(57 days)
No
The document describes a mechanical suture anchor and its intended use, with no mention of AI or ML technology in the device description, intended use, or performance studies.
No.
The device is a fixation device for reattaching soft tissue to bone, which is a surgical tool/implant and not typically classified as a therapeutic device in the sense of delivering therapy (e.g., drug delivery, radiation, or electrical stimulation). Its function is mechanical stabilization rather than direct therapeutic action.
No
Explanation: This device is a surgical fixation device (suture anchor) used for reattaching soft tissue to bone, as described in its "Intended Use" and "Device Description." It does not perform any diagnostic functions.
No
The device description clearly states it is a physical fixation device consisting of an anchor body, inner plug, and insertion device, which are hardware components.
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" for specific orthopedic procedures in the foot, ankle, and knee. This is a surgical/implantable device, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a "fixation device" consisting of an anchor body, inner plug, and insertion device. This aligns with a surgical implant, not a diagnostic kit or instrument.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely mechanical fixation within the body.
N/A
Intended Use / Indications for Use
The FOOTPRINT® MINI PK, 3.5mm 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 Knee:
- · Extra-capsular repairs
- -Medial collateral ligament
- -Lateral collateral ligament
- -Posterior oblique ligament
Product codes
MBI
Device Description
The Smith & Nephew FOOTPRINT? MINI PK, 3.5mm Suture Anchor is a fixation device intended to provide reattachment of soft tissue to bone. The device consists of a two-piece suture anchor comprised of an anchor body and inner plug, preassembled onto an insertion device. The device is sold with a disposable suture threader.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Foot and Ankle, Knee
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 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, and cyclic loading testing. A summary of test acceptance criteria and results have been provided. Results for all tests passed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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 17, 2024
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there 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 Catherine Phelan Senior Regulatory Affairs Specialist 150 Minuteman Road Andover, Massachusetts 01810
Re: K233730
Trade/Device Name: Footprint Mini PK, 3.5mm Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: November 20, 2023 Received: November 21, 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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
Diaitally signed by Jesse Muir 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
2
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
FOOTPRINTO MINI PK, 3.5mm Suture Anchor
Indications for Use (Describe)
The FOOTPRINT MINI PK, 3.5mm 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 Knee:
- · Extra-capsular repairs
- -Medial collateral ligament
- -Lateral collateral ligament
- -Posterior oblique ligament
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
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 time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"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."
4
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: 08 January 2024
| 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 | (508)-446-4542 |
| Device Name & Classification | |
|---|---|
| 510(k) Number | K233730 |
| Proprietary Name | FOOTPRINT® MINI PK, 3.5mm 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 FOOTPRINT® MINI PK, 3.5mm Suture Anchor is substantially equivalent in intended use and fundamental scientific technology to the following legally marketed devices in commercial distribution:
| Description | Submission Number |
|---|---|
| Knotless Instability Anchor | K093428 |
| RAPTORMITE ◊ 3.0 PK Suture Anchor | K071586 |
Legally Marketed Reference Device
| Description | Submission Number |
|---|---|
| MICRORAPTOR ◊ Knotless Suture Anchor | K181746 |
| FAST-FIX◊ FLEX | K203393 |
Device Description
The Smith & Nephew FOOTPRINT? MINI PK, 3.5mm Suture Anchor is a fixation device intended to provide reattachment of soft tissue to bone. The device consists of a two-piece suture anchor comprised of an anchor body and inner plug, preassembled onto an insertion device. The device is sold with a disposable suture threader.
5
Intended Use
The FOOTPRINT® MINI PK, 3.5mm Suture Anchor is intended for use for the reattachment of soft tissue to bone.
Indications for Use
The FOOTPRINT^ MINI PK, 3.5mm Suture Anchor is intended for use only for the reattachment of soft tissue to bone for the following indications:
Foot & Ankle
- Medial or lateral instability repairs/reconstructions
- . Achilles tendon repairs/reconstructions
Knee
- Extra-capsular repairs . -Medial collateral ligament –Lateral collateral ligament –Posterior oblique ligament
Technological Characteristics
The Smith & Nephew FOOTPRINT® MINI PK, 3.5mm Suture Anchor is substantially equivalent to the predicate devices, Smith & Nephew Knotless Instability Anchor (K093428) and RAPTORMITE® 3.0 PK W/ NEEDLES AND TWO SIZE 0 ULTRABRAID SUTURES, CO-BRAID BLUE & WHITE (also referred to as RAPTORMITE® 3.0 PK Suture Anchor) (K071586).
Technological characteristics of the FOOTPRINT® MINI PK, 3.5mm Suture Anchor such as intended use, indications for use, manufacturing processes, sterilization method, materials, packaging configuration, and design are equivalent to the predicate devices. Additionally, the implantable materials in the subject device are equivalent to the materials of the predicate devices. Minor differences between the subject device and predicate devices have been evaluated through performance testing to demonstrate substantial equivalence between the subject devices and predicate devices and raise no new questions of safety or 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, and cyclic loading testing. A summary of test acceptance criteria and results have been provided. Results for all tests passed.
Conclusion
The substantial equivalence of the FOOTPRINT® MINI PK, 3.5mm Suture Anchor is based on similarities in intended use, indications for use, design features, operational principles, material biocompatibility and composition, sterilization, and performance to the predicate/reference devices listed above. Based on the similarities, FOOTPRINT® MINI PK, 3.5mm Suture Anchor is substantially equivalent to its predicates.