(141 days)
K874752A, K001409
Not Found
No
The device description focuses on mechanical components and pressure regulation, with no mention of AI/ML terms or functionalities.
Yes
The device is intended for the treatment of Acute Mountain Sickness (AMS) and its associated mild symptoms, functioning as a hyperbaric chamber to provide mild hyperbaria.
No
The device is intended for treatment (providing mild hyperbaria for AMS), not for diagnosing conditions.
No
The device description clearly outlines a physical hyperbaric chamber with multiple hardware components (bag, valves, gauges, compressor). 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 provide mild hyperbaria for the treatment of Acute Mountain Sickness (AMS) and its associated symptoms. This is a therapeutic treatment, not a diagnostic test performed on samples taken from the human body.
- Device Description: The device is a physical chamber that alters the atmospheric pressure around the patient. It does not involve the analysis of biological samples (blood, urine, tissue, etc.) which is the hallmark of an IVD.
- Lack of IVD-related information: The document does not mention any aspects related to diagnostic testing, sample handling, reagents, or analysis of biological markers.
In summary, the Flexi-Lite Hyperbaric chamber is a therapeutic device used to treat a medical condition by altering the environment around the patient, not a device used to diagnose a condition by testing samples.
N/A
Intended Use / Indications for Use
To provide mild hyperbaria for the treatment of Acute Mountain Sickness (AMS) and its associated mild symptoms.
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 to sale by or on the order of a physician.
Product codes
73 CBF, CBF
Device Description
The Flexi-Lite flexible hyperbaric chamber is a mild hyperbaric chamber for pressures less than 5 psi. This lightweight and portable chamber utilizes atmospheric Air as supplied by a GAST model 0523 "oiless, breathable air compressor" to pressurize the chapplice und provide a suitable environment for the occupant. The Flexi-Lite construction utilizes and bag design with the inner bag containing the pressure and an exterior hag to provide structural support. All components are attached to the inner bag utilizing oulkhead connections. It is outfitted with two externally mounted metal relief valves (set out nedit two metal Air addition valves (one external & one internal), two metal depressurization valves (one external & one internal), two pressure gauges (one external & one internal, and one metal Air sampling port. In total it weighs 39 lbs (compressor adds another 54 lbs).
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
Home, Physicians office, Outdoor environments, Hospital, Sub-acute Institutions, Emergency Services.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K874752A, K001409
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
K 051759
NOV 1 7 2005
Performance Hyperbarics
2599 A Olinda Rd
Makawao, HI 96768
Non-Confidential Summary of Safety and Effectiveness, 510(k) Submission
June 15, 2005
| Performance Hyperbarics | Tel - 808-573-8166 |
|---|---|
| 2599 A Olinda Rd | Fax- 808-573-8976 |
| Makawao, HI 96768 | email- info@hyperbaric-oxygen-chamber.com |
| Official Contact: | Spencer Feldman |
| Proprietary or Trade Name: | Flexi-Lite Hyperbaric Chamber |
| Common Used Name: | Mild Hyperbaric Chamber |
| Classification Name: | Hyperbaric Chamber |
| Regulatory Class: | Class II (two) |
| Product Code: | 73 CBF |
| Device: | Flexible Hyperbaric Chamber with Air Compressor |
| Predicate Devices: | HTI - Gamow Bag -K874752A |
| HTI - Mild Hyperbaric Chamber -K001409 |
Device Description
The Flexi-Lite flexible hyperbaric chamber is a mild hyperbaric chamber for pressures less than 5 psi. This lightweight and portable chamber utilizes atmospheric Air as supplied by a GAST model 0523 "oiless, breathable air compressor" to pressurize the chapplice und provide a suitable environment for the occupant. The Flexi-Lite construction utilizes and bag design with the inner bag containing the pressure and an exterior hag to provide structural support. All components are attached to the inner bag utilizing oulkhead connections. It is outfitted with two externally mounted metal relief valves (set out nedit two metal Air addition valves (one external & one internal), two metal depressurization valves (one external & one internal), two pressure gauges (one external & one internal, and one metal Air sampling port. In total it weighs 39 lbs (compressor adds another 54 lbs).
1
Intended Use
:
| Indicated Use: | To provide mild hyperbaria for the treatment of Acute Mountain
Sickness (AMS) and its associated mild symptoms |
|---------------------|-------------------------------------------------------------------------------------------------------------------|
| Environment of Use: | Home, Physicians office, Outdoor environments, Hospital, Sub-
acute Institutions, Emergency Services. |
| Prescriptive Use: | Caution, Federal law restricts this device to sale by or on the order
of a physician. |
.
- ﺟﺒ
.
