The Riverpoint Medical OrthoButton FL™ is intended for use in the fixation of bone and soft tissue in orthopedic procedures requiring ligament or tendon reconstruction.

Device Description

The Riverpoint Medical OrthoButton FL™ is available in multiple configurations, see device specifications in Attachment 1. Configurations may be comprised of an ultra-high molecular weight polyethylene (UHMWPE) loop provided with or without a titanium (Ti-6Al-4V ELI per ASTM F136) plate or as a single titanium (Ti-6Al-4V ELI per ASTM F136) plate, Additional non-absorbable sutures consisting of UHMWPE, nylon, polyester, or polypropylene are looped through the titanium plate to aide in assembly of the device and passing the plate through the intended void. The UHMWPE is available undyed (white) or with trace filaments of black, blue, or green color suture.

For configurations that do not have a titanium plate preattached, the titanium plate component is affixed to the loop during the procedure. For models that come with a preattached titanium plate, the procedure is the same except the titanium plate is passed through the channel. In both configurations, additional sutures are used to pass the loop and titanium plate (if pre-attached) parallel through the femoral channel and secure into place. The UHMWPE is available undyed (white), dyed blue, dyed black or with trace filaments of black, blue, or green color suture. Available Suture sizes are standard according to USP and EP requirements (dependent on suture type). The OrthoButton FLTM device is provided sterile for single use.

AI/ML Overview

This FDA 510(k) K202399 submission describes a medical device, the Riverpoint Medical OrthoButton FL™, a fastener for bone and soft tissue fixation. The submission focuses on demonstrating substantial equivalence to a predicate device (K171060 – Riverpoint Medical OrthoButton® AL) rather than providing extensive details of a clinical study with detailed acceptance criteria for diagnostic performance outcomes.

Therefore, many of the requested fields (e.g., test set sample size, number of experts, adjudication method, MRMC study, standalone performance, training set size, ground truth for training set) are not applicable or cannot be extracted from this document, as they pertain to studies evaluating the diagnostic or assistive performance of an AI/ML device, which is not the subject of this 510(k). The "acceptance criteria" discussed are primarily for non-clinical performance and safety attributes.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) is for a physical medical device (bone fixation fastener), not an AI/ML device. The "performance" discussed relates to non-clinical testing for safety and functionality rather than diagnostic accuracy. The document states that "All acceptance criteria were met, and the Riverpoint Medical OrthoButton FL performed as intended." However, specific numerical acceptance criteria for each test (e.g., a specific tensile strength value or a specific sterility assurance level) and their corresponding reported results are not quantified in this summary.

Test Category	Acceptance Criteria (Implied)	Reported Device Performance
Sterilization	Per EN ISO14937:2009 standards.	Met all criteria.
Biocompatibility	Per ISO10993-1:2018 standards.	Met all criteria.
Stability (Product/Packaging)	Per ISO 11607-1:2019 standards.	Met all criteria.
Usability	Per EN62366: 2015 standards for simulated use.	Met all criteria.
Endotoxin/Pyrogenicity	Per ANSI/AAMI ST72:2019, USP <161>, and USP <85> standards.	Met all criteria.
Overall Performance	Device performs as intended for bone and soft tissue fixation.	Performed as intended.

2. Sample size used for the test set and the data provenance

Not applicable for diagnostic or AI/ML performance testing as this is a non-AI physical medical device. The "test sets" would refer to samples used for engineering and biocompatibility testing, but specific numbers are not provided in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable for this type of device submission. Ground truth as typically understood for AI/ML diagnostic studies is not relevant here.

4. Adjudication method for the test set

Not applicable.

5. 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. This device is not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For this device, "ground truth" would be related to engineering specifications, material properties, and biological safety standards (e.g., sterility confirmed by lab tests, biocompatibility by toxicology tests, mechanical strength by load testing). The document states that performance testing was conducted according to recognized international and national standards (e.g., ISO, EN, ASTM, USP, AAMI).

8. The sample size for the training set

Not applicable. This device does not involve a training set for an algorithm.

9. How the ground truth for the training set was established

Not applicable.

Summary

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September 18, 2020

Image /page/0/Picture/1 description: The image shows 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Riverpoint Medical Amanda Cole Regulatory Affairs Associate 825 NE 25th Avenue Portland, Oregon 97232

Re: K202399

Trade/Device Name: OrthoButton FLTM Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: August 20, 2020 Received: August 21, 2020

Dear Ms. 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,

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) K202399

Device Name OrthoButton FLTM

Indications for Use (Describe)

The Riverpoint Medical OrthoButton FL™ is intended for use in the fixation of bone and soft tissue in orthopedic procedures requiring ligament or tendon reconstruction.

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 OrthoButton FLTM Line Extension

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:

Device Name

Trade Name:	OrthoButton FLTM
Common or Usual Names:	Suture Retention Device, Button Loop
Classification Name:	Fastener, Fixation, Non-Degradable, Soft Tissue

Device Classification

FDA Class:	II
Product Classification:	888.3040
Classification Code:	MBI
Review Panel	Orthopedic
Premarket Review	Office of Device Evaluation
	Division of Orthopedic Devices (DOD)
	Joint and Fixation Devices Branch

Predicate Device

K171060 – Riverpoint Medical OrthoButton® AL

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Device Description

Intended Use / Indications for Use

The Riverpoint Medical OrthoButton FL™ is intended for use in the fixation of bone and soft tissue in orthopedic procedures requiring ligament or tendon reconstruction.

Performance Data

Non-clinical performance testing for the Riverpoint Medical OrthoButton FL™ included sterilization validation per EN ISO14937:2009 - 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, biocompatibility testing per ISO10993-1:2018 - Biological Evaluation of Medical Devices, stability testing on the product and packaging per ISO 11607-1:2019 - Packaging for terminally sterilized medical devices --Part 1: Requirements for materials, sterile barrier systems and packaging systems, and a simulated use Usability Validation performed per EN62366: 2015- Medical devices -Application of usability engineering to medical devices. Entotoxin/pyrogenicity testing, performed per ANSI/AAMI ST72:2019, USP <161>, and USP <85>. All acceptance criteria were met, and the Riverpoint Medical OrthoButton FL performed as intended.

Substantial Equivalence and Comparison of Technical Characteristics

The OrthoButton FLTM has the same intended use and indications for use, the same principles of operation, and similar technical characteristics as the predicate device. Both the OrthoButton FLTM and the predicate device are sterilized using the same processes, are composed of the same materials, and are tested per the same performance requirements. The minor difference in technical characteristics is limited to the packaging which allows the user to assemble the device prior to the procedure and affixing a clip-on button component for configurations without a preattached button. These minor differences do not raise new questions of safety or effectiveness; therefore, the OrthoButton FLTM line extension is substantially equivalent to the currently marketed OrthoButton®AL predicate device.

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Conclusion

The information provided in this Special 510(k) demonstrates that the Riverpoint Medical OrthoButton FLTM line extension is substantially equivalent to the predicate device.

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.