It is the expressed, intended use of the Fink Engineering SL8/DL8 and TL20 Hyperbaric Oxygen Treatment Facilities 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 their procurement and routine 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:

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 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 SL/DL8 and TL20 Hyperbaric Oxygen Treatment Facilities are Class A multiplace hyperbaric chambers designed to treat up to 8 (SL/DL8) or 20 (TL20) patient at up to a maximum operating pressure of 3 Atmospheres Absolute (ATA) or 29.4 pounds per square inch gauge (psig) for the SL8 and up to 6 Atmospheres Absolute (ATA) or 73.5 psig for the DL8 and TL20. Each facility utilizes air as the pressurization gas and 100% oxygen as the hyperbaric treatment gas.

The SL/DL8/TL20 rectangular hyperbaric chamber(s) include as a key component a new and very user-friendly rectangular chamber designed and manufactured specifically for the medical community to be used for hyperbaric oxygen treatment. The design of this unique ASME PVHO chamber has been driven by comments from hyperbaric physicians, technicians and nurses who require their equipment to be simple, easy to use and to simulate clinical conditions found elsewhere in their working environment.

The SL/DL8/TL20 facilities place major emphasis on patient comfort and user-friendly operator controls and incorporate several innovative and unique features including:

A large, comfortable rectangular hyperbaric chamber that has been outfitted to appear like any other clinical room in a hospital to reduce patient anxiety
A rectangular medical lock with a unique locking system enabling single-handed operation
Large walk-trough rectangular sliding doors that fit flush with the floor so that patients can be wheeled into the chamber without bumping over a door jam
An easy to use control panel with large VDU display to monitor the treatment profile including the internal chamber pressure, temperature, humidity, oxygen and carbon dioxide parameters
An oxygen delivery system with venturi assisted overboard exhaust to eliminate the possibility of "shrink wrapping" patients with their oxygen hoods
Whisper quiet ventilation system to pneumatically control temperature, humidity and upper oxygen limit without the need for internal electrical blowers
Aesthetically pleasing external chamber cladding

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the SL8/DL8 and TL20 Hyperbaric Oxygen Treatment Facilities:

Based on the provided 510(k) summary, the device is a Multiplace Hyperbaric Chamber, and the review focuses on substantial equivalence to predicate devices, rather than a de novo clinical study with specific acceptance criteria in the manner typically applied to novel diagnostic or therapeutic AI algorithms.

Therefore, many of the requested categories for AI-based device studies are not directly applicable to this type of submission. However, an attempt has been made to interpret the available information relative to your request.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are primarily based on demonstrating substantial equivalence to legally marketed predicate devices and adherence to relevant industry standards for safety and performance of hyperbaric chambers. The "performance" here refers to meeting design specifications and intended use as a hyperbaric oxygen treatment facility, rather than a diagnostic accuracy or treatment efficacy metric that would typically be seen in AI studies.

Acceptance Criteria Category	Reported Device Performance/Meeting Criteria
Design and Manufacturing Standards	Adherence to: - ANSI/ASME Boiler and Pressure Vessel Code, Section VIII, Division 1, Pressure Vessels - ANSI/ASME-PVHO-1 (Pressure Vessels for Human Occupancy) - NFPA 99, Health Care Facilities, Chapter 19 (or 20, 2002 Edition), Hyperbaric Facilities
Intended Use	The facilities are intended to provide hyperbaric oxygen therapy for medical conditions identified by the Undersea and Hyperbaric Medical Society (UHMS) as appropriate for HBO. The listed indications for use are identical to those established by UHMS.
Operating Pressure	SL8: 3.0 ATA (Maximum operating pressure up to 3 ATA or 29.4 psig) DL8/TL20: 6.0 ATA (Maximum operating pressure up to 6 ATA or 73.5 psig for DL8 and TL20)
Operating Temperature	62°F to 100°F (across all models)
Design Life	70,000 cycles (30 years) (across all models)
Safety Features	Includes fire suppression (IAW NFPA 99), medical lock, communication systems, oxygen delivery systems to prevent "shrink wrapping" patients, quiet ventilation.
Operational Controls	Manual electropneumatic pressurization/depressurization, digital depth measurement with analog backup, oxygen and carbon dioxide gas analysis, environmental control (heating).

Study Information

Given this is a 510(k) for a multiplace hyperbaric chamber, it is not a clinical study in the sense of comparing a new AI algorithm's performance against a reference standard using patient data. Instead, it's an engineering and regulatory demonstration of substantial equivalence.

