(217 days)
No
The device description and performance studies focus on the physical components (plates, screws) and their mechanical properties, with no mention of AI, ML, image processing, or data-driven analysis.
No.
The device is described as a system of bone plates, screws, and accessories made of titanium, intended for use in cranial surgery and reconstructive procedures to secure bone. It is an implantable medical device for structural support and fixation, rather than a device that provides a therapeutic effect through physiological intervention or treatment of disease.
No
The device description indicates it is a system of bone plates, screws, and accessories used for surgical and reconstructive procedures of the cranial skeleton, not for diagnosing conditions.
No
The device description explicitly states it consists of bone plates, bone screws, and accessories made of titanium, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "selective trauma of the cranial surgery and reconstructive procedures." This describes a surgical implant used in vivo (within the body) during a medical procedure.
- Device Description: The description details bone plates, screws, and accessories made of titanium. These are physical implants and surgical tools, not reagents, instruments, or software used to examine specimens in vitro (outside the body).
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing diagnostic information based on the analysis of specimens
- Reagents, calibrators, or controls
- Laboratory equipment for specimen analysis
The device described is a surgical implant system used to repair and reconstruct the cranial skeleton. This falls under the category of medical devices used directly on or within the patient, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Sterile NS System is intended for use in selective trauma of the cranial surgery and reconstructive procedures.
Product codes
GWO, GXR, HBW
Device Description
The Sterile NS System is designed for use in selective trauma of the craniofacial skeleton, craniofacial surgery and reconstructive procedures. The Sterile NS System consists of bone plates in a variety of shapes and sizes, bone screws to secure the plates, and accessories to assist in the operational procedures. The Sterile NS System 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
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
Non-Clinical Test Summary: The test was conducted to verify that the subject device met all design specifications. The test results demonstrated that the proposed device complies with the following standards and worst case criteria report: - Plate - Dimension test - - Screws - Dimension test - The subject device has the same device characteristics as the predicate (unmodified) device. Clinical Test Summary: No clinical studies were considered necessary and performed.
Key Metrics
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
Public Health Service
Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular pattern.
September 11, 2017
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Jeil Medical Corporation Ji Won Song RA Specialist 55 Digital-ro. 34-gil 702, 703, 704, 705, 706, 804, 805, 807, 812-ho Seoul, 152-728 KR
Re: K170368
Trade/Device Name: Sterile NS System Regulation Number: 21 CFR 882.5320 Regulation Name: Preformed Alterable Cranioplasty Plate Regulatory Class: Class II Product Code: GWO, GXR, HBW Dated: August 9, 2017 Received: August 10, 2017
Dear Ji Won Song:
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
1
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 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 (DICE) 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 (DICE) 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.
Michael J. Hoffmann -S
for
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K170368
Device Name Sterile NS System
Indications for Use (Describe)
The Sterile NS System is intended for use in selective trauma of the cranial surgery and reconstructive procedures.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo and contact information for JEIL MEDICAL CORPORATION. The address is 702-703-704-705-706-804-805-807-812-ho, 55, Digital-ro34-gil, Guro-gu, 08378, Korea. The telephone number is +82 2 850 3533, and the fax number is +82 2 850 3536.
510(k) Summary
[As required by 21 CRF 807.92]
1. Date Prepared [21 CRF 807.92(a)(a)]
20. January 2017
2. Submitter's Information [21 CFR 807.92(a)(1)]
| • Name of Sponsor: | Jeil Medical Corporation |
|---|---|
| - Address: | 702-703-704-705-706-804-805-807-812-ho,55 Digital-ro34-gil |
| Guro-gu, Seoul, 152-728, Korea |
- Contact Name: Ji won Song / RA Specialist
- Telephone No. : +82 2 850 3587 -
- Fax No. : +82 2 850 3536 -
- -Email Address : sjw@jeilmed.co.kr
| Registration Number: | 3004049923 |
|---|---|
| Name of Manufacturer: | Same as Sponsor |
| Address: | Same as Sponsor |
Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)] 3.
