(119 days)
The Femoral Recon Nail System is intended for treatment of fractures in adults and adolescents (12-21) in which the growth plates have fused. Specifically, the system is indicated for:
- Subtrochanteric fractures
- Ipsilateral neck/shaft fractures
- Femoral shaft fractures
- Impending pathologic fractures
- Malunions and nonunions
The Femoral Recon Nail (FRN) System is comprised of intramedullary nailing implants designed to provide stabilization of femoral shaft and neck fractures as well as system specific insertion instruments. The Femoral Recon Nail System offers nailing implants in two different designs which enable a Piriformis Fossa (PF) and a Greater Trochanter (GT) entry point for the insertion of the nailing implant in the femur. The implants are manufactured from Titanium alloy, are provided in a range of dimensions and in Left and Right-oriented versions.
The provided text describes a 510(k) premarket notification for the DePuy Synthes Femoral Recon Nail System. This is a medical device for orthopedic fixation, not an artificial intelligence (AI) or software-as-a-medical-device (SaMD) product. Therefore, much of the information requested in the prompt, which is typically relevant for AI/SaMD studies, is not applicable or available in this document.
However, I can extract the information that is present concerning the device's acceptance criteria and the studies performed.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from predicate equivalence) | Reported Device Performance (Non-Clinical Data) |
|---|---|
| Mechanical performance at least equivalent to predicate device for fatigue. | Fatigue testing of constructs with standard locking and recon locking as well as an analytical evaluation performed. This information supports that the mechanical performance of the subject device is at least equivalent to that of the predicate device (Synthes Lateral Entry Femoral Nail System (K040336)). |
| Specified endotoxin requirement. | Devices meet the specified endotoxin requirement of 20EU/device using the LAL test method. |
2. Sample size used for the test set and the data provenance
Not applicable for this type of medical device (intramedullary fixation rod). The "test set" concept with data provenance is typically relevant for AI/SaMD performance evaluation using clinical data. For this device, physical and analytical testing were performed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth and expert adjudication are relevant for AI/SaMD performance evaluation against human expert assessment. This document describes a physical medical device.
4. Adjudication method for the test set
Not applicable. Adjudication methods are relevant for AI/SaMD performance evaluation where human experts determine ground truth.
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
Not applicable. This is a physical medical device, not an AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
For mechanical performance, the "ground truth" is established through engineering principles, standardized testing methods for fatigue, and comparison to a legally marketed predicate device's established performance. For endotoxin levels, it's a direct measurement against a specified limit using a recognized test method (LAL test).
8. The sample size for the training set
Not applicable. This is a physical medical device. The concept of a "training set" typically applies to AI/machine learning models.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical device.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The study proving the DePuy Synthes Femoral Recon Nail System meets its acceptance criteria is a non-clinical performance study focused on mechanical and material properties.
- Mechanical Testing: Fatigue testing was performed on constructs with standard locking and recon locking configurations. An analytical evaluation was also conducted. The subject device (DePuy Synthes Femoral Recon Nail System) was compared to the primary predicate device (Synthes Lateral Entry Femoral Nail System, K040336). The conclusion from this testing was that the mechanical performance of the subject device is at least equivalent to that of the predicate device.
- Material Testing: The devices were tested for endotoxin levels using the LAL test method. The results demonstrated that the devices meet the specified endotoxin requirement of 20EU/device.
The document explicitly states: "Clinical testing was not necessary for the determination of substantial equivalence." This indicates that the non-clinical performance data was deemed sufficient by the FDA to establish substantial equivalence to the predicate devices. The basis for acceptance is that the device has the same intended use, similar indications for use, and is similar in design, material, and fundamental technology to the predicate devices, with mechanical performance at least equivalent, and no new questions of safety and effectiveness raised by any technological differences.
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November 14, 2017
Synthes (USA) Products, LLC Alexander Zwahlen Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, Pennsylvania 19380
Re: K172157
Trade/Device Name: DePuy Synthes Femoral Recon Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: October 17, 2017 Received: October 19, 2017
Dear Mr. Zwahlen:
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 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Katherine D. Kavlock -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K172157
Device Name
DePuy Synthes Femoral Recon Nail System
Indications for Use (Describe)
The Femoral Recon Nail System is intended for treatment of fractures in adults and adolescents (12-21) in which the growth plates have fused. Specifically, the system is indicated for:
-
Subtrochanteric fractures
-
Ipsilateral neck/shaft fractures
-
Femoral shaft fractures
-
Impending pathologic fractures
-
Malunions and nonunions
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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FORM FDA 3881 (8/14)
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6 510(k) Summary
| Sponsor | DePuy SynthesAlexander Zwahlen1301 Goshen ParkwayWest Chester, PA 19380Phone: +41 32 720 41 04Fax: +41 32 720 71 73 |
|---|---|
| Date Prepared | July 17, 2017 |
| Proprietary Name | DePuy Synthes Femoral Recon Nail System |
| Classification Name | Rod, Fixation, Intramedullary and Accessories |
| Classification | Class IIRegulation Number: 21 CFR 888.3020Product Code: HSB |
| Predicate Devices | Primary Predicate Device:Synthes Lateral Entry Femoral Nail System (K040336)Additional Predicate Device:Synthes Adolescent Lateral Entry Femoral Nail System (K070843)Smith & Nephew Trigen Trochanteric Antegrade Nail (K040462) |
| Device Description | The Femoral Recon Nail (FRN) System is comprised of intramedullary nailingimplants designed to provide stabilization of femoral shaft and neck fractures as wellas system specific insertion instruments. The Femoral Recon Nail System offersnailing implants in two different designs which enable a Piriformis Fossa (PF) and aGreater Trochanter (GT) entry point for the insertion of the nailing implant in thefemur.The implants are manufactured from Titanium alloy, are provided in a range ofdimensions and in Left and Right-oriented versions. |
| Indications for use | The Femoral Recon Nail System is intended for treatment of fractures in adults andadolescents (12-21) in which the growth plates have fused. Specifically, the systemis indicated for:- Subtrochanteric fractures- Ipsilateral neck/shaft fractures- Femoral shaft fractures- Impending pathologic fractures- Malunions and nonunions |
| Non-clinicalPerformance Data | Fatigue testing of constructs with standard locking and recon locking as well as ananalytical evaluation has been performed to compare the subject device DePuySynthes Femoral Recon Nail System to the primary predicate device Synthes LateralEntry Femoral Nail System. This information supports that the mechanicalperformance of the subject device is at least equivalent to that of the predicatedevice.The devices also meet the specified endotoxin requirement of 20EU/device using theLAL test method. |
| ClinicalPerformance Data | Clinical testing was not necessary for the determination of substantial equivalence. |
| Substantial Equivalence | The proposed device has the same intended use as the predicate devices. Theproposed device has similar indications for use, are similar in design, material, andfundamental technology as compared to the predicate devices. |
| The mechanical testing and analytical evaluation included in this submissiondemonstrate that: | |
| Any differences in technological characteristics of the predicate devices do notraise any new questions of safety and effectiveness. | |
| The proposed devices are at least as safe and effective as the predicate devices. | |
| It is concluded that the information provided in this submission supports substantialequivalence. |
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(1) DePuy Synthes
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.