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 Description

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."

AI/ML Overview

This is an interesting case where the provided document is a 510(k) summary for a medical device that isn't AI-powered. Therefore, much of the requested information about AI model performance, ground truth, and expert evaluation is not applicable.

However, I can extract the relevant information regarding the acceptance criteria and the study proving the non-AI device meets those criteria from the provided text.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance data in the traditional sense of a clinical study or AI performance metrics. Instead, it refers to compliance with established international and national standards for medical devices, particularly regarding safety and performance.

Acceptance Criteria (Standard)	Reported Device Performance (Compliance Claim)
EN 60601-1:1990 +A1:1993 +A2:1995 +A13:1996 Part 1: General requirements for safety	Assessed against, thoroughly tested through validation and verification of specifications.
IEC 60601-2-49:2001 (Part 2:-49: Particular requirements for the safety of multifunction patient monitoring equipment)	Assessed against, thoroughly tested through validation and verification of specifications.
21 CFR Part 898 (FDA Radiation Control Regulations for electronic products)	Assessed against, thoroughly tested through validation and verification of specifications.
EN 1041:1998 Information supplied by the manufacturer with medical devices	Assessed against, thoroughly tested through validation and verification of specifications.
EN 980:2003 Graphical symbols for use in the labeling of medical devices	Assessed against, thoroughly tested through validation and verification of specifications.
ISO 10993-5:1995, ISO 10993-10:1996 Biological evaluation of medical devices	Assessed against, thoroughly tested through validation and verification of specifications.
ISO 14971:2000 Medical devices Application of risk management to medical devices	Assessed against, thoroughly tested through validation and verification of specifications.
EN12470-4:2000 Performance of electrical thermometers for continuous measurement	Assessed against, thoroughly tested through validation and verification of specifications.
Accuracy in 32 to 42° C range (Claim of similarity to predicate device)	The proposed reusable temperature probes have "accuracy in 32 to 42° C range" similar to the predicate device, implying this range is met.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is referred to as "validation and verification of specifications" against the listed standards. This is not a clinical study with human subjects, but rather a series of engineering and quality assurance tests. The document states: "The reusable temperature probes... have been assessed against the standards below. The device has been thoroughly tested through validation and verification of specifications."

2. Sample Size Used for the Test Set and Data Provenance

This is not applicable as the device is a physical temperature probe and not an AI algorithm processing data. The "test set" refers to the specific probes manufactured and subjected to testing to ensure compliance with the standards. There is no mention of a fixed "sample size" for a data test set in the context of AI.

The data provenance, again, is not applicable in the AI sense. The "data" here would be the measurements and test results from the physical probes themselves during their validation and verification.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This is not applicable. Ground truth, in the context of AI, refers to annotated data. For a physical device like a temperature probe, the "ground truth" for accuracy is typically established by comparing the probe's readings to highly accurate reference thermometers traceable to national standards, carried out by laboratory technicians or engineers, not medical experts establishing a diagnosis.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods (like 2+1 or 3+1 for resolving disagreements among human annotators) are relevant for establishing ground truth in AI training or evaluation data. For physical device testing, the methods involve standardized test procedures and measurement comparison.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

This is not applicable as the device is a physical temperature probe, not an AI algorithm assisting human readers. Therefore, no MRMC study looking at human reader improvement with AI assistance would have been conducted or is relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable for the same reason as above. This is a physical device, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the performance of these temperature probes (specifically accuracy) would be established by comparison to reference standards (e.g., highly accurate, calibrated thermometers in a controlled environment), not expert consensus, pathology, or outcomes data. The document explicitly mentions "accuracy in 32 to 42° C range" among its similarities to the predicate device, suggesting this was a key performance metric evaluated against an objective standard.

8. The Sample Size for the Training Set

This is not applicable as this is a physical medical device, not an AI model requiring a training set.

9. How the Ground Truth for the Training Set Was Established

This is not applicable as this is a physical medical device, not an AI model.

Summary

{0}------------------------------------------------

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: 781-449-8685 Fax: 781-433-1344

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)

{1}------------------------------------------------

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)

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

Intended use/Indication for use:

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).

{2}------------------------------------------------

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.

{3}------------------------------------------------

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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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:

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

Page __ of .

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

: 10(k) Number:_______________________________________________________________________________________________________________________________________________________________

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.