(111 days)
To hold a bone tendon bone graft in place by cross pinning in the femoral tunnel during a period of time following surgery allowing the natural healing process(es) to occur.
Femoral fixation of autograft or allograft ACL Bone Tendon Bone Grafts
The Cross Pin is 1.654″ long by 0.105″ dia with a conical tip by .180 long. The Cross Pin is molded from Purac(PLA). To hold a bone tendon bone graft in place by cross pinning in the femoral tunnel during a period of time following surgery allowing the natural healing process(es) to occur.
Here's an analysis of the provided text regarding acceptance criteria and supporting studies:
This document describes a medical device submission for a Staple, Fixation, Bone, & soft tissue device, specifically the Mitek BTB Absorbable (PLA) Cross Pin. The submission aims to demonstrate substantial equivalence to a predicate device, the Linvatec PLA Bioscrew.
It's important to note that the provided text focuses on non-clinical (benchtop) tests to demonstrate substantial equivalence. No clinical tests were performed or required for this submission. Therefore, questions related to human reader performance, AI assistance, or clinical ground truth are not applicable in this context.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Mitek BTB Absorbable (PLA) Cross Pin were implicitly established by demonstrating comparable performance to the predicate device, the Linvatec PLA Bioscrew, in specific mechanical tests.
| Acceptance Criteria (Implicit) | Reported Device Performance (Mitek Cross Pin) |
|----------------------------------------------------------------+|---------------------------------------------------------------------------------------------------------------------|
| No significant strength difference in bending tests compared to predicate (Bioscrew). | "Bench top Bending and Shear tests were done on the PLA pins [...] The results showed that there was no significant strength difference between the two." (Implied comparison to Bioscrew) |
| No significant strength difference in shear tests compared to predicate (Bioscrew). | "Bench top Bending and Shear tests were done on the PLA pins [...] The results showed that there was no significant strength difference between the two." (Implied comparison to Bioscrew) |
| Comparable pull-out strength to predicate (Bioscrew). | "strength comparisons to the Bioscrew in pull out tests were done to the Bioscrew. The results showed that there was no significant strength difference between the two." |
| Comparable strength after 8 weeks (in-vitro) to "zero" day results (indicating stability). | "Eight week In-vitro tests were also done and found to have results that were comparable to 'zero' day results." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample size for the benchtop tests (e.g., number of pins tested for bending, shear, or pull-out). It simply states that "Bench top Bending and Shear tests were done on the PLA pins" and "strength comparisons to the Bioscrew in pull out tests were done to the Bioscrew."
The data provenance is laboratory-based benchtop testing. There is no information about country of origin, as it pertains to manufactured devices and their testing, not patient data. The tests are non-clinical and therefore cannot be classified as retrospective or prospective in the human study sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. For this type of non-clinical device submission, ground truth is established through standardized engineering and material science testing methods, not by human expert review of clinical data.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 refer to methodologies used in clinical studies for resolving discrepancies among expert readers. Since this submission relies on benchtop testing, such methods are not relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No MRMC comparative effectiveness study was done. The submission explicitly states: "No clinical tests were done for this product." Therefore, there is no effect size related to human readers improving with or without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This device is a physical medical implant, not an AI algorithm. Therefore, there is no "standalone" algorithm performance to assess.
7. The Type of Ground Truth Used
The ground truth used was mechanical performance data obtained from standardized benchtop testing (Bending, Shear, and Pull-out tests) of the device and a predicate device, as well as in-vitro degradation/stability testing.
8. The Sample Size for the Training Set
Not applicable. Clinical training sets for AI algorithms were not used. The manufacturing process of the pins serves as the "training" for the device itself, adhering to design specifications.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set in the AI sense for this device. The "ground truth" for manufacturing would be the established design specifications, material properties, and quality control parameters.
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Image /page/0/Picture/0 description: The image shows the logo for Mitek Products. The word "mitek" is in bold, sans-serif font, with the "i" dotted with a small circle. Below the word "mitek" is the word "PRODUCTS" in a smaller, sans-serif font. The logo is black and white.
ETHICON...
a fohnson fohnson company
PHONE (781) 251-2700 • TOLL-FREE (800) 356-4835 • FAX (781) 461-9166
MAR - 5 1998
Page 1 of 2
SUBMITTER
NAME ADDRESS TEL# CONTACT DATE
Mitek Surgical Products, Inc. 60 Glacier Drive, Westwood, MA 02090 781-251-2700 Robert Zoletti, Manager, Regulatory Affairs November 14, 1997
NAME OF DEVICE CLASSIFICATION NAME COMMON NAME COMMON
Staple, Fixation, Bone, & soft tissue A device for holding tissue in apposition Mitek BTB Absorbable(PLA)Cross Pin
PROPRIETARY NAME
510(k) SUMMARY FOR K9XXXXX
PREDICATE DEVICE
Linvatec PLA Bioscrew
DESCRIPTION OF DEVICE
FUNCTION
To hold bone graft in position during healing period DEVICE DESIGN
The Cross Pin is 1.654″ long by 0.105″ dia with a conical tip by .180 long.
MATERIALS USED
The Cross Pin is molded from Purac(PLA)
INTENDED USE
ﺮﻳﺰﻳﻨ
To hold a bone tendon bone graft in place by cross pinning in the femoral tunnel during a period of time following surgery allowing the natural healing process(es) to occur.
COMPARISON TO PREDICATE DEVICE
The Cross Pin compares to the predicate device, Linvatec Bioscrew, (K)960940, in that it is made from the same type of material (PLA), and is used to hold the bone graft in place in the femoral tunnel during rehabilitation and healing process. The the preparation for the ACL reconstruction surgery is similar for each device,i.e., tibial and femoral bone tunneling and graft placement into the tunnel. The fixation process of the Bioscrew wedges the bone plug in place while the Cross Pin secures the bone plug by pinning(2 pins)across the plug into the adjacent femur.
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DESCRIPTION OF NON CLINICAL TESTS
Bench top Bending and Shear tests were done on the PLA pins and strength comparisons to the Bioscrew in pull out tests were done to the Bioscrew. The results showed that there was no'significant strength difference between the two. Eight week In-vitro tests were also done and found to have results that were comparable to "zero" day results.
DESCRIPTION OF CLINICAL TESTS No clinical tests were done for this product
CONCLUSIONS FROM TESTS
The bench test performance, molding materials, and intended use show that the two devices perform equally.
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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" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 5 1998
Mr. Edward F. Kent Vice President Regulatory Affairs Mitek® Products 60 Glacier Drive Westwood, Massachusetts 02090
Re: K974291
Trade Name: BTB Absorbable (PLA) Cross Pin Regulatory Class: II Product Codes: HTY and MAI Dated: February 25, 1998 Received: February 27, 1998
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 of the Act. The general controls provisions 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 (OS) 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.
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.
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Page 2 - Mr. Edward F. Kent
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 at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
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):_
Device Name: - MITEK 2.7mm BTB CROSS'PIN
Indications For Use:
Femoral fixation of autograft or allograft ACL Bone Tendon Bone Grafts
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. K974291
Prescription Use (Per 21 CFR 801.109)
ଠନ୍ନ
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 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.