(52 days)
JuggerKnot® Soft Anchors are intended for use in soft tissue to bone fixation for the following indications:
Knee MPFL
Knee Patellar tendon repair
Knee MCL
Knee Quadriceps tendon repair
Hip Acetabular labral repair
Hip Proximal hamstring repair
Hip Hip Labral reconstruction
Foot and Ankle Achilles tendon repair
Foot and Ankle Medial/lateral repair and reconstruction
Foot and Ankle Plantar plate repair
Foot and Ankle Mid- and forefoot repair
Foot and Ankle Metatarsal ligament/tendon repair or reconstruction
Shoulder Rotator Cuff
Shoulder Shoulder Instability
Shoulder Biceps Tenodesis
Elbow Lateral epicondylitis repair
Elbow Biceps tendon reattachment
The JuggerKnot® Soft Anchor is comprised of a suture sleeve structure and working suture. Non-absorbable braided ultra-high molecular weight polyethylene (UHMWPE) sutures are spliced through a non-absorbable braided polyester suture anchor sleeve. Up to three nonabsorbable round and flat braided UHMWPE working sutures can be added inside the suture anchor sleeve. The UHMWPE sutures are available undyed (white), blue, black or with or without a stainless steel needle attached. Available Suture sizes are standard according to USP requirements (dependent on suture type).
Suture supplied meet United States Pharmacopeia (USP) requirements for non-absorbable suture except for diameter. Suture dyes are FDA approved. The inserter is comprised of metallic shaft with overmolded handle. The device is sterilized by ethylene oxide gas, and is provided sterile for single use. JuggerKnot® Soft Anchors are available in common sizes and lengths with or without pre-attached 302 stainless steel needles and will be sold sterile for single use with no components or accessories. The device is intended for use in a hospital/clinic/surgical setting.
The provided document describes the JuggerKnot® Soft Anchor device and its substantial equivalence to a predicate device (K150768 – Zimmer Biomet JuggerKnot® Soft Anchor). This document is a 510(k) summary, which focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device. It addresses performance testing but not in the format of a clinical study with detailed acceptance criteria, sample sizes, expert involvement, or comparative effectiveness studies of human readers with and without AI.
Therefore, much of the requested information regarding detailed acceptance criteria, a specific study proving device meets criteria, sample sizes for test/training sets, data provenance, expert qualifications, adjudication methods, multi-reader multi-case studies, and standalone performance for an AI/algorithm-based device is not applicable to this submission, as the JuggerKnot® Soft Anchor is a physical medical device (a soft anchor for tissue fixation), not an AI/software device.
However, I can extract information related to the performance data provided for the physical device.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of specific quantitative acceptance criteria or detailed reported performance values for mechanical testing. Instead, it states that the device "performed comparably to the predicate device and to other currently marketed soft anchor devices."
| Performance Test Category | General Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Sutures | Meet USP requirements (except diameter) for non-absorbable suture. | Sutures meet USP performance requirements for needle attachment and tensile strength. |
| Sterilization | Validated according to established standards. | Sterilization adoption validation performed. |
| Biocompatibility | Meet ISO10993-1:2018. | Biocompatibility testing performed per ISO10993-1:2018. |
| Stability (Packaging) | Meet ISO 11607-1:2006. | Stability testing on product packaging performed per ISO 11607-1:2006. |
| Usability | Meet EN62366: 2015. | Usability engineering validation with simulated use in cadaveric models performed per EN62366: 2015. |
| Endotoxin/Pyrogenicity | Meet ANSI/AAMI ST72:2019, USP <161>, USP <151>, and USP <85>. | Endotoxin/pyrogenicity testing performed per specified USP and ANSI/AAMI standards. |
| Mechanical Fixation Strength | Perform comparably to the predicate and other marketed soft anchor devices in insertion, cyclic, and pullout testing. | "Device performed comparably to the predicate device and to other currently marketed soft anchor devices in insertion, cyclic and pullout testing." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for mechanical or bench testing. Performance testing normally involves a defined number of units, but "sample size" in the context of an AI device's test set (e.g., number of images or cases) is not relevant here.
- Data Provenance: The usability engineering validation involved "simulated use in a cadaveric models." This implies the data originates from cadaveric human tissue. It is not specified if these cadavers are from a particular country or origin.
