(46 days)
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No
The device description and performance studies focus solely on the physical properties and absorbent capacity of the wound dressing material. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is intended for the management of exudate from chronic and acute wounds, which directly contributes to the healing process and improvement of a patient's condition, classifying it as therapeutic.
No
Explanation: The device is described as an external wound dressing for managing exudate from various wounds. Its intended use focuses on treatment and absorption, not on diagnosing medical conditions or diseases.
No
The device description clearly states it is a "moist wound dressing" composed of a "hydrophilic absorbent matrix processed into a bundled strand format," indicating it is a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that AcryNoodles is an "external wound dressing for use in the management of exudate from chronic and acute wounds." This describes a device that is applied to the body to treat a condition, not a device used to perform tests on samples taken from the body.
- Device Description: The description details a physical wound dressing composed of a hydrophilic absorbent matrix. This aligns with a therapeutic device, not a diagnostic one.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing diagnostic information about a patient's condition.
- Predicate Devices: The predicate devices listed (AcryDerm, Kaltostat, Aquaflo) are all known wound dressings, further supporting the classification as a therapeutic device.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. AcryNoodles does not fit this description.
N/A
Intended Use / Indications for Use
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.
Product codes
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Device Description
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).
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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.
Key Metrics
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Predicate Device(s)
AcryDerm Advanced Wound Dressing, Kaltostat Wound Dressing, Aquaflo Hydrogel Wound Dressing/Packer
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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N/A
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 Plastic |
| Surgery 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