(188 days)
Not Found
No
The document describes a mechanical soft tissue fixation system and does not mention any AI or ML components or functionalities.
Yes
The device is described as aiding in arthroscopic and orthopedic reconstructive procedures for soft tissue to bone fixation, which aligns with the definition of a therapeutic device.
No
The device is intended for soft tissue to bone fixation for various orthopedic repairs and reconstructions, which are therapeutic procedures, not diagnostic ones.
No
The device description explicitly states the system includes "various components including; Juggerknot Soft Anchors or ToggleLoc Button with ZipLoop Technology with or without needles," which are physical implants and not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "soft tissue to bone fixation" for various orthopedic procedures. This involves physically implanting a device to repair or reconstruct tissues within the body.
- Device Description: The description details a "non-resorbable system intended to aid in arthroscopic and orthopedic reconstructive procedures requiring soft tissue to bone fixation." It describes implants like anchors and buttons.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for surgical repair.
N/A
Intended Use / Indications for Use
The 2.9 ToggleLoc and JuggerLoc Soft Tissue 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
Elbow Ulnar or radial collateral ligament reconstruction Lateral epicondylitis repair Biceps tendon reattachment - Knee Extracapsular repair: MCL, LCL, and posterior oblique ligament Illiotibial band tenodesis Patellar tendon repair VMO advancement Joint capsule closure
Product codes
JDR, MBI
Device Description
The JuggerLoc and 2.9 ToggleLoc Soft Tissue System is a non-resorbable system intended to aid in arthroscopic and orthopedic reconstructive procedures requiring soft tissue to bone fixation. The system construct includes various components including; Juggerknot Soft Anchors or ToggleLoc Button with ZipLoop Technology with or without needles. These implants are single use devices and are provided sterile by exposure to Ethylene Oxide.
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
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non clinical Tests: Results from mechanical testing demonstrate the proposed ToggleLoc 2.9 and JuggerLoc Soft Tissue System are substantially equivalent to the predicate devices. No animal or clinical testing was required to support substantial equivalence. A description of the tests and analyses is listed below.
- Device Insertion testing
- Cyclic and Static Tensile testing
Clinical Tests: Not required for this device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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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).
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§ 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 seal of the U.S. Department of Health and Human Services. The seal features the department's name in a circular arrangement around a stylized emblem. The emblem consists of three abstract human profiles facing right, stacked on top of each other, with flowing lines connecting them. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Biomet Manufacturing Corp. Mr. Jared Cooper Regulatory Affairs Specialist 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581-0587 November 19, 2014
Re: K141263
Trade/Device Name: ToggleLoc 2.9 and JuggerLoc Soft Tissue System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: JDR, MBI Dated: October 16, 2014 Received: October 17, 2014
Dear Mr. Cooper:
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
1
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.
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" (21 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,
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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t Notification [510(k)] Submission Under 21 CFR § 807.87 for ToggleLoc 2.9 and JuggerLoc Soft Tissue Devices
Indications for Use
510(k) Number (if known): K141263
Device Name: ToggleLoc 2.9 and JuggerLoc Soft Tissue System
Indications for Use:
The 2.9 ToggleLoc and JuggerLoc Soft Tissue 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
Elbow Ulnar or radial collateral ligament reconstruction Lateral epicondylitis repair Biceps tendon reattachment
- Knee
Extracapsular repair: MCL, LCL, and posterior oblique ligament Illiotibial band tenodesis Patellar tendon repair VMO advancement Joint capsule closure
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR (21 CFR 801 Subpart C)
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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K141263 - Page 1 of 3 fication [510(k)] Submission Under 21 CFR § 807.87 for ToggleLoc 2.9 and JuggerLoc Soft Tissue Devices
In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the ToggleLoc 2.9 and JuggerLoc Soft Tissue System 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on August 12, 2005.
Date: November 13, 2014
Submitter:
Biomet Manufacturing Corp. 56 East Bell Drive P.O. Box 587 Warsaw, IN 46581-0587 Establishment registration number: 1825034
Official Correspondence/Contact Person:
Jared Cooper, PhD Regulatory Affairs Specialist, SET jared.cooper@biomet.com (574) 372-1941
510(k) Preparer:
Jared Cooper
Product Name:
ToggleLoc 2.9 and JuggerLoc Soft Tissue Devices
Device Classification:
JDR - Staple, Fixation, Bone (21 CFR 888.3030)
MBI - Fastener, Fixation, nondegradable, soft tissue (21 CFR 888.3040)
Legally Marketed Predicates:
Biomet ToggleLoc System (K130033) Biomet JuggerKnot Soft Anchor (K110145) Conmed-Linvatec Y-Knot Anchor (K131035)
Device Description:
The JuggerLoc and 2.9 ToggleLoc Soft Tissue System is a non-resorbable system intended to aid in arthroscopic and orthopedic reconstructive procedures requiring soft tissue to bone
4
fixation. The system construct includes various components including; Juggerknot Soft Anchors or ToggleLoc Button with ZipLoop Technology with or without needles. These implants are single use devices and are provided sterile by exposure to Ethylene Oxide.
Intended Use and Indications for Use:
The 2.9 ToggleLoc and JuggerLoc Soft Tissue 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
Elbow
Ulnar or radial collateral ligament reconstruction Lateral epicondylitis repair Biceps tendon reattachment
Knee
Extracapsular repair: MCL, LCL, and posterior oblique ligament Illiotibial band tenodesis Patellar tendon repair VMO advancement Joint capsule closure
Technological Characteristics:
The rationale for substantial equivalence is based on consideration of the following characteristics:
- . Intended Use: The proposed ToggleLoc 2.9 and JuggerLoc Soft Tissue System have the same intended use as the predicate devices for soft tissue to bone fixation.
- Materials: The ToggleLoc 2.9 and JuggerLoc Soft Tissue System Implants are manufactured from UHMWPE and Polyester suture and metal button materials as the predicate JuggerKnot and ToggleLoc devices, which include the same manufacturing processess.
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Notification [510(k)] Submission Under 21 CFR § 807.87 for ToggleLoc 2.9 and JuggerLoc Soft Tissue Devices
- Design Features: The ToggleLoc 2.9 and JuggerLoc Soft Tissue System incorporate the same design features as the predicate devices.
- . Sterilization: The proposed ToggleLoc 2.9 and JuggerLoc Soft Tissue System are provided sterile via the same sterilization methods for single-use as the predicates.
Performance Data (Nonclinical and/or Clinical):
-
Non clinical Tests
Results from mechanical testing demonstrate the proposed ToggleLoc 2.9 and JuggerLoc Soft Tissue System are substantially equivalent to the predicate devices. No animal or clinical testing was required to support substantial equivalence. A description of the tests and analyses is listed below. -
Device Insertion testing
-
Cyclic and Static Tensile testing
-
Clinical Tests ●
Not required for this device.
Conclusions:
The proposed ToggleLoc 2.9 and JuggerLoc Soft Tissue System have similar intended use, technological characteristics, and mechanical performance as the predicate devices. The performance testing data identified no new risks and is substantially equivalent to the legally marketed predicate devices.