(118 days)
The DePuy Mitek INTRAFIX™ Advance Tibial Sheath and Screw System is indicated for fixation of tissue including ligament, or tendon to bone during cruciate ligament reconstruction.
The INTRAFIX™ Advance Tibial Fastener System is an implant system used for fixation of tissue including ligament, or tendon to bone during cruciate ligament reconstruction. The INTRAFIX™ Advance Sheaths are available in absorbable BR and non-absorbable Polypropylene materials. The INTRAFIX™ Advance Screws are available in absorbable BR and non-absorbable PEEK materials. The INTRAFIXTM Advance Tibial Sheaths and Screws are supplied sterile ready to use.
The provided document describes the INTRAFIX™ Advance Tibial Fastener System, a medical device used for fixation of tissue during cruciate ligament reconstruction. The information indicates that this is a 510(k) premarket notification for a Class II medical device, meaning it is substantially equivalent to legally marketed predicate devices.
The document does not describe a study in the context of an AI/ML powered device, or a diagnostic product that would typically involve acceptance criteria related to accuracy metrics (e.g., sensitivity, specificity, AUC) and ground truth establishment by experts. Instead, the "study" referred to here is non-clinical testing to ensure the physical and mechanical performance of the implant.
Therefore, many of the requested points, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, and standalone performance for an algorithm, are not applicable to this type of device submission as described in the provided text.
Here's an attempt to answer the relevant questions based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document mentions "Verification activities were performed on the implant and / or its predicate. Testing assessments include pull out testing, and insertion / failure torque." However, it does not explicitly state specific acceptance criteria values (e.g., "minimum pull-out strength of X Newtons") nor specific performance values obtained from the tests. It only states that "Results of performance testing have demonstrated that the proposed devices are suitable for their intended use."
Without explicit numbers from the document, a table with specific criteria and performance cannot be created.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the provided document. The document refers to "the implant and / or its predicate" for testing, implying physical samples of the device were tested.
- Data Provenance: Not applicable in the context of data for an AI/ML model. The "data" here would be the physical testing results from the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. "Ground truth" in the context of a physical implant's mechanical performance is usually established through standardized engineering test methods (e.g., ASTM standards) rather than expert consensus on medical images or pathology.
4. Adjudication method for the test set
Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert interpretations of data, which is not relevant to mechanical testing.
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 is a submission for a physical medical implant, not an AI/ML-powered diagnostic or assistive device. Therefore, MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No. This is not an algorithm.
7. The type of ground truth used
For this device, the "ground truth" for non-clinical testing would be definitions or measurements established by recognized engineering standards and biocompatibility requirements. The document states "Verification activities were performed on the implant and / or its predicate. Testing assessments include pull out testing, and insertion / failure torque." and "The proposed device also met requirement of bacterial endotoxin testing." This implies adherence to predefined physical and biological safety standards.
8. The sample size for the training set
Not applicable. This device does not involve a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
Not applicable. This device does not involve a "training set."
{0}------------------------------------------------
Image /page/0/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 a stylized image of three human profiles facing right, stacked on top of each other, representing the department's focus on people and health.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 19, 2016
Medos International SARL % Kristine Christo Director. Regulatory Affairs DePuy Mitek, Inc. a Johnson & Johnson Company 325 Paramount Drive Raynham, Massachusetts 02767
Re: K160804
Trade/Device Name: INTRAFIX™ Advance Tibial Fastener System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: MAI, MBI Dated: June 13, 2016 Received: June 14, 2016
Dear Ms. Christo:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
{1}------------------------------------------------
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known)
Device Name INTRAFIXTM Advance Tibial Fastener System
Indications for Use (Describe)
The DePuy Mitek INTRAFIX™ Advance Tibial Sheath and Screw System is indicated for fixation of tissue including ligament, or tendon to bone during cruciate ligament reconstruction.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
SECTION 2 - 510(k) SUMMARY
INTRAFIX™ Advance Tibial Fastener System
| Submitter'sName andAddress | Medos International SARLChemin-Blanc 38, Le Locle NeuchatelCH 2400, SwitzerlandDate Prepared: March 21, 2016 |
|---|---|
| Contact Person | Kristine ChristoDirector, Regulatory AffairsDePuy Mitek, Inc.a Johnson & Johnson company325 Paramount DriveRaynham, MA 02767, USATelephone: 508-828-3359Facsimile: 508-977-6911e-mail: kchristo@its.jnj.com |
| Name ofMedical Device | Proprietary Name: INTRAFIXTM Advance Tibial Fastener System |
| Classification Name: a) Single/multiple component metallic bone fixationappliances and accessoriesb) Smooth or threaded metallic bone fixation fasteners | |
| Common Name: Fastener, fixation, soft tissue | |
| SubstantialEquivalence | The INTRAFIXTM Advance Tibial Fastener System is substantially equivalent to:■ K123362 MILAGRO® ADVANCE Interference ScrewReference devices:■ K130539 Healix AdvanceTM Knotless PEEK Anchor■ K102443 Intrafix Tibial Sheath |
| DeviceClassification | INTRAFIXTM Advance BR Screw and Sheath:■ Single/multiple component metallic bone fixation appliances andaccessories, classified as Class II, product code MAI, regulated under21 CFR 888.3030.INTRAFIXTM Advance PEEK Screw and INTRAFIXTM Advance PP Sheath:■ Smooth or threaded metallic bone fixation fastener, classified as ClassII, product code MBI, regulated under 21 CFR 888.3040. |
| DeviceDescription | The INTRAFIX™ Advance Tibial Fastener System is an implant system used forfixation of tissue including ligament, or tendon to bone during cruciate ligamentreconstruction. The INTRAFIX™ Advance Sheaths are available in absorbable BRand non-absorbable Polypropylene materials. The INTRAFIX™ Advance Screws areavailable in absorbable BR and non-absorbable PEEK materials. The INTRAFIXTMAdvance Tibial Sheaths and Screws are supplied sterile ready to use. |
| TechnologicalCharacteristics | The proposed INTRAFIX™ Advance Sheaths and Screws are similar to the predicateMILAGRO® ADVANCE Interference Screw (K123362) in that they share the sameintended for use, BR material, screw design, sterilization method, and shelf life. Theproposed INTRAFIX™ Advance Screws are similar to the Healix Advance™Knotless PEEK Anchor (K130539) in that they share the same PEEK material. Theproposed INTRAFIX™ Advance Sheaths are similar to the Intrafix Tibial Sheath(K102443) as they share the same Polypropylene material and have a similar designand function. |
| Indications forUse | The DePuy Mitek INTRAFIX™ ADVANCE Tibial Sheath and Screw System isindicated for fixation of tissue including ligament, or tendon to bone during cruciateligament reconstruction. |
| Non clinicalTesting | Verification activities were performed on the implant and / or its predicate. Testingassessments include pull out testing, and insertion / failure torque. |
| Safety andPerformance | Results of performance testing have demonstrated that the proposed devices aresuitable for their intended use. |
| The proposed device also met requirement of bacterial endotoxin testing. | |
| Based on similarities in the indications for use, technological characteristics, andperformance in comparison to the predicate devices, the proposed INTRAFIX™Advance Tibial Fastener System has shown to be substantially equivalent to thepredicate device under the Federal Food, Drug and Cosmetic Act. |
{4}------------------------------------------------
§ 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.