- Retrospective or Prospective: Not applicable in the context of this type of device testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Experts: Not applicable for mechanical bench testing or biocompatibility where ground truth is established by objective measurements against established standards.
- Qualifications: For usability testing ("simulated use in a cadaveric models"), it is implied that qualified surgeons or medical professionals would perform the simulated use, but their number and specific qualifications are not detailed.
4. Adjudication Method for the Test Set
- Not applicable as this is not an AI/algorithm-based diagnostic device requiring expert adjudication of results. Ground truth for most tests (e.g., tensile strength, sterilization) is determined by quantitative measurements against standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. This is a physical medical device, not an AI/diagnostic software. MRMC studies are not relevant.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- No. This is a physical medical device. "Standalone performance" in the context of an algorithm is not relevant.
7. The Type of Ground Truth Used
- For Mechanical Properties (Insertion, Cyclic, Pullout): Comparative performance against a legally marketed predicate device (K150768 JuggerKnot® Soft Anchor) and "other currently marketed soft anchor devices." The criteria for comparability would be defined by the mechanical testing protocols.
- For Material and Biological Properties: Conformance to established international standards (e.g., USP, ISO 10993-1, ISO 11607-1, EN62366, ANSI/AAMI ST72).
8. The Sample Size for the Training Set
- Not applicable. This device does not use a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. This device does not use a "training set" in the context of machine learning or AI.
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February 12, 2021
Riverpoint Medical Amanda Cole Regulatory Affairs Associate 825 NE 25th Ave. Portland, Oregon 97232
Re: K203740
Trade/Device Name: JuggerKnot® Soft Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: December 21, 2020 Received: December 22, 2020
Dear Amanda Cole:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Laura C. Rose, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K203740
Device Name JuggerKnot® Soft Anchor
Indications for Use (Describe) Indicated for use in soft tissue to bone fixation for the following indications: Knee MPFL Knee Patellar tendon repair Knee MCL Knee Quadriceps tendon repair Hip Acetabular labral repair Hip Proximal hamstring repair. Hip Hip labral reconstruction. Foot and Ankle Achilles tendon repair Foot and Ankle Medial/lateral repair and reconstruction Foot and Ankle Plantar plate repair Foot and Ankle Mid- and forefoot repair Foot and Ankle Metatarsal ligament/tendon repair or reconstruction Shoulder Rotator Cuff Shoulder Shoulder Instability Shoulder Biceps Tenodesis Elbow Lateral epicondylitis repair Elbow Biceps tendon reattachment
| 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) |
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510(k) SUMMARY
JuggerKnot® Soft Anchor
Submitter Information
| Submitter's Name: | Riverpoint Medical |
|---|---|
| Address: | 825 NE 25th Ave.Portland, OR 97232 |
| Phone Number: | (503) 517-8001 or 866 445-4923 |
| Fax Number: | (503) 517-8002 |
| Registration Number: | 3006981798 |
| Contact Person: | Amanda Cole(503) 517-8001 |
| Date of Preparation: | December 21, 2020 |
Device Name
| Trade Name: | JuggerKnot® Soft Anchor |
|---|---|
| Common or Usual Names: | Fastener, Fixation, Nondegradable, Soft Tissue |
| Classification Name: | Smooth Or Threaded Metallic Bone Fixation Fastener |
Device Classification
| FDA Class: | II |
|---|---|
| Product Classification: | 888.3040: Smooth Or Threaded Metallic Bone FixationFastener |
| Classification Code: | MBI |
| Review Panel | Orthopedic |
| Premarket Review | Office of Device EvaluationDivision of Orthopedic Devices, Restorative and RepairDevices Branch (RRDB) |
Predicate Device
K150768 – Zimmer Biomet JuggerKnot® Soft Anchor
No reference devices were used in this submission.
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Device Description
The JuggerKnot® Soft Anchor is comprised of a suture sleeve structure and working suture. Non-absorbable braided ultra-high molecular weight polyethylene (UHMWPE) sutures are spliced through a non-absorbable braided polyester suture anchor sleeve. Up to three nonabsorbable round and flat braided UHMWPE working sutures can be added inside the suture anchor sleeve. The UHMWPE sutures are available undyed (white), blue, black or with or without a stainless steel needle attached. Available Suture sizes are standard according to USP requirements (dependent on suture type).
