FLEXI-LITE, MODEL FL-V1.2

K051759 · Performance Hyperbarics · CBF · Nov 17, 2005 · Anesthesiology

Device Facts

• Record ID: K051759
• Device Name: FLEXI-LITE, MODEL FL-V1.2
• Applicant: Performance Hyperbarics
• Product Code: CBF · Anesthesiology
• Decision Date: Nov 17, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

To provide mild hyperbaria for the treatment of Acute Mountain Sickness (AMS) and its associated mild symptoms. Environment of Use: Home, Physicians office, Outdoor environments, Hospital, Sub-acute Institutions, Emergency Services. Prescriptive Use: 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 (pressures < 5 psi) for treating Acute Mountain Sickness (AMS). Device uses atmospheric air supplied by GAST 0523 oil-less compressor to pressurize chamber. Construction features inner bag (pressure containment) and outer bag (structural support). Equipped with metal relief valves, air addition/depressurization valves, pressure gauges, and air sampling port. Operated in home, clinic, hospital, or field settings. Occupant can self-extricate. Healthcare providers prescribe device to provide mild hyperbaric environment, potentially alleviating AMS symptoms.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on descriptive comparisons of design, materials, and intended use to legally marketed predicate devices.

Technological Characteristics

Mild hyperbaric chamber; operating pressure 2-4 psi. Materials: inner bag 880 denier urethane-coated nylon; outer bag 2x2 basket weave urethane-coated nylon. Components: brass/stainless steel relief valves, GAST 0523 oil-less compressor, air filtration, pressure gauges. Dimensions: 8 ft x 30 in. Portable, non-networked, mechanical operation.

Indications for Use

Indicated for treatment of mild symptoms of Acute Mountain Sickness (AMS). Contraindications: colds/flu, recent alcohol consumption, blocked ear canals, otic barotrauma, excessive CO2 exposure, pulmonary hyperexpansion, decompression sickness.

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

• Gamow Bag (K874752A)
• HTI Mild Hyperbaric Chamber (K001409)

Submission Summary (Full Text)

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K 051759

NOV 1 7 2005

Performance Hyperbarics

2599 A Olinda Rd

Makawao, HI 96768

# Non-Confidential Summary of Safety and Effectiveness, 510(k) Submission

June 15, 2005

| Performance Hyperbarics | Tel - 808-573-8166 |
|----------------------------|-------------------------------------------------|
| 2599 A Olinda Rd | Fax- 808-573-8976 |
| Makawao, HI 96768 | email- [e-mail] |
| Official Contact: | Spencer Feldman |
| Proprietary or Trade Name: | Flexi-Lite Hyperbaric Chamber |
| Common Used Name: | Mild Hyperbaric Chamber |
| Classification Name: | Hyperbaric Chamber |
| Regulatory Class: | Class II (two) |
| Product Code: | 73 CBF |
| Device: | Flexible Hyperbaric Chamber with Air Compressor |
| Predicate Devices: | HTI - Gamow Bag -K874752A |
| | HTI - Mild Hyperbaric Chamber -K001409 |

### Device Description

The Flexi-Lite flexible hyperbaric chamber is a mild hyperbaric chamber for pressures less than 5 psi. This lightweight and portable chamber utilizes atmospheric Air as supplied by a GAST model 0523 "oiless, breathable air compressor" to pressurize the chapplice und provide a suitable environment for the occupant. The Flexi-Lite construction utilizes and bag design with the inner bag containing the pressure and an exterior hag to provide structural support. All components are attached to the inner bag utilizing oulkhead connections. It is outfitted with two externally mounted metal relief valves (set out nedit 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

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| Indicated Use: | To provide mild hyperbaria for the treatment of Acute Mountain<br>Sickness (AMS) and its associated mild symptoms |
|---------------------|-------------------------------------------------------------------------------------------------------------------|
| Environment of Use: | Home, Physicians office, Outdoor environments, Hospital, Sub-<br>acute Institutions, Emergency Services. |
| Prescriptive Use: | Caution, Federal law restricts this device to sale by or on the order<br>of a physician. |

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## Comparison To Predicate Devices

| Attribute | Gamow<br>K874752A | HTI Model-2<br>K001409 | HTI Model-3<br>K001409 | Flexi-Lite<br>K051759 |
|-----------------------------------|---------------------------------------------------------------------------------|---------------------------------------------------------------------------------|---------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| Intended Use | Acute Mountain<br>Sickness (AMS)<br>& associated<br>symptoms | Acute Mountain<br>Sickness (AMS)<br>& associated<br>symptoms | Acute Mountain<br>Sickness (AMS)<br>& associated<br>symptoms | Acute Mountain<br>Sickness (AMS)<br>& associated<br>symptoms |
| Prescription Use | Yes | Yes | Yes | Yes |
| Intended<br>Population | Persons with high<br>altitude mountain<br>sickness | Persons with high<br>altitude mountain<br>sickness | Persons with high<br>altitude mountain<br>sickness | Persons with high<br>altitude mountain<br>sickness |
| Intended<br>Environment of<br>Use | Home, Physician<br>Office, Outdoor,<br>Hospital, Sub-<br>acute facility,<br>EMS | Home, Physician<br>Office, Outdoor,<br>Hospital, Sub-<br>acute facility,<br>EMS | Home, Physician<br>Office, Outdoor,<br>Hospital, Sub-<br>acute facility,<br>EMS | Home, Physician<br>Office, Outdoor,<br>Hospital, Sub-<br>acute facility,<br>EMS |
| Weight (lbs) | 6.5 | 11 | 17 | 39 |
| Size<br>Length x<br>inflated dia. | 7 ft x 21 in | 7 ft x 21 in | 7 ft x 21 in | 8 ft x 30 in |
| Windows | 2 | 3 | 3 | 4 |
| Straps for<br>Transport | 2 | none | none | none |
| Relief Valves | Yes-Plastic | Yes-Metal | Yes-Metal | Yes, Qty-2-Metal |
| Dump Valve | yes | yes, 2-way | yes, 2-way | yes-Separate |
| Operating<br>Pressure (psi) | 2-4 | 2-4 | 2-4 | 2-4 |
| Methods of<br>Inflation | Foot pump /<br>Compressor | Compressor | Compressor | GAST Model<br>0523 Compressor |

