PACK & PROPER PACK & PROPER, EAR-THERMOMETER PROBE CAP

K042653 · Pack & Proper Co., Ltd. · FLL · Nov 26, 2004 · General Hospital

Device Facts

• Record ID: K042653
• Device Name: PACK & PROPER PACK & PROPER, EAR-THERMOMETER PROBE CAP
• Applicant: Pack & Proper Co., Ltd.
• Product Code: FLL · General Hospital
• Decision Date: Nov 26, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2

Indications for Use

The disposable PACK & PROPER Ear-Thermometer Prove Cap is used to protect probe of ear thermometer and prevent cross-infection.

Device Story

Disposable probe cover for ear thermometers; functions as physical barrier between thermometer probe and patient ear canal; prevents cross-contamination; used in clinical or home settings; operated by clinicians or patients; simple mechanical accessory; no electronic or software components.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Disposable probe cap; material composition not specified; mechanical barrier design; non-sterile or sterile (not specified); no energy source; no software; no connectivity.

Indications for Use

Indicated for use as a protective barrier for ear thermometer probes to prevent cross-infection during temperature measurement in general patient populations.

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.

Submission Summary (Full Text)

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## Public Health Service

JAN 3 0 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Pack & Proper Company Limited C/O Dr. Jen Ke-Min Official Correspondent ROC Chinese-European Industrial Research Society No. 58 Fu-Chiun Street Hsin Chu City CHINA (TAIWAN) 300

Re: K042653

Trade/Device Name: Pack & Proper, Ear-Thermometer Probe Cap Regulation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: December 2, 2004 Received: December 17, 2004

Dear Dr. Ke-Min:

This letter corrects our substantially equivalent letter of November 26, 2004, regarding the trade name for your device.

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 (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 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 Mr. Ken-Min

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 continue 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Chris Lins, Ph.D.

Chiu Lin. Ph.D. Director Division of Dental. Anesthesiology, General Hospital, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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## 4. INDICATIONS FOR USE STATEMENT

Applicant: 510(k) Number : ______________________________________________________________________________________________________________________________________________________________

Device Name : Pack & Proper Pack & Proper, Ear-Thermometer Probe Cap

Indications for Use :

The disposable PACK & PROPER Ear-Thermometer Prove Cap is used to protect probe of ear thermometer and prevent cross-infection.

(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 √

(Optional Format 1-2-96)

Anak Vina

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

594265 510(k) Number

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## 4. INDICATIONS FOR USE STATEMENT

| Applicant : | PACK & PROPER CO., LTD. |
|-----------------|-------------------------|
| 510(k) Number : | K042653 |

Device Name : Pack & Proper Pack & Proper, Ear-Thermometer Probe Cap

Indications for Use :

The disposable PACK & PROPER Ear-Thermometer Prove Cap is used to protect probe of ear thermometer and prevent cross-infection.

(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

(Optional Format 1-2-96)

Anak Vima

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

254765 510(k) Number: ـ