Revitalair 430+

K220290 · Us Hyperbaric Network · CBF · May 4, 2023 · Anesthesiology

Device Facts

• Record ID: K220290
• Device Name: Revitalair 430+
• Applicant: Us Hyperbaric Network
• Product Code: CBF · Anesthesiology
• Decision Date: May 4, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the Portable Hyperbaric Chamber Revitalair® 430+ 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 Story

Portable hyperbaric chamber for low-pressure treatment (up to 1.5 ATA); semi-rigid design; polyester-based plastic fabric cylinder with aluminum rings; 10 transparent windows for patient monitoring. Operated via external electric compressor; manual valves control inflation; safety relief valves prevent over-pressurization. Used in physician offices and health institutions; operated by healthcare professionals. Provides hyperbaric environment to treat acute mountain sickness; patient comfort monitored visually from exterior. Benefits include non-invasive symptom management for altitude-related conditions.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by non-clinical bench testing, including electrical safety (IEC 60601-1), electromagnetic disturbance (IEC 60601-1-2), biocompatibility (ISO 10993, ISO 18562), and pressure testing (ASME PVHO-1).

Technological Characteristics

Semi-rigid hyperbaric chamber; polyester-based plastic fabric with aluminum ring construction; 900mm x 1850mm dimensions. Operates at 1.3-1.5 ATA via oil-less electric compressor. Includes manual valves, safety relief valves, and 10 transparent windows. Complies with ASME PVHO-1-2012. Biocompatibility per ISO 10993/18562. Electrical safety per IEC 60601-1.

Indications for Use

Indicated for treatment of acute mountain sickness in patients under prescription of a health professional. Contraindications include pneumothorax, pulmonary hyper-expansion, eardrum perforation, asthma, congenital spherocytosis, specific drug use (Cisplatinum, Disulfiram, Doxorubicin, Bleomycina, Sulfamylon, Amphetamines, Nicorette/Nicoderm, narcotic analgesics, steroids), emphysema with CO2 retention, fever (>38.5°C), cold/flu symptoms, history of middle ear surgery/problems, optic neuritis, optic barotrauma, pregnancy, airway diseases, blocked ear canals/sinuses, viral infections, excessive CO2 exposure, and decompression sickness.

Regulatory Classification

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).

Predicate Devices

• Revitalair 430F (K171899)

Reference Devices

• Tampa Hyperbaric Monoplace Chamber (K981938)
• Flexi-Lite Hyperbaric Chamber (K051759)

Submission Summary (Full Text)

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May 4, 2023

US Hyperbaric Network Jorge Millan Regulatory Consultant 7600 NW 69th Ave Medley, Florida 33166

Re: K220290

Trade/Device Name: Revitalair 430+ Regulation Number: 21 CFR 868.5470 Regulation Name: Hyperbaric Chamber Regulatory Class: Class II Product Code: CBF Dated: March 31, 2023 Received: April 3, 2023

Dear Jorge Millan:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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 mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

James J. Lee -S

James J. Lee, Ph.D. Division Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthsia 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) K220290

Device Name REVITALAIR 430F+

Indications for Use (Describe)

The intended use of the Portable Hyperbaric Chamber Revitalair® 430+ is to treat acute mountain sickness under the prescription of a health professional. The medical device is designed for use at health institutions and physician offices.

| 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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## REVITALAIR 430+

K220290

## 510(K) Summary Revitalair 430+

## 1. Submitter Information

| Submitter | US Hyperbaric Network LLC |
|------------------|---------------------------|
| | 789 Shotgun Road |
| | Weston, FL 33326 |
| | USA |
| Contact: | Jorge Millan, PhD |
| | Regulatory Consultant |
| Telephone number | [phone] |
| Fax number | [phone] |
| E-mail | [e-mail] |
| Date prepared: | MAY 3, 2023 |

## 2. Subject Device Name

| Trade/Proprietary Name: | Revitalair® 430+ |
|-------------------------|-----------------------------|
| Common or Usual Name: | Portable Hyperbaric Chamber |
| Regulation Number: | 21 CFR 868.5470 |
| Regulation Name: | Hyperbaric chamber |
| Product Code: | CBF |
| Class | II |
| Panel | Anesthesiology Devices |

## 3. Predicate Devices

| Predicate Devices: | Primary Predicate:<br>Revitalair 430F, K171899<br>Reference devices:<br>Tampa Hyperbaric Monoplace Chamber, K981938<br>K051759, Flexi-Lite Hyperbaric Chamber by Pressure Tech |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

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K220290

## 4. Indications for Use:

The intended use of the Portable Hyperbaric Chamber Revitalair® 430+ 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.

