The Multi-Drive Interference Screw System is intended for soft tissue reattachment, i.e. fixation of ligament and tendon graft tissue and tendon transfers in surgeries of the shoulder, elbow, knee, foot/ankle, and hand /wrist. Specifically:

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

Foot/Ankle:
Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus Transfer for Achilles Tendon Reconstruction, and Flexor Digitorum Longus Transfer for Posterior Tibial Tendon Reconstruction

Knee:
Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis

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

Hand/Wrist:
Scapholunate Ligament Reconstruction, Unar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs. Ligament Reconstruction and Tendon Interposition

Device Description

The Multi-Drive Interference Screw System is a family of interference screws for the reattachment and fixation of tissue in surgeries of the shoulder, elbow, knee, foot/ankle, and hand /wrist. The interference screws are manufactured from HA Enhanced PEEK or titanium alloy in multiple lengths and diameters with key features including a threaded shank, cannulation hole, and multiple drive mating interface. The HA PEEK versions also incorporate tantalum pins for imaging visibility.

AI/ML Overview

The provided text is a 510(k) summary for the Multi-Drive Interference Screw System. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study.

Therefore, many of the requested categories for a study proving acceptance criteria cannot be extracted from this document, as a clinical study with detailed performance metrics was not performed or described.

Here's an analysis based on the information available in the text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria for device performance. Instead, it relies on non-clinical testing to demonstrate substantial equivalence to predicate devices. The "performance" is implicitly that the device performs comparably to or within the established safety and effectiveness profile of the predicate devices.

Acceptance Criteria Category	Reported Device "Performance" (demonstrates equivalence)
Mechanical Strength	- Insertion testing- Insertion/removal torque- Static axial pullout- Engineering analysis comparison of mechanical strength
Biocompatibility	- Pyrogenicity testing (LAL method), with < 20 EU/device bacterial endotoxins

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided as the document describes non-clinical engineering and laboratory tests, not a clinical study on a human test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable/not provided as the document does not describe a study involving expert assessment or ground truth establishment for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/not provided as the document does not describe a study involving expert assessment or ground truth establishment for a test set.

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 study was not done. This device is a physical medical implant (interference screw), not an AI-assisted diagnostic or therapeutic device.

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

This information is not applicable/not provided as the device is not an algorithm but a physical implant.

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

The concept of "ground truth" as typically used in AI/diagnostic studies is not directly applicable here. For mechanical testing, the "ground truth" is derived from established engineering standards (ASTM F543) and testing methodologies to determine physical properties and performance characteristics (e.g., torque values, pullout strength). For biocompatibility, the "ground truth" is adherence to endotoxin limits defined by standards (ANSI/AAMI ST72:2011/R2016).

8. The sample size for the training set

This information is not applicable/not provided. There is no training set mentioned, as this is not an AI/machine learning device.

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

This information is not applicable/not provided. There is no training set mentioned, as this is not an AI/machine learning device.

Summary

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November 10, 2020

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of it.

Nvision Biomedical Technologies, Inc % Jeffrey Brittan Vice President of Product Realization Watershed Idea Foundry 1815 Aston Avenue, Suite 106 Carlsbad, California 92008

Re: K200428

Trade/Device Name: Multi-Drive Interference Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: October 14, 2020 Received: October 15, 2020

Dear Mr. Brittan:

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 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,

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) K200428

Device Name Multi-Drive Interference Screw System

Indications for Use (Describe)

Shoulder:

Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Sepair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

Foot/Ankle:

Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus Transfer for Achilles Tendon Reconstruction, and Flexor Digitorum Longus Transfer for Posterior Tibial Tendon Reconstruction

Knee:

Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis

Elbow:

Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction

Hand/Wrist:

Scapholunate Ligament Reconstruction, Unar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs. Ligament Reconstruction and Tendon Interposition

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/4/Picture/0 description: The image shows the logo for Nvision Biomedical Technologies. The logo features a stylized letter N with a series of short, parallel lines extending from the left side of the N. The text "VISION" is written in a bold, sans-serif font to the right of the N. Below the main logo, the words "biomedical technologies" are written in a smaller, elegant font.

