(118 days)
No
The 510(k) summary describes a mechanical implant system for ligament fixation and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is used for fixation of tissue to bone during ligament reconstruction, which is a surgical procedure, not a therapeutic treatment itself in the context of directly treating a disease or condition.
No
The device is an implant system used for fixation of tissue to bone during cruciate ligament reconstruction. Its purpose is to provide structural support, not to diagnose medical conditions or diseases.
No
The device description explicitly states it is an "implant system" and describes physical components made of absorbable and non-absorbable materials, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "fixation of tissue including ligament, or tendon to bone during cruciate ligament reconstruction." This describes a surgical procedure performed on the patient's body, not a test performed on a sample taken from the patient's body.
- Device Description: The device is described as an "implant system" consisting of sheaths and screws made of materials like BR, Polypropylene, and PEEK. These are materials used for surgical implants, not for diagnostic testing.
- Anatomical Site: The anatomical site is "bone," which is where the implant is placed during surgery.
- Performance Studies: The performance studies mentioned are "pull out testing, and insertion / failure torque," which are tests related to the mechanical strength and performance of a surgical implant, not the accuracy of a diagnostic test.
IVD devices are used to examine specimens (like blood, urine, tissue samples) taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical implant used to repair a ligament, which is a therapeutic intervention, not a diagnostic one.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
MAI, MBI
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Verification activities were performed on the implant and / or its predicate. Testing assessments include pull out testing, and insertion / failure torque. Results of performance testing have demonstrated that the proposed devices are suitable for their intended use. The proposed device also met requirement of bacterial endotoxin testing.
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.
K123362 MILAGRO® ADVANCE Interference Screw
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.
K130539 Healix AdvanceTM Knotless PEEK Anchor, K102443 Intrafix Tibial Sheath
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
§ 888.3030 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.
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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
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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
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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) |
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SECTION 2 - 510(k) SUMMARY
INTRAFIX™ Advance Tibial Fastener System
| Submitter's
Name and
Address | Medos International SARL
Chemin-Blanc 38, Le Locle Neuchatel
CH 2400, Switzerland
Date Prepared: March 21, 2016 |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Kristine Christo
Director, Regulatory Affairs
DePuy Mitek, Inc.
a Johnson & Johnson company
325 Paramount Drive
Raynham, MA 02767, USA
Telephone: 508-828-3359
Facsimile: 508-977-6911
e-mail: kchristo@its.jnj.com |
| Name of
Medical Device | Proprietary Name: INTRAFIXTM Advance Tibial Fastener System |
| | Classification Name: a) Single/multiple component metallic bone fixation
appliances and accessories
b) Smooth or threaded metallic bone fixation fasteners |
| | Common Name: Fastener, fixation, soft tissue |
| Substantial
Equivalence | The INTRAFIXTM Advance Tibial Fastener System is substantially equivalent to:
■ K123362 MILAGRO® ADVANCE Interference Screw
Reference devices:
■ K130539 Healix AdvanceTM Knotless PEEK Anchor
■ K102443 Intrafix Tibial Sheath |
| Device
Classification | INTRAFIXTM Advance BR Screw and Sheath:
■ Single/multiple component metallic bone fixation appliances and
accessories, classified as Class II, product code MAI, regulated under
21 CFR 888.3030.
INTRAFIXTM Advance PEEK Screw and INTRAFIXTM Advance PP Sheath:
■ Smooth or threaded metallic bone fixation fastener, classified as Class
II, product code MBI, regulated under 21 CFR 888.3040. |
| Device
Description | 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. |
| Technological
Characteristics | The proposed INTRAFIX™ Advance Sheaths and Screws are similar to the predicate
MILAGRO® ADVANCE Interference Screw (K123362) in that they share the same
intended for use, BR material, screw design, sterilization method, and shelf life. The
proposed INTRAFIX™ Advance Screws are similar to the Healix Advance™
Knotless PEEK Anchor (K130539) in that they share the same PEEK material. The
proposed INTRAFIX™ Advance Sheaths are similar to the Intrafix Tibial Sheath
(K102443) as they share the same Polypropylene material and have a similar design
and function. |
| Indications for
Use | 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. |
| Non clinical
Testing | Verification activities were performed on the implant and / or its predicate. Testing
assessments include pull out testing, and insertion / failure torque. |
| Safety and
Performance | Results of performance testing have demonstrated that the proposed devices are
suitable for their intended use. |
| | The proposed device also met requirement of bacterial endotoxin testing. |
| | Based on similarities in the indications for use, technological characteristics, and
performance in comparison to the predicate devices, the proposed INTRAFIX™
Advance Tibial Fastener System has shown to be substantially equivalent to the
predicate device under the Federal Food, Drug and Cosmetic Act. |
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