(55 days)
Not Found
No
The device description and performance studies focus on mechanical properties and surgical implantation, with no mention of AI/ML terms or functionalities.
No
The device is described as an implant system (sheath and screw) used for fixation of soft tissue grafts during cruciate ligament reconstruction surgeries, which is a surgical aid rather than a device intended to directly treat or cure a disease or condition itself.
No
Explanation: The device description states its function is to fix soft tissue grafts during cruciate ligament reconstruction surgeries, which is a therapeutic rather than diagnostic function.
No
The device description clearly outlines physical components (Expansion Sheath, Expansion Screw, instrumentation) and mechanical functions (screwing, expanding, compressing, fixation), indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "fixation of soft tissue grafts during cruciate ligament reconstruction surgeries of the knee." This describes a surgical procedure performed directly on a patient's body.
- Device Description: The description details a physical implant (sheath and screw) and instrumentation used to place it within the knee. This is a surgical device, not a device used to examine specimens from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions, or providing information for diagnosis.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is used in vivo (within the body) for surgical fixation.
N/A
Intended Use / Indications for Use
Intrafix Sheath is indicated for fixation of soft tissue grafts during cruciate ligament reconstruction surgeries of the knee.
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
The proposed Intrafix System consists of two components, a non-absorbable Intrafix Expansion Sheath and a non-absorbable Intrafix Expansion Screw. Also included within the system is the instrumentation to place devices and establish the tunnel. The device functions by establishing the tunnel and placing the expansion Sheath into the tibial tunnel by the use of Sheath Inserter. This is followed by screwing an Expansion Screw into the Sheath expanding the Sheath which compresses the graft against the tunnel and creating fixation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee
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, such as, Insertion Torque, Pullout Strength, Displacement Test were performed on the implant and its predicate device. Results of performance and safety testing have demonstrated that the modified device is substantially equivalent to the predicate devices.
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
K102443(1/2)
| RIFER HER | never stop moving . |
|---|---|
| ----------- | --------------------- |
PRODUCT: INTRAFIX TIBIAL SHEATH SUBMISSION DATE: AUGUST 20, 2010 SUBMISSION TYPE: SPECIAL
ATTACHMENT 1
5 I O(k) SUMMARY - INTRAFIX TIBIAL SHEATH
SUBMITTER'S NAME AND ADDRESS
DePuy Mitek, Inc. a Johnson & Johnson company 325 Paramount Drive Raynham, MA 02767
CONTACT PERSON
Deep Pal Regulatory Affairs Specialist II DePuy Mitek, Inc. a Johnson & Johnson company 325 Paramount Drive Raynham, MA 02767 TELEPHONE 508-828-3359
| FACSIMILE | 508-977-6911 |
|---|---|
| dpal3@its.jnj.com | |
| DATE PREPARED | 8/25/2010 |
NAME OF MEDICAL DEVICE
CLASSIFICATION NAME
Fastener, Fixation, Nondegradable, Soft Tissue
COMMON/USUAL NAME
Bone Anchor
PROPRIETARY NAME
Intrafix Tibial Sheath
SUBSTANTIAL EQUIVALENCE
Intrafix Tibial Sheath is substantially equivalent to the following devices.
Intrafix Tibial Sheath (K983560) - Modified Device .
- Femoral Intrafix (K063577) .
FDA PRODUCT CODE
MBI
DEVICE CLASSIFICATION
This type of fixation sheath was originally classified as a Class II medical device by the Orthopedic Review Panel, regulated as 21 CFR 888.3040 Smooth or threaded metallic bone fixation fastener.
OCT 2 0 2010
1
K102443(²/₂)
Image /page/1/Picture/1 description: The image shows the DePuy Synthes logo with the tagline "never stop moving". The logo is black and white and features the DePuy name in a bold font. Below the name is the text "Synthes Inc. a Johnson & Johnson company". The tagline is in a smaller font and is located to the right of the logo.
PRODUCT: INTRAFIX TIBIAL SHEATH SUBMISSION DATE: AUGUST 20, 2010 SUBMISSION TYPE: SPECIAL
Continues ...
ATTACHMENT 1
5 I O(k) SUMMARY - Intrafix TIBIAL SHEATH
DEVICE DESCRIPTION
The proposed Intrafix System consists of two components, a non-absorbable Intrafix Expansion Sheath and a non-absorbable Intrafix Expansion Screw. Also included within the system is the instrumentation to place devices and establish the tunnel. The device functions by establishing the tunnel and placing the expansion Sheath into the tibial tunnel by the use of Sheath Inserter. This is followed by screwing an Expansion Screw into the Sheath expanding the Sheath which compresses the graft against the tunnel and creating fixation.
INDICATIONS FOR USE
Intrafix Sheath is indicated for fixation of soft tissue grafts during cruciate ligament reconstruction surgeries of the knee.
TECHNOLOGICAL CHARACTERSTICS
The design specifications of the proposed Intrafix Tibial Sheath is substantially equivalent to the existing Intrafix Tibial Sheath cleared under 510(k) K983560, except that the proposed Intrafix Tibial Sheath design include the same Sheath material - Polypropylene (Ethicon Prolene) used in the Femoral Intrafix Sheath cleared under K063577. Technological characteristics including design, packaging and indications are the same as the predicate cleared device and use similar or identical material and packaging as the predicates.
NONCLINICAL TESTING
Verification activities, such as, Insertion Torque, Pullout Strength, Displacement Test were performed on the implant and its predicate device.
SAFETY AND PERFORMANCE
Results of performance and safety testing have demonstrated that the modified device is substantially equivalent to the predicate devices.
Based on the indications for use, technological characteristics, and comparison to predicate devices, the proposed Intrafix Tibial Sheath has been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle or bird-like figure with three wing-like shapes stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MID 20993-0002
DePuy Mitek, A Johnson & Johnson Company. % Mr. Deep Pal Regulatory Affairs Specialist II 325 Paramount Drive Raynham, MA 02767
OCT 2 0 2010
Re: K102443
Trade/Device Name: Intrafix Tibial Sheath Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: October 7, 2010 Received: October 12, 2010
Dear Mr. Pal:
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.
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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Mr. Deep Pal
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Clabare Buchus
Mark N. Melke Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
| DePuy
Mitek Inc.
| a johnson&johnson company | never stop moving- |
|---|---|
| -------------------------------------------------- | -------------------- |
PRODUCT: INTRAFIX TIBIAL SHEATH SUBMISSION DATE: AUGUST 20, 2010 SUBMISSION TYPE: SPECIAL
ATTACHMENT 2
| INDICATIONS FOR USE |
|---|
| ---------------------------- |
| 510(k) Number (if known): | K102443 | OCT 20 2010 |
|---|---|---|
| Device Names: | Intrafix Tibial Sheath |
Indications for Use: Intrafix Tibial Sheath is indicated for fixation of soft tissue grafts during cruciate ligament reconstruction surgeries of the knee.
| Prescription Use | √ | AND/OR | Over-The-Counter Use |
|---|---|---|---|
| ------------------ | --- | -------- | ---------------------- |
(Part 21 CFR 801 Subpart D)
AND/OR
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1
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Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K102443