ANSPACH IMRI SAFE SURGICAL DRILL SYSTEM

K061297 · The Anspach Effort, Inc. · HBB · Jan 26, 2007 · Neurology

Device Facts

• Record ID: K061297
• Device Name: ANSPACH IMRI SAFE SURGICAL DRILL SYSTEM
• Applicant: The Anspach Effort, Inc.
• Product Code: HBB · Neurology
• Decision Date: Jan 26, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4370
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Anspach iMRI Surgical Drill System (including pneumatic drill motor, foot control, nosepiece attachments and cutters), is indicated for intra-operative (non-imaging) use within a Magnetic Resonance Imaging (MRI) environment rated at 1.5 Tesla or less, for surgical cutting, shaping and removal of bone, including bones of the skull and spine.

Device Story

Pneumatic surgical drill system designed for use in MRI environments (1.5T or less). System includes drill motor, foot control, nosepiece attachments, and bone dissection cutters. Ferrous metals replaced with low-magnetic susceptibility materials to ensure MRI compatibility. Motor operates at 60-65k RPM; slower than standard models to accommodate MRI environment. Nosepiece attachments minimize vibration and wobble. Operated by surgeons in clinical settings; foot control allows hands-free activation. Cutters are single-use, pre-sterilized; nosepieces are reusable. System includes a locking mechanism preventing interchangeability with non-iMRI components. Device facilitates bone surgery while equipment is present in the MRI suite, provided imaging is not active.

Clinical Evidence

Bench testing only. Testing included evaluation of magnetically induced torque (ASTM F2213-04) and displacement force (ASTM F2052-02) in an MRI environment. No clinical data provided.

Technological Characteristics

Pneumatic drill system. Materials selected for low magnetic susceptibility. Components: motor, foot control, nosepiece attachments, cutters. Sterilization: Radiation (SAL 10-6) for cutters; steam sterilization for reusable components. Standards: ASTM F2213-04, ASTM F2052-02, ISO 13485, ISO 10993-1, ISO 11137, ANSI/AAMI ST37, ISO 11134, ISO 14971.

Indications for Use

Indicated for intra-operative (non-imaging) surgical cutting, shaping, and removal of bone (skull and spine) within a 1.5 Tesla or less MRI environment. Contraindicated for use within Zone IV during active imaging.

Regulatory Classification

Identification

A pneumatic cranial drill motor is a pneumatically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull.

Predicate Devices

• Anspach MRI Surgical Drill System

Reference Devices

• MicroMax
• original 65K

Submission Summary (Full Text)

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# 510(k) Summary of Safety and Effectiveness

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.93

| Submitter | The Anspach Effort<br>4500 Riverside Drive<br>Palm Beach Gardens, FL 33410 | |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact | Jim Banic<br>Senior Regulatory Affairs Specialist<br>The Anspach Effort<br>4500 Riverside Drive<br>Palm Beach Gardens, FL 33410<br>Tel. [phone] ext. 515<br>Fax. [phone]<br>Email: [e-mail] | JAN 26 2007 |
| Date Prepared | January 11, 2007 | |
| Device Name | Anspach iMRI Surgical Drill System | |
| Classification Name | Motor, Drill, Pneumatic | |
| Device<br>Classification | Class II<br>General, Restorative and Neurological Devices<br>21 CFR § 882.4370 | |
| Predicate<br>Devices | Anspach MRI Surgical Drill System | |
| Performance Standards | There are no known performance standards established<br>specifically for an iMRI Surgical Drill System or their<br>accessory devices at this time. However, the following<br>standards are applicable to materials; components<br>and/or processes applied to the design, manufacture and<br>distribution of the current (predicate) Anspach iMRI<br>Surgical Drill System, and are applied to the proposed<br>new device.<br>a) ASTM and other similar recognized material<br>composition-related standards.<br>b) ASTM F2213-04 "Standard Test Method for<br>Measurement of Magnetically Induced Torque on<br>Passive Implants in Magnetic Resonance<br>Environment." | |

.

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- c) ASTM F2052-02 "Standard Test Method for Measurement of magnetically induced Displacement Force on Medical Devices in Magnetic Resonance Environment."
- d) ISO13485 (2003) Medical Devices Quality Systems - - Requirements Management for Regulatory Purposes 2003-07-15, (In addition to and supplementing US QSR):
- AAMI/ANSI/ISO 10993-1 Biological Evaluation of e) Medical Devices - Part 1 Evaluation and Testing 1997 (Used with FDA G95-1 Guidelines)
- AAMI/ANSI/ISO 111137:1994 1) Sterilization of Health Care Products - Requirements for Validation and Routine Control - Radiation Sterilization and ANSI/AAMI/ISO 11137: 1994 (Amended 1:2002) and/or.
- g) AMMI TIR 27:2001 Sterilization of Health Care Products - Radiation Sterilization - Substantiation of 25kGY as a Sterilization Dose - Method VDmax*
- h) ANSI/AAMI ST37 Flash Sterilization (Steam)
- i) ANSI/AAMI/ISO 11134:1993 Validation of Steam Sterilization
- CEN EN 1441:1997, Medical Devices Risk i) Management*
- k) AAMI/ISO 14971-1 Medical Devices Risk Management – Part 1: Application of risk analysis*
- l) GHTF/SG3/N15Rb Final Document Implementation of risk management Principles and Activities Within a Quality System*

