(128 days)
No
The description focuses on robotic alignment based on optical tracking and pre-planned trajectories, without mentioning AI or ML algorithms for image processing, decision making, or trajectory planning.
No.
The device is an accessory to an image-guided localization system that helps surgeons achieve pre-planned trajectories for surgical instruments. It does not directly treat a disease or condition; rather, it assists in the surgical procedure for treatment.
No
Explanation: The device is described as an "intraoperative image guided localization system" that helps surgeons to achieve pre-planned trajectories during surgery. Its primary function is to guide instruments and maintain position, not to diagnose a condition or disease.
No
The device description explicitly states that the device consists of the "Cirq Robotic Alignment Module which is connected to the Surgical Base System from Medineering." It also mentions "Infrared passive marker based tracking as provided by the optical tracking camera unit of the navigation platform" and "a tracked guide attached to the Cirq Robotic Alignment Module." These are all hardware components, indicating it is not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device is an "intraoperative image guided localization system" used to "achieve pre-planned trajectories with surgical instruments" during spinal surgery. It assists the surgeon in placing spinal screws.
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens from the patient. Its function is purely mechanical and navigational, guiding surgical instruments based on pre-operative planning and intraoperative tracking.
Therefore, the CIRQ Robotic Alignment Module falls under the category of a surgical guidance or robotic assistance system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications 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 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.
Product codes
OLO
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeons and OR nurses in a clinical 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
- 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. Conclusion: Verification of general functions successful. All requirements met.
- General design requirements: Verification of general functions to overall design, layout and general behavior. Conclusion: 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. Conclusion: 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. Conclusion: 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. Conclusion: 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. Conclusion: Biocompatibility assessment and reprocessing tests successful.
- Environmental tests: Tests regarding adherence to RoHS, REACH and WEEE directives. Conclusion: Environmental tests successful.
- Compatibility tests with spinal navigation applications and Brainlab navigation platforms: Verification integration of Cirq Robotic Alignment Module into the spinal workflow and compatibility tests with the spinal navigation applications and Brainlab navigation platforms. Conclusion: Integration and compatibility tests successful.
- 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. Conclusion: 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. Conclusion: 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". Conclusion: 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". Conclusion: 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. Conclusion: 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. Conclusion: Stabilization brace integration tests successful.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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) |
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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.