(84 days)
The RootMend MRR devices are intended to be used for suture (soft tissue) fixation to bone in the knee for meniscal root repair.
The RootMend Meniscal Root Repair (MRR) devices are composed of uncoated UHMWPE (ultra-high molecular weight polyethylene) with UHMWPE tracer material. RootMend MRR devices are available with a fixation button composed of a titanium (Ti-6Al-4V) button, or with an attached UHMWPE fixation button. RootMend MRR devices will be provided sterile using ethylene oxide, for single use only, and are not to be resterilized. The UHMWPE is available undyed (white), black, or blue, with trace filaments of black or blue. RootMend MRR devices are intended to be used for suture (soft tissue) fixation to bone in the knee for meniscal root repair.
The provided text from the FDA 510(k) summary for the RootMend MRR device states that "Non-clinical mechanical testing was performed to verify the fixation strength of the RootMend MRR devices and is compared to the predicate device. Testing conducted includes cyclic and ultimate tensile strength (UTS) testing, and assessment of displacement for the subject button and predicate anchor constructs. Usability engineering testing with simulated use in cadaver lab was performed on the subject device per EN62366-1. In all instances of the testing referenced above, the acceptance criteria were met, and the proposed RootMend MRR devices performed as intended."
However, the provided document does not contain the specific acceptance criteria or the detailed results (e.g., reported device performance values) from the mechanical testing and usability testing. It also lacks information regarding sample size, ground truth establishment, expert qualifications, or MRMC studies that would be relevant for an AI/software device evaluation.
Therefore, I cannot fulfill the request the following information based on the provided text:
- A table of acceptance criteria and the reported device performance: Not provided.
- Sample sized used for the test set and the data provenance: Not provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable to this type of device and testing described.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable, as this is a hardware device, not an AI/software device assisting human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For mechanical testing, the "ground truth" is the specified performance thresholds (acceptance criteria) and the measured physical properties. For usability testing, the 'ground truth' is successful completion of tasks by users in a cadaver lab. Specifics are not detailed beyond "performed as intended."
- The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
- How the ground truth for the training set was established: Not applicable.
Based on the available information, here is what can be inferred or directly stated:
1. Acceptance Criteria and Device Performance:
The document states: "In all instances of the testing referenced above, the acceptance criteria were met, and the proposed RootMend MRR devices performed as intended."
- Acceptance Criteria: Not explicitly stated in quantitative terms. They likely relate to minimum cyclic and ultimate tensile strength, and maximum displacement relative to the predicate device.
- Reported Device Performance: Not explicitly stated in quantitative terms. The performance met the unstated acceptance criteria.
2. Sample Size and Data Provenance:
- Sample Size: Not specified for any of the tests (cyclic, UTS, displacement, usability).
- Data Provenance: The tests were "non-clinical mechanical testing" and "usability engineering testing with simulated use in cadaver lab." This implies laboratory/bench testing rather than human clinical data. The location of the testing or data origin (country) is not specified.
3. Experts for Ground Truth / Adjudication / MRMC studies / Standalone Performance:
- These concepts (experts, adjudication, MRMC, standalone performance) are typically relevant for AI/software-based medical devices that interpret medical images or data. The RootMend MRR is a physical orthopedic implant (metallic bone fixation fastener). Therefore, these criteria are not applicable to the device and studies described.
4. Type of Ground Truth:
- For mechanical testing: The ground truth is established by engineering specifications and comparative performance to a predicate device. This would involve objective measurements of strength, fatigue, and displacement against predefined thresholds.
- For usability testing: The ground truth is successful completion of surgical tasks and safe operation in a simulated environment (cadaver lab) as assessed by the test protocol and observations.
5. Training Set Information:
- Sample Size for Training Set: Not applicable. This is not an AI/machine learning device that uses a "training set."
- How Ground Truth for Training Set was Established: Not applicable.
In summary, the provided FDA 510(k) summary provides a high-level statement that the device met acceptance criteria through specified non-clinical mechanical and usability testing, but it does not disclose the quantitative details of those criteria, the measured performance, or the sample sizes used. The remaining questions are not relevant given the nature of the device as a physical implant rather than an AI/software product.
