(61 days)
The Synthes Variable Angle LCP Elbow System is intended for fixation of fractures of the distal humerus, olecranon and ulna in adults and adolescents (12-21) in which the growth plates have fused. Specifically,
· Distal humerus plates are indicated for intra-articular fractures, comminuted supracondylar fractures, osteotomies, malunions and non-unions of the distal humerus.
· Olecranon and Proximal ulna plates are indicated for fractures, osteotomies, malunions and non-unions of the olecranon and proximal ulna.
The Synthes Variable Angle LCP Elbow System contains posterolateral and medial plates intended to treat fractures of the distal humerus. The plates are used together in a two-plate, 90° construct and accept existing screws. New 2.7mm Metaphyseal Screws are also compatible with the System.
This document, K120717, describes the Synthes Variable Angle LCP Elbow System. It's a 510(k) premarket notification for a medical device. Here's an analysis based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Strength (Static and Fatigue) | "Static and fatigue strength testing, as well as an engineering analysis, was completed for Medial and Posterolateral Distal Humerus Plates, demonstrating equal to or greater strength in comparison to the predicate devices and constructs." |
| "Mechanical testing for the 2.7mm Metaphyseal Screws demonstrated substantial equivalence in comparison to the existing 2.7mm VA Locking Screws (K100776)." |
2. Sample size used for the test set and the data provenance
The document describes mechanical testing and engineering analysis, not a clinical study involving human patients or analysis of patient data. Therefore, the concept of a "test set" and "data provenance" (country of origin, retrospective/prospective) in the context of clinical data doesn't apply here. The "sample size" would refer to the number of devices or components tested in the mechanical experiments, but this specific number is not provided in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable. The device's performance was evaluated through mechanical testing against engineering standards and comparison to predicate devices, not by expert consensus on clinical outcomes or diagnoses.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This question is not applicable as there was no clinical test set requiring adjudication in this 510(k) summary.
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
This question is not applicable. This 510(k) pertains to a bone fixation system (hardware), not an AI/software device that would involve human readers or image interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable. This is a physical medical device, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is established by engineering standards and direct comparison of mechanical properties to legally marketed predicate devices. Specifically, the ground truth is that the new device's mechanical strength must be "equal to or greater" than the predicate devices. This is assessed through physical testing methods, not clinical outcomes or expert consensus.
8. The sample size for the training set
This question is not applicable. This is a hardware device; there is no "training set" in the context of an algorithm or AI. The development process would involve engineering design, finite element analysis, and prototyping, not data-driven training as understood in AI.
9. How the ground truth for the training set was established
This question is not applicable for the reasons stated above.
Summary of the Study:
The primary study type conducted for this 510(k) submission was mechanical testing and engineering analysis. The goal was to demonstrate that the new Synthes Variable Angle LCP Elbow System (specifically, the Medial and Posterolateral Distal Humerus Plates and 2.7mm Metaphyseal Screws) is substantially equivalent to predicate devices (Synthes 3.5mm LCP Elbow System (K033995) and Synthes Small Fragment System (K000684), and existing 2.7mm VA Locking Screws (K100776)).
The study found that the new device's components exhibited "equal to or greater strength" in static and fatigue testing compared to the predicate devices and constructs. This demonstrates that the device meets the performance requirements for its intended use, which is critical for bone fixation implants expected to withstand significant biomechanical forces.
{0}------------------------------------------------
Page 1/2
·
:
. 4
.
5.0 - 510(k) Summary
. .
Date Prepared: April 6, 2012
| Sponsor: | SynthesAngela F. Lassandro1301 Goshen ParkwayWest Chester, PA 19380(610) 719-6854 |
|---|---|
| Device Name: | Synthes Variable Angle LCP Elbow System (Medial and Posterolateral DistalHumerus Plates) |
| Classification: | Classification: Class II, §888.3030, Single/multiple component metallic bonefixation appliances and accessories.Product Code: HRS, HWC |
| Predicate Device: | Synthes 3.5mm LCP Elbow System (K033995)Synthes Small Fragment System (K000684)Synthes 2.4 mm / 2.7 mm VA-LCP Forefoot /Midfoot System (K100776)Synthes 2.7/3.5mm VA-LCP Elbow System (K120070) |
| Device Description: | The Synthes Variable Angle LCP Elbow System contains posterolateral andmedial plates intended to treat fractures of the distal humerus. The plates areused together in a two-plate, 90° construct and accept existing screws. New2.7mm Metaphyseal Screws are also compatible with the System. |
| Intended Use: | The Synthes Variable Angle LCP Elbow System is intended for fixationof fractures of the distal humerus, olecranon and ulna in adults andadolescents (12-21) in which the growth plates have fused. Specifically,· Distal humerus plates are indicated for intra-articular fractures,comminuted supracondylar fractures, osteotomies, malunions andnon-unions of the distal humerus.· Olecranon and Proximal ulna plates are indicated for fractures,osteotomies, malunions and non-unions of the olecranon andproximal ulna. |
| Substantial Equivalence: | Both the subject Synthes Variable Angle Elbow System (Medial andPosterolateral Distal Humerus Plates) and predicate Synthes 3.5mm LCP ElbowSystem (K033995) and Synthes Small Fragment System (K000684) have similarindications, design characteristics, materials, and performance characteristics.Static and fatigue strength testing, as well as an engineering analysis, wascompleted for Medial and Posterolateral Distal Humerus Plates, demonstratingequal to or greater strength in comparison to the predicate devices and |
{1}------------------------------------------------
K/20717
.
Page 2/2
constructs. Additionally, mechanical testing for the 2.7mm Metaphyseal Screws demonstrated substantial equivalence in comparison to the existing 2.7mm VA Locking Screws (K100776).
{2}------------------------------------------------
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY - 8 2012
Synthes % Ms. Angela F. Lassandro 1301 Goshen Parkway West Chester, PA 19380
Re: K120717
Trade/Device Name: Synthes Variable Angle LCP Elbow System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Product Code: HRS, HWC Dated: March 5, 2012 Received: March 12, 2012
Dear Ms. Lassandro:
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
{3}------------------------------------------------
Page 2 - Ms. Angela F. Lassandro
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 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Ernst Klett
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use Statement
510(k) Number (if known):
Synthes Variable Angle LCP Elbow System Device Name:
Indications for Use:
The Synthes Variable Angle LCP Elbow System is intended for fixation of fractures of the distal humerus, olecranon and ulna in adults and adolescents (12-21) in which the growth plates have fused. Specifically,
· Distal humerus plates are indicated for intra-articular fractures, comminuted supracondylar fractures, osteotomies, malunions and non-unions of the distal humerus.
· Olecranon and Proximal ulna plates are indicated for fractures, osteotomies, malunions and non-unions of the olecranon and proximal ulna.
Prescription Use X (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)
Andist
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K120217
§ 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.