CECILIA PENGUIN MULTI-USE THERMOMETER, MODEL HP-ETO9999

K993950 · Nien Made Electrnics Corp. · FLL · Aug 23, 2000 · General Hospital

Device Facts

• Record ID: K993950
• Device Name: CECILIA PENGUIN MULTI-USE THERMOMETER, MODEL HP-ETO9999
• Applicant: Nien Made Electrnics Corp.
• Product Code: FLL · General Hospital
• Decision Date: Aug 23, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Cecilia® Thermometer is intended for intermittent measurement of body temperature in individuals of all ages in the home environment by measurement of infrared radiation emitted, solely, from the tympanic membrane.

Device Story

Cecilia® Penguin Multi-Use Thermometer is an electronic clinical thermometer for home use. Device utilizes an infrared (IR) sensor to detect radiation emitted from the tympanic membrane; an electronic signal processing detector converts this input into a temperature reading displayed on a digital LCD. Device requires disposable probe covers for hygiene. Operated by patients or caregivers to monitor body temperature; output provides clinical data for health assessment. Benefits include non-invasive, rapid temperature measurement.

Clinical Evidence

The device underwent safety and performance testing to demonstrate compliance with recognized standards. Testing included laboratory and clinical accuracy assessments to establish performance and reliability characteristics. No specific numerical clinical results (e.g., sensitivity, specificity) are provided in the summary.

Technological Characteristics

Infrared (IR) sensor-based clinical electronic thermometer. Components include IR sensor, electronic signal processing detector, and digital LCD display. Uses disposable probe covers. Operates via infrared radiation detection from the tympanic membrane. Standalone device.

Indications for Use

Indicated for intermittent measurement of body temperature in patients of all ages in the home environment via infrared radiation emitted from the tympanic membrane.

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

• Braun Thermoscan® IRT 3020/3520 (K983295)

Submission Summary (Full Text)

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K993950

## 510(k) Summary As Required By 21 C.F.R. 8807.92

- 1. The submitter of this premarket notification is: James Delaney EXPERTech Associates, Inc. 100 Main Street, Suite 120 Concord. MA 01742 Tel: [phone], Fax: [phone]
This summary was prepared on July 5, 2000

- 2. The name of this device is the Cecilia® Penguin Multi-Use Thermometer. The classification name is as follows:

| Regulation Number &<br>ProCode | Classification<br>Name |
|--------------------------------|---------------------------------|
| 880.2910, 80 FLL | Clinical electronic thermometer |

- 3. The Cecilia® Thermometer is substantially equivalent to the Braun Thermoscan® IRT 3020/3520 (K983295).
- 4. The Cecilia® Thermometer consists of an IR sensor, an electronic signal processing detector, a digital LCD display, and disposable probe covers.
- 5. The Cecilia® Thermometer has the same intended use as the legally marketed predicate device. The Cecilia® Thermometer is intended for intermittent measurement of body temperature in individuals of all ages in the home environment by measurement of infrared radiation emitted, solely, from the tympanic membrane.
- 6. The Cecilia® Thermometer and the predicate Braun Thermoscan® IRT 3020/3520 device both operate using the same IR measurement technology. The measurement technology, including the processing, transmission, and display of signals, are similar, and therefore the technological characteristics of the Cecilia® Thermometer are essentially the same as those of the legally marketed predicate device.
- 7 . The Cecilia® Thermometer was subjected to safety and performance tests for compliance against applicable recognized standards. Additional testing activities were conducted to establish the performance and reliability characteristics of the device, including testing to establish laboratory and clinical accuracy.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, stacked on top of each other, representing the department's focus on people and health.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 3 2000

Nien Made Electrnics Corporation C/O Mr. James M. Delaney Expertech Associates, Incorporated 100 Main Street Suite 120 Concord, Massachusetts 01742

Re : K993950 Cecilia Penquin Multi-Use Thermometer, Trade Name: Model HP-ET09999 Requlatory Class: II Product Code: FLL Dated: July 10, 2000 Received: July 13, 2000

Dear Mr. Delaney:

We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the qeneral 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 TI (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਉ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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## Page 2 - Mr. Delaney

This letter will allow you to begin marketing your device as Inis recter will arrow your emarket notification. The FDA described in your 510(x) promazioe of your device to a legally Illuling of subscancial equire results in a classification for your marketed predicate device robated as to proceed to the market.

If you desire specific advice for your device on our labeling II you debire bpoortary and additionally 809.10 for in regulacion (21 crk rares), please contact the Office of Villo diagnoscic acvices) / productionally, for questions on Compilance at (501) 332 issing of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general premation on your responsibilities under the Act may be Information on your respon of Small Manufacturers Assistance obeathed from the Division [phone] or [phone] or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski
Director

Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

14993950

510 (k) Number (if known)

Device Name

Nien Made Electronics Corporation Cecilia® Penguin Multi-Use Thermometer

Indications for Use

For intermittent measurement of Indications: body temperature in patients of all ages in the home environment by measurement of infrared radiation emitted, solely, from the tympanic membrane.

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

Patricia Currenite

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devic 510(k) Number .