(25 days)
The Q-FIX? ULTRA All-Suture Anchor is only intended for the reattachment of soft tissue to bone for the following indications:
Foot and Ankle:
· Medial or lateral instability repairs/reconstructions
· Achilles tendon repairs/reconstructions
The Smith & Nephew Q-FIX® ULTRA All-Suture Anchor is a fixation device intended to provide reattachment of soft tissue to bone. The device consists of an all-suture anchor with a preloaded ULTRATAPE® suture assembled inside an insertion device.
The provided text is a 510(k) summary for the Smith & Nephew Q-FIX® ULTRA All-Suture Anchor. This document describes a medical device and its equivalence to existing legally marketed devices, primarily through bench testing. It does not describe an AI/ML powered device, nor does it involve a study with human readers, ground truth establishment, or typical AI acceptance criteria.
Therefore, many of the requested fields cannot be populated as they are not applicable to this type of device submission.
Here's the information that can be extracted, and explanations for why other fields are not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
The document states, "Non-clinical bench testing was completed on the subject device, and the device met all required specifications for each test. Testing included insertion testing, static fixation testing, cyclic loading testing, and knot tensile strength testing. A summary of test acceptance criteria and results have been provided. Results for all tests passed."
However, the specific numerical acceptance criteria and the quantitative results for each test are not provided in this summary. The summary only states that the device "met all required specifications" and that "Results for all tests passed."
| Test Type | Acceptance Criteria (Not Explicitly Stated in Document) | Reported Device Performance (Summary) |
|---|---|---|
| Insertion Testing | Not explicitly stated | Met all required specifications / Passed |
| Static Fixation Testing | Not explicitly stated | Met all required specifications / Passed |
| Cyclic Loading Testing | Not explicitly stated | Met all required specifications / Passed |
| Knot Tensile Strength Testing | Not explicitly stated | Met all required specifications / Passed |
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable as this is a non-clinical bench study on a physical medical device. There is no "test set" in the context of an AI/ML algorithm. The "test set" would refer to the number of physical devices or constructs tested for each bench test. This information is not provided in the summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. There is no "ground truth" to establish for a physical medical device bench test in the context of human expert review. The evaluation criteria are based on engineering specifications and physical measurements.
4. Adjudication Method for the Test Set
Not applicable. There is no "adjudication" required for physical device bench testing in the context of human expert disagreement.
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
Not applicable. This is not an AI/ML powered device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML powered device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
Not applicable. For this type of device, the "ground truth" for performance is based on established engineering principles, material properties, and biomechanical standards against which the device's physical performance is measured.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML powered device. There is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. This is not an AI/ML powered device. There is no "training set" or ground truth in the AI context.
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September 8, 2023
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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Smith & Nephew Catherine Phelan Senior Regulatory Affairs Specialist 150 Minuteman Road Andover, Massachusetts 01810
Re: K232457
Trade/Device Name: Q-FIX ULTRA All-Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI, GAT, HTW Dated: August 14, 2023 Received: August 14, 2023
Dear Catherine Phelan:
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,
Jesse Muir-S
Jesse Muir, 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) K232457
Device Name Q-FIX◊ ULTRA All-Suture Anchor
Indications for Use (Describe)
The Q-FIX? ULTRA All-Suture Anchor is only intended for the reattachment of soft tissue to bone for the following indications:
Foot and Ankle:
· Medial or lateral instability repairs/reconstructions
· Achilles tendon repairs/reconstructions
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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Smith & Nephew, Inc. 150 Minuteman Road Andover, MA 01810 Massachusetts, USA
T:+ 1 978 749 1000 T:+ 1 800 343 8386 (USA toll free) www.smith-nephew.com
Smith Nephew
510(k) Summary
Prepared: 06 September 2023
| Submitter Information | Contact Information |
|---|---|
| Smith & Nephew, Inc. | Ms. Catherine Phelan |
| Endoscopy Division | Senior Regulatory Affairs Specialist |
| 150 Minuteman Road | catherine.phelan@smith-nephew.com |
| Andover, MA 01810. |
| Device Name & Classification | |
|---|---|
| Proprietary Name | Q-FIX ® ULTRA All-Suture Anchor |
| Common Name | Soft Tissue Fixation Device |
| Classification Name | Fastener, fixation, biodegradable, soft tissue;fastener, fixation, nondegradable, soft tissue |
| Classification Regulation | 21 CFR 888.3040 |
| Class | II |
| Product Code(s) | MBI |
| Panel | Orthopedic |
Legally Marketed Predicate Devices
The Smith & Nephew O-FIX® ULTRA All-Suture Anchor is substantially equivalent in intended use and fundamental scientific technology to the following legally marketed devices in commercial distribution:
| Description | Submission Number |
|---|---|
| Q-Fix® Suture Anchor | K172165 |
Legally Marketed Reference Device
| Description | Submission Number |
|---|---|
| ULTRATAPE® Suture | K132357 |
| Q-FIX® with Needles | K231376 |
Device Description
The Smith & Nephew Q-FIX® ULTRA All-Suture Anchor is a fixation device intended to provide reattachment of soft tissue to bone. The device consists of an all-suture anchor with a preloaded ULTRATAPE® suture assembled inside an insertion device.
Intended Use
The Q-FIX® ULTRA All-Suture Anchor is intended for use for the reattachment of soft tissue to bone.
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Indications for Use
The O-FIX® ULTRA All-Suture Anchor is only intended for the reattachment of soft tissue to bone for the following indications:
Foot & Ankle
- . Medial or lateral instability repairs/reconstructions
- . Achilles tendon repairs/reconstructions
Technological Characteristics
The changes to the legally marketed predicate device (Q-Fix^ Suture Anchor) include a modified inserter and the addition of preloaded ULTRATAPE^ Suture.
Q-FIX® ULTRA All-Suture Anchor is equivalent in its intended use, indications for use, manufacturing process, sterilization method, materials, packaging configuration, and design. The implantable materials in the subject device are equivalent to the materials of the predicate/reference devices. Additionally, many of the subject device components are identical compared to the predicate/reference devices. The differences between the subject device and predicate device are minor and raise no new questions of safety of effectiveness.
Performance Data
Non-clinical bench testing was completed on the subject device, and the device met all required specifications for each test. Testing included insertion testing, static fixation testing, cyclic loading testing, and knot tensile strength testing. A summary of test acceptance criteria and results have been provided. Results for all tests passed.
The biocompatibility of Q-FIX® ULTRA All-Suture Anchor was evaluated against the requirements per ISO 10993-1 and was deemed biologically safe.
Conclusion
The substantial equivalence of the Q-FIX® ULTRA All-Suture Anchor is based on similarities in indications for use, design features, operational principles, material biocompatibility and composition, and performance to the predicate/reference devices listed above. Based on the similarities, Q-FIX® ULTRA All-Suture Anchor is substantially equivalent to its predicate.
§ 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.