(145 days)
The DePuy Synthes Static Staples are indicated for extra-articular closing-wedge osteotomies of the 1st ray of the forefoot.
The DePuy Synthes Static Staple is an implant for bone fixation designed for extra-articular closing wedge osteotomies of the 1st ray of the forefoot. The implant is offered in two (2) configurations of 26° and 90° to address varying patient anatomy of the foot, particularly the 1st ray of the forefoot. The Static Staple implant is delivered to the operating room in a disposable, sterile kit, preloaded onto a handheld inserter along with drill guide and K-wires.
This appears to be a 510(k) premarket notification for a medical device, specifically the DePuy Synthes Static Staples. For such medical devices, "acceptance criteria" and "device performance" are typically related to mechanical and material properties, rather than diagnostic accuracy or clinical outcomes as might be found for AI/imaging devices.
Based on the provided document, here's an analysis:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" alongside specific "reported device performance" values in a pass/fail format. However, it states that the following non-clinical performance analysis were conducted and implies that the device met acceptable standards as substantial equivalence was claimed:
| Test/Analysis | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Static Bend (according to ASTM F564) | Meet or exceed predicate device performance; demonstrate device integrity under static loading. | (Not explicitly quantified in this summary, but the submission claims substantial equivalence, implying acceptable performance) |
| Dynamic Bending (according to ASTM F564) | Meet or exceed predicate device performance; demonstrate device fatigue resistance under cyclic loading. | (Not explicitly quantified in this summary, but the submission claims substantial equivalence, implying acceptable performance) |
| Pull-out testing (according to ASTM F564) | Meet or exceed predicate device performance; demonstrate secure fixation in bone. | (Not explicitly quantified in this summary, but the submission claims substantial equivalence, implying acceptable performance) |
| MRI Conditional Testing | Establish MR Conditional parameters (e.g., safe magnetic field strength, SAR, temperature rise, image artifacts). | (Not explicitly detailed, but this testing was conducted to establish safe MR Conditional parameters.) |
| Technological Characteristics Comparison | Equivalent to predicate devices in performance, basic design, material, and sizes. | Declared equivalent to predicate devices (K931155) in these aspects. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable as this is not a study focused on a diagnostic algorithm but rather a mechanical device. The "test set" here refers to the physical staples subjected to mechanical testing. The exact number of staples tested for each non-clinical analysis is not specified in this summary.
- Data Provenance: The studies were non-clinical (mechanical testing, MRI conditional testing). The location where these tests were performed is not specified, but the sponsor is DePuy Synthes, located in West Chester, PA, USA. The data is retrospective in the sense that the tests were performed on manufactured devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. "Ground truth" in this context typically refers to clinical diagnosis or pathology in AI/imaging studies. For this mechanical device, the "ground truth" for the tests are the established standards (ASTM F564) and the physical properties of the materials and design. The testing would be performed by engineers and technicians, not clinical experts, and the results interpreted against defined specifications.
4. Adjudication Method for the Test Set
Not applicable. This is not a study requiring adjudication by experts. The results of the mechanical tests are quantitative measurements compared against established standards or predicate device performance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted interpretation devices, not for a bone fixation staple. The document explicitly states: "Clinical testing was not necessary for the determination of substantial equivalence."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a bone fixation staple, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical performance data (mechanical testing and MRI conditional testing) is based on established engineering standards (e.g., ASTM F564) and material science principles, aiming to demonstrate the physical integrity and functional safety of the device. For substantial equivalence, the "ground truth" for comparison is the performance of the legally marketed 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. This is not an AI/machine learning device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the acronym "FDA" followed by the words "U.S. Food & Drug Administration".
Synthes (USA) Products, LLC Suchitra Basu Global Strategy Manager, Regulatory Affairs 1301 Goshen Parkway West Chester, Pennsylvania 19380
July 24, 2018
Re: K180544
Trade/Device Name: DePuy Synthes Static Staples Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: JDR Dated: June 22, 2018 Received: June 25, 2018
Dear Suchitra Basu:
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 comprehensive regulatory information about mediation-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,
Mark N. Melkerson -S
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 | Form Approved: OMB No. 0910-0120 | ||
|---|---|---|---|
| Food and Drug Administration | Expiration Date: 06/30/2020 | ||
| See PRA Statement below. | |||
| 510(k) Number (if known) | K180544 | ||
| Device Name | DePuy Synthes Static Staples | ||
| Indications for Use (Describe) | The DePuy Synthes Static Staples are indicated for extra-articular closing-wedge osteotomies of the 1st ray of the forefoot. | ||
| 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) | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
Date Prepared: July 23, 2018
| Sponsor | DePuy SynthesSuchitra Basu, PhD, RAC1301 Goshen ParkwayWest Chester, PA 19380Phone: +1-610-719-5448 |
|---|---|
| Date Prepared | July 23, 2018 |
| Proprietary Name | DePuy Synthes Static Staples |
| Common or UsualName(s) | Bone Staple, Staple, Accessories |
| Classification Name | Single/multiple component metallic bone fixation appliances and accessories |
| Classification | Class IIRegulation Number: 21 CFR 888.3030Product Code: JDR |
| Predicate Devices | Primary Predicate: Zimmer Biomet Varisation Staple (K931155)Additional Predicates: Trilliant Surgical Sniper Staple System (K162354),EPIC Extremity Small Staple (K163226) |
| Reference Device | Synthes (USA) 1.5mm Mini Fragment LCP System (K090047) |
| Purpose of Submission | This Traditional 510(k) premarket notification is submitted to obtainclearance for the DePuy Synthes Static Staples. |
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| Device Description | The DePuy Synthes Static Staple is an implant for bone fixation designed forextra-articular closing wedge osteotomies of the 1st ray of the forefoot.The implant is offered in two (2) configurations of 26° and 90° to addressvarying patient anatomy of the foot, particularly the 1st ray of the forefoot.The Static Staple implant is delivered to the operating room in a disposable,sterile kit, preloaded onto a handheld inserter along with drill guide and K-wires. |
|---|---|
| Indications for use | The DePuy Synthes Static Staples are indicated for extra-articular closingwedge osteotomies of the 1st ray of the forefoot. |
(1) DePuy Synthes
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| Non-clinicalPerformance Data | The following analysis were conducted:Static Bend according to ASTM F564 Dynamic bending according to ASTM F564 Pull-out testing according to ASTM F564 MRI Conditional Testing to establish MR Conditional parameters |
|---|---|
| ClinicalPerformance Data | Clinical testing was not necessary for the determination of substantial equivalence. |
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| The Static Staples implants possess the equivalent technologicalcharacteristics as that of the primary predicate devices (K931155). Theseinclude:performance, basic design, material and sizes (dimensions are comparable to those offered by the predicate systems). | |
|---|---|
| SubstantialEquivalence | The proposed device has indications for use which are fully encompassed bythe indications for use of the predicate device.The mechanical testing and analytical evaluation included in this submissiondemonstrate that:Any differences in technological characteristics of the subject devices do not raise any new questions of safety and effectiveness. The proposed devices are at least as safe and effective as the predicate devices. Based on the indications for use, technological characteristics, and thesummary of data submitted, it is concluded that the information provided inthis submission supports substantial equivalence. |
§ 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.