#### 5. Device Description:

The Portable Hyperbaric Chamber Revitalair® 430+ is a hyperbaric semi rigid chamber for low pressures (operating at pressures of no greater than 1.5 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® 430+ consists of 2 parts, the cabin or chamber and the 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 of 1.5 ATM which ensures safe operations. The compressor has an additional safety valve for any obstruction of the supply hose from the compressor to the Revitalair® 430+ has 10 transparent windows to let in light, 360º viewing and enable easy verification of the patient's comfort from the outside. The Revitalair® 430+ can be operated from the exterior. After folding it up, the Revitalair® 430+ is placed in its transportation box or in the optional carrying case.

## 6. Substantially Equivalence Discussion

The following table compares the Portable Hyperbaric Chamber Revitalair® 430+ (abbreviated as Revitalair® 430+) to the predicate device with respect to indications for use, principles of operation, technological characteristics, materials, and performance testing. The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence. The subject device does not raise of safety or effectiveness based on the similarities to the predicate device.

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## REVITALAIR 430+

K220290

## Table 5A – Comparison of Characteristics

| Manufacturer | Oxavita S.R.L. | Tampa Hyperbaric<br>Enterprise | Pressure Tech | US Hyperbaric Network | | Prescription - Rx Only | Yes | Yes | Yes | Yes | Same | Target Population | People with medical<br>conditions by altitude<br>sickness | -- | Persons with high<br>altitude mountain<br>sickness | People with medical<br>conditions by altitude<br>sickness | Same |
|-------------------|--------------------|---------------------------------------|----------------------------------|-----------------------|---------------------------|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|-------------------|-----------------------------------------------------------|----|---------------------------------------------------------------------------|-----------------------------------------------------------|---------|
| Trade Name | Revitalair® 430F | Tampa Hyperbaric<br>Monoplace Chamber | Flexi-Lite Hyperbaric<br>Chamber | Revitalair® 430+ | Significant<br>Difference | Max Working<br>Pressure | 1.3 ATA -1.4 ATA | 3.0 ATA | 1.3 ATA | 1.3-1.5 ATA | Difference | Places of Use | Hospitals and clinics | -- | Home, Physician Office,<br>Outdoor, Hospital, Sub-<br>acute facility, EMS | Hospitals and clinics | Similar |
| 510(k) | K171899 | K981938 | K051759 | TBD | | Indications for Use | The intended use of the<br>Portable Hyperbaric<br>Chamber Revitalair®<br>430F is to treat mountain<br>sickness under the<br>prescription of a health<br>professional. The medical<br>device is designed for use<br>at physician offices and<br>health institutions. | -Carbon monoxide<br>poisoning with or<br>without cyanide<br>complications<br>-Smoke inhalation<br>-Exceptional blood loss<br>or anemia<br>-Clostridial myonecrosis<br>(gangrene)<br>Selected problem<br>chronic wounds<br>-Crush injury,<br>compartment<br>syndrome and acute<br>traumatic ischemia<br>-Compromised skin<br>grafts<br>-Osteomyelitis<br>-Thermal burns<br>-Osteoradionecrosis<br>(radiation burns)<br>Necrotizing soft tissue<br>infections<br>-Air and gas embolisms | The Flexi-Lite<br>Hyperbaric chamber is<br>a rugged & portable<br>hyperbaric chamber<br>intended to be used in<br>treating mild symptoms<br>consistent with Acute<br>Mountain Sickness<br>(AMS) as<br>prescribed by or under<br>the direction of a<br>physician.<br>Caution: Federal law<br>restricts this device td<br>sale by or on the order<br>of a<br>physician. | The intended use of the<br>Portable Hyperbaric<br>Chamber Revitalair®<br>430+ is to treat acute<br>mountain sickness<br>under the prescription<br>of a health<br>professional. The<br>medical device is<br>designed for use at<br>physician offices and<br>health institutions. | Similar | | | | | | |
| Product Code | CBF | CBF | CBF | CBF | Same | | | | | | | | | | | | |
| Regulation Number | 868.547 | 868.547 | 21 CFR868.5470 | 868.547 | Same | | | | | | | | | | | | |
| Regulation Name | Hyperbaric Chamber | Hyperbaric Chamber | Hyperbaric Chamber | Hyperbaric Chamber | Same | | | | | | | | | | | | |

