(62 days)
For Transporting and Isolating a TB patient or a suspected TB patient
Not Found
The provided text is a 510(k) summary for a medical device (Failsafe Isolation Systems Transport Model 07 and Portable Isolation Model 77). It is a letter from the FDA confirming substantial equivalence to a predicate device. This type of document does not contain details about specific acceptance criteria, study designs, sample sizes, or ground truth establishment for the device itself.
It focuses on regulatory approval based on equivalence to existing devices, not performance criteria from a clinical trial or algorithm validation study. Therefore, I cannot extract the requested information from the provided text.
To answer your questions, I would need a different type of document, such as a clinical study report, a device validation report, or a detailed technical submission describing the performance evaluation.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
UG 2 9 2002
Mr. Ted Arts President Isolation Systems, Incorporated 79 Fillmore Avenue Tonawanda, New York 14150-2335
Re: K022260
Trade/Device Name: Failsafe Isolation Systems Transport Model 07 and Portable Isolation Model 77 Regulation Number: 880.5450 Regulation Name: Patient Care Reverse Isolation Chamber Regulatory Class: II Product Code: LGM Dated: June 25, 2002 Received: June 28, 2002
Dear Mr. Arts:
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.
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.
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Page 2 - Mr. Arts
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division 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.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
Timothy A. Ulatowski
Tim 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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510(k) Number (If known):
Failsafe Isolation Systems Transport Model 07, Device Name: Portable Isolation Model 77
For Transporting and Isolating a TB patient or a suspected TB patient
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Qius. Lim
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K022260
§ 880.5450 Patient care reverse isolation chamber.
(a)
Identification. A patient care reverse isolation chamber is a device consisting of a roomlike enclosure designed to prevent the entry of harmful airborne material. This device protects a patient who is undergoing treatment for burns or is lacking a normal immunosuppressive defense due to therapy or congenital abnormality. The device includes fans and air filters which maintain an atmosphere of clean air at a pressure greater than the air pressure outside the enclosure.(b)
Classification. Class II (performance standards).