(203 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and clinical outcomes of a physical implant (suture anchor) and do not mention any computational or analytical functions that would typically involve AI/ML.
No
The device is used to anchor suture into bone to reattach soft tissue, which is a structural function rather than a therapeutic one that treats or cures a disease or condition.
No
The device is used to anchor suture into bone to reattach soft tissue. Its purpose is operative, not diagnostic.
No
The device description explicitly states it is a physical threaded anchor made of Titanium 6Al 4V, which is a hardware component.
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 describes a surgical procedure performed directly on a patient's body.
- Device Description: The device is a "threaded anchor" made of Titanium, designed to be implanted into bone.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health. IVDs are used for diagnosis, monitoring, or screening based on analysis of biological samples.
The device described is a surgical implant used in a procedure, not a diagnostic tool used on in vitro samples.
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 expand the indications to include the browlift procedure. 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 Threaded Anchor is a threaded design, 2.0 mm in diameter and 3.6 mm in length. It is manufactured from Titanium 6Al 4V. It is similar in design to the 3.0mm, 4.0mm and the 5.2mm Mitek Threaded Anchor. These designs were cleared to market in K945203.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
The Mitek Threaded Anchor pull tests from cadaveric locations produced an average failure load of 32.7 Ibs, SD 1.9, N=30.
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests: The Mitek Threaded Anchor pull tests from cadaveric locations produced an average failure load of 32.7 Ibs, SD 1.9, N=30.
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.)
The Mitek Threaded Anchor pull tests from cadaveric locations produced an average failure load of 32.7 Ibs, SD 1.9, N=30.
USP knot pull synthetic sterilized suture, double strand, is 6.34 Ibs.
Suture tissue failure 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.
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.
Not Found
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
K961094
Oct. 3, 1996
SUMMARY OF SAFETY AND EFFECTIVENESS MITEK THREADED 2.0mm 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: March 12 . 1996
NAME OF DEVICE
CLASSIFICATION NAME: Staple, Fixation, Bone COMMON NAME: Appliance for reconstruction of bone to soft tissue PROPRIETARY NAME: MITEK THREADED ANCHOR
PREDICATE DEVICE: MITEK THREADED ANCHOR
DESCRIPTION OF DEVICE
FUNCTION
Fixation of USP #2/0 suture below bone surface.
DEVICE DESIGN
The Mitek Threaded Anchor is a threaded design, 2.0 mm in diameter and 3.6 mm in length. It is manufactured from Titanium 6Al 4V. It is similar in design to the 3.0mm, 4.0mm and the 5.2mm Mitek Threaded Anchor. These designs were cleared to market in K945203.
MATERIALS USED
The Mitek Threaded Anchor delivery system consists of a Mitek Threaded Anchor Tab, 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 expand the indications to include the browlift procedure. 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 #2/0 suture, and is the same design as the Mitek 3.0mm, 4.0mm and 5.2mm Mitek Threaded Anchors.
DESCRIPTION OF NON CLINICAL TESTS
The Mitek Threaded Anchor pull tests from cadaveric locations produced an average failure load of 32.7 Ibs, SD 1.9, N=30.
004
1
USP knot pull synthetic sterilized suture, double strand, is 6.34 Ibs.
Suture tissue failure 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.
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