Skin ulcerations due to diabetes, venous stasis, post surgical infections and gangrenous lesions
Decubitus ulcers
Amputations/infected stumps
Skin grafts
Burns
Frostbite

Device Description

The VX-400 Topical Hyperbaric Oxygen Chamber is a small, portable system that provides oxygen, at prescribed pressure for a prescribed duration, to a patient's limb. It is used at home or a clinical setting to help speed wound healing. The system consists of five (5) major components:

1. The Blue/Clear Plastic Chamber
1. The Control Unit
1. The Hand Held Controller
1. The Silicone Sleeve
1. Power Cube (Power Supply)

The VX-400 is a rectangular, yet rounded (10 x 24 x 16) rigid plastic shell constructed of two plastic half-panels, to which epoxy is applied and then heat-sealed together along the edges to form one chamber.

The chamber is a rigid plastic sleeve into which the patient places their limbs. There are two (2) hose barbs on the chamber, one for oxygen tubing that fills the chamber, and one for tubing to a pressure sensor. The controller consists of a plastic box with two (2) pieces of attached clear flexible tubing; these connect to the two (2) barbs on the chamber. The controller has a hose connected from the 50-psi oxygen source, a connector for a "power cube" that plugs into an AC wall outlet, and a cable that connects to the hand controller. The controller also incorporates a flowmeter. The hand-held controller can be programmed by the clinician to the prescribed time and pressure therapy, and then set to allow the patient to only turn the unit on and then off; it has a small 2 line LCD alphanumeric display and several push buttons.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the VX-400 Topical Hyperbaric Oxygen Chamber:

Important Note: The provided document is a 510(k) summary for a medical device seeking substantial equivalence to predicate devices, not a clinical study report or a document explicitly detailing acceptance criteria for a new clinical indication. Therefore, information typically found in clinical trials (like specific quantitative clinical acceptance criteria, sample sizes for test sets, expert ground truth establishment, MRMC studies, etc.) is largely absent. The document focuses on demonstrating engineering performance and safety relative to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (from document)	Reported Device Performance (from document)
Operational Performance	Operations by setting several treatment combinations, checking time and pressure (clock).	"Performance testing to confirm the operations by setting several treatment combinations, and checking time and pressure (clock) was conducted in order to show that the device meets product specifications."
Environmental Performance	Operation at +5°C and at +40°C, 90-95% relative humidity.	"Operation at 5 +5°C and at +40°C, 90- 95% relative humidity (to assure that the device operates normally in the environment of use)" - implies successful operation.
Storage Resistance	Storage at -20°C and at +60°C, 90-95% relative humidity.	"Storage at -20°C and at +60°C, 90-95% relative humidity (storage resistance)" - implies successful storage.
Mechanical Integrity	Sinusoidal vibration.	"Sinusoidal vibration" - implies successful tolerance.
Electrical Safety	Leakage current and dielectric withstand of power cube.	"Leakage current and dielectric withstand of power cube (electrical safety)" - implies compliance.
Thermal Safety	Thermal Safety.	"Thermal Safety" - implies compliance.
Physical Durability	Impact (drop) resistance testing.	"Vascular One, Inc. conducted Impact (drop) resistance testing." - implies successful resistance.
Overall Safety/Effectiveness	Meets requirements of the FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions", DCRND.	"None of the testing demonstrated any design characteristics that violated the requirements of the Reviewer Guidance or resulted in any safety hazard. It was the contract testing laboratory and Vascular One, Inc.'s conclusion that the VX-400 device samples(s) tested met all relevant requirements of the aforementioned test."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify a numerical sample size for the test set. It refers to "VX-400 device samples(s) tested," implying a limited number of physical units were used for the engineering tests. This is typical for premarket device testing where the focus is on device function and safety, not clinical efficacy in a large patient population.
Data Provenance: The data is from non-clinical (engineering/bench) testing. The testing was conducted by "A Contract Testing Laboratory" and "Vascular One, Inc." within the United States. It is retrospective in the sense that the results were submitted after the tests were completed.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable and not provided in the document. The "ground truth" for these engineering tests would be the established scientific and engineering principles and the specifications outlined in the FDA's "Reviewer Guidance." The tests were performed to verify the device's adherence to these specifications, not to assess clinical diagnoses or outcomes requiring expert medical consensus.

4. Adjudication Method for the Test Set

This information is not applicable and not provided in the document. Adjudication methods like 2+1 or 3+1 are used in clinical trials to resolve discrepancies in expert interpretations of medical data. Since this document describes engineering performance tests, such methods are not relevant. The "adjudication" here would be the pass/fail result of each engineering test against its pre-defined criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Discussion of Clinical Tests Performed: Not applicable." This device is a Class III device, but its 510(k) submission relies on substantial equivalence to existing predicate devices, which often means extensive new clinical efficacy studies are not required if technological characteristics are similar and safety is demonstrated through non-clinical means.
Effect Size: Not applicable, as no MRMC study was performed.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This concept is not applicable to this device. The VX-400 is a physical medical device (a hyperbaric oxygen chamber), not an algorithm or AI system. Its performance is inherent in its physical function and control system. While it is "software driven," its "standalone" performance would be its ability to maintain pressure and deliver oxygen as programmed, which is covered under the operational performance tests.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests described in the document is the engineering specifications and safety standards outlined by the manufacturer and the FDA guidance document (FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions", DCRND). The tests were designed to verify that the device performed according to these pre-defined, measurable engineering and safety parameters.

