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 (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)
Delayed radiation injury (soft tissue and bony necrosis)
Skin grafts and flaps (compromised)
Thermal burns
Intracranial abscess

Device Description

The Makai Marine Industries Hyperbaric Chamber System is a Class A multiplace hyperbaric chamber system designed to treat up to 20 patients to a maximum treatment 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 11 feet to 40 feet. Its internal diameter can range from 42 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 oral-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 simple adjustable control valves providing infinite control. Multiple penetrators and/or penetrator plate is provided in the vessel wall to allow user supplied intravenous lines, medical monitoring leads, etc., to be used as required. Where applicable a large rectangular door(s) 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

This document describes a 510(k) premarket notification for the Makai Marine Industries, Inc. (MMI) Hyperbaric Chamber System.

Based on the provided text, there is no acceptance criteria or study demonstrating device performance in the typical sense of a clinical trial with specific metrics like sensitivity, specificity, or reader improvement. This document is a regulatory submission to the FDA seeking substantial equivalence to existing predicate devices, not a report on a clinical performance study.

Here's an analysis based on the structure of your request:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for a clinical study. The acceptance criteria for this 510(k) submission are regulatory in nature, focusing on meeting design standards and demonstrating substantial equivalence to predicate devices.
Reported Device Performance: Not reported in clinical performance metrics. The document describes the device's technical capabilities (e.g., maximum pressure, patient capacity, pressurization gas) and its intended use, which aligns with the indications of existing hyperbaric chambers.

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 does not describe a performance study with a test set. This is a regulatory submission for premarket clearance.

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: As there is no performance study described, there is no ground truth establishment for a test set. The "ground truth" for the device's intended use is established by the medical community, specifically the Undersea and Hyperbaric Medical Society (UHMS), which publishes a list of approved medical conditions (indications for use). This is a consensus-based approach from a medical professional body, not specific experts for a performance study.
- Qualifications of Experts for UHMS lists: The UHMS is a professional medical society. While not explicitly stated in this document, their lists are typically based on extensive scientific data reviewed by committees of hyperbaric medicine specialists (physicians, researchers, etc.) with significant experience in the field.

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

Not Applicable: No test set or performance study is described.

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: No MRMC study was done, as this is not an AI-assisted diagnostic device. It is a hyperbaric chamber.

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

Not Applicable: This is not an algorithm or AI device.

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

The "ground truth" for the indications for use (the medical conditions the device is intended to treat) is based on expert consensus and scientifically validated data collection by the Undersea and Hyperbaric Medical Society (UHMS). The document states: "The disorders on the list have been scientifically validated and verified through extensive data collection." This is not ground truth for a device performance study, but for the medical efficacy of the treatment itself.

8. The sample size for the training set

Not Applicable: There is no "training set" as this is not a machine learning device or a clinical study evaluating its performance against a specific dataset.

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

Not Applicable: No training set.

Summary:

The provided document is a 510(k) premarket notification for a hyperbaric chamber. Its purpose is to demonstrate substantial equivalence to legally marketed predicate devices, not to present a clinical performance study with defined acceptance criteria for metrics like sensitivity or specificity. The "performance" of the device is described in terms of its technical specifications (e.g., pressure, capacity, construction materials meeting standards) and its intended use, which aligns with established medical indications for hyperbaric oxygen therapy as defined by the UHMS.

Summary

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

Image /page/0/Picture/0 description: The image shows the text "K030418" in a handwritten style. The text is oriented diagonally, with the "K" at the bottom left and the "8" at the top right. The handwriting appears to be in black ink on a white background, and the letters are somewhat bold and slightly distorted.

JAN 2 9 2004

Makai Marine Industries, Inc.

EXHIBIT "A"

510(k) NOTIFICATION SUMMARY (Per 21 CFR 807.9)

Prepared: 27 January 2003

TRADE NAME: Makai Marine Industries, Inc. (MMI) Hyperbaric Chamber System COMMON NAME OF DEVICE: Multiplace Hyperbaric Chamber CLASSIFICATION: 73 CBF, 21 CFR 868.5470 ESTABLISHMENT REGISTRATION NUMBER: 1063240

CLAIMED PREDICATE DEVICE(S):

Perry Sigma MP Multiplace Hyperbaric Chamber - K930748

Gulf Coast Hyperbarics Multiplace Hyperbaric Chamber - K950957

Reimers T Class Hyperbaric Facility - K95438

Tampa Hyperbaric Enterprises' Multiplace Hyperbaric Chamber - K960389

ADDRESS OF MANUFACTURER:

Makai Marine Industries, Inc. P.O. Box 272039 Boca Raton, FL 33427-2039 730 S. Deerfield Avenue # 8 & 9 Deerfield Beach, FL 33441

CONTACT PERSON:

