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K Number
K984177
Device Name
MODIFICATION TO SKVEKPATCH
Manufacturer
MARINE POLYMER TECHNOLOGIES, INC.
Date Cleared
1998-12-18

(28 days)

Product Code
KMF
Regulation Number
880.5090
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

ProDein™Patch is indicated for use in the local management of bleeding wounds such as lacerations, abrasions and nose bleeds.

SyvekPatch™ is intended for use under the direction of a healthcare professional for the following indications: SyvekPatch™ is indicated for the promotion of rapid control of bleeding in patients following hemodialysis and in patients on anticoagulation therapy. SyvekPatch™ is indicated for use in the local management of bleeding wounds such as vascular access site, percutaneous catheters or tubes and surgical debridement.

Device Description

Not Found

AI/ML Overview

The provided document is an FDA 510(k) clearance letter for two devices: Syvekpatch (prescription) and Prodein (over-the-counter). It does not contain any information about acceptance criteria, device performance, or any studies conducted to prove the device meets acceptance criteria.

The document primarily focuses on:

  • Substantial Equivalence Determination: The FDA determined that the devices are substantially equivalent to devices marketed prior to May 28, 1976.
  • Limitations on Labeling: Specific claims the device cannot make (e.g., accelerating wound healing, long-term dressing, treatment/cure).
  • Indications for Use:
    • ProDein™ Patch: Local management of bleeding wounds such as lacerations, abrasions, and nosebleeds.
    • SyvekPatch™: Under the direction of a healthcare professional for rapid control of bleeding following hemodialysis, in patients on anticoagulation therapy, and local management of bleeding wounds such as vascular access sites, percutaneous catheters/tubes, and surgical debridement.
  • Regulatory Information: General controls provisions, annual registration, GMP compliance, and other federal laws.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies from this document.

§ 880.5090 Liquid bandage.

(a)
Identification. A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.(b)
Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.