WRIGHT 1000 MONOPLACE HYPERBARIC SYSTEM by WRIGHT INDUSTRIES

l: Air or gas embolism.
2: Carbon monoxide poisoning and smoke inhalation. Carbon monoxide complicated by cyanide poisoning.
3: Clostridial myonecrosis (Gas gangrene).
4: Crush injury, Compartment syndrome, and other acute traumatic ischemias .
5: Decompression sickness.
6: Enhancement of healing in selected problem wounds.
7: Exceptional blood loss (Anemia)
8: Necrotizing soft tissue infections (Subcutaneous tissue, Muscle, Fascia).
9: Osteomyelitis (Refractory).
10: Radiation tissue damage (Osteoradionecrosis).
ll. Skin grafts and flaps (Compromised).
1. Thermal burns.
1. Adjunctive hyperbaric oxygen in intracranial abscess.

Device Description

The Wright 1000 Mono Hyperbaric Camber:

*Max operational pressure 30 PSIG.

*Constructed out of SA516-70N steel

*The 4 Large 14" Windows Constructed out of PVO Acrylic

*Hydrostatic tested at 45 PSIG.

*Welds are X-rayed

*Welds magna Flux tested after hydrostatic test.

*Manufactured by a ASME approved house and certified by ASME. Certification No. 28,352

*Manufactured under PVHO guidelines

*Manufactured under NFPA Guidelines

*Registered with National Board Of Pressure Vessel Inspectors.

*Wiring to National Electrical code.

*Electrical Testing: Electromagnetic and Safety testing Conducted.

*Spacious interior

*2 Way Communications

*Pressure and Oxygen monitoring With alarms.

*Programmable Treatment Pressure Alarms

*Variable ventilation

*Comfortable reclining chair

AI/ML Overview

The provided text is a 510(k) summary for the Wright 1000 Mono Hyperbaric Chamber, a medical device. This document describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about formal acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, or any of the other specific details requested in the prompt regarding a clinical or performance study that proves the device meets acceptance criteria.

The 510(k) notification process focuses on demonstrating substantial equivalence to a predicate device, not necessarily on presenting a new, dedicated study proving performance against defined acceptance criteria in the way a clinical trial or performance study would.

Therefore,Based on the provided text, I cannot describe the acceptance criteria or the study that proves the device meets them because this information is not present in the 510(k) summary. A 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than presenting a novel performance study against predefined acceptance criteria.

The document discusses:

The device's physical specifications and manufacturing standards (e.g., max operational pressure, materials, testing conducted during manufacturing, certifications).
Approved indications and contraindications for hyperbaric oxygen therapy.
Comparison to a predicate device (HYOX System Limited 510(k) No. K874107).

The prompt asks for details that are typically found in a clinical trial report or a dedicated performance study, which are not part of this 510(k) summary document.

To directly answer your numbered points based only on the provided text:

A table of acceptance criteria and the reported device performance: Not provided. The document lists manufacturing specifications and general indications for HBO therapy, but no specific performance acceptance criteria or outcome data from a study.
Sample sized used for the test set and the data provenance: Not provided. No test set or study data is mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided. No test set or ground truth establishment is referenced.
Adjudication method for the test set: Not provided.
If a multi reader multi case (MRMC) comparative effectiveness study was done: Not provided.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not provided. This device is a physical hyperbaric chamber, so an "algorithm only" study is not applicable in this context.
The type of ground truth used: Not provided.
The sample size for the training set: Not provided.
How the ground truth for the training set was established: Not provided.

Summary

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MAY 28 1997

Image /page/0/Picture/1 description: The image contains a handwritten string of characters and numbers. The string begins with the letter 'K', followed by the numbers '95', '25', and '45'. The string also contains a fraction, with '5' as the numerator and '3' as the denominator, separated by a diagonal line.

Image /page/0/Picture/2 description: The image shows a logo for Wright. The logo consists of a stylized letter "W" that is connected to the word "right". The logo is black and white, and it is surrounded by a circle. The logo is simple and modern.

