(74 days)
Not Found
Not Found
No
The description focuses on a collection of standard wound care supplies for convenience and does not mention any AI/ML components or functions.
Yes
This device is intended for wound care management, including cleansing, irrigation, debridement, and dressing changes, which are therapeutic interventions.
No
The provided text describes the device as a kit for wound care management and dressing changes. Its purpose is for convenience during medical procedures, not for diagnosing conditions.
No
The device description explicitly states it is an "assembly of medical products sterilized within a Tyvek®/polyethylene pouch," indicating it is a physical kit containing various medical devices, not a software-only product.
Based on the provided information, the JJ Skinner CareKits™ Wound Care Management/Dressing Change Tray is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for wound care management, including cleansing, irrigation, debridement, and dressing changes. These are procedures performed directly on the patient's body, not on samples taken from the body for diagnostic purposes.
- Device Description: The device is an assembly of medical products used for wound care. It does not involve analyzing biological samples to provide diagnostic information.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (like blood, urine, tissue, etc.) to diagnose a disease or condition.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The JJ Skinner CareKits™ are used in vivo (on the body) for therapeutic and management purposes.
N/A
Intended Use / Indications for 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.
Product codes
79MCY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Healthcare professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
No clinical evaluations were completed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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
Not Found
§ 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).
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ATTACHMENT 1 Page 1 of 2
510(K) SUMMARY
JJ Skinner CareKits™ Wound Care Management/Dressing Change Tray
Submitter Information:
ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘ
JJ Skinner Inc. Stark Bldg. Suite 825 455 South Fourth Avenue Louisville, KY 40202
JUN 1 0 1996
510(k) Summary Prepared By:
Carolann Kotula mdi Consultants, Inc. 55 Northern Blvd. Great Neck, NY 11021 (516) 482-9001
Date 510(k) Summary Prepared: March 20, 1996
Name of the Device:
| Trade or Proprietary Name: | JJ Skinner CareKits™ Wound Care Management/Dressing Change Tray |
|---|---|
| Common Name: | Wound care kit/tray; dressing change kit/tray |
| Classification Name: | Kit, Wound Dressing (Product Code: 79MCY) |
identification of Legally Marketed Device to which the Submitter Claims Equivalence:
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
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ATTACHMENT 1 Page 2 of 2
な
management, and JJ Skinner is not claiming or causing new uses through the intended use of the tray.
Intended Use of the Subiect Devices:
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.
Technological Characteristics of the Subject Device:
characteristics of JJ Skinner CareKits™ Wound Care The technological Management/Dressing Change Trays and the predicate device are substantially equivalent as supported by the comparison of similar significant features, components, and intended use.
No clinical evaluations were completed.