(65 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
The Smith & Nephew Acute QC Strut and Components consist of multiple sized struts (e.g., X Short, Short, Medium, and Long) and components such as nuts, bands, and washers to build an external fixation construct. The proposed devices incorporate design features similar to those currently incorporated in previously cleared Smith & Nephew SMART Taylor Spatial Frame and ILIZAROV™ External Fixation System. The Acute QC Strut and Components will be manufactured from aluminum, composite, and stainless-steel material, which is identical to that of the predicate devices of the SMART Taylor Spatial Frame System (e.g., K210953, S.E. 07/29/2021).
This document is a 510(k) Premarket Notification for a medical device (Acute QC Strut and Components). The acceptance criteria and supporting studies described in such documents are typically related to proving the substantial equivalence of the new device to existing predicate devices, primarily through engineering performance testing and material compatibility, rather than clinical performance (like improved diagnostic accuracy).
Therefore, the provided text does not contain the information requested regarding acceptance criteria related to a study proving the device meets acceptance criteria through clinical performance metrics, such as sensitivity, specificity, or human reader improvement with AI assistance. This type of information is typically found in submissions for AI/ML-enabled diagnostic devices, not for mechanical orthopedic devices like external fixation systems.
The document primarily focuses on demonstrating:
- Substantial Equivalence: The new device has the same intended use, indications for use, similar design, materials, and performance characteristics as legally marketed predicate devices.
- Bench Testing: Mechanical, biological, and MR safety testing to ensure the device performs as expected and is safe.
Given this, I cannot construct the table and detailed answers about clinical performance studies as the information is not present in the provided text.
However, I can interpret the provided text in the context of what was done for this specific device.
What is present in the document:
-
Acceptance Criteria & Performance (Implicit - Mechanical/Material): The acceptance criteria are implicitly met by demonstrating that the mechanical performance, biological safety, and MR safety of the Acute QC Strut and Components are "substantially equivalent" or do not present "greater risk" than the predicate devices. The document states:
- "The subject Acute QC Struts were determined to not present a greater biological risk than the cleared worst-case representative SMART FX STRUT..."
- "Performance testing was conducted on the subject, implantable devices in comparison against one or more of the previously cleared predicate devices... A review of the mechanical data in the submission indicates that the Acute QC Strut and Components are substantially equivalent to the previously cleared predicate devices."
-
Study That Proves the Device Meets Acceptance Criteria: This was primarily through non-clinical performance testing (bench testing) and comparison to predicate devices, rather than a clinical study involving diagnostic accuracy.
The performance testing reviewed included:
- Fully Reversed Compressive Fatigue Loading of the Construct
- Continuous Compressive Static Loading of the Construct
- Static Compressive Bending Load on the Ball Joint Assembly
- Compressive Fatigue Loading of the Ball Joint Assembly
- Torsional Strength Testing of the Subject Half Pin Washer
- Biological risk assessment (ISO 10993-1: 2018)
- MR safety technical memo comparing to predicate devices.
Based on the provided text, the requested information (related to clinical performance of an AI/ML device) is explicitly not present.
The document states: "Clinical data was not needed to support the safety and effectiveness of the subject devices." This confirms that no clinical studies as you've described (e.g., MRMC, standalone AI performance, expert ground truth adjudication) were conducted or deemed necessary for this 510(k) submission.
Therefore, I cannot fill out the requested table or answer the specific questions about clinical performance studies accurately from the provided text.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font.
August 25, 2022
Smith & Nephew, Inc. Amanda Lammey Regulatory Affairs Specialist I 7135 Goodlett Farms Parkway Cordova, Tennessee 38016
Re: K221792
Trade/Device Name: Acute QC Strut and Components 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, JDW Dated: June 17, 2022 Received: June 21, 2022
Dear Amanda Lammey:
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
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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 and Part 809); 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 (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. For: 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)
Device Name Acute QC Strut and Components
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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K221792 Acute QC Strut and Components
| 510(k) Summary Submitted by: | Smith & Nephew, Inc.Advanced Surgical Devices Division7135 Goodlett Farms ParkwayCordova, Tennessee 38016 |
|---|---|
| Date of Submission: | June 18, 2022 |
| Primary Contact Person: | Amanda Lammey, Regulatory Affairs Specialist IM 901-833-1364H 901-386-3453 |
| Secondary Contact Person: | Brad Sheals, Senior Manager Regulatory AffairsM 901-288-7141W 901-399-6897 |
| Name of Device: | Acute QC Strut and Components |
| Common Name: | External Fixation Systems |
| Device Classification Name andReference: | 21 CFR 888.3030 - Single/multiple componentmetallic bone fixation appliances and accessories |
| Device Class: | Class II |
| Panel Code: | Orthopedics/87 |
| Product Code: | KTT, OSN, JDW |
| Predicate Device: | Primary Predicate – K210953 – SMART TaylorSpatial Frame (S.E. 07/29/2021) |
| Secondary Predicate – K994143 – ILIZAROVTMExternal Fixation System (S.E. 02/18/2000) |
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Device Description
The purpose of this Special 510(k) is to notify FDA of our intent to market the subject Smith & Nephew Acute QC Struts. The Smith & Nephew Acute QC Strut and Components consist of multiple sized struts (e.g., X Short, Short, Medium, and Long) and components such as nuts, bands, and washers to build an external fixation construct.
