(290 days)
The Intersurgical Clear-Therm Micro Filter is for use at the patient connection on the patient and equipment and is designed to reduce bacterial/viral contamination between patient and equipment and to reduce the loss of patient heat and humidity. It is for use in the breathing circuit. Federal law restricts this device to sale by or on the order of a physician.
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I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for the "Clear-Therm Micro HME, Model 1441" and mostly discusses regulatory compliance and the device's indications for use. It does not include details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as typically found in a clinical study report or a more detailed technical submission.
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Image /page/0/Picture/1 description: The image is a seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the edge. In the center of the seal is a stylized image of what appears to be an eagle or other bird-like figure with three curved lines representing its body and wings. The image is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 3 2004
Mr. Michacl Zalewski RA/QA Specialist Intersurgical Incorporated 417 Electronics Parkway Liverpool, NY 13088
Re: K032322
Trade/Device Name: Clear-Therm Micro HME, Model 1441 Regulation Number: 21 CFR 868.5620 Regulation Name: Filter, Bacterial, Breathing-Circuit Regulatory Class: Class II Product Code: CAH Dated: March 31, 2004 Received: April 5, 2004
Dcar Mr. Zalewski:
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 cnactment date of the Medical Device Amendthents, 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 gencral approvisions 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 (1 WI ), It hay no cash 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.
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
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Page 2 - Mr. Michael Zalewski
and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice allo listing (21 CFR Part 067), acems (QS) regulation (21 CFR Part 820); and if requirents as set form in the quality of the entrol provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
21 CFR 1000-1030.
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to ough finding of substantial equivalence of your device to a premarket nother on. - The PDF matts 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 at 100 to pliance 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 may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Susan Runny
4
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
510(k) Number (if known): KO32322
Device Name: 1441 Clear-Therm Micro Filter with CO2 Monitoring Port Indications For Use:
The Intersurgical Clear-Therm Micro Filter is for use at the the intersurgious ont is designed to reduce bacterial/viral patient connection on the patient and equipment and to reduce the loss of patient heat and humidity. It is for use in the the 10ss of patient neat and hamestricts this device to sale by or on the order of a physician.
Prescription Use_xxxxx (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
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Page 4 of XXVII
(Division Sion-Off) 1. Simbe General Ho Infection Control. Der
510(k) Number
§ 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).