SIGMA PLUS/ II MULTIPLACE HYPERBARIC SYSTEM

K983648 · Perry Baromedical Services · CBF · Feb 24, 1999 · Anesthesiology

Device Facts

• Record ID: K983648
• Device Name: SIGMA PLUS/ II MULTIPLACE HYPERBARIC SYSTEM
• Applicant: Perry Baromedical Services
• Product Code: CBF · Anesthesiology
• Decision Date: Feb 24, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SIGMA II Dualplace Hyperbaric Chamber is used to provide Hyperbaric Oxygen Therapy, prescribed by a licensed physician, where medical grade oxygen is administered to patients while under pressure, by the patient breathing oxygen from a breathing hood or breathing mask with the chamber pressurized with breathing air. The breathing of oxygen at elevated pressure promotes the movement of oxygen into the patient's tissues.

Device Story

Multiplace hyperbaric chamber for two patients; provides hyperbaric oxygen therapy (HBOT). Input: compressed breathing quality air for chamber pressurization; medical grade oxygen for patient inhalation via hood or mask. Operation: ASME-certified pressure vessel; pneumatic control system for pressurization/depressurization; intrinsically safe communication system; fire suppression/extinguishing systems. Used in clinical settings; operated by trained personnel. Physician prescribes HBOT; patient breathes oxygen at elevated pressure to promote tissue oxygenation. Enhances ease of operation via moveable control arm and pedestal-mounted breathing system controls compared to predicate. Benefits: facilitates treatment of conditions like decompression sickness, wounds, and infections.

Clinical Evidence

No clinical data. Bench testing only; device relies on established ASME pressure vessel standards and substantial equivalence to a previously cleared predicate device.

Technological Characteristics

ASME pressure vessel (Section VIII, Div 1; PVHO-1); acrylic cylinder (40" ID, 65" length, 20:1 safety factor); pneumatic control system (no electrical/electronic components); intrinsically safe communication; fire suppression system; fiberglass cosmetic covers. Pressurization via compressed air.

Indications for Use

Indicated for patients requiring hyperbaric oxygen therapy for: Air or Gas Embolism, Carbon Monoxide/Smoke Inhalation, Compromised Skin Grafts/Flaps, Crush Injuries/Acute Traumatic Ischemias, Decompression Sickness, Enhanced Healing in Selected Problem Wounds, Exceptional Blood Loss (Anemia), Gas Gangrene (Clostridial Myonecrosis), Intracranial Abscess, Necrotizing Soft Tissue Infections, Radiation Tissue Damage (Osteoradionecrosis), Refractory Osteomyelitis, 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).

Predicate Devices

• SIGMA II Dualplace Hyperbaric Chamber (K862198)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Perry Baromedical. The logo consists of a black circle with several black dots clustered on the left side, resembling a stylized atom or molecule. To the right of the circle, the words "PERRY" and "BAROMEDICAL" are stacked vertically, with "PERRY" on top and "BAROMEDICAL" below it. At the top of the image, there is a handwritten date that appears to be "2-24-99".

January 15, 1999

K 885648

7555 GARDEN ROAD Riviera Beach FLORIDA 33404-3411 USA

800 . 7 4 1 . 4 3 7 6 う61・840・0395 Fxx: 561 .840 . 0398 e-mail: [e-mail] web site: www.perrybaromedical.com

## Amended 510(k) K983648 SUMMARY Page 1 of 3

Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Blvd. Rockville, Maryland 20850

Document Control Clerk Attention:

## SIGMA Plus / II Multiplace Hyperbaric Chamber Summary of Safety & Subject: Effectiveness Information - Amended as of January 15, 1999

Gentlemen:

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Substantial Equivalence: The Perry Baromedical Corporation SIGNA Plus / II Multiplace Substantial Equivalence. "The Perry Baromedical Corporation Corporation SIGMA Hyperbaric Chamber is substantially oquili K862198/A]. The SIGMA Plus / Il has the same If Dualplace Tryperbarte Chamoer, [220]. Investeristics as the SIGMA II predicate device.
Intended use and the same technological characteristics as the SIGMA II in in The scope and operation of the SIGMA Plus/ II is identical to that of the SIGMA II in the following areas:

- The critical component of both systems consists of an ASME pressure vessel that is l I he critical component of tested in accordance with the requirements of the ASME designed, labricated, and testode, Section VIII, Division I; and ASME PVHO-1, Safety Standard for Pressure Vessels for Human Occupancy.
- The pressure vessel consists of certified metal components constructed of materials in 2 The pressure vesser consists of occession Pressure Vessel Code, Section II - Materials. Contornatice with the rolling boundary consists of an actylic of an actylic 1 in addition to the mean parts, the requirements of ASME PVHO-1, Safety Standard for Pressure Vessels for Human Occupancy.
- The pressure vessel is protected from accidental over pressurization by an ASME "UV" 3 stamped pressure relief valve.

