(9 days)
The JJ Skinner CareKits™ Minor Surgical Procedure Tray/Kit is intended to be used by Healthcare professionals for minor surgical procedures. Minor surgical procedures are those generally performed on an outpatient basis, under topical anesthetics. These may include dermological excisions or circumcisions.
The devices are an assembly of medical products within Tyvek®/polyethylene breather pouch. The medical products include medical devices, and drugs that are 510(k) approved devices, grandfathered, or exempt. The primary purpose of the assembly is for the convenience of the Medical practitioner. The kit is sterile, single use and disposable. The kits are custom made for the customer, who specifies the name of the kit (i.e.) as well as the contents. Attachment 5 includes a list of the medical components that may be requrested by the customer.
This document is a 510(k) summary for a medical device called "JJ Skinner CareKits™ Minor Surgical Procedure Tray/Kit". It explicitly states "No clinical evaluations were completed." This means there is no study described within this document that proves the device meets specific acceptance criteria based on performance.
Therefore, I cannot provide the requested information.
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MAY 10 1996
ATTACHMENT 1 Page 1 of 2
510(K) SUMMARY
JJ Skinner CareKits™ Minor Surgical Procedure Tray/Kit
Submitter Information:
JJ Skinner Inc. Stark Bldg. Suite 825 455 South Fourth Avenue Louisville, KY 40202
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: April 25, 1996
Name of the Device:
| Trade or Proprietary Name: | JJ Skinner CareKits™ Minor SurgicalProcedure Tray |
|---|---|
| Common Name: | Custom Minor Surgical Procedure Tray/Kit |
| Classification Name: | Tray, Surgical, General Product Code: 79LRP) |
DEVICE DESCRIPTION
The devices are an assembly of medical products within Tyvek®/polyethylene breather pouch. The medical products include medical devices, and drugs that are 510(k) approved devices, grandfathered, or exempt. The primary purpose of the assembly is for the convenience of the Medical practitioner. The kit is sterile, single use and disposable.
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ATTACHMENT 1 Page 2 of 2
The kits are custom made for the customer, who specifies the name of the kit (i.e.) as well as the contents. Attachment 5 includes a list of the medical components that may be requrested by the customer.
Identification of Legally Marketed Device to Which Submitted Substantial Equivalence:
The JJ Skinner CareKits™ Minor Surgical Procedure Tray/Kit is substantially equivalent in intended use and contents to trays legally marketed. Several companies including JJ Skinner's CareKits™ approved under K903545.
Intended Use of the Subject Devices:
The JJ Skinner CareKits™ Minor Surgical Procedure Tray/Kit is intended to be used by Healthcare professionals for minor surgical procedures. Minor surgical procedures are those generally performed on an outpatient basis, under topical anesthetics. These may include dermological excisions or circumcisions.
Technological Characteristics of the Subject Device:
The technological characteristics of JJ Skinner CareKits™ Minor Surgical Procedure Tray/Kit 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.
§ 878.4370 Surgical drape and drape accessories.
(a)
Identification. A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.(b)
Classification. Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.