JuggerKnot Soft Anchor OC 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

Device Description

The JuggerKnot Soft Anchor OC is identical to the previously cleared JuggerKnot Soft Anchor OC except for the presence of a bioceramics embedded in the anchor portion of the device. The JuggerKnot Soft Anchor OC is comprised of a suture sleeve structure and working suture. Nonabsorbable braided ultra-high molecular weight polyethylene (UHMWPE) sutures are spliced through a suture anchor sleeve comprised of non-absorbable braided polyester. Up to two nonabsorbable round or flat braided UHMWPE working sutures can be added inside the suture anchor sleeve. The UHMWPE sutures are available undyed (white) and black. The hydroxyapatite and bioceramic particles are embedded in the surface of the suture anchor material. Sutures supplied meet United States Pharmacopeia (USP) requirements for non-absorbable suture except for diameter. Suture dyes are FDA approved. The inserter is comprised of a metallic shaft with over molded handle. The device is sterilized by ethylene oxide gas and is provided sterile for single use. The JuggerKnot Soft Anchor OC are available in common sizes and lengths and will be sold sterile for single use. The device is intended for use in a hospital/clinic/surgical setting.

AI/ML Overview

The provided text describes a medical device, the JuggerKnot Soft Anchor OC, and its clearance under a 510(k) premarket notification. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting a full clinical trial to prove efficacy and safety from scratch.

Therefore, the specific information requested about acceptance criteria and a study proving the device meets those criteria (especially in terms of diagnostic performance, human reader improvement with AI assistance, standalone algorithm performance, and ground truth establishment for training and test sets) is not applicable in the context of this 510(k) submission.

The document focuses on non-clinical performance testing and substantial equivalence to a predicate device, as opposed to a diagnostic device for which such performance metrics would be relevant.

Here's a breakdown based on the information provided and what is implied by a 510(k) submission for this type of device:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: For this device (a bone fixation fastener), acceptance criteria are primarily related to mechanical performance, biocompatibility, sterilization, and material properties, demonstrating it is as safe and effective as the predicate.
- Reported Device Performance:
  - Mechanical Testing: "performed comparably to the predicate device in insertion, cyclic and pullout testing."
  - Sterilization: "sterilization adoption validation"
  - Biocompatibility: "biocompatibility testing per ISO10993- 1:2018"
  - Stability: "stability testing on the product packaging per ISO 11607-1:2006"
  - Usability Engineering: "usability engineering validation with simulated use in a cadaveric models performed per EN62366: 2015"
  - Endotoxin/Pyrogenicity: "Endotoxin/pyrogenicity testing was performed per ANSI/AAMI ST72:2019, USP <161>, USP <151> and USP <85>."
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Test Set (for mechanical and other non-clinical tests): Not explicitly stated numbers for each test, but standard engineering and biological testing samples would have been used.
- Data Provenance: The tests were likely conducted in laboratories or facilities chosen by the manufacturer, Riverpoint Medical, LLC, which is based in Portland, Oregon, USA. The studies are prospective in the sense that they were conducted for the purpose of this submission.
- Animal Study: "An animal study was performed to evaluate the biological safety and in vivo performance associated with the JuggerKnot Soft Anchor OC." No specific animal numbers are provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This is not applicable as the device is a medical implant (bone fixation fastener), not a diagnostic device requiring expert interpretation of images or other medical data for ground truth. Ground truth for this device relates to physical and biological properties.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This is not applicable for the reasons stated above. Adjudication methods are typically for diagnostic interpretations.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- This is not applicable. The device is an implantable fastener, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable. The device is a physical implant, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical tests, the "ground truth" is based on established engineering standards, material science properties, and biological safety parameters. For the animal study, the "ground truth" would be the observed biological response to the implant in vivo.
The sample size for the training set:
- This is not applicable. This is a physical device submission; there is no "training set" in the context of machine learning or AI.
How the ground truth for the training set was established:
- This is not applicable for the reason stated above.

Summary

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October 6, 2023

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, featuring a stylized depiction of a human figure. To the right of the HHS logo is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Riverpoint Medical, LLC Becca Defrancia Regulatory Affairs Manager 815 NE 25th Ave Portland, Oregon 97232

Re: K232411

Trade/Device Name: JuggerKnot Soft Anchor OC Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: August 10, 2023 Received: August 10, 2023

Dear Becca Defrancia:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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.

