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.

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.

AI/ML Overview

This document primarily concerns the 510(k) premarket notification for the Revitalair® 430F Portable Hyperbaric Chamber, seeking to establish substantial equivalence to an existing predicate device. It does not describe a study involving an AI/Machine Learning device, nor does it list acceptance criteria and performance data for such a device.

The information provided in the document is related to a traditional medical device (a hyperbaric chamber) and its non-clinical performance testing to demonstrate safety and effectiveness.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and the reported device performance: This document does not contain this information for an AI/ML device. It lists non-clinical performance tests for the hyperbaric chamber itself.
Sample sized used for the test set and the data provenance: Not applicable to an AI/ML study from this document.
Number of experts used to establish the ground truth... and qualifications: Not applicable to an AI/ML study from this document.
Adjudication method: Not applicable to an AI/ML study from this document.
If a multi reader multi case (MRMC) comparative effectiveness study was done: The document explicitly states, "There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device." This indicates no MRMC study was performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/ML device.
The type of ground truth used: Not applicable. The "ground truth" for this device would be its physical performance characteristics (e.g., pressure capabilities, material strength), verified through engineering tests, not expert consensus on medical images or patient outcomes.
The sample size for the training set: Not applicable, as this is not an AI/ML device.
How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.

In summary, the provided text is a 510(k) submission for a non-AI/ML medical device (a hyperbaric chamber) and does not contain the information requested about AI device performance studies.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K171899

Device Name Revitalair® 430F

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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X | Prescription Use (Part 21 CFR 801 Subpart D)

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

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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

7. Device Description

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 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.	SignificantDifference
Trade Name	The Grand DiveHD400	The Dive HD250	Revitalair® 430F
510(k)	K072757	K072757
Product Code	CBF	CBF	CBF	Same
RegulationNumber	868.5470	868.5470	868.5470	Same
Regulation Name	HyperbaricChamber	HyperbaricChamber	Hyperbaric Chamber	Same
Intended Use	Acute MountainSickness AMS andits associated mildsymptoms	Acute MountainSickness AMS andits associated mildsymptoms	Acute MountainSickness AMS and itsassociated mildsymptoms	Same
Prescription -Rx Only	Yes	Yes	Yes	Same
Target Population	People with medicalconditions byaltitude sickness	People withmedical conditionsby altitude sickness	People with medicalconditions byaltitude 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
MeasuresDiameter×Length	39.37in x 106.29in(1000mm x2700mm)	26.6in x 82.7in(675mm x2100mm)	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 DiveHD400	The Dive HD250	Revitalair® 430F	Difference
Drain Valves	Yes, integratedemptying and filling	Yes, integratedemptying and filling	Yes, 2 units only foremptying	Same
OperatingPressure	4psi / 1.3 ATA	4psi / 1.3 ATA	4psi / 1.3 ATA	Same
Inflation Method	Gast compressor0523	Gast compressor0523	Oil-less compressor	Same
Locking System	Simple air tightclosure	Simple air tightclosure	System of metalrings	Different
Materials	33-39 oz uretanecoated nylon	33-39 oz uretanecoated nylon	Polyester hatched1100 18x18 Vinylwith 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 theCompressor	Yes	Yes	Yes	Same
PressureMeasurement	Yes	Yes	Yes	Same
Air Filter Chamber	Yes	Yes	Yes	Same
Skills of thePerson to Leavethe Chamber	Yes	Yes	Yes	Same
OperatingTemperature °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.	SignificantDifference
Trade Name	The Grand DiveHD400	The Dive HD250	Revitalair® 430F	Difference
Contraindications	Patients with:Colds, flusymptoms,- Recent Alcoholconsumption,- Blocked earcanals,- Blocked Sinuses,- Otic barotraumas,- Excessive CO2Exposure,- Pulmonary hyperexpansionDecompressionsickness	Patients with:Colds, or flusymptoms,- Recent Alcoholconsumption- Blocked EarCanals,- Blocked Sinuses,- Otic barotraumas,- Excessive C02	Patients with: Colds,or flu symptoms,- Recent Alcoholconsumption- Blocked Ear Canals,- Blocked Sinuses,- Otic barotraumas,- Excessive C02Exposure,- Pulmonary hyperexpansionDecompressionSickness	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

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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.

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).