(30 days)
No
The summary describes a passive, mechatronic arm system for holding and positioning surgical instruments. There is no mention of AI, ML, image processing, or any data training/testing, which are typical indicators of AI/ML technology in medical devices. The software mentioned appears to be for basic control and guidance, not advanced analytical or learning functions.
No.
The device is described as a holding and positioning system for surgical instruments and an accessory to a navigation system used for spinal screw placement. It does not exert therapeutic action itself.
No.
Explanation: The device is described as a holding and positioning system for surgical instruments during spinal screw placement procedures, supporting the surgeon to achieve a pre-defined screw trajectory. Its function is to assist in surgical procedures, not to diagnose conditions.
No
The device description explicitly states it is a "passive, semi-rigid mechatronic arm system with structural components, several modules, instrument holding and clamping mechanisms and software". It also details hardware verification and electrical components, indicating it is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "support the surgeon to achieve a pre-defined screw with surgical instruments during the surgical procedure" for spinal screw placement. This is a surgical assistance device used during a surgical procedure on a patient.
- Device Description: The device is described as a "holding and positioning system" for surgical instruments, attached to an operating table. It is a mechanical device used in the operating room.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (such as blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not perform any such tests on biological samples.
The device is clearly intended for use in vivo (within the living body) as a surgical tool, not in vitro (in glass or outside the living body) for diagnostic testing.
N/A
Intended Use / Indications for Use
As an accessory to the Spine & Trauma Navigation, the Alignment System Spine is intended to surgeon to achieve a pre-defined screw with surgical instruments during the surgical procedure. It is used for spinal screw placement procedures.
Product codes
OLO
Device Description
The Cirq Arm System serves as a holding and positioning system to support the surgeon in reaching a pre-defined screw trajectory with surgical instruments. It consists of a passive, semi-rigid mechatronic arm system with structural components, several modules, instrument holding and clamping mechanisms and software to quide the user.
The Cirq Arm System 2.0 is a passive mechatronic device for holding and positioning surgical instruments; it is evolved from its predecessor, the Surgical Base System 1.4 (K202320).
The Cirq Arm System 2.0 is attached to the side rail of an operating table and is intended to be used in a hospital environment, specifically in rooms which are appropriate for surgical interventions (e.g. operating rooms). The base provides external power and communication with the IGS platforms and Alignment Software Spine (if applicable, ie. if used within the active confiquration).
The Cirq Arm System 2.0 can be manually positioned by releasing the brakes in the joints, using the integrated buttons. The brakes in the joints open when powered (a voltage is supplied), and close without current. Therefore, the brakes close in case of a power failure. The brake state is visualized to the user by LED rings showing different colors for the two different brake states (open/closed) separately for each joint. The electronics and firmware are designed to be ready to operate meaning that the arm can be booted and used quickly after connecting it to the power supply.
The sterility of the device during the surgical intervention is ensured with a sterile drape, which is compatible to the Cirq Arm System 2.0 and the attached application module. The specific workflow and operating principles differ based on the attached module.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, Hospital Environment, Operating Rooms
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
Software verification was performed, verifying the software requirements through integration tests, and unit tests. Incremental test strategies have been set up after verification of the first release candidate for changes with limited scope. In this case, an impact analysis of the modifications is performed and tests to be performed are identified and planned correspondingly. That means, not all tests have to be performed but only a subset, as some of the previous tests are not affected by the change and remain therefore valid.
Software verification verifies all specifications, including SOUP items and cybersecurity.
Hardware verification was performed, verifying the mechanical and electronic requirements, compliance to standards, and verifying the biological safety of materials and surfaces which may come in contact with the user.
Mechanical verification verifies specifications related to the mechanical subsystem, through review of CAD parts and assemblies, calculations, document review, bench testing related to holding force/payload, stiffness, mechanical safety factor, and lifecycle testing.
Electrical verification verifications related to the electrical subsystem, review of documentation and schematics, and physical testing.
