(371 days)
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 contamination between patient and equipment. The HMEF SK203 is for use in hospital, ICU, anesthesia, respiratory therapy, during transport and for associated uses. The device can be used on adult patients. The device is indicated for use by qualified medical personnel only.
Not Found
I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA, which confirms that the Kung Shin HMEF SK203 device is substantially equivalent to a legally marketed predicate device.
Specifically, the text does not include:
- A table of acceptance criteria and reported device performance.
- Details about sample size for test sets or their data provenance.
- Information on the number or qualifications of experts used for ground truth.
- Adjudication methods.
- Information about multi-reader multi-case (MRMC) comparative effectiveness studies.
- Details about standalone algorithm performance studies.
- The type of ground truth used.
- The sample size for the training set or how its ground truth was established.
The document primarily focuses on the FDA's regulatory decision regarding substantial equivalence based on the provided 510(k) application, rather than detailed study results or performance metrics.
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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 (301) 594-4646. 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 (800) 638-2041 or (301) 443-6597 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 of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number:`[K032878](https://510k.innolitics.com/device/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)
§ 868.5260 Breathing circuit bacterial filter.
(a)
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.(b)
Classification. Class II (performance standards).