The Iconix® HA+™ anchors are intended to be used for soft-tissue to bone fixation in the foot, ankle, knee, hip, hand, wrist, elbow and shoulder. Specific indications are listed below.

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Repair

Hand Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, Digital Tendon Repar

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction

Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair. Iliotibial Band Tenodesis. Medial Patellofemoral Ligament (MPFL) Repair/ Reconstruction, Quadriceps Tendon Repair

Hip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair, Proximal Hamstring Repair

Device Description

The Iconix® HA*TM Anchor is comprised of a suture sleeve structure and working suture. Nonabsorbable braided ultra-high molecular weight polyethylene (UHMWPE) sutures are spliced through a suture anchor sleeve comprised of non-absorbable braided polyester and bioceramics. Up to two non- absorbable round or flat braided UHMWPE working sutures can be added inside the suture anchor sleeve. The UHMWPE sutures are available undyed (white) and black.

Sutures 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 over molded handle. The device is sterilized by ethylene oxide gas and is provided sterile for single use. Iconix® HA*M Anchors are available in common sizes and lengths 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.

AI/ML Overview

This document describes the validation study for the Iconix® HA+TM Anchor, a medical device used for soft-tissue to bone fixation. This is a 510(k) Pre-market Notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness. Therefore, the "acceptance criteria" and "device performance" are primarily demonstrated through comparison to the predicate and established performance benchmarks for such devices, rather than a clinical accuracy study for AI/software.

Here's the breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a mechanical device, not an AI/software device, the "acceptance criteria" and "reported device performance" are primarily based on meeting established standards and demonstrating comparable mechanical properties to a predicate device.

Acceptance Criteria Category	Specific Test/Standard	Reported Device Performance
Material Performance	UHMWPE sutures meet USP requirements for non-absorbable suture (except for diameter)	UHMWPE sutures tested per USP performance requirements for tensile strength. (Implicitly, the device met these, as it concluded substantial equivalence.)
Biocompatibility	ISO 10993-1:2018 - Biological Evaluation of Medical Devices	Biocompatibility testing performed per ISO10993-1:2018. An animal study was also performed. (Implicitly, the device met these, demonstrating biological safety.)
Sterilization	Sterilization adoption validation (likely internal protocol based on recognized standards)	Sterilization adoption validation performed. Device is sterilized by ethylene oxide gas and provided sterile. (Implicitly, the device met these.)
Packaging	ISO 11607-1:2006 - Packaging for terminally sterilized medical devices	Stability testing on product packaging per ISO 11607-1:2006. (Implicitly, the device met these.)
Usability	EN 62366: 2015 - Medical devices - Application of usability engineering	Usability engineering validation with simulated use in cadaveric models performed per EN62366:2015. (Implicitly, the device met these.)
Endotoxin/Pyrogenicity	ANSI/AAMI ST72:2019, USP <161>, USP <151>, USP <85>	Endotoxin/pyrogenicity testing performed per specified standards. (Implicitly, the device met these.)
Mechanical Fixation	Comparison to predicate device (K173074) for insertion, cyclic, and pullout testing	"Results of performance testing for the Iconix® HA+TM Anchor device concluded that the device performed comparably to the predicate device and to other currently marketed All-Suture anchor devices in insertion, cyclic and pullout testing and the validations performed demonstrated that the Iconix® HA+TM Anchor met all requirements for its intended use."

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

The provided document describes non-clinical performance testing and an animal study. It does not describe a clinical study with a human-derived test set in the way an AI/software device would.

Non-clinical Mechanical Testing: The sample sizes for insertion, cyclic, and pullout testing are not specified. The studies were performed to compare against the predicate device.
Animal Study: The sample size for the animal study is not specified. The purpose was to evaluate biological safety and in vivo performance.
Data Provenance: The document implies these were prospective laboratory and animal studies conducted by the manufacturer, Riverpoint Medical, LLC. There's no mention of country of origin for the data or whether it was retrospective.

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

This question is not applicable in the context of this device and study type.

For non-clinical mechanical testing, the "ground truth" is typically defined by engineering specifications and objective measurements (e.g., force, displacement), not expert interpretation.
For the animal study, "ground truth" would be established through histological analysis, observation of biological responses, and potentially pathological evaluation, conducted by veterinary pathologists or researchers, but this is not explicitly detailed as "experts establishing ground truth" in the sense of a diagnostic interpretation task.

4. Adjudication Method for the Test Set

This is not applicable. There was no human "test set" requiring adjudication in the context of an AI/software performance study. Mechanical and biological test results are typically objectively measured against defined criteria.

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 is not applicable. This device is a physical bone anchor, not an AI/software diagnostic tool. There were no human "readers" involved in interpreting findings from the device itself.

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

This is not applicable. This device is a physical bone anchor, not an algorithm or software. The mechanical and biological tests assess the device's inherent function, which is a "standalone" evaluation of its physical properties.

7. The Type of Ground Truth Used

Mechanical Testing: Ground truth was based on objective engineering measurements (e.g., load-to-failure, displacement) and comparison to the predicate device's established performance and industry standards for bone anchors.
Biocompatibility/Animal Study: Ground truth was based on biological responses and safety profiles observed in the animal model, likely through histological analysis, gross observations, and clinical pathology, evaluated against established safety benchmarks for implantable materials.
Suture Testing: Ground truth was based on United States Pharmacopeia (USP) requirements for tensile strength.

8. The Sample Size for the Training Set

This is not applicable. This is a physical device, not an AI/software model that requires a training set.

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

This is not applicable, as there was no training set.

Summary

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October 5, 2023

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services-USA. To the right, the FDA logo is displayed in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" written in a clear, sans-serif font. The overall design is clean and professional, reflecting the organization's role in public health and safety.

