(82 days)
The device is intended for the management of minor scrapes, minor bruises, minor abrasions, minor lacerations, and minor burns.
Cellusheet Dressing is a soft, sterile, disposable, absorbent & conformable single use wound dressing. It is hydrophilic dressing composed of fibrous bovine collagen and a non-adherent backing layer. The dressing absorbs wound drainage to cover the topical wounds to provide moist wound environment. The Cellusheet Dressing will be available in 2"X2" and 8"X12" sizes. Cellusheet Dressing is made up of collagen which is the most abundant protein in the human body and to cover the topical wounds to provide moist wound environment.
Cellufil Particles is a bovine (cattle) collagen wound dressing that is sterile, off-white powder that absorbs wound drainages. The dressing is an off-white, colored powder made up of collagen cover the topical wounds to provide moist wound environment. Cellufil Particles consists of spherical hydrophilic particles 0.1mm to 0.3mm in diameter.
This document is a 510(k) summary for medical devices, specifically Cellusheet Dressing and Cellufil Particles, seeking Over-The-Counter (OTC) clearance. It compares these devices to their previously cleared Prescription Use (Rx) predicates, SkinTemp II Dressing and Medifil II Particles, respectively. The core of the submission argues for substantial equivalence primarily based on the devices being identical to their predicates in all aspects except the change from Rx to OTC indication for use.
Here's a breakdown of the requested information, though much of it regarding acceptance criteria and separate performance studies is not applicable or not explicitly detailed in this type of submission, which focuses on substantial equivalence rather than new performance data for this specific submission.
1. A table of acceptance criteria and the reported device performance
This 510(k) submission is for a "Special 510(k)" which modifies the Indications for Use from Prescription (Rx) to Over-The-Counter (OTC) for two previously cleared devices. Therefore, the acceptance criteria and device performance reported are not against new performance standards, but rather demonstrate that the device remains substantially equivalent to its predicates, which already met their respective performance criteria. The document explicitly states: "The subject devices are the same as the predicate devices in all technological characteristics, geometric specifications, packaging, sterilization, manufacturing process and raw materials used. The subject devices do not raise any different questions of safety and effectiveness with regards to the technological characteristics."
Essentially, the acceptance criterion for this submission is Substantial Equivalence to the predicate devices, established by demonstrating no changes in design, materials, manufacturing, or other technological characteristics that would raise new questions of safety or effectiveness for the proposed OTC use.
| Acceptance Criteria (for Substantial Equivalence) | Reported Device Performance (vs. Predicate) |
|---|---|
| Intended Use Comparison: Similar intended use. | Same: "Management of wounds" for both Cellusheet Dressing/Cellufil Particles and SkinTemp II Dressing/Medifil II Particles. |
| Indications for Use Comparison: Proposed indications for use do not raise new questions of safety or effectiveness. | Different, but argued as equivalent: Proposed OTC indications are "Intended for management of minor cuts, minor scrapes, minor bruises, minor abrasions, minor lacerations, and minor burns." Predicate Rx indications are broader: "The device is intended for the management of burns, sores, blisters, scrapes, ulcers and other wounds." The document argues: "The difference in indications from prescription to OTC do not raise different questions of safety or effectiveness. The use of these products for minor wounds is intuitive. Similar products already exist in the OTC market (see K081724)." |
| Technological Characteristics Comparison: Similar design, materials, sterilization, shelf life, configurations, etc. | Same: |
- Sterilization: E-beam. Product supplied STERILE.
- Storage Conditions: Store in a cool and dry place.
- Design: Soft, sterile, disposable, absorbent & conformable single-use wound dressing with non-adherent backing (Cellusheet); Bovine collagen wound dressing that is sterile, off-white powder (Cellufil).
- Primary Constituent Materials: Bovine Collagen, Demineralized Water (Cellusheet only), Buffering agent / Chemical Z.
- Usage Type: Single Patient Use.
- Shelf Life: 5 years.
- Configurations/Particle Size: 2"X2", 3"X4", 8"X12" (Cellusheet); 0.1mm-0.3mm (Cellufil).
- Packaging: 5 sheets/pouches per box.
- Device Class/Product Code: Unclassified, KGN. |
| Biocompatibility: No new biocompatibility concerns. | Same: "All testing performed on predicate will be applicable since there is no change in the product specifications. All testing was performed as per FDA biocompatibility guidance on ISO 10993." |
| Product Integrity/Stability: No new concerns over shelf-life. | Same: "the product integrity testing over the shelf-life period will also be applicable to the subject device in this case." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This submission does not describe a new "test set" or new performance data for the devices. The basis for substantial equivalence is that the devices are identical to previously cleared predicate devices except for the change in marketing from Rx to OTC. Therefore, no new clinical or non-clinical studies specifically for a "test set" for this submission were conducted or reported here. The document states: "The subject devices are the same as the predicate devices... All the testing was submitted in K122325 for SkinTemp II Dressings i.e., the predicate for Device 1 and K910944 for Medifil II Particles i.e., the predicate for Device 2."
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. As this is a Special 510(k) based on substantial equivalence to existing predicate devices, no new "test set" requiring expert-established ground truth for device performance is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No new test set or clinical study requiring adjudication is described in this submission.
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 document pertains to wound dressings and particles, not AI software or diagnostic imaging devices that would typically involve MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable for this Special 510(k) submission. The "ground truth" for the predicate devices, which established their safety and effectiveness for their original Rx indications, would have relied on standard testing and potentially clinical data appropriate for wound care products at the time of their original clearance (K122325, K910944, K925545). This information is not detailed in the current submission.
8. The sample size for the training set
Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. There is no mention of a "training set."
N/A