(166 days)
Not Found
No
The 510(k) summary describes a traditional submission to add MR safety information and update labeling for a previously cleared cabling and plate system. It explicitly states that the technological characteristics, function, materials, sterilization, and manufacturing processes remain unchanged. There is no mention of AI or ML in the intended use, device description, or performance studies. The performance studies focus on MR safety and mechanical testing.
No
The device is an orthopedic fixation system (cables and plates) used for general orthopedic repair procedures and fracture fixation. It is not designed to provide a therapeutic effect on its own but rather to hold bones in place to facilitate healing.
No
This device is described as a cabling and plating system for orthopedic repair procedures, which are treatments, not diagnoses. The "Summary of Performance Studies" section describes MRI compatibility testing, which is about the device's safety in an MRI environment, not its ability to perform diagnostics.
No
The device description explicitly states that the system consists of "Bone plates of various sizes" and "Cables with or without clamps and trochanteric grips," which are physical hardware components. The 510(k) is for adding MR safety information to the labeling of these existing hardware devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes the device as being used for general orthopedic repair procedures, including fracture fixation and reattachment of bone fragments. This is a surgical/implantable device used directly on the patient's body.
- Device Description: The device is described as a cabling system and bone plates, which are physical implants used in orthopedic surgery.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The provided information does not mention any testing of samples or diagnostic purposes.
The information about MRI compatibility testing and mechanical performance studies further confirms that this is a device intended for implantation and use within the body, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Smith & Nephew Cabling System of the Smith & Nephew ACCORD™ Cable System is indicated for general orthopaedic repair procedures including patellar fractures, general cerclage, trochanteric reattachment, femoral and tibial fractures, prophylactic banding, olecranon fractures, ankle fractures, fixation of spiral fractures in conjunction with intramedullary nail and screw fixation techniques.
Trochanteric reattachment whenever the trochanter is osteotomized in any of the procedures listed below:
- Primary total hip arthroplasty.
- Revision total hip arthroplasty.
- Any procedure using anterolateral or lateral approaches.
The ACCORD™ Titanium Plates of the Smith & Nephew ACCORD™ Cable System are indicated for adult or pediatric patients as indicated for pelvic, small, and long bone fracture fixation. Indications for use include fractures of the tibia, fibula, femoral condyle, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, middle hand and middle foot bones; treatment of the calcaneal; hip arthrodesis, and provisional hole fixation.
Product codes (comma separated list FDA assigned to the subject device)
HRS, JDQ
Device Description
The purpose of this Traditional 510(k) is to add MR safety information to the labeling and update the information within the labeling, including the package insert for the subject Smith & Nephew ACCORD™ Cable System. The technological characteristics, function of the devices, packaging and sterilization remain unchanged. No modifications have been made to the materials, sterilization, or the manufacturing processes of the previously cleared devices due to the addition of MR labeling for this subject 510(k). The Smith & Nephew ACCORD™ Cable System consists of the following previously cleared devices:
- The ACCORD™ Titanium Plates: Bone plates of various sizes to accommodate the individual requirements of patient anatomy, cleared under K993106.
- The Smith & Nephew Cabling System: Cables with or without clamps and trochanteric grips, cleared under K031162.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patellar, trochanteric, femoral, tibial, olecranon, ankle, tibia, fibula, femoral condyle, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, middle hand, middle foot bones, calcaneal, hip
Indicated Patient Age Range
adult or pediatric patients
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)
Magnetic Resonance Imaging (MRI) compatibility testing was conducted as per the FDA's Guidance and the Standards listed below:
-
- ASTM F2052-15 Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment.
-
- ASTM F2182-19e2, "Radio Frequency Induced Heating on or Near Passive Implants During Magnetic Resonance Imaging"
-
- FDA Guidance Document: "Testing and Labeling Medical Devices for Safety in the Maqnetic Resonance (MR) Environment: Guidance for Industry and Food and Drug Administration Staff", 20May2021.
-
- Reporting of Computational Modeling in Medical Device Submissions, Guidance for Industry and Food and Drug Administration Staff, September 21, 2016
-
- IEC 60601-2-33 (Ed 3.2), "Medical electrical equipment -Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis" (2015).
-
- ISO/TS 10974:2018(E) "Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device.
MR safety testing/assessments support the appropriate MR parameters and symbols found in the subject device labeling.
Engineering analysis and dynamic tensile strength testing demonstrated substantially equivalent mechanical performance of the plates and cables, respectively.
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.
Not Found
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
§ 888.3030 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.
0
May 30, 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. The logo is simple and professional, and it is easily recognizable.
Smith & Nephew, Inc. Rose Beifuss Senior Manager, Regulatory Affairs 1450 East Brooks Road Memphis, Tennessee 38116
Re: K223762
Trade/Device Name: Smith & Nephew ACCORD™ Cable System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS, JDQ Dated: April 27, 2023 Received: April 27, 2023
Dear Rose Beifuss:
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
1
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 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,
Shumaya Ali-S
Shumaya Ali, M.P.H. 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
2
Indications for Use
510(k) Number (if known) K223762
Device Name Smith & Nephew ACCORD™ Cable System
Indications for Use (Describe)
The Smith & Nephew Cabling System of the Smith & Nephew ACCORD™ Cable System is indicated for general orthopaedic repair procedures including patellar fractures, general cerclage, trochanteric reattachment, femoral and tibial fractures, prophylactic banding, olecranon fractures, fixation of spiral fractures in comjunction with intramedullary nail and screw fixation techniques.
Trochanteric reattachment whenever the trochanter is osteotomized in any of the procedures listed below.
· Primary total hip arthroplasty.
- Revision total hip arthroplasty.
· Any procedure using anterolateral or lateral approaches.
