(879 days)
Not Found
No
The description focuses on the mechanical and electrical components of a hyperbaric chamber and its operation, with no mention of AI or ML technologies.
Yes
The device is intended to treat acute mountain sickness, which is a therapeutic purpose.
No
The device is designed to treat acute mountain sickness by providing a hyperbaric environment, not to diagnose medical conditions.
No
The device description clearly details a physical hyperbaric chamber and its associated hardware components (compressor, valves, fabric, rings, windows). It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to treat acute mountain sickness by enclosing a patient in a hyperbaric chamber. This is a therapeutic treatment applied directly to the patient's body.
- Device Description: The device is a physical chamber and a compressor designed to alter the atmospheric pressure around a person.
- Lack of In Vitro Activity: IVD devices are used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a person's health. This device does not interact with any biological specimens.
The device is clearly a therapeutic medical device used for direct patient treatment, not for diagnostic testing of samples.
N/A
Intended Use / Indications for Use
The intended use of the Portable Hyperbaric Chamber Revitalair® 430F is to treat acute mountain sickness under the prescription of a health professional. The medical device is designed for use at physician offices and health institutions.
Product codes
CBF
Device Description
The Portable Hyperbaric Chamber Revitalair® 430F is a hyperbaric chamber for low pressures (operating at pressures of no greater than 1.4 atmospheres absolute (ATA)). The operational design pressure of a hyperbaric chamber that encloses a human within its pressure boundary falls within the scope of the American Society of Mechanical Engineers Pressure Vessels Human Occupancy 1 (ASME PVHO 1-2012).
Revitalair® 430F consists of 2 parts, the cabin or chamber and the compression system or compressor's cabinet. The chamber, weighing 62 pounds, is constructed of an airtight polyester-based plastic fabric joined by aluminum rings, forming a cylinder 900 mm in diameter and 1850 mm in length (Figure 1).
The chamber is inflated with atmospheric air through an electric compressor. Fittings allow the chamber to be connected to compressed air by means of manually controlled valves.
The safety or relief valves are operated at pressures above 1.3 ATM which ensures safe operations. The compressor has an additional safety valve for any obstruction of the supply hose from the compressor to the chamber.
The Revitalair® 430F has 10 transparent windows to let in light, 360º viewing and enable easy verification of the patient's comfort from the outside.
The Revitalair® 430F can be operated from the interior as well as from the exterior.
After folding it up, the Revitalair® 430F is placed in its transportation box or in the optional carrying case.
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
Physician offices and health institutions.
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)
Non-Clinical Performance Data: Mechanical, electrical safety, electromagnetic disturbance, biocompatibility, and life testing were performed. The device passed all tests and met requirements for overall design, biocompatibility, and electrical safety.
Clinical Performance Data: No human clinical testing was required as the device's indications for use are equivalent to the predicate device, which has a proven safety and efficacy record.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Oxavita S.R.L. % Diane Sudduth Sr. RA/QA Consultant Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, Texas 78746
Re: K171899
Trade/Device Name: Revitalair 430F Regulation Number: 21 CFR 868.5470 Regulation Name: Hyperbaric Chamber Regulatory Class: Class II Product Code: CBF Dated: April 10, 2019 Received: April 11, 2019
Dear Diane Sudduth:
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. 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 located 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.
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
1
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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-regulatoryassistance/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,
Todd Courtney Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K171899
Device Name Revitalair® 430F
Indications for Use (Describe)
The intended use of the Portable Hyperbaric Chamber Revitalair® 430F is to treat acute mountain sickness under the prescription of a health professional. The medical device is designed for use at physician offices and health institutions.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
Revitalair® 430F
K171899
1. Submission Sponsor
Oxavita S.R.L.