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- This is not applicable as there is no "test set" of patient data or algorithm performance evaluation. The submission refers to the design, manufacturing, and technical specifications of the hyperbaric chambers themselves. The "study" is the manufacturing process adhering to established standards and the comparison of the device's specifications to those of predicate devices.
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. There is no ground truth, test set, or expert panel in the context of an AI study. The "ground truth" for this device's utility is the established medical practice of hyperbaric oxygen therapy for the listed indications, as defined by the UHMS.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. There is no test set or adjudication method as described for AI studies.
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 physical hyperbaric chamber, not an AI-assisted diagnostic or therapeutic tool for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for the intended use of the device is the list of medical conditions for which hyperbaric oxygen therapy has been "clearly established as appropriate primary or adjunctive use," as defined and continuously updated by the Undersea and Hyperbaric Medical Society (UHMS). This relies on extensive data collection, validation, and scientific pursuit by a professional medical organization.
The sample size for the training set:
- Not applicable per the typical definition for AI models. The "training" for this device would be analogous to the cumulative engineering knowledge, design principles, and manufacturing processes that conform to established safety and performance standards for hyperbaric chambers.
How the ground truth for the training set was established:
- Not applicable in the AI context. The "ground truth" for the device's design and functionality is established through international and national engineering codes and standards (ASME, NFPA) and the medical consensus on hyperbaric therapy indications (UHMS). The manufacturer's design approach and method of control are compared to well-established predicate devices.

Summary

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K0316449

DEC - 5 2003

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

Prepared: 26 May 2003

TRADE NAME: SL8 Hyperbaric Oxygen Treatment Facility DL8 Hyperbaric Oxygen Treatment Facility TL20 Hyperbaric Oxygen Treatment Facility

COMMON NAME OF DEVICE: Multiplace Hyperbaric Chamber

CLASSIFICATION: 73 CBF, 21 CFR 868.5470

ESTABLISHMENT REGISTRATION NUMBER: Pending

CLAIMED PREDICATE DEVICE(S):

Perry Sigma MP Multiplace Hyperbaric Chamber - K930748 Gulf Coast Multiplace Hyperbaric Chamber - K950957 Reimers T Class Hyperbaric Chamber - K954387

ADDRESS OF MANUFACTURER:

Fink Engineering PTY LTD 100 Talinga Road Cheltenham Victoria 3192 Australia Tele: 03-9585-2966

CONTACT PERSON: Eric Fink, Managing Director

EXECUTIVE SUMMARY

The Undersea and Hyperbaric Medical Society (UHMS) defines hyperbaric oxygen therapy The Ondersea and Hyperbart lessures higher than atmospheric in a hyperbaric chamber. as breating 100% offyger Fire Protection Association (NFPA), hyperbaric chambers are According to the National Fire Fress A (multi-occupant) and Class B (single occupant). The Classined into two outsgen Treatment Facilities are Class A multiplace hyperbaric chambers designed to treat up to 8 (SL/DL8) or 20 (TL20) patient at up to a maximum operating pressure of 3 Atmospheres Absolute (ATA) or 29.4 pounds per square maximum operating procears of 0 %... 8 %... 6 %. or 73.5 psig for the DL8 and TL20. Each incil gauge (psig) for the OLD and up tessurization gas and 100% oxygen as the hyperbaric treatment gas.

The SL/DL8 and TL20 Hyperbaric Oxygen Treatment Facilities are intended to be procured The UEDEO and TEE Fry tribate a variety of medical conditions that respond to hyperbaric and used by pryololane to trout itst of medical conditions that have been identified for the appropriate primary or adjunctive use of hyperbaric oxygen. These approved conditions

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include: air or gas embolism; carbon monoxide poisoning and smoke inhalation; clostridial include. and of gas embolism, oalbert may and partment syndrome and other acute traumatic ischemias; decompression sickness; enhanced healing of selected problem wounds; lightinas, decompreasion visime rotizing soft tissue infections; osteomyelitis (refractory); radiation tissue damage (osteoradionecrosis); compromised skin flaps and grafts; thermal radiation though abscess. Aggressive research into the beneficial effects of burns, and, measure when appropriately applied, will result in additional medical conditions being added to the list of indications by the UHMS.

The SL/DL8 and TL20 Hyperbaric Oxygen Treatment Facilities are designed and fabricated in accordance with the requirements of the ANSI/ASME Boiler and Pressure Vessel Code, in abool admod will, Division 1, Pressure Vessels; ANSI/ASME-PVHO-1 (American Society of Scoton Vill, Engineers-Pressure Vessels for Human Occupancy); and, NFPA 99, Health Care Facilities, Chapter 19 (Chapter 20, 2002 Edition), Hyperbaric Facilities.

