DIVE AND SHALLOW AND GRAND DIVE

K072757 · Summit TO Sea · CBF · Feb 8, 2008 · Anesthesiology

Device Facts

• Record ID: K072757
• Device Name: DIVE AND SHALLOW AND GRAND DIVE
• Applicant: Summit TO Sea
• Product Code: CBF · Anesthesiology
• Decision Date: Feb 8, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Dive Series Hyperbaric Chambers are rugged and portable, intended to be used to treat: 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.

Device Story

Portable mild hyperbaric chamber; treats acute mountain sickness. Device consists of airtight urethane-coated nylon bag; inflated by external electric oil-less compressor (Gast DDL series). User enters bag; zipped shut; chamber pressurized to 1.2 ATA (3 PSI) or 1.3 ATA (4 PSI). Features redundant fill valves, relief valves (set to 2.9-4 PSI), access ports for air sampling, and external pressure gauge. Used in home, clinic, or outdoors; operated by patient or clinician. Provides mild hyperbaric environment to alleviate AMS symptoms. Safety ensured by mechanical relief valves preventing over-pressurization.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and design similarities to legally marketed predicate devices.

Technological Characteristics

Materials: urethane-coated nylon bag, metal/plastic valves and ports. Pressure: 1.2-1.3 ATA (3-4 PSI). Inflation: electric oil-less compressor. Relief valves: redundant, set to 2.9-4 PSI. Dimensions: 7-9 ft length, 27-40 in width. Connectivity: none. Software: none.

Indications for Use

Indicated for treatment of Acute Mountain Sickness (AMS) in patients as prescribed by a physician. Contraindications include: alcohol consumption, colds/flu symptoms, blocked ear canals, blocked sinuses, otic barotraumas, excessive CO2 exposure, pulmonary hyper-expansion, 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

• Gamow Bag (K874752A)
• HTI Model-2 (K001409)
• BLKS-307 Monoplace Hyperbaric Oxygen Treatment System (K060739)

Submission Summary (Full Text)

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# 510(k) Summary

Owner Information Judith McKeeman 1744 Avocet Lane Mound. MN 55364 Phone [phone] Fax [phone]

APR 22 2008

Contact Information Bruce McKeeman

Preparation Date: August 25, 2007

- . Trade name - Hyperbaric Dives Hyperbaric Chamber
- Common name Portable Mild Hyperbaric Chamber .
- Classification name Hyperbaric Chamber (868.5470, Product Code CBF) .

This submission is using the Gamow Bag/HT/ Model-2, manufactured by HT/ as the substantially equivalent devices, The FDA 510K numbers are K874752A for the Gamow bag and K001409 for the HTI Model-2. Also, the BLKS-307 Monoplace Hyperbaric Oxygen Treatment System is used as a substantial equivalent device with the FDA 510 number K060739.

### Device Description

Hyperbaric Dive chambers are mild hyperbaric chambers for pressures less than 5 PSI. This chamber is designed after the Gamow bag. It is composed of an airtight bag which is zipped shut with a person inside. The bag is inflated with atmospheric air with a small electric pump. The Hyperbaric Dive chambers are inflated with the Gast DDL 30. DDL40, or DDL120. The Shallow Dive, The Dive, and the Grand Dive utilize a single airtight bag with a single zipper. The bags have two relief valves set to 3.9 and 4 PSI to ensure safe operation (The Shallow Dives are set to 2.9 and 3 PSI to achieve the lower pressure). The chambers all utilize two redundant fill valves (for pressurizing the chamber from the Gast pump), one - two access ports for sampling inside air and one external pressure gauge. An optional pressure gauge can be added to the air sampling valve and positioned for viewing from the inside of the chamber. The Shallow Dive and the Dive weigh 15 pounds while the Grand Dive weighs 32 pounds. The compressor weighs 24 pounds. The bags are constructed of urethane coated nylon. The valves and ports are constructed of metal and plastic. The Shallow Dive is 7 feet long and 27 inches wide and attains 1.2 ATA (3 PSI), the Dive is 7 feet long and 27 inches wide and the Grand Dive is 9 feet long and 40 inches wide. These two chambers attain 1.3 ATA (4 PSI). All dimensions are with the devices inflated.

Indicated Use: Indications for Use: The Dive Series Hyperbaric Chambers are rugged and portable, intended to be used to treat:

Acute Altitude Sickness

As prescribed by or under the direction of a physician.

The device is intended for use in the home, physicians' offices, outdoors, hospitals/clinics.

