(24 days)
EDGE Orthopaedics' REDUCE® Fracture Plating System is intended for use in stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. The plates are available for use with EDGE Orthopaedics locking and non-locking bone screws.
Plates and screws are intended for single use only. Screws are not intended for use in the spine.
The EDGE Orthopaedics' REDUCE® Fracture Plating System Line Extension has been designed to support multiple indications within the forefoot and mid-foot. The line extension includes titanium alloy, sterile packaged H and Box Plates along with sterile titanium alloy bone screws.
The REDUCE Fracture Plating System is offered in a variety of sizes for use with the nonlocking and locking bone screws. The screws are available in variety of diameters and lengths to help support the fixation, correction or stabilization of bones.
The corresponding instrumentation (depth gauges, screwdrivers, reamers, and plate benders) to facilitate insertion is found in EDGE's RIVAL Instrument Tray.
The only modifications that were made are the two additional fracture plates: H-plate and Box plate. The manufacturing, packaging and sterilization process are the same as the predicate device.
This document, K142135, is a 510(k) Premarket Notification for a line extension to the REDUCE® Fracture Plating System by EDGE Orthopaedics. It focuses on demonstrating substantial equivalence to a previously cleared predicate device (K140876). As such, it does not detail a study proving the device meets specific performance acceptance criteria in the way a new, innovative device might. Instead, it relies on demonstrating that the new elements (H-plate and Box plate) are technologically equivalent and do not introduce new worst-case scenarios compared to the predicate.
Given this context, the request for acceptance criteria and a study that proves the device meets those criteria needs to be interpreted in terms of the information available in this 510(k) submission.
Here's a breakdown based on the provided text, acknowledging that some requested information (like specific test set sizes for clinical data, expert qualifications, adjudication methods, MRMC studies, standalone performance, and detailed ground truth for training) are not typically part of a 510(k) for a line extension based on substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for a 510(k) line extension typically revolve around demonstrating that the new components perform at least as well as, or are equivalent to, the predicate device in terms of safety and effectiveness, leveraging existing data and analyses. Specific numerical performance metrics (like sensitivity, specificity, accuracy) are not reported in this type of submission for this kind of device.
| Acceptance Criteria | Reported Device Performance (based on K142135) |
|---|---|
| Maintain safety and effectiveness of the predicate device. | "The safety and effectiveness of the line extension is adequately supported by the substantial equivalence information as well as CAD and mathematical analysis included in this submission to conclude the line extension did not create a new worst case." (Page 4) |
| Technological characteristics are equivalent to the predicate device. | "The subject device is the same device with respect to design, material and indications to the predicate device. There are no technological differences to the subject device." (Page 4) |
| Intended Use remains the same as the predicate device. | "This is the same intended use as previously cleared for the REDUCE Plating Systems (K140876)." (Page 4) |
| Manufacturing, packaging, and sterilization processes are the same as the predicate device. | "The manufacturing, packaging and sterilization process are the same as the predicate device." (Page 3) |
| Materials are the same as the predicate device. | The line extension includes "titanium alloy" plates and screws, consistent with typical bone fixation devices and implying material equivalence to the predicate. (Page 3) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of this 510(k) submission. No clinical "test set" in the traditional sense was used for a prospective study evaluating the new plates.
- Data Provenance: The reliance is on "CAD and mathematical analysis" (Page 4) to demonstrate that the line extension (H-plate and Box plate) did not create a new worst-case scenario compared to the predicate device. This is a form of in-silico or engineering analysis rather than human-generated clinical data. Since no new clinical data were generated for this line extension, no specific country of origin or retrospective/prospective classification applies to a "test set."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- This information is not provided in the document. As clinical data was not used to determine substantial equivalence (Page 4), there was no "test set" requiring expert-established ground truth in the clinical sense. The ground truth for the CAD and mathematical analysis would be based on established engineering principles and material science, likely performed by engineers, but the specific number or qualifications are not disclosed.
4. Adjudication Method for the Test Set
- Not applicable. Since no clinical test set requiring expert interpretation was used, no adjudication method (e.g., 2+1, 3+1) is mentioned or implied.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC study was not performed. The 510(k) explicitly states, "Clinical data was not used to determine substantial equivalence." (Page 4) Therefore, there's no reported effect size of human readers improving with or without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is a mechanical implant (fracture plating system), not a software algorithm. Therefore, "standalone" algorithm performance is not relevant.
7. The Type of Ground Truth Used
- The "ground truth" for this submission is implicitly based on engineering principles, material science, and prior regulatory clearance of the predicate device. The CAD and mathematical analysis would be evaluated against established biomechanical performance standards and material properties, rather than expert consensus, pathology, or outcomes data specifically generated for this line extension. The previous clearance of the predicate device (K140876) serves as the primary benchmark.
