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

1. Air or gas embolism
1. Carbon monoxide poisoning and carbon monoxide poisoning complicated by cyanide poisoning
1. Clostridial myonecrosis and myonecrosis
1. Crush injuries, compartment syndrome, and other acute traumatic ischemias
1. Decompression sickness
1. Enhancement of healing of selected problem wounds
1. Exceptional blood loss anemia
1. Necrotizing soft tissue infections
1. Osteomyelitis (refractory)
1. Delayed radiation injuries (soft tissue and bony necrosis)
1. Compromised grafts and flaps
1. Acute Thermal Burn Injury
1. Intracranial abscess

Device Description

The FINK Hyperbaric Chamber is the rectangular pressure vessel that is identical in construction to the rectangular hyperbaric chambers covered by Fink's previously cleared K031649 which are all designed and built to meet the Safety Standard for Pressure Vessels for Human Occupancy ASME PVHO-1 and are certified accordingly. Chamber configurations vary depending upon the requirements set forth by the end user and supplied in the following configurations:

Single Compartment - FESL
Double Compartment - FEDL
Triple Compartment FETL ●
Patient capacities can range from four (4) to 28 twenty-eight (28) patients per chamber depending on the number of compartments required by the User. The pressure range for the individual compartments may also vary for the same reason with a minimum of 3.0 ATA to 6.0 ATA maximum allowable working pressures and design temperature range from 15℃ to 38℃ per compartment. The specific parameters for each chamber are defined by a User Design Specification which is approved by a Registered Professional Engineer in accordance with ASME PVHO-1. These chambers also comply with the National Fire Protection Agency (NFPA)
The chambers include the following features:
Fire Protection
Compressed air system ●
Oxygen Delivery ●
Environmental control system ●
Unintended power supply ●
Control Console ●

AI/ML Overview

Based on the provided text, the device in question is a Hyperbaric Chamber, and the submission is a 510(k) premarket notification for substantial equivalence. This type of submission relies on comparing the new device to a legally marketed predicate device rather than presenting detailed clinical study data proving efficacy or standalone performance against specific acceptance criteria for a novel AI/software function.

The document describes the acceptance criteria and study that proves the device meets the acceptance criteria in terms of substantial equivalence to a predicate device, rather than explicit performance metrics for a complex AI algorithm against a ground truth. Therefore, the "acceptance criteria" here refers to the criteria for demonstrating substantial equivalence as required for a 510(k) clearance, and the "study" comprises the validation and verification testing conducted to support that claim.

Here's a breakdown based on the information provided, tailored to the context of a 510(k) submission for a hyperbaric chamber:

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

The "acceptance criteria" for a 510(k) submission revolve around demonstrating that the new device is as safe and effective as a legally marketed predicate device. The performance data presented is primarily to show that any differences in technological characteristics do not raise new questions of safety or effectiveness.

