HS Fiber Cerclage sutures are indicated for use in general soft tissue approximation and/or ligation. These sutures may be used in cardiovascular surgeries, and orthopedic surgeries using allograft tissue. When used as a bone fixation cerclage, the sutures are intended for:

· Trauma surgery indications including olecranon, ankle, patella, and some shoulder rewiring.
· Repair of long bone fracture due to trauma or reconstruction.

Device Description

The Riverpoint Medical HS Fiber® Cerclage sutures are non-absorbable, sterile, surgical sutures composed of multiple single strands of ultra-high molecular weight polyethylene (UHMWPE) braided together to form the implant. HS Fiber Cerclage sutures are available in common sizes and lengths with or without pre-attached needles. Suture supplied meet United States Pharmacopeia (USP) requirements for non-absorbable suture except for diameter. 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

Here's a breakdown of the acceptance criteria and study information for the Riverpoint Medical HS Fiber® Cerclage, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test/Requirement	Reported Device Performance
Material Properties	Suture Material	Multiple single strands of ultra-high molecular weight polyethylene (UHMWPE) braided together.
	Sterilization	Sterilized by ethylene oxide gas. Meets EN ISO14937:2009.
	Biocompatibility	Meets ISO 10993-1:2018.
Device Performance	Needle Attachment	Meets USP performance requirements.
	Tensile Strength	Meets USP performance requirements. Performed comparably to the predicate device.
	Knot Strength	Tested. No specific numerical performance provided, but "met all requirements for its intended use."
	Fatigue Strength	Performed comparably to the predicate device.
	Creep	Performed comparably to the predicate device.
	Wear Debris	Performed comparably to the predicate device. Particle analysis performed.
Packaging & Stability	Product & Packaging Stability	Meets ISO 11607-1:2019.
Human Factors/Usability	Usability Validation	Met all acceptance criteria per EN62366-1: 2015.
Regulatory Compliance	USP Requirements	Meets USP requirements for non-absorbable suture, except for diameter.
	FDA Guidance Compliance	Followed "Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA."

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

The provided text does not explicitly state the sample sizes used for each specific test set. It broadly mentions tests performed, but not the number of units or samples involved in, for example, the tensile strength or fatigue strength testing.

Regarding data provenance, the study appears to be non-clinical, laboratory-based testing conducted by the manufacturer, Riverpoint Medical, LLC. No information is given about the country of origin of the data beyond the manufacturer's location in Portland, Oregon, USA. The studies are retrospective in the sense that they are conducted on manufactured devices as part of the submission process, not on a prospective cohort of patients.

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

This information is not applicable as the studies described are non-clinical, mechanical, and material characteristic tests, not studies requiring expert interpretation of medical images or patient data to establish a ground truth.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3.

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

An MRMC comparative effectiveness study was not done. The device is a physical medical device (suture) and not an AI/software-based medical device that would involve human readers or AI assistance.

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

A standalone performance study was not done. Again, this is a physical medical device, not an algorithm.

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

The "ground truth" for the non-clinical performance studies were:

Established standards and specifications: United States Pharmacopeia (USP) requirements for sutures (primarily for needle attachment and tensile strength), and various ISO and EN standards for sterilization, biocompatibility, packaging, and usability.
Predicate device performance: Comparative testing was conducted against a predicate device (Arthrex FiberTape Cerclage - K170206) to demonstrate comparable performance in areas like tensile strength, fatigue strength, creep, and wear debris.

8. The Sample Size for the Training Set

This information is not applicable as there is no "training set" for this type of physical medical device. The device is manufactured based on design specifications and then tested against these specifications and regulatory standards.

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

This information is not applicable for the same reason as point 8.

Summary

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July 26, 2023

Riverpoint Medical, LLC Edwin Anderson VP of Regulatory Affairs 815 NE 25th Ave Portland, Oregon 97232

Re: K220765

Trade/Device Name: HS Fiber® Cerclage Regulation Number: 21 CFR 888.3010 Regulation Name: Bone Fixation Cerclage Regulatory Class: Class II Product Code: JDQ, GAT Dated: July 13, 2023 Received: July 14, 2023

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 (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

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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 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 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,

Brent Showalter -S

Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal 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) K220765

Device Name HS Fiber® Cerclage

Indications for Use (Describe)

· Trauma surgery indications including olecranon, ankle, patella, and some shoulder rewiring.
· Repair of long bone fracture due to trauma or 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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Image /page/3/Picture/0 description: The image shows the logo for Riverpoint. The logo consists of the letters "RP" in a green rounded square, followed by the word "RIVERPOINT" in green. The font is sans-serif and bold.

510(k) SUMMARY

Riverpoint Medical HS Fiber® Cerclage

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:	Becca DeFrancia(503) 517-8001
Date of Preparation:	July 13, 2023

Device Name

Trade Name:	HS Fiber® Cerclage
Common or Usual Names:	Bone Fixation Cerclage, Suture
Classification Name:	21 CFR 888.3010: Bone Fixation Cerclage21 CFR 878.5000: Nonabsorbable Poly(ethylene) TerephthalateSurgical Suture
Device Classification

Devi

FDA Class:	II
Product Classification:	888.3010, 878.5000
Classification Code:	JDQ, GAT

Predicate Device(s)

K170206 (Primary) – Arthrex FiberTape Cerclage

K100006 (Reference) – Riverpoint Medical HS Fiber (Polyblend)

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Image /page/4/Picture/0 description: The image shows the logo for Riverpoint. The logo consists of the letters "RP" inside of a green rounded square. To the right of the square is the word "RIVERPOINT" in all capital letters and in the same shade of green as the square.

Device Description

The classification for the HS Fiber Cerclage is FDA Class II device with product classification 21 CFR §878.5000, Product Code GAT and subsequent 21 CFR §888.3010, Product Code IDQ.

Indications for Use:

HS Fiber Cerclage sutures are indicated for use in general soft tissue approximation and/or ligation. These sutures may be used in cardiovascular surgeries, and orthopedic surgeries using allograft or autograft tissue. When used as a bone fixation cerclage, the sutures are intended for:

Trauma surgery indications including olecranon, ankle, patella, and some shoulder rewiring. ●
Repair of long bone fracture due to trauma or reconstruction. ●

Performance Data

The sutures used to construct the HS Fiber Cerclage 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 "Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA" were followed during the preparation of this submission.

Non-clinical performance testing for the Riverpoint Medical HS Fiber Cerclage 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 ISO 10993-1:2018 - 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 EN62366-1: 2015- Medical devices -Application of usability engineering to medical devices. All acceptance criteria were met, and the Riverpoint Medical HS Fiber Cerclage Suture performed as intended. Non-clinical mechanical testing was performed to verify the fixation performance for the HS Fiber Cerclage using tensile strength, knot strength, fatigue strength, creep, and wear debris with particle analysis. Results of the performance testing for the HS Fiber Cerclage device concluded that the device performed comparably to the predicate device in tensile strength, fatigue strength, creep, and wear debris. The tests performed demonstrated that the HS Fiber Cerclage met all requirements for its intended use.

Regulation Number and Section

§ 888.3010 Bone fixation cerclage.

(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.