8. The Sample Size for the Training Set
- Not applicable. This submission does not involve a machine learning algorithm; therefore, there is no "training set" in that context. The "training" for the device's design and manufacturing would implicitly be based on historical data and experience with similar devices, including the predicate.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no "training set" in the sense of a machine learning algorithm, there is no method for establishing its ground truth. The design and manufacturing processes are likely informed by industry standards, biomechanical testing protocols, and feedback from clinical experience with similar devices, all of which contribute to the "ground truth" of safe and effective device design. The "Description of the Device" states "The only modifications that were made are the two additional fracture plates: H-plate and Box plate. The manufacturing, packaging and sterilization process are the same as the predicate device." (Page 3). This implies reliance on the established ground truth for the predicate device's design and manufacturing through its prior clearance.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, resembling a family or group of people.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 28, 2014
ICON ORTHOPEDIC CONCEPTS, LLC DBA EDGE ORTHOPAEDICS Ms. Jan Triani Director of Quality Assurance and Regulatory Affairs 6 Mars Court, Unit 6-3 Boonton, New Jersey 07005
Re: K142135 Trade/Device Name: REDUCE® Fracture Plating System Line Extension Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: August 1, 2014 Received: August 4, 2014
Dear Ms. Triani:
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 (reporting of medical
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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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education 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.
Sincerely vours.
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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EDGE Orthopaedics REDUCE® Fracture Plating Line Extension
4. Indications for Use Statement
510(k) Number (if known): K142135
Device Name: REDUCE® Fracture Plating Line Extension
Indications for Use:
EDGE Orthopaedics' REDUCE® Fracture Plating System is intended for use in stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. The plates are available for use with EDGE Orthopaedics locking and non-locking bone screws.
Plates and screws are intended for single use only. Screws are not intended for use in the spine.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page __ of ___
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5. 510(k) Summary
Date Prepared [21 CFR 807.92(a)(1)]
August 26, 2014
Submitter's Information [21 CFR 807.92(a)(1)]
Jan Triani, Directory of Quality Assurance and Regulatory Affairs 6 Mars Court, Unit 6-3 Boonton, NJ 07005 Phone: (201)543-9388 Fax: (973)794-6813
Establishment Registration Number: 3010726797
Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
| Trade Name: | EDGE Orthopaedics REDUCE® Fracture Plating System |
|---|---|
| Common Name: | Plate |
| Classification Name: | Class II, 21 CFR 888.3030, Product Code: HRS |
| Panel Code: | Orthopedics |
Predicate Device [21 CFR 807.92(a)(3)]
EDGE Orthopaedics' VIEW and REDUCE Plating Systems - K140876
Description of the Device [21 CFR 807.92(a)(4)]
The EDGE Orthopaedics' REDUCE® Fracture Plating System Line Extension has been designed to support multiple indications within the forefoot and mid-foot. The line extension includes titanium alloy, sterile packaged H and Box Plates along with sterile titanium alloy bone screws.
The REDUCE Fracture Plating System is offered in a variety of sizes for use with the nonlocking and locking bone screws. The screws are available in variety of diameters and lengths to help support the fixation, correction or stabilization of bones.
The corresponding instrumentation (depth gauges, screwdrivers, reamers, and plate benders) to facilitate insertion is found in EDGE's RIVAL Instrument Tray.
The only modifications that were made are the two additional fracture plates: H-plate and Box plate. The manufacturing, packaging and sterilization process are the same as the predicate device.
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Intended Use [21 CFR 807.92(a)(5)]
EDGE Orthopaedics' REDUCE® Fracture Plating System is intended for use in stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. The plates are available for use with EDGE Orthopaedics' locking and non-locking bone screws.
Plates and screws are intended for single use only. Screws are not intended for use in the spine.
This is the same intended use as previously cleared for the REDUCE Plating Systems (K140876). The indication for use statement can be found in Section 4.
Technological Characteristics [21 CFR 807.92(a)(6)]
The subject device is the same device with respect to design, material and indications to the predicate device. There are no technological differences to the subject device.
Performance Data [21 CFR 807.92(b)(1)]
The safety and effectiveness of the line extension is adequately supported by the substantial equivalence information as well as CAD and mathematical analysis included in this submission to conclude the line extension did not create a new worst case.
Clinical Data [21 CFR 807.92(b)(2)]
Clinical data was not used to determine substantial equivalence.
Conclusion [21 CFR 807.92(b)(3)]
The analysis of the line extension for the REDUCE Fracture Plating System in this Premarket Notification supports the conclusion that the subject devices are substantially equivalent to the predicate device.
§ 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.