Acceptance Criteria (related to Substantial Equivalence)	Reported Device Performance (as demonstrated by testing and comparison)
Identical Indications for Use	The indications for use are identical to the predicate device, derived from the UHMS Hyperbaric Oxygen Therapy Committee Report.
Similar Technological Characteristics (or differences do not raise new safety/effectiveness questions)
Compartment Interior Volume	Expanded (72 SCM to 119 SCM for FETL), but equivalent due to testing to PVHO to ensure construct meets industry requirements, same materials, and identical max pressure.
Patient Capacity	Expanded (up to 28 for FETL vs. up to 20 for TL20), but equivalent as capacity varies by contract, and testing demonstrates applicable standards are met.
Weight	Expanded (up to ~145,000 lbs vs. ~110,231 lbs), but equivalent as weight varies with patient capacity.
Operating Temperature Range	Slightly broader (59°F - 100°F vs. 62°F - 100°F), but does not raise new questions of safety and effectiveness.
Pressure Control Scheme	Changed from Electropneumatic to PLC with manual backup, which is equivalent to the reference device (K152223) and supported by software testing and performance testing. Does not raise new questions of safety and effectiveness.
Emergency Decompression Rate	Same (27.5 ft/min from 6 ATA in 6 mins), adheres to a more current version of NFPA 99 (2005 Ed. vs 2002 Ed.).
Normal Ventilation Rate	Same (3 scfm IAW NFPA 99), adheres to a more current version of NFPA 99 (2005 Ed. vs 2002 Ed.).
Built-in Breathing Systems (BIBS) & Patient Hood System Capacity	Equivalent, expanded patient hood capacity (up to 28 for FETL vs 22 for TL20). Piping and controls remain the same.
Deluge Fire Suppression System (FSS)	Adheres to a more current version of NFPA 99 (2005 Ed. vs 2002 Ed.), demonstrating equivalence.
Compliance with Recognized Standards
Electrical Safety & EMC	Conforms to relevant requirements of ANSI/AAMI ES 60601-1, IEC 60601-1-2, IEC 61000-4-3, IEC 61000-4-39, ETSI TS 138 101-1, IEC 60601-1-8, ANSI C63.27, AAMI TIR69.
Biocompatibility	Evaluated per ISO 18562-1:2017 for particulate matter and VOCs. Toxicological risk assessment conducted.
Software Verification & Validation	Conducted and documented as recommended by FDA guidance for "Enhanced" level of concern (failure could lead to death/serious injury).
Bench Testing for PVHO Integrity	Penetrant Examination (PE), Ultrasonic Testing (UT), Radiographic Examinations (RT), Magnetic Particle Examination (MT), Hydrostatic testing, Chamber pneumatic test, Chamber Relief Valve testing.
Functional Tests	Performed for UPS, Medical Lock, Lighting, Hoods/BIBS Circuits, Gas Analysis, Communications, CCTV, Environmental Control System (ECS), Entertainment, Sanitary system, Fire Suppression System (FSS), Handheld Deluge (HHD), Nurse call, Emergency Breathing Air at Console, Wi-Fi Cyberattack (Windows, FEGen4), Ethernet Cyberattack, Bluetooth Cyberattack, All Stop, Soft All Stop, Hardware verification, Alarms, CPU & Memory test.

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: Not applicable in the context of this 510(k) submission. The "test set" primarily refers to the individual FINK Hyperbaric Chambers (models FESL, FEDL, and FETL) themselves and their components, which underwent a series of engineering and functional tests. There isn't a "test set" of patient data or images as would be seen for an AI diagnostic device.
Data Provenance: The testing data originates from the manufacturer, Fink Engineering Pty Ltd, located in Queensland, Australia. The document does not specify if the testing itself was conducted in Australia or elsewhere, but it's generated by the manufacturer for regulatory submission. The data is implicitly "prospective" in the sense that it's data generated through testing specifically for this submission, not a retrospective analysis of existing patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: Not applicable. For a device like a hyperbaric chamber, "ground truth" is established by adherence to engineering standards (e.g., ASME PVHO-1, NFPA 99), physical measurements, and functional verification. The "User Design Specification" is approved by a Registered Professional Engineer in accordance with ASME PVHO-1.
Qualifications of Experts: A Registered Professional Engineer is mentioned as approving the User Design Specification according to ASME PVHO-1. Other "experts" involved would be qualified testing personnel and engineers performing the various physical and functional tests described.

4. Adjudication method for the test set:

Adjudication Method: Not applicable. Testing against physical and functional standards, as well as software verification and validation, does not involve a human adjudication process in the way a diagnostic algorithm's output would be adjudicated against ground truth labels. The "adjudication" is essentially the successful passing of pre-defined engineering tests and compliance with recognized standards.

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:

MRMC Study: No. This is a medical device (hyperbaric chamber), not a diagnostic AI algorithm. An MRMC study is not relevant or required for this type of submission.

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

Standalone Performance: Not applicable. This device is not an algorithm for standalone diagnosis or prediction. While it has a PLC control system, the "performance" is the safe and effective operation of the physical chamber as a whole, controlled by humans. Software verification and validation (often considered a form of standalone testing for the software component) was performed, and it was categorized as "Enhanced" in terms of risk, meaning a failure could lead to death or serious injury.

