GOOD MEDY, DISPOSABLE THERMOMETER SHEATHS

K061007 · Good Medy Enterprise , Ltd. · FLL · Jun 14, 2006 · General Hospital

Device Facts

• Record ID: K061007
• Device Name: GOOD MEDY, DISPOSABLE THERMOMETER SHEATHS
• Applicant: Good Medy Enterprise , Ltd.
• Product Code: FLL · General Hospital
• Decision Date: Jun 14, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2

Intended Use

The devices are intended for use as a barrier that is used as an accessory to oral or rectal for digital thermometers. These sheaths are non-sterile and intended for single patient use only.

Device Story

Disposable plastic thermometer sheaths function as protective barriers for oral or rectal digital thermometers; prevent cross-contamination between patients; non-sterile; latex-free; single-use; used in clinical or home settings; applied by healthcare providers or patients; simple mechanical barrier; no electronic or active components.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993-5 and ISO 10993-10.

Technological Characteristics

Plastic disposable sheath; non-sterile; latex-free; dimensions similar to predicate; biocompatibility tested per ISO 10993-5 and ISO 10993-10.

Indications for Use

Indicated for use as a barrier accessory for oral or rectal digital thermometers in patients requiring temperature measurement. Intended for single-patient use.

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

• Sanitherm Oral Disposable Thermometer Sheaths (K983406)

Submission Summary (Full Text)

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K061007 Page 1 of 2

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COOD MEL NO. 72 ALLEY 33. LANE 514 INGIL ANG CITY. TAIPELTAIWAN 2

JUN 1 4 2006

Tel: [phone] Fax: [phone] E-mail: ez0888 a ms 56.hiner.net ht p: ' www.probecover.com, w

#### 46 510(k) SUMMARY "

Submitter's Name: GOOD MEDY ENTERPRISE LTD. I FL,NO.72,ALLEY33,LANE514,JONGIENG RD,SHINGJUANG CITY, TAIPEI, TAIWAN, 24255, R.O.C.

## Date summary prepared:

April 2, 2006

### Device Name:

- . Classification name: Thermometer, Electronic, Clinical
- . Classification number: FLL, Class II
- Regulation Number: 880.2910
- Proprietary name: GOOD MEDY, Disposable Thermometer Sheaths
- Common name of device: Disposable Thermometer Sheaths
- Sanitherm Oral Disposable Thermometer Sheaths, K983406 Predicate Device:

#### Indications for Use:

The devices are intended for use as a barrier that is used as an accessory to oral or rectal for These sheaths are non-sterile and intended for single patient use only. digital thermometers.

#### Description of the device:

The disposable thermometer sheaths are plastic coverings used for either oral or rectal for digital thermometer. The products and its packaging are non-sterile and latex-free.

#### Material Testing:

1.Material test report by SGS.

2.1SO10993-5 and ISO10993-10 for biocompatibility test by Biomaterials Laboratory of National Chung Hsing University in Taiwan.

## Legally marketed device for substantial equivalence comparison:

Sanitherm Oral Disposable Thermometer Sheaths, K983406.

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GOOD MEDY EN IFL. No. 72 ALLEY 33. LANE 214. JONGIE SHINGJU ANG CITY. TAIPEI.TAIWAN 242. R Fax: [phone] Tel: [phone] E-mail: ez0888 a mis 56.hinet.net http://www.probecover.com,tw

7

## Summary for substantial equivalence comparison:

The new devices, GOOD MEDY Disposable Thermometer Sheaths, are substantially equivalent to the predicate devices: Sanitherm Oral Disposable Thermometer Sheaths, K983406. The intended use of the two devices is the same, and the overall dimensions are similar. The two devices also had passed the biocompatibility test by ISO10993, same non-sterile and latex-free.

Thus the new devices are substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its body and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 4 2006

Dr. Jen Ke-Min Official Corrsepondent Good Medy Enterprise, Limited 1 F1. No. 72, Alley 33, Lane 514, Jongieng Road Shingjuang City, Taipei, CHINA (Taiwan) 24255

Re: K061007

Trade/Device Name: Good Medy, Disposable Thermometer Sheaths Regulation Number: 21 CFR 880.2910 Regulation Name: Thermometer, Electronic, Clinical Regulatory Class: II Product Code: FLL Dated: April 2, 2006 Received: April 11, 2006

Dear Dr. Ke-Min:

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.

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#### Page 2 – Dr. Ke-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 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), 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/industry/support/index.html.

Sincerely yours,

Cluis

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

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K061007

Image /page/4/Picture/1 description: The image shows a logo with the letters 'EZ' inside of a circle. The letters are stylized and connected, with the 'E' on the left and the 'Z' on the right. The logo is black and white, with the letters and circle being black and the background being white. The logo appears to be a simple and recognizable design.

GOOD MEDY ENTERPRIS IFL. NO. 72-ALLEY 33. LANE 514. JONGIE SHINGH ANG CITY. TAIPELTAIWAN 242, R.O.

Tel: [phone] Fax: [phone] E-mail: ez0888 a mis 56.hinet.net http://www.probecover.com.tw

# Indications for Use

510 (K) Number ( If Known ):

Device Name: GOOD MEDY, Disposable Thermometer Sheaths

Indications for Use:

The devices are intended for use as a barrier that is used as an accessory to oral or rectal for digital thermometers. These sheaths are non-sterile and are intended for single patient use only.

Prescription Use

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Cins 20m

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Sumber:_______________________________________________________________________________________________________________________________________________________________________ K461400