MSI I2010 DUAL PLACE HYPERBARIC CHAMBER

K022214 · Mechidyne Systems, Inc. · CBF · Feb 26, 2003 · Anesthesiology

Device Facts

• Record ID: K022214
• Device Name: MSI I2010 DUAL PLACE HYPERBARIC CHAMBER
• Applicant: Mechidyne Systems, Inc.
• Product Code: CBF · Anesthesiology
• Decision Date: Feb 26, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

1 Air or Gas Embolism 2 Carbon Monoxide Poisoning Carbon Monoxide Poisoning Complicated by Cyanide Poisoning 3 Clostridal Myositis and Myonecrosis (Gas Gangrene) 4 Crush Injury, Compartment Syndrome, and other Acute Traumatic Ischemias 5 Decompression Sickness 6 Enhancement of Healing in Selected Problem Wounds 7 Exceptional Blood Loss (Anemia) 8 Intracranial Abscess 9 Necrotizing Soft Tissue Infections 10 Osteomyelitis (Refractory) 11 Delayed Radiation Injury (Soft Tissue and Bony Necrosis 12 Skin Grafts & Flaps (Compromised) 13 Thermal Burns These are the indicated uses by the Undersea & Hyperbaric Medical Society. The device is designed to be used for the indicated uses only.

Device Story

MSI i2010 Dual Place Hyperbaric Chamber; pressure vessel system for hyperbaric oxygen therapy. Device provides controlled high-pressure environment to facilitate oxygen delivery to patients. Used in clinical settings by trained medical personnel. Operates by pressurizing chamber with oxygen or air to treat specific medical conditions defined by Undersea & Hyperbaric Medical Society. Benefits include enhanced healing, tissue oxygenation, and treatment of gas-related or ischemic pathologies. Output is therapeutic environment; clinical decision-making based on patient condition and standard hyperbaric protocols.

Clinical Evidence

No clinical data provided; substantial equivalence based on device design and intended use for established hyperbaric indications.

Technological Characteristics

Dual-place hyperbaric chamber; pressure vessel construction. Operates via controlled pressurization. No software or electronic algorithm components described.

Indications for Use

Indicated for patients requiring hyperbaric oxygen therapy for conditions including air/gas embolism, carbon monoxide poisoning, gas gangrene, crush injury/acute traumatic ischemia, decompression sickness, problem wounds, anemia, intracranial abscess, necrotizing soft tissue infections, refractory osteomyelitis, delayed radiation injury, compromised skin grafts/flaps, and thermal burns.

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).

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## FEB 2 6 2003

Mr. Audley L. Aaron President Mechidyne Systems, Incorporated 16840 Clay Road Houston, Texas 77084

Re: K022214

Trade/Device Name: MSI i2010 Dual Place Hyperbaric Chamber Regulation Number: 868.5470 Regulation Name: Hyperbaric Chamber Regulatory Class: II Product Code: CBF Dated: October 21, 2002 Received: December 2, 2002

Dear Mr. Aaron:

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.

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Page 2 - Mr. Aaron

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 [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.

Susan Runner

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K022214 Device Name: MSI i2010 Dual Place Hyperbaric Chamber Indications for Use:

- 1 Air or Gas Embolism
- 2 Carbon Monoxide Poisoning Carbon Monoxide Poisoning Complicated by Cyanide Poisoning
- 3 Clostridal Myositis and Myonecrosis (Gas Gangrene)
- Crush Injury, Compartment Syndrome, and other Acute 4 Traumatic Ischemias
- 5 Decompression Sickness
- Enhancement of Healing in Selected Problem Wounds റ
- 7 Exceptional Blood Loss (Anemia)
- 8 Intracranial Abscess
- 9 Necrotizing Soft Tissue Infections
- 10 Osteomyelitis (Refractory)
- 11 Delayed Radiation Injury (Soft Tissue and Bony Necrosis
- 12 Skin Grafts & Flaps (Compromised)
- 13 Thermal Burns

These are the indicated uses by the Undersea & Hyperbaric Medical Society.

The device is designed to be used for the indicated uses only.

Susa Rumpf

on of Anesthesiology, General Hospitzl, ection Control, Dental Devices

510(k) Number _

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Concurrence of CDRH, Office of Device Evaluation (ODE)