(266 days)
No
The summary describes a hyperbaric chamber, a physical pressure vessel with associated control systems for delivering hyperbaric oxygen therapy. There is no mention of any software or algorithms that would suggest the use of AI or ML for diagnosis, treatment planning, or any other function. The performance studies focus on physical, electrical, and software validation of the chamber's control systems, not on the performance of any AI/ML model.
Yes
The device is intended to treat a variety of medical conditions as listed in the 'Intended Use / Indications for Use' section, which defines its therapeutic purpose.
No
The device description clearly states it is a "Hyperbaric Chamber," a pressure vessel designed for hyperbaric oxygen therapy, not for diagnosing medical conditions. The "Intended Use / Indications for Use" section lists conditions that the device treats, not conditions it identifies or diagnoses. The performance studies also focus on safety, electrical compatibility, and functional aspects of the chamber, rather than diagnostic accuracy.
No
The device description clearly details a physical hyperbaric chamber, including its construction, configurations, features (fire protection, compressed air system, etc.), and compliance with physical standards (ASME PVHO-1, NFPA). The performance studies also include testing related to the physical chamber and its components (biocompatibility, electrical safety, bench testing). This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended uses listed are all related to treating various medical conditions in a patient by administering hyperbaric oxygen therapy. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a hyperbaric chamber, a physical structure designed to create a high-pressure environment for a patient. It includes systems for fire protection, air and oxygen delivery, environmental control, power, and control. These are all components of a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. The device's function is to deliver a treatment.
Therefore, the FINK Hyperbaric Chamber is a therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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:
-
- Air or gas embolism
-
- Carbon monoxide poisoning and carbon monoxide poisoning complicated by cyanide poisoning
-
- Clostridial myonecrosis and myonecrosis
-
- Crush injuries, compartment syndrome, and other acute traumatic ischemias
-
- Decompression sickness
-
- Enhancement of healing of selected problem wounds
-
- Exceptional blood loss anemia
-
- Necrotizing soft tissue infections
-
- Osteomyelitis (refractory)
-
- Delayed radiation injuries (soft tissue and bony necrosis)
-
- Compromised grafts and flaps
-
- Acute Thermal Burn Injury
-
- Intracranial abscess
Product codes (comma separated list FDA assigned to the subject device)
CBF
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility Testing
- Study Type: Biocompatibility evaluation
- Sample Size: Not specified
- Key Results: The hyperbaric chamber, being a dry gas pathway contacting only, 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)
- Study Type: Conformity assessment to standards
- Sample Size: Not specified
- Key Results: The Fink Hyperbaric Chambers were assessed for conformity with the relevant requirements of several standards including ANSI/AAMI ES 60601-1:2005, IEC 60601-1-2:2014, IEC 61000-4-3:2010, IEC 61000-4-39:2017, ETSI TS 138 101-1 V17.5.0, IEC 60601-1-8:2006, ANSI C63.27-2021, and AAMI TIR69:2017. They were found to comply.
Software Verification and Validation Testing
- Study Type: Software verification and validation testing
- Sample Size: Not specified
- Key Results: 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
- Study Type: Bench testing and examinations
- Sample Size: Not specified
- Key Results: 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, 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
- Study Type: Not applicable
- Sample Size: Not applicable
- Key Results: Animal studies are not necessary to establish the substantial equivalence of this device.
Clinical Data
- Study Type: Not applicable
- Sample Size: Not applicable
- Key Results: Clinical studies are not necessary to establish the substantial equivalence of this device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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.
1
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
2
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
3
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:
-
- Air or gas embolism
-
- Carbon monoxide poisoning and carbon monoxide poisoning complicated by cyanide poisoning
-
- Clostridial myonecrosis and myonecrosis
-
- Crush injuries, compartment syndrome, and other acute traumatic ischemias
-
- Decompression sickness
-
- Enhancement of healing of selected problem wounds
-
- Exceptional blood loss anemia
-
- Necrotizing soft tissue infections
-
- Osteomyelitis (refractory)
-
- Delayed radiation injuries (soft tissue and bony necrosis)
-
- Compromised grafts and flaps
-
- Acute Thermal Burn Injury
-
- 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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4
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 Ltd
5 Delisser Place
Queensland, Australia 4551
Email: fink@fink.com.au
Phone: +61 7 5438 4900 |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Eric Fink
Managing Director
Email: fink@fink.com.au
Phone: +61 7 5438 4900 |
| Submission Correspondent: | Christy Foreman
Senior Consultant
Biologics Consulting Group, Inc
1555 King Street, Suite 300
Alexandria, VA 22314
Email: cforeman@biologicsconsulting.com
Phone: (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
5
DEVICE DESCRIPTION 4.