Sara S. Thompson -S

For

Jesse Muir, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices

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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) K232411

Device Name JuggerKnot Soft Anchor OC

Indications for Use (Describe) JuggerKnot Soft Anchor OC 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

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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K232411

510(k) SUMMARY

JuggerKnot Soft Anchor OC

Submitter Information

Submitter's Name:	Riverpoint Medical
Address:	825 NE 25th Ave.Portland, OR 97232
Phone Number:	(503) 517-8001
Fax Number:	(503) 517-8002
Registration Number:	3006981798
Contact Person:	Becca DeFrancia(503) 517-8001
Date of Preparation:	August 9, 2023

Device Name

Trade Name:	JuggerKnot Soft Anchor OC
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
Subsequent Code:	MAI

Predicate Devices

Legally Marketed Primary Predicate Device to Which Substantial Equivalence is Claimed:

Riverpoint Medical JuggerKnot Soft Anchor (K203740)
Reference Devices:
Wishbone Medical, Inc. Smart Correction System Rings and Compatible HA-Coated Half Pins ● (K221366)
Smith and Nephew, Inc. Osteoraptor Suture Anchor (K082215) ●
SIGNAFUSE Bioactive Bone Graft (K193513) ●

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ERPOINT

Device Description

Sutures supplied meet United States Pharmacopeia (USP) requirements for non-absorbable suture except for diameter. Suture dyes are FDA approved. The inserter is comprised of a metallic shaft with over molded handle. The device is sterilized by ethylene oxide gas and is provided sterile for single use. The JuggerKnot Soft Anchor OC are available in common sizes and lengths and will be sold sterile for single use. The device is intended for use in a hospital/clinic/surgical setting.

The classification for the JuggerKnot Soft Anchor OC is FDA Class II device with product classification 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener, Product Code MBI with subsequent product classification 21 CFR 888.3030: Single/multiple component metallic bone fixation appliances and accessories, Product Code MAI.

Intended Use and Indications for Use

JuggerKnot Soft Anchor OC 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 Anchor OC meet requirements established by the United States Pharmacopeia (USP), except for diameter. The UHMWPE sutures are tested per USP performance requirements for tensile strength.

FDA Guidance "Bone Anchors - Premarket Notification (510(k)) Submissions Guidance for Industry, Food and Drug Administration Staff', FDA Guidance "Class II Special Controls Guidance Document: Surgical Sutures: Guidance for Industry and FDA", and FDA Guidance "510(K) Information Needed for Hydroxyapatite Coated Orthopedic Implants" were followed during the preparation of this submission.

Non-clinical performance testing for the JuggerKnot Soft Anchor OC 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 JuggerKnot Soft Anchor OC using insertion, cyclic and pullout testing as compared to the predicate device. Results of performance testing for the JuggerKnot Soft Anchor OC device concluded that the device performed comparably to the predicate device in insertion, cyclic and pullout testing and the validations performed demonstrated that the JuggerKnot Soft Anchor OC met all requirements for its intended use. An animal study was performed to evaluate the biological safety and in vivo performance associated with the JuggerKnot Soft Anchor OC. The animal study demonstrated substantially equivalent biological safety and in vivo performance to the predicate device of the JuggerKnot Soft Anchor OC.

The substantial equivalence of the JuggerKnot Soft Anchor OC is supported by the extensive nonclinical and animal testing presented in this 510(k).

Substantial Equivalence and Comparison of Technical Characteristics

The JuggerKnot Soft Anchor OC is substantially equivalent to the previously cleared JuggerKnot Soft Anchor Suture Anchor cleared per K203740 "predicate device." The JuggerKnot Soft Anchor OC has the same intended use, same principles of operation, and similar technological characteristics as the predicate device. The JuggerKnot Soft Anchor OC subject device contains slight technological differences from the predicate device but are within the range of currently marketed devices, and they have been assessed through risk analysis, not raising any new questions of safety or effectiveness.

Therefore, the JuggerKnot Soft Anchor OC "subject device" is substantially equivalent to the predicate device and does not raise any issues of safety or effectiveness.

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VERPOINT

Conclusion

The information provided in this Traditional 510(k) demonstrates that the JuggerKnot Soft Anchor OC is substantially equivalent to the predicate device K203740.

Regulation Number and Section

§ 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.