(30 days)
Not Found
No
The document describes a manual hand drill and its accessories, with no mention of AI, ML, or any computational processing beyond basic mechanical function.
No
The device is a surgical drill intended for creating access through the skull, which is an interventional/surgical tool and not a therapeutic device.
No
The device is a hand drill used for surgical access and procedures like biopsy or catheter placement, not for diagnosing medical conditions.
No
The device description clearly states it is a "hand held manual drill" and mentions physical accessories like drill bits, lancet, depth stop, and ruler, indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide access through the skull for ventriculostomy or other neurological procedures, such as biopsy or catheter placement." This describes a surgical or procedural device used directly on a patient's body.
- Device Description: The description details a "hand held manual drill" and its accessories (drill bits, lancet, depth stop, ruler). These are tools for physical intervention.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such examination of specimens.
Therefore, the SmartTwist™ MRII Hand Drill is a surgical/procedural device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SmartTwist™ MRII Hand Drill and accessories are 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 strength. The SmartTwist MRII Hand Drill and accessories are intended to be used only when the scanner is not performing a scan. The SmartTwist MRII Hand Drill is intended for single use only.
Product codes
HBG
Device Description
The SmartTwist MRII Hand Drill is a hand held manual drill with a 3:1 gear ration. It is intended for use with the drill kit accessory kits SmartTip Drill Kits for a 3.2mm, 4.5mm and 6.0mm drill bit, with 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
OR or MRI Suite
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
The modifications of the SmartTwist MRII Hand Drill were conducted in conformance with the company's design control procedures. Design inputs provided the requirements for the respective product specifications. Design Verification was performed relative to these specifications with acceptable results. Risk analysis was performed with mitigation of all identified risks to acceptable levels. The tests and risk analysis demonstrated that the modified SmartTwist MRII Hand Drill functions as intended and performs comparably to the legally marketed MRII Cranial Drill.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three human profiles facing right, stacked on top of each other. Above the profiles are three curved lines, resembling flowing hair or abstract shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 8, 2015
MRI Interventions, Inc. Mr. E. F. Waddell Director, RA/OA 5 Musick Irvine, California 92618
Re: K151536 Trade/Device Name: SmartTwist MRII Hand Drill, SmartTip MRII Drill Bit Kit, 4.5mm, 6.0mm Regulation Number: 21 CFR 882.4300 Regulation Name: Manual cranial drills, burrs, trephines, and their accessories Regulatory Class: Class II Product Code: HBG Dated: June 6, 2015 Received: June 8, 2015
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
1
related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Carlos L. Pena -$=D/Δ
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page
510 (k) Number (if known)
Device Name
SmartTwist™ MRII Hand Drill, SmartTip™ MRII Drill Bit Kit, 4.5mm, 6.0mm Indications for Use (Describe)
The SmartTwist™ MRII Hand Drill and accessories are 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 strength. The SmartTwist MRII Hand Drill and accessories are intended to be used only when the scanner is not performing a scan. The SmartTwist MRII Hand Drill is intended for single use only.
Type of Use (Select one or both, as applicable)
XX Prescription Use (Part 21 CFR 801 Subpart D) Subpart C)
_ Over-The-Counter Use (21 CFR 801
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
3
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs. gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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510(k) Summary
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR Part 807.92 for the SmartTwist™ MRII Hand Drill and Accessories.
Company Making the Submission: 1.
| Name of Owner: | MRI Interventions, Inc. |
|---|---|
| Address: | 5 Musick |
| Irvine, CA 92618 | |
| Telephone: | 949-900-6833, 949-584-8517 |
| Fax: | 949-900-6834 |
| Contact: | Edward Waddell |
| E-mail: | ewaddell@mriinterventions.com |
2. Date Prepared: July 8, 2015
3. Device Name:
| Common Name: | Manual Drill |
|---|---|
| Proprietary Name: | SmartTwist MRII Hand |
| Drill, SmartTip™ MRII | |
| Drill Bit Kit, 4.5mm, | |
| 6.0mm | |
| Classification: | II |
| Regulation Number: | 21CFR 882.4300 |
| Product Code: | HBG |
3. Predicate Device:
MRII Cranial Drill, K122456
4. Device Description:
The SmartTwist MRII Hand Drill is a hand held manual drill with a 3:1 gear ration. It is intended for use with the drill kit accessory kits SmartTip Drill Kits for a 3.2mm, 4.5mm and 6.0mm drill bit, with lancet, depth stop and ruler.
