(176 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and fixation strength of the anchor, with no mention of AI or ML technologies.
Yes.
The device is used for "repair, repositioning or reattachment of soft tissues, ligament and tendons" and "surgical stabilization," which are considered therapeutic actions.
No
The device description and intended use clearly state that it is for "soft tissue to bone fixation" and the "repair, repositioning or reattachment of soft tissues, ligament and tendons." This indicates a therapeutic or reconstructive function, not a diagnostic one.
No
The device description clearly states it consists of a "coreless sleeve structure and suture," which are physical components, not software. The performance studies also focus on mechanical properties like "pullout strength," further indicating a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "soft tissue to bone fixation" in surgical procedures. This is a direct surgical intervention on the patient's body.
- Device Description: The description details a physical implantable device (anchors and suture) used for mechanical fixation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, urine, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used outside the body to analyze samples and provide diagnostic information. This device is used inside the body for structural repair.
N/A
Intended Use / Indications for Use
The JuggerKnot™ Mini Soft Anchors are intended to be used for soft tissue to bone fixation with indications for use in:
Maxillofacial
For the repair, repositioning or reattachment of soft tissues, ligament and tendons to the mandible for surgical stabilization of the TMJ articular disc.
Product codes
DZL
Device Description
The JuggerKnot™ Mini Soft Anchors consist of a coreless sleeve structure and suture. The anchors are intended for use in soft tissue fixation by bunching against bone when deployed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandible, TMJ articular disc (Maxillofacial)
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:
Non-clinical laboratory testing was performed to verify the fixation strength of the JuggerKnot Mini Soft Anchors in mechanical pullout testing as compared to the predicate devices. Comparison testing was conducted to evaluate the average pullout strength of the JuggerKnot™ Mini Soft Anchors and the Mitek Mini QUICKANCHOR® Plus with the acceptance criteria being that the average pullout strength would be statistically equal to or greater than that of the Mitek anchors. The test results indicate that the Biomet Sports Medicine JuggerKnot™ Mini Soft Anchors provide at least equivalent fixation strength to the predicate devices. The acceptance criteria were met, demonstrating that the JuggerKnot™ Mini Soft Anchors are substantially equivalent in pullout strength to the predicate devices.
Clinical Testing:
None provided as a basis for substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K992623, K992487, K080352, K110879
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.4880 Intraosseous fixation screw or wire.
(a)
Identification. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.(b)
Classification. Class II.
0
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 2,2014
Biomet Sports Medicine Dr. Jared Cooper Regulatory Specialist 56 East Bell Drive Warsaw, Indiana 46582
Re: K140908
Trade/Device Name: JuggerKnot™ Mini Soft Anchors Regulation Number: 21 CFR 872.4880 Regulation Name: Intraosseous Fixation Screw or Wire Regulatory Class: Class II Product Code: DZL Dated: September 2, 2014 Received: September 3, 2014
Dear Dr. 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.
Image /page/0/Picture/10 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, creating a sense of depth and unity. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
1
Page 2 - Dr. Cooper
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 devicerelated 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,
Erin I. Keith, M.S. Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
2
Indications for Use
| 510(k) Number (if known): | K140908 |
|---|---|
| --------------------------- | --------- |
| Page 1 of 1 |
|---|
| ------------- |
Device Name: JuggerKnot™ Mini Soft Anchors
Indications For Use:
The JuggerKnot™ Mini Soft Anchors are intended to be used for soft tissue to bone fixation with indications for use in:
Maxillofacial
For the repair, repositioning or reattachment of soft tissues, ligament and tendons to the mandible for surgical stabilization of the TMJ articular disc.
Prescription Use ____X (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)
3
Image /page/3/Picture/0 description: The image shows the Biomet Sports Medicine logo. The logo consists of the word "BIOMET" in a stylized font, with the letters connected and enclosed in a rectangular border. Below the word "BIOMET" is the phrase "SPORTS MEDICINE" in a simple, sans-serif font. The logo is in black and white.
