(227 days)
Not Found
No
The device description focuses on mechanical components and their physical properties, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is used to create an access hole in the skull for intracranial procedures, which is a surgical tool function, not a therapeutic one. It facilitates a procedure but does not directly treat a condition.
No
Explanation: The device creates an access point (hole) in the skull for intracranial procedures, guides a drill bit, and aids in instrumentation, which are all interventional functions. There is no mention of it collecting or analyzing data to provide insights into a patient's medical condition.
No
The device description explicitly lists multiple physical components made of materials like Peek and 316L Stainless Steel (Drill Guide, Drill Bit, Lancet, Depth Stops, Device Guide), indicating it is a hardware-based medical device kit.
Based on the provided information, the VarioGuide Drill Kit is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is clearly stated as "creating an access point in the skull during intracranial procedures." This is a surgical procedure performed directly on the patient's body.
- Device Description: The description details mechanical components (drill guide, drill bit, lancet, depth stops, device guide) used for physical manipulation of tissue (bone, dura, pia).
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or provide diagnostic information about a patient's condition. IVD devices are used to perform tests on samples taken from the body to diagnose diseases or conditions.
Therefore, the VarioGuide Drill Kit is a surgical instrument, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The VarioGuide Drill Kit used in conjunction with BrainLab's VarioGuide is intended for creating an access point in the skull during intracranial proccdures. The device is not intended for implant. This device is intended for "single patient use only."
Product codes
HBE
Device Description
The VarioGuide Drill Kit is a set of components that work in conjunction with the VarioGuide and each other to guide a drill bit along a desired trajectory to make an access hole in the skull. The components that comprise the VarioCuide Drill Kit are a Drill Guide, a 3.4mm Drill Bit, a Lancet, two Depth Stops and a Device Guide. The Drill Guide is made from Peek and has a 316L Stainless Steel tip which is pressed into the Drill Guide body. The Drill Guide Tip has two unique features. First, the tip has a double-chamfered edge which allows the unique into the bone and that also prevents the tip from bending over. The second feature is windows that allow drilled material to exit through the tip and thus prevents the drill bit from binding. The Drill Guide is used to constrain the prevents access bal access hole creation to a predetermined to assult the unit on unring. 316L Stainless Steel and is used to create an access hole through the skull. The Drill Bit tip is designed so that the amount of drill walk at the start of drilling is limited. This feature also helps Drill Bit to maintain its trajectory. The Lancet is made from 316L Stainless Steel and has a sharp point at the distal end to allow the Lancet to pierce the Dura and/or Pia. The Lancet has a reduced section (0.60)" long) which allows the Lancet to pass through the skull without any wall interference. The Depth Stops are made from 316L Stainless Steel and are used in conjunction with the Drill Bit and Lancet to set the desired depth. The Device Guide is made from Peek and is used to guide an instrument (such as a catherer) on a predetermined path. The Device Guide is available in two sizes, 0.075" for the small and 0.085" for the large.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing to applicable standards has been completed with acceptable outcomes. Design Verification was performed with acceptable results, the tests demonstrated that the VarioGuide Drill Kit functions as intended and is substantially equivalect to the legally marketed device.
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
§ 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories.
(a)
Identification. Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.(b)
Classification. Class II (performance standards).
0
510(k) Summary
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR Part 807.92 for the MRII Varioguide Drill Kit.
- Company Making the Submission: 1.
| Name of Owner: | MRI Interventions, Inc. |
|---|---|
| Address: | 5 Musick |
| Irvine, CA 92618 | |
| Telephone: | 949-900-6833, 949-584-8517 |
| Fax: | 949-900-6834 |
| Contact: | Edward Waddell |
| E-mail: | ewaddell@mriinterventions.com |
2. Device Name:
| Common Name: | Drill Kit |
|---|---|
| Proprietary Name: | Varioguide Drill Kit |
| Classification: | Class II |
| Regulation Number: | 882.4310 |
| Product Code: | HBE |
3. Predicate Device:
MRII Cranial Drill and accessorics, K 122456
4. Intended Use Statement:
The VarioGuide Drill Kit used in conjunction with BrainLab's VarioGuide is intended for creating an access point in the skull during intracranial proccdures. The device is not intended for implant. This device is intended for "single patient use only."
5. Description of Device:
The VarioGuide Drill Kit is a set of components that work in conjunction with the VarioGuide and each other to guide a drill bit along a desired trajectory to make an access hole in the skull. The components that comprise the VarioCuide Drill Kit are a Drill Guide, a 3.4mm Drill Bit, a Lancet, two Depth Stops and a Device Guide. The Drill Guide is made from Peek and has a 316L Stainless Steel tip which is pressed into the Drill Guide body. The Drill Guide Tip has two unique features. First, the tip has a double-chamfered edge which allows the unique
MRI Interventions, Inc.
