(150 days)
OsmoCyte™ Wound Manager Sheet Dressing is indicated for the management of partial and full thickness wounds, both chronic and acute, with low to moderate exudate, including the following: Pressure ulcers, diabetic ulcers, venous stasis ulcers, arterial ulcers, 18 and 200 degree burns, donor sites, postoperative incisions, minor chemical and thermal burns, superficial lacerations, cuts and abrasions, severe sunburn, dermal lesions (e.g. poison ivy), trauma injuries or incisions.
A sterile, hydropolymer dressing which protects the wound and provides a moist wound environment for low to moderate exudating wounds.
The provided 510(k) K965143 for the OsmoCyte™ Wound Manager Sheet Dressing does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way modern device submissions typically do for AI/ML devices or diagnostic tools.
This document is from 1997 and relates to a wound dressing, which falls under a different regulatory pathway and testing paradigm than, for example, a diagnostic AI system. For a wound dressing, the "performance" is more related to its physical characteristics, biocompatibility, and ability to fulfill its intended function (e.g., maintaining a moist wound environment, absorption).
Here's a breakdown based on the information provided and what is absent:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| (Not specified as quantifiable metrics) | - Provides a moist wound environment. |
| (Not specified as quantifiable metrics) | - Protects the wound from the external environment. |
| (Not specified as quantifiable metrics) | - Absorbs excess wound exudate. |
| Biocompatibility (as per ISO 10993-1) | - "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™ Wound Manager Sheet Dressing as a wound dressing temporary in contact with breached or compromised skin." |
Explanation:
The document establishes equivalence to predicate devices based on "function and intended use" and "technological characteristics." The performance is described in terms of its intended actions (moist environment, protection, absorption) and successful biocompatibility testing. There are no specific quantifiable clinical performance metrics (e.g., sensitivity, specificity, accuracy, wound healing rates) stated as acceptance criteria with corresponding performance values, which would be typical for a diagnostic or AI-enabled device.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable / Not mentioned. (The biocompatibility testing described would typically involve animal or in vitro models as per ISO 10993, but specific subject numbers are not provided in this summary.)
- Data Provenance: Not applicable for clinical performance data. Biocompatibility testing follows international standards (ISO 10993-1).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This device is a wound dressing, not a diagnostic tool requiring expert ground truth for a test set.
4. Adjudication method 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. This is not an AI-enabled device or a diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is not an algorithm.
7. The type of ground truth used
- For biocompatibility: Adherence to ISO 10993-1 standards and endpoints (e.g., cytotoxicity, sensitization, irritation).
- For functional claims: The ground truth would be the known physical properties and performance characteristics of similar predicate wound dressings.
8. The sample size for the training set
- Not applicable. This device does not involve a training set as it is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable.
Summary of what is present:
- The device is a sterile, hydropolymer dressing.
- Its function is to protect wounds, provide a moist healing environment, and absorb exudate.
- It is indicated for various partial and full-thickness wounds with low to moderate exudate.
- Biocompatibility testing was performed according to ISO 10993-1, supporting its safe use.
- The claim for substantial equivalence is based on similar function, intended use, and technological characteristics to several predicate wound and burn dressings already on the market.
Conclusion:
The K965143 document focuses on establishing substantial equivalence to existing predicate devices for a wound dressing. It demonstrates that the device functions similarly and is biocompatible. It does not present acceptance criteria or performance studies in the quantifiable, clinical outcome-based manner that would be expected for a diagnostic or AI-powered medical device. The "proof" consists of demonstrating equivalence to legally marketed devices and successful biocompatibility testing.
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10(k) Number: K965143 arch 25, 1997
MAY 2 2 1997
K965
11.9 510(k) Summary
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: December 13, 1996 Name of the Device:
OsmoCyte™ Wound Manager Sheet Dressing Proprietary name: Wound Dressing Common name: Wound and Burn Dressing Classification name:
ldentification of Predicate Devices to which Substantial Equivalence is Being Claimed:
OsmoCyte™ Wound Manager Sheet 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:
- · Kendall Curagel Hydrogel Wound Dressing
- Tielle Hydropolymer Dressing .
- Elasto-Gel Hydrogel Wound Dressing
- Vigilon Primary Wound Dressing ●
- Flexderm Hydrogel Wound Dressing ●
- Inerpan Temporary Wound Dressing .
Device Description:
- A sterile, hydropolymer dressing which protects the wound and provides a . moist wound environment for low to moderate exudating wounds.
Explanation of how the device functions: OsmoCyte™ Wound Manager Sheet Dressing is an absorbent dressing. It also allows the wound to remain This moisture encourages autolytic-debridement which may initially moist. increase lesion size
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510(k) Number: K965143 March 25, 1997 Page 6 of 6
Basic scientific concepts that form the basis for the device:
OsmoCyte™ Wound Manager Sheet Dressing provides a moist wound environment and protection of the wound from the external environment.
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:
OsmoCyte™ Wound Manager Sheet Dressing is designed to protect a wound, provide a moist environment for wound healing, and to absorb excess wound exudate. OsmoCyte™ Wound Manager Sheet Dressing is designed to provide absorbent action while maintaining a moist environment for wounds with low to moderate exudate. OsmoCyte™ Wound Manager Sheet Dressing is indicated for the management of partial and full thickness wounds, both chronic and acute, with low to moderate exudate, including the following: Pressure ulcers, diabetic ulcers, venous stasis ulcers, arterial ulcers, 18 and 200 degree burns, donor sites, postoperative incisions, minor chemical and thermal burns, superficial lacerations, cuts and abrasions, severe sunburn, dermal lesions (e.g. poison ivy), trauma injuries or incisions.
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.
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™ Wound Manager Sheet Dressing as a wound dressing temporary in contact with breached or compromised skin.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird symbol. The logo is presented in black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 1997
Paul Ketteridge, R.Ph. Regulatory Affairs Officer ProCyteTM Corporation ....... 12040 115th Avenue N.E., Suite 210 Kirkland, Washington 98034-6900
Re: K965143 OsmoCyte™ Wound Manager Sheet Dressing Regulatory Class: Unclassified Product Code: MGQ Dated: March 25, 1997 Received: March 27, 1997
Dear Dr. 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.
- This device may not be labeled as having any accelerating effect on the rate 2. of wound healing or epithelization.
-
- 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.
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 - Paul Ketteridge, R.Ph.
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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510(k) Number: K965143 March 25, 1997 Page 1 of 6
STATEMENT OF INDICATIONS FOR USE 3.
| ------ |
|---|
K965143 510(k) Number (if known):
OsmoCyte™ Wound Manager Sheet Dressing Device Name:
Indications For Use:
OsmoCyte™ Wound Manager Sheet Dressing is indicated for the management of following the following OsmoCyte™ Wound Manager Sheet Dressing is includes including the following:
thickness wounds, both chronic and acute, with low to moderate exudate, including the following: thickness wounds, both chronic and active, with low to modelling me burns, Pressure uicers, diabelle uncisions, minor chemical and thermal burns, a meerficial lacerations,
donor sites, postoperative incisions, minor chemical and thema inunies or inc donor sites, postoperative including minor chemical and themal ben of the submitted incisions.
cuts and abrasions, severe sunburn, dermal lesions (e.g. poison ivy), trauma in
(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 | K91-5143 |
| 510(k) Number |
| Prescription Use(Per 21 CFR 801.109) | OR | Over-The-Counter Use(Optional Format 1-2-96) |
|---|---|---|
| ------------------------------------------ | ---- | -------------------------------------------------- |
N/A