DISPOSABLE TEMPERATURE, SKIN AND ESOPHAGEAL PROBES

K051873 · GE Healthcare · FLL · Sep 20, 2005 · General Hospital

Device Facts

• Record ID: K051873
• Device Name: DISPOSABLE TEMPERATURE, SKIN AND ESOPHAGEAL PROBES
• Applicant: GE Healthcare
• Product Code: FLL · General Hospital
• Decision Date: Sep 20, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2

Intended Use

Intended use & Indication for use for GP probes (REF M1024231 and M1024229): The General Purpose Temperature Probe is intended for continuous temperature monitoring. The probe is inserted into the esophagus or the rectum. It is sterile and individually packaged. It has a lowfriction surface finish to make the insertion easier. The temperature probe beneath the cuff at the distal tip is designed for use with Datex-Ohmeda and GE Medical Systems IT monitoring systems and other monitors compatible with 400 Series temperature probes.The device is indicated for use by qualified medical personnel only. Intended use & Indication for use for skin probe (REF M1024222): The Skin Temperature Probe is intended for monitoring the skin surface temperature. It is sterile and individually packaged. There is a temperature sensor affixed to the center of the foam material on the adhesive cover. The disk-shaped adhesive cover has a reflective backing and a hypo-allergenic adhesive which follows closely the contour of the skin. The skin temperature probe is designed for use with Datex-Ohmeda and GE Medical Systems IT monitoring systems and other monitors compatible with 400 Scries temperature probes. The device is indicated for use by qualified medical personnel only. Intended use & Indication for use for esophageal probes (REF M1024205, M1024215 and M1024218): The Esophageal Stethoscope with Temperature Probe is to be used for monitoring temperature, heart, and respiratory sounds on an anesthetized patient. The stethoscope tube is inserted into the esophagus. The probe is sterile, individually packaged and comes in different sizes. It has a low-friction surface finish to make the insertion easier, and a thin cuff to enhance sound transmission and fidelity. The stethoscope has a male luer fitting for attachment to a standard ear picce. The temperature probe, beneath the cuff at the distal tip, is designed for use with Datex-Ohmeda and GE Medical Systems IT monitoring systems and other monitors compatible with 400 Series temperature probes. The device is indicated for use by qualified medical personnel only.

Device Story

Disposable temperature probes; include GP, skin, and esophageal stethoscope variants. Input: thermal energy detected by thermistor at distal tip. Transformation: thermistor resistance changes proportional to temperature; signal transmitted via interconnect cable to compatible 400-series monitoring systems. Output: continuous temperature data displayed on patient monitor; esophageal stethoscope also provides acoustic heart/respiratory sounds via luer fitting. Used in clinical settings by qualified medical personnel. Healthcare providers use output for patient monitoring and clinical decision-making during anesthesia or general care. Benefits: enables continuous, accurate temperature tracking and patient monitoring.

Clinical Evidence

Bench testing only. Device assessed against IEC 60601-1, IEC 60601-2-49, EN 12470-4, ISO 10993 (biocompatibility), ISO 14971 (risk management), and sterility guidance. Verification and validation of specifications performed.

Technological Characteristics

Thermistor-based temperature sensing; 400-series compatible. Materials include low-friction surface finishes, foam adhesive covers with reflective backing, and thin cuffs for stethoscopes. Connectivity via Molex plug and interconnect cable to patient monitors. Sterile, single-use. No software/algorithm.

Indications for Use

Indicated for continuous temperature monitoring (GP probes) via esophageal or rectal insertion; skin surface temperature monitoring (Skin probe); and temperature, heart, and respiratory sound monitoring in anesthetized patients (Esophageal Stethoscope). 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

• DeRoyal temperature probes (K925789)
• DeRoyal temperature probes (K925006)
• DeRoyal temperature probes (K925791)

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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SEP 2 0 2005

K051873

# Premarket Notification 510(k) Summary As required by section 807.92 Disposable Temperature Probes (M1024222, Skin Temperature Probe M1024231, GP Temperature Probe, Adult M1024229, GP Temperature Probe, Pediatric M1024205, Esophageal Stethoscope w/Probe, 9 Fr M1024212, Esophageal Stethoscope w/Probe, 12 Fr M1024215, Esophageal Stethoscope w/Probe, 18 Fr M1024218, Esophageal Stethoscope w/Probe, 24 Fr)