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 ●
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.
6
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:
-
- Air or gas embolism
-
- Carbon monoxide poisoning and carbon monoxide poisoning complicated by cyanide poisoning
-
- Clostridial myonecrosis and myonecrosis
-
- Crush injuries, compartment syndrome, and other acute traumatic ischemias
-
- Decompression sickness
-
- Enhancement of healing of selected problem wounds
-
- Exceptional blood loss anemia
-
- Necrotizing soft tissue infections
-
- Osteomyelitis (refractory)
-
- Delayed radiation injuries (soft tissue and bony necrosis)
-
- Compromised grafts and flaps
-
- Acute Thermal Burn Injury
-
- 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 Chamber | ||
| Systems Series (Fink Chamber) | Fink SL8/DL8/TL20 | N/A | |
| Classification | |||
| Regulation | 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 Society | |||
| Hyperbaric Oxygen Therapy | |||
| Committee | As defined by the Undersea & | ||
| Hyperbaric Medical Society | |||
| Hyperbaric Oxygen Therapy | |||
| Committee | Same | ||
| Compartments | FESL = 1 | ||
| FEDL = 2 | |||
| FETL = 3 | SL8 = 1 | ||
| DL8 = 2 | |||
| TL20 = 3 | Same | ||
| Compartment | |||
| Interior Vol | $\sim586 \text{ ft}^3 - \sim4200 \text{ ft}^3$ | $\sim586 \text{ ft}^3 - \sim2546 \text{ ft}^3$ | Equivalent |
| Multiplace chambers are ordered to | |||
| customer specifications. Each | |||
| chamber is tested to PVHO to | |||
| ensure that the construct of the | |||
| chamber meets industry | |||
| requirements. The same materials | |||
| are used for construction and the | |||
| maximum pressure is identical. | |||
| Size of the chamber was expanded. | |||
| The volume went from 72SCM to | |||
| 119 SCM for the FETL chamber. | |||
| Testing demonstrates applicable | |||
| standards are met. | |||
| Patient Capacity | FESL = up to 8 | ||
| FEDL = up to 8 | |||
| FETL = up to 28 | SL8 = up to 8 | ||
| DL8 = up to 8 | |||
| TL20 = up to 20 | Patient capacity for a chamber may | ||
| vary depending on contract | |||
| requirements | |||
| Weight | $\sim15,432 \text{ lbs} - \sim145,000 \text{lbs}$ | $\sim15,432 \text{ lbs} - \sim110,231 \text{ lbs}$ | Equivalent. Weight varies with |
| patient capacity | |||
| Operating Pressure | Up to 6.0 ATA (73.5 psig) | Up to 6.0 ATA (73.5 psig) | Same |
| Operating | |||
| Temperature | 59°F -100°F | 62°F -100°F | Equivalent |
| The slight modification in operating | |||
| temperature does not raise new or | |||
| different questions of safety and | |||
| effectiveness. | |||
| Pressure Control | |||
| Scheme | PLC with manual backup | Electropneumatic with manual | |
| backup | Equivalent | ||
| The addition of the PLC control | |||
| with manual back is the same as | |||
| Reference Device K152223 | |||
| OxyHeal 5000 Rectangular | |||
| Multiplace Hyperbaric Chamber. | |||
| The PLC change does not raise new | |||
| or different questions of safety and | |||
| effectiveness. Software testing and | |||
| performance testing have been | |||
| conducted in support of the | |||
| modification. | |||
| Pressurization Rate | |||
| (Max) | 1 ft/sec | 1 ft/sec | Same |
| Proposed Device | Predicate Device | Discussion | |
| Pressurization | |||
| Measurement | Digital & analog | Digital & analog | Same |
| Emergency | |||
| Decompression Rate | 27.5 ft/min to achieve minimum | ||
| decompression time of 6 minutes | |||
| or less from 6 ATA IAW NFPA | |||
| 99, 20.2.4.5.1, 2005 Ed. | 27.5 ft/min to achieve minimum | ||
| decompression time of 6 minutes | |||
| or less from 6 ATA IAW NFPA | |||
| 99, 20.2.4.5.1, 2002 Ed. | Same. The subject device adheres to | ||
