(457 days)
No
The description focuses on the mechanical and electrical components of a hyperbaric chamber and does not mention any AI or ML capabilities.
Yes
The intended use explicitly states "to treat acute mountain sickness under the prescription of a health professional," which falls under the definition of a therapeutic purpose.
No
This device is a therapeutic device designed to treat acute mountain sickness by increasing pressure, not a diagnostic device that identifies or characterizes a disease or condition.
No
The device description clearly details a physical hyperbaric chamber with a compressor, constructed from fabric and aluminum rings, and includes physical components like valves and windows. This is a hardware device, not software only.
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 human within a pressurized chamber. This is a therapeutic treatment applied directly to a patient, not a test performed on a sample taken from the body.
- Device Description: The device is a hyperbaric chamber designed to create a specific atmospheric pressure environment for a person. This is a physical therapy device, not a device for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any components or processes related to:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis.
IVD devices are specifically designed to perform tests in vitro (outside the body) on samples to provide diagnostic information. This device operates in vivo (within the body) by altering the atmospheric pressure around the patient.
N/A
# Intended Use / 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 health institutions and physician offices.
# Product codes (comma separated list FDA assigned to the subject device)
CBF
# 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.
# 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
Health professional / Health institutions and physician offices.
# 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: 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:
- 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.
# 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.
[K171899](https://510k.innolitics.com/search/K171899)
# 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.
[K981938](https://510k.innolitics.com/search/K981938), [K051759](https://510k.innolitics.com/search/K051759)
# 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 shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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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3
REVITALAIR 430+
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 | (786) 416-5587 |
| Fax number | (954) 208-0292 |
| sigmabiomedical@gmail.com | |
| 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:
Revitalair 430F, K171899
Reference devices:
Tampa Hyperbaric Monoplace Chamber, K981938
K051759, Flexi-Lite Hyperbaric Chamber by Pressure Tech |
| -------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
4
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.
5
REVITALAIR 430+
Table 5A – Comparison of Characteristics
| Manufacturer | Oxavita S.R.L. | Tampa Hyperbaric
Enterprise | Pressure Tech | US Hyperbaric Network | | Prescription - Rx Only | Yes | Yes | Yes | Yes | Same | Target Population | People with medical
conditions by altitude
sickness | -- | Persons with high
altitude mountain
sickness | People with medical
conditions by altitude
sickness | Same |
|-------------------|--------------------|---------------------------------------|----------------------------------|-----------------------|---------------------------|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|-------------------|-----------------------------------------------------------|----|---------------------------------------------------------------------------|-----------------------------------------------------------|---------|
| Trade Name | Revitalair® 430F | Tampa Hyperbaric
Monoplace Chamber | Flexi-Lite Hyperbaric
Chamber | Revitalair® 430+ | Significant
Difference | Max Working
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,
Outdoor, Hospital, Sub-
acute facility, EMS | Hospitals and clinics | Similar |
| 510(k) | K171899 | K981938 | K051759 | TBD | | Indications for Use | The intended use of the
Portable Hyperbaric
Chamber Revitalair®
430F is to treat mountain
sickness under the
prescription of a health
professional. The medical
device is designed for use
at physician offices and
health institutions. | -Carbon monoxide
poisoning with or
without cyanide
complications
-Smoke inhalation
-Exceptional blood loss
or anemia
-Clostridial myonecrosis
(gangrene)
Selected problem
chronic wounds
-Crush injury,
compartment
syndrome and acute
traumatic ischemia
-Compromised skin
grafts
-Osteomyelitis
-Thermal burns
-Osteoradionecrosis
(radiation burns)
Necrotizing soft tissue
infections
-Air and gas embolisms | The Flexi-Lite
Hyperbaric chamber is
a rugged & portable
hyperbaric chamber
intended to be used in
treating mild symptoms
consistent with Acute
Mountain Sickness
(AMS) as
prescribed by or under
the direction of a
physician.
Caution: Federal law
restricts this device td
sale by or on the order
of a
physician. | 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. | 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 | | | | | | | | | | | | |
6
REVITALAIR 430+
K220290
7
REVITALAIR 430+
8
REVITALAIR 430+
| Device | Revitalair 430F | Revitalair 430+ | Difference/
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
Vinyl with phthalate free | Polyester hatched 1100 18x18
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
Compressor | Yes | Yes | Same |
| Pressure Measurement | Yes | Yes | Same |
| Air Filter Chamber | Yes | Yes | Same |
| Skills of the Person to
Leave the Chamber | Yes | Yes | Same |
| Operating Temperature | 59 °F / 113 °F | 59 °F / 113 °F | Similar,
range |
| Contraindications | Patients with:
-Pneumothorax, Pulmonary hyper expansion
-Eardrum perforation
-Asthma
-Congenital spherocytosis
-The use of any of these drugs:
Cisplatinum, Disulfiram(Antabuse)
Doxorubicin,Adriami cina,
Bleomycina, Sulfamylon,
Anphetamines,Nicorette-
Nicoderm, Narcotic analgesics,
Steroids
-Emphysema with CO2 retention.
-Fever (>38.5° C), Colds, flu symptoms
-Record of medium ear problems or surgery
-Convulsions
-Optic Neuritis, Optic barotraumas | Patients with:
-Pneumothorax, Pulmonary hyper expansion
-Eardrum perforation
-Asthma
-Congenital spherocytosis
-The use of any of these drugs:
Cisplatinum, Disulfiram(Antabuse)
Doxorubicin,Adriami cina,
Bleomycina, Sulfamylon,
Anphetamines,Nicorette-
Nicoderm, Narcotic analgesics,
Steroids
-Emphysema with CO2 retention.
-Fever (>38.5° C), Colds, flu symptoms
-Record of medium ear problems or surgery | Same |
| | -Airways diseases, Blocked ear
-Airways canals, Blocked
-Viral
-Excessive CO2 Exposure
-Decompression sickness | Sinuses infections | -Optic Neuritis, Optic
barotraumas
-Pregnancy
-Airways diseases, Blocked ear
canals, Blocked Sinuses
-Viral infections
-Excessive CO2 Exposure
-Decompression sickness |
9
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
10
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.