Biological safety was verified according to ISO 10993-1:2018. Additional verifications have been conducted for risk-relevant specifications, user manual entries, and production steps.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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
October 27, 2022
Image /page/0/Picture/1 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Brainlab AG Sadwini Suresh QM Consultant Regulatory Affairs Olof-Palme-Str. 9 Munich, Bavaria 81829 Germany
Re: K222966
Trade/Device Name: Cirq Arm System (2.0); Alignment System Spine Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: September 27, 2022 Received: September 27, 2022
Dear Sadwini Suresh:
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-
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-reporting-
mdr-how-report-medical-device-problems.
542 of the Act); 21 CFR 1000-1050.
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.
For: Shumaya Ali, M.P.H. 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) K222966
Device Name
CIRQ Arm System (2.0); Alignment System Spine
Indications for Use (Describe)
As an accessory to the Spine & Trauma Navigation, the Alignment System Spine is intended to surgeon to achieve a pre-defined screw with surgical instruments during the surgical procedure. It is used for spinal screw placement procedures.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/0 description: The image shows the Brainlab logo. The logo consists of a stylized brain icon on the left and the word "BRAINLAB" in capital letters on the right. The color of the logo is pink.
510(k) Summary
September 27, 2022
| General Information | |
|---|---|
| Manufacturer | Brainlab AG; Olof-Palme Str.9; 81829, Munich, Germany |
| Establishment Registration | 8043933 |
| Trade Names | Cirq Arm System (2.0) Alignment System Spine |
| Classification Name | Orthopedic Stereotaxic Instrument |
| Product Code | OLO |
| Regulation Number | 882.4560 |
| Regulatory Class | II |
| Panel | Orthopedic |
| Predicate Device | Cirq Robotic Alignment Module - Spine (K202320) |
| Contact Information | |
| Primary Contact | Sadwini Suresh |
| QM Consultant | |
| Regulatory Affairs | |
| Phone: +49 89 99 15 68 0 | |
| Email: regulatory.affairs@brainlab.com | |
| Alternate Contact | Chiara Cunico |
| Senior Manager Regulatory Affairs | |
| Phone: +49 89 99 15 68 0 | |
| Email: chiara.cunico@brainlab.com |
1. Indication for Use
As an accessory to the Spine & Trauma Navigation, the Alignment System Spine is intended to support the surgeon to achieve a pre-defined screw with surgical instruments during the surgical procedure. It is used for spinal screw placement procedures.
2. Device Description
The Cirq Arm System serves as a holding and positioning system to support the surgeon in reaching a pre-defined screw trajectory with surgical instruments. It consists of a passive, semi-rigid mechatronic arm system with structural components, several modules, instrument holding and clamping mechanisms and software to quide the user.
The Cirq Arm System 2.0 is a passive mechatronic device for holding and positioning surgical instruments; it is evolved from its predecessor, the Surgical Base System 1.4 (K202320).
The Cirq Arm System 2.0 is attached to the side rail of an operating table and is intended to be used in a hospital environment, specifically in rooms which are appropriate for surgical interventions (e.g. operating rooms). The base provides external power and communication with the IGS platforms and Alignment Software Spine (if applicable, ie. if used within the active confiquration).
The Cirq Arm System 2.0 can be manually positioned by releasing the brakes in the joints, using the integrated buttons. The brakes in the joints open when powered (a voltage is
4
Image /page/4/Picture/0 description: The image shows the Brainlab logo. The logo consists of a stylized brain icon on the left and the word "BRAINLAB" in capital letters on the right. The color of the logo is pink.
supplied), and close without current. Therefore, the brakes close in case of a power failure. The brake state is visualized to the user by LED rings showing different colors for the two different brake states (open/closed) separately for each joint. The electronics and firmware are designed to be ready to operate meaning that the arm can be booted and used quickly after connecting it to the power supply.
The sterility of the device during the surgical intervention is ensured with a sterile drape, which is compatible to the Cirq Arm System 2.0 and the attached application module. The specific workflow and operating principles differ based on the attached module.
3. Substantial Equivalence
| Topic/
| Feature | Predicate Device (K202320) | Subject Device | Comments |
|---|---|---|---|
| Component | |||
| overview | Hardware: | ||
| • Surgical Base System 1.4 | |||
| (Art. No. 56000A) | |||
| • Cirq Robotic Alignment | |||
| Module (Art. No. 56100) | |||
| • Cirq Robotic Disposable | |||
| Kinematic Unit (Art. No. |
• Cirq Robotic and
Alignment Instruments
(various)
Software:
Cirq Robotic Alignment
Software 1.0 | Hardware:
• Cirq Arm System 2.0 (Art.
