The Cirq Robotic Alignment Module is an intraoperative robotic positioning system and an accessory to compatible Brainlab IGS Cranial software applications. Using spatial information from an image guided navigation system, the Cirq Robotic Alignment Module enables the surgeon to align and hold surgical instruments according to pre-planned trajectories.

The Cirq Robotic Alignment Module is indicated for stereotactic biopsies of intracranial lesions.

Device Description

The subject device is intended to serve as a positing and holding device for Brainlab instruments such as drill kits, during surgical procedures.

The device consists of:

Medical Electrical Equipment Hardware
I Medical Software
. Reprocessable Surgical Instruments, and
Disposable Instruments
The CIRQ Robotic Alignment Module is an adapter containing a motor unit, which is attached to a user-controlled mechatronic holding arm named CIRQ Arm System. The arm is attached to the side rail of an operating table. Together they form a structure capable of holding and positioning instruments.

By using position information acquired by a compatible IGS platform via infrared tracking method, an instrument can be manually pre-aligned roughly to the region of interest by opening the brakes of the CIRQ Arm System. Following this, the tracking information is used to automatically (via the Kinematic Unit attached to the motor unit) fine align the instrument to achieve a pre-planned trajectory controlled by the CIRQ Robotic Alignment Software. After finishing the alignment, the arm with the instrument attached remains in this position and the surgeon can perform the surgical steps intended without losing the trajectory.

The position of the instruments relatively to the patient is visualized via the Cirq Robotic Alignment Software, which is running in a compatible IGS platform (see Figure 2). This software also controls and monitors the movement of the Cirq Robotic Alignment Module.

There are no variants of the device. There is only one configuration for the cranial use case.

AI/ML Overview

The provided text describes the regulatory clearance for the "Cirq Robotic Alignment Module" for stereotactic biopsies of intracranial lesions. The acceptance criteria and the study proving the device meets these criteria are detailed, primarily focusing on bench performance testing.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Bench Test)	Reported Device Performance
Positional accuracy with a mean error ≤ 2.0 mm (in worst-case configuration)	Demonstrated performance in 3D positional accuracy with a mean error ≤ 2.0 mm (System accuracy test outcome)
Trajectory angle accuracy with a mean error ≤ 2.0 degrees (in worst-case configuration)	Demonstrated performance in trajectory angle accuracy with a mean error ≤ 2.0 degrees (System accuracy test outcome)
Stability of Instrument Holder Interface to ensure safe and effective connection	Tested to ensure safe and effective connection between the Cirq Robotic Alignment Module and the Instrument Set. (Specific performance metric for "stability" is not quantified, but the test affirmed it meets the requirement).
Locking mechanisms of Tracking Arrays performance over complete expected service life	Tested for their performance over the complete expected service life of 5 years. (Specific performance metric is not quantified, but the test affirmed it meets the requirement).
Bone Anchor ensures sufficient fixation to the skull and withstands foreseeable forces	Verified that the Bone Anchor ensures a sufficient fixation to the skull to enable a safe connection to the patient's anatomy during a biopsy procedure and withstands foreseeable forces. (Specific force/fixation metrics are not quantified, but the test affirmed it meets the requirement).
Cutting efficiency of the Drill Bit	Verified in a comparing bench test. (Specific efficiency metrics are not quantified, but the test affirmed it meets the requirement).
Axial holding force of the Depth Stop ensures safe performance during drilling process	Verified to ensure a safe performance during the drilling process. (Specific force metrics are not quantified, but the test affirmed it meets the requirement).
Biocompatibility	Meets the requirements of ISO 10993-1 and ISO 14971 for a device with limited contact duration (≤ 24 hours).

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

The document describes "Performance Testing - Bench" which included "simulation tools" and "physical test setups (Instrument and System Accuracy Test)". It does not specify a distinct "test set" in terms of patient data. The accuracy tests were performed "under representative worst-case configuration."

Sample Size for Test Set: Not explicitly stated regarding the number of test runs or specific items tested for each bench test.
Data Provenance: Bench testing data, conducted in a laboratory setting by the manufacturer, Brainlab AG, which is located in Munich, Germany. The data is prospective as it describes tests performed on the device to prove its performance.

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

Not applicable in this context. The "ground truth" for the bench tests was established through engineering specifications, tolerance analyses, and physical measurement against known standards (e.g., measuring deviation from a planned trajectory/position). There were no human experts establishing ground truth for the device's accuracy in a diagnostic or clinical setting.

4. Adjudication Method for the Test Set:

Not applicable. The tests are objective measurements against established engineering tolerances and specifications, not subjective human assessments requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

A MRMC comparative effectiveness study was not mentioned in the provided document. The device is a robotic positioning system, not an AI diagnostic tool that assists human readers in interpreting medical images. Therefore, improvement in human reader performance with or without AI assistance is not a relevant metric for this device and not discussed.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:

The document describes "Performance Testing - Bench" which evaluated the device's accuracy and functionality independently. In this sense, the positional and trajectory accuracy assessments are a form of standalone performance evaluation of the robotic system itself, separate from its operation during a live surgical procedure with a human surgeon. The device enables the surgeon to align and hold instruments, suggesting a human-in-the-loop for the overall surgical procedure, but the bench tests assess the machine's inherent accuracy and mechanical performance in a standalone manner.

