(147 days)
Not Found
No
The device description and performance studies focus on mechanical properties and biocompatibility, with no mention of AI or ML.
Yes
The device is described as a "cortical fixation system" indicated for "fixation of soft tissue to bone in Femoral Cruciate Ligament Reconstruction," which is a procedure aimed at treating a medical condition and restoring function.
No
The device is a cortical fixation system used for surgical fixation of soft tissue to bone, specifically in Femoral Cruciate Ligament Reconstruction. Its primary function is to provide fixation, not to diagnose a medical condition.
No
The device description explicitly states it is a "cortical fixation system composed of titanium button, adjustable suture... leading suture... and training suture". These are physical components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The RIGIDLOOP Adjustable Cortical Fixation System is a surgical implant used to fix soft tissue to bone during Femoral Cruciate Ligament Reconstruction. It is a physical device used within the body during a surgical procedure, not for testing samples outside the body.
The information provided clearly describes a surgical implant, not a diagnostic test.
N/A
Intended Use / Indications for Use
The RIGIDLOOP Adjustable Cortical Fixation System is indicated for fixation of soft tissue to bone in Femoral Cruciate Ligament Reconstruction.
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
The proposed device is a cortical fixation system composed of titanium button, adjustable suture (Ultra-high molecular polyethylene (UHMWPE)), leading suture (UHMWPE and green Polyester (PET) co-braid) and training suture (green PET). Length of the suture loops is adjustable to the desired length. The proposed device provides a fixation in cruciate ligament reconstructive surgery. The device is provided as sterile for single patient use only.
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)
Non-clinical Testing
Fixation strength testing (bench-top) was conducted. The testing demonstrated substantial equivalence of device performance. The proposed device has been determined biocompatible for the intended use based on biocompatibility data. The proposed device has raised no new issue of safety and efficacy.
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
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510(k) SUMMARY RIGIDLOOP™ Adjustable Cortical Fixation System
| Date Summary
| Prepared | February 7, 2014 | |
|---|---|---|
| Submitter's | ||
| Name and | ||
| Address | Medos International SARL | |
| Chemin-Blanc 38, Case Postale | ||
| CH 2400 Le Locle, Switzerland | ||
| Contact Person | Yayoi Fujimaki | |
| Regulatory Affairs Senior Associate | ||
| DePuy Mitek | ||
| a Johnson & Johnson company | ||
| 325 Paramount Drive | ||
| Raynham, MA 02767, USA | Telephone: 508-828-3541 | |
| Facsimile: 508-977-6911 | ||
| e-mail: yfujimal@its.jnj.com | ||
| Name of | ||
| Medical Device | Trade Name: | RIGIDLOOPTM Adjustable Cortical Fixation System |
| Common Name: | Fastener, fixation, nondegradable, soft tissue | |
| Device | ||
| Classification | MBI - Smooth or threaded metallic bone fixation fastener, classified as Class | |
| II, regulated per 21 CFR 888.3040. | ||
| Orthopedic panel | ||
| Predicate | ||
| Device | ToggleLoc System with ZipLoop Technology (K083070, K130033; Biomet | |
| Sports Medicine) | ||
| Milagro Advance Interference Screw (K123362, DePuy Mitek) | ||
| Indications for | ||
| Use | The RIGIDLOOP Adjustable Cortical Fixation System is indicated for fixation | |
| of soft tissue to bone in Femoral Cruciate Ligament Reconstruction. | ||
| Device | ||
| Description | The proposed device is a cortical fixation system composed of titanium button, | |
| adjustable suture (Ultra-high molecular polyethylene (UHMWPE)), leading | ||
| suture (UHMWPE and green Polyester (PET) co-braid) and training suture | ||
| (green PET). Length of the suture loops is adjustable to the desired length. | ||
| The proposed device provides a fixation in cruciate ligament reconstructive | ||
| surgery. The device is provided as sterile for single patient use only. | ||
| Safety and | ||
| Performance | Non-clinical Testing | |
| Fixation strength testing (bench-top) was conducted. The testing demonstrated | ||
| substantial equivalence of device performance. The proposed device has been | ||
| determined biocompatible for the intended use based on biocompatibility data. | ||
| The proposed device has raised no new issue of safety and efficacy. | ||
| Substantial | ||
| Equivalence | The predicate devices have been used for the proposed indications. The | |
| proposed device is a cortical fixation device that consists of a titanium button | ||
| and non-absorbable sutures. Technological characteristics and fixation strength | ||
| are substantially equivalent to the predicate devices. Differences found between | ||
| the proposed and the predicate devices are considered minor and do not raise | ||
| questions concerning safety and efficacy. | ||
| Based on the indications for use, technological characteristics and comparison | ||
| with the predicate devices, we determined that the proposed device is | ||
| substantially equivalent to the predicate devices. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 7, 2014
Medos International Sárl % Ms. Yavoi Fujimaki DePuv Mitek, a Johnson & Johnson company 325 Paramount Drive Raynham, Massachusetts 02767
Re: K140324
Trade/Device Name: RIGIDLOOP™ Adjustable Cortical Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: June 4, 2014 Received: June 5, 2014
Dear Ms. Fujimaki:
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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
3
Page 2 – Ms. Yayoi Fujimaki
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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (2) CFR 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 yours.
Ronald P. Jean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) K140324
Device Name
RIGIDLOOPTM Adjustable Cortical Fixation System
Indications for Use (Describe)
The RIGIDLOOP Adjustable Cortical Fixation System is indicated for fixation of soft tissue to bone in Femoral 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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | |
|---|---|
| ------------------------------------------------------------------------------ | -- |
| Casey L. Hanley, Ph.D. | |
|---|---|
| Division of Orthopedic Devices | Page 1/1 |
rvices (30) 443-6740 th PSC Publishing Page 003 - 1