7. The type of ground truth used:

Ground Truth: For this device, the "ground truth" is established by:
- Regulatory Standards: Adherence to standards like ASME PVHO-1 (Safety Standard for Pressure Vessels for Human Occupancy) and NFPA 99 (National Fire Protection Agency).
- Engineering Specifications: Successful operation within defined pressure ranges, temperatures, flow rates, and functional parameters.
- Functional Verification: The ability of components (e.g., UPS, medical lock, communications, fire suppression) to operate as designed.
- Biocompatibility Standards: Compliance with ISO 18562-1 and toxicological risk assessment.

8. The sample size for the training set:

Training Set Sample Size: Not applicable. This device does not use machine learning or AI models that require a "training set" of data in the conventional sense. The "training" for such a device is its design, manufacturing, and testing process according to established engineering and safety principles.

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

Ground Truth for Training Set: Not applicable, as there is no "training set" for an AI model. The accumulated knowledge and standards of engineering, pressure vessel design (ASME PVHO-1), and medical gas systems (NFPA 99) form the foundational "ground truth" for the device's design and manufacturing.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services logo. The logo on the right is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 21, 2024

Fink Engineering Pty Ltd % Christy Foreman Senior Consultant Biologics Consulting 1555 King Street, Suite 300 Alexandria, Virginia 22314

Re: K240569

Trade/Device Name: FESL FINK Chamber: FEDL FINK Chamber: FETL FINK Chamber Regulation Number: 21 CFR 868.5470 Regulation Name: Hyperbaric Chamber Regulatory Class: Class II Product Code: CBF Dated: October 25, 2024 Received: October 25, 2024

Dear Christy Foreman:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Bradley Q. Quinn -S

Bradley Quinn Assistant Director DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K240569

Device Name

FESL FINK Chamber;

FEDL FINK Chamber;

FETL FINK Chamber

Indications for Use (Describe)

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

1. Air or gas embolism
1. Carbon monoxide poisoning and carbon monoxide poisoning complicated by cyanide poisoning
1. Clostridial myonecrosis and myonecrosis
1. Crush injuries, compartment syndrome, and other acute traumatic ischemias
1. Decompression sickness
1. Enhancement of healing of selected problem wounds
1. Exceptional blood loss anemia
1. Necrotizing soft tissue infections
1. Osteomyelitis (refractory)
1. Delayed radiation injuries (soft tissue and bony necrosis)
1. Compromised grafts and flaps
1. Acute Thermal Burn Injury
1. Intracranial abscess

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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In accordance with 21 CFR 807.87(h) and 21 CFR 807.92 the 510(k) Summary for the FINK Hyperbaric Chambers (models FESL, FEDL, and FETL) is provided below.

1. SUBMITTER

Applicant:	Fink Engineering Pty Ltd5 Delisser PlaceQueensland, Australia 4551Email: fink@fink.com.auPhone: +61 7 5438 4900
Contact:	Eric FinkManaging DirectorEmail: fink@fink.com.auPhone: +61 7 5438 4900
Submission Correspondent:	Christy ForemanSenior ConsultantBiologics Consulting Group, Inc1555 King Street, Suite 300Alexandria, VA 22314Email: cforeman@biologicsconsulting.comPhone: (301) 325-4245
Date Prepared:	February 26, 2024

2. DEVICE

Device Trade Name:	FINK Hyperbaric Chambers (models FESL, FEDL, and FETL)
Device Common Name:	Hyperbaric Chamber
Classification Name	21 CRF 868.5470 Hyperbaric chamber
Regulatory Class:	II
Product Code:	CBF

3. PREDICATE DEVICE

Predicate Device: K031649 SL8/DL8/TL20 Hyperbaric Oxygen Treatment Facilities Reference Device: K152223 OxyHeal 5000 Rectangular Multiplace Hyperbaric Chamber

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DEVICE DESCRIPTION 4.

Single Compartment - FESL
Double Compartment - FEDL
Triple Compartment FETL ●

Patient capacities can range from four (4) to 28 twenty-eight (28) patients per chamber depending on the number of compartments required by the User. The pressure range for the individual compartments may also vary for the same reason with a minimum of 3.0 ATA to 6.0 ATA maximum allowable working pressures and design temperature range from 15℃ to 38℃ per compartment. The specific parameters for each chamber are defined by a User Design Specification which is approved by a Registered Professional Engineer in accordance with ASME PVHO-1. These chambers also comply with the National Fire Protection Agency (NFPA)

The chambers include the following features:

Fire Protection
Compressed air system ●
Oxygen Delivery ●
Environmental control system ●
Unintended power supply ●
Control Console ●

INTENDED USE/INDICATIONS FOR USE 5.

