(30 days)
Not Found
No
The description focuses on the mechanical components (plates, screws) and their material properties and performance (tensile strength, torsion, pull out). There is no mention of AI, ML, image processing, or data-driven analysis.
No.
The device is a system of bone plates and screws used in cranial surgery and reconstructive procedures, which are physical components for structural support rather than providing therapeutic treatment.
No
The device description indicates that the LeForte Neuro System consists of bone plates, screws, and accessories for surgical and reconstructive procedures of the craniofacial skeleton. There is no mention of diagnostic functions, imaging, or analysis of medical data to determine a medical condition.
No
The device description explicitly states it consists of bone plates, bone screws, convenience kits, and accessories, all of which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "selective trauma of the cranial surgery and reconstructive procedures." This describes a surgical intervention on the human body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device consists of "bone plates in a variety of shapes and sizes, bone screws to secure the plates, convenience kits of bone plates and bone screws, and accessories to assist in the operational procedures." These are implantable medical devices used during surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to be used in vitro (outside the living body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly falls under the category of a surgical implant/instrument.
N/A
Intended Use / Indications for Use
This device is intended for use in selective trauma of the cranial surgery and reconstructive procedures.
Product codes
GWO, GXR, HBW
Device Description
The LeForte Neuro System is designed for use in selective trauma of the craniofacial skeleton, craniofacial surgery and reconstructive procedures. The LeForte Neuro System consists of bone plates in a variety of shapes and sizes, bone screws to secure the plates, convenience kits of bone plates and bone screws, and accessories to assist in the operational procedures. The LeForte Neuro System Bone Plate & Screw is made of pure titanium (ASTM F67) and titanium Alloy (ASTM F136). It is intended for use in selective trauma of cranial skeleton, cranial surgery and reconstructive procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranial skeleton, craniofacial skeleton
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- The modified LeForte Neuro System plates were tested for tensile strength. All the test data met pre-set criteria (over N150).
- The modified LeForte Neuro System bone screws were tested for torsion and pull out. All the test data met pre-set criteria (0.20Nom for torsion, 20N for pull out).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5320 Preformed alterable cranioplasty plate.
(a)
Identification. A preformed alterable cranioplasty plate is a device that is implanted into a patient to repair a skull defect. It is constructed of a material, e.g., tantalum, that can be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).
0
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: May 27, 2014
1. 510K Applicant / Submitter:
Jeil Medical Corporation 702.703.704.705.706.805.807.812-ho 55. Digital-ro 34-gil, Guro-gu, Seoul, 152-728. Republic of Korea Tel : +82-2-850-3524 Fax: +82-2-850-3525
2. Submission Contact Person
LK Consulting Group USA. Inc. 2651 E Chapman Ave Ste 110, Fullerton. CA 92831 Priscilla Juhee Chung Phone: 714.202.5789 Fax: 714-409-3357 Email: juhee.c(@lkconsultinggroup.com
3. Device
- Proprietary Name -LeForte Neuro System Bone Plate & Screw ·
- . Common Name -Neuro Plating System
- Classification Name Preformed Alterable Cranioplasty Plate: . Burr hole cover; Cranioplasty plate fastener
4. Predicate Device
LeForte Neuro System Bone Plate & Screw by Jeil Medical Corporation (K112812)
5. Product Codes:
GWO, GXR. HBW
6. Classification Regulation:
21CFR§882.5320 21CFR§882.5250 21CFR §882.5360
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7. Description:
The LeForte Neuro System is designed for use in selective trauma of the craniofacial skeleton, craniofacial surgery and reconstructive procedures. The LeForte Neuro System consists of bone plates in a variety of shapes and sizes, bone screws to secure the plates, convenience kits of bone plates and bone screws, and accessories to assist in the operational procedures. The LeForte Neuro System Bone Plate & Screw is made of pure titanium (ASTM F67) and titanium Alloy (ASTM F136). It is intended for use in selective trauma of cranial skeleton, cranial surgery and reconstructive procedures.
8. Substantial Equivalence Discussion:
The subject device has the same device characteristics as the predicate (unmodified) device. They have the same intended use, raw material, and use concept and employ the same anodization and sterilization method. The differences are in shape and dimensions; however: the performance test data provided in this submission proves that this differences do not raise new issues in safety and performance.
| Subject Device | Unmodified (Predicate) Device | |
|---|---|---|
| 510K Number | GXR | K112812 |
| Product Code | GWO, GRX, HBW | GWO. GRA HBW |
| Manufacturer | Jeil Medical Corporation | Jeil Medical Corporation |
| Indications for | This device is intended for use in | This device is intended for use in |
| Use | selective trauma of the cranial | sclective trauma of the cranial |
| skeleton, cranial surgery and | skeleton, cranial surgery and | |
| reconstructive procedures. | reconstructive procedures. | |
| Materials | Plate - CP Ti Gr. 1,2,3, and 4 (ASTM | Plate - CP Ti Gr. 1,2,3, and 4 (ASTM |
| F7) | F7) | |
| Screw - Ti 6Al 4V ELI (ASTM | Screw - Ti 6Al 4V ELI (ASTM | |
| FI36) | E136) | |
| Dimensions | Plate thickness 0.3mm~1.0mm | Plate thickness 0.3mm~0.6mm |
| Screw Outer Dia. 1.4~1.8mm | Screw Outer Dia. 1.4~1.8mm | |
| Screw Length 2.2~5.0mm | Screw Length 2.2~5.0mm | |
| Surface Treatment | Plate - Anodization | Plate - Anodization |
| Screw - N/A | Screw - N/A | |
| Sterilization | Non-Sterile | Non-Sterile |
| (Steam sterilization by user using | (Steam sterilization by user) | |
| same parameters as the unmodified | ||
| device) | ||
| Usage | Single Use | Single Use |
| Packaging | Polyethylene Zip Lock Pouch | Polyethylene Zip Lock Pouch |
| Cardboard Box | Cardboard Box |
9. Performance Tests:
- The modified LeForte Neuro System plates were tested for tensile strength. All the test
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data met pre-set criteria (over N150).
- The modified LeForte Neuro System bone screws were tested for torsion and pull out. All the test data met pre-set criteria (0.20Nom for torsion, 20N for pull out).
10. 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 Neuro System Bone Plate & Screw is safe and effective and substantially equivalent to the predicate device as described herein.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60S Silver Spring, MD 20993-0002
July 2, 2014
Jeil Medical Corporation % Ms. Priscilla Chung LK Consulting Group USA, Inc. 2651 E Chapman Ave, Ste. I I 0 Fullerton, California 92831
Re: K141452
Trade/Device Name: Leforte neuro system bone plate and screw Regulation Number: 21 CFR 882.5320 Regulation Name: Preformed Alterable Cranioplasty Plate Regulatory Class: Class II Product Code: GWO, GXR, HBW Dated: May 27, 2014 Received: June 2, 2014
Dear Ms. Chung:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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Page 2 - Ms. Priscilla Chung
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 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/ResourcesforYou/Industry/default.htm. 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 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 yours,
Felipe Aquel -S
Carlos L. Peña, PhD, MS for Director
Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on fast page.
510(k) Number (if known)
K141452
Device Name LeForte Neuro System Bone Plate & Screw
Indications for Use (Describe)
This device is intended for use in selective trauma of the cranial surgery and reconstructive procedures.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Date: Felipe 2014.07.02 Aquel -S 17:29:34 -04'00'