(143 days)
Not Found
Not Found
No
The 510(k) summary describes a wound care gel and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is indicated for the management and treatment of various ulcers and wounds, which are therapeutic uses.
No
Explanation: The device is a gel for wound management, not for diagnosing conditions.
No
The device description clearly states it is a gel containing various chemical components and is packaged in a physical tube, indicating it is a physical medical device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the management of various types of wounds and ulcers. This is a therapeutic application, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is a gel containing various ingredients applied topically to wounds. This is consistent with a wound care product, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting specific markers, or providing diagnostic information.
Therefore, the description clearly indicates a device intended for wound treatment, not for in vitro diagnostic purposes.
N/A
Intended Use / Indications for Use
MULTIDEX* Gel in a multi-use container is indicated for the management of stage II, III, IV pressure sores/ulcers, venous stasis ulcers, varicose ulcers, ischemic arterial ulcers, diabetic ulcers, neuropathic ulcers, poorly healing non-neoplastic wounds/ulcers and wounds/ulcers due to trauma.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
MULTIDEX* (polyglucose) Gel contains 66.9 percent Maltodextrin NF, one percent Ascorbic Acid, USP, 10 percent glycerin USP, 22 percent Purified Water USP, and 0.1 percent sorbic acid in a multi-use container. MULTIDEX Gel in a multi-use container contains the same ingredients as the predicate device with the addition of 0.1 percent sorbic acid as a preservative. It is packaged in a 90 gram low density polyethylene tube.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
DEC I 6 1996
ATTACHMENT 3
510(K) SUMMARY
MULTIDEX* (polyglucose) Gel contains 66.9 percent Maltodextrin NF, one percent Ascorbic Acid, USP, 10 percent glycerin USP, 22 percent Purified Water USP, and 0.1 percent sorbic acid in a multi-use container.
MULTIDEX* Gel in a multi-use container is indicated for the management of stage II, III, IV pressure sores/ulcers, venous stasis ulcers, varicose ulcers, ischemic arterial ulcers, diabetic ulcers, neuropathic ulcers, poorly healing non-neoplastic wounds/ulcers and wounds/ulcers due to trauma. These are the identical indications as the predicate device.
MULTIDEX Gel in a multi-use container contains the same ingredients as the predicate device with the addition of 0.1 percent sorbic acid as a preservative. It is packaged in a 90 gram low density polyethylene tube.