(221 days)
Not Found
No
The description details a manual hand drill and its accessories, with no mention of AI or ML capabilities. The performance studies focus on bench testing and comparison to a predicate manual drill.
No
The device is a surgical tool used to create access through the skull, which is an intervention, not a therapeutic treatment itself. Its purpose is to facilitate other neurological procedures.
No
Explanation: The device, the MRII Cranial Drill, is described as a surgical tool intended to provide access through the skull for various neurological procedures (e.g., ventriculostomy, biopsy, catheter placement). Its function is to create boreholes, not to diagnose medical conditions by acquiring or analyzing data.
No
The device description explicitly states it is a "hand held manual drill" and includes physical accessories like drill bits, a lancet, depth stop, and ruler. This indicates it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The MRII Cranial Drill is a surgical tool used to create access through the skull for neurological procedures. It is used on the patient's body, not on a sample taken from the body.
- Intended Use: The intended use clearly describes a surgical procedure (providing access through the skull) and not a diagnostic test performed on a biological sample.
Therefore, based on the provided information, the MRII Cranial Drill is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MRII Cranial Drill and accessories is intended to provide access through the skull for ventriculostomy or other neurological procedures, such as biopsy or catheter placement, in or near an MR scanner of 3T maximum field strength. The MRII Cranial Drill and accessories are intended to be used only when the scanner is not performing a scan. The MRII Cranial Drill is intended for single use only.
Product codes (comma separated list FDA assigned to the subject device)
HBG
Device Description
The MRII Cranial Drill is a hand held manual drill with a 3:1 gear ration. It is in intended for use with the drill kit accessory kits consisting of a 2.0 or 3.2 mm drill bit, lancet, depth stop and ruler.
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)
Bench testing performed included design verification testing and comparison testing with the predicate Integra Hand Drill, with acceptable results. These tests demonstrated that the MR Cranial Drill functions as intended and is substantially equivalent to legally marketed devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Integra Hand Drill, K961113
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.4300 Manual cranial drills, burrs, trephines, and their accessories
(a)
Identification. Manual cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments that are used without a power source on a patient's skull.(b)
Classification. Class II (performance standards).
0
510(k) (Traditional) Submission Section 5, 510(k) Summary
510(k) Summary
MAR 2 2 2013
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR Part 807.92 for the MRII Cranial Drill and accessories.
-
- Company Making the Submission:
| Name of Owner: | MRI Interventions, Inc. |
|---|---|
| Address: | 5 Musick |
| Irvine, CA 92618 | |
| Telephone: | 949-900-6833 |
| Fax: | 949-900-6834 |
| Contact: | Edward Waddell |
| E-mail: | ewaddell@mriinterventions.com |
2. Device Name:
| Common Name: | Manual Drill |
|---|---|
| Proprietary Name: | MRII Cranial Drill |
| Classification: | Class II |
| Regulation Number: | 882.4300 |
| Product Code: | HBG |
3. Predicate Device
Integra Hand Drill, K961113
4. Intendeded Use Statement:
The MRII Cranial Drill and accessories is intended to provide access through the skull for ventriculostomy or other neurological procedures, such as biopsy or catheter placement, in or near an MR scanner of 3T maximum field strength. The MRII Cranial Drill and accessories are intended to be used only when the scanner is not performing a scan. The MRII Cranial Drill is intended for single use only.
5. Description of Device:
The MRII Cranial Drill is a hand held manual drill with a 3:1 gear ration. It is in intended for use with the drill kit accessory kits consisting of a 2.0 or 3.2 mm drill bit, lancet, depth stop and ruler.
6. Summary of the Technological Characteristics of the Device Compared to the Predicate Device
MRI Interventions, Inc.
1
| | MRII
MRII Cranial Drill | Predicate Device:
Integra Hand Drill
K961113 |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | 21 CFR 882.4300 | 21 CFR 882.4300 |
| Product Code | HBG | HBG |
| Intended Use | The MRII Cranial Drill
and accessories is intended
to provide access through
the skull for
ventriculostomy or other
neurological procedures,
such as biopsy or catheter
placement, in or near an
MR scanner of 3T
maximum field strength.