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

Re: K231078

Trade/Device Name: All-Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: September 7, 2023 Received: April 17, 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 (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 OS 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 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,

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

510(k) Number (if known) K231078

Device Name Iconix® HA+TM Anchor

Indications for Use (Describe)

The Iconix® HA+™ anchors are intended to be used for soft-tissue to bone fixation in the foot, ankle, knee, hip, hand, wrist, elbow and shoulder. Specific indications are listed below.

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Repair

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction

Hip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair, Proximal Hamstring 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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K231078

ERPOINT

510(k) SUMMARY

Iconix® HA+TM Anchor

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:	April 14, 2023

Device Name

Trade Name:	Iconix® HA+TM 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 FixationFastener
Classification Code:	MBI
Review Panel	Orthopedic
Premarket Review	Center for Device and Radiological HealthOffice of Health Technology (OHT6: Orthopedic Devices)Division of Health Technology 6C Restorative, Repair andTrauma Devices

Predicate Device

K173074 – ICONIX XBraid TT Suture Anchor

Reference Devices

K190025 EVOL® -SI Joint Fusion System K101225 - Promimic Dental Implant K150321 - EVOS Lumbar Interbody System K112526 - TWINFIX HA suture anchors

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Device Description

The classification for the Iconix® HA*™ 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 and Indications for Use

The Iconix® HA*TM Anchors are intended to be used for soft-tissue to bone fixation in the foot, ankle, knee, hip, hand, wrist, elbow and shoulder. Specific indications are listed below.

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Repair

Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, Digital Tendon Repair

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Medial Patellofemoral Ligament (MPFL) Repair/ Reconstruction, Quadriceps Tendon Repair

Hip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair, Proximal Hamstring Repair

Performance Data

The sutures used to construct the Iconix® HA*™ Anchor meet requirements established by the United States Pharmacopeia (USP), except for diameter. The UHMWPE sutures are tested per USP performance requirements for tensile strength.

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RIVERPOINT

FDA Guidance "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.

Non-clinical performance testing for the Iconix® HA+TM Anchor included a sterilization adoption validation, biocompatibility testing per ISO10993- 1:2018 - Biological Evaluation of Medical Devices, stability testing on the product packaging per ISO 11607-1:2006 - Packaging for terminally sterilized medical devices -- Part I: 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. Endotoxin/pyrogenicity testing was performed per ANSI/AAMI ST72:2019, USP <161>, USP <151> and USP <85>.

Non-clinical mechanical testing was performed to verify the fixation strength of the Iconixe HA+1M Anchor using insertion, cyclic and pullout testing as compared to the predicate device. Results of performance testing for the Iconix® HA*™ Anchor device concluded that the device performed comparably to the predicate device and to other currently marketed All-Suture anchor devices in insertion, cyclic and pullout testing and the validations performed demonstrated that the Iconix® HA1M Anchor met all requirements for its intended use. An animal study was performed to evaluate the biological safety associated with the Iconix® HATM Anchor. The animal study demonstrated substantially equivalent biological safety and in vivo performance.

Substantial Equivalence and Comparison of Technical Characteristics

The Iconix® HA TM Anchor is substantially equivalent to the previously cleared ICONIX XBraid TT Suture Anchor cleared per K173074 "predicate device." The Iconix® HA110 Anchor has the same intended use, same principles of operation, and similar technological characteristics as the predicate device. The Iconix® HA+™ Anchor "subject device" contains slight technological differences and indications statement from the predicate device but are within the range of currently marketed devices, and they have been assessed through risk analysis, not raising any new questions of safety or effectiveness.

Therefore, the Iconix® HA*™ Anchor "subject device" is substantially equivalent to the predicate device in both technological characteristics and intended use and does not raise any issues of safety or effectiveness.

	Riverpoint MedicalIconix® HA+TM Anchor"Subject Device"	Stryker ICONIX XBraid TTSuture Anchor"Predicate Device" (K173074)
Intended Use	The Iconix® HA+TM Anchors areindicated for use in soft tissue tobone fixation.	The Stryker ICONIX Xbraid TTwith needles devices are intendedto be used for soft-tissue to bonefixation.
Principle of Operation	Preparation of pilot hole, manualinsertion of inserter and deploymentof anchor.	Preparation of pilot hole, manualinsertion of inserter anddeployment of anchor.
Suture Materials	UHMWPE	UHMWPE

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RPOINT

	Riverpoint MedicalIconix® HA+TM Anchor"Subject Device"	Stryker ICONIX XBraid TTSuture Anchor"Predicate Device" (K173074)
Range of Suture Size	For the 1.4mm anchor: 1.2mm, #2For the 2.3mm anchor: 1.8mm or #2	For the 1.4mm anchor: 1.2mm, #2For the 2.3mm anchor: 1.8mm or#2
Anchor Materials	Polyester with bioceramics	Polyester
Anchor Geometry	Cylindrical sleeve	Cylindrical sleeve
Anchor Sizes	1.4mm and 2.3mm	1.4mm and 2.3mm
Method of Fixation ofSuture toAnchor	Splicing of suture through anchor	Splicing of suture through anchor
Inserter Material	Stainless steel with polymer handle	Stainless steel with polymerhandle
Regulation Number	888.3040	888.3040
Regulatory Class	II	II
Prescription or OTC	Prescription	Prescription
Product Code	MBI	MBI
Packaging	Tyvek/Poly Pouch	Tyvek/Poly Pouch
Sterilization	EtO Sterilization	EtO Sterilization

Conclusion

The information provided in this Traditional 510(k) demonstrates that the Iconix® HA+TM Anchor 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.