(93 days)
The 2.4mm Variable Angle LCP Volar Rim Distal Radius Plates are intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones in adults, skeletally mature adolescents, and the following adolescent distal radius fractures: intra-articular fractures exiting the epiphysis, intra-articular fractures exiting the metaphysis, physeal crush injuries, and any injuries which cause growth arrest to the distal radius.
The 2.4mm Variable Angle LCP Distal Radius Plates are used with a range of 2.4 mm variable angle locking screws, 2.4 mm cortex screws, and 2.7 mm cortex screws. These new plates incorporated variable angle locking technology. The Variable Angle LCP Volar Rim Distal Radius Plates are designed as low profile plates, designed to minimize soft tissue irritation by featuring a low contoured plate profile with countersunk screws, rounded edges, and polished surfaces. The plates feature both variable angle locking screw holes in the head and shaft and elongated variable angle combination holes along the shaft only. The plates are offered in 6- and 7-hole head configurations each with two additional contourable wing tabs with screws holes to provide even greater variability in screw placement for additional fragment capture and fracture reduction.
The provided document is a 510(k) summary for the Synthes 2.4mm Variable Angle LCP Volar Rim Distal Radius System. This type of submission is for medical devices that are substantially equivalent to a predicate device and, as such, does not contain acceptance criteria and studies demonstrating device performance in the same way a de novo or PMA submission would.
Instead, the documentation focuses on demonstrating substantial equivalence through:
- Comparison of intended use and design features to predicate devices.
- Mechanical testing to show comparable performance in terms of mechanical strength and fatigue to predicate devices.
Therefore, the requested information regarding acceptance criteria, specific device performance, sample sizes for test and training sets, expert qualifications, ground truth establishment, and MRMC studies are not typically included or required for a 510(k) submission based on substantial equivalence to existing devices. Such detailed studies are usually reserved for novel devices or those with higher risk classifications where clinical efficacy and safety need to be established independently.
However, I can extract the information related to the device description and the type of testing performed to support substantial equivalence.
Here's a breakdown of what can be extracted from the provided text, addressing the closest relevant points:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as pass/fail metrics. The general implied acceptance criterion is "comparable mechanical strength and fatigue" to predicate devices.
- Reported Device Performance: The document states that "Mechanical testing demonstrates substantial equivalence of the subject components to the predicate device in regards to mechanical strength" and "Testing conducted to support the substantial equivalence for the 2.4mm VA-LCP Volar Rim Distal Radius Plates was aimed to assess the fatigue strength of the subject device." It also mentions "Functional & mechanical testing demonstrates the comparable mechanical and functional properties of the 2.4mm Variable Angle LCP Volar Rim Radius System to the predicate devices."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Comparable mechanical strength to predicate device | Mechanical testing demonstrates substantial equivalence in regards to mechanical strength. |
| Comparable fatigue strength to predicate device | Testing assessed the fatigue strength; finite element analysis and dynamic loading testing determined the worst-case construct is substantially equivalent to the predicate device construct. |
| Comparable functional properties to predicate device | Functional & mechanical testing demonstrates comparable mechanical and functional properties. |
2. Sample sized used for the test set and the data provenance
- Sample Size: Not specified. Mechanical testing typically involves a set number of specimens, but this detail is not provided in a 510(k) summary.
- Data Provenance: The testing was conducted by Synthes (USA), the sponsor of the device. The data would be internal to the company, performing the tests to demonstrate equivalence. It is not patient data, but rather mechanical test data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Ground Truth/Experts: This question is not applicable. The "ground truth" for mechanical testing is established by engineering standards and test methods, not by expert consensus on clinical data. No human experts are involved in establishing a "ground truth" for mechanical properties in this context.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. Mechanical test results are objective measurements against defined engineering parameters, not subjective interpretations requiring adjudication.
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
- MRMC Study: No. This is a medical implant (bone plate) used for fixation of fractures, not an image-based diagnostic or AI-powered device. Therefore, MRMC studies are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: No. This is not an algorithmic device. The performance is physical and mechanical.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Ground Truth: For this type of device and study, the "ground truth" refers to established engineering standards for mechanical properties (e.g., strength, fatigue limits) and the mechanical properties of the predicate devices. It is based on objective physical measurements and engineering analysis.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. There is no "training set" as this is not a machine learning/AI device. Finite element analysis (FEA) was used, which involves computational models, not a data training set.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable for the same reason as above. FEA relies on material properties and geometric models, not a "ground truth" for a training set. The FEA was used to "determine the worst case construct" for further dynamic loading testing.
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K110I25 (pg 1/2)
Image /page/0/Picture/1 description: The image shows the word "SYNTHES" in bold, sans-serif font. To the left of the word is a circular logo with a stylized image inside. A small circle with an R inside is located to the upper right of the word "SYNTHES".
