A highly absorptive pillow 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.

Device Description

Osmo/PCA Pillow Wound Dressing utilizes the hydrophilic polymer granules contained in a mesh pillow to absorb up to 20 times their weight in wound exudate. Since the granules are contained in the mesh pillow, they are easily removed, thereby significantly reducing the possibility of retaining granules within the wound and allowing the Osmo/PCA Pillow Wound Dressing to be utilized in wounds with deep cavities or tunnels. Osmo/PCA Pillow Wound Dressing contains highly absorptive polymer granules able to absorb up to 20 times their weigh in wound exudate. The granules are encased in an inert low density polyethylene mesh fabric which allow the wound exudate to pass through and be absorbed by the polymer granules but which contains the granules, thus allowing for the dressing's easy removal from cavity or tunnel wounds.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Osmo/PCA Pillow Wound Dressing:

It's important to note that the provided text is a 510(k) summary for a medical device submitted to the FDA. 510(k) submissions primarily focus on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical trials with detailed statistical performance metrics as might be found for novel, higher-risk devices. Therefore, much of the requested information regarding detailed study design, sample sizes, expert involvement, and comparative effectiveness studies is not present in this type of document.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Material Safety (Biocompatibility)	Deemed safe based on "International Standard for the Biological Evaluation of Medical Devices, ISO 10993-1" testing for contact with breached or compromised skin.
High Absorbency	Absorbs up to 20 times its weight in wound exudate. (Claimed to be comparable to predicate devices.)
Containment of Absorbent Material	Inert low-density polyethylene (LDPE) mesh fabric contains absorbent granules, preventing retention in wounds with deep cavities or tunnels. (Claimed to be an advantage over predicate devices in assuring complete removal.)
Intended Use	For management of exudating wounds (pressure ulcers, diabetic ulcers, venous stasis ulcers, arterial ulcers, 1st and 2nd degree burns, donor sites, post-operative incisions, other bleeding surface wounds, dermal lesions, trauma injuries or incisions).
No Accelerating Effect on Wound Healing	(Implicit acceptance criteria through FDA's labeling limitations) Device must not be labeled as having any accelerating effect on wound healing or epithelization.
Not for Third-Degree Burns	(Implicit acceptance criteria through FDA's labeling limitations) Device must not be labeled for use on third-degree burns.
Not a Long-Term, Permanent, No-Change Dressing, or Artificial Skin	(Implicit acceptance criteria through FDA's labeling limitations) Device must not be labeled as such.
Not a Treatment or Cure	(Implicit acceptance criteria through FDA's labeling limitations) Device must not be labeled as a treatment or a cure for any type of wound.

Study Details

Given the nature of a 510(k) submission for a wound dressing, the "study" primarily consists of biocompatibility testing and claims of comparable technological characteristics to predicate devices rather than a formal clinical trial with an algorithm. This device is not an AI/algorithm-based device, so questions related to AI performance metrics are not applicable.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Sample size: Not specified for the biocompatibility testing. For claims of performance (e.g., absorbency), no specific test set sample size is provided, nor is the data provenance. The claims rely on the inherent properties of the materials.
Data provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. For biocompatibility, testing is typically performed by certified labs according to standards. For performance claims, these are intrinsic material properties or comparative statements to predicate devices, not requiring expert consensus on a test set in the way an AI diagnostic device would.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

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, as this is not an AI/algorithm-based device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable, as this is not an AI/algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For biocompatibility: Ground truth is established by adherence to and passing of tests defined by the "International Standard for the Biological Evaluation of Medical Devices, ISO 10993-1."
For absorbency and containment: Ground truth would be based on laboratory testing of the material's physical properties.
For intended use/indications: Ground truth is implicitly established by the demonstrated safety and performance (biocompatibility, absorbency) along with equivalence to predicate devices that already have these indications.

8. The sample size for the training set:

Not applicable, as this is not an AI/algorithm-based device.

9. How the ground truth for the training set was established:

Not applicable, as this is not an AI/algorithm-based device.