The SL/DL8/TL20 rectangular hyperbaric chamber(s) include as a key component a new and very user-friendly rectangular chamber designed and manufactured specifically for the medical community to be used for hyperbaric oxygen treatment. The design of this unique ASME PVHO chamber has been driven by comments from hyperbaric physicians, technicians and nurses who require their equipment to be simple, easy to use and to simulate toomlount and harded inical conditions found elsewhere in their working environment.

The SL/DL8/TL20 facilities place major emphasis on patient comfort and user-friendly operator controls and incorporate several innovative and unique features including:

A large, comfortable rectangular hyperbaric chamber that has been outfitted t . appear like any other clinical room in a hospital to reduce patient anxiety
A rectangular medical lock with a unique locking system enabling single-handed . operation
Large walk-trough rectangular sliding doors that fit flush with the floor so that . patients can be wheeled into the chamber without bumping over a door jam
An easy to use control panel with large VDU display to monitor the treatment . profile including the internal chamber pressure, temperature, humidity, oxygen and carbon dioxide parameters
An oxygen delivery system with venturi assisted overboard exhaust to eliminate . the possibility of "shrink wrapping" patients with their oxygen hoods
Whisper quiet ventilation system to pneumatically control temperature, humidity . and upper oxygen limit without the need for internal electrical blowers
Aesthetically pleasing external chamber cladding .

Specifications of the SL8 Hyperbaric Oxygen Treatment Facility are as follows:

Design Code	ASME Section VIII, Div 1 and ASME PVHO-1
Operating Pressure	3.0 ATA
Operating Temperature	62°F to 100°F
Design Pressure	32.3 psi
Design Temperature	62°F to 100°F
Design Life	70,000 cycles (30 years)
Hydrostatic Pressure	42.0 psi
Inspection Authority	ASME "U" Stamp
Weight	~15,432 lbs
Dimensions	8.1ftW X 7ftH X 10.8 ft L
Volume	586 ft³
Medical Lock	13.8 in X 13.8 in X 19.7 in
Doorway Size	32.2 in X 75.6 in

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Lighting13 in ID viewports5.9 in ID viewportCapacityFire SuppressionFinishLife Support Controls	Four external dimmable lightsTwo PVHOOne PVHOEight seated personsIAW NFPA 99Shotblasted and PaintedManual electropneumatic pressurizationManual electropneumatic depressurization
Environmental ControlVentilationBIBS with overboard dumpHoods with overboard dumpDepth MeasurementGas AnalysisCommunications	HeatingConstant airflowFourFourDigital with analog backupOxygen and carbon dioxideInternal/external PA SystemSound powered phone backup
EntertainmentTV System	Individual four-channel selection for eight personsExternal color with remote controlAM/FM Tuner/CD & DVD Player

Specifications of the DL8 Hyperbaric Oxygen Treatment Facility are as follows:

Design Code	ASME Section VIII, Div 1 and ASME PVHO-1
Operating Pressure	6.0 ATA
Operating Temperature	62°F to 100°F
Design Pressure	80.0 psi
Design Temperature	62°F to 100°F
Design Life	70,000 cycles (30 years)
Hydrostatic Pressure	104.0 psi
Inspection Authority	ASME "U" Stamp
Weight	~26,400 lbs
Main Lock Dimensions	8.1ftW X 7ftH X 11ftL
Entrance Lock Dimensions	8.1ftW X 7ftH X 4.5ftL
Volume (ML)	614.5 ft3
Volume (EL)	254.3 ft3
Total Volume	868.7 ft3
Medical Lock	13.8 in X 13.8 in X 19.7 in
Main Doorway Size	39.4 in X 75.6 in
Lighting	Six external dimmable lights
13.8 in ID viewports	Two PVHO in ML
5.9 in ID viewports	One PVHO in each lock
Main Lock Capacity	Eight seated personsFour wheelchairsOne hospital gurney
Fire Suppression	IAW NFPA 99
Finish	Shotblasted and Painted
Life Support Controls	Manual electropneumatic pressurizationManual electropneumatic depressurization
Environmental Control	Heating
Ventilation	Constant airflow
BIBS with overboard dump	Two
Hoods with overboard dump	Six
Depth Measurement	Digital with analog backup
Gas Analysis	Oxygen and carbon dioxide
Communications	Internal/external PA SystemSound powered phone backup