8. The Sample Size for the Training Set

This information is not applicable and not provided. "Training set" refers to data used to train algorithms or AI models. This device is a physical hyperbaric chamber, not an AI model requiring a training set for performance.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable and not provided, as there is no training set for this type of device.

Summary

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KO22028

DEC 1 7 2002

Attachment 3

510(K) SUMMARY

This summary of 510(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:________________________________________________________________________________________________________________________________________________

Submitter's Identification: 1.

Vascular One. Inc. 8711 E. Pinnacle Peak Road Suite 306 Scottsdale, AZ 85255-3517

Contact: Mr. Edward Lisinski, President

Date Summary Prepared: June 20, 2002

2. Name of the Device:

VX-400 Topical Hyperbaric Oxygen Chamber

న. Predicate Device Information:

O2 Boot, GWR Medical, LLP, Chadds Ford, PA, K#971507 .
Topox Topical Sacral Hyperbaric Oxygen Chamber, Topox, Inc. North Attleboro, . MA. K#920948
The Topical Hyperbaric Oxygen Extremity Chamber, Advanced Hyberbaric ● Technologies, Inc., Farmingdale, NJ. (Grandfathered, Pre-Amendment Status).

4. Device Description:

1. The Blue/Clear Plastic Chamber
1. The Control Unit
1. The Hand Held Controller
1. The Silicone Sleeve
1. Power Cube (Power Supply)

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ട. Intended Use:

For Treatment of open acute or chronic wounds, e.g.,

Skin ulcerations due to diabetes, venous stasis, post surgical infections and . gangrenous lesions
Decubitus ulcers .
Amputations/infected stumps .
Skin grafts ●
. Burns
Frostbite .

6. Comparison to Predicate Devices:

Both the VX-400 Topical Hyperbaric Oxygen and the Advanced Hyperbaric Technologies Topical Hyperbaric Oxygen Extremity Chamber are constructed of enclosed, rigid plastic to allow for pressures of up to 50 mmHg of the extremities. The VX-400 device is constructed of materials similar to the Advance Hyperbaric device and is used in an identical manner for the treatment of chronic skin and pressure sores of the extremities. The GWR O2 Boot device employs a disposable sleeve, and is flexible in construction. All of the devices are constructed of transparent materials to allow the wounds to be viewed and monitored during set-up and treatment. The VX-400 device and the predicates use the hospital wall oxygen or tank oxygen supplies. The prescribed oxygen pressures are maintained and controlled at all times. The VX-400 device is software driven. The GWR device is not.

7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence is as follows:

Performance testing to confirm the operations by setting several treatment combinations, and checking time and pressure (clock) was conducted in order to show that the device meets product specifications.

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Testing information demonstrating safety and effectiveness of the VX-400 Topical Hyperbaric Qxygen Chamber in the intended environment of use is supported by testing that was conducted in accordance with the FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions", DCRND, which outlines Electrical, Mechanical and Environmental Performance Requirements.

A Contract Testing Laboratory conducted the following testing:

a. Operation at 5 +5°C and at +40°C, 90- 95% relative humidity (to assure that the device operates normally in the environment of use)

b. Storage at -20°C and at +60°C, 90-95% relative humidity (storage resistance)

c. Sinusoidal vibration

d. Leakage current and dielectric withstand of power cube (electrical safety)

e. Thermal Safety

Vascular One, Inc. conducted Impact (drop) resistance testing.

None of the testing demonstrated any design characteristics that violated the requirements of the Reviewer Guidance or resulted in any safety hazard. It was the contract testing laboratory and Vascular One, Inc.'s conclusion that the VX-400 device samples(s) tested met all relevant requirements of the aforementioned test.

8. Discussion of Clinical Tests Performed:

Not applicable

ഗ് Conclusions:

The subject device, The Vascular One VX-400 Topical Hyperbaric Oxygen Chamber, has the same intended use and similar characteristics as the predicate devices. Moreover, bench tenting contained in our submission and non-clinical testing supplied demonstrates that there are no differences in their technological characteristics, thereby not raising any new questions of safety or effectiveness. Thus, the VX-400 Topical Hyperbaric Oxygen Chamber is substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services.

Public Health Service .

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Vascular One, Inc. Susan D. Goldstein-Falk c/o MDI Consultants, Inc. 55 Northern Boulevard, Suite 200 Great Neck, New York 11021

Re: K022028

Trade/Device Name: VX-400 Topical Hyperbaric Oxygen Chamber Regulation Number: 878.5650 Regulation Name: Topical oxygen chamber for extremities Regulatory Class: Class III Product Code: KPJ Dated: September 18, 2002 Received: September 23, 2002

Dear Ms. Goldstein-Falk:

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.

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

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Page 2 - Ms. Susan D. Goldstein-Falk

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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also. please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

for Celia M. Witten, Ph.D., MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Attachment #2

Page __ of

510(k) Number (if known): K#022028

Device Name VX-400 Topical Hyperbaric Oxygen Chamber

Indications For Use:

For Treatment of open acute or chronic wounds, e.g.,

Skin ulcerations due to diabetes, venous stasis, post surgical infections . and gangrenous lesions
Decubitus ulcers t
Amputations/infected stumps 아
Skin grafts
Burns
Frostbite

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

neral, Restorative and Neurological Devices

Number K022028

Regulation Number and Section

§ 878.5650 Topical oxygen chamber for extremities.

(a)
Identification. A topical oxygen chamber for extremities is a device that is intended to surround a patient's limb and apply humidified oxygen topically at a pressure slightly greater than atmospheric pressure to aid healing of chronic skin ulcers such as bedsores.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance: Topical Oxygen Chamber for Extremities.” See § 878.1(e) for the availability of this guidance document.