The Foley Catheter with Temperature Probe is intended for continuous temperature monitoring of patients who are catheterized because of fluid management problems, evaluation of urinary output, urine clearance following surgery or trauma involving pelvic organs, or obstruction or paralysis. Maximum indwelling: 29 days.

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 temperature probes usage. The device is indicated for use by qualified medical personnel only.

Device Description

Disposable Foley catheters with temperature probe are used for drainage of the urinary bladder and simultaneous patient temperature measurement. These Foley catheters with temperature probe consist of the "Molex" plug connector on the adapter cable end, urine output flow path with a balloon and a thermistor inside the catheter. These probes are to be used with 400-series compatible temperature measurement systems only. 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 catheters have a skin and core contact with a patient. Catheters are shipped in sterile condition and there is a shelf life declared for each manufacturing batch. These Foley catheters with temperature probe 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 products (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." There is one instruction for use insert in the sales package of 25 probes.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for Foley catheters with temperature probes. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria based on performance metrics like sensitivity, specificity, or accuracy for a diagnostic AI device.

Therefore, many of the requested sections (Table of acceptance criteria, Sample size for test set, number of experts, adjudication method, MRMC comparative effectiveness study, standalone performance, ground truth type, training set sample size, how training ground truth was established) are not applicable or not provided in this type of submission.

This submission is for a physical medical device (catheter with a temperature sensor), not an AI/ML-driven diagnostic or prognostic device that would typically involve the detailed performance studies you're asking about. The "study" mentioned here refers to verification and validation activities against recognized standards to ensure the device performs as intended and is safe.

Here's what can be extracted and inferred from the document based on the context of a 510(k) submission for this type of device:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a table of specific performance acceptance criteria (like diagnostic accuracy, sensitivity, specificity) with reported device performance for an AI/ML system. Instead, for this device, "acceptance criteria" are related to compliance with recognized standards and demonstrating substantial equivalence.

Acceptance Criteria Category	Specific Standard/Requirement	Reported Device Performance/Conclusion
General Safety	IEC 60601-1:1988 + Amdt. 1:1991 + Amdt. 2:1995 (General requirements for safety)	"The devices have been thoroughly tested through validation and verification of specifications." "No new questions of safety."
Patient Monitoring Safety	IEC 60601-2-49:2001 (Particular requirements for the safety of multifunction patient monitoring equipment)	"The devices have been thoroughly tested through validation and verification of specifications." "No new questions of safety."
Material Biocompatibility	ISO 10993-x Biological evaluation of medical devices	Implied compliance through "thorough validation and verification." "No new questions of safety."
Risk Management	ISO 14971:2000 Medical devices Application of risk management to medical devices	Implied compliance through "thorough validation and verification." "No new questions of safety."
Sterility	510(k) Sterility Review Guidance K90-1	Devices are "shipped in sterile condition" and implied compliance through "thorough validation and verification."
Labeling	ISO 15223:2000, EN 980+A1+A2 (Symbols, Graphical symbols), 21 CFR Part 801 (Labeling)	Compliance with labeling standards is mentioned (e.g., "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.'"). Minor differences in "Labeling, artwork and a different wording of the instruction for use insert" compared to predicate are noted but determined not to affect substantial equivalence.
Accuracy (Temperature)	Implied by "400-series compatible temperature measurement systems" and comparison to predicate device.	The document states the thermistor is identical to the predicate device, implying similar performance. No specific temperature accuracy values are provided in this summary, but these would typically be tested against an internal specification during V&V.
Substantial Equivalence	Comparison to predicate device (DeRoyal disposable Foley catheters with temperature sensor (K041416))	"Substantially equivalent in safety and effectiveness" to the predicate device. Identical features: "Thermistor, materials, cable surface, catheter and catheter material, plug interface and product dimensions."

2. Sample size used for the test set and the data provenance

This document does not describe a "test set" in the context of an AI/ML model for diagnostic performance. The "testing" refers to verification and validation activities conducted on the physical device to ensure compliance with standards and specifications. Therefore, sample sizes and data provenance (country, retrospective/prospective) are not applicable in the AI/ML sense but would refer to engineering test samples and bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This pertains to an AI/ML diagnostic device, not a physical temperature-sensing Foley catheter. The "ground truth" here would be established by reference temperature measurement standards and calibrated equipment during engineering verification.

4. Adjudication method for the test set

Not applicable. As above, this is for AI/ML diagnostic performance testing.

