(70 days)
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
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 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.
The provided text describes the Mitek Micro Anchor, a medical device for fixing sutures to bone. The information about the study and acceptance criteria is extracted below:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (Mitek Micro Anchor) |
|---|---|
| USP Class I knot pull synthetic sterilized #3/0 suture, double strand, single knot: 4.22 lb | 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 with Bone Tunnels: 5.73 lb (SD 0.46) |
The acceptance criteria are implicitly set by the performance of the predicate device (USP Class I suture) and relevant historical data for tissue failure. The Mitek Micro Anchor's performance is presented as exceeding these values.
2. Sample Size Used for the Test Set and Data Provenance:
The document refers to "pull tests from cadaveric and porcine locations."
- Sample Size: Not explicitly stated as a number of samples, but the four categories tested are "Cadaver Hand," "Cadaver Skull," "Pig Metacarpals," and "Suture w/Bone Tunnels."
- Data Provenance:
- Country of Origin: Not specified.
- Retrospective or Prospective: These appear to be prospective, controlled mechanical tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
- This was a non-clinical test (mechanical pull tests), not involving human diagnostic interpretation or clinical ground truth as typically understood in AI/medical imaging studies. Therefore, no experts were used to establish "ground truth" in this context. The "ground truth" here is the measured failure load.
4. Adjudication Method for the Test Set:
- Not applicable as this was a non-clinical, mechanical test, not an expert-driven adjudication process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC study was not performed. This device is a surgical implant, not a diagnostic imaging AI tool that would typically involve human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Yes, the performance presented in the table is a standalone mechanical performance of the device (pull-out strength) without human-in-the-loop interaction in the context of diagnostic interpretation.
7. Type of Ground Truth Used:
- The ground truth for the device's performance was empirically measured failure load (mechanical strength), reported in pounds (LBS). This is compared against the known strength of sutures and historical data on suture and tissue failure.
8. Sample Size for the Training Set:
- The document does not specify a training set. This is a characteristic of engineering/mechanical testing, not typical AI/machine learning development where a training set is used to "teach" an algorithm.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as no training set for an algorithm is mentioned or implied. The device's design is described as "similar in design to the Mitek GII Mini Anchor," suggesting a design based on prior engineering principles and existing devices, rather than an iterative machine learning training process. The "design criteria" mentioned in the conclusion refer to engineering specifications.
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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.
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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. "
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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.
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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
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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
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(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)
§ 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.