(70 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and clinical performance of a surgical anchor and its delivery system, with no mention of AI or ML.
No.
The device is an implantable anchor used for surgical repair, not a therapeutic device designed to treat a condition through therapy.
No
Explanation: The device, a Mitek Micro Anchor, is described as an implant used for the "REPAIR/RECONSTRUCTION OF COLLATERAL LIGAMENTS, FLEXOR AND EXTENSION TENDONS". This indicates a therapeutic or reconstructive purpose, not a diagnostic one.
No
The device description clearly states it is a physical anchor made of Titanium and Nitinol, and includes a delivery system with a drill bit and inserter. This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "REPAIR/RECONSTRUCTION OF COLLATERAL LIGAMENTS, FLEXOR AND EXTENSION TENDONS AT THE PIP (PROXIMAL INTERPHALANGEAL), DIP (DISTAL INTERPHALANGEAL), AND MCP (METACARPAL INTERPHALANGEAL) JOINTS FOR ALL DIGITS". This describes a surgical procedure performed directly on a patient's body.
- Device Description: The device is a "Mitek Micro Anchor" made of titanium and nitinol, used with a drill bit and inserter. This is a physical implant and delivery system for surgical repair.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not perform any such analysis of specimens.
The information provided clearly indicates this is a surgical implant used for musculoskeletal repair, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
The device is used to anchor suture into bone. The suture subsequently used by the surgeon to reartach 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 repair/reconstruction of collateral ligaments, flexor and extension tendons at the PTP (Proximal Tnterphalangeal)DTP (Distal Interphalangeal) , and MCB (Melacarpal Interphalangeal) joints for all digits. The intended use is the same as the predicate device, i.e., suture, when used to approximate soft tissue to bone during a period ot rehabilitation.
REPAIR/RECONSTRUCTION OF COLLATERAL LIGATENTS, FLEXIA AND EXTENSION TENDONS AT THE PIP ( PROXIMAL INTERPRADANGEAL) , DIP ( DISTAL INTERPHALANCEAL), AND MCP ( METACARPAL INTERPHALANGEAL) JOINTS FOR ALL DIGITS
Product codes (comma separated list FDA assigned to the subject device)
JDR, HWC
Device Description
Fixation of USP #3/0 suture below bone surface. The Mitek Micro Anchor is 3 7mm in length by 1.3mm in diameter. It is manufactured from Titanium 6AI 4V and uses a Nitinol arc. It is similar in design to the The same methods Mitek GII Mini Anchor. oi 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
bone, lateral canthus, collateral ligaments, flexor and extension tendons at the PIP (Proximal Interphalangeal), DIP (Distal Interphalangeal), and MCP (Metacarpal Interphalangeal) joints for all digits.
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)
Non-clinical tests: The Mitek Micro Anchor pull cests 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) FIG METACARPALS: 7.28 SD 0.72, 4) SUTURE W/ BONE TUNNELS: 5.73 SD 0.46. USP Class I knot pull synthetic sterilized #3/0 suture, double strand, single knot, is 4.22 lb. Suture tissue failure for tendinous tissue is 15.75 lb., and capsular tissue is 21.00 lb.
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. The device met the design criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Average failure load (LBS) from pull tests:
Cadaver Hand: 9.67 lb (SD 1.32)
Cadaver Skull: 7.97 lb (SD 1.92)
Pig Metacarpals: 7.28 lb (SD 0.72)
Suture w/ Bone Tunnels: 5.73 lb (SD 0.46)
USP Class I knot pull synthetic sterilized #3/0 suture, double strand, single knot: 4.22 lb
Suture tissue failure for tendinous tissue: 15.75 lb
Suture tissue failure for capsular tissue: 21.00 lb
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
§ 888.3030 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
08/13/08 11:35 8781 461 9166
MITEK PRODUCTS
K982 420
AUG 2 4 1998
mitek
PRODUCTS
ETHICON.INC.
