(30 days)
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.
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 guide 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 configuration).
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.
The provided text does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. Instead, it is a 510(k) summary for the Brainlab Cirq Arm System (2.0), focusing on demonstrating substantial equivalence to a predicate device.
The document discusses:
- Device Description and Indications for Use: What the device is and what it's intended for (spinal screw placement procedures).
- Substantial Equivalence Comparison: A table comparing the subject device (Cirq Arm System 2.0) with its predicate device (Cirq Robotic Alignment Module - Spine, K202320) in terms of hardware, software, weight, dimensions, maximum payload, and brake/joint design. The intent of this comparison is to show that the new device has similar functionality, intended use, and technological characteristics.
- Performance Data (Verification): This section details the types of verification performed (software and hardware verification), but does not provide acceptance criteria or specific results in terms of device performance against those criteria. It mentions:
- Software Verification: Performed through integration tests and unit tests. It also states that incremental test strategies were used for changes with limited scope, and that software verification covers all specifications, including SOUP items and cybersecurity.
- Hardware Verification: Verified mechanical and electronic requirements, compliance to standards, and biological safety.
- Mechanical verification: Conducted through CAD review, calculations, document review, and bench testing for holding force/payload, stiffness, mechanical safety factor, and lifecycle testing.
- Electrical verification: Included documentation and schematics review, and physical testing.
- Biological safety: Verified according to ISO 10993-1:2018.
Therefore, I cannot extract the requested information (acceptance criteria, reported device performance, sample size, data provenance, expert details, adjudication, MRMC study, standalone performance, ground truth type, training set size, or training set ground truth establishment) because it is not present in the provided text.
The document states that the performance testing conducted supports the conclusion that the device is substantially equivalent to the predicate, but it does not detail the specific performance metrics or the study results themselves.
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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.
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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
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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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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 SureshQM ConsultantRegulatory AffairsPhone: +49 89 99 15 68 0Email: regulatory.affairs@brainlab.com |
| Alternate Contact | Chiara CunicoSenior Manager Regulatory AffairsPhone: +49 89 99 15 68 0Email: 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
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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 |
|---|---|---|---|
| Componentoverview | Hardware:• Surgical Base System 1.4(Art. No. 56000A)• Cirq Robotic AlignmentModule (Art. No. 56100)• Cirq Robotic DisposableKinematic Unit (Art. No.56102)• Cirq Robotic andAlignment Instruments(various)Software:Cirq Robotic AlignmentSoftware 1.0 | Hardware:• Cirq Arm System 2.0 (Art.No. 56500)• Cirq Robotic AlignmentModule (Art. No. 56100)• Cirq Robotic DisposableKinematic Unit (Art. No.56102)• Cirq Robotic andAlignment Instruments(various)• Cirq Instrument HolderModule (Art. No. 56200A)• Cirq Instrument HolderSpinal Drilling (Art. No.56202)• Accessory Package SpineDrilling for Cirq Passive(various)Software:• Alignment Software Spine2.0 | The main changes relative tothe predicate is iteration of thealignment software (CirqRobotic Alignment Software 1.0to Alignment Software Spine2.0, cleared in K221618), theiteration of the arm hardware(Surgical Base System 1.4 toCirq Arm System 2.0), and theinclusion of additionalhardware. The operatingprinciple is maintained relativeto the predicate, including withthe additional hardware. |
| Arm weight | Total weight of the arm is11.5 kg. | Total weight of the arm is 16kg. | Increased weight compared topredicate device. |
| Armdimensions | The overall length of the armin its extended position isapproximately 1200 mm. | The overall length of the armin its extended position isapproximately 1272 mm. | The reach of the arm has beenincreased. |
| Maximumpayload | The defined maximumpayload of the device is 1.9kg. The holding force issupported by a technicalfunction called Brake Boost. | The defined maximumpayload of the device is 3.0kg. This is based on the geardriven joints in joints 1-4,replacing the Brake Boostfunction. | Increasing the maximumpayload presents no substantialdifferences regarding basicfunctionality in comparison topredicate device. |
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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 andjoint design | The device featurespermanent magnetic brakesin each of the 7 axes, whichensure the holding force ofthe positioning arm in theclosed state, and enablespatial positioning duringsurgical procedure. A certainstiffness is provided. | The device featurespermanent magnetic brakesin axes 5-7 and spring-applied brakes in axes 1-4.Additionally, axes 1-4 consistof harmonic drive gears. Dueto the transmission of thegears, the system is stifferthan the previous version ofthe 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.
§ 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).