(149 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and biocompatibility of a physical implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is used for the fixation of soft tissue to bone in orthopedic procedures like ACL repair, which describes a therapeutic function.
No
The device description indicates that the Button Loop is a "machined titanium implant designed to provide fixation in the repair of tendons and ligaments." Its intended use is "for the fixation of soft tissue to bone in orthopedic procedures such as ACL repair." This describes a surgical implant used for structural support, not for diagnosing conditions.
No
The device description clearly states it is a "machined titanium implant" and describes physical components like a button and loop, indicating it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Button Loop Function: The Button Loop is a surgical implant used within the body to fix soft tissue to bone during orthopedic procedures. It does not analyze any biological samples.
The description clearly states its use in surgical procedures and its function as a mechanical fixation device.
N/A
Intended Use / Indications for Use
The Button Loop is used for the fixation of soft tissue to bone in orthopedic procedures such as ACL repair.
Product codes
MBI
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 cytotoxicity
- ISO 10993-6: 2016 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
- 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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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
2
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) |
|---|---|
| --------------------------------------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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
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and review the collection of information. Send comments regarding this burden estimate or any other aspect
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"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."
Type of Use (Select one or both, as applicable)
3
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
-
- Date of Preparation: 12/16/2020
-
- 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
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person)
- Designated Submission Correspondent
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
4
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
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.
-
ર. Identification of Predicate Device
510(k) Number: K130814 Product Name: RIGIDLOOP Cortical Fixation System -
- 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:
- Non-Clinical Test Conclusion
-
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
5
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 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.
-
- Clinical Test Conclusion
No clinical study is included in this submission.
- Clinical Test Conclusion
6
| 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 the | |
| fixation of soft tissue to bone in | ||
| orthopedic procedures such as ACL | ||
| repair. | The RIGIDLOOP™ Cortical | |
| Fixation System is used for the | ||
| fixation of soft tissue to bone in | ||
| orthopedic procedures such as | ||
| ACL repair. | ||
| Composition | Button | |
| Loop | ||
| Suture | Button | |
| Loop | ||
| Suture | ||
| 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
7
-
- 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.
- Substantially Equivalent (SE) Conclusion