(257 days)
No
The description focuses on image registration, optical tracking, and navigation based on pre-operative scans and intra-operative data, without mentioning AI or ML algorithms for analysis or decision support.
No
The device is an image guidance system and navigation system used by surgeons to assist with surgical procedures, rather than directly treating a disease or condition.
No
The 7D Surgical System is an image-guided navigation system that assists surgeons in spatially positioning and orienting neurosurgical instruments during spine surgery. It tracks instruments relative to preoperative scan data and provides guidance, rather than diagnosing a condition.
No
The device description explicitly mentions hardware components such as a structured light scanner, wireless optically tracked Spinal Instruments (including the 7D Surgical Pedicle Probe and Awl, and IZI Pedicle Access Kit), passive reflective marker spheres, and a workstation. While software is a key component, it links these hardware elements and displays navigational data, indicating it is part of a larger hardware system.
Based on the provided information, the 7D Surgical System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- 7D Surgical System Function: The 7D Surgical System is a surgical navigation system. It uses imaging data (preoperative scans and intraoperative structured light) to guide the surgeon's instruments during surgery. It does not analyze biological specimens.
- Intended Use: The intended use clearly states its purpose is for "spatial positioning and orientation of neurosurgical instruments used by surgeons" and as a "primary surgical luminaire." This is a surgical guidance function, not an in vitro diagnostic function.
Therefore, the 7D Surgical System falls under the category of a surgical navigation or image-guided surgery system, not an IVD.
N/A
Intended Use / Indications for Use
The 7D Surgical System is a stereotaxic image guidance system intended for the spatial positioning and orientation of neurosurgical instruments used by surgeons. The system is also intended to be used as the primary surgical luminaire during image guided surgery. The device is indicated for posterior approach spine surgery where reference to a rigid anatomical structure can be identified.
Product codes
OLO
Device Description
The 7D Surgical System is intended for use as a stereotaxic image guided surgical navigation system during spine surgery. The system provides image registration between preoperative scan data and data captured intraoperatively from the 7D Surgical System structured light scanner and/or user selected points. The system provides guidance data by tracking and displaying the position and orientation of wireless optically tracked Spinal Instruments including the 7D Surgical Pedicle Probe and Awl, now including the IZI Pedicle Access Kit, relative to the patient. Position and orientation data of tracked Spinal Instruments are linked to the preoperative scan data using the 7D Surgical System workstation. The system is intended to be used as the primary surgical luminaire for image guided surgery.
The system is intended to be used for both image fusion and navigation for neurological applications where reference to a rigid structure can be identified relative to a preoperative image data of the anatomy.
The Tracking System enables the surgeon to view the position and orientation of 7D Surgical System Spinal Instruments relative to registered preoperative image data while performing the surgical procedure. Each of the 7D Surgical System instruments, including the IZI Pedicle Access Kit, utilizes commercially available passive reflective marker spheres to determine the position and orientation of instruments. Each tracked Instruments requires a unique marker position configuration to enable the tracking system to distinguish the tools from one to the other.
The Software links all system components and displays navigational data to the surgeon. It provides methods for loading preoperative scans and guides the surgeon through the process of surface model creation, structured light acquisition, registration, registration verification, and navigation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
structured light scanner
Anatomical Site
spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeons
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
Non-Clinical System, Software, and Instrumentation Verification and Validation
Non-Clinical Performance Surgical Simulations Conducted on Phantom Models
Compliance Conformity Assessments
ASTM F2554-10 Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems
Device performance tests were performed to verify the absolute accuracy and repeatability of the accuracy of the device, and the navigation accuracy according to ASTM F2554-10. In addition, Target Registration Error (TRE) has been used to evaluate the clinical accuracy of the system on phantom models in a clinical simulated environment. TRE evaluates the error discrepancy between the position reported by the image guided surgery system and the ground truth position measured physically or otherwise.
All accuracy specifications have been met for the IZI Pedicle Access Kit. Accuracy testing for the currently cleared Reference Frame, Awl and Pedicle Probe have been verified in previous application K180352.
