The proposed device, Button Loop is a machined titanium implant designed to provide fixation in the repair of tendons and ligaments. It consists of a titanium implantable button with a pre-attached loop. This implantable loop has non-absorbable suture attached to the button for assisting in the button placement and is discarded after the device placement. The button is offered in 12mm one size and loop is available in size ranges of 10~60mm in 5mm increments to accommodate different graft sizes.

AI/ML Overview

This FDA 510(k) premarket notification for the "Button Loop" device does not contain information about acceptance criteria or a study proving that the device meets those criteria in the context of an AI/ML algorithm.

The document describes a medical device called the "Button Loop," which is a metallic bone fixation fastener used for soft tissue to bone fixation in orthopedic procedures like ACL repair. The submission is focused on demonstrating substantial equivalence to a predicate device (RIGIDLOOP Cortical Fixation System) based on non-clinical tests (biocompatibility, mechanical tests, sterilization) and technological characteristics.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes for test sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details, as this device is not an AI/ML powered device, nor does the document describe such a study.

The "Non-Clinical Test Conclusion" (Section 6) and "Table 1 Comparison of Technology Characteristics" (Section 7) of the 510(k) summary are the closest to performance evaluation in this document. They cover aspects like mechanical strength, biocompatibility, and sterilization, but these do not involve the types of acceptance criteria and studies typically associated with AI/ML device performance.

Summary

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January 8, 2020

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square are the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" in smaller blue letters below.

Yunyi (Beijing) Medical Device Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd. P.O. Box 120-119 Shanghai. 200120 China

Re: K202291

Trade/Device Name: Button Loop Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: December 16, 2020 Received: December 18, 2020

Dear Ms. Hong:

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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K202291 - Diana Hong

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 (OS) 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 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,

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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Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2020

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

Device Name Button Loop

Indications for Use (Describe)

The Button Loop is used for the fixation of soft tissue to bone in orthopedic procedures such as ACL repair.

☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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Type of Use (Select one or both, as applicable)

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Tab #6 510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

The assigned 510(k) Number: K202291

1. Date of Preparation: 12/16/2020
1. Sponsor Identification

Yunyi (Beijing) Medical Device Co., LTD.

Floor 1-4, Building 4, No. 9 Tianfu Street, Biomedical Base, Daxing District, Beijing 102600, People's Republic of China

Establishment Registration Number: Not registered

Contact Person: Xiaowei Liu Position: Quality Manager Tel: +86-10-57234533 Fax: +86=10-57234533 Email:liuxiaowei@yunyimedical.com

1. Designated Submission Correspondent
  Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person)

Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China

Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net

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4. Identification of Proposed Device

Trade Name: Button Loop Common Name: Fastener, Fixation, Soft Tissue

Regulatory Information

Classification Name: fastener, fixation, nondegradable, soft tissue Classification: II; Product Code: MBI Regulation Number: 21 CFR Part 888.3040 Review Panel: Orthopedic

Indication for Use Statement:

The Button Loop is used for the fixation of soft tissue to bone in orthopedic procedures such as ACL repair.

Device Description

ર. Identification of Predicate Device
510(k) Number: K130814 Product Name: RIGIDLOOP Cortical Fixation System
1. Non-Clinical Test Conclusion
  Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
ISO 10993-3: 2014 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
ISO 10993-5: 2009 Biological evaluation of medical devices - Part 5: Tests for in vitro

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cytotoxicity

ISO 10993-6: 2016 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
A ISO 10993-7: 2008 Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals
ISO 10993-10: 2010 Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization
ISO 10993-11: 2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
USP <85> Bacterial Endotoxins Test
ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
ASTM F88/88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials

Mechanical test has been conducted on the proposed device and predicate device to evaluate its mechanical strength. The mechanical test include fatigue test and static test. The fatigue test evaluate the maximum tensile load and displacement, after fatigue test the static force was tested to evaluate the force when device failure occurred. The test result demonstrated that there was no significant difference between the proposed device and predicate device.

1. Clinical Test Conclusion
  No clinical study is included in this submission.

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Table 1 Comparison of Technology Characteristics
	Proposed Device	Predicate Device
Item	K113091
Product Code	MBI	MBI
Classification	II	II
Regulation Number	CFR 888.3040	CFR 888.3040
Intended Use	The Button Loop is used for thefixation of soft tissue to bone inorthopedic procedures such as ACLrepair.	The RIGIDLOOP™ CorticalFixation System is used for thefixation of soft tissue to bone inorthopedic procedures such asACL repair.
Composition	ButtonLoopSuture	ButtonLoopSuture
Button	12mm	12mm
Loop	10mm, 15mm, 20mm, 25mm, 30mm,40mm, 45mm, 50mm, 55mm, 60mm	15mm, 20mm, 25mm, 30mm,40mm, 45mm, 50mm, 55mm,60mm
Single Use	Single Use	Single Use
Patient contact material
Loop	UHMWPE	UHMWPE
Button	Titanium Alloy	Titanium Alloy
Suture	UHMWPE	PE, polyester
Biocompatibility
Cytotoxicity	No cytotoxicity	Comply with ISO 10993 standards
Intracutaneous Study	No irritation
Sensitization	No sensitization
Pyrogenicity Test	No pyrogenicity
Acute Systemic Toxicity	No systemic toxicity
Bacterial Reverse Mutation	Not induce backward mutation
Gene Mutation Test	Non-mutagenic
Muscle Implantation Test	Non-irritant to the muscle tissue
Subchronic Toxicity Test	No subchronic toxicity
Sterilization
Method	Ethylene Oxide	Ethylene Oxide
SAL	10 $^{-6}$	10 $^{-6}$
Endotoxin Limit	20EU/device	20EU/device
Labeling	Conform with 21 CFR Part 801	Conform with 21 CFR Part 801

8. Substantially Equivalent (SE) Comparison

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1. Substantially Equivalent (SE) Conclusion
  Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) 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.