(111 days)
(K)960940
Not Found
No
The device description and performance studies focus on the mechanical properties and material of a physical pin used for surgical fixation, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is used to hold a bone tendon bone graft in place during healing after surgery, which directly contributes to the restoration of normal function and improves a health condition.
No
The device description clearly states its purpose is for "Femoral fixation of autograft or allograft ACL Bone Tendon Bone Grafts" to "hold a bone tendon bone graft in place by cross pinning." This indicates a therapeutic function, not a diagnostic one.
No
The device description clearly describes a physical implantable device made of PLA, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states the device is a "Cross Pin" used for "Femoral fixation of autograft or allograft ACL Bone Tendon Bone Grafts." It's a physical implant used to hold a graft in place within the body.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens. Its function is purely mechanical and structural within the body.
Therefore, based on the provided information, this device is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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
Product codes (comma separated list FDA assigned to the subject device)
HTY and MAI
Device Description
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral tunnel
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)
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. No clinical tests were done for this product.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Linvatec Bioscrew, (K)960940
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.
Not Found
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
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.
1
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.
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" 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.
3
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)