The conditions listed as appropriate for the use of HBO in the current edition of the Hyperbaric Oxygen Therapy Committee Report (1999) are as follows:

Air or gas embolism
Carbon monoxide poisoning and carbon monoxide poisoning complicated by cyanide poisoning
Clostridial myositis and myonecrosis
Crush injury, compartment syndrome, and other acute traumatic ischemias
Decompression sickness
Enhanced healing of selected problem wounds
Exceptional blood loss anemia
Necrotizing soft tissue infections
Osteomyelitis (refractory)
Delayed radiation injury (soft tissue and bony necrosis)
Skin grafts and flaps (compromised)
Thermal burns
Intracranial abscess

Device Description

The OxyHeal 2000 series is a Class A multiplace hyperbaric chamber system designed to treat up to 12 patients to a maximum operating pressure of 6 Atmospheres Absolute (ATA) or 73.5 pounds per square inch gauge (psig). The chamber uses compressed air as the pressurization gas and 100% oxygen as the hyperbaric treatment gas. The overall external length of the chamber can range from 12 feet to 20 feet. Its internal diameter can range from 72 inches to 180 inches. Large circular windows create a more open atmosphere and help reduce patient claustrophobia. Pressurization is provided by compressed air with 100% oxygen administered to the patient by using properly fitting oro-nasal masks or head tents. A low-voltage patient intercommunication system provides communications between the patients in the chamber and the outside chamber operator. Single operator chamber pressure control is achieved via a simple industrial adjustable controller with output and input feedback. A pneumatic and manually operated control system is provided for triple control redundancy. A penetrator plate is provided in the vessel wall to allow user supplied intravenous lines, medical monitoring leads, etc., to be used as required. The large rectangular door allows a normal size patient gurney or wheelchair to be used to transport nonambulatory patients without having to transfer the patient to a smaller transport device.

AI/ML Overview

The provided text, a 510(k) Notification Summary for the OxyHeal 2000 Hyperbaric Chamber Series (K011866), describes a medical device rather than an AI algorithm or software. Therefore, the typical "acceptance criteria" and "study that proves the device meets the acceptance criteria" as requested for an AI/software device performance evaluation are not directly applicable in the same manner.

This document describes the device's technical specifications, intended use, and claims substantial equivalence to predicate devices, which is the regulatory pathway for this type of medical device. The "study" here refers to the comparison of the device's design and performance against established standards and predicate devices, rather than a clinical trial validating an algorithm's diagnostic accuracy.

However, I can extract information relevant to the intent of your request by describing the device's compliance with established standards and its equivalence to predicate devices, which served as the basis for its market acceptance.

Acceptance Criteria and Device Performance for OxyHeal 2000 Hyperbaric Chamber Series (K011866)

For this type of device (a hyperbaric chamber), the concept of "acceptance criteria" is largely defined by adherence to recognized engineering standards and clinical practice guidelines, and demonstration of substantial equivalence to already approved devices. Device performance is typically evaluated against these standards and the capabilities of predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Standard	Reported Device Performance (OxyHeal 2000 Series)
Design & Fabrication	ANSI/ASME Boiler and Pressure Vessel Code, Section VIII, Division 1. Pressure Vessels	Designed and fabricated in accordance with these requirements.
	ANSI/ASME-PVHO-1 (Pressure Vessels for Human Occupancy)	Designed and fabricated in accordance with these requirements.
Facility Requirements	NFPA 99, Health Care Facilities, Chapter 19, Hyperbaric Facilities	Designed and fabricated in accordance with these requirements; intended for installation and operation in medical facilities as defined by NFPA 99.
Max Operating Pressure	Capability to treat to specific pressures	Maximum operating pressure of 6 Atmospheres Absolute (ATA) or 73.5 psig.
Patient Capacity	Accommodation for multiple patients	Treats up to 12 patients.
Pressurization Gas	Use of appropriate gas	Uses compressed air as the pressurization gas.
Treatment Gas	Use of appropriate gas at concentration	Uses 100% oxygen as the hyperbaric treatment gas (administered via oro-nasal masks or head tents).
Patient Comfort/Access	Features for patient and staff	Large circular windows (reduce claustrophobia), large rectangular door (accommodates gurney/wheelchair), accommodates 1-12 ambulatory patients in comfort.
Communication System	Compliance with safety standards	Low-voltage patient intercommunication system designed and installed in accordance with NFPA 99, Chapter 19.
Pressure Control	Safety and redundancy in control	Single operator control, pneumatic and manually operated control system for triple control redundancy.
Additional Access	Medical penetrations	Penetrator plate for IV lines, medical monitoring leads.
Intended Use Conditions	Adherence to recognized medical indications	Intended use for 13 specific medical conditions listed by the Undersea and Hyperbaric Medical Society (UHMS) Hyperbaric Oxygen Therapy Committee Report (1999).