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| Zipper | Pressure seal | Double zipper w/<br>seal-flap, 2-way | Double zipper w/<br>seal-flap, 2-way | Single zipper |
|---------------------------------|-----------------------------------------|--------------------------------------------------------|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Materials | | | | |
| Attribute | Gamow<br>K874752A | HTI Model-2<br>K001409 | HTI Model-3<br>K001409 | Flexi-Lite<br>K051759 |
| Chamber | 420 denier-<br>urethane coated<br>nylon | 420 denier and<br>33-39 oz<br>urethane coated<br>nylon | 33-39 oz urethane<br>coated nylon | inner bag-880<br>denier-urethane<br>coated nylon<br>outer bag- 2 x 2<br>basket weave, 2-<br>side-urethane<br>coated nylon |
| Relief valves | Plastic | Stainless Steel | Stainless Steel | Brass & Stainless |
| Compressor | GAST oil-less | GAST oil-less | GAST oil-less | GAST 0523 oil-<br>less |
| Air Filtration on<br>compressor | yes | yes | yes | yes |
| Pressure Gauge | yes | yes | yes | yes |
| Air Filtration on<br>chamber | ? | ? | ? | Yes |

۔۔۔ ﺟ

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| Ability for<br>person inside to<br>extricate<br>themselves if<br>needed | no | yes | yes | yes |
|-------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Attribute | Gamow<br>K874752A | HTI Model-2<br>K001409 | HTI Model-3<br>K001409 | Flexi-Lite<br>K051759 |
| Operating<br>Temperatures | -50F to + 120F | -50F to + 120F | -50F to + 120F | -50F to + 120F |
| Contraindicatio<br>ns | Patients with:<br>-Colds or flu<br>symptoms<br>-Recent alcohol<br>consumption<br>-Blocked ear<br>canals for any<br>reason<br>-Otic barotrauma<br>-Excessive CO2<br>exposure<br>-Pulmonary<br>hyperexpansion<br>-Decompression<br>Sickness | Patients with:<br>-Colds or flu<br>symptoms<br>-Recent alcohol<br>consumption<br>-Blocked ear<br>canals for any<br>reason<br>-Otic barotrauma<br>-Excessive CO2<br>exposure<br>-Pulmonary<br>hyperexpansion<br>-Decompression<br>Sickness | Patients with:<br>-Colds or flu<br>symptoms<br>-Recent alcohol<br>consumption<br>-Blocked ear<br>canals for any<br>reason<br>-Otic barotrauma<br>-Excessive CO2<br>exposure<br>-Pulmonary<br>hyperexpansion<br>-Decompression<br>Sickness | Patients with:<br>-Colds or flu<br>symptoms<br>-Recent alcohol<br>consumption<br>-Blocked ear<br>canals for any<br>reason<br>-Otic barotrauma<br>-Excessive CO2<br>exposure<br>-Pulmonary<br>hyperexpansion<br>-Decompression<br>Sickness |
| Labeling | Comparable | Comparable | Comparable | Comparable |

# Differences Between Other Legally Marketed Devices:

. .

There are no significant differences between the FlexiLite and the predicates - Gamow Bag K874752A -HTI Models 2 or 3 K001409 ـ - ﺣﺘﻰ

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Image /page/5/Picture/1 description: The image is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the edge. In the center of the seal is a stylized eagle emblem. The eagle is depicted with three curved lines representing its wings and body.

Public Health Service

NOV 1 7 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Spencer Feldman President Performance Hyperbarics 2599 A Olinda Road Makawao, Hawaii 96768

Re: K051759

Trade/Device Name: Flexi-Lite Regulation Number: 868.5470 Regulation Name: Hyperbaric Chamber Regulatory Class: II Product Code: CBF Dated: October 21, 2005 Received: October 21, 2005

Dear Mr. Feldman:

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.

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Page 2 - Mr. Feldman

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 Office of Compliance at [phone]. 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 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 vours.

Susan Gunno

Chiu Lin, Ph.D.

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): K051759

Device Name: Flexi-Lite

The Flexi-Lite Hyperbaric chamber is a rugged & portable Indications For Use: 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 (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)

Ciara Sullivan

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Sion of Anesthesiology, General Hospital, Control, Dental Devices

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