2
Comparison To Predicate Devices
| Attribute | Gamow
K874752A | HTI Model-2
K001409 | HTI Model-3
K001409 | Flexi-Lite
K051759 |
|-----------------------------------|---------------------------------------------------------------------------------|---------------------------------------------------------------------------------|---------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| Intended Use | Acute Mountain
Sickness (AMS)
& associated
symptoms | Acute Mountain
Sickness (AMS)
& associated
symptoms | Acute Mountain
Sickness (AMS)
& associated
symptoms | Acute Mountain
Sickness (AMS)
& associated
symptoms |
| Prescription Use | Yes | Yes | Yes | Yes |
| Intended
Population | Persons with high
altitude mountain
sickness | Persons with high
altitude mountain
sickness | Persons with high
altitude mountain
sickness | Persons with high
altitude mountain
sickness |
| Intended
Environment of
Use | Home, Physician
Office, Outdoor,
Hospital, Sub-
acute facility,
EMS | Home, Physician
Office, Outdoor,
Hospital, Sub-
acute facility,
EMS | Home, Physician
Office, Outdoor,
Hospital, Sub-
acute facility,
EMS | Home, Physician
Office, Outdoor,
Hospital, Sub-
acute facility,
EMS |
| Weight (lbs) | 6.5 | 11 | 17 | 39 |
| Size
Length x
inflated dia. | 7 ft x 21 in | 7 ft x 21 in | 7 ft x 21 in | 8 ft x 30 in |
| Windows | 2 | 3 | 3 | 4 |
| Straps for
Transport | 2 | none | none | none |
| Relief Valves | Yes-Plastic | Yes-Metal | Yes-Metal | Yes, Qty-2-Metal |
| Dump Valve | yes | yes, 2-way | yes, 2-way | yes-Separate |
| Operating
Pressure (psi) | 2-4 | 2-4 | 2-4 | 2-4 |
| Methods of
Inflation | Foot pump /
Compressor | Compressor | Compressor | GAST Model
0523 Compressor |
3
| Zipper | Pressure seal | Double zipper w/
seal-flap, 2-way | Double zipper w/
seal-flap, 2-way | Single zipper |
|---------------------------------|-----------------------------------------|--------------------------------------------------------|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Materials | | | | |
| Attribute | Gamow
K874752A | HTI Model-2
K001409 | HTI Model-3
K001409 | Flexi-Lite
K051759 |
| Chamber | 420 denier-
urethane coated
nylon | 420 denier and
33-39 oz
urethane coated
nylon | 33-39 oz urethane
coated nylon | inner bag-880
denier-urethane
coated nylon
outer bag- 2 x 2
basket weave, 2-
side-urethane
coated nylon |
| Relief valves | Plastic | Stainless Steel | Stainless Steel | Brass & Stainless |
| Compressor | GAST oil-less | GAST oil-less | GAST oil-less | GAST 0523 oil-
less |
| Air Filtration on
compressor | yes | yes | yes | yes |
| Pressure Gauge | yes | yes | yes | yes |
| Air Filtration on
chamber | ? | ? | ? | Yes |
۔۔۔ ﺟ
:
4
| Ability for
person inside to
extricate
themselves if
| needed | no | yes | yes | yes |
|---|---|---|---|---|
| Attribute | Gamow | |||
| K874752A | HTI Model-2 | |||
| K001409 | HTI Model-3 | |||
| K001409 | Flexi-Lite | |||
| K051759 | ||||
| Operating | ||||
| Temperatures | -50F to + 120F | -50F to + 120F | -50F to + 120F | -50F to + 120F |
| Contraindicatio | ||||
| ns | Patients with: | |||
| -Colds or flu | ||||
| symptoms | ||||
| -Recent alcohol | ||||
| consumption | ||||
| -Blocked ear | ||||
| canals for any | ||||
| reason | ||||
| -Otic barotrauma | ||||
| -Excessive CO2 | ||||
| exposure | ||||
| -Pulmonary | ||||
| hyperexpansion | ||||
| -Decompression | ||||
| Sickness | Patients with: | |||
| -Colds or flu | ||||
| symptoms | ||||
| -Recent alcohol | ||||
| consumption | ||||
| -Blocked ear | ||||
| canals for any | ||||
| reason | ||||
| -Otic barotrauma | ||||
| -Excessive CO2 | ||||
| exposure | ||||
| -Pulmonary | ||||
| hyperexpansion | ||||
| -Decompression | ||||
| Sickness | Patients with: | |||
| -Colds or flu | ||||
| symptoms | ||||
| -Recent alcohol | ||||
| consumption | ||||
| -Blocked ear | ||||
| canals for any | ||||
| reason | ||||
| -Otic barotrauma | ||||
| -Excessive CO2 | ||||
| exposure | ||||
| -Pulmonary | ||||
| hyperexpansion | ||||
| -Decompression | ||||
| Sickness | Patients with: | |||
| -Colds or flu | ||||
| symptoms | ||||
| -Recent alcohol | ||||
| consumption | ||||
| -Blocked ear | ||||
| canals for any | ||||
| reason | ||||
| -Otic barotrauma | ||||
| -Excessive CO2 | ||||
| exposure | ||||
| -Pulmonary | ||||
| hyperexpansion | ||||
| -Decompression | ||||
| Sickness | ||||
| Labeling | Comparable | Comparable | Comparable | Comparable |
Differences Between Other Legally Marketed Devices:
. .
There are no significant differences between the FlexiLite and the predicates - Gamow Bag K874752A -HTI Models 2 or 3 K001409 ـ - ﺣﺘﻰ
.
5
Image /page/5/Picture/1 description: The image is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the edge. In the center of the seal is a stylized eagle emblem. The eagle is depicted with three curved lines representing its wings and body.
Public Health Service
NOV 1 7 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Spencer Feldman President Performance Hyperbarics 2599 A Olinda Road Makawao, Hawaii 96768
Re: K051759
Trade/Device Name: Flexi-Lite Regulation Number: 868.5470 Regulation Name: Hyperbaric Chamber Regulatory Class: II Product Code: CBF Dated: October 21, 2005 Received: October 21, 2005
Dear Mr. Feldman:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
6
Page 2 - Mr. Feldman
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Susan Gunno
Chiu Lin, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Indications For Use
510(k) Number (if known): K051759
Device Name: Flexi-Lite
The Flexi-Lite Hyperbaric chamber is a rugged & portable Indications For Use: 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 to sale by or on the order of a physician.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-the-Counter Use (21 CFR 807 Subpart C )
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ciara Sullivan
്ഥാ ടിğn-Off)
Sion of Anesthesiology, General Hospital, Control, Dental Devices
ා වලදා) Number: