(209 days)
Not Found
No
The device description focuses on mechanical components and materials, with no mention of software, algorithms, or data processing that would indicate AI/ML. The performance studies are mechanical and MR evaluations, not related to algorithmic performance.
Yes.
The device is used for soft tissue to bone fixation for various orthopedic indications, such as Bankart lesion repair, ACL/PCL reconstruction, and Achilles tendon repair, which are all therapeutic procedures.
No
The device is intended for soft tissue to bone fixation and reconstruction procedures, which are therapeutic interventions, not diagnostic ones.
No
The device description explicitly states it is made up of various combinations of components including titanium and stainless steel devices, buttons, and loops, which are hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for "soft tissue to bone fixation" in various anatomical locations (Shoulder, Foot and Ankle, Elbow, Knee, Hand and Wrist, Hip). This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as a "System" made up of "titanium and stainless steel ToggleLoc devices," including "buttons," "constructs," and "loops." These are physical implants used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body, while this device is a surgical implant used to repair and reconstruct tissues within the body.
N/A
Intended Use / Indications for Use
The ToggleLoc™ System devices, except the ToggleLoc XTender and ToggleLoc XL devices, are intended for soft tissue to bone fixation for the following indications:
Shoulder: Bankart lesion repair, SLAP lesion repairs Acromio-clavicular repair, Capsular shift/capsulolabral reconstruction, Deltoid repair, Rotator cuff tear repair, Biceps Tenodesis
Foot and Ankle: Medial/lateral repair and reconstruction, Mid- and forefoot repair, Hallux valgus reconstruction, Metatarsal ligament/tendon repair or reconstruction, Achilles tendon repair, Ankle Syndesmosis fixation (Syndesmosis disruptions) and as an adjunct in connection with trauma hardware for Weber B and C ankle fractures (only for ToggleLoc™ with ZipTight™)
Elbow: Ulnar or radial collateral ligament reconstruction, Lateral epicondylitis repair, Biceps tendon reattachment
Knee: ACL/PCL repair / reconstruction, ACL/PCL patellar bone-tendon-bone grafts, Double-Tunnel ACL reconstruction, Extracapsular repair: MCL, LCL, and posterior oblique ligament, Iliotibial band tenodesis, Patellar tendon repair, VMO advancement, Joint capsule closure
Hand and Wrist: Collateral ligament repair, Scapholunate ligament reconstruction, Tendon transfers in phalanx, Volar plate reconstruction
Hip: Acetabular labral repair
The ToggleLoc XTender and ToggleLoc XL devices are used for fixation of tendons and ligaments in cases of unanticipated intraoperative complications such as cortical breaching during orthopedic reconstruction procedures, such as Anterior Cruciate (ACL) or Posterior Cruciate (PCL) Reconstruction. The ToggleLoc™ XTender is for use in conjunction with a titanium alloy ToggleLoc™ device, excluding the ToggleLoc™ XL devices.
Product codes
MBI, JDR
Device Description
This submission is for the ToggleLoc™ System in which a series of titanium and stainless steel ToggleLoc devices are being included. These items include the ToggleLoc™ XTender, ToggleLoc™ XL with ZipLoop™ Technology, ToggleLoc™ with ZipLoop™ Inline, expanded offering of components of the previously cleared ToggleLoc™ with ZipLoop™ System (K083070), and implants previously cleared in K083070 being included in this submission to add MRI language.
The ToggleLoc™ System is made up of various combinations of components, including: ToggleLoc™ buttons, ZipTight construct and buttons, Continuous Loops, and ZipLoop™ Technology.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Foot and Ankle, Elbow, Knee, Hand and Wrist, Hip
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 was conducted to demonstrate that the differences did not adversely affect safety and efficacy, and to demonstrate substantial equivalence to the predicate components. All testing met or exceeded the established acceptance criteria.
The following tests were performed on the ToggleLoc™ System:
Static Load Testing: ToggleLoc™ System Line Extensions
Cyclic Load Testing: ToggleLoc™ System Line Extensions
MR Evaluation/Simulations
No clinical testing was necessary for a determination of substantial equivalence.
