Grappler Suture Anchor R3FLEX IOL System by Paragon 28, Inc.

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, Ulnar or Radial Collateral Ligament Reconstruction, TFCC

Foot/Ankle: Lateral Stabilization (Brostrom, Brostrom-Gould, Christman-Snook Repair), Ankle Ligament Repair, Medial Stabilization (Deltoid, Spring Ligament Repair), Achilles Tendon Repair, Metatarsal Ligament Repair, Syndesmosis Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction, LisFranc Repair

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Extra Capsular Reconstruction, Patellar Ligament and Tendon Avulsion Repair

Hip: Capsular Repair, Acetabular Labral Repair

The plate interacting anchors are only indicated for the above Hand/Wrist and Foot/Ankle indications.

Device Description

The Grappler Suture Anchor R3FLEX IOL System consists of suture anchors, suture, and the accompanying instrumentation for the intended use of soft tissue damage repair. The anchors are provided in titanium and all-suture and are connected by suture composed of UHMWPE.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the Grappler Suture Anchor R3FLEX IOL System. It is a submission to the FDA (Food and Drug Administration) for clearance to market the device. The document states that the device is substantially equivalent to previously cleared predicate devices.

Here's an analysis of the provided text in relation to your request about acceptance criteria and supporting studies:

This document does not contain the detailed information you are requesting about acceptance criteria and study particulars for an AI/software-based medical device. This submission is for a physical medical device (suture anchors) and not an AI or software product.

The relevant section in the document for performance testing is:

Performance Testing:

"Engineering analysis is presented to provide evidence that the original testing and subsequent performance is not adversely affected by the modifications to the subject devices. Specifically, an analysis was presented for Suture Abrasion and Dynamic Axial Dissociation Testing. The results of this testing demonstrate the subject device is substantially equivalent to the predicate devices. Bacterial endotoxin testing was conducted and the test results meet acceptance criteria of FDA recognized standards."

Given the nature of the device (suture anchors), the "acceptance criteria" and "study" mentioned refer to engineering and biocompatibility tests for the physical product, not clinical performance studies or AI algorithm validation studies.

Therefore, I cannot populate the table or answer most of your detailed questions regarding AI/software performance acceptance criteria and studies because this information is not present in the provided text, as it's not applicable to this type of device submission.

However, I can extract what is mentioned about the performance testing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance (Summary from text)
Mechanical Performance	Engineering analysis demonstrated that the original testing and subsequent performance were not adversely affected by device modifications. Results of Suture Abrasion and Dynamic Axial Dissociation Testing demonstrated substantial equivalence to predicate devices.
Material Biocompatibility	Bacterial endotoxin testing was conducted, and test results met acceptance criteria of FDA recognized standards.

Regarding the other questions, the document does not provide the requested information because it pertains to a physical medical device, not an AI/software product.

Here's why the specific questions cannot be answered from the provided text:

2. Sample size used for the test set and data provenance: This is relevant for AI model testing with patient data. For a physical device, 'test set' usually refers to samples tested in an engineering lab. The document does not specify sample sizes for the Suture Abrasion, Dynamic Axial Dissociation, or Bacterial Endotoxin tests. Data provenance (country, retrospective/prospective) is not applicable or specified for these types of engineering tests.
3. Number of experts used to establish the ground truth... and qualifications: Not applicable. Ground truth for a physical device's mechanical or biocompatibility performance is established by engineering standards and laboratory measurements, not expert consensus on interpretations of data.
4. Adjudication method: Not applicable for engineering tests.
5. Multi-reader multi-case (MRMC) comparative effectiveness study... human readers improve with AI vs without AI assistance: Not applicable. This is for AI-assisted diagnostic or interpretive devices.
6. Standalone (algorithm only without human-in-the-loop performance): Not applicable, as there is no algorithm, only a physical device.
7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this physical device, the "ground truth" would be the established engineering specifications and biological safety standards that the device must meet, verified through laboratory testing.
8. Sample size for the training set: Not applicable, as there is no AI model or training set.
9. How the ground truth for the training set was established: Not applicable, as there is no AI model or training set.

In summary, the provided FDA 510(k) clearance letter and summary are for a physical medical device (suture anchors) and thus the content focuses on manufacturing, materials, and mechanical performance testing to demonstrate substantial equivalence, not on AI/software performance criteria or studies.

Summary

{0}------------------------------------------------

March 26, 2024

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Paragon 28, Inc. Edward Wells-Spicer Regulatory Affairs Specialist II 14445 Grasslands Dr. Englewood, Colorado 80112

Re: K240594

Trade/Device Name: Grappler Suture Anchor R3FLEX IOL System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: March 1, 2024 Received: March 4, 2024

Dear Edward Wells-Spicer:

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"

{1}------------------------------------------------

(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 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 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.

