The ProCinch, QuadCinch Adjustable Loop Device 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 ProCinch, QuadCinch adjustable button loop is comprised of an ultra-high molecular weight polyethylene (UHMWPE) loop provided with or without a titanium (Ti-6Al-4V ELI per ASTM F136) plate. Additional non-absorbable sutures consisting of UHMWPE, or polyester 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 blue or green color suture.

For configurations that do not have a titanium plate preattached, a 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, or with trace filaments of blue or green color suture. The device is sterilized by ethylene oxide gas and is provided sterile for single use. The device is intended for use in a hospital/clinic/surgical setting.

AI/ML Overview

This FDA 510(k) K240194 submission for the Riverpoint Medical ProCinch, QuadCinch device does not describe an AI/ML powered device or a study involving human readers with or without AI assistance. Therefore, many of the requested criteria related to AI/ML performance and human reader studies are not applicable or cannot be extracted from the provided text.

The document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data and a comparison of technical characteristics for a medical device (adjustable button loop for tissue fixation), not an AI/ML algorithm.

Here's the information that can be extracted based on the provided text, with clarifications where the criteria are not applicable:

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

As this submission is for a medical device (ProCinch, QuadCinch Adjustable Button Loop) and not an AI/ML powered diagnostic or assistive device, the "acceptance criteria" and "study" described are primarily focused on demonstrating the device's safety and effectiveness through comparison with a predicate device and adherence to relevant standards for medical devices. The performance data focuses on mechanical testing, sterilization, biocompatibility, and packaging validation.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by adherence to established standards and comparable performance to the predicate device. The performance reported is that the device met all requirements and performed comparably.

Acceptance Criteria Category	Specific Criteria (Implied)	Reported Device Performance
Material Performance	USP requirements for tensile strength of sutures (except diameter)	Met USP performance requirements for tensile strength
Biocompatibility	Compliant with ISO 10993-1:2018	Biocompatible per ISO 10993
Sterilization	Validated for sterility	Sterilization adoption validated; EtO Sterilization
Packaging	Compliant with ISO 11607-1:2006	Product packaging validated per ISO 11607-1:2006
Usability	Compliant with EN62366:2015	Usability engineering validation with simulated use in cadaveric models performed
Pyrogenicity	No pyrogenicity concerns	LAL and rabbit pyrogenicity testing demonstrated no additional concerns
Fixation Strength	Comparable to predicate device through cyclic testing	Performed comparably to the predicate device
Overall	Meet all requirements for intended use, demonstrate substantial equivalence	Met all requirements for its intended use; substantially equivalent to predicate

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "cadaveric models" for usability testing and "non-clinical mechanical testing" and "LAL and rabbit pyrogenicity testing." However, specific sample sizes for these tests are not provided in the given text. The provenance includes:

Cadaveric models: (location not specified, likely lab-based)
Animal testing: Rabbit pyrogenicity testing (location not specified, likely lab-based)
Mechanical testing: In-vitro lab testing (location not specified, likely lab-based)

The data is non-clinical and largely prospective in the context of the device's development and testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This criterion is not applicable as this is not an AI/ML device relying on human expert annotations for ground truth. The "ground truth" for this device's performance is established through physical and chemical testing against recognized standards (e.g., ISO, USP) and comparison to a predicate device.

4. Adjudication Method for the Test Set

This criterion is not applicable as this is not an AI/ML device requiring human expert adjudication of results. Testing is based on objective measurements against established standards.

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

This criterion is not applicable. No AI assistance is mentioned or involved with this device.

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

This criterion is not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for this medical device's performance is established through:

Adherence to recognized standards: e.g., USP for sutures, ISO 10993 for biocompatibility, ISO 11607 for packaging, EN62366 for usability.
Empirical mechanical testing: Comparing fixation strength against a predicate device.
Biological testing: LAL and rabbit pyrogenicity testing.

8. The Sample Size for the Training Set

This criterion is not applicable as this is a physical medical device, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established

This criterion is not applicable as this is a physical medical device, not an AI/ML algorithm.

Summary

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February 21, 2024

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 Paulie Vagts Senior Regulatory Affairs Associate III 825 NE 25th Ave Portland, Oregon 97232

Re: K240194

Trade/Device Name: ProCinch, QuadCinch Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: January 24, 2024 Received: January 24, 2024

Dear Paulie Vagts:

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" (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).

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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.