The MRII Cranial Drill
and accessories are
intended to be used only
when the scanner is not
performing a scan. The
MRII Cranial Drill is
intended for single use
only. | The drill is intended to be
used with an external
drainage and monitoring
system in selected patients
to reduce intracranial
pressure (ICP), to monitor
CSF, to provide temporary
drainage of CSF and to
monitor ICP. The drill is
intended for single use
only. |
| Environment | OR or MRI Suite | OR |
| Drill Bit
Included with
Drill | No | No |
| Gear Ratio | 3:1 | 3.5:1 |
| Integral Bit | Yes (316L SS) | Yes |
| Drill Bit Sizes | 2.0mm
3.2mm | 3/16" (4.7mm)
5/32" (3.97mm)
13/64" (5.31mm)
1/4" (6.35mm) |
| Adjustable
Depth Guard | Yes | Yes |
| Set Screw with
Hex Wrench | No | No |
| Packaging | Drill: Sterile, CSR Warp in
Tyvek Peel Pouch.
Kit: Sterile, inside tray with
Tyvek Lid and external | Sterile, CSR Wrap in
Tyvek Peel Pouch |
| MRII
MRII Cranial Drill | Predicate Device:
Integra Hand Drill
K961113 | |
| Tyvek Pouch | | |
.
:
MRI Interventions, Inc.
Section 5 510(k) Submission Page #
2
7. Testing:
Testing to applicable standards has been completed with acceptable outcomes.
Bench testing performed included design verification testing and comparison testing with the predicate Integra Hand Drill, with acceptable results. These tests demonstrated that the MR Cranial Drill functions as intended and is substantially equivalent to legally marketed devices.
Rx or OTC: 8.
The MRI Cranial Drill is an Rx prescription device per 21 CFR Part 801, Subpart D.
9. Substantial Equivalence:
The MR Cranial Drill is as safe and effective as the predicate Integra Hand Drill, The MR Cranial Drill has the same intended uses and similar indications. technological characteristics, and principles of operation as its predicate device. The minor technological differences between the MR Cranial Drill and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the MR Cranial Drill is as safe and effective as the Integra Hand Drill. Thus, the MRI Cranial Drill is substantially equivalent.
MRI Interventions, Inc.
E. Waddell
Edward Waddell Director of Regulatory Affairs
Date: 12/12/12
MRI Interventions, Inc.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 caduceus symbol, which features a staff with a snake entwined around it, and three horizontal bars above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Public Health Service
EASY
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
MRI Interventions, Inc. Mr. Edward Waddell 5 Musick Irvine, CA, 92618
Re: K122456
Trade/Device Name: MRII Cranial Drill Regulation Number: 21 CFR 882.4300 Regulation Name: Manual Cranial Drills, Burrs, Trephines, and their accessories Regulatory Class: Class II Product Code: HBG Dated: February 15, 2013 Received: March 7, 2013
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
March 22, 2013
4
Page 2 - Mr. Edward Waddell
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Image /page/4/Picture/6 description: The image shows the name "Joyce M.Whang" in a stylized font. The name is written in black ink and appears to be a signature or logo. The letters "M" and "W" are more stylized than the rest of the name.
for Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K122456
Device Name: MRII Cranial Drill
Indications For Use:
The MRII Cranial Drill and accessories is intended to provide access through the skull for ventriculostomy or other neurological procedures, such as biopsy or catheter placement, in or near an MR scanner of 3T maximum field strength. The MRI Cranial Drill and accessories are intended to be used only when the scanner is not performing a scan. The MRII Cranial Drill is intended for single use only.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
==============================================================================================================================================================================
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Joyce M. Whang
| (Division Sign Off) | |
|---|---|
| Division of Neurological and Physical Medicine Devices (DNPMD) | |
| 510(k) Number | K122456 |