FAILSAFE - PORTABLE INFECTION CONTROL SYSTEMS

K022260 · Isolation Systems, Inc. · LGM · Aug 29, 2002 · General Hospital

Device Facts

• Record ID: K022260
• Device Name: FAILSAFE - PORTABLE INFECTION CONTROL SYSTEMS
• Applicant: Isolation Systems, Inc.
• Product Code: LGM · General Hospital
• Decision Date: Aug 29, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5450
• Device Class: Class 2

Indications for Use

For Transporting and Isolating a TB patient or a suspected TB patient

Device Story

Failsafe Isolation Systems Transport Model 07 and Portable Isolation Model 77 are designed for the containment and transport of patients with suspected or confirmed tuberculosis. The devices function as patient care reverse isolation chambers to prevent the spread of airborne pathogens. Used in clinical or transport settings, these systems provide a controlled environment for the patient, protecting healthcare providers and the surrounding environment from potential contamination. The devices are operated by healthcare personnel to facilitate safe movement or temporary isolation of infectious patients.

Clinical Evidence

No clinical data provided; substantial equivalence is based on device design and intended use for isolation.

Technological Characteristics

Patient care reverse isolation chamber; designed for airborne pathogen containment during patient transport and isolation. Specific materials and ASTM standards are not detailed in the provided documentation.

Indications for Use

Indicated for the transport and isolation of patients with confirmed or suspected tuberculosis (TB).

Regulatory Classification

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.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized symbol that resembles three human profiles facing to the right, stacked on top of each other.

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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