SIGMA 3400 MONOPLACE HYPERBARIC CHAMBER

K990927 · Perry Baromedical Corp. · CBF · Nov 12, 1999 · Anesthesiology

Device Facts

• Record ID: K990927
• Device Name: SIGMA 3400 MONOPLACE HYPERBARIC CHAMBER
• Applicant: Perry Baromedical Corp.
• Product Code: CBF · Anesthesiology
• Decision Date: Nov 12, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SIGMA I, SIGMA Plus and SIGMA 3400 chambers are 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 the chamber atmosphere that is pressurized with pure oxygen. The breathing of oxygen at elevated pressure promotes the movement of oxygen into the patient's tissues.

Device Story

Monoplace hyperbaric chamber; provides hyperbaric oxygen therapy (HBOT) to single patient. Input: medical grade oxygen for chamber pressurization. Operation: patient breathes oxygen-enriched atmosphere at elevated pressure to promote tissue oxygenation. Control: fully pneumatic system; no electrical/electronic components. Features: ASME-certified pressure vessel; acrylic cylinder; intrinsically safe communication system. Usage: clinical setting; prescribed by physician. Output: pressurized oxygen environment. Benefit: enhanced tissue oxygenation for specified medical conditions. SIGMA 3400 includes provision for switching between oxygen and air pressurization.

Clinical Evidence

Bench testing only. Device relies on established safety standards for pressure vessels (ASME Boiler and Pressure Vessel Code Section VIII, Division 1; ASME PVHO-1). No clinical data presented.

Technological Characteristics

Class B monoplace hyperbaric system. Materials: ASME-certified metal components (ASME Section II) and acrylic plastic cylinder (ASME PVHO-1). Energy: fully pneumatic (no electrical/electronic components). Dimensions: 33.3" ID x 90" L acrylic cylinder. Connectivity: none. Sterilization: N/A (pressurized oxygen environment).

Indications for Use

Indicated for patients requiring hyperbaric oxygen therapy for: air/gas embolism, carbon monoxide/smoke inhalation, compromised skin grafts/flaps, crush injuries/acute traumatic ischemias, decompression sickness, problem wounds, exceptional blood loss (anemia), gas gangrene, 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 I Monoplace Hyperbaric Chamber (K832127)
• SIGMA Plus Monoplace Hyperbaric Chamber (974863)

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 circular graphic on the left and the text "PERRY BAROMEDICAL" on the right. The graphic is a stylized representation of a circle with several smaller circles arranged around it. The text is in a bold, serif font, with "PERRY" on top of "BAROMEDICAL".

March 17, 1999

3660 Interstate Parkway Riviera Beach Florida 33404 USA 800-741-4376 561 =840=0395 FAX: [phone]

K990927

11-12-99

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 3400 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 of 1990 and 21 CFR 807.92.

Substantial Equivalence: The Perry Baromedical Corporation SIGMA 3400 Monoplace Hyperbaric Chamber is substantially equivalent to the Perry Baromedical Corporation SIGMA I Monoplace Hyperbaric Chamber, [510(k) K832127], and the Perry Baromedical Corporation SIGMA Plus Monoplace Hyperbaric Chamber, [510(k) 974863].

The SIGMA 3400 has the same intended use and the same technological characteristics as the SIGMA I and SIGMA Plus predicate devices. The scope and operation of the SIGMA 3400 is identical to that of the SIGMA I and SIGMA Plus in the following areas:

- The critical component of both systems consists of an ASME pressure vessel that is 1 designed, fabricated, and tested in accordance with the requirements of the ASME Boiler and Pressure Vessel Code, Section VIII, Division 1; 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 cylinder, designed and constructed to the requirements of ASME PVHO-1, Safety Standard for Pressure Vessels for Human Occupancy.

10

MULTIPLACE HYPERBARIC THERAPY SYSTEMS MONOPLACE . DUALPLACE

2)

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- The pressure vessel is protected from accidental over pressurization by an ASME "UV" 3 stamped pressure relief valve.
- The medium used for pressurization of the chamber is medical grade oxygen. 4
- Treatment capacity of the chamber is one patient. 5
- Communication between the patient / attendants is through an intrinsically safe б communications system.
- The SIGMA I, SIGMA Plus and SIGMA 3400 chambers are used to provide 7 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 the chamber atmosphere that is pressurized with pure oxygen. 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.
- Chambers are Class "B" monoplace hyperbaric systems. 9

Differences do exist between the SIGMA 3400 ,the SIGMA Plus and the SIGMA I chambers; they include:

