All of the contemporary substantially equivalent systems listed in Attachment 12 are used for the same indications as listed in the Hyperbaric Oxygen Therapy: Committee Report, Undersea and Hyperbaric Medical Society, Inc., Revised 1999.

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 .
Enhancement of Healing in Selected Problem Wounds ●
Exceptional Blood Loss (Anemia) .
. Intracranial Abscess
Necrotizing Soft Tissue Infections .
Osteomyelitis (Refractory) .
Delayed Radiation Injury (Soft Tissue and Bony Necrosis) .
Skin Grafts and Flaps (Compromised) ●
Thermal Burns .

Device Description

The BARA-MED® and its predicate devices have the same intended use: to promote the movement of oxygen into a patient's tissues by causing him to resvire oxygen at a pressure that is greater than that of the earth's atmosphere (i.e., 1 ATA). Specifically, the BARA-MED® and the predicate devices are indicated for 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; enhancement of healing in selected problem wounds; exceptional blood loss (anemia); intracranial abscess; necrotizing soft tissue infections; refractory osteomyelitis; delayed radiation injury (soft tissue and bony necrosis); compromised skin grafts and flaps; thermal burns. These indications for use are in accordance with the recommendations made by the Undersea and Hyperbaric Medical Society for the medical application of hyperbaric chambers.

The BARA-MED® and its predicate devices have very similar general principles of operation. All of these chambers are pressurized and ventilated continuously with pure oxygen, and the patient breathes the chamber atmosphere. Also, in each of the chambers, the pressure-time profile i.e., the rate and direction of pressure change and the time held at any particular pressure), as well as the oxygen ventilation rate of any treatment, are controlled by the chamber's operator, either directly by means of a pneumatic or electronic system, or indirectly by means of an automatic electronic system. The purposes of such controls are to be able to conduct the particular hyperbaric oxygen treatment prescribed by the physician in a way that is save and comfortable for the patient, and to be able to respond appropriately and effectively to any contingency circumstance.

The ETC BARA-MED® is designed and manufactured in accordance with the applicable sections of:

ASME Boiler and Presser Vessel Code, Section VII, Rules for ● Construction of Pressure Vessels, Division 1, 1998 Edition.
. ASME PVHO-1-1997, Safety Standard for Pressure Vessels for Human Occupancy.
NFPA 99, Standard for Health Care Facilities, Chapter 19, 199 . Edition.

In all respects, the BARA-MED® is substantially equivalent to one or more clinical monoplace hyperbaric chambers that are legally marketed for the conduct of hyperbaric oxygen therapy.

AI/ML Overview

This K993010 premarket notification describes a hyperbaric chamber, which is a medical device and not an AI/ML device. Therefore, the requested information on acceptance criteria and study details related to AI/ML device performance (e.g., sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, standalone performance) is not applicable and cannot be extracted from the provided text.

The provided text focuses on demonstrating the substantial equivalence of the "BARA-MED® Acrylic Monoplace Hyperbaric Chamber" to predicate devices, based on intended use, principles of operation, and compliance with engineering standards.

Here's the relevant information that can be extracted from the document:

1. Acceptance Criteria and Reported Device Performance (as related to a non-AI/ML device):

Acceptance Criteria (based on existing standards)	Reported Device Performance
Intended Use: Promote oxygen movement into patient tissues at pressures greater than 1 ATA for specific indications (as listed in Section {1} and {5})	The BARA-MED® and its predicate devices have the same intended use. (Section {1})
General Principles of Operation: Pressurized and ventilated continuously with pure oxygen, patient breathes chamber atmosphere, operator controls pressure-time profile and oxygen ventilation rate.	The BARA-MED® and its predicate devices have very similar general principles of operation. (Section {1})
Design and Manufacturing Standards Compliance:	ETC BARA-MED® is designed and manufactured in accordance with: (Section {1})
- ASME Boiler and Pressure Vessel Code, Section VII, Division 1, 1998 Edition	Meets this standard.
- ASME PVHO-1-1997, Safety Standard for Pressure Vessels for Human Occupancy	Meets this standard.
- NFPA 99, Standard for Health Care Facilities, Chapter 19, 1999 Edition	Meets this standard.
Substantial Equivalence: To one or more legally marketed clinical monoplace hyperbaric chambers.	In all respects, the BARA-MED® is substantially equivalent to one or more clinical monoplace hyperbaric chambers. (Section {1})

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 is a medical device submission based on substantial equivalence to existing devices and compliance with engineering standards, not a data-driven AI/ML study. Performance testing indicated "to demonstrate that the device meets the standards referenced above" (Section {2}) would refer to engineering and safety performance, not diagnostic accuracy on a dataset.

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. This is not an AI/ML device study.