It is the expressed, intended use of the FINK Hyperbaric Chambers (models FESL, FEDL, and FETL) 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 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 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.

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

1. Air or gas embolism
1. Carbon monoxide poisoning and carbon monoxide poisoning complicated by cyanide poisoning
1. Clostridial myonecrosis and myonecrosis
1. Crush injuries, compartment syndrome, and other acute traumatic ischemias
1. Decompression sickness
1. Enhancement of healing of selected problem wounds
1. Exceptional blood loss anemia
1. Necrotizing soft tissue infections
1. Osteomyelitis (refractory)
1. Delayed radiation injuries (soft tissue and bony necrosis)
1. Compromised grafts and flaps
1. Acute Thermal Burn Injury
1. Intracranial abscess

6. SUBSTANTIAL EQUIVALENCE

Comparison of Intended Use and Indications for Use

The intended use of the predicate device, the reference device and the proposed device are identical. The indications for use are all derived from the Undersea and Hyperbaric Medical Society recommendations for HBOT. The indications for use of the subject and predicate device are identical. The indications of use of the predicate device is a subset of the indications for use of the reference device.

Technological Comparisons

The table below compares the key technological feature of the subject devices to the predicate device (K031649 SL8/DL8/TL20 Hyperbaric Oxygen Treatment Facilities).

