(44 days)
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.
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.
The provided text is a summary of safety and effectiveness for a Laceration Tray, a collection of common medical devices used for minor surgical procedures. It details the device's name, predicate device, description, intended use, and a comparison of technological characteristics. Crucially, it does not contain any information about acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, multi-reader multi-case studies, or standalone algorithm performance.
The "Safety" section primarily discusses a review of MDR (Medical Device Report) records to ensure no adverse events were reported for similar devices. This is a regulatory diligence step, not a study to prove device performance against acceptance criteria in the context of diagnostic accuracy or AI.
Therefore, I cannot fulfill your request as the necessary information is not present in the provided text. The document describes a physical medical device (a Laceration Tray), not a diagnostic algorithm or AI-powered device that would typically have the kind of performance metrics and study details you're asking for.
{0}------------------------------------------------
KCXCOSOX(
J. SUMMARY OF SAFETY AND EFFECTIVENESS
木
MAR 21 152
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.
{1}------------------------------------------------
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.
§ 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).