(44 days)
No
The 510(k) summary describes a collection of standard surgical accessories and makes no mention of AI or ML technology.
No
The Laceration Tray is described as an assemblage of surgical accessories used during minor surgical procedures such as wound closures, incisions, and drainage. While these procedures are part of medical treatment, the tray itself is a collection of instruments and not a device that directly treats a condition through a therapeutic mechanism (e.g., delivering energy, substances, or affecting physiological processes directly for therapy). It facilitates therapeutic procedures performed by a medical professional but is not a standalone therapeutic device.
No
The device description indicates it is an "assemblage of common medical devices which are used by medical professionals during minor surgical procedures," primarily for wound closure and other comparable minor procedures. It does not mention any function related to diagnosing a condition or disease.
No
The device description explicitly states it is an "assemblage of common medical devices" and a "convenient assemblage of surgical accessories," indicating it is a collection of physical medical devices, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "minor surgical procedures," specifically mentioning "wound closures, incisions and drainage." These are procedures performed on the patient's body, not on samples taken from the body for diagnostic purposes.
- Device Description: The description reinforces this by stating it's an "assemblage of common medical devices which are used by medical professionals during minor surgical procedures."
- Lack of IVD Indicators: There is no mention of analyzing samples (blood, urine, tissue, etc.), diagnostic purposes, or any of the typical characteristics of an IVD device.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This laceration tray is a collection of tools for performing a surgical procedure, not for analyzing a sample.
N/A
Intended Use / Indications for 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.
Product codes
LRO
Device Description
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.
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
medical 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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).
0
KCXCOSOX(
J. SUMMARY OF SAFETY AND EFFECTIVENESS
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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.