Tamborini 5813
Buenos Aires, Argentina
Contact: Eduardo Northing
Title: Exports and Logistics
2. Submission Correspondent
Emergo Global Consulting, LLC
2500 Bee Cave Road
Building 1, Suite 300
Austin, TX 78746
USA Office Phone: (512) 327.9997
Contact: Dr. Diane Sudduth
Title: Senior Consultant, RA
3. Date Prepared
11/22/19
4. Device Identification
| Trade/Proprietary Name: | Revitalair® 430F |
|---|---|
| Common/Usual Name: | Portable Hyperbaric Chamber |
| Classification Name: | Chamber, Hyperbaric |
| Regulation Number: | 21 CFR 868.5470 |
| Product Code: | CBF |
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Device Class: Class II
Classification Panel: Anesthesiology Devices
5. Legally Marketed Predicate Device(s)
K072757, The Dive HD250 and The Grand Dive HD400, SUMMIT TO SEA
6. Indication for Use Statement
The intended use of the Portable Hyperbaric Chamber Revitalair® 430F is to treat acute mountain sickness under the prescription of a health professional. The medical device is designed for use at physician offices and health institutions.
7. Device Description
The Portable Hyperbaric Chamber Revitalair® 430F is a hyperbaric chamber for low pressures (operating at pressures of no greater than 1.4 atmospheres absolute (ATA)). The operational design pressure of a hyperbaric chamber that encloses a human within its pressure boundary falls within the scope of the American Society of Mechanical Engineers Pressure Vessels Human Occupancy 1 (ASME PVHO 1-2012).
Revitalair® 430F consists of 2 parts, the cabin or chamber and the compression system or compressor's cabinet. The chamber, weighing 62 pounds, is constructed of an airtight polyester-based plastic fabric joined by aluminum rings, forming a cylinder 900 mm in diameter and 1850 mm in length (Figure 1).
The chamber is inflated with atmospheric air through an electric compressor. Fittings allow the chamber to be connected to compressed air by means of manually controlled valves.
The safety or relief valves are operated at pressures above 1.3 ATM which ensures safe operations. The compressor has an additional safety valve for any obstruction of the supply hose from the compressor to the chamber.
The Revitalair® 430F has 10 transparent windows to let in light, 360º viewing and enable easy verification of the patient's comfort from the outside.
The Revitalair® 430F can be operated from the interior as well as from the exterior.
After folding it up, the Revitalair® 430F is placed in its transportation box or in the optional carrying case.
8. Substantial Equivalence Discussion
The following table compares the Portable Hyperbaric Chamber Revitalair® 430F (abbreviated as Revitalair® 430F) to the predicate device with respect to indications for use, principles of operation, technological characteristics, materials, and performance testing.
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| Manufacturer | SUMMIT TO SEA | SUMMIT TO SEA | Oxavita S.R.L. | Significant
Difference |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| Trade Name | The Grand Dive
HD400 | The Dive HD250 | Revitalair® 430F | |
| 510(k) | K072757 | K072757 | | |
| Product Code | CBF | CBF | CBF | Same |
| Regulation
Number | 868.5470 | 868.5470 | 868.5470 | Same |
| Regulation Name | Hyperbaric
Chamber | Hyperbaric
Chamber | Hyperbaric Chamber | Same |
| Intended Use | Acute Mountain
Sickness AMS and
its associated mild
symptoms | Acute Mountain
Sickness AMS and
its associated mild
symptoms | Acute Mountain
Sickness AMS and its
associated mild
symptoms | Same |
| Prescription -
Rx Only | Yes | Yes | Yes | Same |
| Target Population | People with medical
conditions by
altitude sickness | People with
medical conditions
by altitude sickness | People with medical
conditions by
altitude sickness | Same |
| Places of Use | Homes, gyms,
offices, outdoor,
hospitals and clinics | Homes, gyms,
offices, outdoor,
hospitals and clinics | Hospitals and clinics | Similar |
| Weight | 32 lb | 15 lb | 62 lb | Different |
| Measures
Diameter
×
Length | 39.37in x 106.29in
(1000mm x
2700mm) | 26.6in x 82.7in
(675mm x
