SIGMA PLUS MONOPLACE HYPERBARIC CHAMBER

K974868 · Perry Baromedical Corp. · CBF · Jul 2, 1998 · Anesthesiology

Device Facts

• Record ID: K974868
• Device Name: SIGMA PLUS MONOPLACE HYPERBARIC CHAMBER
• Applicant: Perry Baromedical Corp.
• Product Code: CBF · Anesthesiology
• Decision Date: Jul 2, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The monoplace hyperbaric chamber is indicated for use for the following clinical medical conditions in accordance with guidelines established by the Undersea and Hyperbaric Medical Society, as follows: - Air or Gas Embolism - Carbon Monoxide / Smoke Inhalation - Compromised Skin Grafts and 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 - Thermal Burns

Device Story

Monoplace hyperbaric chamber for single-patient hyperbaric oxygen therapy (HBOT). Input: compressed pure oxygen or breathing air. Operation: patient breathes oxygen (via chamber atmosphere or hood/mask) at elevated pressure to promote tissue oxygenation. Chamber consists of ASME-certified pressure vessel with acrylic cylinder; pneumatic control system (no electrical/electronic components). Used in clinical settings; operated by trained personnel. Output: pressurized environment for therapeutic oxygen delivery. Benefits: enhanced healing for specified medical conditions. Differences from predicate include larger acrylic cylinder (40" vs 25.25" diameter), moveable arm-mounted pneumatic controls, and fiberglass cosmetic covers.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics, design standards (ASME/PVHO-1), and identical treatment methodology to the predicate device.

Technological Characteristics

ASME pressure vessel; acrylic plastic cylinder (PVHO-1 compliant); pneumatic control system (no electrical/electronic components); 40" inside diameter cylinder; fiberglass cosmetic covers; moveable arm-mounted control box. Pressurization via compressed oxygen or breathing air.

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 ischemias, decompression sickness, problem wounds, anemia, gas gangrene, intracranial abscess, necrotizing soft tissue infections, radiation tissue damage, 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 I Monoplace Hyperbaric Chamber (K832127)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the date "JUL 2 1998". The month is "JUL", the day is "2", and the year is "1998". The text is in a bold, sans-serif font.

Image /page/0/Picture/1 description: The image shows a black and white graphic. The graphic is a partial ring shape, with a section missing from the outer edge. The ring is thick and solid black, contrasting with the white background.

December 24, 1997

K974868

7 555 GARDES ROWN REFERA BEACH Frorton 33404 - 3411 LSA

800 · 7 + 1 · + 3 7 () うの】●840 ● (1395 1 : x : うか | . 840 · 0308 e mail haromediaaol com wch sne a ww perrybaromedical com

510(k) 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 Monoplace Hyperbaric Chamber Summary of Safety & Subject: Effectiveness Information

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 SIGMA Plus Monoplace Hyperbaric Chamber is substantially equivalent to the Perry Baromedical Corporation SIGMA I Monoplace Hyperbaric Chamber, [510(k) K832127]. The SIGMA Plus has the same intended use and the same technological characteristics as the SIGMA I predicate device. The scope and operation of the SIGMA Plus is identical to that of the SIGMA I in the following areas:

- The critical component of both systems consists of an ASME pressure vessel that is l designed, fabricated, and tested in accordance with the requirements of the ASME Boiler and Pressure Vessel Code, 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 conformance with the ASME Boiler and Pressure Vessel Code, Section II - Materials. In addition to the metal parts, the pressure retaining boundary consists of an acrylic plastic cvlinder, designed and constructed to 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.

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows a logo with a circular design on the left and the text "PERRY BAROMEDICAL" on the right. The circular design consists of a semi-circular arc and several smaller circles arranged in a pattern. The text is stacked vertically, with "PERRY" on top of "BAROMEDICAL". The font appears to be a serif typeface.

Research and Children 年来看到了 - 大 - 大 - 大 - 大 - 大 - 大 -ﺍﯾﻦ ﺍﺳﺖ.

SIGMA Plus 510(k) Summary Page 2 of 3

- The medium used for pressurization of the chamber is either compressed pure oxygen or 4 compressed breathing air.
- Treatment capacity of the chamber is one (1) patient. 5
- Communication between the patients / attendants is through an intrinsically safe 6 communications system.
- The SIGMA I and SIGMA Plus 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; either by the patient breathing the chamber atmosphere, (when pressurized with oxygen), or by the patient breathing oxygen from a breathing hood or breathing mask, (when 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 pneumatic, 8 with no electrical or electronic components.

Differences do exist between the SIGMA Plus and the SIGMA I Monoplace chamber; they include:

- l The PVHO-1 acrylic cylinder in the SIGMA Plus chamber is 40" inside diameter, and the P VHO-1 acrylic cylinder in the SIGMA I chamber is 25.25" inside diameter. Both acrylic cylinders are designed with a 20 to 1 safety factor.
- 2 The pneumatic controls for the SIGMA Plus chamber are mounted in a control box that is suspended from a moveable arm, allowing use from either side of the chamber; while the pneumatic controls for the SIGMA I chamber are mounted in a panel on one side of the chamber.
- 3 The SIGMA Plus Monoplace Hyperbaric Chamber has painted fiberglass cosmetic covers on the sides and ends of the chamber; the SIGMA I Monoplace Hyperbaric Chamber has a wheeled aluminum support chassis.

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for Perry Baromedical. The logo consists of a semi-circular shape with several dots emanating from the open side. To the right of the shape is the text "Perry Baromedical" stacked on two lines.

! : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

SIGMA Plus 510(k) Summary Page 3 of 3

:

The changes to the SIGMA I system resulting in the SIGMA Plus Monoplace 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 size has been increased.

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

## Perry Baromedical Corporation

Aarons Dock

12-24-17
Date

James P. Dodson Quality Assurance Manager

12-24-71
Date

{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 image of three human profiles facing right, with flowing lines above them that could represent hair or wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2 1998

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

Re : K974868 SIGMA Plus Monoplace Hyperbaric Chamber Regulatory Class: II (two) Product Code: 73 CBF Dated: April 3, 1998 Received: April 6, 1998

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, Druq, 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 requlations.

{4}------------------------------------------------

Page 2 - Mr. James P. Dodson

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), 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, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

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

Enclosure

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image contains the text "Attachment 3A". The text is oriented diagonally in the image. The text is in a simple, sans-serif font.

Operations & Maintenance Manual Addenda

The image does not contain any text.

PERRY BAROMEDICAL CORPORATION 7555 Garden Rd "B" Riviera Beach FL 33404 [phone]

April 1, 1998

## FDA Indications for Use Statement Subject :

The monoplace hyperbaric chamber is indicated for use for the following clinical medical I he monopiace nyperbare chamber is marcated for accords.
cpndconditions accordance with 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 5.
- Enhanced Healing in Selected Problem Wounds ର.
- Exceptional Blood Loss (Anemia) 7.
- Gas Gangrene (Clostridial Myonecrosis) 8.
- Intracranial Abscess ರು
- Necrotizing Soft Tissue Infections 10.
- Radiation Tissue Damage (Osteoradionecrosis) l l .
- Refractory Osteomyelitis l 2.
- Thermal Burns 13.

Mark Kramer

(Division Sign-Off Division of Continuascular, Respirato and Neurolo ne .. Dev 510(k) ivumber

↓ Prescription Use