7. Type of Ground Truth Used:

For the bench performance tests, the ground truth was engineering specifications and physical measurements against known standards. For example, the "mean error ≤ 2.0 mm" and "mean error ≤ 2.0 degrees" are measured deviations from predefined, ideal positions and trajectories.

8. Sample Size for the Training Set:

Not applicable. The provided document concerns a robotic surgical guidance system, not a machine learning or AI algorithm that requires a training set of data. The device's functionality is based on established robotics and image-guided navigation principles.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no mention of a training set or machine learning components for this device in the provided text.

Summary

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November 12, 2021

Brainlab AG Chiara Cunico Manager Regulatory Affairs Olof-Palme-Str. 9 Munich, Germany 81829

Re: K210989

Trade/Device Name: Cirq, Cirg Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirg Robotic Alignment Module, Cirg Robotic Alignment Cranial And Spine, CIRQ Robotic Alignment Cranial And Spine System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: October 12, 2021 Received: October 15, 2021

Dear Chiara Cunico:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K210989

Device Name

Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic Alignment Cranial And Spine CIRQ Robotic alignment cranial and spine system

Indications for Use (Describe)

The Cirq Robotic Alignment Module is indicated for stereotactic biopsies of intracranial lesions.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary

November 12, 2021

General Information
Manufacturer	Brainlab AG, Olof-Palme Str.9, 81829, Munich, Germany
Applicant Details	Chiara CunicoManager, Regulatory Affairs+49899915680
Establishment Registration	8043933
Trade Name	Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment ModuleCranial, Cirq Robotic Alignment Cranial And Spine, CIRQ Roboticalignment cranial and spine system
Classification Name	Neurological Stereotaxic Instrument
Product Code	HAW
Regulation Number	882.4560
Regulatory Class	II
Panel	Neurology
Predicate Device	Medtronic Stealth Autoguide™ System (K191597) by Medtronic
Reference Device	Cirq Robotic Alignment System (K202320) by Brainlab

1. Indications for Use

The Cirq Robotic Alignment Module is indicated for stereotactic biopsies of intracranial lesions.

2. Device Description

The subject device is intended to serve as a positing and holding device for Brainlab instruments such as drill kits, during surgical procedures.

The device consists of:

Medical Electrical Equipment Hardware
I Medical Software
. Reprocessable Surgical Instruments, and

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Disposable Instruments
The CIRQ Robotic Alignment Module is an adapter containing a motor unit, which is attached to a user-controlled mechatronic holding arm named CIRQ Arm System. The arm is attached to the side rail of an operating table. Together they form a structure capable of holding and positioning instruments.

There are no variants of the device. There is only one configuration for the cranial use case.

3. Substantial Equivalence

Parameters	Subject Device	Primary Predicate	Reference Device
	Cirq	Medtronic Stealth	Cirq Robotic Alignment
		Autoguide™ System	System (K202320)
		(K191597)
Indications for	The Cirq Robotic	The Stealth Autoguide™	For spinal use, the Cirq
Use/ Intended	Alignment Module is an	System is a positioning	Robotic Alignment
use	intraoperative robotic	and guidance system	Module is an accessory to
	positioning system and an	intended for the spatial	the compatible Brainlab
	accessory to compatible	positioning and	IGS Spinal software
	Brainlab IGS Cranial	orientation of instrument	applications and is
	software applications.	holders or tool guides to	intended to be an
	Using spatial information	be used by	intraoperative image
	from an image guided	neurosurgeons to guide	guided localization
	navigation system, the	standard neurosurgical	system to support the
	Cirq Robotic Alignment	instruments, based on a	surgeon to achieve pre-
	Module enables the	pre-operative plan and	planned trajectories with
	surgeon to align and hold	feedback from an image-	surgical instruments.
	surgical instruments	guided navigation system
	according to pre-planned	with three-dimensional
	trajectories.	imaging software.
Indications for	The Cirq Robotic	The Stealth Autoguide™	The medical indications
use	Alignment Module is	System is a remotely-	for use of the Cirq
	indicated for stereotactic	operated positioning and	Robotic Alignment
	biopsies of intracranial	guidance system,	Module for spinal use is
	lesions.	indicated for any	the treatment of diseases
		neurological condition in
Parameters	Subject Device	Primary Predicate	Reference Device
	Cirq	Medtronic StealthAutoguide™ System(K191597)	Cirq Robotic AlignmentSystem (K202320)
		which the use ofstereotactic surgery maybe appropriate (forexample, stereotacticbiopsy, stereotactic EEG,laser tissue ablation,etc.).	where the placement ofspinal screws is indicated.
Operatingprinciple	Preoperative images(Cranial IGS)Surgical planning (CranialIGS)Patient registration(Cranial IGS)Guidance of instruments	Preoperative images(StealthStation)Surgical planning(StealthStation)Patient registrationGuidance of instruments	Preoperative images(Spine IGS)Surgical planningPatient registration(Spine IGS)Guidance of instruments