Subject of this premarket notification is the Acute QC Strut and Components. The Smith & Nephew Acute QC Strut and Components consist of multiple sized struts (e.g., X Short, Short, Medium, and Long) and components such as nuts, bands, and washers to build an external fixation construct. The proposed devices incorporate design features similar to those currently incorporated in previously cleared Smith & Nephew SMART Taylor Spatial Frame and ILIZAROV™ External Fixation System. The Acute QC Strut and Components will be manufactured from aluminum, composite, and stainless-steel material, which is identical to that of the predicate devices of the SMART Taylor Spatial Frame System (e.g., K210953, S.E. 07/29/2021).
The Smith & Nephew Acute QC Strut and Components are line additions to the predicate, SMART Taylor Spatial Frame System, which allows for acute multi-planer angular corrections to bone alignment due to a trauma event. The subject Acute QC Strut and Components and the predicate SMART Taylor Spatial Frame are identical in intended use and indications for use. The subject Acute QC Strut and Components are identical in indications for use also to the predicate ILIZAROV™ External Fixation System except for two statements: post-traumatic joint contracture which has resulted in loss of range of motion and management of comminuted intraarticular fractures of the distal radius. Both predicates are used in this submission because the subject Acute QC Strut and Components are line additions to the SMART Taylor Spatial Frame System which is based on the ILIZAROV™ Method. Therefore, the SMART Taylor Spatial
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Frame System is the primary predicate and the ILIZAROV™ External Fixation System is the secondary predicate. The subject Acute QC Strut and Components: Acute QC Strut X Short, Acute QC Strut Short, Acute QC Strut Medium, Acute QC Strut Long, and Acute QC Strut Band are substantially equivalent to the cleared SMART Taylor Spatial Frame devices cleared via premarket notification K210953 (S.E. 07/29/2021). The subject Acute QC Strut and Components: Speed Nut, Half Pin Washer 2MM, and the Half Pin Washer 4MM are substantially equivalent to the previously cleared ILIZAROV™ External Fixation System devices: NUT, FIXATION BOLT WASHER 2MM and the FIXATION BOLT WASHER 4MM cleared via premarket notification K994143 (S.E. 02/18/2000).
Intended Use
External fixation devices are used on adults or pediatric patients as required. External fixation systems consist of various components that are used to build fixator assemblies unique to the patient's needs. These devices are modular; therefore, a multitude of different fixator frame configurations are possible. External fixation devices are used for the following indications below.
Indications for Use
The indications for the Smith & Nephew Acute QC Strut and Components 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
-
- Pseudarthrosis of long bones
-
- Limb lengthening by distraction
-
- Correction of bony or soft tissue deformities
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-
- Joint arthrodesis
-
- Infected fractures
-
- Nonunions
These indications are identical to the indications of the subject devices and the primary predicate devices of the SMART Taylor Spatial Frame System (e.g., K210953, S.E. 07/29/2021). All of the subject devices, primary predicate devices, and secondary predicate devices are intended for single use.
Technological Characteristics
Device comparisons described in this premarket notification demonstrate that the subject devices, Acute QC Strut and Components, are substantially equivalent to legally marketed predicates with respect to intended use, indications for use, similar design, and performance characteristics. Clinical data was not needed to support the safety and effectiveness of the subject devices.
Design Changes
The overall kinematics, intended use, material, and manufacturing process of the new device mimics those of the predicate devices. Design modifications have been introduced which provided a lock multiplanar mechanism to provide surgeons the ability to quickly build a circular frame to correct multiplanar deformities and fractures in trauma settings. The subject Acute QC Struts removed the universal joints that the primary predicate, SMART Taylor Spatial Frame (e.g., K210953, S.E. 07/29/2021), uses and replaced it with a ball joint. The subject Acute QC Strut Band removed the laseretch number from the predicate SMART FX ID Band (K210953) which was only used when utilizing the program software from the predicate SMART Taylor Spatial Frame System. The software is not used for the subject Acute QC Strut Band. The
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subject Speed Nut modified the predicate, ILIZAROV™ External Fixation System (e.g., K994143 S.E. 01/18/2000), nut by adding knurled sections to the nut. The modifications were made by adding knurled sections to the nut to provide the ability to advance the nut without the use of instruments such as a wrench. The subject Half Pin Washers modified the predicate WASHER FIX BOLTS (K994143) by adding raised posts to provide additional stability to the 3sided half pins. The intended use of the subject devices did not change from the predicate devices. For detailed technology changes and visualizations of the subject and predicate devices, see Section 12 of this submission.
