(132 days)
SUTURE
No
The summary describes a mechanical suture anchor and its delivery system, with no mention of AI or ML technology in its function, design, or intended use.
Yes
The device is used to reattach soft tissue to bone during a period of rehabilitation, which is a therapeutic purpose.
No
The device is described as being used to anchor suture into bone for reattaching soft tissue, which is a therapeutic rather than a diagnostic function.
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 hardware device.
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" and "reattach the repositioned/injured soft tissue to bone." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a physical implant (anchor) made of titanium and nitinol, along with a delivery system (drill bit and inserter).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide information about a person's health status. This device is a surgical tool and implant used for structural repair within the body.
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
collateral ligament(s) around the (PIP) joint
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted 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 TELEPHONE: 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 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.