1
into the bone and that also prevents the tip from bending over. The second feature is windows that allow drilled material to exit through the tip and thus prevents the drill bit from binding. The Drill Guide is used to constrain the prevents
access bal access hole creation to a predetermined to assult the unit on unring. 316L Stainless Steel and is used to create an access hole through the skull. The Drill Bit tip is designed so that the amount of drill walk at the start of drilling is limited. This feature also helps Drill Bit to maintain its trajectory. The Lancet is made from 316L Stainless Steel and has a sharp point at the distal end to allow the Lancet to pierce the Dura and/or Pia. The Lancet has a reduced section (0.60)" long) which allows the Lancet to pass through the skull without any wall interference. The Depth Stops are made from 316L Stainless Steel and are used in conjunction with the Drill Bit and Lancet to set the desired depth. The Device Guide is made from Peek and is used to guide an instrument (such as a catherer) on a predetermined path. The Device Guide is available in two sizes, 0.075" for the small and 0.085" for the large.
| MRI | Predicate Device: | |
|---|---|---|
| VarioGuide Drill Kit | MRII Cranial Drill | |
| K122456 | ||
| Classification | 21 CFR 882.4310 | 21 CFR 882.4300 |
| Product Code | HBE | HBG |
| Intended Use | The VarioGuide Drill Kit | |
| used in conjunction with | ||
| BrainLab's VarioGuide is | ||
| intended for creating an | ||
| access point in the skull | ||
| during intracranial | ||
| procedures. The device is | ||
| not intended for implant. | ||
| This device is intended for | ||
| "single patient use only." | The MRII Cranial Drill is | |
| intended to provide access | ||
| through the skull for | ||
| ventriculostomy and other | ||
| neurological procedures, such | ||
| as biopsy or catheter placement, | ||
| in proximity of an MR scanner | ||
| of 3T maximum field strength. | ||
| The MRII Cranial Drill is | ||
| intended for single use only | ||
| Environment | OR | OR or MRI Suite |
| Drill Bit Included | ||
| with Drill | No | No |
| Integral Bit | Yes (316L SS) | Yes (316L SS) |
| Drill Bit Sizes | 3.4mm | 2.0mm |
| 3.2mm | ||
| Toolless Adjustable | ||
| Depth Stop | Yes | Yes |
| Packaging | Sterile, Sealed Tray, Inside Sterile | |
| Tyvek Pouch | Sterile, Inside Double Sterile | |
| Tyvek Pouch |
6. Summary of the Technological Characteristics of the Device Compared to the Predicate Device
MRI Interventions. Inc.
2
7. Testing:
Testing to applicable standards has been completed with acceptable outcomes. Design Verification was performed with acceptable results, the tests demonstrated that the VarioGuide Drill Kit functions as intended and is substantially equivalect to the legally marketed device.
8. Rx or OTC:
The Varioguide Drill Kit is an Rx prescription device per 21 CFR Part 801, C Subpart D.
9. Substantial Equivalence:
The VarioGuide Drill Kit is as safe and effective as the predicate MRI Cranial Drill and accessories. The VarioGuide Drill Kit has the same intended use and similar indication, technologies characteristics, and principles of operation as a predicate device. The minor technological differences between the VarioGuide Drill Kit and its predicate devices raise ne new issues of safety and effectiveness. Performance data demonstrates that the VarioGuide Drill Kit is as safe and effective as the MRI Cranial Drill and accessories. Thus, the VarioGuide Drill Kit is substantially cquivalent.
MRI Interventions, Inc.
Et Waddell 7/31/13
E. F. Waddell
Director of Regulatory Affairs
3
Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in a bold, sans-serif font. The text is centered horizontally in the image. The background of the image is white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 20, 2014
MRI Interventions, Inc. Mr. Edward Waddell 5 Musick Irvine, CA, 92618
Re: K132436
Trade/Device Name: Varioguide Drill Kit Regulation Number: 21 CFR 882.4310 Regulation Name: Powered simple cranial drills, burrs, trephines, and their accessories. Regulatory Class: Class II Product Code: HBE Dated: February 14, 2014 Received: February 18, 2014
Dear Mr. Waddell:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 - Mr. Edward Waddell
forth in the quality systems (OS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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/ResourcesforYou/Industry/default.htm.
Sincerely vours,
Joyce M. Whang -S
for Carlos L. Peña, Ph.D., M.S. Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Slatement on last page.
510(k) Number (if known) K132436
Device Name Varioguide Drill Kit
Indications for Use (Describe)
The VarioGuide Drill Kit used in conjunction with BrainLab's intended for creating an access point in the skull during intracranial procedures. The device is not intended for implant. This device is intended for "single patient use only."
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)
FORM FDA 3881 (1/14)
PSC Publishing Services (301) 443-6740 E
6
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