FLEXI-LITE

K101262 · Pressure-Tech, Inc. · CBF · Jun 10, 2010 · Anesthesiology

Device Facts

• Record ID: K101262
• Device Name: FLEXI-LITE
• Applicant: Pressure-Tech, Inc.
• Product Code: CBF · Anesthesiology
• Decision Date: Jun 10, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5470
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Flexi-Lite Hyperbaric chamber is a hyperbaric chamber intended to be used in treating mild symptoms consistent with Acute Mountain Sickness (AMS) as prescribed by or under the direction of a physician. Caution: Federal law restricts this device to sale by or on the order of a physician.

Device Story

Flexi-Lite is a portable, mild hyperbaric chamber (operating pressure 2-4 psi) designed for treating Acute Mountain Sickness (AMS). The device features a dual-bag construction: an inner pressure-retaining bag and an outer structural support bag, both made of urethane-coated nylon. It is pressurized using an external GAST model 0523/1023 oil-less air compressor. The system includes two metal relief valves (set at 4 psi), air addition and depressurization valves, internal and external pressure gauges, and an air sampling port. Used in various settings including homes, physician offices, hospitals, and subacute facilities, it is operated under the direction of a physician. The device provides a pressurized environment to alleviate AMS symptoms. It is a mechanical system without electronic or software-based control components.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Dual-bag hyperbaric chamber; inner bag 880 denier urethane-coated nylon; outer bag 2x2 basket weave urethane-coated nylon. Operating pressure 2-4 psi. Powered by external GAST 0523/1023 oil-less air compressor. Includes brass/stainless steel relief valves, air filtration, and pressure gauges. Mechanical operation; no software or electronic components.

Indications for Use

Indicated for persons with mild symptoms of Acute Mountain Sickness (AMS). Prescription use only.

Regulatory Classification

Identification

A hyperbaric chamber is a device that is intended to increase the environmental oxygen pressure to promote the movement of oxygen from the environment to a patient's tissue by means of pressurization that is greater than atmospheric pressure. This device does not include topical oxygen chambers for extremities (§ 878.5650).

Predicate Devices

• Flexi-Lite Hyperbaric Chamber (K051759)

Submission Summary (Full Text)

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## Exhibit 1

### 510(K) SUMMARY

This summary of 5l0(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 5l0(k) number is: K101262

### Submitter's Identification: . 1.

JUN 1 0 2010

Pressure Tech, Inc. 102 Woodcleft Avenue Freeport, NY 11520

Phone: [phone] Contact: Charlie Johnson

Date Summary Prepared: February 16, 2010

- Name of the Device: 2. -Flexi-Lite
- Common or Usual Name: 3. Hyperbaric Chamber Requlation: 21 CFR868.5470 Product Code: CBF
- Predicate Device Information: 4. Flexi-Lite Hyperbaric Chamber K051759

### 5. Device Description:

The Flexi-Lite flexible hyperbaric chamber is a mild hyperbaric chamber for pressures less than 4 psi. This lightweight and portable chamber utilizes atmospheric Air as supplied by a GAST model 0523/1023 "oil-less, breathable air compressor" to pressurize the chamber and provide a suitable environment for the occupant. The Flexi-Lite construction utilizes a dual bag design with the inner the ooonpining the pressure and an exterior bag to provide structural support. All components are attached to the inner bag utilizing bulkhead connections. It is outfitted with two externally mounted metal relief valves (set at 4 psi), two metal Air addition valves (one external & one internal), two metal depressurization valves (one external & one internal), two pressure gauges (one external & one internal), and one metal Air sampling port. In total it weighs 39 lbs (compressor adds another 54 lbs).

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#### Intended Use: 6. .

The Flexi-Lite Hyperbaric chamber is a hyperbaric chamber intended to be used in treating mild symptoms consistent with Acute Mountain Sickness (AMS) as prescribed by or under the direction of a physician.

Caution: Federal law restricts this device to sale by or on the order of a physician.

### Comparison to Predicate Devices: 7.

| Item | Subject Device | Substantially<br>Equivalent<br>(SE) or<br>different |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|
| Intended Use | The Flexi-Lite Hyperbaric chamber is a rugged &<br>portable hyperbaric chamber intended to be used<br>in treating mild symptoms consistent with Acute<br>Mountain Sickness (AMS) as prescribed by or<br>under the direction of a physician.<br>Caution: Federal law restricts this device to sale<br>by or on the order of a physician. | SE |
| Intended<br>population | Persons with High altitude mountain sickness | SE |
| Intended<br>Environment of<br>use | Home, Physician office, outdoor, hospital,<br>subacute facility, EMS | SE |
| Relief valves | Yes - Qty 2 metal | SE |
| Dump valve | Yes - separate | SE |
| Operating<br>Pressure (psi) | 2-4 | SE |
| Method of<br>inflation | GAST Model 0523/1023 Compressor | SE |
| Chamber | Inner bag - 880 denier-urethand coated nylon<br>Outer bag 2 x 2 basket weave, 2-side -urethane<br>coated nylon | SE |
| Relief valves | Brass and stainless | SE |
| Compressor | GAST 0523/1023 oil-less | SE |
| Air Filtration on<br>compressor | Yes | SE |
| Pressure Gauge | Yes | SE |
| Air filtration on<br>chamber | Yes | SE |

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### Discussion of Non-Clinical Tests Performed for Determination of 8. Substantial Equivalence are as follows:

Bench testing was performed as determined by the hazard analysis. The Flexi-Lite passed all bench testing.

#### 10. Conclusions: .

There are no significant differences between the Flexi-Lite and the predicate device therefore we have concluded that the Flexi-Lite is substantially equivalent.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Pressure-Tech, Incorporated C/O Ms. Maria Griffin MDI Consultants, Incorporated 55 Northern Boulevard, Suite 200 Great Neck, New York 11021

Re: K101262

Trade/Device Name: Flexi-Lite Regulation Number: 21 CFR 868.5470 Regulation Name: Hyperbaric Chamber Regulatory Class: II Product Code: CBF Dated: May 27, 2010 Received: May 28, 2010

Dear Ms. Griffin:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

# JUN 1 0 2010

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### Page 2- Ms. Maria Griffin

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

for

Anthony D. Watson, B.S., M.S., M.B.A. 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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Exhibit 3

# Indications for Use

Page . 1 of

## 510(k) Number (if known): K101262

Device Name: Flexi-Lite

Indications For Use:

The Flexi-Lite Hyperbaric chamber is a hyperbaric chamber intended to be used in treating mild symptoms consistent with Acute Mountain Sickness (AMS) as prescribed by or under the direction of a physician.

Caution: Federal law restricts this device to sale by or on the order of a physician.

Prescription Use X (Per 21 CFR 801 Subpart D)

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)

L. Schultz

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: k101262