(27 days)
No
The device description and performance studies focus on the mechanical properties and usability of a soft tissue anchor and inserter, with no mention of AI or ML technology.
Yes
The device is described as "intended for use in soft tissue to bone fixation" for various repairs (e.g., tendon, ligament, rotator cuff), which aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
The device is a surgical implant (suture anchor) used for soft tissue to bone fixation, not for diagnosing medical conditions.
No
The device description clearly outlines physical components such as suture sleeves, working sutures, and an inserter, indicating it is a hardware medical device.
Based on the provided information, 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 (Knee, Foot and Ankle, Shoulder, Elbow). This is a surgical procedure performed directly on the patient's body.
- Device Description: The device description details a physical implant (suture anchor) and an inserter tool. These are surgical instruments and implants, not devices used to examine specimens derived from the human body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze samples like blood, urine, tissue, etc., which is the defining characteristic of an IVD.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is used in vivo (inside the body) for surgical repair.
N/A
Intended Use / Indications for Use
OC JuggerKnot® Soft Anchor 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 |
| 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 |
Product codes
MBI, MAI
Device Description
The OC 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 non- absorbable 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). The hydroxyapatite and bioceramic particles are embedded in the surface of the suture anchor material.
Suture supplied meet United States Pharmacopeia (USP) requirements for nonabsorbable suture except for diameter. Suture dyes are FDA approved. The inserter is comprised of a metallic shaft with a self-punching tip and an overmolded handle. The device is sterilized by ethylene oxide gas, and is provided sterile for single use. OC JuqgerKnot® 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 OC 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 with subsequent product classification 21 CFR §888.3030: Sinqle/multiple component metallic bone fixation appliances and accessories, Product Code MAI.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee, Foot and Ankle, Shoulder, Elbow
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital/clinic/surgical setting.
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)
Nonclinical performance testing for the OC JuggerKnot® Soft Anchor with self-punching inserter included a 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 , USP and USP . Non-clinical mechanical testing was performed to verify the fixation strength of the OC JuggerKnot® Soft Anchor with self-punching inserter using insertion, cyclic and pullout testing as compared to the predicate device. Results of performance testing for the OC JuggerKnot® Soft Anchor device with self-punching inserter concluded that the device performed comparably to the predicate device and to other currently marketed soft anchor devices with self-punching inserters in insertion, cyclic and pullout testing and the validations performed demonstrated that the OC JuggerKnot® Soft Anchor with selfpunching inserter met all requirements for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
April 11, 2024
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Riverpoint Medical Becca Defrancia Regulatory Affairs Manager 825 NE 25th Ave Portland, Oregon 97232
Re: K240719
Trade/Device Name: OC 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, MAI Dated: March 7, 2024 Received: March 15, 2024
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"
1
(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. Digitally signed by Ryan Ryan Trombetta -S Trombetta -S Date: 2024.04.11 16:01:21 -04'00' For: Jesse Muir, 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
2
Enclosure
3
Indications for Use
Submission Number (if known)
K240719
Device Name
OC JuggerKnot® Soft Anchor
Indications for Use (Describe)
OC JuggerKnot® Soft Anchor 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 |
| 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)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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Image /page/4/Picture/0 description: The image shows the logo for Riverpoint. The logo has the letters RP in a green box on the left. To the right of the box, the word RIVERPOINT is written in green, sans-serif font.
510(k) SUMMARY Riverpoint Medical OC JuggerKnot® Soft Anchor
Submitter Information
| Submitter's Name: | Riverpoint Medical |
|---|---|
| Address: | 825 NE 25th Ave. |
| Portland, OR 97232 | |
| Phone Number: | (503) 517-8001 or (971) 288-1083 |
| Fax Number: | (503) 517-8002 |
| Registration Number: | 3006981798 |
| Contact Person: | Becca DeFrancia |
| (503) 517-8001 | |
| Date of Preparation: | March 8, 2024 |
| Device Name | |
| Trade Name: | OC 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 |
| fixation fastener | |
| Primary Product Code: | MBI |
| Product Code: | MAI |
Predicate Device
K232411 – Riverpoint Medical JuggerKnot® Soft Anchor with OC Coating
Reference Device
K231128 – Riverpoint Medical JuggerKnot® Soft Anchor
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Image /page/5/Picture/0 description: The image contains the logo for Riverpoint. The logo consists of the letters "RP" in white on a green square. To the right of the square is the word "RIVERPOINT" in green.
Device Description
The OC 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 non- absorbable 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). The hydroxyapatite and bioceramic particles are embedded in the surface of the suture anchor material.
Suture supplied meet United States Pharmacopeia (USP) requirements for nonabsorbable suture except for diameter. Suture dyes are FDA approved. The inserter is comprised of a metallic shaft with a self-punching tip and an overmolded handle. The device is sterilized by ethylene oxide gas, and is provided sterile for single use. OC JuqgerKnot® 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 OC 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 with subsequent product classification 21 CFR §888.3030: Sinqle/multiple component metallic bone fixation appliances and accessories, Product Code MAI.
Intended Use / Indications for Use
OC 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 |
| 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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Image /page/6/Picture/0 description: The image shows the logo for Riverpoint. The logo consists of the letters RP inside of a green square. To the right of the square is the word RIVERPOINT in green, sans-serif font.
The sutures used to construct the OC 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. Nonclinical performance testing for the OC JuggerKnot® Soft Anchor with self-punching inserter included a 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 , USP and USP . Non-clinical mechanical testing was performed to verify the fixation strength of the OC JuggerKnot® Soft Anchor with self-punching inserter using insertion, cyclic and pullout testing as compared to the predicate device. Results of performance testing for the OC JuggerKnot® Soft Anchor device with self-punching inserter concluded that the device performed comparably to the predicate device and to other currently marketed soft anchor devices with self-punching inserters in insertion, cyclic and pullout testing and the validations performed demonstrated that the OC JuggerKnot® Soft Anchor with selfpunching inserter met all requirements for its intended use.
Substantial Equivalence and Comparison of Technical Characteristics
The OC JuggerKnot® Soft Anchor with self-punching inserter is substantially equivalent to the previously cleared JuggerKnot® Soft Anchor with OC coating cleared per K232411 "predicate device." The OC JuggerKnot® Soft Anchor with self-punching inserter has the same intended use, similar principles of operation, and similar technological characteristics as the predicate device. Both the OC JuggerKnot® Soft Anchor with self-punching inserter and the predicate device are comprised of the same materials, packaged using the same packaging materials and sterilized using the same processes. The OC JuggerKnot® Soft Anchor subject device contains slight technological differences from the JuqgerKnot® with OC coating predicate device in the following way: the self-punching inserter tip configuration. However, these technical characteristics are within the range of currently marketed devices such as reference device JuggerKnot® Soft Anchor with self-punching inserter. Therefore, the OC JuggerKnot® Soft Anchor "subject device" with self-punching inserter is substantially equivalent to the predicate device in both technological characteristics and intended use and does not raise any issues of safety or effectiveness.
Conclusion
The information provided in this Special 510(k) demonstrates that the Riverpoint Medical OC JuggerKnot® Soft Anchor subject device with self-punching inserter is substantially equivalent to the predicate device.