The ACCORD™ Titanium Plates of the Smith & Nephew ACCORD™ Cable System are indicated for adult or pediatric patients as indicated for pelvic, small, and long bone fracture fixations for use include fractures of the tibia, fibula, femoral condyle, pelvis, acetabulum, metatarsals, humerus, ulna, middle hand and middle foot bones; treatment of the calcaneal; hip arthrodesis, and provisional hole fixation.
| 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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3
510(k) Summary
| Submitted by: | Smith & Nephew, Inc.
Orthopedic Division
1450 East Brooks Road
Memphis, Tennessee 38116 |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date of Submission: | May 25, 2023 |
| Contact Person: | Rose Beifuss
Senior Manager, Regulatory Affairs
Rose.Beifuss@smith-nephew.com
Mobile: (385)253-2551 |
| | Jessica Roach
Regulatory Affairs Specialist II
Jessica.Roach@smith-nephew.com
Mobile: (713)855-1291 |
| Name of Device: | Smith & Nephew ACCORD™ Cable System |
| Common Name: | Bone Plates, Cabling System |
| Device Classification Name
and Reference: | 21 CFR 888.3030 – Single/Multiple Component
Metallic Bone Fixation Appliances and
Accessories |
| | 21 CFR 888.3010 – Bone Fixation Cerclage |
| Device Class: | Class II |
| Panel Code: | Orthopaedics/87 |
| Product Codes: | HRS, JDQ |
| Predicate Devices: | Smith & Nephew Bone Plate System (Bone
Plates, Bone Screws and Accessories)
(K993106 S.E. 12/09/1999)Smith & Nephew Orthopaedic Cabling
SystemK031162 (S.E. 05/01/2003) |
4
Device Description
The purpose of this Traditional 510(k) is to add MR safety information to the labeling and update the information within the labeling, including the package insert for the subject Smith & Nephew ACCORD™ Cable System. The technological characteristics, function of the devices, packaging and sterilization remain unchanged. No modifications have been made to the materials, sterilization, or the manufacturing processes of the previously cleared devices due tothe addition of MR labeling for this subject 510(k). The Smith & Nephew ACCORD™ Cable System consists of the following previously cleared devices:
- . The ACCORD™ Titanium Plates: Bone plates of various sizes to accommodate the individual requirements of patient anatomy, cleared under K993106.
- The Smith & Nephew Cabling System: Cables with or without clamps and . trochanteric grips, cleared under K031162.
Indications for Use
The Smith & Nephew Cabling System of the Smith & Nephew ACCORD™ Cable System is indicated for general orthopaedic repair procedures including patellar fractures, general cerclage, trochanteric reattachment, femoral and tibial fractures, prophylactic banding, olecranon fractures, ankle fractures, fixation of spiral fractures in conjunction with intramedullary nail and screw fixation techniques.
Trochanteric reattachment whenever the trochanter is osteotomized in any of the procedures listed below:
- Primary total hip arthroplasty. .
- Revision total hip arthroplasty. .
- . Any procedure using anterolateral or lateral approaches.
The ACCORD™ Titanium Plates of the Smith & Nephew ACCORD™ Cable System are indicated for adult or pediatric patients as indicated for pelvic, small, and long bone fracture fixation. Indications for use include fractures of the tibia, fibula, femoral
5
condyle, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, middle hand and middle foot bones; treatment of the calcaneal; hip arthrodesis, and provisional hole fixation.
Technological Characteristics
The material of the subject devices is the same as the predicate Smith & Nephew components cleared under the premarket notifications listed in Table 5.1. The designs of the subject devices are equivalent to those of the predicate Smith & Nephew components cleared under the premarket notifications listed in Table 5.1.
Performance Data
Magnetic Resonance Imaging (MRI) compatibility testing was conducted as per the FDA's Guidance and the Standards listed below:
-
- ASTM F2052-15 Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment.
-
- ASTM F2182-19e2, "Radio Frequency Induced Heating on or Near Passive Implants During Magnetic Resonance Imaging"
-
FDA Guidance Document: "Testing and Labeling Medical Devices for Safety in the Maqnetic Resonance (MR) Environment: Guidance for Industry and Food and Drug Administration Staff", 20May2021.
-
Reporting of Computational Modeling in Medical Device Submissions, Guidance for Industry and Food and Drug Administration Staff, September 21, 2016
-
IEC 60601-2-33 (Ed 3.2), "Medical electrical equipment -Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis" (2015). 6. ISO/TS 10974:2018(E) "Assessment of the safety of magnetic
resonance imaging for patients with an active implantable medical device.
6
MR safety testing/assessments support the appropriate MR parameters and symbols found in the subject device labeling.
Engineering analysis and dynamic tensile strength testing demonstrated substantially equivalent mechanical performance of the plates and cables, respectively.
Substantial Equivalence Information
The subject components are identical in function, materials, sterilization, manufacturing methods and operational principles to the commercially available predicate devices listed in Table 5.1 below.
| Table 5.1: Substantially Equivalent Predicate Devices |
|---|
| ------------------------------------------------------- |
| Manufacturer | Description | Submission
Number | Clearance Date |
|-------------------------|-------------------------------|----------------------|----------------|
| Smith &
Nephew, Inc. | Bone Plate System | K993106 | 12/09/1999 |
| Smith &
Nephew, Inc. | Orthopaedic
Cabling System | K031162 | 05/01/2003 |
Conclusion
In summary, the Smith & Nephew ACCORD™ Cable System is identical in function, materials, sterilization, manufacturing methods and operational principles to what was previously 510(k) cleared and do not affect the safety and effectiveness of the subject devices when used as labeled. Due to the supporting documentation within this filing, it is concluded that the subject devices are substantially equivalent to the predicate devices.