(217 days)
Not Found
No
The summary describes a mechanical cranial fixation system made of standard materials, with no mention of software, algorithms, or any technology related to AI or ML.
No
The device is described as a burr hole cover and/or skull bone fixation for use after cranial surgery, and its materials and mechanical tests are described. It does not appear to treat or diagnose a disease or condition, which are characteristics of a therapeutic device.
No
The device is described as a cranial fixation system (burr hole covers and plates) used after craniotomy, cranioplasty, or craniectomy surgery to cover burr holes and/or fix skull bone. Its purpose is structural, not to diagnose a condition.
No
The device description explicitly states it is a system of physical burr hole covers, plates, and associated surgical instrumentation made of titanium and PEEK. It also describes mechanical testing of these physical components.
Based on the provided information, the NeuroVention Cranial Fixation System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for surgical fixation of the skull following procedures like craniotomy, cranioplasty, or craniectomy. This is a surgical implant used directly on the patient's body.
- Device Description: The device consists of physical implants (burr hole covers and plates) and surgical instruments. It does not involve the analysis of biological samples (like blood, urine, or tissue) outside of the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting substances, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The NeuroVention Cranial Fixation System does not fit this description.
N/A
Intended Use / Indications for Use
The NeuroVention Cranial Fixation System is intended for use as a burr hole cover and/or skull bone fixation following craniotomy, cranioplasty, or craniectomy surgery.
Product codes
GXR, GWO, HBW, HBG
Device Description
The NeuroVention Cranial Fixation System is a series of burr hole covers and plates with various configurations to facilitate surgeon selection of the implant he/she determines to be most appropriate for the patient and the surgical circumstances. Each is provided non-sterile single use and is made of titanium as per ASTM F67, titanium alloy (Ti-6AI4V ELI) implantable components that comply with ASTM F136 or PEEK per ASTM F2026. Class I exempt instrumentation is available for delivery and removal: Screwdriver Adapter (handle), Torx Drivers, Forceps. Additionally, a Class II Drill bit is included to create pilot holes for the screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skull
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
The potential hazards have been evaluated and controlled through Risk Management. All testing met or exceeded the requirements as established by the test protocols and applicable standards. A review of the mechanical data indicates that the components of the Subject device are capable of withstanding expected loads without failure. The Subject device was therefore found to be substantially equivalent to the Predicates. Clinical data was not needed to support the safety and effectiveness of the Subject Device.
The following mechanical testing was performed:
- Static Compression
- Skull Conformity
- Screw Axial Pushout
- Screw Torque to Failure per ASTM F543-13
- Usability testing of Drill Bit
All results passed acceptance criteria and were equivalent or better when compared to the predicates.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5250 Burr hole cover.
(a)
Identification. A burr hole cover is a plastic or metal device used to cover or plug holes drilled into the skull during surgery and to reattach cranial bone removed during surgery.(b)
Classification. Class II (performance standards).
0
March 13, 2020
NeuroVention, LLC Rohit Khanna President 645 S. Beach St. Daytona Beach, Florida 32114
Re: K192162
Trade/Device Name: NeuroVention Cranial Fixation System. NuCrani Plates, KTC Burr Hole Cover, DC Plate Regulation Number: 21 CFR 882.5250 Regulation Name: Burr Hole Cover Regulatory Class: Class II Product Code: GXR, GWO, HBW Dated: February 11, 2020 Received: February 12, 2020
Dear Rohit Khanna:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Matthew Krueger, M.S.E. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K192162
Device Name
NeuroVention Cranial Fixation System
Indications for Use (Describe)
The NeuroVention Cranial Fixation System is intended for use as a burr hole cover and/or skull bone fixation following craniotomy, cranioplasty, or craniectomy surgery.