| a more current version of the same | |||
| standard. | |||
| Normal Ventilation | |||
| Rate | 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 to |
| a more current version of the same | |||
| standard. | |||
| Medical Transfer | |||
| Lock | Yes | Yes | Same |
| Backup Electrical | |||
| Power | UPS | UPS | Same |
| Communications | PA System with Patient | ||
| Entertainment - sound powered | |||
| backup. Wireless is optional | PA System with Patient | ||
| Entertainment - sound powered | |||
| backup. Wireless is optional | Same | ||
| CCTV | Yes | Yes | Same |
| Viewports | Circular (3-9) | Circular (3-9) | Same. |
| Minimum - one per | |||
| compartment | Minimum - one per | ||
| compartment | |||
| 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 | ||
| Auxiliary | |||
| Penetrators | Yes | Yes | Same |
| Proposed Device | Predicate Device | Discussion | |
| Built in Breathing | |||
| Systems (BIBS) with | |||
| Oxygen Overboard | |||
| Dump | Yes | ||
| FESL = 2 min per compartment | |||
| FEDL = 2 min per compartment | |||
| FETL = 2 min per compartment | Yes | ||
| SL8 = 2 min per compartment | |||
| DL8 = 2 min per compartment | |||
| TL20 = 2 min per compartment | Equivalent | ||
| Allows for each Attendant to be | |||
| fully supported. Piping and controls | |||
| remain the same. BIBS are for | |||
| Attendants only. | |||
| Terminology in prior submissions | |||
| used the term BIBS interchangeably | |||
| for patients and for attendants. | |||
| However, current preference is to | |||
| indicate BIBS is for the attendant | |||
| and the hood is for the patient. | |||
| Patient Hood | |||
| System with Oxygen | |||
| Overboard Dump | Yes | ||
| FESL = up to 8 | |||
| FEDL = up to 8 | |||
| FETL = up to 28 | Yes | ||
| SL8 = 8 | |||
| DL8 = 8 | |||
| TL20 = 22 | Equivalent | ||
| Allows for each patient to be fully | |||
| supported. Piping and controls | |||
| remain the same. Refer to the row | |||
| "Patient Capacity" above. | |||
| Emergency | |||
| Breathing Air | |||
| Crossover | Yes | Yes | Same |
| Medical Suction | Yes | Yes | Same |
| Door Style | Rectangular | Rectangular | Same |
| Deluge Fire | |||
| Suppression System | |||
| (FSS) | Yes, IAW NFPA 99, Ch 20, | ||
| 2005 Ed | Yes, IAW NFPA 99, Ch 20, | ||
| 2002 Ed | Equivalent. The subject device | ||
| adheres to a more current version of | |||
| the same standard. | |||
| FSS Audio/visual | |||
| Alarm | Yes | Yes | Same |
| Environmental | |||
| Control | Yes (Heating & Cooling) | Yes (Heating & Cooling) | Same |
| Temperature & | |||
| Humidity | |||
| Monitoring | Yes (Digital) | Yes (Digital) | Same |
| Air Supply | Oil-free, Low-Pressure | ||
| compressor | Oil-free, Low-Pressure | ||
| compressor | Same | ||
| Backup Air Supply | Yes | Yes | Same |
| Air Supply | |||
| Filtration | Yes/Coalescing and Active | ||
| Carbon | Yes/Coalescing and Active | ||
| Carbon | Same | ||
| Air & CO Analysis | Yes | Yes | Same |
| Low Pressure Air | |||
| Distribution | Yes | Yes | Same |
| Gas Distribution | |||
| Panel | Yes | Yes | Same |
| Gas Monitoring | Yes (Oxygen & CO2) | Yes (Oxygen & CO2) | Same |
| Proposed Device | Predicate Device | Discussion | |
| Emergency | |||
| Breathing Air At | |||
| Operator Console | Yes | Yes | Same |
| Optional Patient | |||
| Toilet & Sink | Yes | Yes | Same |
| Optional Medical | |||
| Sink | Yes | Yes | Same |
Table 1: Technological Comparison
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8
9
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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 ●
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- 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.