(266 days)
This device is intended for use in selective trauma of the mid-face, reconstruction procedures and selective orthognathic surgery of the maxilla and chin.
The LeForte System Bone Plates are manufactured of pure Titanium (ASTM F67 Grades 1.2, and 3) and Screws of Titanium Alloy (ASTM F136), supplied non-sterile and intended for single use in selective trauma of the mid-face; reconstruction procedures; and selective orthognathic surgery of the maxilla and chin. This 510(k) notification includes the addition of LeForte System Bone Plates (Orbital Mesh, A, Angled Locking, Pre-bending L, Curved Locking, Straight reconstruction Locking, Straight BSSO Locking, Angled Reconstruction Locking, Multi Reconstruction Locking, and Straight Locking) having thicknesses of 0.2 to 2.5mm, lengths of 5.2 to 223.5mm and heights of 4.2 to 46.8mm, and Bone Plate Screws (Mini Locking Auto Screw, Maxi Locking Auto Screw, Mini Locking Common Screw and Maxi Locking Common Screw) having head diameters of 1.2 to 2.65mm, thread diameters of 0.7 to 1.6mm and lengths of 4.0 to 18.0mm.
The LeForte System Bone Plate & Screw is a medical device intended for use in selective trauma of the mid-face, reconstruction procedures, and selective orthognathic surgery of the maxilla and chin. This 510(k) summary provides details on the device's acceptance criteria and the studies conducted to demonstrate its performance and substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
For medical devices like bone plates and screws which are compared to predicate devices for substantial equivalence, the "acceptance criteria" are typically demonstrating that the new device performs at least as well as, or equivalently to, the predicate device across defined engineering and material properties, and that it maintains the same intended use. The "reported device performance" refers to the results of the pre-clinical tests conducted on the new device.
| Parameter | Acceptance Criteria (Measured against predicate devices and pre-defined standards/design controls) | Reported Device Performance |
|---|---|---|
| Material | Plates: Pure Titanium (ASTM F67 Grades 1, 2, and 3) Screws: Titanium Alloy (ASTM F136) | Plates: Titanium ASTM F67 Grade 1, 2, 3 Screws: Titanium Alloy ASTM F136 |
| Dimensions | Within ranges established for predicate devices and compliant with design specifications for new additional shapes/sizes | Plates: Length 5.2 ~ 223.5mm, Thickness 0.2 |
| Mechanical Strength | Performance comparable to predicate devices and acceptable for intended use based on industry standards and pre-defined design controls for mechanical properties (e.g., torsion, pull-out, bending, tensile strength). | Results of dimensional, torsion, pull-out, four-point bending, and tensile strength tests demonstrated compliance to pre-defined standards and Jeil Medical design controls. (Specific quantitative values are not provided in this summary but were likely included in the full submission). |
| Biocompatibility | Materials are well-established and used in predicate devices, implying biocompatibility. | Materials used (Pure Titanium, Titanium Alloy) are standard and recognized for biocompatibility in these applications. No new biocompatibility concerns were raised. |
| Sterilization | Non-sterile, single-use, consistent with predicate devices. | Supplied non-sterile, single-use. |
| Indications for Use | Same as predicate devices. The device is for selective trauma of the mid-face, reconstruction procedures, and selective orthognathic surgery of the maxilla and chin. | Same as predicate devices. Device is for selective trauma of the mid-face, reconstruction procedures, and selective orthognathic surgery of the maxilla and chin. |
2. Sample Size Used for the Test Set and the Data Provenance
The document describes pre-clinical testing which included dimensional, torsion, pull-out, four-point bending, and tensile strength tests. For such tests, the "test set" would refer to the physical samples of the LeForte System Bone Plate & Screw that were subjected to these mechanical evaluations.
- Sample Size: The document does not specify the exact number of samples used for each type of mechanical test (e.g., how many plates for four-point bending, how many screws for pull-out). This level of detail is typically found in the full test reports within the 510(k) submission, not typically in the summary. However, regulatory standards and good laboratory practices dictate that a sufficient number of samples are tested to ensure statistical significance and reliable results for each test.
- Data Provenance: The tests were conducted by the manufacturer, Jeil Medical Corporation. The location for these specific pre-clinical tests is not explicitly stated, but it is implied to be part of the manufacturer's internal testing process. The overall sponsor and manufacturer are based in Republic of Korea. The data is prospective in the sense that these tests were performed specifically for the purpose of this 510(k) submission to demonstrate the performance of the new device and its modifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This section is not applicable in the context of this 510(k) summary. "Ground truth" established by experts is relevant for studies involving medical image analysis, clinical diagnoses, or subjective evaluations. For bone plates and screws, the "ground truth" for acceptance is based on objective, quantifiable engineering and material standards, as well as comparison to the performance of predicate devices, rather than expert clinical interpretation of results. The "experts" involved would be mechanical engineers, material scientists, and regulatory specialists defining and interpreting the test results against established standards.