| 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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510(k) Summary
(as required by 21 CFR 807.92)
| Submitter | NeuroVention LLC |
|---|---|
| Address | 645 S Beach Street |
| Daytona Beach, FL 32114 | |
| Telephone | 386-238-9638 |
| Fax | 386-253-8174 |
| Contact Person | Rohit Khanna, M.D. |
| khanna@neurovention.com | |
| Date Prepared | January 27, 2020 |
| Trade Name | Neurovention Cranial Fixation System |
| Includes: NuCrani Plates, DC Plate, and KTC burr hole cove | |
| Common Name | Neuro plating system |
| Panel Code | Neurological Devices |
| Classification Name | Burr Hole Cover (GXR) |
| Preformed Alterable Cranioplasty Plate (GWO) | |
| Cranioplasty Plate Fastener (HBW) | |
| Drills, Burrs, Trephines & Accessories- Manual (HBG) | |
| Class | Class II |
| Regulation Number | 21 CFR 888.5250 21 CFR 888.5320 |
| 21 CFR 888.5360 | |
| 21 CFR 882.4300 | |
| Product Code | GXR, GWO, HBW, HBG |
| Predicate Device Name | 510(k) Number | Manufacturer |
|---|---|---|
| Stryker Universal Neuro 3 System | K112557 | Stryker |
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Description
The NeuroVention Cranial Fixation System is a series of burr hole covers and plates with various configurations to facilitate surgeon selection of the implant he/she determines to be most appropriate for the patient and the surgical circumstances. Each is provided non-sterile single use and is made of titanium as per ASTM F67, titanium alloy (Ti-6AI4V ELI) implantable components that comply with ASTM F136 or PEEK per ASTM F2026. Class I exempt instrumentation is available for delivery and removal: Screwdriver Adapter (handle), Torx Drivers, Forceps. Additionally, a Class II Drill bit is included to create pilot holes for the screws.
Indications and Intended Use
The NeuroVention Cranial Fixation System is intended for use as a burr hole cover and/or skull bone fixation following craniotomy, cranioplasty, or craniectomy surgery.
Technological Characteristics and Substantial Equivalence
Documentation was provided to demonstrate that the NeuroVention Cranial Fixation System is substantially equivalent to the legally marketed predicates. It consists of a storage module that contains the various shapes of implants, screws and implantation instruments. The devices and accessories included in the Subject device and the predicate devices are both burr hole covers, cranioplasty plates and screws. The NeuroVention Cranial Fixation System is substantially equivalent to the predicate devices in intended use, site of application, patient populations of use, mechanical performances, basic design, and operating principles. The NeuroVention Cranial Fixation System is comparable to its predicate in size and materials. Mechanical testing shows the mechanical strength of the Subject device to be equivalent or better than the predicate devices.
| | NeuroVention Cranial
Fixation System | Stryker Universal Neuro 3 System | | |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Manufacturer | NeuroVention | Stryker | | |
| 510(k)
number | This application | K112557 | | |
| Product
Code | GXR, GWO, HBW | GXR, GWO, HBW | | |
| Classification
Regulation | 21 CFR 882.5250, 882.5320,
882.5360 | 21 CFR 882.5250, 882.5320,
882.5360 | | |
| Common
Name | Burr Hole Cover, Preformed
Alterable Cranioplasty Plate,
Cranioplasty Plate Fastener | Burr Hole Cover, Preformed
Alterable Cranioplasty Plate,
Cranioplasty Plate Fastener | | |
| Class | II | II | | |
| Implantable
components | Yes | Yes | | |
| Anatomic
Locations | Skull | Skull | | |
| Intended
Use | Cover burr holes and skull
bone fixation following
craniotomy, cranioplasty, or
craniectomy surgery. | Cover burr holes and skull bone
fixation following craniotomy,
cranioplasty, or craniectomy
surgery. | | |
| Indications
for Use
Statement | The NeuroVention Cranial
Fixation System is intended
for use as a burr hole cover
and/or skull bone fixation
following craniotomy,
cranioplasty, or | The Stryker Universal Neuro 3
System is intended for
reconstruction, stabilization, and/or
rigid fixation of non-loadbearing
areas subsequent to craniotomy,
craniectomy, and cranial fractures | | |
| | craniectomy surgery. | In adults and adolescents (age 12 and higher). | | |
| Implant Material | Titanium, Titanium alloy (Ti6AL4V ELI)
PEEK (VESTAKEEP) per ASTM F2026 | Titanium, Titanium alloy (Ti6AL4V ELI) | | |
| Instrument materials | Stainless Steel | Stainless Steel | | |
| Sterilization | Provided non-sterile to be steam sterilized by user facility | Provided non-sterile to be steam sterilized by user facility | | |
| MRI compatibility | Non-clinical testing has demonstrated the NeuroVention Cranial Plate System is MR Conditional. A patient with this device can be safely scanned in an MR system meeting the following conditions:
• Static magnetic field of 1.5 T and 3.0 T;
• Maximum spatial field gradient of 6,200 G/cm (62 T/m);
• Quadrature driven, Circular Polarized (CP) Mode Only
• Maximum MR system-reported, whole-body averaged specific absorption rate (SAR) of 2 W/kg (Normal Control Mode).