Study Proving Device Meets Acceptance Criteria:

The "study" in this context is the 510(k) Premarket Notification itself, which substantiates substantial equivalence to legally marketed predicate devices and compliance with relevant standards. No separate, formal clinical trial or AI performance study is described in this document for the OxyHeal 2000.

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

Not applicable in the context of an AI/software device. This device is a physical hyperbaric chamber. The "test set" for its acceptance is primarily its design documents, manufacturing processes, and comparison to predicate devices, and adherence to engineering and safety standards.

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

Not directly applicable in the terms for AI/software. However, the ground truth for the medical indications for use is established by the Undersea and Hyperbaric Medical Society (UHMS). The UHMS is a professional medical organization that produces a list of medical conditions for which hyperbaric oxygen therapy is appropriate, based on scientific validation and extensive data collection. While specific numbers of individual experts are not named, the UHMS represents a consensus of medical professionals specializing in hyperbaric medicine.

4. Adjudication Method for the Test Set:

Not applicable as an adjudication method for a "test set" as understood for AI/software. The regulatory assessment involves the FDA's review of the submitted documentation, including design specifications, manufacturing controls, and the comparison to predicate devices.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This is not an AI diagnostic or assistance tool for human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. This is a physical medical device (hyperbaric chamber), not an algorithm.

7. The Type of Ground Truth Used:

The primary ground truth for the clinical indications and safety standards for hyperbaric oxygen therapy is:

Expert Consensus / Clinical Guidelines: The listed medical conditions for hyperbaric oxygen therapy are based on the Undersea and Hyperbaric Medical Society (UHMS) Hyperbaric Oxygen Therapy Committee Report (1999). The UHMS scientifically validates and verifies these indications through extensive data collection.
Engineering and Safety Standards: Compliance with ANSI/ASME Boiler and Pressure Vessel Code, ANSI/ASME-PVHO-1, and NFPA 99 for the physical design and operation of the chamber serves as a "ground truth" for safe and effective device construction.

8. Sample Size for the Training Set:

Not applicable. This is not an AI/machine learning device. The "training" for this device would refer to its design and manufacturing informed by existing engineering principles and predicate devices.

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

Not applicable as for an AI/machine learning algorithm. For a physical device, its "ground truth" or foundational knowledge comes from established engineering principles, material science, safety regulations, and the design and operational history of predicate devices. The substantial equivalence argument relies on demonstrating that the new device meets or exceeds the safety and efficacy profiles of these established products.

Summary

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K011866

OxyHeal Health Group, Inc. OxyHeal 2000 Hyperbaric Chamber Series 510(K) NOTIFICATION SUMMARY

OxyHeal Health Group, Inc. P.O. Box 1987 La Jolla, CA 92038

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510(k) NOTIFICATION SUMMARY (Per 21 CFR 807.92)

Prepared: 10 June 2001

TRADE NAME: OxyHeal 2000 Hyperbaric Chamber Series

COMMON NAME OF DEVICE: Multiplace Hyperbaric Chamber

CLASSIFICATION: 73 CBF, 21 CFR 868.5470

ESTABLISHMENT REGISTRATION NUMBER: 2029408

CLAIMED PREDICATE DEVICE(S):

