CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal, Cirq Robotic Alignment Cranial and Spine, CIRQ Robotic Alignment Cranial and Spine System

Q: Who is the manufacturer of CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal, Cirq Robotic Alignment Cranial and Spine, CIRQ Robotic Alignment Cranial and Spine System?

Brainlab AG filed the 510(k) submission for CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal, Cirq Robotic Alignment Cranial and Spine, CIRQ Robotic Alignment Cranial and Spine System (K202320).

Q: What is the FDA product code for CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal, Cirq Robotic Alignment Cranial and Spine, CIRQ Robotic Alignment Cranial and Spine System?

OLO. It is classified under 21 CFR 882.4560 as a Class 2 device in the Neurology panel.

Q: What is the regulatory pathway for CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal, Cirq Robotic Alignment Cranial and Spine, CIRQ Robotic Alignment Cranial and Spine System?

510(k) clearance (submission type: Traditional).

Q: Who can help prepare an FDA 510(k) submission like CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal, Cirq Robotic Alignment Cranial and Spine, CIRQ Robotic Alignment Cranial and Spine System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K202320 · Brainlab AG · OLO · Dec 23, 2020 · Neurology

Device Facts

Record ID	K202320
Device Name	CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal, Cirq Robotic Alignment Cranial and Spine, CIRQ Robotic Alignment Cranial and Spine System
Applicant	Brainlab AG
Product Code	OLO · Neurology
Decision Date	Dec 23, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.4560
Device Class	Class 2

Intended Use

For spinal use the CIRQ Robotic Alignment Module is an accessory to the compatible Brainlab IGS Spinal software applications and is intended to be an intraoperative image guided localization system to support the surgeon to achieve pre-planned trajectories with surgical instruments.

Device Story

CIRQ Robotic Alignment Module is an intraoperative image-guided localization accessory for Brainlab IGS Spinal software. Used in OR by surgeons; system integrates with Medineering Surgical Base System. Input: infrared passive marker tracking data from navigation platform cameras to determine patient/instrument position. Operation: surgeon manually pre-aligns device to region of interest using 7-DOF brakes; system then automatically fine-aligns a tracked guide to a pre-planned trajectory via CIRQ Robotic Application Software. Output: physical alignment of surgical guide to trajectory. Benefit: assists surgeon in achieving accurate pre-planned trajectories for spinal screw placement. Healthcare providers use visual guidance on navigation platform to monitor alignment; device maintains position for surgical steps.

Clinical Evidence

Bench testing only. Verification included MIS Spine Training Model simulations by spinal surgeons, usability testing with surgeons/OR nurses, mechanical stability/lifecycle testing, and integration testing with navigation platforms. Compliance with AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 80601-2-77, and AIM 7351731 demonstrated.

Technological Characteristics

Robotic alignment module with 7-DOF Surgical Base System; infrared passive marker optical tracking; motorized positioning; networked communication. Software-controlled alignment. Biocompatible materials tested for reprocessing. Standards: AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 80601-2-77, AIM 7351731.

Indications for Use

Indicated for patients requiring spinal screw placement for the treatment of spinal diseases.

Regulatory Classification

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.

Predicate Devices

Spine Trauma 3D (K183605)

Related Devices

K221618 — Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma, Alignment System Spine, Alignment Software Spine, Cirq Arm System · Brainlab AG · Aug 30, 2022
K252755 — POINT Kinguide Agile Robotic Arm Surgical Stereotactic System · Point Robotics MedTech, Inc. · Jan 23, 2026
K201189 — Stealthstation S8 Spine Software v1.3.0 · Medtronic Navigation, Inc. · May 29, 2020
K183605 — Spine & Trauma Navigation · Brainlab AG · Aug 29, 2019
K223070 — Remi Robotic Navigation System · Fusion Robotics, LLC · Oct 28, 2022