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March 20, 2025
Riverpoint Medical LLC Edwin Anderson Official Correspondent 825 NE 25th Ave Portland, Oregon 97272
Re: K243988
Trade/Device Name: RootMend MRR Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI, HTN Dated: December 23, 2024 Received: December 26, 2024
Dear Edwin Anderson:
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.
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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" (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 QS 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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 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-regulatory
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assistance/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,
CHRISTOPHER FERREIRA -S
Christopher Ferreira, M.S. 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
Submission Number (if known)
Device Name
RootMend MRR
Indications for Use (Describe)
The RootMend MRR devices are intended to be used for suture (soft tissue) fixation to bone in the knee for meniscal root repair.
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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Image /page/4/Picture/1 description: The image shows 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.
510(k) SUMMARY RootMend Meniscal Root Repair (MRR) Devices
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: | Edwin Anderson(503) 517-8001 | |
| Date of Preparation: | December 23rd, 2024 | |
| Device Name | ||
| Trade Name: | RootMend MRR | |
| Common or Usual Names: | Fastener, fixation, nondegradable, soft tissue | |
| Primary Device Classification | ||
| Product Codes: | MBI, HTN | |
| FDA Class: | 2 | |
| Regulation Number: | 888.3040: Smooth or threaded metallic bonefixation fastener. |
Predicate Device
K203495 – Arthrex SwiveLock Anchor
Reference Device
K230212 - OrthoButton AL
Device Description
The RootMend Meniscal Root Repair (MRR) devices are composed of uncoated UHMWPE (ultra-high molecular weight polyethylene) with UHMWPE tracer material. RootMend MRR devices are available with a fixation button composed of a titanium (Ti-6Al-4V) button, or with an attached UHMWPE fixation button. RootMend MRR devices will be provided sterile using ethylene oxide, for single use only, and are not to be resterilized. The UHMWPE is available undyed (white), black, or blue, with trace filaments of black or blue. RootMend MRR devices are intended to be used for suture (soft tissue) fixation to bone in the knee for meniscal root repair.
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Image /page/5/Picture/1 description: The image contains the logo for Riverpoint. The logo consists of the letters "RP" in a green rounded square, followed by the word "RIVERPOINT" in green sans-serif font. The logo is simple and modern, and the green color suggests growth and stability.
Intended Use / Indications for Use
The RootMend MRR devices are intended to be used for suture (soft tissue) fixation to bone in the knee for meniscal root repair.
Performance Data
Non-clinical mechanical testing was performed to verify the fixation strength of the RootMend MRR devices and is compared to the predicate device. Testing conducted includes cyclic and ultimate tensile strength (UTS) testing, and assessment of displacement for the subject button and predicate anchor constructs. Usability engineering testing with simulated use in cadaver lab was performed on the subject device per EN62366-1. In all instances of the testing referenced above, the acceptance criteria were met, and the proposed RootMend MRR devices performed as intended.
Additional non-clinical testing for the RootMend MRR materials and packaging included sterilization validation per ISO 14937:2009 Sterilization of health care products- General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices including biocompatibility ISO 10993-7:2008 for Biological evaluation of medical devices-Part 7 Ethylene Oxide Sterilization Residuals, biocompatibility testing per ISO10993-1:2009 -Biological Evaluation of Medical Devices, stability testing on the product material and packaging per ISO 11607-1:2006 - Packaging for terminally sterilized medical devices --Part 1: Requirements for materials, sterile barrier systems and packaging systems. LAL and rabbit pyrogenicity testing has demonstrated that the materials used in the RootMend MRR devices do not raise any additional concerns.
Substantial Equivalence and Comparison of Technical Characteristics
The proposed RootMend MRR device is within the scope of the intended use and indications, has similar principles of operation, and has similar technical characteristics as the predicate Arthrex SwiveLock (K203495) and reference OrthoButton AL (K230212). The minor technical differences are that the subject device is provided with an adjustable loop and a titanium or all-suture soft button for fixation to the bone instead of using an anchor body. These minor differences are within the range of currently marketed devices (K203495, K230212, K160655, K223284), and therefore, do not raise any issues of safety or effectiveness.
Conclusion
The information provided in this Traditional 510(k) demonstrated that the RootMend MRR subject device is substantially equivalent to the predicate.
N/A