| ● | Trade Name: | Sterile NS System |
|---|---|---|
| ● | Common Name: | Bone plate & screw |
| ● | ClassificationName: | Preformed alterable cranioplasty plate |
| appliances and accessories | ||
| ● | ClassificationPanel: | Neurology |
| ● | ClassificationRegulation: | 21 CFR 882.5320, 21 CFR 882.5250, 21 CFR 882.5360 |
| ● | Product Code: | GWO, GXR, HBW |
| ● | Device Class: | II |
4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)]
The identified predicate devices within this submission are shown as follow;
| • 510(k) Number: | K112812, K141452 |
|---|---|
| • Applicant: | Jeil Medical Corporation |
| • Common Name: | Bone plate & screw |
| • Device Name: | Leforte Neuro System Bone plate and |
- Device Name: Leforte Neuro System Bone plate and screw
4
Image /page/4/Picture/0 description: The image shows the logo and contact information for JEIL MEDICAL CORPORATION. The address is 702-703-704-705-706-804-805-807-812-ho, 55, Digital-ro34-gil, Guro-gu, 08378, Korea. The telephone number is +82 2 850 3533 and the fax number is +82 2 850 3536.
Bone plate & screw
There are no significant differences between the subject devices and the predicate devices (K112812, K141452) that would adversely affect the use of the product.
Description of the Device [21 CFR 807.92(a)(4)] 5.
The Sterile NS System is designed for use in selective trauma of the craniofacial skeleton, craniofacial surgery and reconstructive procedures. The Sterile NS System consists of bone plates in a variety of shapes and sizes, bone screws to secure the plates, and accessories to assist in the operational procedures. The Sterile NS System 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.
Intended Use [21 CFR 807.92(a)(5)] 6.
The Sterile NS System is intended for use in selective trauma of the cranial skeleton, cranial surgery and reconstructive procedures.
7. Technological Characteristics [21 CFR 807.92(a)(6)]
Sterile NS System, Neurology: With same thickness, titanium grade, dimensions. However, the subject device changed sterile method under the predicate devices (K112812, K141452).
Non-Clinical Test Summary:
The test was conducted to verify that the subject device met all design specifications. The test results demonstrated that the proposed device complies with the following standards and worst case criteria report:
- . Plate
- Dimension test -
- . Screws
- Dimension test -
The subject device has the same device characteristics as the predicate (unmodified) device.
Clinical Test Summary:
No clinical studies were considered necessary and performed.
Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92] 8.
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, shape and dimensions. The differences are sterilization method; however; the performance test data provided in this submission proves that this differences do not raise new issues in safety and performance.
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| Predicate (Unmodified) device | Subject device | |
|---|---|---|
| 510k Number | K112812, K141452 | - |
| Manufacturer | Jeil Medical Corporation | Jeil Medical Corporation |
| Product Code | GWO, GXR, HBW | GWO, GXR, HBW |
| Intended use | The Leforte Neuro System Bone | |
| Plate and Screw is intended for use | ||
| in selective trauma of the cranial | ||
| skeleton, cranial surgery and | ||
| reconstructiveprocedures. | The Sterile NS System is intended | |
| for use in selective trauma of the | ||
| cranial skeleton, cranial surgery and | ||
| reconstructiveprocedures. | ||
| Material | Plate- Pure titanium Grade4 | |
| (ASTM F67) | ||
| Screw- Titanium alloy | ||
| (Ti-6AL-4V ELI, ASTM F136) | Plate- Pure titanium Grade4 | |
| (ASTM F67) | ||
| Screw- Titanium alloy | ||
| (Ti-6AL-4V ELI, ASTM F136) | ||
| Design features | Plate |
- Plate thickness 0.3mm ~ 1.0mm
- Surface: Anodized
Screw
- Screw Outer Dia. 1.4 ~ 1.8mm
- Screw Length 2.2~5.0mm
- Surface: N/A | Plate
- Plate thickness 0.3mm ~ 1.0mm
- Surface: Anodized
Screw
- Screw Outer Dia. 1.4 ~ 1.8mm
- Screw Length 2.2~5.0mm
- Surface: N/A |
| Sterilization | Non-Sterile
(Steam sterilization by user) | Sterile
(Radiation-sterile) |
| Usage | Single use | Single use |
| Packaging | Polyethylene Zip Lock Pouch
Cardboard Box | PET, Tyvek,
Cardboard Box |
| Biocompatibility | Conform | Conform |
Conclusion [21 CFR 807.92(b)(3)] 9.
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 Sterile NS System is as safe and effective and substantially equivalent to the predicate device as described herein.