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

Not applicable. This is not an AI/ML 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 is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

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

Not applicable. The "ground truth" in this context is adherence to established engineering and safety standards, and conformity to the intended use and operational principles of legally marketed predicate devices.

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/ML device.

Summary

{0}------------------------------------------------

K993010

510(k) SUMMARY

Environmental Tectonics Corporation's BARA-MED® Acrylic Monoplace Hyperbaric Chamber

SUBMITTER'S NAME AND ADDRESS

Environmental Tectonics Corporation ("ETC") Hyperbaric Division 125 James Way Southampton, PA 18966

CONTACT PERSON AND TELEPHONE/FACSIMILE NUMBERS

Micheal W. Allen Director, Hyperbaric Division Environmental Tectonics Corporation 125 James Way Southampton, PA 18966

Phone: (215) 355-9100. Ext. 373 Facsimile: (215) 357-4000

DATE PREPARED: September 3, 1999

NAME OF DEVICE

Trade of Proprietary Name: BARA-MED® Clinical Acrylic Monoplace Hyperbarid Chamber

Common Name: Hyperbaric Chamber

Classification Name: Hyperbaric chamber, 21 C.F.R. § 868.5470

PREDICATE DEVICES

Dixie Manufacturing Co.'s Dixie 800-45 (pre-amendment device) �
Perry Baromedical's Sigma I (pre-amendment device) �
Sechrist Industry's Sechrist 2500 (pre-amendment device) �
Sechrist Industry's Sechrist 2500E (K934164) �
Sechrist Industry's Sechrist 3200 (K950386) �

{1}------------------------------------------------

DEVICE DESCRIPTION/SUBSTANTIAL EQUIVALENCE

The ETC BARA-MED® is designed and manufactured in accordance with the applicable sections of:

ASME Boiler and Presser Vessel Code, Section VII, Rules for ● Construction of Pressure Vessels, Division 1, 1998 Edition.
. ASME PVHO-1-1997, Safety Standard for Pressure Vessels for Human Occupancy.
NFPA 99, Standard for Health Care Facilities, Chapter 19, 199 . Edition.

In all respects, the BARA-MED® is substantially equivalent to one or more clinical monoplace hyperbaric chambers that are legally marketed for the conduct of hyperbaric oxygen therapy.

{2}------------------------------------------------

PERFORMANCE DATA

Testing was indicated to demonstrate that the device meets the standards referenced above.

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

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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized wing-like shapes.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 3 0 2000

Environmental Tectonics Corp. C/O Hogan & Hartson L.L.P. 555 Thirteenth Street, N.W. Washington, DC 20004

Re: K993010 Rasa-Med, Acrylic Monoplace Hyperbaric Chamber Regulatory Class: II (two) 73 CBF Product Code: Dated: February 28, 2000 Received: March 1, 2000

Dear Mr. Holstein:

We have reviewed your Section 510(k) notification of intent to market we nave reviewed your beceien drown have determined the device is the device fereiched above and indications for use stated in the Substantially equivalence (essent to the devices marketed in encrosure) to regarif marito May 28, 1976, the enactment date of the Interstate Commerce prior co the devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and In accordance with the provident of ce, market the device, subject to the general controls provisions of the Act. The general controls che general conclude requirements for annual registration, pisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special II your device ID Class III (Premarket Approval), it may be subject to such controls) of Craco - Existing major regulations affecting your device aan be found in the Code of Federal Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. ed 653. If babbandad in the Practice requirements, as set with the Ourchio System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS ocheral regaracton od Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in assumptions. Turrare of comp-in, FDA may publish further announcements regaratory acurrently in the Federal Register. Please note: this concerning your dovemarket notification submission does not affect any reopone of your pat have under sections 531 through 542 of the Act obrigation you might have andric Product Radiation Control provisions, or other Federal laws or regulations.

{4}------------------------------------------------

Page 2 - Mr. Howard Holstein

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) 594-4648. 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 general 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/dsma/dsmamain.html".

Sincerely yours,

Mark N Millenson

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Page 1 of 1

510(k) Number (if known):

Device Name: BARA-MED® ACRYLIC MONOPLACE CHAMBER

Indications For Use:

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 .
Enhancement of Healing in Selected Problem Wounds ●
Exceptional Blood Loss (Anemia) .
. Intracranial Abscess
Necrotizing Soft Tissue Infections .
Osteomyelitis (Refractory) .
Delayed Radiation Injury (Soft Tissue and Bony Necrosis) .
Skin Grafts and Flaps (Compromised) ●
Thermal Burns .

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Mcllven K993610
Division Sign Off

Division of Cardiovascular, Respiratory, and Neurological Devices 93010 519(k) Number _

(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).