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 Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Enclosure

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Indications for Use

Submission Number (if known)

K240194

Device Name

ProCinch, QuadCinch

Indications for Use (Describe)

The ProCinch, QuadCinch Adjustable Loop Device 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 K240194 ProCinch, QuadCinch Adjustable Button Loop

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:	Paul Vagts(503) 517-8001
Date of Preparation:	February 14th, 2024
Trade Name:	ProCinch, QuadCinch
Common or Usual Names:	Suture Retention Device, Button Loop
Classification Name:	Fastener, Fixation, Non-Degradable, Soft Tissue
FDA Class:	II
Product Classification:	888.3040: Smooth or threaded metallic bonefixation fastener
Classification Code:	MBI

Predicate Device

K202399 - Riverpoint Medical OrthoButton FL

Device Description

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secure into place. The UHMWPE is available undyed (white), dyed blue, or with trace filaments of blue or green color suture. The device is sterilized by ethylene oxide gas and is provided sterile for single use. The device is intended for use in a hospital/clinic/surgical setting.

The classification for the ProCinch, QuadCinch 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

The ProCinch, QuadCinch is intended for use in the fixation of bone and soft tissue in orthopedic procedures requiring ligament or tendon reconstruction.

Performance Data

The sutures used to construct the ProCinch. QuadCinch meet requirements established by the United States Pharmacopeia (USP), except for diameter. The UHMWPE, polyester, or polyblend sutures are tested per USP performance requirements for tensile strength. Non-clinical performance testing for the ProCinch, QuadCinch included a sterilization adoption validation, biocompatibility testing per ISO10993-1:2018 -Biological Evaluation of Medical Devices, product packaging validation 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. LAL and rabbit pyrogencity testing have demonstrated that the ProCinch, QuadCinch does not raise any additional concerns regarding pyrogenicity. Non-clinical mechanical testing was performed to verify the fixation strength of the ProCinch, QuadCinch using cyclic testing as compared to the predicate device. Results of performance testing for the ProCinch, QuadCinch device concluded that the device performed comparably to the predicate device and the validations performed demonstrated that the ProCinch, QuadCinch met all requirements for its intended use.

Substantial Equivalence and Comparison of Technical Characteristics

As reflected in the following substantial equivalence table, the ProCinch, QuadCinch has the same intended use and indications for use, the same principles of operation, and similar technical characteristics as the predicate device. Both the ProCinch, QuadCinch and the predicate device are sterilized using the same processes, are composed of the same materials, and are tested per the same performance requirements.

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Device	Riverpoint MedicalProCinch, QuadCinchAdjustable Button Loop	Riverpoint MedicalOrthoButton AL AdjustableButton Loop(K171060, K230212)	Comparison
Intended Use /Indications for Use	The Riverpoint MedicalProCinch, QuadCinch is intendedfor use in the fixation of bone andsoft tissue in orthopedicprocedures requiring ligament ortendon reconstruction.	The Riverpoint MedicalOrthoButton AL is intended foruse in the fixation of bone andsoft tissue in orthopedicprocedures requiring ligament ortendon reconstruction.	Identical
Loop Material	UHMWPE/Polyester	UHMWPE/Polyester	Identical
Additional Sutures	UHMWPE, polyester	UHMWPE, nylon, polyester,polypropylene	Included
Color Additive	21CFR74	21CFR74 and 21CFR73	Included
Button Material	Titanium (Ti-6AI-4V ELI perASTM F136)	Titanium (Ti-6AI-4V ELI perASTM F136)	Identical
Finished Loop Length	15-60mm	15-60mm	Identical
Regulation Number	888.3040	888.3040	Identical
Regulatory Class	II	II	Identical
Prescription or OTC	Prescription	Prescription	Identical
Product Code	MBI	MBI	Identical
Principle of Operation	Manual fixation	Manual fixation	Identical
Packaging	Tyvek/Poly Pouch	Tyvek/Poly Pouch	Identical
Biocompatibility	Biocompatible per ISO 10993	Biocompatible per ISO 10993	Identical
Sterilization	EtO Sterilization	EtO Sterilization	Identical
Shelf Life	5 Years	5 Years	Identical

The minor difference in technical characteristics is limited to 1) the subject device is provided with the adjustable loop fully assembled whereas the predicate device is assembled intraoperatively and 2) new packaging insert. These minor differences do not raise new questions of safety or effectiveness; therefore, the ProCinch, QuadCinch is substantially equivalent to the currently marketed OrthoButton FL predicate device.

Conclusion

The information provided in this Special 510(k) demonstrates that the Riverpoint Medical ProCinch, QuadCinch 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.