(86 days)
Shoulder:. Bankart repairSLAP Lesion repair acromio-clavicular separation, rotator cuff repair,capsule shift/capsulo-labral reconstruction, biceps tenodesis, deltoid repair. Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction, midfoot reconstruction. Foot: Hallux Valgus reconstruction. Elbow: Tennis Elbow repair, biceps tendon reattchment. Knee: Extra capsular repairs,Reattachment of: medial collateral ligament, lateral collateral ligament, posterior oblique ligament, or joint capsule to tibia and joint capsult closure to anterior proximal tibia, extra capsular reconstruction, ITBtenodesis, patellar ligament and tendon avulsions
The device is 0.430″ lg by 0.109″ wide with with two 0.026″ by 85 degree arcs. Titanium body and Nitinol arcs. Hold soft tissue in apposition during healing process.
The provided text primarily details a 510(k) summary for the Mitek Knotless Anchor, focusing on its substantial equivalence to a predicate device. While it mentions bench-top tests, it does not explicitly define acceptance criteria in terms of specific performance metrics or studies proving the device meets them. Instead, it indicates that clinical tests were done "in accordance with IDE G880026" but does not provide results or details of these tests.
Therefore, many of the requested details cannot be extracted directly from this document.
However, I can extract information related to the bench-top tests:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Statistically equivalent strength to the predicate device (Mitek GII) | Mitek GII pull-out failure force: 26.03 lbs (SD 17.12) Knotless Anchor pull-out failure force: 60.96 lbs (SD 14.29) |
| Implied: Demonstrate sufficient pull-out strength in pig femora. | Knotless Anchor (60.96 lbs) showed significantly higher pull-out strength than the GII (26.03 lbs). |
Note: While the document states "statistically equivalent strength," the reported mean pull-out forces (60.96 lbs vs. 26.03 lbs) and standard deviations (14.29 vs 17.12) suggest the Knotless Anchor was actually stronger, not just equivalent. This phrasing could be interpreted as "at least equivalent" or could be a simplification in the summary. For the purpose of answering, I've reported the stated requirement and the performance provided.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated for pull-out tests.
- Data Provenance: The tests were conducted using "pig femora." The country of origin of the data is not specified, and it's a bench-top test, not human data. This would be considered a prospective bench study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This was a physical bench-top test measuring mechanical properties, not a study requiring expert interpretation or ground truth establishment in that sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This was a physical bench-top test measuring mechanical properties.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, this information is not present. This document describes a medical device, not an AI or imaging diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the bench-top test, the "ground truth" was the measured physical pull-out force from pig femora, determined through mechanical testing.
8. The sample size for the training set
Not applicable. There's no mention of a "training set" as this is a physical device, not a machine learning model.
9. How the ground truth for the training set was established
Not applicable for the same reason as point 8.
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FEB 13 1998
Image /page/0/Picture/1 description: The image shows the logo for Mitek Products. The word "mitek" is in bold, sans-serif font, with the "m" and "i" connected. Below the word "mitek" is the word "PRODUCTS" in a smaller, sans-serif font. The logo is black and white.
Page 1 of 2
Johnson-Johnson company
01 356-4835 · FAX (781) 461-9166
| K974345 |
|---|
| K9XXXXXX |
510(k) SUMMARY FOR
SUBMITTER
Mitek Surgical Products, Inc. NAME 60 Glacier Drive, Westwood, MA 02090 ADDRESS 781-251-2700 TEL# Robert Zoletti, Manager, Regulatory Affairs CONTACT November 19, 1997 DATE
NAME OF DEVICE
Staple,fixation, bone & soft tissue CLASSIFICATION NAME Device for holding soft tissue in COMMON NAME apposition Mitek Knotless Anchor PROPRIETARY NAME
PREDICATE DEVICE Mitek GII
DESCRIPTION OF DEVICE
FUNCTION
Hold soft tissue in apposition during healing process DEVICE DESIGN
The device is 0.430″ lg by 0.109″ wide with with two 0.026″ by 85 degree arcs.
MATERIALS USED
Titanium body and Nitinol arcs
INTENDED USE
BB our during the healing process
COMPARISON TO PREDICATE DEVICE
Identical intended use with variance in suture handling and knotless function. Made from identical materials. Patient preparation is same with the exception of the tissue apposition process,i.e., the knotless anchor uses a looped version of suture to hold the tissue in place and the GII uses knots to perform the tissue appositon.
DESCRIPTION OF NON CLINICAL TESTS
Bench top tests showed statistically equivalent strength between the knotless and GII anchors. The pull out failure force from pig femora for : Mitek purr out railare 26.03. SD 17.12, and for Knotless Anchor was 60.96lbs, SD 14.29.
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DESCRIPTION OF CLINICAL TESTS RIPTION OF CLINICAL Tools
Clinical tests for the Mitek anchors were done in accordance with IDE G880026.
CONCLUSIONS FROM TESTS
JOSTONS INCH ILJIS K892126.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) in the USA. The logo consists of a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol representing the human form, composed of three abstract figures in profile, suggesting a sense of community and support.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 3 1998
Mr. Edward F. Kent Vice President Requlatory Affairs Mitek Products 60 Glacier Drive 02090 Westwood, Massachusetts
Re: K974345 Mitek Knotless Anchor Trade Name: Regulatory Class: II Product Code: MBI November 19, 1997 Dated: November 19,1997 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, Drug, 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 against 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. A ........................................................................................................................... substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. 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,
C. Galie M. Witter, Ph.D.
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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Page_l__of_l
510(k) Number (if known): _ K97 4345
Mitek Knotless Anchor Device Name:
Indications For Use:
Shoulder:. Bankart repairSLAP Lesion repair acromio-clavicular separation, rotator cuff repair,capsule shift/capsulo-labral reconstruction, biceps tenodesis, deltoid repair. Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction, midfoot reconstruction. Foot: Hallux Valgus reconstruction. Elbow: Tennis Elbow repair, biceps tendon reattchment. Knee: Extra capsular repairs,Reattachment of: medial collateral ligament, lateral collateral ligament, posterior oblique ligament, or joint capsule to tibia and joint capsult closure to anterior proximal tibia, extra capsular reconstruction, ITBtenodesis, patellar ligament and tendon avulsions
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_ × (Per 21 CFR 801.109)
09
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
s collete
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. K974345
009004
§ 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.