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
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August 7, 2019
7D Surgical Inc. Daniel Ziskind Director, Quality & Regulatory 60 Scarsdale Road, Unit 118 Toronto, M3B 2R7 CA
Re: K183276
Trade/Device Name: 7D Surgical System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: June 24, 2019 Received: June 25, 2019
Dear Daniel Ziskind:
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 531-542 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
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Indications for Use
510(k) Number (if known) K183276
Device Name 7D Surgical System
Indications for Use (Describe)
The 7D Surgical System is a stereotaxic image guidance system intended for the spatial positioning and orientation of neurosurgical instruments used by surgeons. The system is also intended to be used as the primary surgical luminaire during image guided surgery. The device is indicated for posterior approach spine surgery where reference to a rigid anatomical structure can be identified.
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 of Safety and Effectiveness 7D Surgical System
This summary of safety and effectiveness information is submitted in accordance with 21CFR §807.92.
1. Submitter's name, address, telephone number, contact person.
7D Surgical, Inc. 60 Scarsdale Road, Unit 118 Toronto, ON, M3B 2R7, Canada
Contact person: Daniel Ziskind Quality and Regulatory, Director 7D Surgical, Inc. 60 Scarsdale Road, Unit 118 Toronto, ON, M3B 2R7, Canada Phone: (647) 484-0079 Fax: (647) 749-0400 (wait until you hear a message, then press 7) Email: daniel.ziskind@7dsurgical.com
Date prepared: November 15, 2018
-
- Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known:
| Common/usual name: | Computer-assisted surgical device |
|---|---|
| Proprietary name: | 7D Surgical System |
These devices are classified as follows:
| Classification Name | 21 CFR Section | Product Code |
|---|---|---|
| Stereotaxic instrument | 21 CFR §882.4560 | OLO; HAW |
3. Substantially Equivalent Devices
7D Surgical believes the 7D Surgical System is substantially equivalent to the following currently marketed devices:
| Product | 510(k) |
|---|---|
| 7D Surgical System | K180352 |
The indications for use of the subject device 7D Surgical System are equivalent to the predicate device K180352. Furthermore, the technological characteristics of the 7D Surgical System are substantially equivalent. The differences in the technological
4
characteristics do not raise new questions of safety and effectiveness. Consequently, the subject is substantially equivalent to the predicate device.
4. Purpose of Submission
The proposed software change for the 7D Surgical System is intended to enable compatibility with the IZI Medical Products LLC Navigated Pedicle Access Kit.
It is important to note that the Medtronic StealthStation System (K133444) and the Medtronic HORIZON Spinal System (K153442) are considered reference devices for the proposed submission.
5. Indications for Use
The 7D Surgical System is a stereotaxic image guidance system intended for the spatial positioning and orientation of neurosurgical instruments used by surgeons. The system is also intended to be used as the primary surgical luminaire during image guided surgery. The device is indicated for posterior approach spine surgery where reference to a rigid anatomical structure can be identified.
6. Device Description and Technical Comparison to Predicate Devices
The 7D Surgical System is intended for use as a stereotaxic image guided surgical navigation system during spine surgery. The system provides image registration between preoperative scan data and data captured intraoperatively from the 7D Surgical System structured light scanner and/or user selected points. The system provides guidance data by tracking and displaying the position and orientation of wireless optically tracked Spinal Instruments including the 7D Surgical Pedicle Probe and Awl, now including the IZI Pedicle Access Kit, relative to the patient. Position and orientation data of tracked Spinal Instruments are linked to the preoperative scan data using the 7D Surgical System workstation. The system is intended to be used as the primary surgical luminaire for image guided surgery.
The system is intended to be used for both image fusion and navigation for neurological applications where reference to a rigid structure can be identified relative to a preoperative image data of the anatomy.
The Tracking System enables the surgeon to view the position and orientation of 7D Surgical System Spinal Instruments relative to registered preoperative image data while performing the surgical procedure. Each of the 7D Surgical System instruments, including the IZI Pedicle Access Kit, utilizes commercially available passive reflective marker spheres to determine the position and orientation of instruments. Each tracked Instruments requires a unique marker position configuration to enable the tracking system to distinguish the tools from one to the other.
5
The Software links all system components and displays navigational data to the surgeon. It provides methods for loading preoperative scans and guides the surgeon through the process of surface model creation, structured light acquisition, registration, registration verification, and navigation.
