WHS-1000 WOUND HEALING SYSTEM

K050156 · Iyia Technologies, Inc. · KPJ · Jun 17, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K050156
• Device Name: WHS-1000 WOUND HEALING SYSTEM
• Applicant: Iyia Technologies, Inc.
• Product Code: KPJ · General, Plastic Surgery
• Decision Date: Jun 17, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5650
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Misty™ Wound Treatment System provides humidified hyperbaric oxygen to open, chronic wounds as an adjunct therapy in wound management and treatment. In addition, the device can also provide heat, gentle massage, moisture, and infrared and ultraviolet light therapy. The device is intended for the treatment of the following kinds of wounds: - skin ulcerations due to diabetes, venous stasis, and post surgical infections - gangrenous lesions. - decubitus ulcers - amputations/infected stumps - skin grafts - burns - frostbite Caution: Federal law restricts this device to use by or on the order of a physician or podiatrist.

Device Story

WHS-1000 Wound Treatment System (Misty™) is a rigid plastic chamber for extremity wound treatment. Device delivers humidified hyperbaric oxygen, heat, massage, moisture, and infrared/ultraviolet light to open, chronic wounds. System includes oxygen tubing, pressure sensor, mist delivery, and water transfer fittings; controlled via external plastic panel with switches and timer. Operated by physician or podiatrist in clinical setting. Provides adjunct therapy to promote wound management; output effects clinical decision-making by facilitating wound healing through localized hyperbaric environment and therapeutic modalities.

Clinical Evidence

No clinical data.

Technological Characteristics

Rigid plastic shell chamber for extremities. Features oxygen, pressure, mist, and water transfer ports. Includes control panel with switches and timer. Powered by AC outlet. Materials tested to ASTM specifications and ISO biocompatibility standards. Non-software based control system.

Indications for Use

Indicated for patients with open, chronic wounds including diabetic skin ulcerations, venous stasis ulcers, post-surgical infections, gangrenous lesions, decubitus ulcers, amputations/infected stumps, skin grafts, burns, and frostbite. Restricted to use by or on the order of a physician or podiatrist.

Regulatory Classification

Identification

A topical oxygen chamber for extremities is a device that is intended to surround a patient's limb and apply humidified oxygen topically at a pressure slightly greater than atmospheric pressure to aid healing of chronic skin ulcers such as bedsores.

Special Controls

*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance: Topical Oxygen Chamber for Extremities.” See § 878.1(e) for the availability of this guidance document.

Predicate Devices

• VX-400 Topical Hyperbaric Oxygen Chamber, Vascular One, Inc. (K022028)

Submission Summary (Full Text)

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# XVI. PREMARKET NOTIFICATION [510(K)] SUMMARY - K050156

#### Applicant name:

IYIA Technologies, Inc. 870 Rancheros Drive San Marcos, CA 92069 [phone] [phone] (fax)

Contact Person: Mr. Adrian Pelkus, President Date Summary Prepared: May 27, 2005

# Device Name:

| Trade Name: | WHS-1000 Wound Treatment System |
|----------------------|-------------------------------------------|
| Common Name: | Misty™ |
| Classification Name: | Hyperbaric Oxygen Chamber for Extremities |
| Classification No .: | 878.5650 |

### Claiming Substantial Equivalence To:

VX-400 Topical Hyperbaric Oxygen Chamber, Vascular One, Inc., K022028.

# Device Description

The Wound Treatment System is composed of a rectangular, rigid plastic shell that is of sufficient size to accommodate the patient's foot. There are four fittings on the chamber: one for oxygen tubing that fills the chamber, one for a pressure sensor, one to allow the mist to enter the chamber and one for water transfer. The front panel control consists of a plastic panel with switches, indicators and timer controls; these connect to the Wound Treatment System via a cable. The system plugs into an AC wall outlet.

#### The Product and Its Intended Use

The Misty™ Wound Treatment System provides humidified hyperbaric oxygen to open, chronic wounds as an adjunct therapy in wound management and treatment. In addition, the device can also provide heat, gentle massage, moisture, and infrared and ultraviolet light therapy.

The device is intended for the treatment of the following kinds of wounds:

- skin ulcerations due to diabetes, venous stasis, and post surgical infections
- gangrenous lesions. .

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K05°156 P²/₁

- decubitus ulcers ●
- amputations/infected stumps .
- skin grafts .
- burns
- frostbite .

Caution: Federal law restricts this device to use by or on the order of a physician or podiatrist.

# Summary of Technological Characteristics

The Misty™ Wound Treatment System WHS-1000 has the same technological characteristics as its predicate devices.

Nonclinical Testing: The physical properties of the materials used to manufacture the IYIA Wound Treatment System are tested by the suppliers to ensure they meet the specifications for the finished device. The testing standards are established by ASTM. The materials that come in contact with the body are also tested using ISO methods for biocompatibility. All of the materials meet the specifications for the device, as certified by the supplier of the materials to IYIA Technologies, Inc.

# Performance Data: N/A

Clinical Data: N/A

-- END OF 510(k) SUMMARY --

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines forming the snake and staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 17 2005

IYIA Technologies Incorporated C/o Mr. Alan Donald, MS, MBA, RAC Matrix Medical Consulting Incorporated 11440 West Bernardo Court, Suite 380 San Diego, California 92127-1644

Re: K050156

Trade/Device Name: WHS-1000 Wound Treatment System Regulation Number: 21 CFR 878.5650 Regulation Name: Topical oxygen chamber for extremities Regulatory Class: III Product Code: KPJ Dated: April 26, 2005 Received: April 27, 2005

Dear Mr. Donald:

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 vour 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.

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.

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# Page 2 – Mr. Alan Donald, MS, MBA, RAC

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/cdrb/industry/support/index.html.

Sincerely yours,

Signature

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# INDICATIONS FOR USE STATEMENT

(As required by ODE for all 510(k)'s received after 1/2/96.)

510(k) Number:

K050156

Misty™ Wound Treatment System Device Name:

Indications for Use:

The Misty™ Wound Treatment System provides humidified hyperbaric oxygen to open, chronic wounds as an adjunct therapy in wound management and treatment. In addition, the device can also provide heat, gentle massage, moisture, and infrared and ultraviolet light therapy.

The device is intended for the treatment of the following kinds of wounds:

- skin ulcerations due to diabetes, venous stasis, and post surgical infections ◆
- gangrenous lesions, ●
- decubitus ulcers .
- amputations/infected stumps .
- . skin grafts
- . burns
- frostbite ♥

Caution: Federal law restricts this device to use by or on the order of a physician or podiatrist.

Prescription Use (Per 21 CFR 801.109)

OR

Over the Counter Use

Concurrence of CDRH, Office of Device Evaluation (ODE)

ision

General, Restorative
Neurological Devices
K050151