(19 days)
The Philips Baby Thermometer Set is intended for determination of a baby's oral, rectal, or axillary temperature. The set contains three items: A pacifier thermometer to detect baby's oral temperature. An ordinary pacifier can be used as a daily use pacifier to help accustom the baby to the shape of the pacifier-thermometer. A digital flexible-tip thermometer to detect baby's rectal or underarm (axillary) temperature.
The Philips Baby Thermometer set allows parents to accurately and conveniently measure the baby's temperature. The baby thermometer set is designed for he baby's safety, comfort, well-being and, therefore, parents own peace of mind. The set contains three items: A soother thermometer to reliably measure baby's temperature. It is very convenient to use both for parents and baby. A digital flexible-tip thermometer that measures baby's body temperature rectally if parents want added reassurance.
The Philips Baby Thermometer Set (model SBC SC530) is the subject of this 510(k) summary. The acceptance criteria and the study proving the device meets these criteria are detailed below.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Physical Requirements (ASTM1112, "Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature") | Conforms to ASTM1112 |
| Operating Parameters (ASTM1112, "Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature") | Conforms to ASTM1112 |
| EPA Requirements for Nitro-amines | Meets EPA requirements |
| Consumer Product Safety Commission (CPSC 1511) Requirements for Baby Pacifiers (choking hazards) | Meets CPSC 1511 requirements |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "Clinical testing previously performed for the Paci-Temp and Pro-Flex also applies to the Philips Baby Thermometer Set." This indicates that no new clinical test set data was generated specifically for the Philips Baby Thermometer Set. Instead, the performance of the Philips device is asserted to be equivalent to the predicate devices based on non-clinical tests and the applicability of existing clinical data. Therefore, details regarding a specific sample size, country of origin, or retrospective/prospective nature of a new test set are not provided for this specific submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not provided in the document. As noted above, the submission relies on previous clinical testing for predicate devices and non-clinical testing for the current device.
4. Adjudication Method for the Test Set
This information is not provided in the document, as no specific clinical test set was generated for this device submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. The device is a thermometer, not an AI-assisted diagnostic tool for human readers.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical thermometer.
7. The Type of Ground Truth Used
For the non-clinical tests, the ground truth was established by adherence to recognized industry standards (ASTM1112) and regulatory requirements (EPA, CPSC 1511) which specify performance benchmarks for physical characteristics and operating parameters. For the clinical aspects, the ground truth was based on the performance demonstrated by the predicate devices based on their own prior clinical testing.
8. The Sample Size for the Training Set
This information is not provided because, as mentioned, the clinical performance relies on previously established data from predicate devices, and the submission focuses on demonstrating substantial equivalence through non-clinical testing. New clinical data for a "training set" for an algorithm is not relevant to this device submission.
9. How the Ground Truth for the Training Set was Established
This information is not provided. The term "training set" typically refers to data used to train machine learning algorithms, which is not applicable to the Philips Baby Thermometer Set. For the non-clinical tests, the ground truth was established by the specifications defined in the relevant standards and regulations (ASTM1112, EPA, CPSC 1511). For the clinical performance, the ground truth was established through the original clinical studies performed on the predicate devices.
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Philips Consumer Electronics Company
510(k) Summary
(As required by 21 CFR 807.92)
Premarket Notification Number:
-
- Submitter's Identification:
Philips Consumer Electronics One Philips Drive, Knoxville, TN 37914 Phone: (865) 521-4701 Fax: (865) 521-3402 Contact: Mr. Bob Pooler
- Submitter's Identification:
Date Summary Prepared: July 18, 2002
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- Name of the Device:
Philips Baby Thermometer Set (SBC SC530)
- Name of the Device:
3. Predicate Device Information:
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- The Paci-Temp Pacifier Thermometer, K952073, Intelligent Products L.C., Orem, Utah (presently owned by Acute Ideas Co., Ltd.)
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- The Pro-Flex Digital Thermometer with Flexible Probe, K961357, Intelligent Products L.C., Orem, Utah (presently owned by Acute Ideas Co., Ltd.)
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- Device Description:
The Philips Baby Thermometer set allows parents to accurately and conveniently measure the baby's temperature. The baby thermometer set is designed for he baby's safety, comfort, well-being and, therefore, parents own peace of mind.
The set contains three items:
- A soother thermometer to reliably measure baby's temperature. It is very convenient to ー use both for parents and baby.
Philips Consumer Electronics Company A Division of North American Philips Corporation Product Safety and Compliance One Philips Drive, P.O. Box 14810 Knoxville, TN 37914-1810
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K0 22542
page 2 of 2
- A digital flexible-tip thermometer that measures baby's body temperature rectally if parents want added reassurance.
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- Intended Use:
The Philips Baby Thermometer Set is intended for determination of baby's temperature. The set contains three items:
- A pacifier thermometer to detect baby's oral temperature. -
- An ordinary pacifier can be used as a daily used regular pacifier -
- A digital flexible-tip thermometer to detect baby's rectal or underarm (axillary) temperature.
-
- Comparison to Predicate Devices:
The Philips Baby Thermometer Set contains a pacifier thermometer and a digital flexible-tip thermometer which are substantially equivalent to the Pacifier thermometer and Pro-Flex Digital Thermometer with Flexible Probe.
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- Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
The Philips Baby Thermometer Set conforms to physical requirements and operating parameters outlined in ASTM1112, "Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature". It also meets EPA requirements for nitro-amines and Consumer Product Safety Commission (CPSC 1511) requirements for Baby Pacifiers (choking hazards).
- Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
-
- Discussion of Clinical Tests Performed:
Clinical testing previously performed for the Paci-Temp and Pro-Flex also applies to the Philips Baby Thermometer Set.
- Discussion of Clinical Tests Performed:
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- Conclusions:
The Philips Baby Thermometer Set is substantially equivalent in intended use, design, material and technology to the Paci-Temp and Pro-Flex, which contains both of these items in one set. Thus, when compared to the predicate devices, the Philips Baby Thermometer Set does not incorporate any significant changes in intended use, method of operation, material, or design that could affect safety or effectiveness.
- Conclusions:
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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines above them.
Public Health Service
AUG 2 0 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Robert Pooler Manager, Product Safety & Compliance Division Phillips Consumer Electronics One Phillips Drive Knoxville, Tennessee 37914
Re: K022542
Trade/Device Name: Philips Baby Thermometer Set (SBC SC530) Regulation Number: 880.2910 Regulation Name: Regulatory Class: II Product Code: FLL Dated: July 18, 2002 Received: August 1, 2002
Dear Mr. Pooler:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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.
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Page 2 - Mr. Pooler
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 (OS) 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division 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/dsma/dsmamain.html
Sincerely yours.
Susan Runner
Timothy A. Ulatowski 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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510(k) Number (if known): . . . . . . . . . . . .
______________________________________________________________________________________________________________________________________________________________________________ Philips Baby Thermometer Set (SBC SC530) Device Name :
Indications For Use :
The Philips Baby Thermometer Set is intended for determination of a baby's oral, rectal, or axillary temperature.
The set contains three items:
- A pacifier thermometer to detect baby's oral temperature. .
- An ordinary pacifier can be used as a daily use pacifier to help accustom the baby to . the shape of the pacifier-thermometer.
- A digital flexible-tip thermometer to detect baby's rectal or underarm (axillary) . temperature.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ( Per 21 CFR 801.109 OR
Over-The-Counter Use ﻣﺴﺴﺴﻪ
Patricio Cucumite
510(k) Number: K022542
(Optional Format 1-2-96)
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§ 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.