7. Safety Considerations
This change to add compatibility to the 7D System to include navigational tracking of the IZI Pedicle Access Kit did not impact conformity to regulatory compliance standards as only the system software has been modified to support this new feature. Software and User Instructions risk control measures have been implemented to ensure all new risks associated with use of the IZI Pedicle Access Kit have been adequately controlled.
8. Technological Characteristics
The literature research and the comparison to the predicate devices show that the device makes use of equivalent technological characteristics and functionality and is intended for equivalent surgical procedures as compared to the predicate devices.
9. Nonclinical Performance Data
Verification and Validation activities have been conducted to provide assurance that the device meets the performance requirements under the indications for use conditions.
7D Surgical performed the following testing to ensure the safety and effectiveness of the 7D Surgical System device:
- Non-Clinical System, Software, and Instrumentation Verification and Validation
- Non-Clinical Performance Surgical Simulations Conducted on Phantom Models
- Compliance Conformity Assessments
- . ASTM F2554-10 Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems
Device performance tests were performed to verify the absolute accuracy and repeatability of the accuracy of the device, and the navigation accuracy according to ASTM F2554-10. In addition, Target Registration Error (TRE) has been used to evaluate the clinical accuracy of the system on phantom models in a clinical simulated environment. TRE evaluates the error discrepancy between the position reported by the image guided surgery system and the ground truth position measured physically or otherwise.
The following table contains a summary of verification and validation performed on the 7D Surgical System:
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| System Verification | Scope of the test is to verify
the design requirement
specifications of 7D Surgical
System under test case
protocols. | Verification successful, all
design requirements have
been fulfilled. |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| System Validation | Scope of the test is to
validate the Indications For
Use and Customer
Requirements of the 7D
Surgical System under
simulated use case situations. | Validation successful, all user
needs met. |
| Safety regarding risk analysis | Implementation and
effectiveness of all risk
control requirements
specified in the 7D Surgical
System risk analysis are
tested and verified. | Risk Control requirements
are effective and mitigate the
associated risks to an
acceptable level. |
| Product Safety standards | The 7D Surgical System and
Instrumentation was tested
to the following recognized
standards:
IEC 60601-1, IEC 60601-1-2,
IEC 60601-1-6, IEC 60601-2-
41, IEC 60825-1, ISO 10993-1,
and ISO 17665-1. | Compliance with recognized
standards have been verified
in the previous application
K142344. Previous test results
have not been affected by
this change. Please see
application K162375 for
testing results related to the
7D Surgical System. |
| Non-Clinical Accuracy | System's accuracy is tested
using the 7D Surgical System
on phantom models
following the ASTM F2554-10
Standard Practice for
Measurement of Positional
Accuracy of Computer
Assisted Surgical Systems in
addition to Target
Registration Error. | All accuracy specifications
have been met for the IZI
Pedicle Access Kit. Accuracy
testing for the currently
cleared Reference Frame,
Awl and Pedicle Probe have
been verified in previous
application K180352. |
All non-clinical tests successfully passed demonstrating that the subject device performs as safely and effectively as the predicate device and supporting substantial equivalence.
10. Clinical Data
A clinical trial was not required to demonstrate safety and effectiveness of the 7D Surgical System. Clinical validation is unnecessary as the 7D Surgical System introduces no new indications for use, and device features are equivalent to the previously cleared predicate device identified. The clinical safety and effectiveness of Image Guided Surgery Systems are historically accepted for both the predicate and subject device.
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11. Conclusion
The 7D Surgical System is substantially equivalent in safety and effectiveness to the predicate devices identified above:
- The predicate devices and 7D Surgical System use equivalent ● technologies.
- The predicate devices and 7D Surgical System are designed and manufactured to the similar electrical and physical safety standards.
The non-clinical verification and validation performed support the safety and effectiveness of the 7D Surgical System compatibility with the IZI Pedicle Access Kit. The conclusions drawn from the non-clinical tests demonstrate that the 7D Surgical System performs as safely and effectively as the legally marketed device according to the comparison based on the requirements of 21 CFR §882.4560 and the information provided herein. It is concluded that the 7D Surgical System is substantially equivalent to the predicate device with respect to its indications for use, technological characteristics, and performance characteristics.
514 Performance Standards
There are no Sec. 514 performance standards for this device.