K Number
K192140
Device Name
7D Surgical System
Manufacturer
Date Cleared
2019-11-05

(89 days)

Product Code
Regulation Number
882.4560
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
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 Universal Tracking Clamp, 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. Similar to the previously cleared 7D Surgical System and Brainlab, the system tracks the position and orientation of a Universal Tracking Clamp. 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 Universal Tracking Clamp, 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. lt 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. The 7D Surgical Universal Tracking Clamp consists of two different size tracking arrays which hold the reflective marker spheres both with a unique marker arrangement to distinguish one from the other. The tracker arrays attach to two different clamps of different sizes which attach to 30 party spinal surgical instruments. The Universal Tracking Clamp when attached to 30 party spinal instruments requires calibration in order to accurately display the position and orientation of the tool in the 7D Surgical System software.
More Information

No
The summary describes a stereotaxic image guidance system using structured light scanning, optical tracking with passive markers, and software for registration and navigation. There is no mention of AI or ML algorithms being used for image processing, registration, tracking, or any other function. The performance studies focus on traditional accuracy metrics like TRE and ATE, not metrics typically associated with AI/ML performance.

No

The device is an image guidance and navigation system that assists surgeons in spatially positioning instruments during surgery; it does not directly treat or cure a disease or condition.

No

Explanation: The device is described as a surgical navigation system that assists surgeons with spatial positioning and orientation of instruments. It provides guidance data and tracks instrument positions relative to the patient and preoperative scan data for surgical procedures. It does not diagnose diseases or conditions.

No

The device description explicitly mentions hardware components like a structured light scanner, wireless optically tracked Spinal Instruments, passive reflective marker spheres, and a Universal Tracking Clamp, in addition to the software. The performance studies also include verification and validation of instrumentation.

Based on the provided information, the 7D Surgical System is not an In Vitro Diagnostic (IVD) device.

Here's why:

  • IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
  • 7D Surgical System's Intended Use: The intended use of the 7D Surgical System is for the spatial positioning and orientation of neurosurgical instruments during surgery. It's a surgical navigation system that uses imaging data to guide the surgeon's tools in real-time.
  • No Specimen Examination: The device does not involve the collection, preparation, or examination of any specimens from the human body. It works with pre-operative and intra-operative imaging data and tracks the position of surgical instruments relative to the patient's anatomy.

Therefore, the 7D Surgical System falls under the category of a surgical navigation system, not an In Vitro Diagnostic device.

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 (comma separated list FDA assigned to the subject device)

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 Universal Tracking Clamp, 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. Similar to the previously cleared 7D Surgical System and Brainlab, the system tracks the position and orientation of a Universal Tracking Clamp.

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 Universal Tracking Clamp, 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.

The 7D Surgical Universal Tracking Clamp consists of two different size tracking arrays which hold the reflective marker spheres both with a unique marker arrangement to distinguish one from the other. The tracker arrays attach to two different clamps of different sizes which attach to 30 party spinal surgical instruments. The Universal Tracking Clamp when attached to 30 party spinal instruments requires calibration in order to accurately display the position and orientation of the tool in the 7D Surgical System software.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

preoperative scan data, structured light scanner

Anatomical Site

neurological applications where reference to a rigid structure can be identified

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

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) and Angular Trajectory Error (ATE) has been used to evaluate the clinical accuracy of the system on phantom models in a clinical simulated environment. TRE and ATE evaluates the error discrepancy between the position reported by the image guided surgery system and the ground truth position measured physically or otherwise.
System Verification: Verification successful, all design requirements have been fulfilled.
System Validation: Validation successful, all user needs met.
Safety regarding risk analysis: Risk Control requirements are effective and mitigate the associated risks to an acceptable level.
Product Safety standards: Compliance with recognized standards have been verified.
Non-Clinical Accuracy: All accuracy specifications have been met for the Universal Tracking Clamp. Accuracy testing for the currently cleared Reference Frame, Awl and Pedicle Probe have been verified.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K180352

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K082060

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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).

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November 5, 2019

7D Surgical Inc. Daniel Ziskind Director, Quality & Regulatory 60 Scarsdale Road, Unit 118 Toronto, M3B 2R7 Canada

Re: K192140

Trade/Device Name: 7D Surgical System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: August 7, 2019 Received: August 8, 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.

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

1

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 (OS) 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 mediation-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, 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) K192140

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 05, 2019

    1. 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 Name21 CFR SectionProduct Code
Stereotaxic instrument21 CFR §882.4560OLO

3. Substantially Equivalent Devices

7D Surgical believes the 7D Surgical System and Universal Tracking Clamp is substantially equivalent to the following currently marketed devices:

Product510(k)
7D Surgical SystemK180352
BrainLAB Vectorvision (Starlink)K082060

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

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Surgical System are substantially equivalent. The differences in the technological characteristics do not raise new questions of safety and effectiveness. Consequently, the subject is substantially equivalent to the predicate device. It is important to note the 7D Surgical System K180352 is considered the Primary Predicate Device for this application.

It is important to note that the BrainLAB Vectorvision K082060, which consists of a Starlink Adapter Clamp, is a Reference Device to the 7D Surgical Universal Tracking Clamp as they are comparable in intended use, functional and dimensional characteristics, and overall performance.

4. Purpose of Submission

The proposed change for the 7D Surgical System is to introduce the 7D Surgical Universal Tracking Clamp. The Universal Tracking Clamp, which consists of a tracking array, is designed to clamp onto the shaft of a non-tracked spinal surgical instrument. After the system performs a calibration of the Universal Tracking Clamp when attached to a spinal surgical instrument, the system can display the position and orientation of the instrument, enabling real-time image guided navigation.

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 Universal Tracking Clamp, 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. Similar to the previously cleared 7D Surgical System and Brainlab, the system tracks the position and orientation of a Universal Tracking Clamp.

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.

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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 Universal Tracking Clamp, 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. lt 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.

The 7D Surgical Universal Tracking Clamp consists of two different size tracking arrays which hold the reflective marker spheres both with a unique marker arrangement to distinguish one from the other. The tracker arrays attach to two different clamps of different sizes which attach to 30 party spinal surgical instruments. The Universal Tracking Clamp when attached to 30 party spinal instruments requires calibration in order to accurately display the position and orientation of the tool in the 7D Surgical System software.

7. 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.

8. 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) and Angular Trajectory Error (ATE) has been used to evaluate the clinical accuracy of the system on phantom models in a clinical simulated

6

environment. TRE and ATE 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:

Verification and ValidationDescriptionConclusion
System VerificationScope 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 ValidationScope 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 analysisImplementation 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 standardsThe 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.
Non-Clinical AccuracySystem'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
Universal Tracking Clamp.
Accuracy testing for the
currently cleared Reference
Frame, Awl and Pedicle Probe
have been verified.

All non-clinical tests successfully passed demonstrating that the subject device performs as safely and effectively as the predicate device and supporting substantial equivalence.

9. 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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10. 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 Universal Tracking Clamp. 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.