(25 days)
No
The device description and performance studies focus on the mechanical properties and biocompatibility of a physical suture anchor, with no mention of software, algorithms, or data processing related to AI/ML.
Yes
The device is described as a "fixation device intended to provide reattachment of soft tissue to bone" and is specifically indicated for "Medial or lateral instability repairs/reconstructions" and "Achilles tendon repairs/reconstructions," which are therapeutic interventions.
No
The device description clearly states it is a "fixation device intended to provide reattachment of soft tissue to bone," which is a therapeutic function, not a diagnostic one. Its intended use is for surgical repair, not for identifying a condition or disease.
No
The device description clearly states it is a "fixation device" consisting of an "all-suture anchor" and an "insertion device," which are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "reattachment of soft tissue to bone". This is a surgical procedure performed directly on the patient's body.
- Device Description: The description details a "fixation device" consisting of an "all-suture anchor" and an "insertion device". These are physical implants and tools used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health status, diagnose, monitor, or screen for diseases.
IVD devices are used to perform tests on samples taken from the body, while this device is used for surgical repair within the body.
N/A
Intended Use / Indications for Use
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
Product codes (comma separated list FDA assigned to the subject device)
MBI, GAT, HTW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Foot and Ankle
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical bench testing was completed on the subject device. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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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
1
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.