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 Description

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.

AI/ML Overview

The provided text is a 510(k) summary for the OsmoCyte® Island Wound Dressing. This type of regulatory submission in the U.S. demonstrates substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria in the same way a new device would.

Therefore, the document does not contain information about acceptance criteria or a study designed to prove the device meets those criteria in terms of performance metrics like sensitivity, specificity, or reader improvement with AI.

Instead, the "Assessment of Performance Data" section states:

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.

This indicates that the primary "acceptance criteria" for this type of device (a wound dressing) in this regulatory context are related to biocompatibility and substantial equivalence to existing devices, rather than a quantitative performance metric.

Given the nature of the document, the following sections from your request cannot be fully answered as they pertain to clinical or algorithm performance studies not described within this 510(k) submission:

1. A table of acceptance criteria and the reported device performance: Not applicable. The "performance" aspect discussed is biocompatibility and comparability to predicates in terms of absorption.
2. Sample sized used for the test set and the data provenance: Not applicable, no test set for performance described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, this is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, this is not an AI device.
7. The type of ground truth used: Not applicable for performance metrics. For biocompatibility, the "ground truth" would be the ISO standard's pass/fail criteria.
8. The sample size for the training set: Not applicable (no algorithm).
9. How the ground truth for the training set was established: Not applicable (no algorithm or training set).

Summary of available information:

Device: OsmoCyte® Island Wound Dressing
Type of "Study" to meet acceptance criteria: Biocompatibility testing as per ISO 10993-1.
Implicit Acceptance Criteria: The device must demonstrate biocompatibility according to ISO 10993-1 standards and be substantially equivalent to predicate wound dressings in function (e.g., absorption) and intended use.
Reported Device Performance (for biocompatibility): "These tests support the safe use of OsmoCyte® Island Wound Dressing as a wound dressing temporary in contact with breached or compromised skin."

Limitations on Labeling (from FDA's response letter):

The FDA's clearance letter also specifies important limitations on labeling, which act as "acceptance criteria" for claims and intended use:

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

The core of this submission relies on demonstrating substantial equivalence to predicate devices already on the market, rather than conducting de novo performance studies with quantitative acceptance criteria typically seen for novel devices or AI/software.

Summary

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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) ●

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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:

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.

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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.

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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 (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

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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

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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® 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) ●

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sland Wound Dressing e 2 of 3

Device Description:

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:

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:

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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:

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.

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Page 2 - Mr. Paul Ketteridge

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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

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510(k) Number (if known):	K972150
Device Name:	OsmoCyte ® 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
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Over-The-Counter Use (Optional Format 1-2-96)
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Regulation Number and Section

§ 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.