(46 days)
AcryNoodles is intended as an external wound dressing for use in the management of exudate from chronic wounds such as pressure sores, arterial ulcers, diabetic ulcers, and venous stasis ulcers and acute wounds such as draining surgical wounds, lacerations, donor site, and exudating first and second degree burns, and abrasions. It is not intended for use on third degree burns.
AcryNoodles Absorbent Wound Dressing (AcryNoodles™) is a moist wound dressing for external use that is composed of a hydrophilic absorbent matrix processed into a bundled strand format. AcryNoodles will be supplied in the following sizes: 5-1/2" x 3/4"; 5-1/2" x 1-1/2"; 5-1/2" x 3"; and 10" x 10-1/2" all with cross-sectional strand dimensions of 0.05 x 0.05". AcryNoodles will be supplied sterile, packaged as an individual bundle, in heat sealed medical grade form-vac blister packs with product information applied to the flat surfaced pealable cover. Primaries will be packed, with Instructions For Use, 5 primaries per intermediate carton, and 10 intermediate cartons per case.
The provided 510(k) summary for the AcryNoodles Absorbent Wound Dressing does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in a clinical setting. It primarily focuses on demonstrating substantial equivalence to predicate devices based on:
- Intended Use: Similar applications for chronic and acute wounds.
- Technological Characteristics: Composition (synthetic polyacrylate hydrogel) and manufacturing process are substantially similar to the predicate device, AcryDerm Advanced Wound Dressing. The form factor (bundled strands) is compared to Kaltostat.
- Performance Characteristics (Laboratory): The document states: "Laboratory tests have shown that AcryNoodles has an identical absorbent capacity for aqueous moisture as AcryDerm. The device however absorbs moisture substantially faster than AcryDerm."
Therefore, most of the requested information cannot be extracted from this document as it pertains to clinical performance and validation, which is not detailed here.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Absorbent Capacity (aqueous moisture) | Identical to AcryDerm Advanced Wound Dressing (predicate device) |
| Speed of Absorption (aqueous moisture) | Substantially faster than AcryDerm Advanced Wound Dressing (predicate device) |
| Biocompatibility | Established according to Part-1 of the ISO standard (Biological Evaluation of Medical Devices) |
| Manufacturing | According to product specifications and good manufacturing practices |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The document only mentions "Laboratory tests". There's no information on the sample size of these tests or data provenance.
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. This relates to clinical studies and expert review, which are not described in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This relates to clinical studies and expert review, which are not described in the document.
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 describes a wound dressing, not an AI-assisted diagnostic or interpretative device. No such study was performed or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical wound dressing, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the laboratory performance, the "ground truth" was likely established by comparing the AcryNoodles' performance (absorbent capacity, absorption speed) against that of the predicate device, AcryDerm Advanced Wound Dressing, under controlled laboratory conditions, using established test methods for fluid absorption.
8. The sample size for the training set
- Not applicable. This is a physical device, not a machine learning model. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
- Not applicable. (See point 8).
{0}------------------------------------------------
K96285
510(k) Summary
SEP - 6 1996
510(k) Summ
| Contact Person: | Dr. Bruce L. Gibbins, President & CEO |
|---|---|
| Date of preparation: | July 15, 1996 |
| Device Name (proprietary): | AcryNoodles™ Absorbent Wound Dressing |
| Common Name: | Moist wound dressing |
| Classification Name: | Hydrogel wound dressing |
| Classification: | Unclassified; as recommended by the General and PlasticSurgery Devices Panel 79 |
| Legally marketed device(s) for substantial equivalence comparison: | |
| AcryDerm Advanced Wound Dressing, (AcryMed, Inc.) | |
| Kaltostat Wound Dressing , (Calgon Vestal Laboratories) | |
| Aquaflo Hydrogel Wound Dressing/Packer, (Sherwood Medical Co.) | |
| Description of Device: AcryNoodles Absorbent Wound Dressing (AcryNoodles™) is a moist | |
| wound dressing for external use that is composed of a hydrophilic absorbent matrix processed | |
| into a bundled strand format. AcryNoodles will be supplied in the following sizes: 5-1/2" x |
3/4"; 5-1/2" x 1-1/2"; 5-1/2" x 3"; and 10" x 10-1/2" all with cross-sectional strand dimensions of 0.05 x 0.05". AcryNoodles will be supplied sterile, packaged as an individual bundle, in heat sealed medical grade form-vac blister packs with product information applied to the flat surfaced pealable cover. Primaries will be packed, with Instructions For Use, 5 primaries per intermediate carton, and 10 intermediate cartons per case. Biocompatibility has been established according to Part-1 of the ISO standard (Biological Evaluation of Medical Devices).
Intended Use of the Device: AcryNoodles is intended as an external wound dressing for use in the management of exudate from chronic wounds such as pressure sores, arterial ulcers, diabetic ulcers, and venous stasis ulcers and acute wounds such as draining surgical wounds, lacerations, donor site, and exudating first and second degree burns, and abrasions. It is not intended for use on third degree burns.
Technological Characteristics: AcryNoodles Absorbent Wound Dressing is composed of an unsupported synthetic polyacrylate hydrogel. It carries the same general classification name. "Hydrogel", as AcryDerm Advanced Wound Dressing and AquaFlo Hydrogel Wound Dressing/Packer . The composition of AcryNoodles is substantially similar to the predicate device, AcryDerm Advanced Wound Dressing. The method of manufacturing of AcryNooldes is identical to that of the predicate device, AcryDerm Advanced Wound Dressing. AcryNoodles is a bundle of absorbent strands for placement in cavitated wounds similar to Kaltostat Wound Dressing.
Performance Characteristics: AcryNoodles Absorbent Wound Dressing is a highly absorbent device that is designed to perform like the predicate devices. Laboratory tests have shown that AcryNoodles has an identical absorbent capacity for aqueous moisture as AcryDerm. The device however absorbs moisture substantially faster than AcryDerm.
Manufacturing: AcryNoodles Absorbent Wound Dressing will be manufactured according to the product specifications and under good manufacturing practices that ensure the device is safe and effective for its intended use.
Bruce V. Atkins 8-19-96
N/A