Tampa Hyperbaric Enterprises' Multiplace Hyperbaric Chamber - K960389 Perry Sigma MP Multiplace Hyperbaric Chamber - K930748 Gulf Coast Hyperbarics Multiplace Hyperbaric Chamber - K 950957 Reimers T Class Hyperbaric Facility - K95438

ADDRESS OF MANUFACTURER:

OxyHeal Health Group, Inc. P.O. Box 1987 La Jolla, CA 92038

CONTACT PERSON: Dave Heaney

EXECUTIVE SUMMARY

The Undersea and Hyperbaric Medical Society (UHMS) defines hyperbaric oxygen therapy as breathing 100% oxygen at pressures higher than atmospheric in a hyperbaric chamber. Accordina to the National Fire Protection Association (NFPA), hyperbaric chambers are classified into two categories: Class A (multi-occupant) and Class B (single occupant). The OxyHeal 2000 series is a Class A multiplace hyperbaric chamber system designed to treat up to 12 patients to a maximum operating pressure of 6 Atmospheres Absolute (ATA) or 73.5 pounds per square inch gauge (psig). The chamber uses compressed air as the pressurization gas and 100% oxygen as the hyperbaric treatment gas.

The OxyHeal 2000 hyperbaric chamber series is intended to be procured and used by physicians to treat a variety of medical conditions that respond to hyperbaric oxygen. The Undersea and Hyperbaric Medical Society (UHMS) produces a list of medical conditions that have been identified for the appropriate primary or adjunctive use of hyperbaric oxygen. These approved conditions include: air or gas embolism; carbon monoxide poisoning and carbon monoxide poisoning complicated by cyanide poisoning; clostridial myositis and myonecrosis (gas gangrene); crush injury, compartment syndrome and other acute traumatic ischemias; decompression sickness; enhanced healing of selected problem wounds; exceptional blood loss anemia; necrotizing soft tissue infections; osteomyelitis (refractory);

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delaved radiation injury (soft tissue and bony necrosis); compromised skin flaps and graffs; thermal burns; and, intracranial abscess. Aggressive research into the beneficial effects of hyperbaric oxygen, when appropriately applied, will result in additional medical conditions being added to the list of indications by the UHMS.

The OxyHeal 2000 hyperbaric chamber series is designed and fabricated in accordance with the requirements of the ANSI/ASME Boiler and Pressure Vessel Code, Section VIII, Division 1. Pressure Vessels: ANSI/ASME-PVHO-1 (American Society of Mechanical Engineers-Pressure Vessels for Human Occupancy); and, NFPA 99, Health Care Facilities, Chapter 19, Hyperbaric Facilities. The overall external length of the chamber can range from 12 feet to 20 feet. Its internal diameter can range from 72 inches to 180 inches. When combined, these features allow for the state of the art, hands on treatment of one (1) to 12 ambulatory patients in comfort. Large circular windows create a more open atmosphere and help reduce patient claustrophobia. Pressurization is provided by compressed air with 100% oxygen ( administered to the patient by using properly fitting oro-nasal masks or head tents.

A low-voltage patient intercommunication system designed and installed in accordance with NFPA 99. Chapter 19 and provides communications between the patients in the chamber and the outside chamber operator. It also provides patients with audio program content from external sources such as TV's, cassette players, radios, etc. The system consists of a master station mounted on the chamber operator's control console that contains all of the controls and connection points.

Single operator chamber pressure control is achieved via a simple industrial adjustable controller with output and input feedback. A pneumatic and manually operated control system is provided for triple control redundancy.