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

## COMPANY NAME/ADDRESS/PHONF/FAX:

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

## NAME OF CONTACT:

Mr. Joel Kent

#### DATE:

July 7, 2005

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

### TRADE NAME:

Disposable Temperature Probes M1024222, Skin Temperature Probe M1024231, GP Temperature Probe, Adult M1024229, GP Temperature Probe, Pediatric M1024205, Esophageal Stethoscope w/Probe, 9 Fr M1024212, Esophageal Stethoscope w/Probe, 12 Fr M1024215, Esophageal Stethoscope w/Probe, 18 Fr M1024218, Esophageal Stethoscope w/Probe, 24 Fr)

## COMMON NAME:

Temperature probe

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#### CLASSIFICATION NAME:

#### The following Class II classifications appear applicable:

| FLL | Clinical electronic thermometer | 21 CFR 880.2910 |
|-----|-----------------------------------------------------|-----------------|
| BZT | Stethoscope, esophageal, with electrical conductors | 21 CFR 868.1920 |

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

The disposable temperature probes (REF M1024229, M1024229, M1024205, M1024212, M1024215 and M1024218) are substantially equivalent in safety and effectiveness to the predicate DeRoyal temperature probes (K925789, K925006, K925791).

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

Disposable temperature probes (Table below) are used during patient temperature measurement. These probes consist of the "Molex" plug connector on 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. Esophageal stethoscopes with temperature probes have a dual role, in addition to temperature probe they can be used also as a stethoscope. The temperature probe measures 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. Probes are shipped in sterile condition and there is a shelf life declared for each manufacturing batch.

| REF | NAME |
|----------|---------------------------------------|
| M1024222 | Skin Temperature Probe |
| M1024231 | GP Temperature Probe, Adult |
| M1024229 | GP Temperature Probe, Pediatric |
| M1024205 | Esophageal Stethoscope w/Probe, 9 Fr |
| M1024212 | Esophageal Stethoscope w/Probe, 12 Fr |
| M1024215 | Esophageal Stethoscope w/Probe, 18 Fr |
| M1024218 | Esophageal Stethoscope w/Probe, 24 Fr |

These temperature probes can be 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 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 plastic/paper pouch) in 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.".

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

Intended use & Indication for use for GP probes (REF M1024231 and M1024229): The General Purpose Temperature Probe is intended for continuous temperature monitoring. The probe is inserted into the esophagus or the rectum. It is sterile and individually packaged. It has a lowfriction surface finish to make the insertion easier. The temperature probe beneath the cuff at the distal tip is designed for use with Datex-Ohmeda and GE Medical Systems IT monitoring systems and other monitors compatible with 400 Series temperature probes.The device is indicated for use by qualified medical personnel only.

Intended use & Indication for use for skin probe (REF M1024222): The Skin Temperature Probe is intended for monitoring the skin surface temperature. It is sterile and individually packaged. There is a temperature sensor affixed to the center of the foam material on the adhesive cover. The disk-shaped adhesive cover has a reflective backing and a hypo-allergenic adhesive which follows closely the contour of the skin. The skin temperature probe is designed for use with Datex-Ohmeda and GE Medical Systems IT monitoring systems and other monitors compatible with 400 Scries temperature probes. The device is indicated for use by qualified medical personnel only.

Intended use & Indication for use for esophageal probes (REF M1024205, M1024215 and M1024218): The Esophageal Stethoscope with Temperature Probe is to be used for monitoring temperature, heart, and respiratory sounds on an anesthetized patient. The stethoscope tube is inserted into the esophagus. The probe is sterile, individually packaged and comes in different sizes. It has a low-friction surface finish to make the insertion easier, and a thin cuff to enhance sound transmission and fidelity. The stethoscope has a male luer fitting for attachment to a standard ear picce. The temperature probe, beneath the cuff at the distal tip, is designed for use with Datex-Ohmeda and GE Medical Systems IT monitoring systems and other monitors compatible with 400 Series temperature probes. The device is indicated for use by qualified medical personnel only.

## SUMMARY OF TECHNOLOGICAL CHARACTERITICS OF DEVICE COMPARED TO THE PREDICATE DEV1CE as required by 807.92(a)(6)

The disposable temperature probes (REF M1024231, M1024222, M1024205, M1024212, M1024215 and M1024218) are substantially equivalent in safety and effectiveness to the predicate DeRoval temperature probes (K925789, K925006, K925791).