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. December 23, 2020 Brainlab AG Cunico Chiara Manager Regulatory Affairs Olof-Palme-Str. 9 Munich, 80809 Germany Re: K202320 Trade/Device Name: CIRQ Robotic Alignment Module, Cirg, Cirq Robotic Alignment Module Spinal, Cirq 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: OLO Dated: November 17, 2020 Received: November 19, 2020 Dear Cunico Chiara: 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. {1}------------------------------------------------ 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 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 (QS) 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 medical devices and radiation-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, Shumaya Ali, MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K202320 #### Device Name CIRO Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal, Cirq Robotic Alignment Cranial and Spine, CIRQ Robotic Alignment Cranial and Spine System ### Indications for Use (Describe) For spinal use the CIRQ Robotic Alignment Module is an accessory to the compatible Brainlab IGS Spinal software applications and is intended to be an intraoperative image guided localization system to achieve pre-planned trajectories with surgical instruments. The medical indications for use of the CIRQ Robotic Alignment Module for spinal use is the treatment of diseases where the placement of spinal screws is indicated. Type of Use (Select one or both, as applicable) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | |-------------------------------------------------------------| | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. 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 Drug 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." {3}------------------------------------------------ Image /page/3/Picture/1 description: The image is an abstract design featuring a series of interconnected triangles. The triangles vary in size and shade, transitioning from a darker blue on the left to a lighter blue and almost white on the right. White lines separate the triangles, creating a fragmented, geometric pattern across the image. Image /page/3/Picture/2 description: The image shows the word "BRAINLAB" in all capital letters. To the left of the word is a logo that appears to be a stylized representation of the brain. The text and logo are in black and are set against a white background. The logo is smaller than the text and is positioned slightly above the baseline of the text. # 510(k) Summary November 17, 2020 | General Information | | |-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | Brainlab AG | | Establishment Registration | 8043933 | | Device Name | CIRQ Robotic Alignment | | Trade Name | Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Spinal, Cirq Robotic Alignment Cranial And Spine, CIRQ Robotic Alignment Cranial and Spine System | | Classification Name | Orthopedic Stereotaxic Instrument | | Product Code | OLO | | Regulation Number | 882.4560 | | Regulatory Class | II | | Panel | Orthopedic | | Predicate Device and K Number | Spine Trauma 3D - K183605 | | Contact Information | | |-----------------------------------|----------------------------------------| | Primary Contact | Alternate Contact | | Chiara Cunico | Regulatory Affairs Brainlab | | Manager RA | Phone: +49 89 99 15 68 0 | | Phone: +49 89 99 15 68 0 | Fax: +49 89 99 15 68 5033 | | Email: chiara.cunico@brainlab.com | Email: regulatory.affairs@brainlab.com | ## 1. Intended Use and Indication for Use For spinal use the CIRQ Robotic Alignment Module is an accessory to the compatible Brainlab IGS Spinal software applications and is intended to be an intraoperative image guided localization system to support the surgeon to achieve pre-planned trajectories with surgical instruments. The medical indications for use of the CIRQ Robotic Alignment Module for spinal use is the treatment of diseases where the placement of spinal screws is indicated. #### 2. Device Description The device is an accessory to the compatible Brainlab IGS Spinal software applications (K183605) and is intended to be an intraoperative image guided localization system to support the surgeon to achieve pre-planned trajectories with surgical instruments. The device consists of the Cirq Robotic Alignment Module which is connected to the Surgical Base System from Medineering. It serves to align instruments to a pre-planned trajectory during surgical {4}------------------------------------------------ procedures using the Cirg Robotic Application Software together with the Brainlab IGS Spinal software applications. Infrared passive marker based tracking as provided by the optical tracking camera unit of the navigation platform is used to determine the instrument's and patient's position. The relation between the patient and the reference attached to the patient is realized with a registration (manually or automatically). The device is manually pre-aligned roughly to the region of interest by opening the brakes of the Surgical Base System using its 7 degrees of freedom. Following this, the tracking information is used to automatically fine align a tracked quide attached to the Cirg Robotic Alignment Module to achieve a pre-planned trajectory controlled by the CIRQ Robotic Application Software. After finishing the alignment, the device remains in this position and the surgical instruments through the provided guide to perform the surgical steps intended without losing the trajectory. ## 3. Substantial Equivalence The subject device has been compared with the predicate device (K183605). The main differences are listed below. Please see Substantial Equivalence Cirq Robotic Alignment Module for full details as well as the demonstration of equivalence. | Topic | Changes included in Subject Device Cirq Robotic Alignment Module | |-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Platform | • Updated IGS platform with Touchscreen Monitor and Stereotactic Camera system | | Instruments / Hardware Components | • Surgical Base System communicates with Navigation platform and attached Cirq Robotic Alignment Module • Cirq Robotic Alignment Module for robotic fine alignment of a tracked guide • Surgical instruments