- The PVHO-1 acrylic cylinder in the SIGMA 3400 chamber is 33.3" inside diameter and 1 90" long; the PVHO-1 acrylic cylinder in the SIGMA Plus chamber is 40" inside diameter by 65" long, and the PVHO-1 acrylic cylinder in the SIGMA I chamber is 25.25" inside diameter by 80" long.
- The acrylic cylinder of the SIGMA 3400 has been designed for a operational 2. temperature range of 32 degrees F to 100 degrees F. The SIGMA I and SIGMA Plus cylinders were designed for a 32 degree F to 125 degree F operating range. Based on the actual operating environment of a hospital, the higher 125 degree temperature limit would never be reached in normal operation, as the chamber rooms are required to be maintained at temperatures less than 75 degrees F for patient comfort.
- The pneumatic controls for the SIGMA 3400 chamber and the SIGMA I chamber are 3. mounted in a panel mounted on one side of the chamber. The pneumatic controls for the SIGMA Plus chamber are mounted in a control box that is suspended from a moveable arm.

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- The SIGMA 3400 monoplace chamber has an aluminum chassis with integral side 4 covers; the SIGMA Plus Chamber has gelcoated fiberglass cosmetic covers on the sides and ends of the chamber; and the SIGMA I Hyperbaric Chamber has aluminum side cosmetic covers as part of the chassis.
- The SIGMA 3400 monopiace chamber has provision for changing from oxygen to air 5. pressurization during treatment, which allows the operator more control of the environment inside the chamber. The SIGMA Plus and SIGMA I chambers are oxygen only pressurization.

The changes to the SIGMA I and SIGMA Plus systems resulting in the SIGMA 3400 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 diameter, length and operating temperature range 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

James Dodson
James P. Dodson

Quality Assurance Manager

31/2-99
Date

ત્વ

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Nov 1 2 1999

Mr. James P. Dodson Perry Baromedical Corp. 3660 Interstate Parkway Riviera Beach, FL 33404-3411

Re: K990927 SIGMA 3400 Monoplace Hyperbaric Chamber Regulatory Class: II (two) Product Code: 73 CBF August 27, 1999 Dated: Received: August 30, 1999

Dear Mr. Dodson:

We have reviewed your Section 510(k) notification of intent to market we nave referenced above and we have determined the device is the device referenced about a 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 Medical Device Amendales, is the Federal Food, Drug, and In accordance with the provibitions of therefore, market the device, subject to The general controls the general controls provisions of the Act. che general controlo proclude requirements for annual registration, provisions of the , good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special It your device is cremarket Approval), it may be subject to such controls) of Craoo Irs (isting major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. 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 Failure to comply with the GMP regulation may result in assumptions. 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 This letter will allow you to begin marketing of substantial in your 510(k) premation to a legally marketed predicate device equivalence of your device co a regarly marked on thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling If you desire specific advice for your and additionally 809.10 for in vitro regulation (21 CFR Parl and and the Office of Compliance at diagnostic devices), prease contact the promotion and [phone]. Additionally, for questions on fire packson
advertising of your device, please contact the office of Compliance at
advertising of your devices nota the regula [phone]. Also, please note the regulation entitled, [phone]. Also, premarket notification"(21 CER 807.97).
"Misbranding by reference to premarket notifiitia under the Act may "Misbranding by reference on your responsibilities under the Act may Other general information of Small Manufacturers Assistance at its internet be obtained from the Division of Small Hands 6597, or at its internet
toll-free number (800) 638–2041 or (301) 443–6597, or at its internet toff-free "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

for H. Winterkorn for,

celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 510(k) K 990927

## SIGMA 3400 Monoplace Hyperbaric Chamber

## INDICATIONS FOR USE

The SIGMA 3400 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 1.
- Carbon Monoxide / Smoke Inhalation 2.
- Compromised Skin Grafts and Flaps 3.
- Crush Injuries / Acute Traumatic Ischemias 4.
- Decompression Sickness ર
- Enhanced Healing in Selected Problem Wounds 6.
- Exceptional Blood Loss (Anemia) 7.
- Gas Gangrene (Clostridial Myonecrosis) 8.
- Intracranial Abscess 9.
- Necrotizing Soft Tissue Infections 10.
- Radiation Tissue Damage (Osteoradionecrosis) 11.
- Refractory Osteomyelitis 12.
- Thermal Burns 13.

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | <span style="text-decoration: overline;">✓</span> | OR | Over-The-Counter-Use<br>(Optional Format 1-2-96) | <span style="text-decoration: overline;"></span> |
|------------------------------------------|---------------------------------------------------|----|--------------------------------------------------|--------------------------------------------------|
|------------------------------------------|---------------------------------------------------|----|--------------------------------------------------|--------------------------------------------------|

Joan JA Wetherh

(Division Sign-Off)

Division of Cardiovascular, Respiratory,

and Neurological Devices

| 510(k) Number | <span style="text-decoration: overline;">K990927</span> |
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