4. Adjudication Method for the Test Set
This section is also not applicable for the type of pre-clinical mechanical testing described. Adjudication methods (like 2+1 or 3+1) are used in clinical trials or studies where there are subjective assessments (e.g., by multiple readers/clinicians) that need to be resolved to establish a definitive ground truth. For mechanical tests, the results are objective measurements (e.g., load at failure, displacement, torque values) and do not require adjudication in the same manner.
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
There was no MRMC comparative effectiveness study done. This type of study is relevant for diagnostic devices, particularly those involving Artificial Intelligence (AI) or image interpretation, where human performance is being evaluated and potentially augmented by technology. The LeForte System Bone Plate & Screw is a physical implant, not an AI-powered diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
There was no standalone (algorithm only) performance study done. This concept is applicable to AI or software medical devices; the LeForte System Bone Plate & Screw is a physical medical implant.
7. The Type of Ground Truth Used
As previously mentioned, the concept of "ground truth" for expert consensus, pathology, or outcomes data is not directly applicable here. The "ground truth" for this device's performance demonstration relies on:
- Established engineering standards: ASTM F67 (for pure Titanium) and ASTM F136 (for Titanium Alloy) provide the material specifications.
- Pre-defined design controls: Internal specifications for the mechanical properties and dimensions that the device must meet.
- Predicate device characteristics: The existing LeForte Neuro System Bone Plate and Screw served as the benchmark for material, design, and intended use equivalence.
The "ground truth" is that the new device, including its modifications, meets these established standards and performs comparably to the legally marketed predicate devices, thereby establishing substantial equivalence.
8. The Sample Size for the Training Set
This information is not applicable. The concept of a "training set" refers to data used to train machine learning algorithms. The LeForte System Bone Plate & Screw is a physical device, and its approval is based on pre-clinical mechanical testing and comparison to predicate devices, not on data-driven model training.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the same reason as point 8. There was no training set because no machine learning algorithm was developed or evaluated for this device.
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Special 510(k) - LeForte System Bone Plate & Screw
MAY 1 8 2012
510 (k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92
Date: April 23, 2012
Sponsor:
| Company | |
|---|---|
| Name | Jeil Medical Corporation |
| Address | #702, Kolon Science Valley 2nd811, Guro-dong, Guro-gu, Seoul, 152-050,Republic of Korea |
| Phone | +82 2 850-3524 |
| Fax | +82 2 850-3525 |
| Contact | Mr. Ron Arkin |
| Internet | ronarkin@arkinconsulting.com |
2. Device:
- Proprietary Name LeForte System Bone Plate & Screw .
- Common Name Bone Plate, Bone Screw
- Classification Name Plate, Bone
Screw, Fixation, Intraosseous
3. Predicate Devices:
- Jeil Medical Corporation/ LeForte Neuro System Bone Plate / K091679
- Jeil Medical Corporation/ LeForte Neuro System Bone Plate / K103778 +
- Jeil Medical Corporation/ LeForte Neuro System Bone Screw / K091686
- Regulatory Classifications, Product Code: 4.
21 CFR 872.4760, JEY, Bone Plate, Class 2
21 CFR 872.4880, DZL, Screw, Fixation, Intraosseous, Class 2
5. Performance Standards:
No applicable performance standards have been issued under section 514 or under section 513(b) of the Food, Drug and Cosmetic Act.
-
- Description:
The LeForte System Bone Plates are manufactured of pure Titanium (ASTM F67 Grades 1.2, and 3) and Screws of Titanium Alloy (ASTM F136), supplied non-sterile and
- Description:
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Special 510(k) - LeForte System Bone Plate & Screw
intended for single use in selective trauma of the mid-face; reconstruction procedures; and selective orthognathic surgery of the maxilla and chin.
This 510(k) notification includes the addition of LeForte System Bone Plates (Orbital Mesh, A, Angled Locking, Pre-bending L, Curved Locking, Straight reconstruction Locking, Straight BSSO Locking, Angled Reconstruction Locking, Multi Reconstruction Locking, and Straight Locking) having thicknesses of 0.2 to 2.5mm, lengths of 5.2 to 223.5mm and heights of 4.2 to 46.8mm, and Bone Plate Screws (Mini Locking Auto Screw, Maxi Locking Auto Screw, Mini Locking Common Screw and Maxi Locking Common Screw) having head diameters of 1.2 to 2.65mm, thread diameters of 0.7 to 1.6mm and lengths of 4.0 to 18.0mm.
