(262 days)
Anspach MRI Surgical Drill System
Not Found
No
The summary describes a pneumatic surgical drill system designed for use in an MRI environment, focusing on material composition and mechanical function. There is no mention of AI or ML capabilities.
No.
The device is used for surgical cutting, shaping, and removal of bone, which is an interventional/surgical procedure, not a therapeutic treatment.
No
The device is indicated for surgical cutting, shaping, and removal of bone. It is an operative tool, not a diagnostic device.
No
The device description explicitly lists hardware components such as a pneumatic drill motor, foot control, nosepiece attachments, and cutters.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Function: The Anspach iMRI Surgical Drill System is used for surgical cutting, shaping, and removal of bone within the body during surgery. It is a surgical tool, not a diagnostic test performed on a sample.
- Intended Use: The intended use clearly states "intra-operative use" for surgical procedures.
Therefore, based on its function and intended use, the Anspach iMRI Surgical Drill System is a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes
HBB
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bones of the skull and spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon's foot / intra-operative (non-imaging) use within a Magnetic Resonance Imaging (MRI) environment
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Anspach MRI Surgical Drill System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.4370 Pneumatic cranial drill motor.
(a)
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.(b)
Classification. Class II (performance standards).
0
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
4500 Riverside Drive
Palm Beach Gardens, FL 33410 | |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact | Jim Banic
Senior Regulatory Affairs Specialist
The Anspach Effort
4500 Riverside Drive
Palm Beach Gardens, FL 33410
Tel. 561-627-1080 ext. 515
Fax. 561-625-9110
Email: jimb@anspach.com | JAN 26 2007 |
| Date Prepared | January 11, 2007 | |
| Device Name | Anspach iMRI Surgical Drill System | |
| Classification Name | Motor, Drill, Pneumatic | |
| Device
Classification | Class II
General, Restorative and Neurological Devices
21 CFR § 882.4370 | |
| Predicate
Devices | Anspach MRI Surgical Drill System | |
| Performance Standards | There are no known performance standards established
specifically for an iMRI Surgical Drill System or their
accessory devices at this time. However, the following
standards are applicable to materials; components
and/or processes applied to the design, manufacture and
distribution of the current (predicate) Anspach iMRI
Surgical Drill System, and are applied to the proposed
new device.
a) ASTM and other similar recognized material
composition-related standards.
b) ASTM F2213-04 "Standard Test Method for
Measurement of Magnetically Induced Torque on
Passive Implants in Magnetic Resonance
Environment." | |
.
1
- 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
3
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 (240) 276-0115. 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 (800) 632-2041 or (240) 276-3150 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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