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 PAH-S1 Hyperbaric Chamber System is a Class B monoplace hyperbaric chamber designed to treat one patient at up to a maximum operating pressure of 3 Atmospheres Absolute (ATA) or 29.4 pounds per square inch gauge (psig). The chamber uses 100% oxygen as the pressurization gas and patient breathes the oxygen contained inside the chamber as the hyperbaric treatment das. The overall external length of the chamber is 2200mm (approx, 7.22 ft). Its internal diameter is 813mm (approx. 32 inches). The chamber is constructed by half-steel and half-acrylic tube. 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. The system consists of an operator control panel that contains all of the controls and connection points. Single operator chamber pressure control is achieved via a simple manual pneumatic control. Spare penetrators are provided to allow user supplied medical monitoring leads, etc., to be used as required. Patient is loaded and unloaded by a retractable qurnev. The chamber is also equipped with for pressurization. There is no gas supply for pressurization before the chamber's door is closed and secured thoroughly.

AI/ML Overview

This is a 510(k) premarket notification for a hyperbaric chamber system, not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, multi-reader multi-case studies, standalone performance, and ground truth for an AI device is not applicable and cannot be extracted from the provided text.

The document focuses on demonstrating substantial equivalence to predicate hyperbaric chambers by adhering to established safety and performance standards for such medical devices.

Here's a breakdown of what can be extracted, though it doesn't fit the AI/ML framework:

1. Acceptance Criteria and Reported Device Performance (Non-AI Context):

While not framed as "acceptance criteria" for an AI model, the submission implies adherence to specific engineering and safety standards, which serve as performance benchmarks for a hyperbaric chamber.

Acceptance Criteria (Implied by Standards)	Reported Device Performance
Maximum Operating Pressure	Up to 3 Atmospheres Absolute (ATA) or 29.4 pounds per square inch gauge (psig)
Pressurization Gas	100% oxygen
Construction Standards	Designed and fabricated in accordance with: - 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) - NFPA 99, Health Care Facilities, Chapter 20, Hyperbaric Facilities, 2002 Edition
Intercommunication System	Low-voltage system designed and installed in accordance with NFPA 99, Chapter 19 Maximum power to speaker: 250 mW at 1.4 volts (NFPA 99, Chapter 20 limit is 500 mW and 28 volts)
Operator Control	Single operator chamber pressure control achieved via a simple manual pneumatic control.
Safety Features	No gas supply for pressurization before the chamber's door is closed and secured thoroughly.
Intended Use	Therapy for selected medical conditions determined to respond to hyperbaric oxygen, as per UHMS guidelines (e.g., air/gas embolism, CO poisoning, decompression sickness, problem wounds, etc.)
Installation and Operation Environment	Designed to be installed and operated in medical facilities as defined by NFPA 99, Chapter 20. Intended to be operated only by medical personnel specifically trained in HBO use and safe operation.

The following points are not applicable/found in the document for this type of device:

Sample size used for the test set and the data provenance: Not applicable. This is a hardware device; testing involves engineering and safety validation, not a "test set" of data in the AI sense.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a hyperbaric chamber involves engineering specifications and safety standards, not expert consensus on medical image interpretation or similar AI tasks.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 for human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's safety and performance is adherence to recognized engineering and medical standards (ASME, NFPA 99, UHMS guidelines for indications).
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary

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K021693

OCT 2 4 2002

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

Prepared: May 12, 2002

TRADE NAME: Pan-America Hyperbarics, Inc., PAH-S1 Hyperbaric Chamber System

COMMON NAME OF DEVICE: Monoplace Hyperbaric Chamber

CLASSIFICATION: 73 CBF, 21 CFR 868.5470

ESTABLISHMENT REGISTRATION NUMBER: Pending

CLAIMED PREDICATE DEVICE(S):

Sechrist 2500 (K934164) Sechrist 2800 (K950386) Sechrist 3200 (K950386) Perry Sigma 1 (K832127) Perry Sigma 34 (K990927) ETC BaraMed (K993010) Tampa Hyperbarics "T.H.E." Chamber (K981938) HyperTec 3200 (K002795)

ADDRESS OF MANUFACTURER:

Pan-America Hyperbarics, Inc. No. 9, Lane 12, Guang Feng 1st Street Ba-de City, Tao Yuan County Taiwan, R.O.C. (886)-3-3676676

CONTACT PERSON: Cheng, Kuo-Chung, General Manager

EXECUTIVE SUMMARY

The PAH-S1 Hyperbaric Oxygen System 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 20, Hyperbaric Facilities, 2002 Edition. The overall external length of the chamber is 2200mm (approx, 7.22 ft). Its internal diameter is 813mm (approx. 32 inches). The chamber is constructed by half-steel and half-acrylic tube. A low-voltage patient intercommunication system designed and installed in accordance with NFPA 99, Chapter 19 and provides communications between the patients in the

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chamber and the outside chamber operator. Maximum power to the speaker is limited by the intercom circuitry to 250 mW at 1.4 volts (NFPA 99, Chapter 20 limit is 500 mW and 28 volts).

The system consists of an operator control panel that contains all of the controls and connection points. Single operator chamber pressure control is achieved via a simple manual pneumatic control. Spare penetrators are provided to allow user supplied medical monitoring leads. etc., to be used as required. Patient is loaded and unloaded by a retractable qurnev. When loading. patient lies down on the fire retardant foamed bunk, aligned to the rails of the chamber and fixes four wheels of the qurney, then push the bunk into the chamber. Unloading the patient with an opposite procedure. The chamber is also equipped with for pressurization. There is no gas supply for pressurization before the chamber's door is closed and secured thoroughly.

Intended Use:

It is the expressed, intended use of the Pan-America Hyperbarics, Inc., PAH-S1 Hyperbaric Chamber System 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.

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 1.
Carbon monoxide poisoning and carbon monoxide poisoning complicated by cyanide 2. poisoning
Clostridial myositis and myonecrosis 3.
Crush injury, compartment syndrome, and other acute traumatic ischemias 4.
Decompression sickness 5.
Enhanced healing of selected problem wounds 6.
Exceptional blood loss anemia 7.
Necrotizing soft tissue infections 8.
ഗ് Osteomyelitis (refractory)
1. Delayed radiation injury (soft tissue and bony necrosis)
1. Skin grafts and flaps (compromised)
1. Thermal burns
1. Intracranial abscess

The Pan-America Hyperbarics, Inc., PAH-S1 Hyperbaric Chamber System is designed to be installed and operated in medical facilities as defined by the NFPA 99, Health Care Facilities, Chapter 20, 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 operation of all related equipment such as the hyperbaric chamber.

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Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features an abstract design of three human profiles facing right, stacked on top of each other. The profiles are rendered in black against a white background. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the design.

OCT 2 4 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Pan-America Hyperbarics, Incorporated C/O Mr. W. T. Workman Workman Hyperbaric Services, Incorporated 18111 Copper Ridge Drive San Antonio, Texas 78259-3612

Re: K021693

Trade/Device Name: Hyperbaric Chamber System, Model PAH-S1 Regulation Number: 868.5470 Regulation Name: Hyperbaric Chamber Regulatory Class: II Product Code: CBF Dated: September 5, 2002 Received: September 6, 2002

Dear Mr. Workman:

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.

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Page 2 - Mr. Workman

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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ulatowski

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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510(k) Number (if known): KO21643

Device Name: Pan-America Hyperbarics, Inc., PAH-S1 Hyperbaric Chamber System

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
Enhanced healing of selected problem wounds 6.
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)

fothin

Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K032693

(Optional Format 3-10-98)

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).