*NOTE: Full conformance to these standards is not intended to be implied or declared, as implementation of various specific aspects of the standards are not yet fully established. These standards are referenced, as current quality system elements affected bv requirements of the standards, are under revision to include or exclude (i.e. CEN EN 1441) requirements of the standards as applicable.

This list may not represent all standards routinely used or applied of current or proposed devices.

P. 204

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The iMRI Surgical Drill System is a Class II medical device which includes a pneumatic drill motor and foot control; a variety of nosepiece attachments; and various bone dissection tools (cutters). To make the drill system "MRI useable", ferrous metals comprising each system component have been replaced with materials known to have significantly lower or no discernable magnetic susceptibility.

The iMRI Drill System foot control was tested with the Drill System within Zone IV. It was located on the floor within easy access to be activated by the surgeon's foot. The iMRI motor does not require continuous oiling and therefore runs at slower speeds (60 - 65k RPM) than noniMRI Anspach motors (80 - 85k RPM). Nosepiece attachments (bearing tubes) support the cutter to minimize vibration , wobble and whipping. They are a direct contact (with patient) device and are distributed clean, non-sterile for reusable applications. iMRI cutters are identical to other Anspach non-iMRI cutters with exception of materials and indications for use. Cutters are surgically invasive, direct contact (with patient) devices and are distributed presterilized to a SAL 10-6. iMRI cutters carry additional warnings to advise the user "dulling" may occur faster than other Anspach non-iMRI cutters, especially if overused or reused. Anspach cutters are not designed for and should never be reprocessed for reuse.

The Anspach iMRI Surgical Drill System (including pneumatic drill motor, foot control, nosepiece attachments and cutters), is indicated for intra-operative (non-imaging) use within a Magnetic Resonance Imaging (MRI) environment rated at 1.5 Tesla or less, for surgical cutting, shaping and removal of bone, including bones of the skull and spine.

The iMRI Drill System (including motor, foot control, nosepiece attachments and cutters), is indicated for intraoperative (non-imaging) use within an MRI system rated at 1.5 Tesla or less, for surgical cutting, shaping and removal of bone, including bones of the skull and spine. The iMRI Surgical Drill System (including drill motor and foot control, nosepiece attachments and cutters), is contraindicated for presence within Zone IV of an iMRI system while imaging is actually being accomplished. Presence of the equipment in Zone IV** during imaging

#### Indications for Use

Technological Characteristics

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could cause unacceptable image distortion. Cleaning, sterilization and storage conditions are specified on product package inserts and product labeling complies with US, European Union and in other global market requirements.

## Conclusion

The iMRI Drill System is substantially equivalent in form and design to other Anspach pneumatic drill systems including MicroMax, the original 65K, and their nosepiece attachments and cutters. Principle design differences are in materials, indications for use and a slightly modified locking mechanism, which prevents interchangeability between iMRI and non-iMRI system components.

** Zones are based on the definitions listed by the American College of Radiology White Paper on MR Safety.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle with its wings spread, rendered in black lines. The eagle is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

The Anspach Effort % Mr. Jim Banic Senior Regulatory Affairs Specialist 4500 Riverside Drive Palm Beach Gardens, Florida 33410

JAN 2 6 2007

Re: K061297

Trade/Device Name: iMRI Surgical System Regulation Number: 21 CFR 882.4370 Regulation Name: Pneumatic cranial drill motor Regulatory Class: II Product Code: HBB Dated: January 11, 2007 Received: January 12, 2007

Dear Mr. Banic:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set 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.

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Page 2 - Mr. Jim Banic

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/odrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

ark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K061297

Device Name: iMRI Surgical System

Indications for Use: -

The Anspach iMRI Surgical Drill System (including pneumatic drill motor, foot control, nosepiece attachments and cutters), is indicated for intra-operative (non-imaging) use within a Magnetic Resonance Imaging (MRI) environment rated at 1.5 Tesla or less, for surgical cutting, shaping and removal of bone, including bones of the skull and spine.

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) -

R
(Division Sign Off)

(Division Sign-O Division of General, Restorative, and Neurological Devices

510(k) Number K061292

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