JJ SKINNER CAREKITS MINOR SURGICAL PROCEDURE TRAY

K961683 · J.J. Skinner, Inc. · LRO · May 10, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K961683
• Device Name: JJ SKINNER CAREKITS MINOR SURGICAL PROCEDURE TRAY
• Applicant: J.J. Skinner, Inc.
• Product Code: LRO · General, Plastic Surgery
• Decision Date: May 10, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4370
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

Assembly of pre-cleared, grandfathered, or exempt medical devices and drugs into a single sterile, single-use, disposable tray; packaged in Tyvek®/polyethylene breather pouch. Custom-configured by customer for convenience of medical practitioners in outpatient settings. Facilitates minor surgical procedures; reduces preparation time for clinicians. No active components or software.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Sterile, single-use, disposable tray assembly. Components housed in Tyvek®/polyethylene breather pouch. No active energy source or software.

Indications for Use

Indicated for healthcare professionals performing minor surgical procedures, such as dermatological excisions or circumcisions, on an outpatient basis under topical anesthesia.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• JJ Skinner CareKits™ (K903545)

Submission Summary (Full Text)

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K96/683
MAY 10 1996
ATTACHMENT 1
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# 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
[phone]

**Date 510(k) Summary Prepared:** April 25, 1996

### Name of the Device:

**Trade or Proprietary Name:** JJ Skinner CareKits™ Minor Surgical Procedure 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
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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 requested 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.