The results of mechanical testing indicated the devices performed mechanically equivalent to marketed devices and did not raise any new safety and efficacy issues. The results of the MR evaluation indicated that the devices are MR Conditional.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K130033
510(k) SUMMARY
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92
| Submitter Information | |
|---|---|
| Name | Biomet Manufacturing Corp. |
| Address | 56 East Bell Drive |
| Warsaw, IN 46581-0857 | |
| Phone number | (574) 267-6639 |
| Fax number | (574) 371-1027 |
| Establishment | 1825034 |
| Registration Number | |
| Name of contact person | Elizabeth Wray |
| Date prepared | June 21, 2013 |
| Name of device | |
| Trade or proprietary | |
| name | ToggleLoc™ System |
| Common or usual | |
| name | Soft tissue fixation devices |
| Classification name | - fastener, fixation, nondegradable, soft tissue |
- staple, fixation, bone |
| Classification panel | Orthopedic |
| Regulation | 888.3040 and 888.3030 |
| Product Code(s) | MBI and JDR |
| Legally marketed device(s)
to which equivalence is
claimed | K083070 ToggleLoc™ System (Biomet)
K102982 EndoButton CL (Smith & Nephew)
K112990 TightRope RT (Arthrex) |
| Reason for 510(k)
submission | Additional metallic ToggleLoc™ buttons and ZipLoop™ constructs.
Addition of magnetic resonance (MR) compatibility language to
product labeling. |
| Device description | This submission is for the ToggleLoc™ System in which a series
of titanium and stainless steel ToggleLoc devices are being
included. These items include the ToggleLoc™ XTender,
ToggleLoc™ XL with ZipLoop™ Technology, ToggleLoc™ with
ZipLoop™ Inline, expanded offering of components of the
previously cleared ToggleLoc™ with ZipLoop™ System
(K083070), and implants previously cleared in K083070 being
included in this submission to add MRI language. |
| Intended use of the device | Soft tissue fixation |
| K130033 | |
| Indications for use | The ToggleLoc™ System devices, except the ToggleLoc XTender
and ToggleLoc XL devices, are intended for soft tissue to bone
fixation for the following indications: |
| | Shoulder: Bankart lesion repair, SLAP lesion repairs
Acromio-clavicular repair, Capsular shift/capsulolabral
reconstruction, Deltoid repair, Rotator cuff tear repair,
Biceps Tenodesis |
| | Foot and Ankle: Medial/lateral repair and
reconstruction, Mid- and forefoot repair, Hallux valgus
reconstruction, Metatarsal ligament/tendon repair or
reconstruction, Achilles tendon repair, Ankle
Syndesmosis fixation (Syndesmosis disruptions) and as
an adjunct in connection with trauma hardware for
Weber B and C ankle fractures ( only for ToggleLoc™
with ZipTight™ ) |
| | Elbow: Ulnar or radial collateral ligament
reconstruction, Lateral epicondylitis repair, Biceps
tendon reattachment |
| | Knee: ACL/PCL repair / reconstruction, ACL/PCL patellar
bone-tendon-bone grafts,
Double-Tunnel ACL reconstruction, Extracapsular repair:
MCL, LCL, and posterior oblique ligament, Iliotibial band
tenodesis, Patellar tendon repair, VMO advancement,
Joint capsule closure |
| | Hand and Wrist: Collateral ligament repair,
Scapholunate ligament reconstruction, Tendon transfers
in phalanx, Volar plate reconstruction |
| | Hip: Acetabular labral repair |
| | The ToggleLoc XTender and ToggleLoc XL devices are used for
fixation of tendons and ligaments in cases of unanticipated
intraoperative complications such as cortical breaching during
orthopedic reconstruction procedures, such as Anterior Cruciate
(ACL) or Posterior Cruciate (PCL) Reconstruction. The
ToggleLoc™ XTender is for use in conjunction with a titanium
alloy ToggleLoc™ device, excluding the ToggleLoc™ XL devices. |
| Summary of the Technologies | The ToggleLoc™ System is made up of various combinations of components, including: ToggleLoc™ |
1
buttons, ZipTight construct and buttons, Continuous Loops, and ZipLoop™ Technology.