Suture supplied meet United States Pharmacopeia (USP) requirements for non-absorbable suture except for diameter. Suture dyes are FDA approved. The inserter is comprised of metallic shaft with overmolded handle. The device is sterilized by ethylene oxide gas, and is provided sterile for single use. JuggerKnot® Soft Anchors are available in common sizes and lengths with or without pre-attached 302 stainless steel needles and will be sold sterile for single use with no components or accessories. The device is intended for use in a hospital/clinic/surgical setting.
The classification for the JuggerKnot® Soft Anchor is FDA Class II device with product classification 21 CFR §888.3040: Smooth or threaded metallic bone fixation fastener, Product Code MBI.
Intended Use and Indications for Use
JuggerKnot® Soft Anchors are intended for use in soft tissue to bone fixation for the following indications:
| Knee | MPFL |
|---|---|
| Knee | Patellar tendon repair |
| Knee | MCL |
| Knee | Quadriceps tendon repair |
| Hip | Acetabular labral repair |
| Hip | Proximal hamstring repair |
| Hip | Hip Labral reconstruction |
| Foot and Ankle | Achilles tendon repair |
| Foot and Ankle | Medial/lateral repair and reconstruction |
| Foot and Ankle | Plantar plate repair |
| Foot and Ankle | Mid- and forefoot repair |
| Foot and Ankle | Metatarsal ligament/tendon repair or reconstruction |
| Shoulder | Rotator Cuff |
| Shoulder | Shoulder Instability |
| Shoulder | Biceps Tenodesis |
| Elbow | Lateral epicondylitis repair |
| Elbow | Biceps tendon reattachment |
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Performance Data
The sutures used to construct the JuggerKnot® Soft Anchors meet requirements established by the United States Pharmacopeia (USP), except for diameter. The UHMWPE sutures are tested per USP performance requirements for needle attachment and tensile strength. FDA Guidance "Bone Anchors - Premarket Notification (510(k)) Submissions Guidance for Industry and Food and Drug Administration Staff' and FDA Guidance "Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA" were followed during the preparation of this submission. Non-clinical performance testing for the JuggerKnot® Soft Anchor included a sterilization adoption validation, biocompatibility testing per ISO10993-1:2018 - Biological Evaluation of Medical Devices, stability testing on the product packaging per ISO 11607-1:2006 - Packaging for terminally sterilized medical devices -- Part 1: Requirements for materials, sterile barrier systems and packaging systems, usability engineering validation with simulated use in a cadaveric models performed per EN62366: 2015- Medical devices -Application of usability engineering to medical devices. Endotoxin/pyrogenicity testing was performed per ANSI/AAMI ST72:2019, USP <161>, USP <151> and USP <85>. Non-clinical mechanical testing was performed to verify the fixation strength of the JuggerKnot® Soft Anchor using insertion, cyclic and pullout testing as compared to the predicate device. Results of performance testing for the JuggerKnot® Soft Anchor device concluded that the device performed comparably to the predicate device and to other currently marketed soft anchor devices in insertion, cyclic and pullout testing and the validations performed demonstrated that the JuggerKnot® Soft Anchor met all requirements for its intended use.
Substantial Equivalence and Comparison of Technical Characteristics
The JuggerKnot® Soft Anchor is substantially equivalent to the previously cleared JuggerKnot® Soft Anchor cleared per K150768 "predicate device." The JuggerKnot® Soft Anchor has the same intended use, the same principles of operation, and similar technological characteristics as the predicate device. Both the JuggerKnot® Soft Anchor and the predicate device are comprised of the same materials, packaged using the same packaging materials and sterilized using the same processes. The JuggerKnot® Soft Anchor subject device contains slight technological differences from the JuggerKnot® predicate device in the following ways: i) the flat braid configuration of UHMWPE sutures ii) triple loaded anchor configuration (up to three sutures spliced into the anchor) and iii) fixed (non-sliding) positioning of the suture anchor. The JuggerKnot® Soft Anchor predicate device anchor is a sliding anchor with up to two round braid UHMWPE working sutures spliced in the anchor. However, these technical characteristics is within the range of currently marketed devices. Therefore, the JuggerKnot® Soft Anchor "subject device" is substantially equivalent to the predicate devices in both technological characteristics and intended use and does not raise any issues of safety or effectiveness.
Conclusion
The information provided in this Traditional 510(k) demonstrates that the JuggerKnot® Soft Anchor substantially equivalent to the predicate device.
§ 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.