Substantial Equivalence
The overall design, materials, and indications for use for the Acute QC Strut and Components are substantially equivalent to the predicate devices listed in the Table 6.1 below.
Table 6.1: Substantially Equivalent Predicate Devices
| Manufacturer | Description | Submission Number | Pro Code | Clearance Date | |
|---|---|---|---|---|---|
| PrimaryPredicate | Smith &Nephew, Inc. | SMART TaylorSpatial Frame | K210953 | KTT,OSN | July 29, 2021 |
| SecondaryPredicate | Smith &Nephew, Inc. | ILIZAROV™External FixationSystem | K994143 | JDW | February 18, 2000 |
Performance Testing:
To further support a determination of substantial equivalence, performance testing was
conducted on the subject, implantable devices in comparison against one or
more of the previously cleared predicate devices described in Table 6.1 above. A review
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of the mechanical data in the submission indicates that the Acute QC Strut and Components are substantially equivalent to the previously cleared predicate devices. The following characteristics and performance testing were reviewed to determine the substantial equivalence.
- Fully Reversed Compressive Fatigue Loading of the Construct .
- o Continuous Compressive Static Loading of the Construct
- Static Compressive Bending Load on the Ball Joint Assembly ●
- Compressive Fatigue Loading of the Ball Joint Assembly
- o Torsional Strength Testing of the Subject Half Pin Washer
A rationale was provided for the subject Acute QC Strut and Components which states that the subject devices match the pyrogenicity information of the primary predicate, SMART Taylor Spatial Frame System (e.g., K210953, S.E. 07/29/2021).
A biological risk assessment of the devices was evaluated and completed in compliance with ISO 10993-1: 2018 – Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process to assess the risk of harm to health resulting from exposure to the device for the intended duration of contact. The subject Acute QC Struts are classified as surface-contacting devices that contact intact skin for prolonged durations (>24 hr to 30 days). The subject Acute QC Struts were determined to not present a greater biological risk than the cleared worst-case representative SMART FX STRUT (e.g., K210953, S.E. 07/29/2021). The Acute QC Strut Band, Speed Nut, and Half Pin Washers are all nonpatient contacting devices that are not required to have detailed biological endpoint evaluation per ISO 10993-1. All manufacture materials of these devices have long histories of safe use in medical devices.
An MR safety technical memo, which can be found in Exhibit 9 of this submission, was completed comparing the subject Acute QC Strut to external fixation devices of similar
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indications which have been previously evaluated for MRI safety and compatibility. The material and devices associated with the subject Acute QC Strut and Components are the same as the previously evaluated Smith and Nephew, Inc. external fixation system, SMART Taylor Spatial Frame (e.g., K210953, S.E. 07/29/2021). The subject Acute QC Strut is considered at least similar in maximum mass, maximum length, material, surface finish, overall shape, and location/orientation as compared to the corresponding tests in the predicate studies. Thus, the subject Acute QC Strut would be expected to have at least similar responses in consideration of magnetically induced RF heating, magnetically induced displacement force, magnetically induced torque, and the MR image artifact as the previously cleared premarket notification tests determined. This technical memo matches the MR parameters of the cleared primary predicate, SMART Taylor Spatial Frame (e.g., K210953, S.E. 07/29/2021) and the subject Acute QC Strut and Components were determined to be MR Unsafe.
The packaging and labeling, including the instructions for use (Exhibit 4) and package insert (Exhibit 5) which was previously submitted to the FDA via premarket notification K210953 (S.E. 07/29/2021) for the SMART Taylor Spatial Frame System, also contains the MR Unsafe icons and/or parameters as specified in ASTM F2503, as appropriate.
Conclusion
In summary, this Special 510(k) premarket notification is being submitted to request clearance for the subject Acute QC Strut and Components. Based on similarities to the predicate SMART Taylor Spatial Frame and ILIZAROV™ External Fixation System, the subject line additions introduce no new risks related to the safety and effectiveness of the devices and Smith&Nephew, Inc believes the subject devices are substantially equivalent to the commercially available predicate devices listed in Table 6.1.
§ 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.