(27 days)
No reference devices were used in this submission.
No
The device description and performance studies focus on the mechanical properties and usability of a soft tissue anchor, with no mention of AI or ML.
Yes
The device is a medical implant intended for soft tissue to bone fixation, which directly treats injuries and helps in the healing process.
No
Explanation: The device, JuggerKnot® Soft Anchors, is an implantable medical device intended for soft tissue to bone fixation. Its description and intended use focus on repair and reconstruction procedures, not on identifying or determining the nature of a disease or condition.
No
The device description clearly details physical components such as sutures, a suture anchor sleeve, a metallic shaft inserter, and needles. It also mentions sterilization and packaging as a sterile, single-use device, all indicative of 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 is 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 is a physical implant (suture anchor) used to attach soft tissue to bone. It is comprised of sutures and an inserter.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
IVD devices are used in vitro (outside the body) to analyze samples like blood, urine, or tissue to diagnose or monitor medical conditions. This device is used in vivo (inside the body) for surgical repair.
N/A
Intended Use / Indications for Use
JuggerKnot® Soft Anchors are intended for 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 (comma separated list FDA assigned to the subject device)
MBI
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 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. 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.
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)
Non-clinical performance testing for the JuggerKnot® Soft Anchor 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 to demonstrate that the device meets pyrogen limit specifications. 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 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 JuggerKnot® Soft Anchor met all requirements for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
No reference devices were used in this submission.
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).
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
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Riverpoint Medical LLC Rebecca Defrancia Regulatory Affairs Manager 825 NE 25th Ave. Portland, Oregon 97232
Re: K231128
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: April 20, 2023 Received: April 20, 2023
Dear Ms. 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 (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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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.
Image /page/1/Picture/5 description: The image shows two lines of text. The first line reads "Yu-chieh", and the second line reads "Chiu -S". The text is written in a clear, sans-serif font and is horizontally aligned. The background is plain white.
Digitally signed by Yuchieh Chiu -S Date: 2023.05.17 16:03:53 -04'00'
Yu-Chieh Chiu, Ph.D. Acting 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
2
Indications for Use
510(k) Number (if known) K231128
Device Name JuggerKnot® Soft Anchor
Indications for Use (Describe) JuggerKnot® Soft Anchors are intended for 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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY
Riverpoint Medical JuggerKnot Soft Anchor with self punching inserter
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: | Rebecca DeFrancia |
| (503) 517-8001 | |
| Date of Preparation: | April 19, 2023 |
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 Fixation |
| Fastener | |
| Classification Code: | MBI |
| Review Panel | Orthopedic |
Predicate Device
K203740 – Riverpoint 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 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. 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 / 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 |
| 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 |
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
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"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. The proposed device has the same biocompatibility profile, sterilization method, packaging, and material stability. Non-clinical performance testing for the JuggerKnot® Soft Anchor 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 to demonstrate that the device meets pyrogen limit specifications. 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 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 JuggerKnot® Soft Anchor met all requirements for its intended use.
Substantial Equivalence and Comparison of Technical Characteristics The JuggerKnot® Soft Anchor with self-punching inserter is substantially equivalent to the previously cleared JuggerKnot® Soft Anchor cleared per K203740 "predicate device." The 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 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 JuggerKnot® Soft Anchor subject device contains slight technological differences from the JuggerKnot® predicate device in the following way: the self-punching inserter tip configuration. However, these technical characteristics are within the range of currently marketed devices. Therefore, the 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 JuggerKnot® Soft Anchor subject device with self-punching inserter is substantially equivalent to the predicate device.