5. Indications for Use
The SmartTwist MRII Hand Drill and accessories are 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 strength. The SmartTwist MRII Hand Drill and accessories are intended to be used only when the scanner is not performing a scan. The SmartTwist MRII Hand Drill is intended for single use only.
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6. Summary of the Technological Characteristics of the Device Compared to the Predicate Device:
Modifications of the predicate MRII Hand Drill are the additions of two additional drill kits.
a) SmartTip Drill Bit Kit, 4.5-mm, with 4.5-mm Surgibit® Drill Bit, Drill Stop, Ruler, and Lancet
b) SmartTip Drill Bit Kit, 6-mm, with 6-mm Surgibit® Drill Stop, Ruler, and Lancet
| | MRII Hand Drill and
Accessories
4.5 & 6.0mm Drill Kits | Predicate Device
MRII Cranial Drill and
Accessories
K122456 |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | 21 CFR 882.4300 | 21 CFR 882.4300 |
| Product Code | HBG | HBG |
| Intended Use | The SmartTwist MRII Hand
Drill and accessories are
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
strength. The SmartTwist MRII
Hand Drill and accessories are
intended to be used only when
the scanner is not performing a
scan. The SmartTwist MRII
Hand Drill is intended for
single use only. | The MRII Cranial Drill and
accessories are 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
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 |
| Environment | OR or MRI Suite | OR or MRI Suite |
| Sterilization | EO 10-6 SAL | EO 10-6 SAL |
| Drill Bit Included
with Drill | No | No |
| Drill Bit Sizes | 4.5mm
6.0mm | 2.0mm
3.2mm |
| Drill Bit Material | 316L SST | 316L SST |
| Adjustable Depth
Guard | Yes | Yes |
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| Packaging | Kit: Sterile, inside tray with
Tyvek Lid and external Tyvek
Pouch | Drill: Sterile, CSR Wrap in
Tyvek Peel Pouch
Kit: Sterile, inside tray with
Tyvek Lid and external Tyvek
Pouch |
| ------------------ | ------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------- |
|---|
The addition of drill sizes is at the request of clinicians.
The addition of two drill kit sizes as accessories to the SmartTwist MRII Hand Drill is equivalent in intended use, technological characteristics and principles of operation to the predicate MRII Cranial Drill.
7. Performance Data:
The modifications of the SmartTwist MRII Hand Drill were conducted in conformance with the company's design control procedures. Design inputs provided the requirements for the respective product specifications. Design Verification was performed relative to these specifications with acceptable results. Risk analysis was performed with mitigation of all identified risks to acceptable levels. The tests and risk analysis demonstrated that the modified SmartTwist MRII Hand Drill functions as intended and performs comparably to the legally marketed MRII Cranial Drill.
8. Consensus Standards:
The SmartTip MRII Drill Kits comply with the following recognized consensus standards:
- AAMI/ANSI/ISO 10993-1 Biological evaluation of medical devices Part ● 1: Evaluation and testing.
- ANSI/AAMI/ISO 1135-1 Sterilization of health care products Ethylene . oxide - Part 1: Requirements for development, validation, and routine control of sterilization process for medical devices
- ASTM F2052-05e1, Standard Test method for Measurement of ● Magnetically Induced Displacement Force on Medical Devcies in an MRI Environment.
9. Conclusion:
The modifications to the SmartTwist MRII Hand Drill were made in conformance with the company's design control procedures. Performance testing established the equivalence of the modified SmartTip Drill Kits to the predicate SmartTwist MRII Hand Drill and accessories, including design verification testing. No new materials have been introduced so the safety testing with the MRI Cranial Drill Kits is fully applicable to the modified SmartTwist MRII Hand Drill and accessories.
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The SmartTwist MRII Hand Drill has the same intended use and indications for use and similar technologies characteristics and principles of operation as the predicate MRII Cranial Drill. The minor technological differences between the SmartTwist MRII Hand Drill and accessories and its predicate raise no new issues of safety and effectiveness. Thus the modified SmartTwist MRII Hand Drill including the SmartTip Drill bit Kits 4.5mm and 6.0mm perform comparably to the predicate device that is currently marketed for the same intended use.