2100mm) | 35.4in x 74.8in
(900mm x 1900mm) | Similar |
| Windows | 4 | 2 | 10 | Different |
| Transport Belts | 4 | 4 | 2 | Different |
| Relief Valves | Yes | Yes | Yes, Metal | Same |
| Manufacturer | SUMMIT TO SEA | SUMMIT TO SEA | Oxavita S.R.L. | Significant |
| Trade Name | The Grand Dive
HD400 | The Dive HD250 | Revitalair® 430F | Difference |
| Drain Valves | Yes, integrated
emptying and filling | Yes, integrated
emptying and filling | Yes, 2 units only for
emptying | Same |
| Operating
Pressure | 4psi / 1.3 ATA | 4psi / 1.3 ATA | 4psi / 1.3 ATA | Same |
| Inflation Method | Gast compressor
0523 | Gast compressor
0523 | Oil-less compressor | Same |
| Locking System | Simple air tight
closure | Simple air tight
closure | System of metal
rings | Different |
| Materials | 33-39 oz uretane
coated nylon | 33-39 oz uretane
coated nylon | Polyester hatched
1100 18x18 Vinyl
with phthalate free | Similar |
| Relief Valves | Plastic & Metal | Plastic & Metal | 2 by Plastic & Metal | Similar |
| Compressor | Gast oil-less | Gast oil-less | Oil-less | Similar |
| Air Filter in the
Compressor | Yes | Yes | Yes | Same |
| Pressure
Measurement | Yes | Yes | Yes | Same |
| Air Filter Chamber | Yes | Yes | Yes | Same |
| Skills of the
Person to Leave
the Chamber | Yes | Yes | Yes | Same |
| Operating
Temperature °C | -50°F to 125°F | -50°F to 125°F | 59 °F / 113 °F | Similar |
| Manufacturer | SUMMIT TO SEA | SUMMIT TO SEA | Oxavita S.R.L. | Significant
Difference |
| Trade Name | The Grand Dive
HD400 | The Dive HD250 | Revitalair® 430F | Difference |
| Contraindications | Patients with:
Colds, flu
symptoms,
- Recent Alcohol
consumption, - Blocked ear
canals, - Blocked Sinuses,
- Otic barotraumas,
- Excessive CO2
Exposure, - Pulmonary hyper
expansion
Decompression
sickness | Patients with:
Colds, or flu
symptoms, - Recent Alcohol
consumption - Blocked Ear
Canals, - Blocked Sinuses,
- Otic barotraumas,
- Excessive C02
| Patients with: Colds,
or flu symptoms, - Recent Alcohol
consumption - Blocked Ear Canals,
- Blocked Sinuses,
- Otic barotraumas,
- Excessive C02
Exposure, - Pulmonary hyper
expansion
Decompression
Sickness | Same |
| Labeling | Comparable | Comparable | Comparable | Same |
Table 5A – Comparison of Characteristics
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9. Non-Clinical Performance Data
As part of demonstrating safety and effectiveness of the Revitalair® 430F Hyperbaric Chamber and in showing substantial equivalence to the predicate device that are subject to this 510(k) submission, Oxavita completed an number of non-clinical performance tests. Testing was performed as determined by the hazard analysis. The Revitalair® 430F Hyperbaric Chamber meets all the requirements for overall design, biocompatibility, and electrical safety results confirming that the design output meets the design inputs and specifications for the device.
The Revitalair® 430F Hyperbaric Chamber passed all the testing in accordance with internal requirements, and the standards shown below to support substantial equivalence of the subject device:
- . Electrical safety testing per IEC 60601-1
- Electromagnetic Disturbance (EMD) testing per IEC 60601-1-2
- Biocompatibility testing - Cytotoxicity, Sensitization, Gas emission VOC, Particulates, Inorganic gases (Ozone, CO, CO2) per ISO 10993 and ISO 18562
8
In addition to the guidance and standards testing, the following life testing was performed:
- Device Life Report which address's the device's useful life based on reliability analysis of the individual components
- . Pressure Testing based on ASME PVHO-1-2007, sections: 2-7.2 al 2-7.7; 4-8.1.1; 4-8.1.2; 4-8.1.4 which address's the device's response to excessive pressures.
10. Clinical Performance Data
There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for many years with proven safety and efficacy for the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.
11. Statement of Substantial Equivalence
The Portable Hyperbaric Chamber Revitalair® 430F, as designed and manufactured, is determined to be substantially equivalent to the cited predicate devices.