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Entertainment	Individual four-channel selection for eight persons
TV System	External color with remote control
Compartment Relief	AM/FM Tuner/CD & DVD Player
Compartment Drain	ASME certified relief valve
	One manual drain valve in each lock

Specifications of the TL20 Hyperbaric Oxygen Treatment Facility are as follows:

ASME Section VIII, Div 1 and ASME PVHO-1 Design Code Operating Pressure 6.0 ATA 62°F to 100°F Operating Temperature 80 psi Design Pressure 62°F to 100°F Design Temperature 70,000 cycles (30 years) Design Life 104.0 psi Hydrostatic Pressure ASME "U" Stamp Inspection Authority ~110,231 lbs Weight 10.3 ftW X 7ftH X 19.3 ftL Main Lock Dimensions 7.8 ftW X 7 ftH X 10.8ftL Entrance Lock Dimensions 7/8 ftW X 7 ftH X 10.8 ftL Inner Lock Dimensions 1536.2 ft3 Volume (ML) 529.7 ft3
480.3 ft3 Volume (EL) Volume (IL) 2546.2 H³ Total Volume 13.8 in X 13.8 in X 19.7 in Medical Lock 39.4 in X 75.6 in Main Doorway Size Fourteen external dimmable lights Lighting 23.6 in ID viewports Four PVHO Three PVHO 13 in ID viewports Two PVHO 6 in ID viewports Up to twenty persons Capacity Fire Suppression IAW NFPA 99 Shotblasted and Painted Finish Manual electropneumatic pressurization Life Support Controls Manual electropneumatic depressurization Environmental Control Heating Constant airflow Ventilation BIBS with overboard dump Four Twenty-two Hoods with overboard dump Digital with analog backup Depth Measurement Oxygen and carbon dioxide Gas Analysis Internal/external PA System Communications Sound powered phone backup Individual four-channel selection for eight persons Entertainment External color with remote control TV System AM/FM Tuner/CD & DVD Player

Fink Engineering has concluded that the general design approach, method of pressure control, and intended use of the SL&/DL8 and TL 20 Hyperbaric Oxygen Treatment Facilities are substantially equivalent to the Perry Baromedical Services Sigma MP Multiplace are ouberantially oque (KS30748), the Gulf Coast Multiplace Hyperbaric Chamber (K950957) and the Reimers Engineering T Class Multiplace Hyperbaric Chamber (K954387) and is proposing them as predicate devices for the SL8/DL8 and TL20 Hyperbaric Oxygen Treatment Facilities.

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Intended Use:

It is the expressed, intended use of the Fink Engineering SL8/DL8 and TL20 Hyperbaric Oxygen Treatment Facilities to provide therapy to those patients with selected medical Oxygen Trouthons 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 their 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 our cloning the appropriations that have been clearly established as appropriate primary or adjunctive use of hyperbaric oxygen (HBO). The disorders on the list have been primary of dajaridated 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 2. cvanide poisoning
Clostridial myositis and myonecrosis ന്
Crush injury, compartment syndrome, and other acute traumatic ischemias 4.
Decompression sickness ട്.
Enhanced of selected problem wounds .
Exceptional blood loss anemia 7.
Necrotizing soft tissue infections 8.
Osteomyelitis (refractory) ഗ്
1. Delayed radiation injury (soft tissue and bony necrosis)
1. Skin grafts and flaps (compromised)
1. Thermal burns
1. Intracranial abscess

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Image /page/5/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 graphic of an eagle or bird-like symbol with three curved lines representing its wings or body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 5 2003

Fink Engineering Pty. Ltd. c/o Mr. W. T. Workman Workman Hyperbaric Services. Inc. 18111 Copper Ridge Dr. San Antonio, TX 78259

Re: K031649

Trade/Device Name: Multiplace Hyperbaric Oxygen Treatment Chamber, Models SL8/DL8/TL20 Regulation Number: 868.5470 Regulation Name: Hyperbaric Chamber Regulatory Class: II Product Code: CBF Dated: September 30, 2003 Received: October 1, 2003

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.

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Page 2 - Mr. W. T. 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 (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), please contact 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 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,

Susan Runnd

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): K031649

Device Name: Fink Engineering PTY LTD, SL8/DL8 and TL20 Hyperbaric Treatment Facilities

Indications For Use:

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 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

X Prescription Use _ (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 IN NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Intochu

Page 1 of

510(k) Number: K031649

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).