OSMOCYTE RA WOUND DRESSING

K972329 · Procyte Corp. · KMF · Dec 10, 1997 · General Hospital

Device Facts

• Record ID: K972329
• Device Name: OSMOCYTE RA WOUND DRESSING
• Applicant: Procyte Corp.
• Product Code: KMF · General Hospital
• Decision Date: Dec 10, 1997
• Decision: SN
• Submission Type: Traditional
• Regulation: 21 CFR 880.5090
• Device Class: Class 1

Indications for Use

Exudating wounds, infected or non-infected including pressure ulcers, diabetic ulcers, venous stasis ulcers, arterial ulcers, 1st and 2nd degree burns, donor sites, postoperative incisions, other bleeding surface wounds, dermal lesions, trauma injuries or incisions, cuts, abrasions and general first aid.

Device Story

OsmoCyte® RA Wound Dressing is a passive wound dressing consisting of a powdered polymer absorbent pad within a non-woven mesh pillow, attached to a polyurethane foam sheet with a medical-grade acrylic emulsion adhesive. It is applied topically to manage wound exudate. The device functions by absorbing wound fluid into the polymer pad. It is intended for use in clinical or home settings for various wound types. The dressing provides a physical barrier and moisture management, aiding in the protection of the wound site. It does not accelerate healing or act as a permanent skin substitute.

Clinical Evidence

Bench testing only. Biocompatibility testing performed in accordance with ISO 10993-1 standards to support safety for temporary contact with breached or compromised skin.

Technological Characteristics

Materials: powdered polymer absorbent pad, non-woven mesh, polyurethane foam, medical-grade acrylic emulsion adhesive. Function: passive absorption of wound exudate. Form factor: adhesive dressing/pillow. Sterilization: not specified. Connectivity: none.

Indications for Use

Indicated for patients with exudating wounds, including pressure, diabetic, venous stasis, and arterial ulcers; 1st and 2nd degree burns; donor sites; postoperative incisions; bleeding surface wounds; dermal lesions; trauma injuries; cuts; abrasions; and general first aid. Not indicated for 3rd degree burns.

Regulatory Classification

Identification

A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.

Predicate Devices

• OsmoCyte® Pillow Wound Dressing (ProCyte)
• Elastogel™ Island Dressing (Southwest Technologies)
• Vigilon® Primary Wound Dressing (Bard)
• PolyMem® Adhesive Urethane Dressing (Ferris)

Submission Summary (Full Text)

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

$$\text{אַזיין געגען } \mathbf{a}$$

DEC 10 1997

#### 510(k) Summary 11.2

### Submitter's Name and Address:

| ProCyte Corporation | Mailing Address: |
|-----------------------------|------------------------|
| 8511 - 154th Ave NE, Bldg A | PO Box 808 |
| Redmond, Washington 98052 | Redmond, WA 98073-0808 |

#### Contact person and telephone number:

Paul Ketteridge Regulatory Affairs Officer Telephone: [phone]; Fax: [phone] Date summary was prepared: June 20, 1997

#### Name of the Device:

| Proprietary name: | OsmoCyte® RA Wound Dressing |
|----------------------|-----------------------------|
| Common name: | Wound Dressing |
| Classification name: | Wound and Burn Dressing |

## Identification of Predicate Devices to which Substantial Equivalence is Being Claimed:

OsmoCyte® RA Wound Dressing is substantially equivalent in function and intended use to the following non-classified commercially available or 510(k) cleared non-interactive wound and burn dressings:

- OsmoCyte® Pillow Wound Dressing (ProCyte) .
- Elastogel™ Island Dressing (Southwest Technologies) .
- Vigilon® Primary Wound Dressing (Bard) .
- . PolyMem® Adhesive Urethane Dressing (Ferris)

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

te® RA Wound Dressing Page 2 of 3

#### Device Description:

Explanation of how the device functions: OsmoCyte® RA Wound Dressing utilizes a powdered polymer absorbent pad contained in a non-woven mesh pillow attached to a sheet of foam polyurethane and coated with a medical grade acrylic emulsion adhesive.

