(168 days)
The D-RAD SMART PACK is intended for the fixation of fractures involving the distal radius.
The D-RAD SMART PACK is a cost-effective sterile procedural kit that contains an anatomically contoured volar distal radius plate and single-use instruments to treat extra-articular and intra-articular distal radius fractures. The Kit consists of an anatomically shaped distal radius fixation plate, associated locking and non-locking screws and pegs, and instrumentation to assist in implantation of the fixation construct.
The provided document, K132296, for the Smith & Nephew D-RAD SMART PACK is a 510(k) Premarket Notification. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than on proving performance against specific acceptance criteria through a clinical study. Therefore, much of the requested information (like acceptance criteria, specific device performance metrics beyond mechanical testing, sample sizes for test/training sets, expert qualifications for ground truth, adjudication methods, MRMC studies, standalone performance, and detailed ground truth establishment) is not typically found or required in a 510(k) submission for this type of device.
The document explicitly states: "Mechanical testing and analysis has been conducted on the devices to ensure that they meet or exceed predicate standards in terms of fatigue, material strength, and biocompatibility." This indicates that mechanical testing was the primary method used to demonstrate that the device performs equivalently to the predicate devices.
Here's an attempt to answer the questions based on the available information, noting where information is not present in the document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Device meets or exceeds predicate standards for fatigue, material strength, and biocompatibility. | Devices meet or exceed predicate standards in terms of fatigue, material strength, and biocompatibility. (Stated in "Technological Characteristics" section) |
| Functional Equivalence | Identical function to predicate devices. | Identical in function to predicate devices. (Stated in "Substantial Equivalence Information" and "Conclusion" sections) |
| Intended Use | Identical intended use to predicate devices for distal radius fractures. | Identical in intended use for distal radius fractures. (Stated in "Intended Use" and "Conclusion" sections) |
| Material/Design | Similar materials, processing, and design to predicate devices. | Similar in materials, processing, design. (Stated in "Conclusion" section) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable or not specified for a clinical study. The "test set" here refers to the actual device components undergoing mechanical testing. The exact number of samples tested is not provided in this summary.
- Data Provenance: Not applicable for a clinical study. Data would be generated from laboratory mechanical testing. The country of origin for this testing is not specified. It is laboratory data, not patient data (retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. Ground truth as typically understood in AI/imaging studies (e.g., expert consensus on diagnoses) is not relevant for this type of medical device submission. The "ground truth" for mechanical performance is established by standardized material and mechanical testing protocols, interpreted by engineers and regulatory experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is not a study involving human interpretation or adjudication of cases. Mechanical testing results are typically evaluated against pre-defined engineering specifications.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This device is a bone plate and screw system, not an AI-assisted diagnostic or therapeutic device. Therefore, a MRMC comparative effectiveness study involving human readers and AI assistance was not conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This device is a physical implant and surgical instrumentation, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For mechanical performance: Compliance with established industry standards and engineering specifications for fatigue, material strength, and biocompatibility. These standards themselves are developed from extensive research and clinical experience.
- For substantial equivalence: Comparison against the design, materials, and mechanical properties of the predicate devices.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. No training set for an algorithm was used.
Summary of the Study (Mechanical Testing for Substantial Equivalence):
The "study" referenced in this 510(k) submission is primarily a series of mechanical tests and analyses designed to demonstrate that the D-RAD SMART PACK meets or exceeds the performance standards of its predicate devices in terms of fatigue, material strength, and biocompatibility. This type of testing is standard for orthopedic implants. The document indicates that the device's functional characteristics, intended use, and materials were also compared directly to three predicate devices previously cleared by the FDA (K993106, K051735, K083032). The conclusion is based on this direct comparison and mechanical data rather than a clinical trial or AI performance study.
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JAN - 7 2014
- We are smith&nephew
Submitted by:
Smith & Nephew, Inc. Orthopaedic Division 1450 East Brooks Road Memphis, Tennessee 38116
November 26, 2013
Date of Summary:
Contact Person and Address:
Martin Ostmann Requlatory Affairs Specialist T 901-399-1809 F 901-566-7080 Smith & Nephew, Inc. D-RAD SMART PACK
Name of Device: Common Name:
Bone Plates and Bone Screws
Device Classification Name and Reference:
21 CFR 888.3030, single/multiple component metallic bone fixation appliances and accessories - Class II 21 CFR 888.3040, smooth or threaded metallic bone fixation fastener - Class II Class II
Device Class:
Panel Code:
Product Code:
HRS; HWC
Orthopaedics/87
Device Description
The D-RAD SMART PACK is a cost-effective sterile procedural kit that contains an anatomically contoured volar distal radius plate and single-use instruments to treat extra-articular and intra-articular distal radius fractures. The Kit consists of an anatomically shaped distal radius fixation plate, associated locking and non-locking screws and pegs, and instrumentation to assist in implantation of the fixation construct.
Intended Use
The D-RAD SMART PACK is intended for the fixation of fractures involving the distal radius.
Technological Characteristics
The construct consist of anatomically shaped plate which used Peri-Loc VLP screw locking technology. Single use instrumentation is contained in the kit which aides in size selection and implantation of the fixation construct. Mechanical testing and analysis has been conducted on the devices to ensure that they meet or exceed predicate standards in terms of fatigue, material strength, and biocompatibility.
Substantial Equivalence Information
The subject devices are identical in function, intended use, indications for use, and material composition with respect to their function to treat fractures of the distal
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radius, and very similar in overall design to the predicate devices listed in Table 1 below.
| Table 1: Substantially Equivalent Predicates to the D-RAD SMART PACK | |||
|---|---|---|---|
| Manufacturer | Description | SubmissionNumber | Clearance Date |
| Smith & Nephew, Inc. | Bone Plate System | K993106 | 12/9/99 |
| Smith & Nephew, Inc. | Peri-Loc VDR | K051735 | 7/19/05 |
| Smith & Nephew, Inc. | Peri-Loc Bone Plating System | K083032 | 1/7/09 |
Conclusion
.
The subject implants and instruments of this 510(k) are identical to the predicates in their indications for use for the distal radius. Furthermore, the subject devices are similar in materials, processing, design, and intended use to the predicate devices listed in Table 1.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the text "Public Health Service" in a bold, sans-serif font. The text is arranged on a single line. The words are clearly legible and the overall image appears to be a close-up of the text.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Central Center - WO66-G609 Silver Spring, MD 20993-0002
January 7, 2014
Smith & Nephew, Incorporated Mr. Martin Ostmann Regulatory Affairs Specialist 1450 Brooks Road Memphis, Tennessee 38116
Re: K132296
Trade/Device Name: Distal Radius Fracture Kit (D-RAD SMART PACK) Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: November 27, 2013 Received: November 29, 2013
Dear Mr. Ostmann:
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. 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 trathful 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
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Page 2 - Mr. Martin Ostmann
:
CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 http://www.fda.gov/McdicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Ronald#Wean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K132296
Premarket Notification Indications for Use Statement
510(k) Number (if known): __ K132296_
Device Name: Distal Radius Fracture Kit (D-RAD SMART PACK).
Indications for Use:
2020 - 11:46 - 11:42
The D-RAD SMART PACK is intended for the fixation of fractures involving the distal radius.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabeth L. Frank -S
Division of Orthopedic Devices
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§ 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.