510(k) Number: K200428 Date Received: 02/24/2020

K200428 Page 1 of 3

510(k) Summary

DATE PREPARED

October 22, 2020

MANUFACTURER AND 510(k) OWNER

Nvision Biomedical Technologies, Inc. 4590 Lockhill Selma San Antonio, TX 78249, USA Telephone: (210) 545-3713 Fax: (866) 764-1139 Official Contact: Diana Langham, Director of Regulatory and Corporate Compliance

REPRESENTATIVE/CONSULTANT

Jeffrey Brittan Vice President of Product Realization Watershed Ideas Foundry Telephone: (714) 287-6780 Email: jeffbrittan@watershedideas.com

PROPRIETARY NAME OF SUBJECT DEVICE

Multi-Drive Interference Screw System

COMMON NAME Interference Screw (fastener, fixation, nondegradable, soft tissue)

DEVICE CLASSIFICATION

Smooth or threaded metallic bone fixation fastener (Classification Regulations: 21 CFR 888.3040, Product Code: MBI, Class: II)

PREMARKET REVIEW

Orthopedic Devices

INDICATIONS FOR USE

Shoulder:

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

Foot/Ankle:

Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus

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Image /page/5/Picture/0 description: The image is a logo for Nvision biomedical technologies. The logo features a stylized letter N with a series of horizontal lines emanating from it. The word "vision" is written in a modern, sans-serif font to the right of the N. Below the word "vision" is the phrase "biomedical technologies" in a smaller, serif font.

Transfer for Achilles Tendon Reconstruction, and Flexor Digitorum Longus Transfer for Posterior Tibial Tendon Reconstruction

Knee:

Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis

Elbow:

Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction

Hand/Wrist:

Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs. Ligament Reconstruction and Tendon Interposition

DEVICE DESCRIPTION

PREDICATE DEVICE IDENTIFICATION

The Multi-Drive Interference Screw System is substantially equivalent to the following predicates:

510(k) Number	Predicate Device Name & Manufacturer	PrimaryPredicate
K183690	Paragon 28's Tenodesis Screw System	✓
K180573	Responsive Arthroscopy's Interference Screw System
K170877	Parcus Medical's SLIK Fix Interference Screw

The following reference devices are also cited in this submission:

Nvision Biomedical's Vector Hammertoe Correction System (K183055)
Nvision Biomedical's Trigon™ Ti Stand-Alone Wedge Fixation System (K192645) ●
Nvision Biomedical's Healix Compression Screw System (K182949) ●

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Image /page/6/Picture/0 description: The image shows the logo for NVision biomedical technologies. The logo has a stylized "N" with horizontal lines in gold and black. The word "VISION" is in a sans-serif font in black, and the words "biomedical technologies" are in a smaller font in gold below the main logo.

SUMMARY OF NON-CLINICAL TESTING

No FDA performance standards have been established for the Multi-Drive Interference Screw System. The following testing was performed:

. Mechanical testing in accordance with ASTM F543 including insertion testing, insertion/removal torque, and static axial pullout
Engineering analysis comparison of mechanical strength
. Pyrogenicity testing (LAL method), with results demonstrating bacterial endotoxins less than 20 EU/device in accordance with ANSI/AAMI ST72:2011/R2016

The results of these tests indicate that the Multi-Drive Interference Screw System is substantially equivalent to the predicate devices.

EQUIVALENCE TO PREDICATE DEVICES

Nvision believes that the Multi-Drive Interference Screw System is substantially equivalent to the identified predicate devices. The subject device has similar dimensions, and uses similar or identical materials. The subject device has the same indications for use and intended use, as well as similar technological characteristics (threaded screws in a range of diameters and lengths with a mating interface and central cannulation hole). The subject screw incorporates a multi-drive mating interface while the predicates utilize a single drive, and although this multi-drive offers additional options for insertion/removal, it utilizes the equivalent operating principle and function. These technological characteristics have undergone testing/analysis to ensure the subject device is equivalent to the predicates.

CONCLUSION

Based on the testing performed, including engineering analysis of mechanical strength, it can be concluded that the subject device does not raise new issues of safety or efficacy compared to the predicate devices. The similar indications for use, technological characteristics, and performance characteristics for the proposed Multi-Drive Interference Screw System are assessed to be substantially equivalent to the predicate devices.

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.