(121 days)
- Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
- Open and closed fracture fixation
- Pseudarthrosis of long bones
- Limb lengthening by distraction
- Correction of bony or soft tissue deformities
- Joint arthrodesis
- Infected fractures
- Nonunions
Subject of this premarket notification is the SMART Taylor Spatial Frame. The proposed devices incorporate design features similar to those currently incorporated on previously cleared Smith & Nephew multilateral external fixation systems. The SMART Taylor Spatial Frame consists of full or partial rings, telescoping struts other fixation accessories made from aluminum and stainless steel materials. The system also includes a web-based software component designed for use in assisting physicians creating fixator adjustment schedules and mobile app.
The provided text describes a 510(k) premarket notification for the "SMART Taylor Spatial Frame," a metallic bone fixation appliance and accessories. This document primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices through engineering and software testing. It does not contain information about a study involving human readers or AI performance metrics.
Therefore, the following information cannot be extracted from the provided text:
- Acceptance criteria related to AI performance or human reader improvements.
- Reported device performance against such criteria.
- Sample size used for the test set or data provenance for a clinical study comparing AI to human readers.
- Number of experts and their qualifications used to establish ground truth for a clinical study.
- Adjudication method for a clinical study.
- Multi-reader multi-case (MRMC) comparative effectiveness study results or effect size of AI assistance.
- Standalone algorithm performance study details.
- Type of ground truth (expert consensus, pathology, outcomes data, etc.) for a clinical study comparing AI to human readers.
- Sample size for the training set of an AI algorithm.
- How ground truth for the training set was established for an AI algorithm.
The document does mention software verification and validation, but this refers to the software component of the device itself (for assisting physicians in creating fixator adjustment schedules and a mobile app), not an AI algorithm performing diagnostic or assistive tasks in a clinical setting in the way typically discussed in AI/ML medical device submissions.
The "Summary of Pre-Clinical Testing" section mentions:
- Construct and frame component testing: Per ASTM F1541 "Standard Specification and Test Methods for External Skeletal Fixation Devices."
- Magnetic resonance imaging (MRI) compatibility testing: As per FDA's guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment," December 11, 2014.
- Software Verification and Validation: Per FDA guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" dated May 11, 2005, and "General Principles of Software Validation" dated January 11, 2002.
However, these are engineering and software validation tests for the physical device and its associated software, not AI performance studies as requested in the prompt.
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July 29, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left is the Department of Health & Human Services logo, and on the right is the FDA logo. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Smith & Nephew, Inc. Thomas Fearnley Senior Regulatory Affairs Specialist 1450 E Brooks Rd Memphis. Tennessee 38116
Re: K210953
Trade/Device Name: SMART Taylor Spatial Frame Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT, OSN Dated: June 29, 2021 Received: June 30, 2021
Dear Thomas Fearnley:
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
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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 (QS) 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,
Ting Song, Ph.D., R.A.C. Assistant Director DHT6A: Division of Joint Arthroplasty 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) K210953
Device Name SMART Taylor Spatial Frame
Indications for Use (Describe)
-
Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
-
Open and closed fracture fixation
-
- Pseudarthrosis of long bones
-
- Limb lengthening by distraction
-
- Correction of bony or soft tissue deformities
-
- Joint arthrodesis
-
- Infected fractures
-
- Nonunions
| 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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Image /page/3/Picture/1 description: The image shows the Smith & Nephew logo. The logo consists of an orange flower-like symbol on the left, followed by the text "We are smith&nephew". The words "We are" are in gray, while "smith&nephew" is in orange.
| Submitted by: | Smith & Nephew, Inc.Orthopaedic Division1450 East Brooks RoadMemphis, Tennessee 38116 |
|---|---|
| Date of Summary: | July 28, 2021 |
| Thomas FearnleySenior Regulatory Affairs SpecialistT 901-399-1224F 901-566-7022 | |
| Name of Device: | SMART Taylor Spatial Frame |
| Common Name: | Multilateral Fixators and Accessories |
| Device Classification Name andReference: | 21 CFR 888.3030 Single/multiple component metallic bonefixation appliances and accessories |
| Device Class: | Class II |
| Panel Code: | Orthopaedics/87 |
| Product Code: | KTT, OSN |
Predicates
| Manufacturer | Description | Submission Number | Clearance Date |
|---|---|---|---|
| Smith & Nephew, Inc. | Smith & Nephew TSF and CircularFixation System (primarypredicate) | K093047 | September 27,2010 |
| Smith & Nephew, Inc. | Smith & Nephew, Inc.Spatialframe.Com V5.0 Web-BasedSoftware | K142520 | November 20,2014 |
| Smith & Nephew, Inc. | Smith & Nephew External FixationSystem – Unilateral (Linear) &Multilateral (Circular) Fixators andAccessories | K994143 | February 18, 2000 |
| Smith & Nephew, Inc. | Taylor Spatial Frame ExternalFixation System | K970748 | May 9, 1997 |
Device Description
Subject of this premarket notification is the SMART Taylor Spatial Frame. The proposed devices incorporate design features similar to those currently incorporated on previously cleared Smith & Nephew multilateral external fixation systems. The SMART Taylor Spatial Frame consists of full or partial rings, telescoping struts other fixation accessories made from aluminum and stainless steel materials. The system also includes a web-based software component designed for use in assisting physicians creating fixator adjustment schedules and mobile app.
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Indications for Use
The indications for the Smith & Nephew SMART Taylor Spatial Frame are the following:
-
- Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
- Open and closed fracture fixation 2.
- Pseudarthrosis of long bones 3.
-
- Limb lengthening by distraction
-
- Correction of bony or soft tissue deformities
-
- Joint arthrodesis
-
- Infected fractures
-
- Nonunions
Technological Characteristics
Device comparisons described in this premarket notification demonstrated that the proposed devices are substantially equivalent to legally marketed predicates with respect to intended use, indications, and performance characteristics.
Summary of Pre-Clinical Testing
- Construct and frame component testing were completed per ASTM F1541 "Standard ● Specification and Test Methods for External Skeletal Fixation Devices"
- Magnetic resonance imaging (MRI) compatibility testing was conducted as per the FDA's ● guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment", December 11, 2014.
- Software Verification and Validation per FDA guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" dated May 11, 2005 and "General Principles of Software Validation" dated January 11, 2002.
Conclusion
This Traditional 510(k) premarket notification is being submitted to request clearance for the SMART Taylor Spatial Frame. Based on similarities to the predicate multilateral external fixation systems and a review of the mechanical and software testing performed, the subject devices are substantially equivalent to the predicate devices.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.