(88 days)
Giltech Plus Hydrogel Wound Dressing is intended to be used in the management of.
- Minor burns
- Decubitus ulcers
- Superficial lacerations, cuts and abrasions
- Postoperative incisions
- Sunburn
This hydrogel retains cold temperature. Its' high specific heat, due to high water content, allows it to have a cooling effect.
This document is a 510(k) clearance letter from the FDA for a medical device called "Hydrogel Wound Dressing". This type of document does not contain the detailed study information requested in the prompt.
Here's why and what information can be extracted:
- 510(k) Clearance: This is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. It does not typically require extensive clinical trials with detailed acceptance criteria and performance data like a PMA (Premarket Approval) submission would.
- "Substantially Equivalent": The core of a 510(k) is to show substantial equivalence to a predicate device, meaning it has the same intended use and technological characteristics, or different technological characteristics that do not raise different questions of safety and effectiveness. The studies conducted are often limited and comparative, not necessarily focused on meeting specific quantitative performance metrics against a hard acceptance criterion in the way an AI algorithm study would.
Therefore, most of the requested information cannot be found in this document:
- Table of acceptance criteria and reported device performance: Not present. This document only states that the device is "substantially equivalent" to predicate devices.
- Sample size, data provenance: Not mentioned.
- Number of experts and qualifications: Not mentioned.
- Adjudication method: Not mentioned.
- MRMC comparative effectiveness study: Not applicable or mentioned. This is a physical wound dressing, not an AI algorithm.
- Standalone performance: Not applicable or mentioned for an AI device. The document is about a hydrogel dressing.
- Type of ground truth: Not applicable or mentioned.
- Sample size for training set: Not applicable or mentioned.
- Ground truth for training set: Not applicable or mentioned.
Information that can be extracted:
- Device Name: Hydrogel Wound Dressing (Trade Name: Giltech Plus Hydrogel Wound Dressing)
- Indications for Use:
- Minor burns
- Decubitus ulcers
- Superficial lacerations, cuts and abrasions
- Postoperative incisions
- Sunburn
- Regulatory Class: Unclassified
- Product Code: MGQ
- Applicant: Giltech Plus, Inc.
To get the type of detailed study information requested, you would typically need to consult a Premarket Approval (PMA) document, a clinical study report linked to an IDE (Investigational Device Exemption), or a scientific publication detailing the device's development and testing, rather than a 510(k) clearance letter.
§ 878.4022 Hydrogel wound dressing and burn dressing.
(a)
Identification. A hydrogel wound dressing is a sterile or non-sterile device intended to cover a wound, to absorb wound exudate, to control bleeding or fluid loss, and to protect against abrasion, friction, desiccation, and contamination. It consists of a nonresorbable matrix made of hydrophilic polymers or other material in combination with water (at least 50 percent) and capable of absorbing exudate. This classification does not include a hydrogel wound dressing that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter subject to the limitations in § 878.9.