The HEALIX Compression Screw (HCS) System is indicated for Bone Fractures, Osteotomies, Arthrodeses, Osteochondritis, and Tendon Reattachment. It is intended for, but not limited to, Hand Surgery, Orthopedic Surgery, and Podiatric Surgery but is not intended for attachment or fixation to the posterior elements (pedicles) of the spine.

Device Description

The Healix Compression Screw (HCS) System consists of cannulated, solid titanium allov. headless, headed screws and specialized instrumentation. This submission expands the Healix offering and includes longer screws ranging from 31 to 130mm in length for the 2.0 to 7.5mm diameters.

AI/ML Overview

The provided text is a 510(k) summary for the Nvision Biomedical Technologies' Healix Compression Screw System. This document focuses on demonstrating substantial equivalence to predicate devices, primarily through engineering analysis. It does not contain information about acceptance criteria or a study proving that a device meets those criteria in the context of AI/ML or diagnostic performance.

Instead, this document is a regulatory submission for a physical medical device (bone fixation screws) and relies on mechanical performance characteristics and a comparison to existing predicate devices.

Therefore, I cannot extract the requested information (items 1-9) as it pertains to AI/ML device performance from the provided text. The document clearly states:

"No FDA performance standards have been established for the Healix Compression Screw System."
"The following was performed to demonstrate safety per methods of the previous submission: . Engineering analysis comparison of mechanical performance characteristics"
"The results of the engineering analysis indicate that the Healix Compression Screw System is substantially equivalent to the predicate devices."

This indicates the evaluation was based on engineering analysis and comparison against physical predicate devices, not on a study proving a device meets acceptance criteria related to diagnostic performance, human-in-the-loop improvements, or ground truth establishment for AI/ML.

Summary

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May 5, 2020

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

Re: K200914

Trade/Device Name: Healix Compression Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: March 25, 2020 Received: April 6, 2020

Dear Jeffrey 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.

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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 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.

Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K200914

Device Name HEALIX Compression Screw System

Indications for Use (Describe)

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 Nvision Biomedical Technologies. The logo features a stylized "N" with a series of vertical lines to the left of the "N". The rest of the company name, "vision biomedical technologies", is written in a sans-serif font to the right of the "N". The words "biomedical technologies" are written in a smaller font size and in a lighter color than the rest of the logo.

510(k) Summary

DATE PREPARED

April 27, 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 Idea Foundry Telephone: (714) 287-6780 Email: jeffbrittan@watershedideas.com

PROPRIETARY NAME OF SUBJECT DEVICE

Healix™ Compression Screw System

COMMON NAME Bone Fixation Screw System

DEVICE CLASSIFICATION

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

PREMARKET REVIEW

Orthopedic Devices

INDICATIONS FOR USE

DEVICE DESCRIPTION

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Image /page/4/Picture/0 description: The image shows the logo for "Nvision biomedical technologies". The logo has a stylized "N" with a series of short, parallel lines to the left of the "N". The text "biomedical technologies" is in a smaller font size and is located below the main logo. The colors used in the logo are black and gold.

PREDICATE DEVICE IDENTIFICATION

The subject Healix Compression Screw system is substantially equivalent to the following predicates:

510(k) Number	Predicate Device Name / Manufacturer	PrimaryPredicate
K182949	Healix Compression Screw System / Nvision Biomedical	✓
K014154	Vilex Cannulated Bone Screw System
K081149	BioPro GO-EZ Screw System

SUMMARY OF NON-CLINICAL TESTING

No FDA performance standards have been established for the Healix Compression Screw System. The following was performed to demonstrate safety per methods of the previous submission:

. Engineering analysis comparison of mechanical performance characteristics
The results of the engineering analysis indicate that the Healix Compression Screw System is substantially equivalent to the predicate devices.

EQUIVALENCE TO PREDICATE DEVICES

Nvision believes that the Healix Compression Screw System modification is substantially equivalent to the predicate devices. The subject implants maintain the same features as the previously cleared devices but add screw length options that are within the range of the predicates. This modification does not change the intended use or performance of the device and does not raise additional questions of substantial equivalence. These technological characteristics have undergone engineering analysis to ensure the device is as safe and effective as the predicates.

CONCLUSION

Based on the engineering analysis of device characteristics, 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 Healix Compression Screw System options 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.