No. 56500)
• Cirq Robotic Alignment
Module (Art. No. 56100)
• Cirq Robotic Disposable
Kinematic Unit (Art. No.
56102)
• Cirq Robotic and
Alignment Instruments
(various)
• Cirq Instrument Holder
Module (Art. No. 56200A)
• Cirq Instrument Holder
Spinal Drilling (Art. No.
56202)
• Accessory Package Spine
Drilling for Cirq Passive
(various)
Software:
• Alignment Software Spine
2.0 | The main changes relative to
the predicate is iteration of the
alignment software (Cirq
Robotic Alignment Software 1.0
to Alignment Software Spine
2.0, cleared in K221618), the
iteration of the arm hardware
(Surgical Base System 1.4 to
Cirq Arm System 2.0), and the
inclusion of additional
hardware. The operating
principle is maintained relative
to the predicate, including with
the additional hardware. |
| Arm weight | Total weight of the arm is
11.5 kg. | Total weight of the arm is 16
kg. | Increased weight compared to
predicate device. |
| Arm
dimensions | The overall length of the arm
in its extended position is
approximately 1200 mm. | The overall length of the arm
in its extended position is
approximately 1272 mm. | The reach of the arm has been
increased. |
| Maximum
payload | The defined maximum
payload of the device is 1.9
kg. The holding force is
supported by a technical
function called Brake Boost. | The defined maximum
payload of the device is 3.0
kg. This is based on the gear
driven joints in joints 1-4,
replacing the Brake Boost
function. | Increasing the maximum
payload presents no substantial
differences regarding basic
functionality in comparison to
predicate device. |
5
Image /page/5/Picture/0 description: The image shows the Brainlab logo. The logo consists of a stylized pink brain icon on the left and the word "BRAINLAB" in pink capital letters on the right. The brain icon is abstract and appears to be made up of interconnected shapes.
| Topic/
| Feature | Predicate Device (K202320) | Subject Device | Comments |
|---|---|---|---|
| Brake and | |||
| joint design | The device features | ||
| permanent magnetic brakes | |||
| in each of the 7 axes, which | |||
| ensure the holding force of | |||
| the positioning arm in the | |||
| closed state, and enable | |||
| spatial positioning during | |||
| surgical procedure. A certain | |||
| stiffness is provided. | The device features | ||
| permanent magnetic brakes | |||
| in axes 5-7 and spring- | |||
| applied brakes in axes 1-4. | |||
| Additionally, axes 1-4 consist | |||
| of harmonic drive gears. Due | |||
| to the transmission of the | |||
| gears, the system is stiffer | |||
| than the previous version of | |||
| the device. | Improvement in stability. |
4. Performance Data
Software Verification:
Software verification was performed, verifying the software requirements through integration tests, and unit tests. Incremental test strategies have been set up after verification of the first release candidate for changes with limited scope. In this case, an impact analysis of the modifications is performed and tests to be performed are identified and planned correspondingly. That means, not all tests have to be performed but only a subset, as some of the previous tests are not affected by the change and remain therefore valid.
Software verification verifies all specifications, including SOUP items and cybersecurity.
Hardware Verification:
Hardware verification was performed, verifying the mechanical and electronic requirements, compliance to standards, and verifying the biological safety of materials and surfaces which may come in contact with the user.
Mechanical verification verifies specifications related to the mechanical subsystem, through review of CAD parts and assemblies, calculations, document review, bench testing related to holding force/payload, stiffness, mechanical safety factor, and lifecycle testing.
Electrical verification verifications related to the electrical subsystem, review of documentation and schematics, and physical testing.
Biological safety was verified according to ISO 10993-1:2018. Additional verifications have been conducted for risk-relevant specifications, user manual entries, and production steps.
5. Conclusion
The comparison of the Subject Device with the predicate device shows that the Cirq Arm System 2.0 has similar functionality, intended use and technological characteristics as the predicate device. Based on the comparison to the predicate and the performance testing conducted, the Subject Device is considered substantially equivalent to the predicate device.