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APR 2 1 2011
| 3.0 | 510(k) Summary |
|---|---|
| Prepared: January 14, 2011 | |
| Page 1 of 2 | |
| Purpose for Submission: | To Introduce a new plate system (2.4mm Variable Angle LCP Volar Rim Radius System) into interstate commerce with the following indication: "skeletally mature adolescents and the following adolescent distal radius fractures: intra-articular fractures exiting the epiphysis, intra-articular fractures exiting the metaphysic, physeal crush injuries, and any injuries which cause growth arrest to the distal radius." |
| Sponsor: | Synthes (USA)Christopher Hack, Esq.1301 Goshen ParkwayWest Chester, PA 19380(610) 719-6940 |
| Device Name: | 2.4mm Variable Angle LCP Volar Rim Distal Radius System |
| Classification: | Class II, §888.3030 - Single/multiple component metallic bone fixation appliances and accessories, HRS |
| Class II, §888.3040 - Smooth or threaded metallic bone fixation fastener | |
| Predicate Device: | Synthes 2.4 LCP Volar Column Distal Radius Plating System - (K102694)Synthes Volar Distal Radius Plate - (K953644)Synthes Variable Angle Locking Compression Plate - (K071184)Synthes Locking Distal Radius Plating System - (K102694)Synthes Stainless Steel Modular Hand System - (K030310)Synthes Small Titanium Wrist Fusion Plate - (K023987) |
| Device Description: | The 2.4mm Variable Angle LCP Distal Radius Plates are used with a range of 2.4 mm variable angle locking screws, 2.4 mm cortex screws, and 2.7 mm cortex screws. These new plates incorporated variable angle locking technology. The Variable Angle LCP Volar Rim Distal Radius Plates are designed as low profile plates, designed to minimize soft tissue irritation by featuring a low contoured plate profile with countersunk screws, rounded edges, and polished surfaces. The plates feature both variable angle locking screw holes in the head and shaft and elongated variable angle combination holes along the shaft only. The plates are offered in 6- and 7-hole head configurations each with two additional contourable wing tabs with screws holes to provide even greater variability in screw placement for additional fragment capture and fracture reduction. |
| Intended Use: | The 2.4mm Variable Angle LCP Volar Rim Distal Radius Plates are indicated for fixation of complex intra- and extra-articular fractures of the distal radius and other small bones in adults, skeletally mature adolescents, and the following adolescent distal radius fractures: intra- articular fractures exiting the epiphysis, intra-articular fractures exiting the metaphysis, physeal crush injuries, and any injuries which cause growth arrest to the distal radius. |
| Substantial | The features of the subject components are substantially equivalent to the |
predicate devices based on similarities in intended use and design.
Premarket Notification 510(k): 16 Synthes (USA) 2.4mm VA-LCP Volar Rim Distal Radius Plates.
Equivalence:
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Image /page/1/Picture/1 description: The image shows the word "SYNTHES" in a bold, sans-serif font. To the left of the word is a circular logo with a stylized image inside. The logo appears to be a medical device company. The registered trademark symbol is located to the upper right of the word.
Mechanical testing demonstrates substantial equivalence of the subject Mechanical testing Genionstrates cacommiddly to mechanical strength. In
components to the predicate devise in regards to mechanine, and components to the predicate devise in regaries, packaging, and addition, the intended use, manafavoring one one one identical.
The subject and predicate devices are made from stainless steel and The subject and predioute de Functional and mechanical testing commercially pure thanium. Tanetional & functional properies of the demonstrates the comparable meena.near Radius System to the predicate devices.
Testing conducted to support the substantial equivalence for the 2.4mm I esting conducted to support the substantial organized to assess the fatigue
VA-LCP Volar Rim Distal Radius Plates was aimed to assess the fatigue VA-LCP Volar Kini Distar Radios Printe element analysis was used to
strength of the subject device. Finite element analysis was used to strength of the subject device. I mine cromon and dynamic loading testing was used
determine the worst case construct and dynamic lungagiyalent to determine the worst case construct and ayer is substantially equivalent to the predicates device construct.
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Image /page/2/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or other bird-like figure with outstretched wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
APR 2 1 2011
Synthes USA % Christopher Hack 1301 Goshen Parkway West Chester, PA 19380
Re: K110125
Trade/Device Name: 2.4mm Variable Angle LCP Volar Rim Distal Radius 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. HWC Dated: November 2, 2010 Received: November 3, 2010
Dear Mr. Hack:
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
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Page - 2 - Mr. Christopher Hack
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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 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.
Sincerely yours.
Aing B. Mh
fu
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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2.0 Indications for Use
510(k) Number (if known):
1110125 (pg 1/1)
Synthes (USA) 2.4mm Variable Angle LCP Volar Rim Distal Radius Plates . Device Name:
Indications for Use:
The 2.4mm Variable Angle LCP Volar Rim Distal Radius Plates are intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones in adults, skeletally mature adolescents, and the following adolescent distal radius fractures: intra-articular fractures exiting the epiphysis, intra-articular fractures exiting the metaphysis, physeal crush injuries, and any injuries which cause growth arrest to the distal radius.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)
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)
for M. Melkerson
(Division Sign Off)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K11/0125
§ 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.