SIGMA SERIES HYPERBARIC CHAMBER

K072427 · Perry Baromedical Corp. · CBF · Jun 11, 2008 · Anesthesiology

Device Facts

• Record ID: K072427
• Device Name: SIGMA SERIES HYPERBARIC CHAMBER
• Applicant: Perry Baromedical Corp.
• Product Code: CBF · Anesthesiology
• Decision Date: Jun 11, 2008
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 868.5470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SIGMA Elite 34, 36 and 40 Monoplace Hyperbaric Chambers are intended for use for the following clinical medical conditions in accordance with guidelines established by the Undersea and Hyperbaric Medical Society, as follows: 1. Air or Gas Embolism 2. Carbon Monoxide / Smoke Inhalation 3. Compromised Skin Grafts and Flaps 4. Crush Injuries / Acute Traumatic Ischemia 5. Decompression Sickness 6. Enhanced Healing in Selected Problem Wounds 7. Exceptional Blood Loss (Anemia) 8. Gas Gangrene (Clostridia Myonecrosis) 9. Intracranial Abscess 10. Necrotizing Soft Tissue Infections 11. Radiation Tissue Damage (Osteoradionecrosis) 12. Refractory Osteomyelitis 13. Thermal Burns

Device Story

Monoplace hyperbaric chamber; delivers whole-body oxygen therapy at pressures up to 3 ATA. Input: pure oxygen atmosphere; patient breathes chamber air. Operation: chamber pressurized and ventilated with oxygen; pressure-time profile and ventilation rate controlled by operator via pneumatic or automatic electronic system. Used in clinical settings by trained personnel. Output: controlled hyperbaric environment. Benefit: facilitates prescribed hyperbaric oxygen treatment for specific medical conditions; allows operator to adjust parameters for patient safety and comfort.

Clinical Evidence

No clinical data. Bench testing only to demonstrate compliance with ASME Boiler and Pressure Vessel Code, ASME PVHO-1, NFPA 99, and electrical/EMC safety standards.

Technological Characteristics

Monoplace hyperbaric chamber; pressure vessel construction per ASME Boiler and Pressure Vessel Code Section VIII and ASME PVHO-1. Complies with NFPA 99 (hyperbaric facilities) and CAN/CSA C22.2 60601-1-1-02/EN60601-1-2 (electrical/EMC). Pneumatic or electronic control system for pressure and oxygen ventilation.

Indications for Use

Indicated for patients requiring hyperbaric oxygen therapy for conditions including air/gas embolism, carbon monoxide/smoke inhalation, compromised skin grafts/flaps, crush injuries/acute traumatic ischemia, decompression sickness, problem wounds, exceptional blood loss, gas gangrene, intracranial abscess, necrotizing soft tissue infections, radiation tissue damage, refractory osteomyelitis, and thermal burns. Prescription use only.

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

• SIGMA 34 (K990927)
• Sechrist 3300E/ER (K052713)
• BARA-MED (K020974)

Submission Summary (Full Text)

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K072427

Perry Baromedical Corporation 510(k) Submission

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Page 10

JUN 1 1 2008

| | Perry Baromedical Corporation | July 12, 2007 |
|-----|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 510(k) SUMMARY | |
| 1. | Submitter<br>Information | Perry Baromedical Corporation (“PBC”)<br>3660 Interstate Parkway, Riviera Beach, Florida 33404 |
| 2. | Contact<br>Information | John Crocker, Quality Manager<br>Tel: [phone] Ext. 206 Fax: [phone] |
| 3. | Trade Name | SIGMA <i>Elite</i> XX Monoplace Hyperbaric Chamber<br>Where XX can be 34, 36, or 40 |
| 4. | Common Name | Hyperbaric Chamber |
| 5. | Device Class | Class II |
| 6. | Product Code | CBF |
| 7. | Product<br>Classification | per 21 CFR § 868.5470 |
| 8. | Classification<br>Panel | Anesthesiology |
| 9. | Predicate<br>Devices | Perry Baromedical's, SIGMA 34 (K990927)<br>Sechrist Industry's, Sechrist 3300E/ER (K052713)<br>Environmental Techtonics' BARA-MED (K020974) |
| 10. | Device<br>Description | The SIGMA <i>Elite</i> Series Hyperbaric Chambers and their predicate devices<br>have the same intended use; as a prescription device intended for the whole<br>body administration of oxygen to a patient at pressures not exceeding 3 ATA.<br><br>The SIGMA <i>Elite</i> Series Hyperbaric Chambers and their predicate devices<br>have very similar general principles of operation. All of these chambers are<br>pressurized and ventilated continuously with pure oxygen, and the patient<br>breathes the chamber atmosphere. Also, in each of the chambers, the<br>pressure-time profile (i.e. the rate and direction of pressure change and the<br>time held at any particular pressure), as well as the oxygen ventilation rate of<br>any treatment, are controlled by the chamber's operator, either directly by<br>means of a pneumatic or an automatic electronic system. The purpose of such<br>controls are to be able to conduct the particular hyperbaric oxygen treatment<br>prescribed by the physician in a way that is safe and comfortable for the<br>patient, and to be able to respond appropriately and effectively to any<br>contingency circumstance. |