510(k) Summary
| Preparation Date: | 2 September, 2014 |
|---|---|
| Applicant/Sponsor: | Biomet Sports Medicine |
| Contact Person: | Jared Cooper, Regulatory Specialist – Sports Medicine |
| Proprietary Name: | JuggerKnot™ Mini Soft Anchors |
| Common Name: | Soft Tissue Fixation Device |
| Classification Name: | Intraosseous fixation screw or wire (21 CFR 872.4880) DZL. |
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
| K992623 | Mitek® Mini Anchor |
|---|---|
| K992487 | Mitek Mini QUICKANCHOR Plus |
| K080352 | Mitek Mini QUICKANCHOR Plus and Microfix QUICKANCHOR Plus |
| K110879 | Biomet Sports Medicine JuggerKnot™ Mini Soft Anchors |
Device Description:
The JuggerKnot™ Mini Soft Anchors consist of a coreless sleeve structure and suture. The anchors are intended for use in soft tissue fixation by bunching against bone when deployed.
Intended Use / Indications for Use:
The JuggerKnot™ Mini Soft Anchors are intended to be used for soft tissue to bone fixation with indications for use in:
Maxillofacial
For the repair, repositioning or reattachment of soft tissues, ligament and tendons to the mandible for surgical stabilization of the TMJ articular disc.
Summary of Technologies:
The JuggerKnot™ Mini Soft Anchors are similar or identical to the predicate devices in the following technological characteristics:
The JuggerKnot™ Mini Soft Anchors are made from Polyester and Anchor Material: Polyethylene. These are the same materials as the predicate JuggerKnot™ Mini Soft Anchors (K110879).
ailing Address oll Free: 800 348 95
Shipping Address:
56 East Bell Drive
Warsaw, IN 46582
4
| Suture Material: | The suture material for the JuggerKnot™ Mini Soft Anchors
is a combination of Polyester, Polyethylene, Polypropylene
and/or Nylon. These are the same suture materials as the predicate
JuggerKnot™ Mini Soft Anchors (K110879). The predicate Mitek
Anchors (K992623 and K080352) include a polyester suture material
that is similar. The suture needles used in all of the anchors that
include a suture needle are made of surgical stainless steel. |
|------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Design: | The JuggerKnot™ Mini Soft Anchors consist of a coreless sleeve
designed to be inserted into a pre-drilled hole and anchor into the
bone. This is the same design as the predicate JuggerKnot™ Mini
Soft Anchors (K110879). The predicate Mitek Anchors consist of a
solid anchor designed to be inserted into a pre-drilled hole and anchor
into the bone. |
| Fixation Mode: | The JuggerKnot™ Mini Soft Anchors are held in place by
compression of the sleeve within the hole. This is identical to the
fixation mode of the predicate JuggerKnot™ Mini Soft Anchors
(K110879). |
Non-Clinical Testing:
Non-clinical laboratory testing was performed to verify the fixation strength of the JuggerKnot Mini Soft Anchors in mechanical pullout testing as compared to the predicate devices. Comparison testing was conducted to evaluate the average pullout strength of the JuggerKnot™ Mini Soft Anchors and the Mitek Mini QUICKANCHOR® Plus with the acceptance criteria being that the average pullout strength would be statistically equal to or greater than that of the Mitek anchors. The test results indicate that the Biomet Sports Medicine JuggerKnot™ Mini Soft Anchors provide at least equivalent fixation strength to the predicate devices. The acceptance criteria were met, demonstrating that the JuggerKnot™ Mini Soft Anchors are substantially equivalent in pullout strength to the predicate devices.
Clinical Testing:
None provided as a basis for substantial equivalence.
Conclusions:
The similarities in material, design and fixation mode between the subject JuggerKnot™ Mini Soft Anchors and the predicate devices, in conjunction with the comparison testing demonstrate that the JuggerKnot" Mini Soft Anchors are as safe, as effective, and perform as well as the predicate devices.
All trademarks are the property of Biomet, Inc., except for Mitek® and QUICKANCHOR® which are the property of DePuy Mitek / Mitek Products.