(170 days)
Not Found
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of a wound dressing, with no mention of AI or ML technologies.
Yes
The device is used for treating various types of wounds, indicating a therapeutic purpose.
No
This device is described as a wound dressing, intended for managing exudating wounds. Its description details its physical components (powdered polymer absorbent pad, non-woven mesh pillow, foam polyurethane, adhesive) and its function in wound care, which is therapeutic rather than diagnostic. There is no mention of it being used to detect, monitor, or identify a medical condition or disease.
No
The device description clearly states it is a wound dressing utilizing a powdered polymer absorbent pad, non-woven mesh pillow, foam polyurethane, and medical grade acrylic emulsion adhesive, indicating it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as a wound dressing for various types of wounds. This is a topical application for treating the wound itself, not for analyzing a sample from the body to provide diagnostic information.
- Device Description: The description details a physical wound dressing with absorbent and adhesive components. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing blood, urine, tissue, or any other bodily fluid or sample for diagnostic purposes. The device's function is to manage the wound environment.
IVD devices are used to examine specimens from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This wound dressing does not fit that description.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
KMF
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5090 Liquid bandage.
(a)
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.(b)
Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
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: 425-869-1239; Fax: 425-869-1229 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.
2
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 .
-
- These devices may not be labeled as having any accelerating effect on the rate of wound healing or epithelization.
-
- These devices may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.
-
- These devices may not be labeled as a treatment or a cure for any type of wound.
DEC 1 0 1997
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,
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: 425-869-1239; Fax: 425-869-1229 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 .
-
- These devices may not be labeled as having any accelerating effect on the rate of wound healing or epithelization.
-
- These devices may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.
-
- 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 (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
| DEC-5-97 FRI 9:23 | PROOC TE 3CK | |
|---|---|---|
| ------------------- | -------------- | -- |
| 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
(Per 21 CFR 801.109) | X | OR | Over-The-Counter Use
(Optional Format 1-2-96) |
| ------------------------------------------ | --- | ---- | -------------------------------------------------- |
|---|