addressing similar use and use cases that can be inserted into above tracked guide | | Robotic Application | • UI with guidance for manual pre-alignment • Communicates with Surgical Base System to provide positioning information to attached Cirq Robotic Alignment Module | | Compatibility | • Different Drape from 3rd party manufacturer | Both devices are intended as image guided localization systems to position instruments. The intended use of the subject device is limited to achieving pre-planned trajectories which is a subset of the intended use of the predicate device. The indications for use of the subject device to treat diseases where the placement of spinal screws is indicated is a subset of the indications for use of the predicate device. The Technological Characteristics are the same as for the predicate device. Both devices - use the same tracking technology, o - consist of a computer workstation, a tracking camera, tracked instruments o - are a combination of software, electrical and non-electrical components O - have motorized components O - communicate over the network O {5}------------------------------------------------ | Test | Description | Conclusion / Result | |-------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------| | Verification of general functions | Tests regarding accurate positioning of surgical instruments to planned trajectory as well as maintenance of a position during the procedure and usefulness of the subject device in open or percutaneous, minimally invasive approaches have been conducted on a MIS Spine Training Model in a simulated clinical environment and where performed by spinal surgeons. | Verification of general functions successful. All requirements met. | | General design requirements | Verification of general functions to overall design, layout and general behavior. | Verification of general design requirements successful. | | Safety tests regarding risk analysis | Implementation and effectiveness of all risk control measures specified for the Cirq Robotic Alignment Module are tested and verified. | Risk control measures are effective and mitigate the associated risks. | | Human factors / Usability Testing | Usability tests with surgeons and OR nurses were performed in a simulated clinical environment covering the complete clinical workflow with the Cirq Robotic Alignment Module in combination with the spine navigation applications and Brainlab navigation platform. | System is safe and effective to use. | | Product safety tests | Compliance of Cirq Robotic Alignment Module including the Surgical Base System and the drape has been tested according to the following standards: AAMI/ANSI ES60601 -1:2005/(R)2012 for medical electrical equipment - General requirements for basic safety and essential performance IEC 60601-1-2 General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests IEC 80601-2-77 Particular requirements for the basic safety and essential performance of for robotically assisted surgical equipment AIM standard 7351731 Immunity Test For Exposure To Radio Frequency Identification Readers | Compliance with standards requirements demonstrated, no deviations. | | Biocompatibility / Reprocessing | Material properties in relation to biocompatibility and their response to cleaning, disinfection and sterilization have been assessed and tested. | Biocompatibility assessment and reprocessing tests successful. | | Environmental tests | Tests regarding adherence to RoHS, REACH and WEEE directives. | Environmental tests successful. | | Compatibility tests with spinal navigation applications and Brainlab | Verification integration of Cirq Robotic Alignment Module into the spinal workflow and compatibility tests with the spinal navigation applications and Brainlab navigation platforms. | Integration and compatibility tests successful. | | navigation platforms | | | | Mechanical tests | Mechanical stability tests, lifecycle tests and interface tests of the components of the Cirq Robotic Alignment Module from fixating the Surgical Base System to the OR table to holding surgical instruments with a defined holding force. | Mechanical tests successful. | | Integration tests Robotic Application, Surgical Base System, Cirq Robotic Alignment Module and instruments. | Tested integration of Robotic Application with Surgical Base System, mounted Cirq Robotic Alignment Module and attached instruments including cybersecurity tests, verification tests ensuring that the specified braking concept for the Surgical Base System is correctly implemented and verification test on aligning to a desired position. | Integration tests Robotic Application with other components successful. | | Surgical Base System firmware software verification | Tested software according to IEC 62304 and "FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" | Surgical Base System software verification successful. | | Robotic Application software verification | Tested software according to IEC 62304 and "FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" | Robotic Application software verification successful. | | Integration tests of sterile drape | The Cirq Robotic Alignment Module integrates a drape to ensure sterile environment to the surgical instruments. Tested that the drape matches in form, fit and function with the mechanical dimension onto the components of the Cirq Robotic Alignment Module, ensures a sterile barrier and is compatible with the navigation. | Drape integration tests successful. | | Integration tests of stabilization brace | The Cirq Robotic Alignment Module integrates a stabilization brace to increase stability to the system. Tested that brace matches in form, fit and function with the mechanical dimensions of the Surgical Base System. | Stabilization brace integration tests successful. | The various tests carried out on the subject device has been listed below: {6}------------------------------------------------ ## Conclusion The changes described above do not alter intended use or the fundamental scientific technology of the device and these changes do not present any new issues of safety and effectiveness when compared to the predicate device. Therefore, we believe that the Subject Device and the predicate are substantially equivalent.