MRII CRAINIAL DRILL

K122456 · Mri Interventions, Inc. · HBG · Mar 22, 2013 · Neurology

Device Facts

• Record ID: K122456
• Device Name: MRII CRAINIAL DRILL
• Applicant: Mri Interventions, Inc.
• Product Code: HBG · Neurology
• Decision Date: Mar 22, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4300
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

MRII Cranial Drill is a handheld manual drill; 3:1 gear ratio; used for cranial access (ventriculostomy, biopsy, catheter placement). Operates in OR or MRI suite; used by physicians. Compatible with 3T MR scanners; must be used only when scanner is not active. Includes accessory kit with 2.0mm or 3.2mm drill bits, lancet, depth stop, and ruler. Single-use device; provides mechanical drilling capability for neurosurgical procedures.

Clinical Evidence

Bench testing only. Design verification and comparison testing against the predicate Integra Hand Drill demonstrated functional equivalence.

Technological Characteristics

Manual handheld drill; 3:1 gear ratio; 316L stainless steel drill bits (2.0mm and 3.2mm); adjustable depth guard. Sterile, single-use. Non-powered mechanical device.

Indications for Use

Indicated for patients requiring cranial access for ventriculostomy, biopsy, or catheter placement. Used in or near 3T MR scanners when not scanning. Single use only.

Regulatory Classification

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.

Predicate Devices

• Integra Hand Drill (K961113)

Submission Summary (Full Text)

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K122456

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.

- 1. Company Making the Submission:

| Name of Owner: | MRI Interventions, Inc. |
|----------------|-------------------------------|
| Address: | 5 Musick<br>Irvine, CA 92618 |
| Telephone: | 949-900-6833 |
| Fax: | 949-900-6834 |
| Contact: | Edward Waddell |
| E-mail: | [e-mail] |

#### 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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| | MRII<br>MRII Cranial Drill | Predicate Device:<br>Integra Hand Drill<br>K961113 |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | 21 CFR 882.4300 | 21 CFR 882.4300 |
| Product Code | HBG | HBG |
| Intended Use | The MRII Cranial Drill<br>and accessories is intended<br>to provide access through<br>the skull for<br>ventriculostomy or other<br>neurological procedures,<br>such as biopsy or catheter<br>placement, in or near an<br>MR scanner of 3T<br>maximum field strength.<br>The MRII Cranial Drill<br>and accessories are<br>intended to be used only<br>when the scanner is not<br>performing a scan. The<br>MRII Cranial Drill is<br>intended for single use<br>only. | The drill is intended to be<br>used with an external<br>drainage and monitoring<br>system in selected patients<br>to reduce intracranial<br>pressure (ICP), to monitor<br>CSF, to provide temporary<br>drainage of CSF and to<br>monitor ICP. The drill is<br>intended for single use<br>only. |
| Environment | OR or MRI Suite | OR |
| Drill Bit<br>Included with<br>Drill | No | No |
| Gear Ratio | 3:1 | 3.5:1 |
| Integral Bit | Yes (316L SS) | Yes |
| Drill Bit Sizes | 2.0mm<br>3.2mm | 3/16" (4.7mm)<br>5/32" (3.97mm)<br>13/64" (5.31mm)<br>1/4" (6.35mm) |
| Adjustable<br>Depth Guard | Yes | Yes |
| Set Screw with<br>Hex Wrench | No | No |
| Packaging | Drill: Sterile, CSR Warp in<br>Tyvek Peel Pouch.<br>Kit: Sterile, inside tray with<br>Tyvek Lid and external | Sterile, CSR Wrap in<br>Tyvek Peel Pouch |
| MRII<br>MRII Cranial Drill | Predicate Device:<br>Integra Hand Drill<br>K961113 | |
| 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 [phone] or [phone] 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 |