It is the expressed, intended use of the Hyperbaric America, LLC, Presidential Hyperbaric Chamber Systems 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 conditions listed as appropriate for the use of HBO by the Undersea & Hyperbaric Medical Society's Hyperbaric Oxygen Therapy Committee Report (2003) are as follows:

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

Device Description

The Hyperbaric America Presidential Monoplace Hyperbaric Chamber Systems (Model HA-34 and HA-38) are Class B monoplace hyperbaric chambers 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 gas. Air pressurization with oxygen delivery by mask is optional

The Presidential Hyperbaric Oxygen Systems are 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, 2007 Edition); and, NFPA 99, Health Care Facilities, Chapter 20, Hyperbaric Facilities, 2005 Edition. The overall external length of both models is 92 inches. The internal diameter of Model HA-34 is 33.5 inches and of Model HA-38 is 38 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 20 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 qurney. When loading, patient lies down on the fire retardant foamed bunk, aligned to the rails of the chamber and fixes four wheels of the gurney, 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.

AI/ML Overview

The provided text is a 510(k) Notification Summary for a medical device: the Hyperbaric America, LLC, Presidential Monoplace Hyperbaric Chamber Systems. This document is a regulatory submission for premarket notification to the FDA, demonstrating substantial equivalence to predicate devices, rather than a study report proving device performance against acceptance criteria in the typical sense of a diagnostic or AI-driven device.

Therefore, the requested information elements related to the acceptance criteria, study data, ground truth establishment, sample sizes, and expert reviews for such a study are not applicable to this type of document and device. This document describes the device, its intended use, and its adherence to established engineering and safety standards, rather than clinical performance metrics.

Here is a summary of the requested information, noting its applicability to the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Safety and Design Standards Compliance:
ANSI/ASME Boiler and Pressure Vessel Code, Section VIII, Division 1, Pressure Vessels	"designed and fabricated in accordance with the requirements"
ANSI/ASME-PVHO-1 (American Society of Mechanical Engineers-Pressure Vessels for Human Occupancy, 2007 Edition)	"designed and fabricated in accordance with the requirements"
NFPA 99, Health Care Facilities, Chapter 20, Hyperbaric Facilities, 2005 Edition	"designed and fabricated in accordance with the requirements" and "designed to be installed and operated in medical facilities as defined by the NFPA 99"
Operating Pressure:
Max operating pressure of 3 Atmospheres Absolute (ATA) or 29.4 psig	Device designed to treat one patient at up to a maximum operating pressure of 3 ATA or 29.4 psig
Patient Intercommunication:
Low-voltage patient intercommunication system meeting NFPA 99, Chapter 20 standards	"A low-voltage patient intercommunication system designed and installed in accordance with NFPA 99, Chapter 20 and provides communications between the patients in the chamber and the outside chamber operator."
Intended Use Conditions:
Appropriate for HBO use as per Undersea & Hyperbaric Medical Society's Hyperbaric Oxygen Therapy Committee Report (2003)	The device is intended to treat the 13 specified conditions listed in the 2003 report.
Material Specifications:
Constructed by half-steel and half-acrylic tube	"The chamber is constructed by half-steel and half-acrylic tube."
Fire retardant foamed bunk	"patient lies down on the fire retardant foamed bunk"

Note: This document focuses on demonstrating substantial equivalence to predicate devices and adherence to recognized safety and engineering standards for market clearance. It does not present clinical performance data in terms of accuracy, sensitivity, or specificity as would be expected for a diagnostic or AI-driven device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. This document is a regulatory submission for a medical device (hyperbaric chamber) and does not involve a "test set" of data in the context of diagnostic performance evaluation or AI model validation. The "study" mentioned here refers to the engineering design and manufacturing process adhering to established standards, rather than a clinical trial with a test set of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. "Ground truth" in the context of expert consensus on diagnostic images or outcomes data is not relevant to the approval of a hyperbaric chamber. The "truth" in this context is adherence to engineering codes and safety standards, and the recognized indications for hyperbaric oxygen therapy as established by medical societies.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. There is no "test set" or adjudication process described as this is not a diagnostic device study.

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 a hyperbaric chamber, not an AI-assisted diagnostic tool.

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

Not Applicable. This device is a hyperbaric chamber, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's approval is primarily based on:
- Adherence to recognized engineering and safety standards: ANSI/ASME Boiler and Pressure Vessel Code, ANSI/ASME-PVHO-1, and NFPA 99.
- Established medical literature and society recommendations: The conditions suitable for HBO therapy are those listed by "the Undersea & Hyperbaric Medical Society's Hyperbaric Oxygen Therapy Committee Report (2003)."

8. The sample size for the training set

Not Applicable. This document pertains to a physical medical 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. As there is no training set, this question is not relevant.

Summary

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KOSI 506

JUL 2 5 2008

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

Prepared: May 26, 2008

TRADE NAME: Hyperbaric America, LLC, Presidential Monoplace Hyperbaric Chamber Systems

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) Pan America Hyperbarics PAH-S1 (K021693) HyperTec 3200 (K002795)

ADDRESS OF MANUFACTURER:

284 Ridge Road Hinckley, OH 44233

CONTACT PERSON: Joe Adkins (216) 849-7847

SUMMARY

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Intended Use:

The conditions listed as appropriate for the use of HBO by the Undersea & Hyperbaric Medical Society's Hyperbaric Oxygen Therapy Committee Report (2003) are as follows:

1. Air or gas embolism
Carbon monoxide poisoning and carbon monoxide poisoning complicated by cyanide 2. poisoning
Clostridial myositis and myonecrosis ന്
ধ: Crush injury, compartment syndrome, and other acute traumatic ischemias
Decompression sickness ട്.
Enhanced healing of selected problem wounds 6.
1. Exceptional blood loss anemia
Necrotizing soft tissue infections 8.
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 Hyperbaric America, LLC, Presidential Hyperbaric Chamber Systems are 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, a symbol often associated with medicine and healthcare, placed to the right of the department's name. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the caduceus. The logo is presented in black and white.

Public Health Service

UUL 8 1 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Tom Workman Hyperbaric America, LLC 1811 Copper Ridge Drive San Antonio, TX 78259-3612

Re: K081506

Trade/Device Name: Hyperbaric America, LLC, Presidential Monoplace Hyperbaric Chamber Systems Regulation Number: 21 CFR 868.5470 Regulation Name: Hyperbaric Chamber Regulatory Class: II Product Code: CBF Dated: May 12, 2008 Received: May 2, 2008

Dear Mr. Workman:

This letter corrects our substantially equivalent letter of July 25, 2008.

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 (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 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. Workman

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to continue 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 (240) 276-[see OC organization structure below for correct phone extension]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Chih-Lin, Ph.D.

Chiu Lin, Ph.D. 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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Indications for Use

510(k) Number (if known): Pending

Device Name: Hyperbaric America, LLC, Presidential Monoplace Hyperbaric Chamber Systems

Indications for Use:

The conditions listed as appropriate for the use of HBO by the Undersea & Hyperbaric Medical Society's Hyperbaric Oxygen Therapy Committee Report (2003) are as follows:

1. Air or gas embolism
·2. 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. Osteomvelitis (refractory)
1. Delayed radiation injury (soft tissue and bony necrosis)
1. Skin grafts and flaps (compromised)
1. Thermal burns

Intracranial abscess

Prescription Use XX (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

vision of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

Page 1 of 1

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).