(144 days)
An absorptive pillow dressing for the management of exudating wounds, infected and noninfected, including pressure ulcers, diabetic ulcers, venous stasis ulcers, 1st and 2nd degree burns, donor sites, postoperative incisions, other bleeding surface wounds, dermal lesions, trauma injuries or incisions.
OsmoCyte™ Ultra/PE Pillow Wound Dressing utilizes the hydrophilic polymer granules contained in a mesh pillow to absorb many 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 OsmoCyte™ Ultra/PE Pillow Wound Dressing to be utilized in wounds with deep cavities or tunnels. OsmoCyte™ Ultra/PE Pillow Wound Dressing contains a highly absorptive polymer able to absorb many times its weight 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.
The provided text is a 510(k) summary for the OsmoCyte™ Ultra/PE Pillow Wound Dressing, a medical device for wound care. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, the document does not contain information on performance criteria or a study demonstrating that the device meets specific acceptance criteria.
The "Assessment of Performance Data" section only mentions biocompatibility testing
per ISO 10993-1, which supports the safe use of the device. It does not provide any quantitative or qualitative performance criteria regarding the device's efficacy (e.g., absorption capacity, healing rates, or infection reduction) or a study to demonstrate these.
Therefore, I cannot populate the requested table or answer most of the other questions because the necessary information is not present in the provided text.
Here's what can be inferred or stated as missing based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| (Not specified in document) | The device passed "Biocompatibility testing... as recommended in the 'International Standard for the Biological Evaluation of Medical Devices, ISO 10993-1.'" This supports the device's safe use as a temporary wound dressing in contact with breached or compromised skin. |
2. Sample size used for the test set and the data provenance:
- Not specified. The document does not mention a "test set" in the context of performance efficacy, only biocompatibility testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. Ground truth establishment for a test set is not mentioned as such a study is not detailed.
4. Adjudication method for the test set:
- Not applicable/Not specified. Adjudication is not mentioned as such a study is not detailed.
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:
- No. This device is a wound dressing, not an AI-assisted diagnostic tool. An MRMC study is not relevant to this medical device type.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This device is a wound dressing, not an algorithm.
7. The type of ground truth used:
- Not applicable/Not specified, as no formal performance study beyond biocompatibility is described. For biocompatibility, the "ground truth" would be the biological response observed in adherence to ISO 10993-1.
8. The sample size for the training set:
- Not applicable/Not specified. This device is a wound dressing, not an AI model requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable/Not specified. This device is a wound dressing, not an AI model.
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510(k) Number K962623 Summary September 6, 1996
ATTACHMENT 8
NOV 26 1996
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 (206) 820-4548 Telephone: (206) 820-7611 Fax:
Date summary was prepared: September 4, 1996
Name of the Device:
| Proprietary name: | OsmoCyte™ Ultra/PE Pillow Wound Dressing |
|---|---|
| Common name: | Wound Dressing |
| Classification name: | Wound and Burn Dressing |
ldentification of Predicate Devices to which Substantial Equivalence is Being Claimed:
OsmoCyte™ Ultra/PE 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:
- HyQ Wound Dressing (Kingston Technologies) .
- Allevyn Cavity Dressing (Smith + Nephew) .
- . Kaltostat Wound Packing (Calgon Vestal)
- . Aquacel (Convatec)
- Sorbsan Topical Wound Dressing (Dow Hickam)
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Device Description:
Explanation of how the device functions: OsmoCyte™ Ultra/PE Pillow Wound Dressing utilizes the hydrophilic polymer granules contained in a mesh pillow to absorb many 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 OsmoCyte™ Ultra/PE Pillow Wound Dressing to be utilized in wounds with deep cavities or tunnels.
Basic scientific concepts that form the basis for the device: OsmoCyte™ Ultra/PE Pillow Wound Dressing contains a highly absorptive polymer able to absorb many times its weight in wound exudate.
Significant physical and performance characteristics of the device such as device design, materials used, and physical properties: OsmoCyte™ Ultra/PE Pillow Wound Dressing contains highly absorptive polymer granules able to absorb many times their weight 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.
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:
An absorptive pillow dressing for the management of exudating wounds, infected and noninfected, including pressure ulcers, diabetic ulcers, venous stasis ulcers, 1st and 2nd degree burns, donor sites, postoperative incisions, other bleeding surface wounds, dermal lesions, 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. 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, OsmoCyte™
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Ultra/PE 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 OsmoCyte™ Ultra/PE Pillow Wound Dressing as a wound dressing temporary in contact with breached or compromised skin.
§ 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.