• Maximum Head SAR of 3.2 W/kg.
Under the scan conditions defined above, the NeuroVention Cranial Plate System is expected to produce a maximum temperature rise of less than 2.5 °C after 15 minutes of continuous scanning at 1.5 T and less than 3.5 °C after 15 minutes of continuous scanning at 3.0 T.
In non-clinical testing, the image artifact caused by the device extends approximately 13 mm from the NeuroVention Cranial Plate System when imaged with a gradient echo pulse sequence and a 3 T MRI system. | "has not been evaluated for safety and compatibility in the MR environment" and that it "has not been tested for heating or migration in the MR environment." | | |
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| Name of
Device | NeuroVention Cranial Fixation System | Stryker Universal
Neuro 3 System |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Implant Size
Ranges | NuCrani Small Rectangular 4 hole plate, 12 x 20 mm
· NuCrani Medium Circular 8 hole plate
· NuCrani Large Circular 7 hole Plate, 20 x 27 mm
• KTC Burr Hole Cover 26.5 mm
• DC plate, 15 x 24 mm
· 2.0mm Self Tapping Screws, 6-10 mm
· 2.3 mm Self Tapping Rescue Screws, 6-10 mm | • 2 hole dogbone
plate
· Straight plate 2
hole
· Straight plate 8
hole
· Straight plate 16
hole
· Double Y plate
• Box plate 2x2 hole
· Rectangle plate
· X plate
· Gap plate, small
· Gap plate, large
• Burr hole cover,
7mm
• Burr hole cover,
10mm
• Burr hole cover
14mm
• Burr hole cover,
20mm
• Burr hole cover,
24mm
• Round malleable
plate, 42-58 mm
· Suboccipital
malleable plate,
62 x 30 mm
· Subocciptial
malleable plate,
65 x 40 mm
• Temporal
malleable plate,
47 x 29 mm
• Translabyrithine
malleable plate, 54
x 52 mm
· Translabyrinthine
malleable plate, 60
x 60 mm
· 1.5 mm Self Drilling
Screws, 3-5 mm
• 1.5 mm Self
Tapping screws, 4-
6 mm
· 1.7 mm Emergency
Screws, 4mm |
| Manual Drill Bit | 1.5 mm diameter | 1.2 mm diameter |
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Performance Data The potential hazards have been evaluated and controlled through Risk Management.
All testing met or exceeded the requirements as established by the test protocols and applicable standards. A review of the mechanical data indicates that the components of the Subject device are capable of withstanding expected loads without failure. The Subject device was therefore found to be substantially equivalent to the Predicates. Clinical data was not needed to support the safety and effectiveness of the Subject Device.
The following mechanical testing was performed:
- Static Compression
- . Skull Conformity
- Screw Axial Pushout •
- . Screw Torque to Failure per ASTM F543-13
- . Usability testing of Drill Bit
All results passed acceptance criteria and were equivalent or better when compared to the predicates.
Biocompatibility The components of the predicate device for the implantable components, are manufactured from the same titanium and titanium alloy for implantable components in conformity with ASTM F67-13 and ASTM F136. The Subject device also has a PEEK configuration made from VESTAKEEP by Evonik Industries per ASTM F2026. The instruments are made of the same stainless steel in conformance with ASTM F899. These materials are well known and well characterized have been used in other commercially available cranial implants. The predicate devices are used for the same duration and come into contact with the patient in the same manner and in the same body parts. The materials are considered to be biocompatible and have a long history of safe use as part of medical devices marketed in the United States and around the world. The Subject and predicate devices as well as a large number of implantable devices are manufactured in the same way with the same materials.
- Conclusion Based on design, materials, intended use, technological characteristics, and comparison to predicate devices, the Subject Neurovention Cranial Fixation System has been shown to be substantially equivalent to legally marketed predicate device.