Summary of Device Performance Study for 510(k):

The "study" for the Osmo/PCA Pillow Wound Dressing to meet its acceptance criteria, as presented in this 510(k) summary, primarily relies on:

Biocompatibility Testing: Performed according to "International Standard for the Biological Evaluation of Medical Devices, ISO 10993-1," supporting its safe use for temporary contact with breached skin.
Engineering and Material Science Principles: The device's ability to absorb exudate (20 times its weight) and contain its granules within an LDPE mesh is a direct result of its material composition and design. These are inherent physical properties and are likely confirmed through in-house lab testing, not a clinical trial.
Substantial Equivalence to Predicate Devices: The core of a 510(k) is to demonstrate that the new device has the same intended use and similar technological characteristics as legally marketed predicate devices (OsmoCyte™ Pillow Wound Dressing, Lamin® Hydrating Gel). This comparison effectively "proves" that the device meets acceptance criteria by showing it's "as safe and effective" as something already on the market, rather than through a standalone, comprehensive clinical study for de novo devices. The indications for use are explicitly stated to be "not different from the predicate devices identified above."

Summary

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4 7 1 6 1 2

MAR 1 6 1998

11.2 510(k) Summary 11.2 -

Submitter's Name and Address:

ProCyte Corporation 12040 115th Ave NE #210 Kirkland, Washington 98034-6900

Contact person and telephone number:

Paul Ketteridge Regulatory Affairs Officer Telephone: (206) 820-4548 Fax: (206) 820-7611

Date summary was prepared: April 29, 1997

Name of the Device:

Proprietary name:	Osmo/PCA Pillow Wound Dressing
Common name:	Wound Dressing
Classification name:	Wound and Burn Dressing

ldentification of Predicate Devices to which Substantial Equivalence is Being Claimed:

Osmo/PCA Pillow 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 .
lamin® Hydrating Gel .

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K971 K=1 R

A Pillow Wound Dressing

Device Description:

Explanation of how the device functions: Osmo/PCA Pillow Wound Dressing utilizes the hydrophilic polymer granules contained in a mesh pillow to absorb up to 20 times their weight in wound exudate. Since the granules are contained in the mesh pillow, they are easily removed, thereby significantly reducing the possibility of retaining granules within the wound and allowing the Osmo/PCA Pillow Wound Dressing to be utilized in wounds with deep cavities or tunnels.

Basic scientific concepts that form the basis for the device: Osmo/PCA Pillow Wound Dressing contains a highly absorptive polymer able to absorb up to 20 times its weight in wound exudate.

Significant physical and performance characteristics of the device such as device design, materials used, and physical properties: Osmo/PCA Pillow Wound Dressing contains highly absorptive polymer granules able to absorb up to 20 times their weigh in wound exudate. The granules are encased in an inert low density polyethylene mesh fabric which allow the wound exudate to pass through and be absorbed by the polymer granules but which contains the granules, thus allowing for the dressing's easy removal from cavity or tunnel wounds.

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PCA Pillow Wound Dressing oril 30, 1997 Page 3 of 3

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, coupled with the ability to be used safely in deep cavity or tunnel wounds is comparable to several the predicate devices. In addition, Osmo/PCA Pillow Wound Dressing has the advantage, by using an inert LDPE mesh, containing the absorbent granules, to assuring its complete removal from the wound.

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 Osmo/PCA Pillow Wound Dressing as a wound dressing temporary in contact with breached or compromised skin.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. 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

MAR 1 6 1998

Mr. Paul Ketteridge Regulatory Affairs Officer Procyte Corporation 12040 115th Avenue NE, Suite 210 Kirkland, Washington 98034-6900

Re: K971612 Trade Name: OSMO/PCA Pillow Wound Dressing Regulatory Class: Unclassified Product Code: KMF Dated: January 12, 1998 Received: January 16, 1998

Dear Mr. Ketteridge:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is 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 device subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) and the following limitations:

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

The labeling claims listed above would be considered a major modification in the intended use of the device 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.

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Page 2 - Mr. Ketteridge

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device 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 device in the Federal Register. Please note: this response to your premarket notification submission 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 device as described in your 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 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 device, 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 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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INDICATIONS FOR USE

Page 1 of 1

510(k) Number (if known):	K971612
Device Name:	OSMO/PCA Pillow Wound Dressings

Indications For Use:

Indications:

.. "

mulcations.
Exudating wounds, including pressure ulcers, venus stasis ulcers, arena injurise or Exudating wounds, including probodro alsore, alsole attive incisions, trauma injuries or incisions.

(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	K971612

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

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.