A penetrator plate is provided in the vessel wall to allow user supplied intravenous lines, medical monitoring leads, etc., to be used as required. The large rectangular door allows a normal size patient gurney or wheelchair to be used to transport nonambulatory patients without having to transfer the patient to a smaller transport device. This feature greatly improves patient handling safety. OxyHeal has concluded that the general design approach, method of pressure control, and intended use of the OxyHeal 2000 hyperbaric chamber series is substantially equivalent to the Tampa Hyperbaric Enterprises' Hyperbaric Chamber (K960389). the Perry Baromedical Services Sigma MP Multiplace Hyperbaric Chamber (K930748), the Gulf Coast Hyperbarics, Inc. Multiplace Hyperbaric Treatment System (K950957), the Reimers Engineering T Class Hyperbaric Facility (K954387) and is proposing them as predicate devices for the OxyHeal 2000.

Intended Use:

It is the expressed, intended use of the OxvHeal 2000 hyperbaric chamber series to provide therapy to those patients with selected medical conditions that have been determined to respond to the application of hyperbaric oxygen. As a Class II prescriptive device, it is further intended for physician involvement in its procurement and routine use.

The UHMS is the professional medical organization chartered with setting the standards of care defining the appropriate use of hyperbaric oxygen. More specifically, the UHMS publishes a listing of medical conditions that have been clearly established as appropriate primary or adjunctive use of hyperbaric oxygen (HBO). The disorders on the list have been scientifically validated and verified through extensive data collection. It should be noted that the list is dynamic. Based on the strength of the scientific data, disorders are both added and removed from the list, depending on the outcomes of scientific pursuit.

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The conditions listed as appropriate for the use of HBO in the current edition of the Hyperbaric Oxygen Therapy Committee Report (1999) are as follows:

1. Air or gas embolism
1. Carbon monoxide poisoning and carbon monoxide poisoning complicated by cyanide poisoning
1. Clostridial myositis and myonecrosis
1. Crush injury, compartment syndrome, and other acute traumatic ischemias
1. Decompression sickness
1. Enhanced of selected problem wounds
1. Exceptional blood loss anemia
1. Necrotizing soft tissue infections
တ် Osteomyelitis (refractory)
1. Delayed radiation injury (soft tissue and bony necrosis)
1. Skin grafts and flaps (compromised)
1. Thermal burns
1. Intracranial abscess

The OxyHeal 2000 hyperbaric chamber series is designed to be installed and operated in medical facilities as defined by the NFPA 99, Health Care Facilities, Chapter 19, Hyperbaric Facilities. Further, this system is intended to be operated only by medical personnel specifically trained in the appropriate use of HBO and the safe operations of all related equipment such as the hyperbaric chamber.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, represented by a series of curved lines.

Public Health Service

JUN : 6 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Hyperbaric Technologies, Inc c/o Mr. Dave Heaney 3224 Hoover Avenue National City, CA 91950

Re: K011866

Oxyheal 2000 Hyperbaric Chamber Series Regulation Number: 868.5470 Regulation Name: Hyperbaric Chamber Regulatory Class: II (two) Product Code: CBF Dated: March 7, 2002 Received: March 13, 2002

Dear Mr. Heaney:

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. Dave Heaney

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 and additionally 21 CFR Part 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" (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.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Da Tule

Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known): Koll Blo ها

Device Name: OxyHeal 2000 Hyperbaric Chamber Series

Indications for Use:

The conditions listed as appropriate for the use of HBO in the current edition of the Hyperbaric Oxygen Therapy Committee Report (1999) are as follows:

1. Air or gas embolism
1. Carbon monoxide poisoning and carbon monoxide poisoning complicated by cyanide poisoning
1. Clostridial myositis and myonecrosis
1. Crush injury, compartment syndrome, and other acute traumatic ischemias
1. Decompression sickness
1. Enhanced healing of selected problem wounds
1. Exceptional blood loss anemia
1. Necrotizing soft tissue infections
1. Osteomyelitis (refractory)
1. Delayed radiation injury (soft tissue and bony necrosis)
1. Skin grafts and flaps (compromised)
1. Thermal burns
1. Intracranial abscess

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number K011866

(Optional Format 3-10-98)

Prescription Use
(Per 21 CFR 801.109)

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).