(143 days)
The ULTRABUTTON QUAD, BB, and TIB Adjustable Fixation Devices are indicated for soft tissue to bone or bone-tendon to bone fixation for: ACL/PCL Repair/Reconstruction and soft tissue to bone fixation for Extracapsular Repair: MCL, LCL.
The Smith & Nephew ULTRABUTTON QUAD, BB, and TIB Adjustable Fixation Devices consist of an ultra-high molecular weight polyethylene graft suspension loop and a titanium cortical button. The devices facilitate knee ligament repair/reconstruction through placement and retention of soft tissue or bone-tendon within bone.
The ULTRABUTTON QUAD Adjustable Fixation Device and the ULTRABUTTON BB Adjustable Fixation Device is available in one size. The UTLRABUTTON TIB Adjustable Fixation Device is available in a small, medium, or large size.
The provided text does not contain information about acceptance criteria and a study proving a device meets them in the context of an AI/ML-based medical device. Instead, it is an FDA 510(k) clearance letter and summary for a physical medical device: the ULTRABUTTON QUAD, BB, and TIB Adjustable Fixation Devices.
Therefore, I cannot extract the requested information regarding:
- A table of acceptance criteria and reported device performance (for an AI/ML device)
- Sample size used for the test set and data provenance
- Number and qualifications of experts for ground truth
- Adjudication method
- MRMC comparative effectiveness study results
- Standalone performance
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
The available text describes the device, its intended use, indications for use, and a summary of performance data for non-clinical testing to demonstrate substantial equivalence to a predicate device. This performance data relates to mechanical and material characteristics of the physical device, not an AI algorithm.
Specifically, the "Summary of Performance Data" section states:
- "Device cyclic displacement, device repair strength, and construct stiffness met the acceptance criteria established by the predicate device (K153186)."
- "Biocompatibility testing per ISO 10993-1:2018 demonstrated passing results."
- "Bacterial endotoxin testing was completed and met acceptable limits per ANSI/AAMI ST72:2019."
- "The devices have a three (3) year shelf-life. Storage and stability is based on completed packaging material storage stability testing, device storage stability testing, and distribution testing. Packaging testing per ISO 11607-1:2019 demonstrated passing results."
- "Sterile adoption was completed per ISO 11135:2014+A1:2018."
These are typical performance tests for surgical fixation devices to ensure mechanical integrity, biocompatibility, sterility, and shelf-life, not for assessing the diagnostic or predictive performance of an AI algorithm.
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February 17, 2023
Image /page/0/Picture/1 description: The image contains 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 is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Smith & Nephew Inc Dongeun Lopresti Senior Regulatory Affairs Specialist 150 Minuteman Road Andover, Massachusetts 01810
Re: K222971
Trade/Device Name: ULTRABUTTON OUAD Adjustable Fixation Device: ULTRABUTTON BB Adjustable Fixation Device; ULTRABUTTON TIB Adjustable Fixation Device Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: September 26, 2022 Received: September 27, 2022
Dear Ms. Dongeun Lopresti:
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
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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 (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 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,
Sara S. Thompson -S
For
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) K222971
Device Name
ULTRABUTTON QUAD Adjustable Fixation Device; ULTRABUTTON BB Adjustable Fixation Device; ULTRABUTTON TIB Adjustable Fixation Device
Indications for Use (Describe)
The ULTRABUTTON QUAD, BB, and TIB Adjustable Fixation Devices are indicated for soft tissue to bone or bonetendon to bone fixation for: ACL/PCL Repair/Reconstruction and soft tissue to bone fixation for Extracapsular Repair: MCL, LCL.
| 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)
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510(k) Summary
February 16, 2023
| Submitter Information | Contact Information |
|---|---|
| Smith & Nephew, Inc. | Ms. Dongeun LoPresti |
| Endoscopy Division | Senior Regulatory Affairs Specialist |
| 150 Minuteman Road | (412)-683-3844 |
| Andover, MA 01810 |
| Device Name & Classification | |
|---|---|
| Proprietary Name | ULTRABUTTON ◊ QUAD Adjustable Fixation DeviceULTRABUTTON BB Adjustable Fixation DeviceULTRABUTTON TIB Adjustable Fixation Device |
| Common Name | Fastener, Fixation, Nondegradable, Soft Tissue |
| Classification Name | Smooth or threaded metallic bone fixation fastener |
| Classification Regulation | 21 CFR 888.3040 |
| Class | 2 |
| Product Code | MBI |
| Panel | Orthopedic Devices (OHT6) |
Legally Marketed Predicate Device
The Smith & Nephew ULTRABUTTON QUAD, BB, and TIB Adjustable Fixation devices are substantially equivalent in intended use and fundamental scientific technology to the following legally marketed predicate device:
| Description | Submission Number | Clearance Date |
|---|---|---|
| Adjustable Fixation Device | K153186 | January 1, 2016 |
Device Description
The Smith & Nephew ULTRABUTTON QUAD, BB, and TIB Adjustable Fixation Devices consist of an ultra-high molecular weight polyethylene graft suspension loop and a titanium cortical button. The devices facilitate knee ligament repair/reconstruction through placement and retention of soft tissue or bone-tendon within bone.
The ULTRABUTTON QUAD Adjustable Fixation Device and the ULTRABUTTON BB Adjustable Fixation Device is available in one size. The UTLRABUTTON TIB Adjustable Fixation Device is available in a small, medium, or large size.
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Intended Use
The ULTRABUTTON QUAD, BB, and TIB Adjustable Fixation Devices are intended for soft tissue to bone or bone-tendon to bone fixation.
Indications for Use
The ULTRABUTTON QUAD, BB, and TIB Adjustable Fixation Devices are indicated for soft tissue to bone or bone-tendon to bone fixation for: ACL/PCL Repair/Reconstruction and soft tissue to bone fixation for Extracapsular Repair: MCL, LCL.
Technological Characteristics
The Smith & Nephew ULTRABUTTON QUAD, BB, and TIB Adjustable Fixation Devices are substantially equivalent to the predicate Smith & Nephew Adjustable Fixation Device (K153186). Technological characteristics such as intended use, indications for use, sterilization method, and shelf-life are identical to the predicate device. There are minor changes in technological characteristics, such as design and material, compared to the predicate device. However, performance data demonstrates that the ULTRABUTTON QUAD, BB, and TIB Adjustable Fixation Devices are substantially equivalent to the predicate device in these regards, and raise no new or different questions of safety and effectiveness.
Summary of Performance Data
- Device cyclic displacement, device repair strength, and construct stiffness met the ● acceptance criteria established by the predicate device (K153186).
- Biocompatibility testing per ISO 10993-1:2018 demonstrated passing results. ●
- Bacterial endotoxin testing was completed and met acceptable limits per ANSI/AAMI ST72:2019.
- The devices have a three (3) year shelf-life. Storage and stability is based on completed ● packaging material storage stability testing, device storage stability testing, and distribution testing. Packaging testing per ISO 11607-1:2019 demonstrated passing results.
- Sterile adoption was completed per ISO 11135:2014+A1:2018. ●
Conclusion
There is no change in intended use, indications for use, sterilization method, and shelf-life. Changes in design and material are minor, and do not raise new or different questions of safety and effectiveness compared to the predicate device. The non-clinical testing has demonstrated that the ULTRABUTTON QUAD, BB, and TIB Adjustable Fixation Devices are substantially equivalent to their predicate device.
N/A