KUNG SHIN, HMEF SK203

K032878 · Kung Shin Plastics Co., Ltd. · CAH · Sep 20, 2004 · Anesthesiology

Device Facts

• Record ID: K032878
• Device Name: KUNG SHIN, HMEF SK203
• Applicant: Kung Shin Plastics Co., Ltd.
• Product Code: CAH · Anesthesiology
• Decision Date: Sep 20, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5260
• Device Class: Class 2

Intended Use

The HMEF SK203 is a disposable single-use device indicated for adult patients who require humidification during the delivery of ventilator gases and provide filtration for reducing cross-contamination between patient and equipment. The HMEF SK203 possesses in hospital, ICU, anesthesia, respiratory therapy, during transport and for associated applications. The device can be used on adult patients. The device is indicated for use by qualified medical personnel only.

Device Story

The HMEF SK203 is a disposable, single-use heat and moisture exchanger with a bacterial filter. It is placed in the breathing circuit between the patient and the ventilator/anesthesia equipment. It functions by capturing heat and moisture from the patient's exhaled breath and returning it to the inspired gas, while simultaneously filtering the air to reduce cross-contamination. It is intended for use by qualified medical personnel in clinical settings such as hospitals, ICUs, and during patient transport. The device benefits patients by providing humidified, filtered air during mechanical ventilation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Disposable, single-use heat and moisture exchanger with integrated bacterial filter. Designed for adult breathing circuits. Class II device (21 CFR 868.5260).

Indications for Use

Indicated for adult patients requiring humidification of ventilator gases and filtration to reduce cross-contamination between patient and equipment in hospital, ICU, anesthesia, and respiratory therapy settings, including transport. For use by qualified medical personnel only.

Regulatory Classification

Identification

A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 0 2004

Kung Shin Plastics 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: K032878

Trade/Device Name: Kung Shin, HMEF SK203 Regulation Number: 868.5260 Regulation Name: Breathing Circuit Bacterial Filter Regulatory Class: II Product Code: CAH Dated: August 15, 2004 Received: August 26, 2004

Dear Dr. Min:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rottowed your and have determined the device is substantially equivalent (for the referenced above and not in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, or to devices that have been reclassified in accordance with the provisions of Amendinents, or to do roug, 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 approvisions of the Act. The general controls provisions of the Act include controls providents or 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 (1 Will), it hay of each of Federal Regulations, Title 21, Parts 800 to 898. In your device ear or roundsh further announcements concerning your device in the Federal Register.

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Page 2 - Dr. Min

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that I DA s issualled on that your device complies with other requirements mean that IDA nas made a deceminations administered by other Federal agencies. of the Act of ally I ederal statues and registments, including, but not limited to: registration You mast comply with an the Hecked required (21 CFR Part 801); good manufacturing practice and listing (21 CFR Pat 607), laceling (21 cms (QS) regulation (21 CFR Part 820); and if requirents as set form in the quality bjoches (Sections (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) This letter will anow you to begal finding of substantial equivalence of your device to a premarket nonneation. - The PDF riskes 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), If you desire specific auvres for your de 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 Inay obtain of Small Manufacturers, International and Consumer Assistance at its toll-free Driston [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Chih-Lin, Ph.D.

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

Enclosure

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## INDICATIONS FOR USE STATEMENT 4.

Applicant : __________________________________________________________________________________________________________________________________________________________________

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Device Name: KUNG SHIN, HMEF SK203

## Indications for Use :

The HMEF SK203 is a disposable single-use device indicated for adult patients who require humidification during the delivery of ventilator gases and provide filtration for require namination between patient between patient and equipment. The HMEF reducing possesses in hospital, ICU, anesthesia, respiratory therapy, during transport and ST203 to for aco an associators. The device can be used on adult patients. The device is indicated for use by qualified medical personnel only.

Sion
```(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number:`K032878`

Prescription Use √
(Part 21 CFR 801 Subpart D)

AND/OR
(21 CFR 807 Subpart C)

Over-The-Counter Use **__**

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

Concurrence of CDRH, Office of Device Evaluation (ODE)