To provide mild hyperbaria for the treatment of Acute Mountain Sickness (AMS) and its associated mild symptoms. The Flexi-Lite Hyperbaric chamber is a rugged & portable 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.

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).

AI/ML Overview

This document is a 510(k) premarket notification for the Flexi-Lite Hyperbaric Chamber, seeking to demonstrate substantial equivalence to legally marketed predicate devices. The document does not describe acceptance criteria for a study demonstrating device performance, nor does it present results from such a study.

Instead, the submission focuses on comparing the new device's attributes, intended use, and specifications to existing, predicate hyperbaric chambers to argue for substantial equivalence. The FDA letter confirms the determination of substantial equivalence based on the provided information, allowing the device to be marketed.

Therefore, I cannot provide the requested information about acceptance criteria and study results because this type of information is not present in the provided text. The document is a regulatory submission for market clearance, not a clinical or performance study report.

Summary

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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- info@hyperbaric-oxygen-chamber.com
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

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Intended Use

Indicated Use:	To provide mild hyperbaria for the treatment of Acute MountainSickness (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 orderof a physician.

ﺟﺒ

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Comparison To Predicate Devices

Attribute	GamowK874752A	HTI Model-2K001409	HTI Model-3K001409	Flexi-LiteK051759
Intended Use	Acute MountainSickness (AMS)& associatedsymptoms	Acute MountainSickness (AMS)& associatedsymptoms	Acute MountainSickness (AMS)& associatedsymptoms	Acute MountainSickness (AMS)& associatedsymptoms
Prescription Use	Yes	Yes	Yes	Yes
IntendedPopulation	Persons with highaltitude mountainsickness	Persons with highaltitude mountainsickness	Persons with highaltitude mountainsickness	Persons with highaltitude mountainsickness
IntendedEnvironment ofUse	Home, PhysicianOffice, Outdoor,Hospital, Sub-acute facility,EMS	Home, PhysicianOffice, Outdoor,Hospital, Sub-acute facility,EMS	Home, PhysicianOffice, Outdoor,Hospital, Sub-acute facility,EMS	Home, PhysicianOffice, Outdoor,Hospital, Sub-acute facility,EMS
Weight (lbs)	6.5	11	17	39
SizeLength xinflated 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 forTransport	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
OperatingPressure (psi)	2-4	2-4	2-4	2-4
Methods ofInflation	Foot pump /Compressor	Compressor	Compressor	GAST Model0523 Compressor

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Zipper	Pressure seal	Double zipper w/seal-flap, 2-way	Double zipper w/seal-flap, 2-way	Single zipper
Materials
Attribute	GamowK874752A	HTI Model-2K001409	HTI Model-3K001409	Flexi-LiteK051759
Chamber	420 denier-urethane coatednylon	420 denier and33-39 ozurethane coatednylon	33-39 oz urethanecoated nylon	inner bag-880denier-urethanecoated nylonouter bag- 2 x 2basket weave, 2-side-urethanecoated nylon
Relief valves	Plastic	Stainless Steel	Stainless Steel	Brass & Stainless
Compressor	GAST oil-less	GAST oil-less	GAST oil-less	GAST 0523 oil-less
Air Filtration oncompressor	yes	yes	yes	yes
Pressure Gauge	yes	yes	yes	yes
Air Filtration onchamber	?	?	?	Yes

۔۔۔ ﺟ

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Ability forperson inside toextricatethemselves ifneeded	no	yes	yes	yes
Attribute	GamowK874752A	HTI Model-2K001409	HTI Model-3K001409	Flexi-LiteK051759
OperatingTemperatures	-50F to + 120F	-50F to + 120F	-50F to + 120F	-50F to + 120F
Contraindications	Patients with:-Colds or flusymptoms-Recent alcoholconsumption-Blocked earcanals for anyreason-Otic barotrauma-Excessive CO2exposure-Pulmonaryhyperexpansion-DecompressionSickness	Patients with:-Colds or flusymptoms-Recent alcoholconsumption-Blocked earcanals for anyreason-Otic barotrauma-Excessive CO2exposure-Pulmonaryhyperexpansion-DecompressionSickness	Patients with:-Colds or flusymptoms-Recent alcoholconsumption-Blocked earcanals for anyreason-Otic barotrauma-Excessive CO2exposure-Pulmonaryhyperexpansion-DecompressionSickness	Patients with:-Colds or flusymptoms-Recent alcoholconsumption-Blocked earcanals for anyreason-Otic barotrauma-Excessive CO2exposure-Pulmonaryhyperexpansion-DecompressionSickness
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 (240) 276-0120. 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 (800) 638-2041 or (301) 443-6597 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

ා වලදා) Number:

Regulation Number and Section

§ 868.5470 Hyperbaric chamber.

(a)
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).(b)
Classification. Class II (performance standards).