(56 days)
The Femoral Intrafix Screw and Sheath is indicated for fixation of soft tissue grafts during cruciate ligament reconstruction.
The Femoral Intrafix Screw and Sheath are non-absorbable implants used to secure soft tissue grafts to the bone during cruciate ligament reconstruction. The two-part system consists of an expandable sheath that is inserted into the center of the tunnel. The sheath separates the graft strands and places them against the tunnel wall. The screw is inserted into the center of the expansion sheath. sheath and compresses the tissue against the bone. This device system consists of the following components: Femoral Intrafix Screws and Sheaths in various sizes *Various manual surgical instruments * The various manual surgical instruments are Class I exempt (per 21 CFS 888.4540 "Orthopaedic Manual Surgical Instruments) stand-alone instruments used as an aide during the surgical application.
The provided text describes a 510(k) summary for a medical device called "Femoral Intrafix Screw and Sheath." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a standalone study structured to meet specific efficacy endpoints.
Therefore, the information requested regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not directly applicable or available in the provided 510(k) summary.
Here's a breakdown of why these questions cannot be answered based on the provided text, and what information is available:
1. A table of acceptance criteria and the reported device performance
- Not applicable/Available: The 510(k) pathway for medical devices focuses on demonstrating substantial equivalence to a predicate device, not on meeting specific, de novo acceptance criteria for performance. The summary states, "Results of performance and safety testing have demonstrated that the modified device is substantially equivalent to the predicate devices." It does not provide a table of acceptance criteria or detailed performance metrics.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not available: The summary does not describe a clinical study or a test set with a specific sample size for evaluating performance in the way implied by the question. The "performance and safety testing" mentioned would typically involve mechanical testing, biocompatibility, and sterilization validation, not patient-level data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Available: No clinical test set requiring expert-established ground truth is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Available: No clinical test set is described.
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
- Not applicable/Available: This device is a surgical implant (screw and sheath), not an AI-powered diagnostic tool, so an MRMC study is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Available: This device is not an algorithm or AI system.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable/Available: No clinical study requiring ground truth is described.
8. The sample size for the training set
- Not applicable/Available: This device is not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable/Available: This device is not an AI algorithm.
Summary of available information from the text:
- Device Name: Femoral Intrafix Screw and Sheath
- Indications for Use: Fixation of soft tissue grafts during cruciate ligament reconstruction.
- Predicate Devices: Intrafix Screw and Sheath (K983560); Milagro Interference Screw (K032717); Bio-Intrafix Screw and Sheath (K032167).
- Safety and Performance Statement: "Results of performance and safety testing have demonstrated that the modified device is substantially equivalent to the predicate devices." This is the core "study" and "acceptance criteria" in the context of a 510(k) – showing equivalence, not de novo performance against specific metrics.
- Device Description: A two-part non-absorbable implant system (expandable sheath and screw) used to secure soft tissue grafts against the tunnel wall during cruciate ligament reconstruction.
- Classification: Class II, Product Codes MBI and HWC, under 21 CFR 888.3040 (Smooth or threaded metallic bone fixation fastener).
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SECTION 2 – 510(k) SUMMARY
Femoral Intrafix Screw and Sheath
| JAN 2 5 2007 | |
|---|---|
| Submitter's Name andAddress: | DePuy Miteka Johnson & Johnson company325 Paramount DriveRaynham, MA 02767 |
| Contact Person | Ruth C. ForstadtProject Management Lead, Regulatory AffairsDePuy Miteka Johnson & Johnson company325 Paramount DriveRaynham, MA 02767Telephone: 508-977-3988Facsimile: 508-828-3750e-mail: rforstad@dpyus.jnj.com |
| Name of Medical Device | Classification Name: Fastener, Fixation, Nondegradable, SoftTissue Smooth or threaded metallic bonefixation fasteners |
| Common/Usual Name: Orthopedic Screw, Fixation DeviceProprietary Name: Femoral Intrafix Screw and Sheath | |
| Substantial Equivalence | The Femoral Intrafix Screw and Sheath is substantially equivalent to:Intrafix Screw and Sheath (K983560); the Milagro Interference Screw(K032717) and the Bio-Intrafix Screw and Sheath (K032167). |
| Device Classification | This device carries an FDA product code MBI and HWC, and isclassified as Fastener, Fixation, Nondegradable, Soft Tissue Smooth orthreaded metallic bone fixation fasteners under 21 CFR 888.3040. |
| Device Description | The Femoral Intrafix Screw and Sheath are non-absorbable implantsused to secure soft tissue grafts to the bone during cruciate ligamentreconstruction. The two-part system consists of an expandable sheaththat is inserted into the center of the tunnel. The sheath separates thegraft strands and places them against the tunnel wall. The screw isinserted into the center of the expansion sheath. |
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sheath and compresses the tissue against the bone. This device system
consists of the following components:
Femoral Intrafix Screws and Sheaths in various sizes
*Various manual surgical instruments
- The various manual surgical instruments are Class I exempt (per 21
CFS 888.4540 "Orthopaedic Manual Surgical Instruments) stand-alone
instruments used as an aide during the surgical application.
| Indications for Use | Femoral Intrafix Screw and Sheath is indicated for fixation of soft tissue grafts during cruciate ligament reconstruction. |
|---|---|
| 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 Femoral Intrafix Screw and Sheath has been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act. |
:
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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 stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DePuy Mitek A Johnson & Johnson company % Ms. Ruth C. Forstadt Project Management Lead, Regulatory Affairs 325 Paramount Drive Raynham, Massachusetts 02767
JAN 2 5 2007
Re: K063577
Trade/Device Name: Femoral Intrafix Screw and Sheath Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI and HWC Dated: November 29, 2006 Received: November 30, 2006
Dear Ms. Forstadt:
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 such 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); good manufacturing practice requirements as set
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Page 2 – Ms. Ruth C. Forstadt
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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally premated predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0210 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
N. Melkerson Director Division of General, Restorative and Neurological 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 Names: Femoral Intrafix Screw and Sheath
The Femoral Intrafix Screw and Sheath is indicated for fixation of soft tissue grafts during cruciate ligament reconstruction.
Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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 _______
(Division Sign-Off)
Division of General Restorative,
and Neurological Devices
| 510(k) Number | 1063577 |
|---|---|
| --------------- | --------- |
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§ 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.