REUSABLE TEMPERATURE PROBES (M1024254 SKIN TEMPERATURE PROBE, REUSABLE; M1024247, GP TEMPERATURE PROBE, ADULT, RESUABLE

K050837 · GE Healthcare · FLL · Apr 27, 2005 · General Hospital

Device Facts

• Record ID: K050837
• Device Name: REUSABLE TEMPERATURE PROBES (M1024254 SKIN TEMPERATURE PROBE, REUSABLE; M1024247, GP TEMPERATURE PROBE, ADULT, RESUABLE
• Applicant: GE Healthcare
• Product Code: FLL · General Hospital
• Decision Date: Apr 27, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The reusable temperature probes are intended to be used for monitoring temperature. 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. These devices are indicated for use by qualified medical personnel only ..

Device Story

Reusable temperature probes (skin, adult GP, pediatric GP) measure patient temperature via thermistor technology. Probes connect to compatible patient monitors (e.g., GE Dash, Solar, TRAM, Datex-Ohmeda series) via phono plug or interconnect cable. Device provides continuous temperature data to monitor; healthcare providers use output for clinical assessment. Used in clinical settings by qualified medical personnel. Benefits include accurate, continuous temperature tracking for patient management.

Clinical Evidence

Bench testing only. Device validated against standards including EN 60601-1, IEC 60601-2-49, ISO 10993-5/10 (biocompatibility), and EN 12470-4 (performance of electrical thermometers). No clinical data presented.

Technological Characteristics

Reusable thermistor-based temperature probes. Components: phono plug connector, thermistor, cable. Compatible with 400-series monitoring systems. Biocompatible materials per ISO 10993-5/10. Non-sterile. Standards: EN 60601-1, IEC 60601-2-49, EN 12470-4.

Indications for Use

Indicated for temperature monitoring in patients using compatible 400-series monitoring systems. For use by qualified medical personnel only.

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

• YSI temperature probes (K962070)

Reference Devices

• Dash 3000/4000 (K033304)
• Solar (K012467)
• TRAM (K900540)
• M-PRESTN (K041772)
• Cardiocap 5 (K992323)
• Light (K981378)
• M-ESTPR (K953175)

Submission Summary (Full Text)

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R 2 7 2005

K050837

## Premarket Notification 510(k) Summary As required by section 807.92 Reusable Temperature Probes (M1024254 Skin Temperature probe, reusable; M1024247, GP Temperature Probe, Adult, reusable; M1024251 GP Temperature Probe, Pediatric, reusable)

## 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:

March 28, 2005

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

#### TRADE NAME:

Reusable Temperature Probes M1024254, Skin Temperature Probe, reusable M1024247, GP Temperature Probe, Adult, reusable M1024251, GP Temperature Probe, Pediatric, reusable

#### 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)

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The Reusable Temperature Probes (M1024254 Skin Temperature probe, reusable; M1024247, GP Temperature Probe, Adult, reusable; M1024251 GP Temperature Probe, Pediatric, reusable) are substantially equivalent in safety and effectiveness to the predicate YSI temperature probes (K962070).

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

Reusable temperature probes (M1024254 Skin Temperature probe, reusable; M1024247, GP Temperature Probe, Adult, reusable; M1024251 GP Temperature Probe, Pediatric, reusable) are used during patient temperature measurement. These probes consist of a phone plug connector on the monitor end and a thermistor on the patient end. These probes are to be used with 400-series compatible temperature measurement systems only.

Temperature probes measure temperature by a resistor that is sensitive to temperature changes. The probe is connected to the patient monitor either directly by using a phono plug or by an interconnect cable. These probes have a skin or core contact with a patient.

These temperature probes are typically used with legacy GE Medical System monitors like Dash 3000/4000 (K033304), Solar (K012467), TRAM (K900540) and also with the new GE Healthcare S/5 modules like M-PRESTN (K041772) and also legacy Datex-Ohmeda patient monitors and modules like Cardiocap 5 (K992323), Light (K981378) or M-ESTPR (K953175).

Products are packed individually into a plastic bag in non-sterile condition. Package label describes product REF codes, manufacturing date, 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." ..

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

#### Intended use/Indication for use:

The reusable temperature probes are intended to be used for monitoring temperature. 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. These devices are 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 reusable temperature probes (REF M1024254, M1024251) and M1024251) are substantially equivalent in safety and effectiveness to the predicate YSI temperature probes (K962070). The reusable temperature probes have the following similarities to the predicate device: - Surface materials, thermistor, cable and cable surface, plug interface, accuracy in 32 to 42° C range.

The proposed reusable temperature probes have the following differences compared to the predicate device:

- Labeling, plug angle, strain relief fibers inside probe

In summary, reusable temperature probes, described in this submission are substantially equivalent to the predicate YSI temperature probes (K962070).

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

The reusable temperature probes (REF M1024254, M1024247 and M1024251) have been assessed against the standards below. The device has been thoroughly tested through validation and verification of specifications.

- EN 60601-1:1990 +A1:1993 +A2:1995 +A13:1996Part 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 .
- . EN 1041:1998 Information supplied by the manufacturer with medical devices
- EN 980:2003 Graphical symbols for use in the labeling of medical devices .
- ISO 10993-5:1995, ISO 10993-10:1996Biological evaluation of medical devices .
- ISO 14971:2000 Medical devices Application of risk management to medical devices .
- EN12470-4:2000 Performance of electrical thermometers for continuous measurement .

#### CONCLUSION:

The summary above shows that there are no new questions of safety and effectiveness for the reusable temperature probes (REF M1024254, M1024247 and M1024251) as compared to the predicate device.

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APR 2 7 2005

Food 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

Re: K050837

Trade/Device Name: Reusable Temperature Probes (M1024254 Skin Temperature Frade, Device Namer 100247, GP Temperature Probe, Adult, Reusable; M1024251 GP Temperature Probe, Pediatric, Reusable) Regulation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: March 31, 2005 Received: April 6, 2005

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 mendments, 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 the Federal 1 000; Drag, aAa You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions of 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 If your device is classified (see as additional controls. Existing major regulations affecting (I MA), it may of subject to taxes and of Federal Regulations, Title 21, Parts 800 to 898. In your device ear be found in the lee 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 I reast be auvrsou that i Dr. I to mornitiation that your device complies with other requirements mean that I DA may Federal statutes and regulations administered by other Federal agencies. or the For of ally I outstal ethe Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and fishing (21 01 read in the quality systems (QS) regulation (21 CFR Part 820); and if requirence as better in 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) This letter will anon your cognification 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), 11 you desire specific as a 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 may overn 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,

Quitte Michael Dms.

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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# Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Reusable Temperature Probes (M1024254 Skin Temperature probe, reusable; M1024247, GP Temperature Probe, Adult, reusable; M1024251 GP Temperature Probe, Pediatric, reusable)

Indications for Use:

The reusable temperature probes are intended to be used for monitoring temperature. 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.

These devices are indicated for use by qualified medical personnel only.

Over-The-Counter Use _ Prescription Use _ × AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (Please do not write below this line-continue on another page of needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Aithun V, me

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ann of Anesthesiology, General Hospital. Infoction Control, Dontal Devices

: 10(k) Number:_______________________________________________________________________________________________________________________________________________________________