Material Production

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SIGMA Plus 510(k) K983648 Amended Summary Page 2 of 3

- The medium used for pressurization of the chamber is compressed breathing quality air. 4
- Treatment capacity of the chamber is two (2) patients. 5
- Communication between the patients / attendants is through an intrinsically safe б communications system.
- The SIGMA II and SIGMA Plus/ II chambers are used to provide Hyperbaric Oxygen 7 Therapy, prescribed by a licensed physician, where medical grade oxygen is administered to patients while under pressure, by the patient breathing oxygen from a breathing hood or breathing mask with the chamber pressurized with breathing air. The breathing of oxygen at elevated pressure promotes the movement of oxygen into the patient's tissues.
- The chamber pressurization and depressurization control system is completely 8 pneumatic, with no electrical or electronic components.
- Both chambers are Class "A" multiplace hyperbaric systems, with Fire Suppression 9 Systems and independent hand line fire extinguishing systems.

Differences do exist between the SIGMA Plus/ II and the SIGMA II Dualplace chamber; they include:

- The PVHO-1 acrylic cylinder in the SIGMA Plus / II chamber is 40" inside diameter l and 65" long, and the PVHO-1 acrylic cylinder in the SIGMA II chamber is 40" inside diameter by 85" long. Both acrylic cylinders are designed with a 20 to 1 safety factor.
- The pneumatic controls for the SIGMA Plus / II chamber are mounted in a control 2 box that is suspended from a moveable arm, allowing use from either side of the chamber; while the pneumatic controls for the SIGMA II chamber are mounted in a console panel mounted on one side of the chamber.

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SIGMA Plus 510(k) K983648 Amended Summary Page 3 of 3

- The SIGMA Plus/ II Multilace Hyperbaric Chamber has painted fiberglass cosmetic 3 covers on the sides and ends of the chamber; the SIGMA II Dualplace Hyperbaric Chamber has aluminum side cosmetic covers.
- The Built-In Breathing System controls for the SIGMA Plus / II are mounted in a 4 pedestal mounted moveable control panel, allowing positioning to suit the operator location. The SIGMA II Built-In Breathing System controls are mounted in the control console positioned at the side of the chamber.
- The SIGMA II Dualplace chamber is available with an Entry Lock and a Medical Lock 5 feature, which are not offered with the SIGMA Plus / II.

The changes to the SIGMA II system resulting in the SIGMA Plus/ II Dualplace Hyperbaric Chamber enhance its ease of operation, and do not adversely effect the safety and effectiveness of the device. The basic treatment method is identical, only the chamber acrylic window length size has been changed

None of the above information is confidential and all may be made available to the public upon written request.

Perry Baromedical Corporation

Aames Dodes 1-15.99

es P. Dodson Quality Assurance Manager

Date

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with stylized wings and tail feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 4 1999

Mr. James P. Dodson Perry Baromedical Services 7555 Garden Road Riviera Beach, FL 33404-3411

K983648 Re: SIGMA Plus/II Multiplace Hyperbaric Chamber Requlatory Class: II (two) Product Code: 73 CBF January 26, 1999 Dated: Received: February 2, 1999

Dear Mr. Dodson:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. James P. Dodson

This letter will allow you to begin marketing your device as described inis recei will arrow you co icention. The FDA finding of substantial in your Srown, promativice to a legally marketed predicate device equivalence or your dontion for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling II you actire bpoorted 801 and additionally 809.10 for in vitro reguration (Er Crs), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, (21 CFR 807. Hisbianaling by Formation on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its be obtained trom [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/5/Picture/0 description: The image shows the logo for Perry Baromedical. The logo consists of a black graphic on the left, resembling a partial circle with several dots inside and around it. To the right of the graphic, the words "PERRY" and "BAROMEDICAL" are stacked vertically in a serif font. The text is in a lighter color, contrasting with the black graphic.

7555 GARDEN ROAD RIVIERA BEACH FLORIDA 33404-3411 USA

800 • 7 4 1 • 4 3 7 6 561 •840 •0395 Fxx: 561.840.0398 e-mail: [e-mail] web site: www.pcrrybaromedical.com

## INDICATIONS FOR USE

The SIGMA Plus / II Multiplace hyperbaric System is indicated for use for the following The SIGNA I has 7 21 Muniputo hyperomith guidelines established by the Undersea and Hyperbaric Medical Society, as follows:

- Air or Gas Embolism 1.
- Carbon Monoxide / Smoke Inhalation 2.
- Compromised Skin Grafts and Flaps 3.
- Crush Injuries / Acute Traumatic Ischemias 4.
- Decompression Sickness રે.
- Enhanced Healing in Selected Problem Wounds ર.
- Exceptional Blood Loss (Anemia) 7.
- Gas Gangrene (Clostridial Myonecrosis) 8.
- Intracranial Abscess ರು.
- Necrotizing Soft Tissue Infections 10.
- Radiation Tissue Damage (Osteoradionecrosis) 11.
- Refractory Osteomyelitis 12.
- Thermal Burns 13.

Prescription Device
mKramer

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number K453446

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