LACERATION TRAY

K960520 · Medco Instruments, Inc. · FRG · Mar 21, 1996 · General Hospital

Device Facts

• Record ID: K960520
• Device Name: LACERATION TRAY
• Applicant: Medco Instruments, Inc.
• Product Code: FRG · General Hospital
• Decision Date: Mar 21, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Laceration Tray is an assemblage of surgical accessories, each of which is intended to be used in accordance with generally accepted minor surgical procedures.

Device Story

Laceration Tray; sterile assemblage of common medical devices/surgical accessories. Used by medical professionals in clinical settings for minor surgical procedures (wound closure, incision, drainage). Device provides convenience by grouping necessary instruments for procedure. Output is the physical tray of instruments used by the clinician to perform the procedure; facilitates efficient minor surgery.

Clinical Evidence

No clinical data. Safety assessment based on review of MDR records for laceration trays and related surgical kits; no reported malfunctions for laceration trays.

Technological Characteristics

Sterile tray containing assemblage of surgical accessories. No specific materials, dimensions, or energy sources described.

Indications for Use

Indicated for use by medical professionals during minor surgical procedures, including wound closures, incisions, drainage, and comparable minor procedures.

Regulatory Classification

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.

Predicate Devices

• Medikmark's Laceration Tray (K920341)

Submission Summary (Full Text)

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K920520
1240600

# J. SUMMARY OF SAFETY AND EFFECTIVENESS

MAR 21 1990

## 1. Name and Address

This Summary of Safety and Effectiveness is being submitted by Medco Instruments, Inc., 4500 W. 137th Street, Crestwood, IL 60445. The telephone number is 708-597-7400.

## 2. Name of the Device

The device is generally known as a Laceration Tray.

## 3. Identification of the Predicate Device

Medikmark's Laceration Tray, K920341.

## 4. Description of the Device

Medco's Laceration Tray is a convenient assemblage of common medical devices which are used by medical professionals during minor surgical procedures, including, but not limited to, wound closures, incisions and drainage and comparable minor procedures. The tray is sold sterile.

## 5. Intended Use of the Device

The Laceration Tray is an assemblage of surgical accessories, each of which is intended to be used in accordance with generally accepted minor surgical procedures.

## 6. Comparison of Technological Characteristics

The differences between Medco's Laceration Tray and Medikmark's Laceration Tray are minor and do not impact the safety and effectiveness of the device in any significant way.

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7. Safety

Medco reviewed the MDR records filed with CDRH relating to laceration trays. A manual search was conducted in the Product SOS™² book; no MDRs were reported for laceration trays. There are 3 surgical instrument trays that malfunctioned; one is a tubing organizer and two are sterilization container systems, all of which are very different from a laceration tray. An additional search was done in a CD ROM database³ for laceration trays. No MDRs were filed for laceration trays. We then searched for the product code, LRO which resulted in 2 MDRs. One is a skin scrub tray and the other is a spray kit. Finally, we searched for surgical procedure packs/kits and one report indicated that a cannula malfunctioned in the kit resulting in chamber collapse. All of these reports are attached.

² Product SOS™, Medical Economics Data Production Company, Montvale, NJ 07645-1742.

³ The Medical Device Library, IHS Regulatory Products, 15 Inverness Way East, Englewood, CO 80150.

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