## Statement of the Intended Use of the Device, Including General Description of the Conditions the Device Will Mitigate and the Patient Population for which the Device Is Intended:

Exudating wounds, infected or non-infected including pressure ulcers, diabetic ulcers, venous stasis ulcers, arterial ulcers, 1st and 2nd degree burns, donor sites, postoperative incisions, other bleeding surface wounds, dermal lesions, trauma injuries or incisions, cuts, abrasions and general first aid.

These indication statements are not different from the predicate devices identified above.

## Statement of how the Technological Characteristics of the Device Compare to those of the Predicate Device:

The technological characteristics of the device are similar to the predicate devices. The ability to absorb large amounts of wound exudate is comparable to several the predicate devices.

#### Assessment of Performance Data:

Biocompatibility testing has been performed as recommended in the "International Standard for the Biological Evaluation of Medical Devices, ISO 10993-1." These tests support the safe use of OsmoCyte® RA Wound Dressing as a wound dressing temporary in contact with breached or compromised skin.

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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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Paul Ketteridge Regulatory Affairs Officer ProCyte Corporation PO Box 808 Redmond, Washington 98073-0808

K972150 OsmoCyte® Island Wound Dressing Re: K972329 OsmoCyte® RA Wound Dressing Regulatory Class: Unclassified Product Code: KMF Dated: September 26, 1997 Received: September 29, 1997

Dear Mr. Ketteridge:

We have reviewed your Section 510(k) notifications of intent to market the devices referenced above and we have determined the devices are substantially equivalent (for the indications for use stated in the enclosure) to 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 (the Act). You may, therefore, market your devices subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) and the following limitations:

- These devices may not be labeled for use on third degree burns. 1 .
- 2. These devices may not be labeled as having any accelerating effect on the rate of wound healing or epithelization.
- 3. These devices may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.
- 4. These devices may not be labeled as a treatment or a cure for any type of wound.

DEC 1 0 1997

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#### Page 2 - Mr. Paul Ketteridge

The labeling claims listed above would be considered a major modification in the intended use of the devices and would require a premarket notification submission (21 CFR 807.81).The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.

If your devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval) they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations (CFR), Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practices (GMP) for Medical Devices: General GMP regulation (21 CFR Part 820) and that, through periodic GMP 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 devices in the Federal Register. Please note: this response to your premarket notification submissions 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.

This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices 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 devices 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 devices, 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

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

Page 3 - Mr. Paul Ketteridge

Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or 301-443-6597 or at its internet address http://www.fda.gov/cdrh/dsmamain.html.

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

$$\text{אַזיין געגען } \mathbf{a}$$

DEC 10 1997

#### 510(k) Summary 11.2

### Submitter's Name and Address:

| ProCyte Corporation | Mailing Address: |
|-----------------------------|------------------------|
| 8511 - 154th Ave NE, Bldg A | PO Box 808 |
| Redmond, Washington 98052 | Redmond, WA 98073-0808 |

#### Contact person and telephone number:

Paul Ketteridge Regulatory Affairs Officer Telephone: [phone]; Fax: [phone] Date summary was prepared: June 20, 1997

#### Name of the Device:

| Proprietary name: | OsmoCyte® RA Wound Dressing |
|----------------------|-----------------------------|
| Common name: | Wound Dressing |
| Classification name: | Wound and Burn Dressing |

## Identification of Predicate Devices to which Substantial Equivalence is Being Claimed:

OsmoCyte® RA Wound Dressing is substantially equivalent in function and intended use to the following non-classified commercially available or 510(k) cleared non-interactive wound and burn dressings:

- OsmoCyte® Pillow Wound Dressing (ProCyte) .
- Elastogel™ Island Dressing (Southwest Technologies) .
- Vigilon® Primary Wound Dressing (Bard) .
- . PolyMem® Adhesive Urethane Dressing (Ferris)

{6}------------------------------------------------

te® RA Wound Dressing Page 2 of 3

#### Device Description:

Explanation of how the device functions: OsmoCyte® RA Wound Dressing utilizes a powdered polymer absorbent pad contained in a non-woven mesh pillow attached to a sheet of foam polyurethane and coated with a medical grade acrylic emulsion adhesive.