Localizationmeans	The infrared light isemitted by IR LEDslocated in the cameras.This light is reflected bythe highly reflectingmarkers mounted on theseveral tools. The camerareceives the reflectedlight for furtherprocessing	Optical markers on toolholder	The infrared light isemitted by IR LEDslocated in the cameras.This light is reflected bythe highly reflectingmarkers mounted on theseveral tools. The camerareceives the reflectedlight for furtherprocessing




Image-Guided	Yes	Yes (on StealthStation)	Yes
Planningsoftware	Compatible with:Cranial 3.1Trajectory 2.5	Compatible with:S8 Cranial v1.1Synergy Cranial v.3.1	---


System accuracyrequirement	Under representativeworstcase configuration,the Cirq RoboticAlignment with CranialIGS Software, hasdemonstratedperformance in 3Dpositional accuracy with amean error ≤ 2.0 mm andin trajectory angleaccuracy with a meanerror ≤ 2.0 degrees.	Under representativeworstcase configuration,the StealthStation®System with CranialSoftware used withStealth Autoguide™System, hasdemonstratedperformance in 3Dpositional accuracy with amean error ≤ 2.0 mm andin trajectory angleaccuracy with a meanerror ≤ 2.0 degrees	---
Parameters	Subject Device	Primary Predicate	Reference Device
	Cirq	Medtronic Stealth	Cirq Robotic Alignment
		Autoguide™ System(K191597)	System (K202320)
Guide positionadjustment	Robotic movement	Robotic movement	Robotic movement
Accessories	Sterile DrapeStabilization BraceCable Sets (part ofSurgical Base System)Instrument CalibrationMatrixScrewdriver for CranialDepth StopSterilization Tray RoboticCranial for CirqDisposable reflectivemarker sphere	Sterile DrapesHead Frame AdapterCable Sets	Sterile DrapeStabilization BraceCable Sets (part ofSurgical Base System)Instrument CalibrationMatrixSterilization Tray RoboticSpinal Drilling for CirqDisposable reflectivemarker sphereBone Drill Bits for spinaluse cases
Real-timeinstrumentposition	Yes	Yes (on StealthStation)	Yes
Patientregistration	Optical patientregistration used fromCranial 3.1	Optical RegistrationDevice (viaStealthStation)	Patient registration usedfrom Spine IGS
Surgeonperforms finalinstrumentdelivery throughinstrumentguide	Yes	Yes	Yes

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4. Performance Data

The following performance data were provided in support of the substantial equivalence determination.

Performance Testing - Bench:

Performance testing as bench testing was performed for the instrument set as part of the subject device. The specified accuracy of the instrument sets is verified using tolerance analysis and simulation tools, as well as physical test setups (Instrument and System Accuracy Test). The outcome of the system accuracy test showed that the set acceptance criteria (positional accuracy with a mean error ≤ 2.0 mm and a trajectory angle accuracy with a mean error ≤ 2.0 degrees) are met and the system is equivalent to the predicate device in its worst-case configuration. Additionally, possible impacts on the accuracy performance due to repeated sterilization of the Instrument Set were considered.

The stability of the Instrument Holder Interface was tested to ensure safe and effective connection between the Cirq Robotic Alignment Module and the Instrument Set. The locking

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mechanisms of the Tracking Arrays were tested for their performance over the complete expected service life of 5 years.

Additional verification activities were focused on the Biopsy Drill Kit which consists of Guide Tube, Bone Anchor, Drill Bit and Depth Stop. It has been verified that the Bone Anchor ensures a sufficient fixation to the skull to enable a safe connection to the patients anatomy during a biopsy procedure. Furthermore, it was verified that the Bone Anchor withstands foreseeable forces which could occur during a biopsy procedure. The cutting efficiency of the Drill Bit was verified in a comparing bench test. The axial holding force of the Depth Stop was verified to ensure a safe performance during the drilling process.

Biocompatibility Evaluation

The biocompatibility evaluation for the Subject Device was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA.

Based on the biological toxicological evaluation of existing data and test results, the device is considered to meet the requirements of ISO 10993-1 and ISO 14971 for a device with limited contact duration (≤ 24 hours) and can be considered safe and suitable for its intended use.

5. Conclusion

The comparison of the Subject Device with the predicate device shows that the device has similar functionality, intended use, technological characteristics, and typical users as the predicate device. Verification and validation activities ensured that the design specifications are met and that the differences does not introduce new issues concerning safety and effectiveness. Hence, the Subject Device is substantially equivalent to the predicate device.

Regulation Number and Section

§ 882.4560 Stereotaxic instrument.

(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).