The disposable temperature probes have the following similarities to the predicate device: - Have the same indicated use and shelf life

- Mechanical design, including colours, dimensions, materials and manufacturing processes are equal

- Thermistor and functional performance are equal

- Process of stcrilization is equal

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

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

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

The disposable temperature probes (REF M1024229, M1024229, M1024222, M1024205, M1024212, M1024215 and M1024218) have been assessed against the standards below. The device has 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)
- EN 12470-4, Performance of Electrical Thermometers .
- 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 Graphical symbols for use in the labeling of medical devices .
- ISO 10993-xBiological evaluation of medical devices .
- ISO 14971:2000 Medical devices Application of risk management to medical devices .
- 510(k) Sterility Review Guidance K90-1;Guidance for Industry and FDA, August 30, 2002 .

### CONCLUSION:

The summary above shows that there are no new questions of safety and effectiveness for the disposable temperature probes (REF M1024231, M1024229, M1024205, M1024205, M1024212, M1024215 and M1024218) as compared to the predicate devices.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" arranged around the perimeter. Inside the circle is a stylized representation of a human figure, with three overlapping profiles suggesting a sense of community and support.

SEP 2 0 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: K051873

Trade/Device Name: Disposable Temperature Probes (REF M1024231 and M1024205, Skin probe (REF M1024222) and Esophageal probes (REF M1024205, M1024212, M1024215 and M1024218) Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: July 7, 2005 Received: July 11, 2005

Dear Mr. Kent:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becaren or co (e) fee device 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 encroours) is togens and ment date of the Medical Device Amendments, or to Conninered pror to May 20, 1978, the excordance with the provisions of the Federal Food, Drug, devices filat have been recease not require approval of a premarket approval application (PMA). alla Cosmetic rece (110c) that to hevice, subject to the general controls provisions of the Act. The 1 ou may, morelore, mains of the Act include requirements for annual registration, listing of general controls proficioning 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 If your device is classified (600 a00 rols. Existing major regulations affecting your device can may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Outs neements 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 I loast be advised and I Dr. mination that your device complies with other requirements of the Act that I Dri has made a actuations administered by other Federal agencies. You must or any I cachi suxures and regirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CITY art 6075; adomig (21 CFR Part 820); and if applicable, the electronic forth in the quality by some (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) I mis letter wifi and in you to boga finding of substantial equivalence of your device to a legally premaired 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 if you door office of Compliance at [phone]. Also, please note the regulation entitled, Connact the Office of Course to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on 70% Copymer Assistance at its toll-free number [phone] or Manufacturers; international address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Qre

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: Disposable Temperature Probes (GP probes (REF M1024231 and M1024229), Skin probe (REF M1024222) and Esophageal probes (REF M1024205, M1024212, M1024215 and M1024218))

Indications for Use:

GP probes (REF M1024231 and M1024229): The General Purpose Temperature Probe is intended for continuous temperature monitoring. The probe is inserted into the esophagus or the rectum. It is sterile and individually packaged. It has a low-friction surface finish to make the insertion easier. The temperature probe beneath the cuff at the distal tip is designed for use with Datex-Ohmeda and GE Medical Systems IT monitoring systems and other monitors compatible with 400 Series temperature probes.The device is indicated for use by qualified medical personnel only.

Skin probe (REF M1024222): The Skin Temperature Probe is intended for monitoring the skin surface temperature. It is sterile and individually packaged. There is a temperature sensor affixed to the center of the foam naterial on the adhesive cover. The disk-shaped adhesive cover has a reflective backing and a hypo-allergenic adhesive which follows closely the contour of the skin. The skin temperature probe is designed for use with Datex-Ohmeda and GE Medical Systems IT monitoring systems and other monitors compatible with 400 Scries temperature probes. The device is indicated for use by qualified medical personnel only.

Esophageal probes (REF M1024205, M1024212, M1024215 and M1024218): The Esophageal Stethoscope with Temperature Probe is to be used for monitoring temperature, heart, and respiratory sounds on an anesthetized patient. The stethoscope tube is inserted into the esophagus. The probe is sterile, individually packaged and connes in different sizes. It has a low-friction surface finish to make the insertion easier, and a thin cuff to enhance sound transmission and fidelity. The stethoscope has a male luer fitting for attachment to a standard ear piece. The temperature probe, beneath the cuff at the distal tip, is designed for use with Datex-Ohmeda and GE Medical Systems IT monitoring systems and other monitors compatible with 400 Series temperature probes. The device is indicated for use by qualified medical personnel only.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Cim Ven

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

510(k) Number: K953873