PATIENT ISOLATION UNIT, MODEL G019-1000

K080117 · Gentex Corporation · LGM · Jan 30, 2009 · General Hospital

Device Facts

• Record ID: K080117
• Device Name: PATIENT ISOLATION UNIT, MODEL G019-1000
• Applicant: Gentex Corporation
• Product Code: LGM · General Hospital
• Decision Date: Jan 30, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5450
• Device Class: Class 2

Indications for Use

The Gentex Patient Isolation Unit (PIU) is a temporary, single-use, portable structure that is designed to fully contain and transport a patient and prevent particulate crosscontamination between the patient, the external environment and the caregivers. The PIU is designed to enable medical care-giving to the patient via integrated medical bulkheads interfaced with end-user supplied medical products and equipment. The PIU is intended to be used as a means to temporarily isolate a contaminated patient , outside or within patient care facilities. The PIU can also be used to transport those patients within vehicles, including aircraft, via a NATO-type or similar litter/gumey.

Device Story

Patient Isolation Unit (PIU) Model G019-1000; temporary, single-use, portable containment structure. Input: patient requiring isolation. Operation: physical barrier containment; integrated medical bulkheads allow interface with external medical equipment for patient care. Output: isolated patient environment. Used in clinical facilities, field settings, or transport vehicles (including aircraft) via NATO-type litter/gurney. Operated by healthcare providers or emergency personnel. Benefit: prevents particulate cross-contamination between patient, environment, and caregivers during transport or temporary isolation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Portable, single-use containment structure; integrated medical bulkheads for equipment interface; compatible with NATO-type litters/gurneys. Mechanical barrier design.

Indications for Use

Indicated for temporary isolation and transport of contaminated patients within or outside healthcare facilities, including transport via vehicles or aircraft, to prevent particulate cross-contamination between patient, environment, and caregivers.

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)

{0}------------------------------------------------

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract image of an eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Barry Shope Vice President - Market Development & Sales GENTEX Corporation 11525 6th Street Rancho Cucamonga, California 91730

JAN 3 0 2009

Re: K080117

Trade/Device Name: Patient Isolation Unit, Model G019-1000 Regulation Number: 21 CFR 880.5450 Regulation Name: Patient Care Reverse Isolation Chamber Regulatory Class: II Product Code: LGM Dated: January 22, 2009 Received: January 26, 2009

Dear Mr. Shope:

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 vour device in the Federal Register.

{1}------------------------------------------------

### Page 2 - Mr. Shope

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 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act 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.gov/cdrh/industry/support/index.html.

Sincerely yours,

Anthony D, Newton for

Ginette Michaud, M.D. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

#### Enclosure

{2}------------------------------------------------

# Indications for Use

#### 510(k) Number (if known): K080117

## Device Name: Patient Isolation Unit Model G019-1000

Indications For Use:

The Gentex Patient Isolation Unit (PIU) is a temporary, single-use, portable structure that is designed to fully contain and transport a patient and prevent particulate crosscontamination between the patient, the external environment and the caregivers. The PIU is designed to enable medical care-giving to the patient via integrated medical bulkheads interfaced with end-user supplied medical products and equipment. The PIU is intended to be used as a means to temporarily isolate a contaminated patient , outside or within patient care facilities. The PIU can also be used to transport those patients within vehicles, including aircraft, via a NATO-type or similar litter/gumey.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use × (21 CFR 801 Subpart)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

K. Murphy

Page 1 of 1

(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number. K080117