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| Attribute | Gamow K874752A | HTI Model-2 K001409 | The Shallow Dive | The Dive | The Grand Dive | | | | | |
|---------------------------------|-------------------------------------------------------------------------------------|--------------------------------------------------------------------|-------------------------------------------------------------------------------------|--------------------------------------------------------------------|--------------------------------------------------------------------------|--------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| | | | Model HD220 | Model HD250 | Model HD400 | | | | | |
| | | | 510K K072757 | 510K K072757 | 510K K072757 | | | | | |
| Intended Use | Acute Mountain Sickness (AMS) and its associated mild symptoms | Acute Mountain Sickness (AMS) and its associated mild symptoms | Same | Same | Same | | | | | |
| Prescription Use | Yes | Yes | Yes | Yes | Yes | | | | | |
| Intended population | People with High altitude mountain sickness | People with High altitude mountain sickness | Same | Same | Same | | | | | |
| Intended place of use | home, physicians offices, outdoors, hospitals/clinics | home, physicians offices, outdoors, hospitals/clinics | Same | Same | Same | | | | | |
| Weight | 6.5 lbs. | 11 lbs. | 15 lbs. | 15 lbs. | 32 lbs. | | | | | |
| Size | 7' X 21" | 7' X 21" | 7' X 27" | 7' X 27" | 9' X 40" | | | | | |
| Length X<br>Width (inflated) | | | | | | | | | | |
| Windows | 2 | 3 | 2-3 | 2-3 | 2-4 | | | | | |
| Straps for transport | 2 | none | 4 | 4 | 4 | | | | | |
| Relief Valves | Yes, plastic | Yes(plastic/<br>metal) | Yes | Yes | Yes | | | | | |
| Dump Valve | Yes | Yes (two-way) | Yes Integrated in<br>Relief an Fill<br>valves | Yes Integrated in Relief an Fill valves | Yes Integrated in Relief<br>an Fill valves | | | | | |
| Operating Pressure | 2-4 PSI/1-1.3<br>ATA | 2-4 PSI/1-1.3<br>ATA | 3 PSI/1-1.2 ATA | 4 PSI/1-1.3 ATA | 4 PSI/1-1.3 ATA | | | | | |
| Method for inflation | Foot<br>pump/compressor | Compressor | Compressor | Compressor | Compressor | | | | | |
| Zipper | Pressure seal | Double zipper<br>with seal flap<br>two-way | Single airtight<br>zipper | Single airtight zipper | Single airtight zipper | | | | | |
| Chamber | 420 denier &<br>33-39 oz.<br>urethane<br>coated nylon | 420 denier &<br>33-39 oz.<br>urethane<br>coated nylon | Same HTI Model-<br>2 K001409 | Same HTI Model-2<br>K001409 | Same HTI Model-2<br>K001409 | | | | | |
| Relief Valves | Plastic | Stainless steel | NA for K060739<br>Plastic and Metal | NA for K060739<br>Plastic and Metal | NA for K060739<br>Plastic and Metal | | | | | |
| Compressor | | Gast oil-less | Gast oil-less | Gast oil-less | Gast oil-less | | | | | |
| Air Filtration on<br>Compressor | Yes | Yes | Yes | Yes | Yes | | | | | |
| Pressure Gauge | Yes | Yes | Yes | Yes | Yes | | | | | |
| Operating Temperature | -50F to +125F | -50F to +125F | -50F to 125F | -50F to 125F | -50F to 125F | | | | | |
| Contradictions | Alcohol<br>consumption<br>- Blocked Ear<br>Canals<br>- Blocked<br>Sinuses<br>- Otic | Patients with:<br>colds, or flu<br>symptoms<br>- Recent<br>Alcohol | Alcohol<br>consumption<br>- Blocked Ear<br>Canals<br>- Blocked<br>Sinuses<br>- Otic | Patients with:<br>colds, or flu<br>symptoms<br>- Recent<br>Alcohol | - Blocked Ear<br>Canals<br>- Blocked<br>Sinuses<br>- Otic<br>barotraumas | Patients with:<br>colds, or flu<br>symptoms<br>- Recent Alcohol<br>consumption | - Blocked Ear<br>Canals<br>- Blocked Sinuses<br>- Otic barotraumas<br>- Excessive CO2<br>exposure | Patients with:<br>colds, or flu<br>symptoms<br>- Recent Alcohol<br>consumption | - Blocked Sinuses<br>- Otic barotraumas<br>- Excessive CO2<br>exposure | Patients with: colds,<br>or flu symptoms<br>- Recent Alcohol<br>consumption<br>- Blocked Ear Canals |

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| | barotraumas<br>- Excessive<br>CO2 exposure<br>- Pulmonary<br>hyper<br>expansion<br>Decompression<br>Sickness | barotraumas<br>- Excessive<br>CO2 exposure<br>- Pulmonary<br>hyper<br>expansion<br>Decompression<br>Sickness | - Excessive CO2<br>exposure<br>- Pulmonary<br>hyper expansion<br>Decompression<br>Sickness | - Pulmonary hyper<br>expansion<br>Decompression<br>Sickness | - Pulmonary hyper<br>expansion<br>Decompression<br>Sickness |
|----------|--------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|-------------------------------------------------------------|-------------------------------------------------------------|
| Labeling | Compatible | Compatible | Compatible | Compatible | Compatible |

## Differences between other Legally Marketed Devices:

1 .

There is no significance difference between The Shallow Dive, The Grand Dive and the predicate Gamow Bag K874752A and HTI Model-2 K001409.

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The overall design is simple and professional, reflecting the department's role in public health and welfare.

Public Health Service

APR 22 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Bruce McKeeman Manager Summit to Sea 1744 Avocet Lane Mound, Minnesota 55364

Re: K072757

Trade/Device Name: The Shallow Dive, The Dive, and The Grand Dive Regulation Number: 21 CFR 868.5470 Regulation Name: Hyperbaric Chamber Regulatory Class: II Product Code: CBF Dated: January 28, 2008 Received: January 28, 2008

Dear Mr. McKeeman:

This letter corrects our substantially equivalent letter of February 8, 2008.

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 (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 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.

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## Page 2 - Mr. McKeeman

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 continue 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Qurs

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

Enclosures

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# Indications for Use

510(k) Number (if known): K072757.

Device Name: The Shallow Dive, The Dive, and The Grand Dive

Indications for Use: The Dive Series Hyperbaric Chambers are rugged and portable, intended to be used to treat:

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 X (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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