(76 days)
SUTURE
No
The summary describes a mechanical suture anchor and delivery system with no mention of AI or ML capabilities.
No.
The device is used to anchor suture into bone to reattach soft tissue, thus acting as a mechanical aid during rehabilitation and not providing direct therapy itself.
No
The device is a surgical anchor used to reattach soft tissue to bone, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it is manufactured from Titanium and uses a Nitinol arc, and includes a delivery system with a drill bit and inserter, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "anchor suture into bone" for reattaching soft tissue. This is a surgical procedure performed in vivo (within the body), not a test performed in vitro (outside the body) on biological samples to diagnose a condition.
- Device Description: The device is a physical anchor and delivery system, not a reagent, instrument, or kit used for diagnostic testing.
- Performance Studies: The performance studies described are mechanical pull tests and clinical trials evaluating the device's function in a surgical setting, not studies evaluating the accuracy of a diagnostic test.
IVD devices are used to examine specimens such as blood, urine, or tissue to provide information for diagnosis, monitoring, or screening. This device is a surgical implant used to facilitate tissue repair.
N/A
Intended Use / Indications for Use
The device is used to anchor suture into bone . The suture is subsequently used by the surgeon to reattach the repositioned/injured soft tissue to bone. The purpose of this 510(k) submission is to obtain clearance for the Mitek Micro Anchor for the lateral canthoplasty and collateral ligament(s) around the (PIP) joint. The intended use is the same as the predicate device, i.e., suture. when used to approximate soft tissue to bone during a period of rehabilitation.
Product codes
Not Found
Device Description
The Mitek Micro Anchor is 3.7mm in length by 1.3mm in diameter. It is manufactured from Titanium 6Al 4V and uses a Nitinol arc. It is similar in design to the Mitek GII Mini Anchor. The same methods of manufacturing and assembly are used for the Micro Anchor as those used for manufacturing all other Mitek metal anchors. The Mitek Mini anchor design was first cleared to market by US FDA in K915089 and K930892. The Mitek Micro Anchor delivery system consists of a Mitek Micro Anchor, a drill bit, and an Inserter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lateral canthoplasty and collateral ligament(s) around the (PIP) joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon
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
The MitekMicro Anchor pull tests from cadaveric and porcine locations produced an average failure load (LBS) of:
- CADAVER HAND 9.67, SD 1.32
- CADAVER SKULL 7.97, SD 1.92
- PIG METACARPALS 7.28, SD 0.72
- SUTURE W/ BONE TUNNELS 5.73, SD 0.46
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
DESCRIPTION OF NON CLINICAL TESTS
The MitekMicro Anchor pull tests from cadaveric and porcine locations produced an average failure load (LBS) of:
- CADAVER HAND 9.67, SD 1.32
- CADAVER SKULL 7.97, SD 1.92
- PIG METACARPALS 7.28, SD 0.72
- SUTURE W/ BONE TUNNELS 5.73, SD 0.46
USP Class I knot pull synthetic sterilized #4/0 suture, double strand, single knot, is 2.64 lbs.
Suture tissue failure for tendinous tissue is 15.75 lbs, and capsular tissue is 21.80 Ibs. Reference: Soft Tissue Fixation to Bone, Daniel B. Robertson, M.D. et al, The American Journal of Sports Medicine, Vol. 14, No. 5, 1986.
DESCRIPTION OF CLINICAL TESTS
The clinical tests were done in accordance with IDE #G880026. Safety and effectiveness was based upon the results obtained in the clinical trials and their equivalence to historical data for the identical surgical procedure.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
SUTURE
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
SUMMARY OF SAFETY AND EFFECTIVENESS MITEK MICRO ANCHOR
SUBMITTER:
NAME: Mitek Surgical Products, Inc. ADDRESS: 60 Glacier Drive, Westwood, MA 02090 TEL#: 617-461-9700 CONTACT: Edward F. Kent, Vice President, Regulatory Affairs DATE: June 28, 1996
NAME OF DEVICE
CLASSIFICATION NAME: Staple, Fixation, Bone COMMON NAME: Appliance for reconstruction of bone to soft tissue PROPRIETARY NAME: MITEK MICRO ANCHOR
PREDICATE DEVICE: SUTURE
DESCRIPTION OF DEVICE
FUNCTION
Fixation of USP #4/0 suture below bone surface.
DEVICE DESIGN
The Mitek Micro Anchor is 3.7mm in length by 1.3mm in diameter. It is manufactured from Titanium 6Al 4V and uses a Nitinol arc. It is similar in design to the Mitek GII Mini Anchor. The same methods of manufacturing and assembly are used for the Micro Anchor as those used for manufacturing all other Mitek metal anchors. The Mitek Mini anchor design was first cleared to market by US FDA in K915089 and K930892.
MATERIAL USED
The Mitek Micro Anchor delivery system consists of a Mitek Micro Anchor, a drill bit, and an Inserter.
INTENDED USE
The device is used to anchor suture into bone . The suture is subsequently used by the surgeon to reattach the repositioned/injured soft tissue to bone. The purpose of this 510(k) submission is to obtain clearance for the Mitek Micro Anchor for the lateral canthoplasty and collateral ligament(s) around the (PIP) joint. The intended use is the same as the predicate device, i.e., suture. when used to approximate soft tissue to bone during a period of rehabilitation.
COMPARISON TO PREDICATE DEVICE
It has greater strength than USP #4/0 suture, and is the same "design" as the Mitek Mini Anchor.
1
DESCRIPTION OF NON CLINICAL TESTS
The MitekMicro Anchor pull tests from cadaveric and porcine locations produced an average failure load (LBS) of:
| 1) CADAVER HAND | 9.67, SD 1.32 |
|---|---|
| 2) CADAVER SKULL | 7.97, SD 1.92 |
| 3) PIG METACARPALS | 7.28, SD 0.72 |
| 4) SUTURE W/ BONE TUNNELS | 5.73, SD 0.46 |
USP Class I knot pull synthetic sterilized #4/0 suture, double strand, single knot, is 2.64 lbs.
Suture tissue failure for tendinous tissue is 15.75 lbs, and capsular tissue is 21.80 Ibs. Reference: Soft Tissue Fixation to Bone, Daniel B. Robertson, M.D. et al, The American Journal of Sports Medicine, Vol. 14, No. 5, 1986.
DESCRIPTION OF CLINICAL TESTS
The clinical tests were done in accordance with IDE #G880026. Safety and effectiveness was based upon the results obtained in the clinical trials and their equivalence to historical data for the identical surgical procedure.