The technological characteristics of the ToggleLoc™ System are the same as those of predicate
2
devices (K083070) in terms of design, material, and principles of operation with the exception of slight modifications as described in this 510(k). The ToggleLoc™ System utilizes the identical manufacturing processes as the predicates (K083070).
Non-clinical testing was conducted to demonstrate that the differences did not adversely affect safety and efficacy, and to demonstrate substantial equivalence to the predicate components. All testing met or exceeded the established acceptance criteria. This information is detailed below in the Performance (Non-clinical) section.
PERFORMANCE DATA
SUMMARY OF NON-CLINICAL TESTS
Performance Test Summary-New Device
The following tests were performed on the ToggleLoc™ System:
Static Load Testing: ToggleLoc™ System Line Extensions Cyclic Load Testing: ToggleLoc™ System Line Extensions MR Evaluation/Simulations
SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION
Clinical Performance Data/Information: N/A
CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA
No clinical testing was necessary for a determination of substantial equivalence.
The results of mechanical testing indicated the devices performed mechanically equivalent to marketed devices and did not raise any new safety and efficacy issues. The results of the MR evaluation indicated that the devices are MR Conditional.
3
Image /page/3/Picture/0 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 symbol that resembles three abstract shapes, possibly representing human figures or abstract forms, arranged in a dynamic, flowing manner.
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
Biomet Manufacturing Corporation % Ms. Elizabeth Wray Global Regulatory Project Manager 56 East Bell Drive Warsaw, Indiana 46581
August 1. 2013
Re: K130033
Trade/Device Name: Toggleloc™ System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI, JDR Dated: June 28, 2013 Received: July 3, 2013
Dear Ms. Wray:
We have reviewed vour 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
4
Page 2 - Ms. Elizabeth Wray
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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, plcase 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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.
Sincercly yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: Toggleloc™ System
Indications For Use:
The ToogleLoc™ System devices, except the TogaleLoc XTender and TogaleLoc XL devices, are intended for soft tissue to bone fixation for the following indications:
Shoulder
Bankart lesion repair SLAP lesion repairs Acromio-clavicular repair Capsular shift/capsulolabral reconstruction Deltoid repair Rotator cuff tear repair Biceps Tenodesis
Foot and Ankle
Medial/lateral repair and reconstruction Mid- and forefoot repair Hallux valqus reconstruction Metatarsal ligament/tendon repair or reconstruction Achilles tendon repair Ankle Syndesmosis fixation (Syndesmosis disruptions) and as an adjunct in connection with trauma hardware for Weber B and C ankle fractures (only for ToggleLoc™ with ZipTight™)
Prescription Use × (Part 21 CFR 801 Subpart D) Over-The-Counter Use NO (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR -
Concurrence of CDRH, Office of Device Evaluation (ODE)
Casey L. Hanley, Ph.D.
Division of Orthopedic Devices
Page 1 of 3
6
K130033 510(k) Number (if known):____
Device Name: Toggleloc™ System
Indications For Use:
Elbow
Ulnar or radial collateral ligament reconstruction Lateral epicondylitis repair Biceps tendon reattachment
Knee
ACL/PCL repair / reconstruction ACL/PCL patellar bone-tendon-bone grafts Double-Tunnel ACL reconstruction Extracapsular repair: MCL, LCL, and posterior oblique ligament Iliotibial band tenodesis Patellar tendon repair VMO advancement Joint capsule closure
Hand and Wrist
Collateral ligament repair Scapholunate ligament reconstruction Tendon transfers in phalanx Volar plate reconstruction
Hip
Acetabular labral repair
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ NO (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)
Casey L. Hanley, Ph.D.
Division of Orthopedic Devices
Page 2 of 3
510(k) Number (if known): _
7
K130033
Device Name: Toggleloc™ System
Indications For Use:
The ToggleLoc XTender device is used for fixation of tendons and ligaments in cases of unanticipated intraoperative complications such as cortical breaching during orthopedic reconstruction procedures, such as Anterior Cruciate (ACL) or Posterior Cruciate (PCL) Reconstruction. The ToggleLoc™ XTender is for use in conjunction with a titanium alloy ToggleLoc™ device, excluding the ToggleLoc™ XL devices.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)
Casey, L. Hanley, Ph.D.
Page 3 of 3
Division of Orthopedic Devices .. ..