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

Not applicable. This device is a physical catheter with a temperature sensor, not an AI/ML system that directly assists human readers/diagnosticians.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is a physical catheter, not an algorithm. Its "standalone" performance would be measured as part of its physical and electrical testing (e.g., temperature accuracy, material integrity).

7. The type of ground truth used

For the temperature sensing function, the "ground truth" for proving accuracy would be established using calibrated reference thermometers and temperature control baths. For the catheter's physical properties, the ground truth would be established through material specifications, mechanical testing standards, and biological compatibility testing protocols.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/ML device.

Summary

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K061918

Page 1 of 3

AUG 1 8 2006

Premarket Notification 510(k) Summary As required by section 807.92 Foley catheters with temperature probe (Foley Catheter with Temperature sensor, 14 F (M1024239), Foley Catheter with Temperature sensor, 16 F (M1024242), Foley Catheter with Temperature sensor, 18 F (M1024244))

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:

June 30, 2006

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

TRADE NAME:

Foley catheters with temperature probe:

Foley Catheter with Temperature sensor, 14 F (M1024239) Foley Catheter with Temperature sensor, 16 F (M1024242) Foley Catheter with Temperature sensor, 18 F (M1024244))

COMMON NAME:

Urinary catheter, with Temperature Probe

CLASSIFICATION NAME:

The following Class II classifications appear applicable:

FLL	Clinical electronic thermometer	21 CFR 880.2910
EYC	Catheter, Upper urinary Tract	21 CFR 876.5130
EZL	Catheter, Retention Type, Balloon	21 CFR 876.5130

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

The disposable Foley catheters with temperature probe (REF M1024239, M1024242 and M1024244) are substantially equivalent in safety and effectiveness to the predicate DeRoyal disposable Foley catheters with temperature sensor (K041416).

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

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

Intended use/Indication for use: Foley catheters with temperature probe (REF M1024239, M1024242 and M1024244):

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

The disposable Foley catheters with temperature probe have the following identical features to the predicate device:

Thermistor, materials, cable surface, catheter and catheter material, plug interface and product dimensions

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The proposed disposable Foley catheters with temperature sensor have the following differences compared to the predicate device:

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

In summary, disposable Foley catheters with temperature probe, described in this submission are substantially equivalent to the predicate DeRoyal Foley catheters with temperature sensor (K041416).

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

The Foley catheters with temperature probe (REF M1024239, M1024242 and M1024244) 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 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 Foley catheters with temperature probe (REF M1024239, M1024242 and M1024244) as compared to the predicate device.

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Image /page/3/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized symbol resembling an abstract human figure with outstretched arms. The symbol is enclosed within a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

AUG 1 8 2006

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

Re: K061918

Trade/Device Name: Foley Catheter with Temperature sensor, 14 F (M1024239) Foley Catheter with Temperature sensor, 16 F (M1024242) Foley Catheter with Temperature sensor, 18 F (M1024244) Regulation Number: 21 CFR $876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EYC Dated: July 5, 2006 Received: July 6, 2006

Dear Mr. Kent:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rotened your booken on the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce ass stated in all of the enactment date of the Medical Device Amendments, or to devices that provision 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 (Premarket it your do revis encerities (see such additional controls. Existing major regulations affecting your r tpp. o arr, to any of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/3/Picture/10 description: The image shows a circular logo with the text "1906-2006" at the top and "Centennial" at the bottom. In the center of the logo, the letters "FDA" are prominently displayed. The logo is surrounded by a circular border with additional text, and there are three stars located below the word "Centennial".

Promoting Public H

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Page 2 –

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 one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

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 (800) 638-2041 or (240) 276-3150

or at its Internet address http://www.fda.gov/cdrlv/industry/support/index.html.

Sincerely yours,

Nancy C. Hodgdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological 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: - Foley catheters with temperature probe (Foley Catheter with Temperature sensor, 14 F (M1024239), Foley Catheter with Temperature sensor, 16 F (M1024242), Foley Catheter with Temperature sensor, 18 F (M1024244))

Indications for Use:

Foley catheters with temperature probe (REF M1024239, M1024242 and M1024244):

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)

Page __ of __

Daniel R. Leger
(Division Sign-Off)

ivision of Reproductive, Abdomi and Radiological Dev 510(k) Number

Regulation Number and Section

§ 876.5130 Urological catheter and accessories.

(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.