BARCHENS COMPANY DIGITAL PACIFIER THERMOMETER

K983619 · Barchens Co. · FLL · Nov 2, 1998 · General Hospital

Device Facts

• Record ID: K983619
• Device Name: BARCHENS COMPANY DIGITAL PACIFIER THERMOMETER
• Applicant: Barchens Co.
• Product Code: FLL · General Hospital
• Decision Date: Nov 2, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The Barchens Digital Pacifier Thermometer is a non-sterile, re-usable clinical thermometer intended for the determination of oral body temperature in infants to children five years of age.

Device Story

Battery-powered digital thermometer embedded in silicone rubber nipple; body constructed of ABS plastic. Device measures oral body temperature in infants and children up to five years old. Reusable; non-sterile. Operated by caregivers/parents in home or clinical settings. Provides temperature reading via liquid crystal display (LCD). Assists in monitoring health status of pediatric patients.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Battery-powered digital thermometer; medical silicone rubber nipple; ABS plastic body; liquid crystal display (LCD); reusable; non-sterile.

Indications for Use

Indicated for determination of oral body temperature in infants and children up to five years of age.

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

• Pro-Check Pacifier Digital Thermometer (K972259)
• Pasi-Temp Pacifier Digital Thermometer (K952073)
• Basis Baby-Temp Pacifier Digital Thermometer (K962991)

Submission Summary (Full Text)

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K983619

NOV 2 1998

EXHIBIT #1

# 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is:__________

## Submitter's Identification: 1.

Barchens Company 7F-4, No. 246, Sec. 2 Chang-An East Road Taipai, Taiwan R.O.C. Contact: Mr. Frank Hsieh

Date Summary Prepared: October 13, 1998

### 2. Name of the Device:

Barchens Digital Pacifier Thermometer

## 3. Predicate Device Information:

- 1. The Pro-Check™ Pacifier Digital Thermometer K#972259.
2. The Pasi-Temp Pacifier Digital Thermometer, K#952073, Intelligent Product Ltd. Co., Orem, Utah (presently owned by Acute Ideas Co., Ltd.)

3. The Basis® Baby-Temp Pacifier Digital Thermometer, K#962991, Polymedica Industries. Inc. Golden Colorado

#### এ. Device Description:

The Barchens Digital Pacifier Thermometer, is a battery-powered, liquid crystal display device using a thermometer embedded in the nipple. The patient contact portion is composed of medical silicone rubber. The body is of ABS plastic . This device is reusable and no components are disposable. This device is not intended for use with other sheaths or devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with healthcare, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The caduceus is depicted with three lines forming a wing-like shape above a staff with a snake winding around it. The overall design is simple and monochromatic.

DEC 2 8 1898

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Barchens Company C/O Ms. Susan Goldstein-Falk Official Correspondent for Barchens Company Mdi Consultants, Incorporated 55 Northern Boulevard, Suite 200 Great Neck, New York 11021

Re : K983619 Trade Name: Barchens Company Digital Pacifier Thermometer Regulatory Class : II Product Code: FLT October 13, 1998 Dated: Received: October 15, 1998

Dear Ms. Goldstein-Falk:

This letter corrects our substantially equivalent letter of November 2, 1998, regarding the company name.

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 II (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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General (QS) regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug

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Page 2 - Ms. Goldstein-Falk

Administration (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.

This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at their toll free number [phone] or at [phone] or at its internet address

"http://www.fda.gov/cdrh/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

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Exhibit #B

of Page !

510(k) NUMBER (IF KNOWN): K9836/9 The Barchens Digital Pacifier Thermometer DEVICE NAME:

INDICATIONS FOR USE:

The Barchens Digital Pacifier Thermometer is a non-sterile, re-usable clinical thermometer intended for the determination of oral body temperature in infants to children five years of age.

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

Concurrent of CDRH, Office of Device Evaluation i (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over - The - Counter - Use سم (Optional Format 1-2-96)

Patricia Crecenik
(Division Sign-Off)

Division of Demal, Infection and General Hospital, Infection, and General Hospital Devices ះរវាព្រៃប្រ

510(k) Number K983619