OSMOCYTE ISLAND WOUND DRESSING
Device Facts
| Record ID | K972150 |
|---|---|
| Device Name | OSMOCYTE ISLAND 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 |
| Attributes | Therapeutic |
Indications for Use
A self adhesive highly absorptive island dressing for the management of exudating wounds, infected and 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® Island Wound Dressing is a self-adhesive, highly absorptive wound dressing; utilizes a powdered polymer absorbent pad contained in a non-woven mesh pillow; attached to a sheet of foam polyurethane; coated with medical-grade acrylic emulsion adhesive. Designed for management of exudating wounds; applied by clinicians or patients for first aid. Functions as a passive dressing to absorb wound exudate; does not accelerate healing or act as artificial skin. Benefits patient by managing wound moisture and protecting the wound site.
Clinical Evidence
Bench testing only. Biocompatibility testing performed in accordance with ISO 10993-1 standards to support safe use for temporary contact with breached or compromised skin.
Technological Characteristics
Materials: powdered polymer absorbent pad, non-woven mesh, foam polyurethane, medical-grade acrylic emulsion adhesive. Form factor: self-adhesive island dressing. Function: passive absorption of wound exudate. Biocompatibility: tested per ISO 10993-1.
Indications for Use
Indicated for management of 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. Contraindicated 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)
- CombiDERM™ ACD™ (Convatec)
- Tielle™ Hydropolymer Dressing (Johnson & Johnson)
- ElastogeI™ Island Dressing (Southwest Technologies)
- Vigilon® Primary Wound Dressing (Bard)
- PolyMem® Adhesive Urethance Dressing (Ferris)
Submission Summary (Full Text)
{0}------------------------------------------------
1972150
A 1 0 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: 425-869-1239; Fax: 425-869-1229 Date summary was prepared: June 4, 1997
### Name of the Device:
| Proprietary name: | OsmoCyte® Island Wound Dressing |
|----------------------|---------------------------------|
| Common name: | Wound Dressing |
| Classification name: | Wound and Burn Dressing |
# Identification of Predicate Devices to which Substantial Equivalence is Being Claimed:
OsmoCyte® Island 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) .
- CombiDERM™ ACD™(Convatec) ●
- Tielle™ Hydropolymer Dressing (Johnson & Johnson) ●
- ElastogeI™ Island Dressing (Southwest Technologies) �
- Vigilon® Primary Wound Dressing (Bard) ●
- PolyMem® Adhesive Urethance Dressing (Ferris) ●
{1}------------------------------------------------
sland Wound Dressing e 2 of 3
## Device Description:
Explanation of how the device functions: OsmoCyte® Island 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:
A self adhesive highly absorptive island dressing for the management of exudating wounds, infected and 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® Island Wound Dressing as a wound dressing temporary in contact with breached or compromised skin.
{2}------------------------------------------------
Image /page/2/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 an eagle with three stripes forming its wing and body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular pattern around the eagle.
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
DEC 1 0 1997
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.
- These devices may not be labeled as having any accelerating effect on the 2. rate of wound healing or epithelization.
- These devices may not be labeled as a long-term, permanent, or no-change 3. dressing, or as an artificial (synthetic) skin.
- These devices may not be labeled as a treatment or a cure for any type of 4. wound.
{3}------------------------------------------------
### 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 (301) 594-4595. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or 301-443-6597 or at its internet address http://www.fda.gov/cdrh/dsmamain.html.
Sincerely yours,
Diollefa
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}------------------------------------------------
1972150
A 1 0 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: 425-869-1239; Fax: 425-869-1229 Date summary was prepared: June 4, 1997
### Name of the Device:
| Proprietary name: | OsmoCyte® Island Wound Dressing |
|----------------------|---------------------------------|
| Common name: | Wound Dressing |
| Classification name: | Wound and Burn Dressing |
# Identification of Predicate Devices to which Substantial Equivalence is Being Claimed:
OsmoCyte® Island 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) .
- CombiDERM™ ACD™(Convatec) ●
- Tielle™ Hydropolymer Dressing (Johnson & Johnson) ●
- ElastogeI™ Island Dressing (Southwest Technologies) �
- Vigilon® Primary Wound Dressing (Bard) ●
- PolyMem® Adhesive Urethance Dressing (Ferris) ●
{6}------------------------------------------------
sland Wound Dressing e 2 of 3
## Device Description:
Explanation of how the device functions: OsmoCyte® Island 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:
A self adhesive highly absorptive island dressing for the management of exudating wounds, infected and 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® Island Wound Dressing as a wound dressing temporary in contact with breached or compromised skin.
{7}------------------------------------------------
Image /page/7/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 an eagle with three stripes forming its wing and body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular pattern around the eagle.
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
DEC 1 0 1997
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.
- These devices may not be labeled as having any accelerating effect on the 2. rate of wound healing or epithelization.
- These devices may not be labeled as a long-term, permanent, or no-change 3. dressing, or as an artificial (synthetic) skin.
- These devices may not be labeled as a treatment or a cure for any type of 4. wound.
{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 (301) 594-4595. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 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
{10}------------------------------------------------
| 510(k) Number (if known): | K972150 |
|---------------------------|---------------------------------------------|
| Device Name: | OsmoCyte <sup>®</sup> Island Wound Dressing |
k972150
Page 1 of 1
DEC- 5-97 FRI 9:23 PROCYTE CORP FAX NO. 4258698901 P. 02
0 00
Indications For Use:
ﺳ
OsmoCyte® Island Wound Dressing is intended for exudating wounds, infected or non-infected Osmoby.co found Wound Oroomy is incers, venous stars, arterial ulcers, 1st and 2nd degree including prossore diobro, wabolis there, vourds, dermal lesions, trauma injuries or incisions, cuts 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 | K972150 |
| Prescription Use (Per 21 CFR 801.109) | X |
|---------------------------------------|---|
|---------------------------------------|---|
OR
| Over-The-Counter Use (Optional Format 1-2-96) |
|-----------------------------------------------|
|-----------------------------------------------|
