Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on the mechanical components and operation of a hyperbaric chamber, with no mention of AI or ML technologies.

Therapeutic

Yes
The device is intended to treat Acute Mountain Sickness (AMS), indicating a therapeutic purpose.

Diagnostic

No

Explanation: The device is intended for treating Acute Mountain Sickness (AMS), which is a therapeutic rather than a diagnostic function.

SaMD (Software as a Medical Device)

No

The device description clearly details physical components such as an airtight bag, zipper, electric pump, valves, ports, and pressure gauges, indicating it is a hardware device.

IVD (In Vitro Diagnostic)

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 (AMS) by placing a person inside the chamber and increasing the pressure. This is a therapeutic treatment applied directly to a living person.
Device Description: The description details a physical chamber designed to contain a person and alter the atmospheric pressure around them. It does not involve analyzing samples taken from the body (like blood, urine, or tissue).
Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information about a disease or condition based on sample analysis.
- Using reagents or assays.

IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This hyperbaric chamber does not fit that description. It is a therapeutic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended 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.

Product codes (comma separated list FDA assigned to the subject device)

CBF

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.

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' offices, outdoors, hospitals/clinics.

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): 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.

K874752A, K001409, K060739

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.

Not Found

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

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).

Summary

0

510(k) Summary

Owner Information Judith McKeeman 1744 Avocet Lane Mound. MN 55364 Phone (612)325-8243 Fax (952)955-6090

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.

1

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
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/
metal)	Yes	Yes	Yes
Dump Valve	Yes	Yes (two-way)	Yes Integrated in
Relief an Fill
valves	Yes Integrated in Relief an Fill valves	Yes Integrated in Relief
an Fill valves
Operating Pressure	2-4 PSI/1-1.3
ATA	2-4 PSI/1-1.3
ATA	3 PSI/1-1.2 ATA	4 PSI/1-1.3 ATA	4 PSI/1-1.3 ATA
Method for inflation	Foot
pump/compressor	Compressor	Compressor	Compressor	Compressor
Zipper	Pressure seal	Double zipper
with seal flap
two-way	Single airtight
zipper	Single airtight zipper	Single airtight zipper
Chamber	420 denier &
33-39 oz.
urethane
coated nylon	420 denier &
33-39 oz.
urethane
coated nylon	Same HTI Model-
2 K001409	Same HTI Model-2
K001409	Same HTI Model-2
K001409
Relief Valves	Plastic	Stainless steel	NA for K060739
Plastic and Metal	NA for K060739
Plastic and Metal	NA for K060739
Plastic and Metal
Compressor		Gast oil-less	Gast oil-less	Gast oil-less	Gast oil-less
Air Filtration on
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
consumption

Blocked Ear
Canals
Blocked
Sinuses
Otic | Patients with:
colds, or flu
symptoms
Recent
Alcohol | Alcohol
consumption
Blocked Ear
Canals
Blocked
Sinuses
Otic | Patients with:
colds, or flu
symptoms
Recent
Alcohol | - Blocked Ear
Canals
Blocked
Sinuses
Otic
barotraumas | Patients with:
colds, or flu
symptoms
Recent Alcohol
consumption | - Blocked Ear
Canals
Blocked Sinuses
Otic barotraumas
Excessive CO2
exposure | Patients with:
colds, or flu
symptoms
Recent Alcohol
consumption | - Blocked Sinuses
Otic barotraumas
Excessive CO2
exposure | Patients with: colds,
or flu symptoms
Recent Alcohol
consumption
Blocked Ear Canals |

2

| | barotraumas

Excessive
CO2 exposure
Pulmonary
hyper
expansion
Decompression
Sickness | barotraumas
Excessive
CO2 exposure
Pulmonary
hyper
expansion
Decompression
Sickness | - Excessive CO2
exposure
Pulmonary
hyper expansion
Decompression
Sickness | - Pulmonary hyper
expansion
Decompression
Sickness | - Pulmonary hyper
expansion
Decompression
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.

3

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.

4

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 (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 (240) 276-3150 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

5

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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