a Johnson Johnson company
Page 1 of 2
WESTWOOD = MA = 02000 HONE (781) 281-2700 - TOLL-FRET (000) 330-4835 - FAX (781) 481-9100
510 (k) Summary For 8883440
SUBMITTER
NAME ADDRESS 1'5', # CONTACT DATE
Mitek Surgical Products, Inc. 60 Glacier Drive. Westwood, MA 02090 781-251-2700 Robert Zoletti, Manager, Regulatory Affairs August 13, 1998
NAME OF DEVICE
CLASSIFICATION NAME COMMON NAME
Staple, Fixalion, Bone Appliance for reconstruction 01 bone to soft tissue Mitek Micro Anchor
PROPRIETARY NAME
PREDICATE DEVICE
Suturc
DESCRIPTION OF DEVICE
FUNCTION
Fixation of USP #3/0 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 6AI 4V and uses a Nitinol arc. It is similar in design to the The same methods Mitek GII Mini Anchor. oi 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.
MATERTAT S 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 subsequently used by the surgeon to reartach the ມຸກ repositioned/injured soft tissue to bone. The purpose of this 510(k) submission is to obtain clearance for the Mitek for the lateral canthoplasty Micro -Anchor repair/reconstruction of collateral ligaments, flexor and extension tendons at the PTP (Proximal Tnterphalangeal)DTP MCB (Melacarpal (Distal Interphalangeal) , તાવે Interphalangeal) joints for all digits. The intended use is the same as the predicate device, i.e., suture, when used to approximate soft tissue to bone during a period ot rehabilitation.
1
SIU(k) SUMMARY FOR K982440
Page 2 of 2
COMPARISON TO PREDICATE DEVICE
It has greater strength than IISP #3/0 suture, and is the same "design" as the Mitek Mini Anchor.
DESCRIBLITOR OF NOW CRINICAT TESTS
The Mitek Micro Anchor pull cests 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) FIG METACARPALS | 7.28 | SD 0.72 |
| 4) SUTURE W/ BONE TUNNELS | 5.73 | SD 0.46 |
USP Class I knot pull synthetic sterilized #3/0 suture, double strand, single knot, is 4.22 lb. Suture tissue failure for tendinous tissue is 15.75 lb., and capsular tissue is 21.00 lb. Reference: 3oft Tissue Fixation to Bone, Daniel B. Robertson, MD 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.
CONCLUSIONS FROM TESTS
The device met the design criteria. "
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three stylized human figures.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 24 1998
Mr. Edward F. Kent Mitek Products 60 Glacier Drive 02090 Westwood, Massachusetts
Re : K982420 Mitek Micro Anchor Trade Name: Regulatory Class: II Product Codes: JDR and HWC Dated: June 12, 1998 June 15, 1998 Received:
Dear Mr. Kent:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਚੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set --forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Mr. Edward F. Kent
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".
Sincerely yours,
Russell Sager
Celia M. Witten, Ph.D.
Kr Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): K982420
流論となる。
MITEK HICRO ANCHOR Device Name:
Indications For Use:
11:10
US: Lo: US
REPAIR/RECONSTRUCTION OF COLLATERAL LIGATENTS, FLEXIA AND EXTENSION TENDONS AT THE PIP ( PROXIMAL INTERPRADANGEAL) , DIP ( DISTAL INTERPHALANCEAL), AND MCP ( METACARPAL INTERPHALANGEAL) JOINTS FOR ALL DIGITS
图 LEE ME MENNE SA SA SE LE LE PART PART PART POST POST POST POST POST POST POST TO
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Aun Paymer for IZD
(Division Sign-Off) Division of General Restorative Devices
510(k) Number ________________________________________________________________________________________________________________________
X Prescription Use (Per 21 CFR 801.109)
Ox
Over-The-Counter Use_
(Optional Format 1-2-95)