature Probe w/o foam (M1024237)

SEP 2 9 2006

# GENERAL COMPANY INFORMATION as required by 807.92(a)(1)

## COMPANY NAME/ADDRESS/PHONE/FAX:

GE Healthcare 86 Pilgrim Road Needham, MA 02492 USA Tel: [phone] Fax: [phone]

### NAME OF CONTACT:

Mr. Joel Kent

DATE:

July 5, 2006

#### DEVICE NAME as required by 807.92(a)(2)

TRADE NAME:

Tympanic Temperature Probe with foam (M1024233) Tympanic Temperature Probe w/o foam (M1024237)

COMMON NAME:

Temperature probe

CLASSIFICATION NAME:

The following Class II classifications appear applicable:

FLL Clinical electronic thermometer 21 CFR 880.2910

NAME OF LEGALLY MARKETED DEVICE FOR WHICH A CLAIM OF SUBSTANTIAL EQUIVALENCE IS MADE as required by 807.92(a)(3)

The disposable tympanic temperature probes (REF M1024237): are substantially equivalent in safety and effectiveness to the predicate DeRoyal temperature probes (K925792).

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## DEVICE DESCRIPTION as required by 807.92(a)(4)

Disposable tympanic temperature probes are used during patient temperature measurement from the outer auditory canal. These probes are assu auring patient temperature from the adapter cable end and a thermistor on the patient end. These probes are to be used with 400-series compatible temperature measurement systems only. The temperature probe measures temparature by a resistor that is sensitive to temperature changes. The probe is connected to the patient monitor by a using an interconnect cable. These strobes have skin contact with a patient. Probes are shipped in non-sterile condition and there is a shelf life declared for each manufacturing batch. These temperature probes can be used with legacy GE Medical System monitors like Dash 300/4000 (K033304), Solar (K012467), TRAM (K900540) and also with the new GE Healthcare S/3 modules like M-PRESTN (K041772) and also with legacy Datex-Ohmeda patient monitors and modules like Cardiocap 5 (K992323), Light (K981378) or M-ESTPR (K953175). Products are packed inside a cardboard box having 25 pcs of individually packed probes (inside a plantics are pouch) in non-sterile condition. The package label describes product REF codes, manufacturing date, shelf life, CE-mark, legal entity information and a caution "Rx Only (USA), U.S. Federal law restricts this device to sale by or on the order of a physician.". There is one instruction for use insert in the sales package of 25 probes.

#### INTENDED USE as required by 807.92(a)(5)

Intended use & Indication for use for tympanic probes (REF M1024233 and M1024237):

The Tympanic Temperature Probe is intended for atraumatic placement in proximity of the tympanic membrane.

The temperature probes are designed for use with Datex-Ohmeda and GE Medical Systems IT monitoring systems and other monitors compatible with 400 Series temperature probes. Please consult your monitoring system manual for information specific to the temperature probe usage. The device is indicated for use by qualified medical personnel only

## SUMMARY OF TECHNOLOGICAL CHARACTERITICS OF DEVICE COMPARED TO THE PREDICATE DEVICE as required by 807.92(a)(6)

The disposable tympanic temperature probes (REF M1024233 and M1024237): are substantially equivalent in safety and effectiveness to the predicate DeRoyal temperature probes (K925792). The disposable tympanic temperature probes have the following similarities to the predicate device:

- Have the same indicated use and shelf life

100

- Mechanical design, including colors, dimensions, materials and manufacturing processes are equal between GE Healthcare and DeRoyal tympanic probes

- Thermistor and functional performance are equal between GE Healthcare and DeRoyal tympanic probes

- Process of sterilization is equal between GE Healthcare and DeRoyal tympanic probes The proposed disposable temperature probes have the following differences compand to the predicate device:

- Labeling, artwork, LOGO and different wording of the instruction for use insert

In summary, disposable temperature probes, described in this submission are substantially equivalent to the predicate DeRoyal tympanic temperature probes (1895/92).

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## SUMMARY OF NONCLINICAL TESTING FOR THE DEVICE and CONCLUSIONS as required by 807.92(b)(1)(3)

Tympanic Temperature Probe with foam (M1024233) and Tympanic Temperature Probe w/o foam (M1024237) have been assessed against the standards below. The devices have been thoroughly tested through validation and verification of specifications.

- IEC 60601-1:1988 + Amdt. 1:1991 + Amdt. 2:1995 (Part 1: General requirements for safety) ●
- IEC 60601-2-49:2001 (Part 2:-49: Particular requirements for the safety of multifunction patient . monitoring equipment)
- 21 CFR Part 898 .
- ISO 15223:2000 Medical Devices Symbols to be used with medical device labeling and . information to be supplied
- . EN 980+A1+A2
- ISO 10993-x .
- ISO 14971:2000 Medical devices Application of risk management to medical devices .

### CONCLUSION:

The summary above shows that there are no new questions of safety and effectiveness for the Tympanic Temperature Probe with foam (M1024233) and Tympanic Temperature Probe w/o foam (M1024237) as compared to the predicate device.

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od and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Joel C. Kent Manager. Quality and Regulatory Affairs GE Healthcare 86 Pilgrim Road Needham, Massachusetts 02492

SEF & ST 2006

Re: K061942

Trade/Device Name: Tympanic Temperature Probe with Foam (M1024233) and Tympanic Temperature Probe w/o Foam (M1024237) Regulation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: July 5, 2006 Received: July 10, 2006

Dear Mr. Kent:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Kent

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

Chih-Lin, Ph.D.

Chiu Lin, Ph.D. 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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K061942

# Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Tympanic Temperature Probe with foam (M1024233) and

## Tympanic Temperature Probe w/o foam (M1024237)

Indications for Use:

Intended use & Indication for use for tympanic probes (REF M1024233 and M1024237):

The Tympanic Temperature Probe is intended for atraumatic placement in proximity of the tympanic membrane.

The temperature probes are designed for use with Datex-Ohmeda and GE Medical Systems IT monitoring systems and other monitors compatible with 400 Series temperature probes. Please consult your monitoring system manual for information specific to the temperature probe usage.

The device is indicated for use by qualified medical personnel only

Over-The-Counter Use Prescription Use _ X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page __ of _

Chm Wrt

f Anesthesiology, General Hosp.,
Control, Dental Devices

Number. K41. 1942