	Proposed Device	Predicate Device	Discussion
510(k) Number	K240569	K031649	N/A
Applicant	Fink Engineering PTY LTD	Fink Engineering PTY LTD	Same
Device Name	Fink Engineering ChamberSystems Series (Fink Chamber)	Fink SL8/DL8/TL20	N/A
ClassificationRegulation	21 CFR 868.5470	21 CFR 868.5470	Same
Product Code	CBF	CBF	Same
	Proposed Device	Predicate Device	Discussion
Indications for Use	As defined by the Undersea &Hyperbaric Medical SocietyHyperbaric Oxygen TherapyCommittee	As defined by the Undersea &Hyperbaric Medical SocietyHyperbaric Oxygen TherapyCommittee	Same
Compartments	FESL = 1FEDL = 2FETL = 3	SL8 = 1DL8 = 2TL20 = 3	Same
CompartmentInterior Vol	$\sim586 \text{ ft}^3 - \sim4200 \text{ ft}^3$	$\sim586 \text{ ft}^3 - \sim2546 \text{ ft}^3$	EquivalentMultiplace chambers are ordered tocustomer specifications. Eachchamber is tested to PVHO toensure that the construct of thechamber meets industryrequirements. The same materialsare used for construction and themaximum pressure is identical.Size of the chamber was expanded.The volume went from 72SCM to119 SCM for the FETL chamber.Testing demonstrates applicablestandards are met.
Patient Capacity	FESL = up to 8FEDL = up to 8FETL = up to 28	SL8 = up to 8DL8 = up to 8TL20 = up to 20	Patient capacity for a chamber mayvary depending on contractrequirements
Weight	$\sim15,432 \text{ lbs} - \sim145,000 \text{lbs}$	$\sim15,432 \text{ lbs} - \sim110,231 \text{ lbs}$	Equivalent. Weight varies withpatient capacity
Operating Pressure	Up to 6.0 ATA (73.5 psig)	Up to 6.0 ATA (73.5 psig)	Same
OperatingTemperature	59°F -100°F	62°F -100°F	EquivalentThe slight modification in operatingtemperature does not raise new ordifferent questions of safety andeffectiveness.
Pressure ControlScheme	PLC with manual backup	Electropneumatic with manualbackup	EquivalentThe addition of the PLC controlwith manual back is the same asReference Device K152223OxyHeal 5000 RectangularMultiplace Hyperbaric Chamber.The PLC change does not raise newor different questions of safety andeffectiveness. Software testing andperformance testing have beenconducted in support of themodification.
Pressurization Rate(Max)	1 ft/sec	1 ft/sec	Same
	Proposed Device	Predicate Device	Discussion
PressurizationMeasurement	Digital & analog	Digital & analog	Same
EmergencyDecompression Rate	27.5 ft/min to achieve minimumdecompression time of 6 minutesor less from 6 ATA IAW NFPA99, 20.2.4.5.1, 2005 Ed.	27.5 ft/min to achieve minimumdecompression time of 6 minutesor less from 6 ATA IAW NFPA99, 20.2.4.5.1, 2002 Ed.	Same. The subject device adheres toa more current version of the samestandard.
Normal VentilationRate	3 scfm IAW NFPA 99,20.2.4.1.1, 2005 Ed	3 scfm IAW NFPA 99,20.2.4.1.1, 2002 Ed	Same.
Chamber Lighting	External – dimmable	External - dimmable	Same. The subject device adheres toa more current version of the samestandard.
Medical TransferLock	Yes	Yes	Same
Backup ElectricalPower	UPS	UPS	Same
Communications	PA System with PatientEntertainment - sound poweredbackup. Wireless is optional	PA System with PatientEntertainment - sound poweredbackup. Wireless is optional	Same
CCTV	Yes	Yes	Same
Viewports	Circular (3-9)	Circular (3-9)	Same.
	Minimum - one percompartment	Minimum - one percompartment
	Minimum size - Ø6"	Minimum size - Ø6"
	Maximum size - Ø30"	Maximum size - Ø30"
	FESL = 1-3	SL8 = 1-3
	FEDL = 2-4	DL8 = 2-4
	FETL = 3-9	TL20 = 3-9
AuxiliaryPenetrators	Yes	Yes	Same
	Proposed Device	Predicate Device	Discussion
Built in BreathingSystems (BIBS) withOxygen OverboardDump	YesFESL = 2 min per compartmentFEDL = 2 min per compartmentFETL = 2 min per compartment	YesSL8 = 2 min per compartmentDL8 = 2 min per compartmentTL20 = 2 min per compartment	EquivalentAllows for each Attendant to befully supported. Piping and controlsremain the same. BIBS are forAttendants only.Terminology in prior submissionsused the term BIBS interchangeablyfor patients and for attendants.However, current preference is toindicate BIBS is for the attendantand the hood is for the patient.
Patient HoodSystem with OxygenOverboard Dump	YesFESL = up to 8FEDL = up to 8FETL = up to 28	YesSL8 = 8DL8 = 8TL20 = 22	EquivalentAllows for each patient to be fullysupported. Piping and controlsremain the same. Refer to the row"Patient Capacity" above.
EmergencyBreathing AirCrossover	Yes	Yes	Same
Medical Suction	Yes	Yes	Same
Door Style	Rectangular	Rectangular	Same
Deluge FireSuppression System(FSS)	Yes, IAW NFPA 99, Ch 20,2005 Ed	Yes, IAW NFPA 99, Ch 20,2002 Ed	Equivalent. The subject deviceadheres to a more current version ofthe same standard.
FSS Audio/visualAlarm	Yes	Yes	Same
EnvironmentalControl	Yes (Heating & Cooling)	Yes (Heating & Cooling)	Same
Temperature &HumidityMonitoring	Yes (Digital)	Yes (Digital)	Same
Air Supply	Oil-free, Low-Pressurecompressor	Oil-free, Low-Pressurecompressor	Same
Backup Air Supply	Yes	Yes	Same
Air SupplyFiltration	Yes/Coalescing and ActiveCarbon	Yes/Coalescing and ActiveCarbon	Same
Air & CO Analysis	Yes	Yes	Same
Low Pressure AirDistribution	Yes	Yes	Same
Gas DistributionPanel	Yes	Yes	Same
Gas Monitoring	Yes (Oxygen & CO2)	Yes (Oxygen & CO2)	Same
	Proposed Device	Predicate Device	Discussion
EmergencyBreathing Air AtOperator Console	Yes	Yes	Same
Optional PatientToilet & Sink	Yes	Yes	Same
Optional MedicalSink	Yes	Yes	Same

Table 1: Technological Comparison

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The addition of the PLC control with manual back is the same as the reference device. This type of control mechanism change has been implemented in a number of 510(k) submissions. The PLC change does not raise new or different questions of safety and effectiveness. The change can be supported with data. The OxyHeal device is cited as a reference device to support the test methods which is primarily software verification and validation.