7. Indication for use:
This device is intended for use in selective trauma of the mid-face, reconstruction procedures and selective orthognathic surgery of the maxilla and chin.
-
- Contraindications:
- · Not for use in cases of active or suspected infection or in patients previously sensitized to Titanium.
- · Not for use in patients exhibiting disorders which would cause the patient to ignore the limitations of rigid fixation plate and screw implants.
-
- Potential Adverse Affects:
- Poor bone formulation, Osteoporosis, Osteolysis, Osteomyelitis, inhibited revascularization, or infection can cause loosening, bending, cracking or fracture of the device or premature loss of fixation with the bone, leading to nonunion.
- Nonunion or delayed union which may lead to breakage of the implant .
- Migration, bending, fracture or loosening of the implant .
- Metal sensitivity, or allergic reaction to foreign body "
- Decrease in bone density due to stress shielding .
- Pain, discomfort, or abnormal sensation due to the presence of the device .
- Increased fibrous tissue response around the fracture site and/or the implant
- Necrosis of bone .
- . Inadequate healing
Apart from these adverse effects there are always possible complications of any surgical procedure such as but not limited to, infection, nerve damage and pain which may not be related to the implant.
- Predicate comparison:
The LeForte System Bone Plates & Screws have the same device characteristics, material, design and intended use as the predicate devices.
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· ·
| Parameter | LeForte SystemBone Plate & ScrewJeil Medical Corporation | LeForte Neuro System Bone Plate,LeForte Neuro System Bone ScrewJeil Medical Corporation |
|---|---|---|
| 510(K) # | Modified | K091679, K103778, K091686 |
| Indicationsfor use | This device is intended for use in selective trauma of the mid-face, reconstruction procedures and selective orthognathic surgery of the maxilla and chin. | |
| Shape | The same models as the rightplusOrbital MeshAAngled LockingPre-bending LCurved LockingStraight reconstruction LockingStraight BSSO LockingAngled Reconstruction LockingMulti Reconstruction LockingStraight Locking | LTMeshStraightYHCurvedSquareQuadXCalvariumHexagonDouble YRCZICompressionChinRigid StraightBSSOAngled ReconstructionMGCommon Screw-MicroCommon Screw-MidCommon Screw-MiniCommon Screw-MaxiAuto Screw-MicroAuto Screw-MidAuto Screw-Mini |
| Material | Plates - Titanium ASTM F67 Grade1, 2, 3Screws - Titanium Alloy ASTM F136 | |
| Dimensions | PlatesLength 5.2 ~ 223.5mmThickness 0.2~2.5mm | ScrewsOuter (head) diameter 1.2 |
| Surface | Plate: AnodizingScrew: N/A | |
| Sterilization | Non sterile | |
| Single use | Yes | |
| Packaging | Vial, PA+PE film sealing |
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11. Pre-clinical Testing:
Pre-clinical performance testing included dimensional, torsion, pull-out, four point bending and tensile strength tests for the compliance to pre-defined standards and Jeil Medical design controls.
12. Conclusions:
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification Jeil Medical Corporation Concludes that the LeForte System Bone Plate & Screw is substantially equivalent to the predicate device as described herein.
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY 1 8 2012
Mr. Paul Sumner Vice President Arkin Consulting Group 1733 Canton Lane Marietta, Georgia 30062
Re: K112457
Trade/Device Name: LeForte System Bone Plate & Screw Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: April 25, 2012 Received: April 27, 2012
Dear Mr. Sumner:
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.
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Page 2 – Mr. Sumner
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 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,
Wh for
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Special 510(k) -- LeForte System Bone Plate & Screw
Indications for Use Statement
510(k) Number (if known)
Device Name
LeForte System Bone Plate & Screw
Indications for Use
This device is intended for use in selective trauma of the mid-face, reconstruction procedures and selective orthognathic surgery of the maxilla and chin.
Prescription Use
(Per 21 CFR 801. Subpart D)
OR
Over-The-Counter Use (21CFR801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sween Rumm
Division Sign-Off) ്വീഴിടിon Sign-On/
Jivision of Anesthesiology, General Hospital nfection Control, Dental Devices
510(k) Number: KC1)2457
Indications For Use Statement
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.