INDUSTRIES

C. Wright Industries 13760 S. Gramercy PL. Gardena, CA. 90249 Phone: 310-523-5132 310-523-1825 Fax: Contact: Charles Wright Date:4-15-1997

RECEIVED

21 APR 97 13 56

FDA/CDRH/ODE/DH

510(k) Summery

Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFC-401) 9200 Corporate Boulevard Rockville, Maryland 20850

Re: 510 (k) Notification Re: 510 (K) Notification # K95245 K952545 Proprietary Name: Wright 1000 Mono Hyperbaric Chamber. Common Name: Hyperbaric Chamber. ochanes craner arressure Vessel for Human Occupancy.
Calssification Name: (PVHO) Pressure Vessel for Human Occupancy.
Predicate Device: HYOX System Limited 510(k) No. K874107

Attention: Christy Foreman

Sincerely Yours

Charles Wright

Charles Wright Owner/Operator C. Wright Industries

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HYPERBARIC TREATMENT:

Hyperbaric oxygen therapy (HBO)is a medical treatment where a patient is placed in a specially designed vessel and placed under pressure greater then sea level and breathes 100% oxygen intermittently. Alveolar oxygen pressure is increased causing a rise in plasma oxygen content which results in enhanced tissue oxygen delivery. the amount of pressure increases and the length of time under pressure are determined by the condition being treated. Treatment pressures are usually between 2 and 3 times atmospheric. treatment usually lasts from 1 to 2 hours at full pressure.

The following are approved indications:

l: Air or gas embolism.
2: Carbon monoxide poisoning and smoke inhalation. Carbon monoxide complicated by cyanide poisoning.
3: Clostridial myonecrosis (Gas gangrene).
4: Crush injury, Compartment syndrome, and other acute traumatic ischemias .
5: Decompression sickness.
6: Enhancement of healing in selected problem wounds.
7: Exceptional blood loss (Anemia)
8: Necrotizing soft tissue infections (Subcutaneous tissue, Muscle, Fascia).
9: Osteomyelitis (Refractory).
10: Radiation tissue damage (Osteoradionecrosis).
ll. Skin grafts and flaps (Compromised).
1. Thermal burns.
1. Adjunctive hyperbaric oxygen in intracranial abscess.

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CONTRAINDICATIONS:

Only previously listed indications are approved all others are considered contraindications.

REFERANCES :

l: HYPERBARIC MEDICINE PROCEDURES. 1996

2: HYPERBARIC OXYGEN THERAPY: A COMMITTEE REPORT. 1996

3: MONOPLACE HYPERBARIC CHAMBER SAFTY GUIDELINES. 1991

{3}------------------------------------------------

The Wright 1000 Mono Hyperbaric Camber:

*Max operational pressure 30 PSIG.

*Constructed out of SA516-70N steel

*The 4 Large 14" Windows Constructed out of PVO Acrylic

*Hydrostatic tested at 45 PSIG.

*Welds are X-rayed

*Welds magna Flux tested after hydrostatic test.

*Manufactured by a ASME approved house and certified by ASME. Certification No. 28,352

*Manufactured under PVHO guidelines

*Manufactured under NFPA Guidelines

*Registered with National Board Of Pressure Vessel Inspectors.

*Wiring to National Electrical code.

*Electrical Testing: Electromagnetic and Safety testing Conducted.

*Spacious interior

*2 Way Communications

*Pressure and Oxygen monitoring With alarms.

*Programmable Treatment Pressure Alarms

*Variable ventilation

*Comfortable reclining chair

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (USA). The seal is circular and contains the department's name around the perimeter. In the center is an abstract symbol that resembles a stylized caduceus or a representation of human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 28 1997

Mr.. Charles Wright Wright Industries 13760 South Gramercy Place Gardena, California 90249

Re: K952545 Wright 1000 Mono Hyperbaric Chamber Regulatory Class: II (two) Product Code: 73 CBF Dated: April 15, 1997 Received: April 21, 1997

Dear Mr. Wright:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent to 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). 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, qood manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 620) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Page 2 - Mr. Charles Wright

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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" (21 CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

ﺮ ﺍ

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).