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 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).

AI/ML Overview

Here's an analysis of the provided text regarding the Flexi-Lite Hyperbaric Chamber (K101262), focusing on acceptance criteria and supporting studies.

Based on the provided 510(k) summary, the device is a hyperbaric chamber, not an AI/ML-driven device, diagnostic algorithm, or medical imaging analysis tool. Therefore, many of the requested categories related to algorithm performance, expert review, and ground truth for AI studies are not applicable to this submission.

The document describes a traditional medical device submission for substantial equivalence to a predicate device. The "acceptance criteria" discussed are primarily related to the device's functional and safety characteristics compared to its predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Criterion	Acceptance Standard (Predicated on K051759)	Reported Device Performance (Flexi-Lite)	Met?
Intended Use	Treating mild symptoms consistent with Acute Mountain Sickness (AMS) as prescribed by or under the direction of a physician.	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.	Yes (SE)
Intended Population	Persons with High altitude mountain sickness	Persons with High altitude mountain sickness	Yes (SE)
Intended Environment of Use	Home, Physician office, outdoor, hospital, subacute facility, EMS	Home, Physician office, outdoor, hospital, subacute facility, EMS	Yes (SE)
Relief Valves	Present (Qty and material not specified for predicate, but assumed to be functionally equivalent)	Qty 2 metal (Brass and stainless for materials)	Yes (SE)
Dump Valve	Separate dump valve	Yes - separate	Yes (SE)
Operating Pressure (psi)	2-4 psi	2-4 psi	Yes (SE)
Method of Inflation	Compressor (GAST Model 0523/1023 assumed for predicate or equivalent)	GAST Model 0523/1023 Compressor	Yes (SE)
Chamber Material	(Material not explicitly detailed for predicate, but assumed to be functionally equivalent)	Inner bag - 880 denier-urethane coated nylon Outer bag 2 x 2 basket weave, 2-side - urethane coated nylon	Yes (SE)
Compressor Type	Oil-less compressor (GAST 0523/1023 assumed for predicate or equivalent)	GAST 0523/1023 oil-less	Yes (SE)
Air Filtration on Compressor	Yes	Yes	Yes (SE)
Pressure Gauge	Yes	Yes	Yes (SE)
Air Filtration on Chamber	Yes	Yes	Yes (SE)
Hazard Analysis & Bench Testing	Must pass all identified bench tests per hazard analysis.	"Bench testing was performed as determined by the hazard analysis. The Flexi-Lite passed all bench testing."	Yes

Note: "SE" indicates Substantially Equivalent to the predicate device, K051759.

2. Sample size used for the test set and the data provenance

The document explicitly states: "Bench testing was performed as determined by the hazard analysis." This indicates physical testing on the device itself.

Sample Size for Test Set: Not explicitly stated for each test, but it would typically involve one or more physical units of the Flexi-Lite hyperbaric chamber. The nature of bench testing implies testing of representative product units rather than a "data set" in the context of an algorithm.
Data Provenance: The testing was non-clinical, meaning it focused on engineering performance and safety. It doesn't involve patient data, country of origin of data, or retrospective/prospective studies in the sense of clinical trials. The data would originate from the manufacturer's internal testing facilities or an accredited testing lab.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The "ground truth" for this type of device (a physical hyperbaric chamber) is its functional performance, safety features (e.g., relief valve settings), and material specifications, as validated by engineering tests against predetermined criteria or predicate device specifications. This doesn't involve "experts" establishing ground truth in the way a diagnostic algorithm requires clinical expert consensus.

4. Adjudication method for the test set

Not applicable. This is not a comparative clinical study requiring adjudication of interpretations. Bench testing results are typically objective measurements or pass/fail determinations based on engineering standards.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is not an AI-assisted diagnostic tool. No MRMC study was performed as it is not relevant to a hyperbaric chamber.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is not an algorithm.

7. The type of ground truth used

The "ground truth" for this device's substantial equivalence determination relies on:

Engineering Specifications: Adherence to defined physical dimensions, material properties, pressure ranges, and component functionality (e.g., relief valve settings).
Safety Standards: Compliance with recognized safety standards relevant to medical devices and pressure vessels.
Predicate Device Equivalence: Direct comparison of features and performance parameters to a legally marketed predicate device (Flexi-Lite Hyperbaric Chamber K051759). The predicate device itself serves as the benchmark for acceptable performance and safety.
Hazard Analysis: Identification and mitigation of potential hazards, with "bench testing" verifying that these mitigations are effective.

8. The sample size for the training set

Not applicable. This is a physical device, not a machine learning model, so there is no "training set."

9. How the ground truth for the training set was established

Not applicable. There is no training set for this device.

Summary

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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: 516 546 2030 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:

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Intended Use: 6. .

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

Comparison to Predicate Devices: 7.

Item	Subject Device	SubstantiallyEquivalent(SE) ordifferent
Intended Use	The Flexi-Lite Hyperbaric chamber is a rugged &portable hyperbaric chamber intended to be usedin treating mild symptoms consistent with AcuteMountain Sickness (AMS) as prescribed by orunder the direction of a physician.Caution: Federal law restricts this device to saleby or on the order of a physician.	SE
Intendedpopulation	Persons with High altitude mountain sickness	SE
IntendedEnvironment ofuse	Home, Physician office, outdoor, hospital,subacute facility, EMS	SE
Relief valves	Yes - Qty 2 metal	SE
Dump valve	Yes - separate	SE
OperatingPressure (psi)	2-4	SE
Method ofinflation	GAST Model 0523/1023 Compressor	SE
Chamber	Inner bag - 880 denier-urethand coated nylonOuter bag 2 x 2 basket weave, 2-side -urethanecoated nylon	SE
Relief valves	Brass and stainless	SE
Compressor	GAST 0523/1023 oil-less	SE
Air Filtration oncompressor	Yes	SE
Pressure Gauge	Yes	SE
Air filtration onchamber	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 (800) 638-2041 or (301) 796-7100 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:

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)

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

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).