(84 days)
Not Found
No
The summary describes a mechanical fixation device made of bioabsorbable material and focuses on bench testing for strength and biocompatibility. There is no mention of AI, ML, image processing, or data-driven algorithms.
Yes
The device is used for the "fixation of autograft or allograft ACL bone-tendon-bone (BTB) grafts", which is a therapeutic intervention.
No
The device is described as a "cross pin kit" for femoral and tibial fixation of ACL grafts, indicating it is an implant or fixation device used during surgery, not a device for diagnosing medical conditions.
No
The device description explicitly states it is a sterile, disposable device with cross pins constructed of bioabsorbable Poly Lactic Acid (PLA), indicating it is a physical medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "femoral and tibial fixation of autograft or allograft ACL bone-tendon-bone (BTB) grafts." This describes a surgical implant used within the body to fix tissue, not a test performed outside the body on samples like blood or urine.
- Device Description: The description details a "sterile, disposable, device designed for single patient use only" and mentions the material (bioabsorbable Poly Lactic Acid). This aligns with a surgical implant.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
The RigidFix™ 2.7mm BTB Cross Pin Kit is a surgical implant used in orthopedic procedures.
N/A
Intended Use / Indications for Use
The RigidFix™ 2.7mm BTB Cross Pin Kit is indicated for femoral and tibial fixation of autograft or allograft ACL bone-tendon-bone (BTB) grafts.
The Mitek RigidFix 2.7mm BTB Cross Pin Kit is indicated for femoral and tibial fixations for 050. “The Ingraft ACL bone-tendon-bone grafts.
Product codes (comma separated list FDA assigned to the subject device)
HTY, MAI
Device Description
The device described in this 510(k) is a sterile, disposable, device designed for single patient use only. The cross pins are constructed of bioabsorbable Poly Lactic Acid (PLA).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Femoral and tibial
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)
Functional and integrity bench testing and Biocompatibility testing (according Sately and I criormance. I antenoid and ante and Memoradum #G95-1, 1995, Use of International Standard to die FDA garadies dooament, OB B Medical Devices Part 1: Evaluation and Testing” were performed, 100-10035, “brooked the substantial equivalence of the proposed RigidFix™ 2.7mm BTB Cross Pin Kit. Specifically, testing was performed to determine the initial fixation strength of the proposed RigidFix™ Diporneany, tosting was for Bone-Tendon-Bone grafted ACL Reconstructions.
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.
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
ATTACHMENT H
FEB 0 6 2002
SUMMARY OF SAFETY & EFFECTIVENESS
Pursuant to §513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Mitek Products is requires assets and r ulsulant to 915(1)(3)(1) or the Food, 27th, adequate summary of any information respecting safety and this Frenarket Northeaton will be made available upon request of any person." Mitek Products choose to submit a summary of information respecting safety and effectiveness. According to $13(i)(3)(B), "Any summary under subparagraph (A) respecting a device shall contain detailed information regarding data concerning adverse health effects ... "
The summary regarding the adverse health effects of the proposed RigidFix™ 2.7mm BTB Cross Pin Kit is as follows:
| Trade Name: | RigidFix™ 2.7mm BTB Cross Pin Kit |
|---|---|
| Sponsor: | Mitek Products |
| 249 Vanderbilt Avenue | |
| Norwood, MA 02062 | |
| Registration: 1221934 | |
| Device Generic Name: | Appliance for reconstruction of bone to soft tissue |
| Classification: | According to Section 13 of the Federal Food, Drug and Cosmetic Act, the |
| device classification is Class II, Performance Standards. | |
| Predicate Devices: | Mitek - RigidFix™ 2.7mm BTB Cross Pin Kit (K974291) |
| Linvatec BioScrew® Absorbable Interference Screw (K973758) |
All of the devices mentioned above have been determined substantially equivalent by FDA.
Device Description: The device described in this 510(k) is a sterile, disposable, device designed for single patient use only. The cross pins are constructed of bioabsorbable Poly Lactic Acid (PLA).
Indications for Use: The RigidFix™ 2.7mm BTB Cross Pin Kit is indicated for femoral and tibial fixation of autograft or allograft ACL bone-tendon-bone (BTB) grafts.
Safety and Performance: Functional and integrity bench testing and Biocompatibility testing (according Sately and I criormance. I antenoid and ante and Memoradum #G95-1, 1995, Use of International Standard to die FDA garadies dooament, OB B Medical Devices Part 1: Evaluation and Testing" were performed, 100-10035, "brooked the substantial equivalence of the proposed RigidFix™ 2.7mm BTB Cross Pin Kit. Specifically, testing was performed to determine the initial fixation strength of the proposed RigidFix™ Diporneany, tosting was for Bone-Tendon-Bone grafted ACL Reconstructions.
Conclusion: Based on the Indications for Use, design, technological characteristics and safety and performance testing, the proposed RigidFix™ 2.7mm BTB Cross Pin Kit has been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three wavy lines, resembling a bird or a symbol representing health and human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 0 6 2002
Ms. Jennifer Johnson Regulatory Affairs Associate Mitek Products Ethicon, Inc., a Johnson & Johnson Company 249 Vanderbilt Avenue Norwood, Massachusetts 02062
Re: K013781
Trade Name: Rigidfix ™ 2.7mm BTB Cross Pin Kit Regulation Number: 888.3030 Regulation Number. 866:5050
Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HTY, MAI Dated: November 13, 2001 Received: November 14, 2001
Dear Ms. Johnson:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have reviewed your Section > roke its 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 Your may enactment uate of the Medical Dories Finesal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general therefore, market the device, basyev to equirements for annual registration, listing of devices, Controls provisions of the receively, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (see acc re) and additional controls. Existing major regulations (Fremarks) Approval), it they of Sale of Federal Regulations, Title 21, Parts 800 to 895. arrecting your do rios bant determination assumes compliance with the current Good A substantially cquiralent determination as set forth in the Quality System Regulation (QS) for Manufacturing Fractice requirements, as 3 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure 10 Inspections, the rood and Drug Nammonation of Collection. In addition, FDA may publish comply with the GMT regaration may readine in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might response to your premation stations 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) prematet notification. The FDA finding of substantial equivalence of your device to a legally marketed noutheation. The I Driving of cassion for your device and thus, permits your device to proceed to the market.
2
Page 2 – Ms. Jennifer Johnson
If you desire specific advice for your device on our labeling regulation (21 CFF Part 801 and IT you desire specific days. I four astic devices), please contact the Office of Compliance at additionally 607.10 for in This dagliestions on the promotion and advertising of your device, (201) 594-4037. Additionally, for quest at (301) 594-4639. Also, please note the regulation prease connect the Orifice or Compilance an (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small
information on your responsibilities under the Act may be obtained from 112012 1 miorination on your responsibilities and in and in at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
lo Mark N Wilkerson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
RigidFix 2.7mm BTB Tibial Cross Pin Kit
November 13, 2001
FEB 0 6 2002
Page of 1 1
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Rigidfix(tm) 2.7mm BTB Cross Pin Kit
Indications for Use: The Mitek RigidFix 2.7mm BTB Cross Pin Kit is indicated for femoral and tibial fixations for 050. "The Ingraft 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)
X Prescription Use (Per 21 CFR 801.109) Over-the -Counter Use ________________________________________________________________________________________________________________________________________________________
Mark N. Milliken
OR
'estorative
510(k) Number