Other minor changes have been also been supported with the appropriate supportive testing and do not raise new issues of safety or effectiveness.

7. PERFORMANCE DATA

Biocompatibility Testing

As the hyperbaric chamber is dry gas pathway contacting only, it was evaluated in accordance with ISO 18562-1: 2017 and tested for particulate matter and volatile organic compounds (VOCs). A toxicological risk assessment was also conducted.

Electrical safety and electromagnetic compatibility (EMC)

The Fink Hyperbaric Chambers were assessed for conformity with the relevant requirements of the following standards and found to comply:

ANSI/AAMI ES 60601-1:2005/(R) 2012 and A1:2012, C1:2009/(R) 2012 and ● A2:2010/(R) 2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
IEC 60601-1-2:2014+A1:2020, Medical electrical equipment -- Part 1-2: General ● requirements for basic safety and essential performance - Collateral Standard: electromagnetic disturbances - Requirements and tests.
. IEC 61000-4-3:2010 - Electromagnetic Compatibility-Part 4: Testing and measurement techniques - Section 3: Radiated, radiofrequency, electromagnetic field immunity test - Proximity Fields, Table 9
. IEC 61000-4-39:2017- Electromagnetic Compatibility (EMC) -- Part 4-39: Testing And Measurement Techniques - Radiated Fields In Close Proximity - Immunity Test, Table 11
ETSI TS 138 101-1 V17.5.0 (2022-05)

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IEC 60601-1-8:2006, AMD1:2012, AMD2:2020 Medical electrical equipment Part . 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
ANSI C63.27-2021 American National Standard for Evaluation of Wireless Coexistence
AAMI TIR69:2017 (R2020) Technical Information Report Risk management of ● radio-frequency wireless coexistence for medical devices and systems.

Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions." Enhanced documentation was provided since a failure or flaw of any device software function(s) could present a hazardous situation with a probable risk of death or serious injury, either to a patient, user of the device, or others in the environment of use.

Bench Testing

The following testing and /or examinations were used in whole or in part for certifying the weld integrity and the integrity of the entire pressure vessel for human occupancy (PVHO) (the hyperbaric chamber):

Penetrant Examination (PE) ●
Ultrasonic Testing (UT) ●
Radiographic Examinations (RT) ●
Magnetic Particle Examination (MT) ●

The following additional tests were also performed:

Hydrostatic testing
Chamber pneumatic test
Chamber Relief Valve testing ●
Air quality testing ●
Max Pressurization Rate ●
Maximum Depressurization Rate
Treatment Pressure Profiles
Functional test - Uninterrupted Power Supply (UPS)
Functional test - Medical Lock
Functional test - Lighting
Functional test - Hoods/BIBS Circuits
Functional test- Gas Analysis
. Functional test - Communications
Functional test CCTV ●
Functional test Environmental Control System (ECS) ●
Functional test Entertainment ●

{12}------------------------------------------------

Functional test - Sanitary system
Functional test Fire Suppression System (FSS) ●
Functional test - Handheld Deluge (HHD)
Functional test Nurse call ●
Functional test - Emergency Breathing Air at Console
Functional test - Wi-Fi Cyberattack - Windows
Functional test - Wi-Fi Cyberattack - FEGen4
Functional test Wi-Fi Cyberattack- FEGen4 ●
Functional test - Cyberattack - Ethernet
Functional test Cyberattack Bluetooth ●
Functional Test - All Stop
Functional Test - Soft All Stop
Functional Test Hardware verification ●
Functional Test - Alarms
Functional Test CPU & Memory test ●

Animal Testing

Not applicable. Animal studies are not necessary to establish the substantial equivalence of this device.

Clinical Data

Not applicable. Clinical studies are not necessary to establish the substantial equivalence of this device.

CONCLUSION 8.

Based on the detailed comparison between the predicate devices and the subject devices, the performance testing and conformance with applicable standards, the Fink Chamber can be found substantially equivalent to the predicate device.

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).