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.

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.

AI/ML Overview

The provided document is a 510(k) summary for the SmartTwist™ MRII Hand Drill, SmartTip™ MRII Drill Bit Kit, 4.5mm, 6.0mm, seeking substantial equivalence to the predicate device, the MRII Cranial Drill, K122456.

The document describes the performance data and acceptance criteria in terms of demonstrating substantial equivalence, rather than a traditional study with strict acceptance criteria and performance metrics for an AI/software device. This is a physical medical device, specifically a hand drill and drill bit kits.

Here's an breakdown based on the provided text, focusing on how the device meets "acceptance criteria" through comparison with its predicate:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (manual surgical drill), "acceptance criteria" are not reported as specific performance metrics (e.g., accuracy, sensitivity) like for diagnostics or AI. Instead, the acceptance is based on demonstrating substantial equivalence to a previously cleared predicate device, meaning it has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness. The performance is therefore reported in terms of equivalence to the predicate and compliance with recognized standards.

Feature / Criteria (Implied by Substantial Equivalence)	Predicate Device (MRII Cranial Drill)	Subject Device (SmartTwist MRII Hand Drill w/ 4.5mm & 6.0mm Kits)	Acceptance/Performance (Comparison/Result)
Intended Use	Same	Same	Meets: Intended to provide access through the skull for neurological procedures in/near a 3T MR scanner, used when scanner not performing a scan, single use only.
Technological Characteristics	Similar (manual drill, specific materials, adjustable depth guard, sterilization method)	Similar (manual drill, specific materials, adjustable depth guard, sterilization method)	Meets: Same classification, product code, environment, sterilization, drill bit material (316L SST), and adjustable depth guard. Main difference is additional drill bit sizes.
Principles of Operation	Similar	Similar	Meets: Operates as a manual hand drill with gear ratio to facilitate drilling.
Safety & Effectiveness	Established (previously cleared predicate)	No new issues raised	Meets: "The minor technological differences... raise no new issues of safety and effectiveness." Performance testing "established the equivalence" and "functions as intended and performs comparably." Risk analysis performed with mitigation of all identified risks.
Biocompatibility	Complies with AAMI/ANSI/ISO 10993-1	Complies with AAMI/ANSI/ISO 10993-1	Meets: Stated compliance. "No new materials have been introduced so the safety testing with the MRI Cranial Drill Kits is fully applicable."
Sterilization Efficacy	Complies with ANSI/AAMI/ISO 1135-1	Complies with ANSI/AAMI/ISO 1135-1	Meets: Stated compliance for EO 10-6 SAL sterilization.
MRI Safety (Magnetically Induced Displacement Force)	Complies with ASTM F2052-05e1	Complies with ASTM F2052-05e1	Meets: Stated compliance.

Key Differences from Predicate (and how they meet criteria):

Drill Bit Sizes: Predicate: 2.0mm, 3.2mm. Subject Device: 4.5mm, 6.0mm (addition of two new sizes).
- Acceptance: This "addition of drill sizes is at the request of clinicians" and is deemed "equivalent in intended use, technological characteristics and principles of operation to the predicate MRII Cranial Drill."
Packaging: Slight variation (Predicate: Drill is CSR Wrap in Tyvek Peel Pouch, Kit is Sterile, inside tray with Tyvek Lid and external Tyvek Pouch. Subject: Kit: Sterile, inside tray with Tyvek Lid and external Tyvek Pouch).
- Acceptance: Not highlighted as a safety concern; assumes equivalent sterile barrier properties.

2. Sample Size Used for the Test Set and the Data Provenance

This document does not describe a clinical study in the sense of a test set with patient data for determining diagnostic accuracy or treatment outcomes. Instead, it refers to "Performance Data" from "Design Verification" and "Risk Analysis."

Sample Size: Not specified in terms of patient data or number of devices tested in a formal sample size calculation. The verification likely involved destructive and non-destructive testing on a representative number of devices/components to ensure manufacturing quality and performance.
Data Provenance: Not applicable in the context of patient data. The "performance data" would originate from internal lab testing, engineering assessments, and risk management activities conducted by MRI Interventions, Inc. in the USA. The data is retrospective in the sense that it's generated during the design and manufacturing process, not from a prospective clinical trial.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of those Experts

Not applicable. This is not a study assessing diagnostic performance or requiring expert ground truth in the traditional sense. The "ground truth" for demonstrating the device works as intended comes from established engineering principles, recognized consensus standards, and comparison to the predicate device's cleared performance. Clinician request for the new drill sizes implies clinical input, but not as part of a formal ground truth adjudication.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" requiring adjudication by multiple experts, as this is a physical device clearance based on substantial equivalence and engineering verification.

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 is a manual surgical drill, not an AI/software device, and no MRMC study was conducted.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a manual surgical drill, not an algorithm, and its use inherently involves human interaction.

7. The Type of Ground Truth Used

The "ground truth" for this submission revolves around:

Predicate Device Performance: The established safety and effectiveness of the legally marketed MRII Cranial Drill.
Consensus Standards: Compliance with recognized international and national standards (e.g., ISO 10993-1 for biocompatibility, ISO 11135-1 for sterilization, ASTM F2052-05e1 for MRI safety).
Design Verification Testing: Internal testing to ensure the device meets its own design specifications.
Risk Analysis: Identification and mitigation of potential risks.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/machine learning algorithm, so there is no concept of a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

Summary

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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

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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)

K151536

Device Name

SmartTwist™ MRII Hand Drill, SmartTip™ MRII Drill Bit Kit, 4.5mm, 6.0mm Indications for Use (Describe)

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)

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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 MusickIrvine, 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 HandDrill, SmartTip™ MRIIDrill 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:

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 andAccessories4.5 & 6.0mm Drill Kits	Predicate DeviceMRII Cranial Drill andAccessoriesK122456
Classification	21 CFR 882.4300	21 CFR 882.4300
Product Code	HBG	HBG
Intended Use	The SmartTwist MRII HandDrill and accessories areintended to provide accessthrough the skull forventriculostomy or otherneurological procedures, suchas biopsy or catheterplacement, in or near an MRscanner of 3T maximumstrength. The SmartTwist MRIIHand Drill and accessories areintended to be used only whenthe scanner is not performing ascan. The SmartTwist MRIIHand Drill is intended forsingle use only.	The MRII Cranial Drill andaccessories are intended toprovide access through theskull for ventriculostomy orother neurological procedures,such as biopsy or catheterplacement, in or near an MRscanner of 3T maximumstrength. The MRII CranialDrill and accessories areintended to be used only whenthe scanner is not performing ascan. The MRII Cranial Drillis 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 Includedwith Drill	No	No
Drill Bit Sizes	4.5mm6.0mm	2.0mm3.2mm
Drill Bit Material	316L SST	316L SST
Adjustable DepthGuard	Yes	Yes

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Packaging	Kit: Sterile, inside tray withTyvek Lid and external TyvekPouch	Drill: Sterile, CSR Wrap inTyvek Peel PouchKit: Sterile, inside tray withTyvek Lid and external TyvekPouch
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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.

Regulation Number and Section

§ 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).