## Statement of the Intended Use of the Device, Including General Description of the Conditions the Device Will Mitigate and the Patient Population for which the Device Is Intended:

Exudating wounds, infected or non-infected including pressure ulcers, diabetic ulcers, venous stasis ulcers, arterial ulcers, 1st and 2nd degree burns, donor sites, postoperative incisions, other bleeding surface wounds, dermal lesions, trauma injuries or incisions, cuts, abrasions and general first aid.

These indication statements are not different from the predicate devices identified above.

## Statement of how the Technological Characteristics of the Device Compare to those of the Predicate Device:

The technological characteristics of the device are similar to the predicate devices. The ability to absorb large amounts of wound exudate is comparable to several the predicate devices.

#### Assessment of Performance Data:

Biocompatibility testing has been performed as recommended in the "International Standard for the Biological Evaluation of Medical Devices, ISO 10993-1." These tests support the safe use of OsmoCyte® RA Wound Dressing as a wound dressing temporary in contact with breached or compromised skin.

{7}------------------------------------------------

Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the symbol. The logo is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Paul Ketteridge Regulatory Affairs Officer ProCyte Corporation PO Box 808 Redmond, Washington 98073-0808

K972150 OsmoCyte® Island Wound Dressing Re: K972329 OsmoCyte® RA Wound Dressing Regulatory Class: Unclassified Product Code: KMF Dated: September 26, 1997 Received: September 29, 1997

Dear Mr. Ketteridge:

We have reviewed your Section 510(k) notifications of intent to market the devices referenced above and we have determined the devices are substantially equivalent (for the indications for use stated in the enclosure) to 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 (the Act). You may, therefore, market your devices subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) and the following limitations:

- These devices may not be labeled for use on third degree burns. 1 .
- 2. These devices may not be labeled as having any accelerating effect on the rate of wound healing or epithelization.
- 3. These devices may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.
- 4. These devices may not be labeled as a treatment or a cure for any type of wound.

DEC 1 0 1997

{8}------------------------------------------------

#### Page 2 - Mr. Paul Ketteridge

The labeling claims listed above would be considered a major modification in the intended use of the devices and would require a premarket notification submission (21 CFR 807.81).The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.

If your devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval) they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations (CFR), Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practices (GMP) for Medical Devices: General GMP regulation (21 CFR Part 820) and that, through periodic GMP 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 devices in the Federal Register. Please note: this response to your premarket notification submissions 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.

This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices 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 devices 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 devices, 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

{9}------------------------------------------------

Page 3 - Mr. Paul Ketteridge

Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or 301-443-6597 or at its internet address http://www.fda.gov/cdrh/dsmamain.html.

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| DEC-5-97 FRI 9:23 | PROOC TE 3CK | |
|-------------------|--------------|--|
|-------------------|--------------|--|

K972329

| | Page 1 of 1 |
|---------------------------|-----------------------------------------|
| 510(k) Number (if known): | K972329 |
| Device Name: | OsmoCyte ^® RA Wound Dressing |
| Indications For Use: | |

3,03

Exudating wounds, infected or non-infected including pressure ulcers, venous
t in the supportuly indease, for and 2nd decree hurgs, donor sites, postoperative incisions, othe Exudating wounds, infected on non-mected including pressure includes includes and and and and and and and and and and and and and and and and and and and and and and any of t stasis ulcers, arterial ulcers, 1st and 2nd degree burns, donor situs, posts and abrasions.

# (Please Do Not Write Below This Line-Continue On Another Page If Needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of General Restorative Devices | |
| 510(k) Number | K972329 |

| Prescription Use<br>(Per 21 CFR 801.109) | X | OR | Over-The-Counter Use<br>(Optional Format 1-2-96) |
|------------------------------------------|---|----|--------------------------------------------------|
|------------------------------------------|---|----|--------------------------------------------------|