(221 days)
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 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.
The provided 510(k) summary for the MRII Cranial Drill does not describe acceptance criteria or a study proving that the device meets specific performance criteria.
Instead, this submission focuses on demonstrating substantial equivalence to a predicate device, the Integra Hand Drill (K961113), primarily through a comparison of technological characteristics and bench testing.
Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is conspicuously absent:
1. A table of acceptance criteria and the reported device performance
Not provided in the document. The submission states that "Testing to applicable standards has been completed with acceptable outcomes" and "Bench testing performed included design verification testing and comparison testing with the predicate Integra Hand Drill, with acceptable results." However, it does not explicitly list specific acceptance criteria (e.g., maximum deflection under load, specific torque requirements, material strength thresholds) or quantitative performance data against those criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not provided in the document. The submission mentions "Bench testing," but no details about sample size, test methodologies, or the provenance of any data (e.g., human or animal cadavers for drilling tests) are included.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable/Not provided. This type of information is typically relevant for studies involving subjective human assessment (like image interpretation). For a mechanical device like a drill, "ground truth" would be established through objective physical measurements or functional tests, not expert consensus in the diagnostic sense. The document does not describe any such expert involvement.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Not provided. Adjudication methods are specific to studies involving multiple readers or assessors to resolve discrepancies, often in diagnostic imaging. This concept does not apply to the type of bench testing described for a manual cranial drill.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This section is entirely irrelevant to the MRII Cranial Drill, which is a manual surgical instrument and not an AI-powered diagnostic tool. No MRMC study was performed or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This section is entirely irrelevant to the MRII Cranial Drill. As a manual surgical instrument, it does not possess an "algorithm" in the sense of AI or software-driven performance that would operate in a standalone manner.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not provided/Implied by "Bench Testing". For a mechanical device, "ground truth" would typically refer to objective measurements of physical properties, functional performance (e.g., drilling time, force required, material integrity post-drilling), and compliance with engineering specifications. The submission only states "Bench testing performed included design verification testing and comparison testing with the predicate Integra Hand Drill." It does not specify the exact parameters measured or how success was defined.
8. The sample size for the training set
Not applicable. This device is a manual cranial drill. It does not employ machine learning or AI, and therefore, there is no "training set."
9. How the ground truth for the training set was established
Not applicable. As there is no training set for this device, this question is not relevant.
In summary, the K122456 submission for the MRII Cranial Drill relies on demonstrating "substantial equivalence" to a predicate device through a comparison of technological characteristics and general statements about "bench testing" that yielded "acceptable results." It does not specify detailed acceptance criteria or present quantitative study data to prove the device meets pre-defined performance thresholds, which is common for 510(k) submissions for devices considered low-risk and similar to existing predicate devices.
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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 MusickIrvine, 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.
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| MRIIMRII Cranial Drill | Predicate Device:Integra Hand DrillK961113 | |
|---|---|---|
| Classification | 21 CFR 882.4300 | 21 CFR 882.4300 |
| Product Code | HBG | HBG |
| Intended Use | The MRII Cranial Drilland accessories is intendedto provide access throughthe skull forventriculostomy or otherneurological procedures,such as biopsy or catheterplacement, in or near anMR scanner of 3Tmaximum field strength.The MRII Cranial Drilland accessories areintended to be used onlywhen the scanner is notperforming a scan. TheMRII Cranial Drill isintended for single useonly. | The drill is intended to beused with an externaldrainage and monitoringsystem in selected patientsto reduce intracranialpressure (ICP), to monitorCSF, to provide temporarydrainage of CSF and tomonitor ICP. The drill isintended for single useonly. |
| Environment | OR or MRI Suite | OR |
| Drill BitIncluded withDrill | No | No |
| Gear Ratio | 3:1 | 3.5:1 |
| Integral Bit | Yes (316L SS) | Yes |
| Drill Bit Sizes | 2.0mm3.2mm | 3/16" (4.7mm)5/32" (3.97mm)13/64" (5.31mm)1/4" (6.35mm) |
| AdjustableDepth Guard | Yes | Yes |
| Set Screw withHex Wrench | No | No |
| Packaging | Drill: Sterile, CSR Warp inTyvek Peel Pouch.Kit: Sterile, inside tray withTyvek Lid and external | Sterile, CSR Wrap inTyvek Peel Pouch |
| MRIIMRII Cranial Drill | Predicate Device:Integra Hand DrillK961113 | |
| Tyvek Pouch |
.
:
MRI Interventions, Inc.
Section 5 510(k) Submission Page #
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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.
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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
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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
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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)
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(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 |
§ 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).