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## REVITALAIR 430+

## K220290

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## REVITALAIR 430+

K220290

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REVITALAIR 430+

K220290

| Device | Revitalair 430F | Revitalair 430+ | Difference/<br>Similarity |
|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) | K171899 | K220290 | Similarity |
| Type of construction | Semi rigid | Semi rigid | Same |
| Dimensions | 36.2in x 74.8in | 36.2in x 74.8in | Same |
| Windows | 10 | 10 | Same |
| Transport Belts | 2 | 2 | Same |
| Relief Valves | Yes, Metal | Yes, Metal | Same |
| Drain Valves | Yes, 2 units only for emptying | Yes, 2 units only for emptying | Same |
| Operating Pressure | 1.3 -1.4 ATA | 1.3 ATA-1.5 ATA | Different |
| Inflation Method | Oil-less compressor | Oil-less compressor | Same |
| Locking System | System of metal rings | System of metal rings | Same |
| Materials | Polyester hatched 1100 18x18<br>Vinyl with phthalate free | Polyester hatched 1100 18x18<br>Vinyl with phthalate free | Same |
| Relief Valves | 2 by Plastic & Metal | 2 by Plastic & Metal | Same |
| Compressor | Oil-less | Oil-less | Same |
| Air Filter in the<br>Compressor | Yes | Yes | Same |
| Pressure Measurement | Yes | Yes | Same |
| Air Filter Chamber | Yes | Yes | Same |
| Skills of the Person to<br>Leave the Chamber | Yes | Yes | Same |
| Operating Temperature | 59 °F / 113 °F | 59 °F / 113 °F | Similar,<br>range |
| Contraindications | Patients with:<br>-Pneumothorax, Pulmonary hyper expansion<br>-Eardrum perforation<br>-Asthma<br>-Congenital spherocytosis<br>-The use of any of these drugs:<br>Cisplatinum, Disulfiram(Antabuse)<br>Doxorubicin,Adriami cina,<br>Bleomycina, Sulfamylon,<br>Anphetamines,Nicorette-<br>Nicoderm, Narcotic analgesics,<br>Steroids<br>-Emphysema with CO2 retention.<br>-Fever (>38.5° C), Colds, flu symptoms<br>-Record of medium ear problems or surgery<br>-Convulsions<br>-Optic Neuritis, Optic barotraumas | Patients with:<br>-Pneumothorax, Pulmonary hyper expansion<br>-Eardrum perforation<br>-Asthma<br>-Congenital spherocytosis<br>-The use of any of these drugs:<br>Cisplatinum, Disulfiram(Antabuse)<br>Doxorubicin,Adriami cina,<br>Bleomycina, Sulfamylon,<br>Anphetamines,Nicorette-<br>Nicoderm, Narcotic analgesics,<br>Steroids<br>-Emphysema with CO2 retention.<br>-Fever (>38.5° C), Colds, flu symptoms<br>-Record of medium ear problems or surgery | Same |
| | -Airways diseases, Blocked ear<br>-Airways canals, Blocked<br>-Viral<br>-Excessive CO2 Exposure<br>-Decompression sickness | Sinuses infections | -Optic Neuritis, Optic<br>barotraumas<br>-Pregnancy<br>-Airways diseases, Blocked ear<br>canals, Blocked Sinuses<br>-Viral infections<br>-Excessive CO2 Exposure<br>-Decompression sickness |

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## K220290

## Discussion of Similarities:

All systems presented make use of a compressor to provide inflation of a rigid or semi rigid chamber. All systems use similar design principles, designs and technologies to achieve the intended use. All system use drain valves, locking system and materials. The design, technology, materials, manufacturing processes are similar.

## Discussion of Differences

When comparing the Revitalair 430+ to the Primary Predicate (Revitalair 430F) there is a difference in the operating pressure. Revitalair 430+ can be operated at maximum of 1.5 ATA, while Revitalair 430F operates at 1.3-1.4 ATA. The operating temperature difference is about 7%-15% higher than the maximum pressure of the 430F. The increase in operating pressure does not raise new safety issues as hyperbaric chambers can be run at higher pressures than 1.3 ATA. The reference predicate K981938, for example, operates at pressures of up to 3 ATA. The 430+ hyperbaric chamber has been validated when operated at 1.5 ATA with safety testing and found to meet safety requirements.

## 7. Non-Clinical Performance Data:

As part of demonstrating safety and effectiveness of the Revitalair® 430+ Hyperbaric Chamber and in showing substantial equivalence to the predicate device to this 510(k) submission, US Hyperbaric Network completed an number of non-clinical performance tests. Testing was performed as determined by the hazard analysis.

The Revitalair® 430+ 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® 430+ Hyperbaric Chamber passed all the testing in accordance with internal requirements, and the standards shown below to support substantial equivalence of the subject device:

## Section 5

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# US HYPERBARIC NET

K220290 REVITALAIR 430+

- 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

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; 4-8.1.4 which address's the device's response to excessive pressures.

## 8. 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.

## 9. Conclusion:

The Portable Hyperbaric Chamber Revitalair® 430+, as designed and manufactured, is determined to be substantially equivalent to the cited primary predicate device Revitalair 430+ and its primary predicate device have the similar intended use, have similar technological characteristics, and are made of similar materials. All devices encompass the same range of physical dimensions and similar ranges of operating pressures.