Marc Kaiser (305) 987-2247, Fax (305) 856-8795

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

EXECUTIVE SUMMARY

The Undersea and Hyperbaric Medical Society (UHMS) defines hyperbaric oxygen therapy as Inc Onection and Ityperoat pressures higher than atmospheric in a hyperbaric chamber. breating to the National Fire Protection Association (NFPA), hyperbaric chambers for humans are classified into two categories: Class A (multi-occupant) and Class B (single occupant). The Makai Marine Industries Hyperbaric Chamber System is a Class A multiplace hyperbaric chamber system designed to treat up to 20 patients to a maximum treatment 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 Makai Marine Industries, Inc. (MMI) Hyperbaric Chamber System is intended to be Procured and used by physicians to treat a variety of medical conditions that respond to produces and and as a los by of the 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), delayed radiation injury (soft tissue and bony necrosis); compromised skin flaps and grafts; thermal bums; 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 Makai Marine Industries, Inc. (MMI) Hyperbaric Chamber System is designed and will be fabricated in accordance with the requirements of the ANSI/ASME Boiler and Pressure Vessel Code, Section VIII, Division 1, Pressure Vessels; ANSVASME-PVHO-1 (American Society of Mechanical Engineers Pressure Vessels for Human Occupancy); and, NFPA 99, Health Care Facilities, Chapter 20, Hyperbaric Facilities. The overall external length of the chamber can range from 11 feet to 40 feet. Its internal diameter can range from 42 inches to 180 inches. When combined, these features allow for the state of the art, hands on treatment of one (1) to 20 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 oral-nasal masks or head tents.

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. 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 simple adjustable control valves providing infinite control.

Multiple penetrators and/or penetrator plate is provided in the vessel wall to allow user supplied intravenous lines, medical monitoring leads, etc., to be used as required. Where applicable a large rectangular door(s) allows a normal size patient gurney or wheelchair to be

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

used to transport nonambulatory patients without having to transfer the patient to a smaller transport device. This feature greatly improves patient handling safety. MMI has concluded that the general design approach, method of pressure control, and intended use of the Makai Marine Industries, Inc. (MMI) Hyperbaric Chamber System is substantially equivalent to the Perry Industries, the (innif) fryperoats Multiplace Hyperbaric Chamber (K930748); the Tampa Baronical Berrices brighternaric Chamber (K960389); the Gulf Coast Hyperbarics, Inc. Hyperbaric Enterprises Tryportant System (K950957); the Reimers Engineering T Class Multiplace Tryperbaric Treamean bys proposing them as predicate devices for the MMI Hyperbaric Chamber System.

INTENDED USE:

It is the expressed, intended use of the Makai Marine Industries, Inc. MMI 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 Is ratther medical organization chartered with setting the standards of care defining the propriate 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:

1. Air or gas embolism
1. Carbon monoxide poisoning and carbon monoxide poisoning complicated by cyanide poisoning
1. Clostridial myositis and Myonecrosis (Gas Gangrene)
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
1. Intracranial abscess

The Makai Marine Industries, Inc. (MMI) 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 operations of all related equipment such as the hyperbaric chamber.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

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 a stylized symbol that resembles three parallel lines curving upwards and to the right, with a wavy line underneath.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 9 2004

Mr. Marc R. Kaiser Makai Marine Industries, Inc. P.O. Box 27-2039 Boca Raton, FI. 33427-2039

Re: K030418

Trade/Device Name: Model MMI Multiplace Hyperbaric Chamber Regulation Number: 868.5470 Regulation Name: Hyperbaric Chamber Regulatory Class: II Product Code: CBF Dated: November 4, 2003 Received: November 10, 2003

Dear Mr. Kaiser:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becases is see is substantially equivalent (for the referenced above and have determined are to tegally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device interstate conmicree prior to thay 20, 1978, clossified in accordance with the provisions of Amendinents, on to devices that have book (Act) that do not require approval of a premarket the Federal Food, Drug, and Cosment I 100 may, therefore, subject to the general approval approvision (1 hirvest. The general controls provisions of the Act include controls provisions of the Fre. - The Litting of devices, good manufacturing practice, lequirements for aihitions 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 (PMA), It may be subject to such adam size and Regulations, Title 21, Parts 800 to 898. In the And your device can oc found in the Could receined.
addition, FDA may publish further announcements concerning your device in the Federal Register.

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

Page 2 – Mr. Marc R. Kaiser

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. or the rest or mily 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 requirentle, 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 premaired 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), 11 you dontact the Office of Compliance at (301) 594-4646. 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 Inter 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,

Chiu Lin, Ph.D.

Director Division of Anesthesiology, General IIospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known): #K030418

Device Name: MMI 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 (Gas Gangrene)
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

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

signature

Anesthesiology Genera

510(k) Number

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).