PHILIPS AVENT DIGITAL THERMOMETER SET, MODEL SCH540 by PHILIPS ELECTRONICS UK LIMITED

A pacifier thermometer to detect baby's oral temperature.
. An ordinary pacifier that can be used as a daily used regular pacifier.
A digital flexible-tip thermometer that measures the oral, rectal, and axillary body temperature of humans.

Device Description

The Philips AVENT Digital Thermometer Set contains three items:

A pacifier thermometer to detect baby's oral temperature.
. An ordinary pacifier that can be used as a daily used regular pacifier.
A digital flexible-tip thermometer that measures the oral, rectal, and axillary body temperature of humans.

AI/ML Overview

The provided text is related to a 510(k) premarket notification for a medical device: Philips Avent Digital Thermometer Set, Model SCH540. It is a clearance letter from the FDA, and as such, it does not contain the detailed study information or acceptance criteria specifications that would typically be found in a clinical study report or a more comprehensive regulatory submission.

The document primarily focuses on the FDA's determination of substantial equivalence to predicate devices and outlines general regulatory compliance requirements.

Therefore, I cannot fulfill all parts of your request based on the provided text. Specifically, the following information is not available in the given document:

A table of acceptance criteria and the reported device performance: This document does not specify any performance metrics or acceptance criteria used in testing.
Sample sized used for the test set and the data provenance: Not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
Adjudication method for the test set: Not mentioned.
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 device is a thermometer, not an AI-assisted diagnostic tool. Therefore, an MRMC study is not relevant, and no information about it is provided.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not relevant for a thermometer.
The type of ground truth used: For a thermometer, "ground truth" would typically refer to a reference temperature measurement method, but the details are not provided.
The sample size for the training set: Not mentioned.
How the ground truth for the training set was established: Not mentioned.

Based on the available text, here's what can be inferred or stated:

The document confirms that the Philips Avent Digital Thermometer Set, Model SCH540, has received 510(k) clearance from the FDA. This indicates that the manufacturer submitted data demonstrating that their device is substantially equivalent to legally marketed predicate devices. The "substantial equivalence" determination implies that the device performs as safely and effectively as a predicate device.

The intended uses of the device are explicitly stated in the "Indications for Use" section:

Indications for Use: The Philips AVENT Digital Thermometer Set is intended for determination of temperature. The set contains three items:
- A pacifier thermometer to detect baby's oral temperature.
- An ordinary pacifier that can be used as a daily used regular pacifier.
- A digital flexible-tip thermometer that measures the oral, rectal, and axillary body temperature of humans.

Without the full 510(k) submission (which includes performance data, test protocols, and acceptance criteria), it is impossible to provide the specific details requested in your prompt regarding the study and acceptance criteria.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Miriam Sharif-Murray Regulatory Affairs Manager Philips Electronics UK Limited Lower Road Glemsford, Suffolk United Kingdom CO10 7QS

JUN 2 2 2010

Re: K100495

Trade/Device Name: Philips Avent Digital Thermometer Set, Model SCH540 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: June 8, 2010 Received: June 8, 2010

Dear Ms. Sharif-Murray:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Susan Punner

Anthony D. Watson, B.S., M.S., M.B.A. 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: Philips AVENT Digital Thermometer Set (SCH540)

Indications For Use:

The Philips AVENT Digital Thermometer Set is intended for determination of temperature. The set contains three items:

A pacifier thermometer to detect baby's oral temperature.
. An ordinary pacifier that can be used as a daily used regular pacifier.
A digital flexible-tip thermometer that measures the oral, rectal, and axillary body temperature of humans.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use X (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Wagn

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number: Page 1 of 1

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.