Jesse Muir -S Digitally signed by Jess
Date: 2024.03.26 11:47:

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

{2}------------------------------------------------

Enclosure

{3}------------------------------------------------

Indications for Use

Submission Number (if known)

K240594

Device Name

Grappler Suture Anchor R3FLEX IOL System

Indications for Use (Describe)

The Grappler Suture Anchor R3FLEX IOL System is intended for the fixation of soft tissue to bone including:

Elbow: Biceps Tendon Reattachment, Lateral Epicondylitis Repair, Tennis Elbow Repair

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, Ulnar or Radial Collateral Ligament Reconstruction, TFCC

Hip: Capsular Repair, Acetabular Labral Repair

The plate interacting anchors are only indicated for the above Hand/Wrist and Foot/Ankle
indications.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number.

{4}------------------------------------------------

510(K) SUMMARY

Manufacturer:	Paragon 28, Inc.
	14445 Grasslands Dr.
	Englewood, CO 80112
Contact:	Edward (E.J.) Wells-Spicer
	Regulatory Affairs Specialist II
	Paragon 28, Inc.
	14445 Grasslands Dr.
	Englewood, CO 80112
	Phone: 720-994-5481
	ewspicer@paragon28.com
Date Prepared:	March 21, 2024
Device Trade Name:	Grappler Suture Anchor R3FLEX IOL System
Device Class andCommon Name:	Class II, Fastener, Fixation, Nondegradable, Soft Tissue
Classification:	21 CFR 888.3040: Smooth or threaded metallic bone fixationfastener
Product Codes:	MBI
Indications for Use:	The Grappler Suture Anchor R3FLEX IOL System isintended for the fixation of soft tissue to bone including:
	Elbow: Biceps Tendon Reattachment, Lateral EpicondylitisRepair, Tennis Elbow Repair
	Shoulder: Rotator Cuff Repair, Bankart Repair, SLAPLesion Repair, Biceps Tenodesis, Acromio-ClavicularSeparation Repair, Deltoid Repair, Capsular Shift orCapsulolabral Repair
	Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnaror Radial Collateral Ligament Reconstruction, TFCC.
	Foot/Ankle: Lateral Stabilization (Brostrom, Brostrom-Gould, Christman-Snook Repair), Ankle Ligament Repair,
	Medial Stabilization (Deltoid, Spring Ligament Repair),Achilles Tendon Repair, Metatarsal Ligament Repair,Syndesmosis Repair, Hallux Valgus Reconstruction, DigitalTendon Transfers, Mid-foot Reconstruction, LisFrancRepair
	Knee: Medial Collateral Ligament Repair, Lateral CollateralLigament Repair, Posterior Oblique Ligament Repair,Iliotibial Band Tenodesis, Extra Capsular Reconstruction,Patellar Ligament and Tendon Avulsion Repair
	Hip: Capsular Repair, Acetabular Labral Repair
	The plate interacting anchors are only indicated for the aboveHand/Wrist and Foot/Ankle indications.
Device Description:	The Grappler Suture Anchor R3FLEX IOL System consistsof suture anchors, suture, and the accompanyinginstrumentation for the intended use of soft tissue damagerepair. The anchors are provided in titanium and all-sutureand are connected by suture composed of UHMWPE.
Predicate Device:	Grappler Suture Anchor R3FLEX IOL System (K223589)
Secondary PredicateDevice:	Grappler Suture Anchor System (K211002)
SubstantialEquivalence:	The Grappler Suture Anchor R3FLEX IOL System aresubstantially equivalent to the primary predicate GrapplerSuture Anchor R3FLEX IOL System (K223589) andsecondary predicate Grappler Suture Anchor System(K211002) with respect to indications, design, material andfunction.
Performance Testing:	Engineering analysis is presented to provide evidence thatthe original testing and subsequent performance is notadversely affected by the modifications to the subjectdevices. Specifically, an analysis was presented for SutureAbrasion and Dynamic Axial Dissociation Testing. Theresults of this testing demonstrate the subject device issubstantially equivalent to the predicate devices. Bacterialendotoxin testing was conducted and the testresults meet acceptance criteria of FDA recognized standards.
Conclusions:	The Grappler Suture Anchor R3FLEX IOL System subject tothis submission possesses the same intended use and

{5}------------------------------------------------

{6}------------------------------------------------

technological characteristics as the predicate device system components. All performance testing conducted for the Grappler Suture Anchor R3FLEX IOL System met the predetermined acceptance criteria or were otherwise considered acceptable. As such, the Grappler Suture Anchor R3FLEX IOL System components are substantially equivalent to the predicate devices for the intended use.

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.