(38 days)
Acufex suture retrograder, Innovasive suture passer
None
No
The summary describes a mechanical device for passing sutures and contains no mention of AI, ML, image processing, or data sets typically associated with AI/ML development.
No
The device, a suture retrograder, is used to pass suture through soft tissue. This is an instrument used during a procedure, not a device that directly treats or prevents a disease or condition itself. Therapeutic devices typically interact with the body to achieve a therapeutic effect.
No
The device is described as a "suture retrograder" used to "retrograde (pass) suture through soft tissue." This function is interventional (performing a procedure) rather than diagnostic (identifying or characterizing a medical condition).
No
The device description clearly states it is a "suture retrograder" used to "pass suture through soft tissue," which describes a physical tool or instrument, 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 "Retrograde suture through soft tissue." This describes a surgical procedure involving passing suture through tissue, which is a mechanical action performed on the body.
- Device Description: The device is described as a "suture retrograder" used to "pass suture through soft tissue." This further reinforces its function as a surgical tool.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. The provided description does not mention any interaction with bodily specimens or diagnostic purposes.
Therefore, this device is a surgical instrument, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Retrograde suture through soft tissue
Product codes
87HWQ
Device Description
The suture retrograder is used to retrograde (pass) suture through soft tissue. The handle is molded from gamma stable Lexan with the remaining materials being made from stainless steel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Bench tests were done to demonstrate performance equivalence to predicate devices on the market.
Key Metrics
Not Found
Predicate Device(s)
Acufex suture retrograder, Innovasive suture passer
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.4540 Orthopedic manual surgical instrument.
(a)
Identification. An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.
0
January 10, 1997
SUMMARY OF SAFETY AND EFFECTIVENESS MITEK SUTURE RETROGRADER
MAR 1 0 1997
SUBMITTER
| NAME
ADDRESS | Mitek Products
60 Glacier Drive, Westwood, MA 02090 |
|-----------------|--------------------------------------------------------|
| TEL # | 617-461-9700 |
| CONTACT | Edward F. Kent Vice President
Regulatory Affairs |
DATE
NAME OF DEVICE
| CLASSIFICATION NAME | SUTURE PASSER, 87HWQ |
|---|---|
| COMMON NAME | Instrument to retrograde suture through |
| tissue | |
| PROPRIETARY NAME | MITEK Suture Retrograder |
PREDICATE DEVICE
Acufex suture retrograder, and Innovasive suture passer
DESCRIPTION OF DEVICE FUNCTION The suture retrograder is used to retrograde (pass) suture through soft tissue.
MATERIALS USED
The handle is molded from gamma stable Lexan with the remaining materials being made from stainless steel.
INTENDED USE
Retrograde suture through soft tissue
COMPARISON TO PREDICATE DEVICE(S)
Same function, hand held suture retrograde instrument to pass or retrograde suture through tissue in either open or arthroscopic procedures.
DESCRIPTION OF NON CLINICAL TESTS
Bench tests were done to demonstrate performance equivalence to predicate devices on the market.