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K Number
K961227
Device Name
JJ SKINNER CAREKITS WOUND CARE MANAGEMENT/DRESSING CHANGE TRAY
Manufacturer
J.J. SKINNER, INC.
Date Cleared
1996-06-10

(74 days)

Product Code
FRG,79M
Regulation Number
880.6850
Type
Traditional
Panel
HO
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The JJ Skinner CareKits™ Wound Care Management/Dressing Change Tray is intended to be used by Healthcare professionals for wound care management, including, cleansing, irrigation, debridement, and dressing changes.

Device Description

The JJ Skinner CareKits™ Wound Care Management/Dressing Change Tray is an assembly of medical products sterilized within a Tyvek®/polyethylene pouch. The trays are sterile, disposable, and single use. The primary purpose is for the convenience of the Healthcare professional. The trays are custom to the customer, and include a variety of medical devices that are legally marketed, are exempt, or are grandfathered. These components of the tray are commonly used for wound management, and JJ Skinner is not claiming or causing new uses through the intended use of the tray.

AI/ML Overview

The provided text describes a 510(k) summary for the "JJ Skinner CareKits™ Wound Care Management/Dressing Change Tray." It explicitly states: "No clinical evaluations were completed."

Therefore, there is no information available in the given text regarding:

  1. A table of acceptance criteria and the reported device performance: No performance data or acceptance criteria are provided.
  2. Sample size used for the test set and the data provenance: No test set information is available.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment is described.
  4. Adjudication method for the test set: No adjudication method is described.
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No such study was conducted.
  6. If a standalone performance (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable as this is not an AI/algorithm device.
  7. The type of ground truth used: No ground truth was established.
  8. The sample size for the training set: Not applicable as this is not an AI/algorithm device.
  9. How the ground truth for the training set was established: Not applicable as this is not an AI/algorithm device.

The submission is based on the device being an assembly of legally marketed, exempt, or grandfathered medical products, and its substantial equivalence to a predicate device through the comparison of similar significant features, components, and intended use.

§ 880.6850 Sterilization wrap.

(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).