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The SIGMA Olite Series of Hyperbaric Chambers is designed and manufactured in accordance with the applicable sections of:

- ASME Boiler and Pressure Vessel Code, Section VIII, Rules for . Construction of Pressure Vessels, Division 1, 2003 Edition
- ASME PVHO-1, Safety Standard for Pressure Vessels for Human . Occupancy, 2002 Edition
- NFPA 99, Standard for Health Care Facilities, Chapter 19, . Hyperbaric Facilities, 2005 Edition
- CAN/CSA C22.2 60601-1-1-02 Safety Requirements for Medical . Electrical Systems, 2002 Edition EN60601-1-2:2002
- EMC Standard for Medical Devices, 2002 Edition .
- These devices are to be used by properly trained personnel to deliver Intended Use 11. hyperbaric oxygen therapy as prescribed by the attending physician. Testing was indicated to demonstrate that the devices meet the standards 12. Performance Data referenced above.
- Clinical Tests None 13.
- 14. Conclusion In all respects, the SIGMA Glite Series of Hyperbaric Chambers are substantially equivalent to one or more clinical monoplace hyperbaric chambers that are legally marketed for the conduct of hyperbaric oxygen therapy.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text surrounding a stylized image of an eagle. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The eagle is depicted with its wings forming a protective shape.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUN 11 2008

Mr. John Crocker Quality Manager Perry Baromedical Corporation 3660 Interstate Parkway Riviera Beach, Florida 33404

Re: K072427

Trade/Device Name: SIGMA Elite 34, 36, and 40 Regulation Number: 21CFR 868.5470 Regulation Name: Hyperbaric Chamber Regulatory Class: II Product Code: CBF Dated: May 29, 2008 Received: June 2, 2008

Dear Mr. Crocker:

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. Crocker

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/industry/support/index.html.

Sincerely yours,

Sayette Y. Michaud.

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

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Perry Baromedical Corporation 510(k) Submission K072427

Supplemental Materials Request Page Amendment 9(a)

## Indications for Use Statement

| 510(k) Number | K072427 |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | SIGMA Elite 34, 36, and 40 |
| Indications for Use | The SIGMA Elite 34, 36 and 40 Monoplace Hyperbaric Chambers are intended for use for the following clinical medical conditions in accordance with guidelines established by the Undersea and Hyperbaric Medical Society, as follows: <ol><li>Air or Gas Embolism</li><li>Carbon Monoxide / Smoke Inhalation</li><li>Compromised Skin Grafts and Flaps</li><li>Crush Injuries / Acute Traumatic Ischemia</li><li>Decompression Sickness</li><li>Enhanced Healing in Selected Problem Wounds</li><li>Exceptional Blood Loss (Anemia)</li><li>Gas Gangrene (Clostridia Myonecrosis)</li><li>Intracranial Abscess</li><li>Necrotizing Soft Tissue Infections</li><li>Radiation Tissue Damage (Osteoradionecrosis)</li><li>Refractory Osteomyelitis</li><li>Thermal Burns</li></ol> |

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

(Division Sign-Off)Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_ X (Per 21 CFR 801.109)

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Over-The-Counter Use_ ________________________________________________________________________________________________________________________________________________________