(127 days)
No
The summary describes a stereotaxic image guidance system that uses image registration and optical tracking for surgical navigation. There is no mention of AI or ML in the device description, intended use, or performance studies. The system relies on established image processing and tracking techniques, not AI/ML algorithms for decision-making or analysis.
No
The device is an image guidance system used for navigation and spationing of surgical instruments, not directly for treating conditions.
No
The device is described as an "Image Guidance System" and a "surgical navigation system" used to guide instruments during surgery, not to diagnose medical conditions.
No
The device description explicitly lists "Cart", "Arm", "Head", and "Tracked surgical Envision 3D™ Spinal Instruments" as major components in addition to the software. This indicates the device includes significant hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
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 about a person's health. This information is used for diagnosis, monitoring, or screening.
- Envision 3D™ Function: The Envision 3D™: Image Guidance System is a surgical navigation system. It uses imaging data (preoperative scans and intraoperative scans) to guide the surgeon during a procedure. It helps with the spatial positioning and orientation of surgical instruments relative to the patient's anatomy.
- No Specimen Analysis: The device does not analyze any biological specimens taken from the patient. It works with imaging data and the physical location of instruments.
The description clearly indicates its purpose is to assist surgeons during surgery by providing visual guidance based on imaging, not to diagnose or monitor a condition by analyzing biological samples.
N/A
Intended Use / Indications for Use
The Envision 3D™: Image Guidance System is a stereotaxic image guidance system intended for the spationing 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 Envision 3D™: Image Guidance 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 Envision 3D™ integrated structured light scanner and/or user selected points. The system provides guidance data by displaying the locations of wireless optically tracked Envision 3D™ Spinal Instruments (examples include pedicle probe and awl) relative to the patient. Position and orientation data of tracked Envision 3D™ Spinal Instruments are linked to the preoperative scan data using the Envision 3D™ 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 Envision 3D™: Image Guidance System is comprised of 5 major components:
-
- Cart
-
- Arm
-
- Head
-
- Tracked surgical Envision 3D™ Spinal Instruments
-
- Software
The Cart of the system serves the following purposes:
- Easy movement of system with secure attachment of all moveable components to the cart.
- Space efficient storage of system, when not used.
- Allow stable positioning of the entire system when in use. •
- · Safe enclosure of the computer and electric supplies.
- . Allow user interaction and data-transfer to and from the computer workstation
The Arm of the system serves the following purposes:
- Link the cart and the head allowing easy positioning of the head by the sterile surgeon but is stable otherwise (no motion of the head after positioning)
- ・ Allow positioning of the head outside of the sterile field in all positions
- ・ Provides mechanisms for routing cables between the head and the cart
The Head of the system serves 3 main purposes:
- Capture 3D structured light images of the intraoperative patient anatomy to facilitate registration of patient preoperative data with the local surgical coordinate system to enable surgical navigation
- To passively track the location of Envision 3D™ Spinal Instruments awl, pedicle probe) and a reference frame within the surgical field and provide intraoperative guidance to the surgeon
- To illuminate the surgical field during navigated portions of the surgery. The incorporation of an illumination module into the system is driven by the fact that the use of standard surgical lighting during navigated parts of the procedure prevent the acquisition of structured light images due to saturation of cameras.
The Tracking System enables the surgeon to view the position and orientation of these Envision 3D™ Spinal Instruments relative to registered pre-operative image data while performing the surgical procedure. Each Envision 3D™ Instrument utilizes 4 commercially available passive reflective marker spheres [Manufactured by NORTHERN DIGITAL, INC.; 510(k) K033621] used to determine the position and orientation of each Envision 3D™ Instrument. Each Envision 3D™ Instrument 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
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Structured light images, preoperative scan data
Anatomical Site
Spine, neurological applications where reference to a rigid structure can be identified relative to a preoperative image data of the anatomy.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeons / Not Found (implied surgical setting)
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)
- Study Type: Non-Clinical System, Software, and Instrumentation Verification and Validation; Non-Clinical Performance Surgical Simulations Conducted on Phantom Models; Surgeon Performed Human Cadaveric Workflow Study; Cadaveric Porcine Study Performed on Reference Frame Clamp Stability; Compliance Conformity Assessments. 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. Target Registration Error has been used to evaluate the clinical accuracy of the system on phantom models in a clinical simulated environment.
- Sample Size: Not specified for individual studies.
- AUC: Not Found
- MRMC: Not Found
- Standalone Performance: Not Found
- Key Results:
- System Verification: "Verification successful, all design requirements have been fulfilled"
- System Validation: "Validation successful, all user needs met"
- Usability: "Validation successful with respect to use errors"
- 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"
- All non-clinical tests successfully passed demonstrating that the subject device performs as safely and effectively as the predicate device and supporting substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy, repeatability of accuracy, navigation accuracy (according to ASTM F2554-10), Target Registration Error.
Specific quantitative values for these metrics are not provided in this summary.
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).
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 29, 2016
7D Surgical, Inc. Daniel Ziskind Director. Quality & Regulatory 60 Scarsdale Road, Unit 118 Toronto. Ontario M3B 2R7 Canada
Re: K162375
Trade/Device Name: Envision 3D 104: Image Guidance System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: November 29, 2016 Received: November 30, 2016
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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Caroline Rhim -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K162375
Device Name Envision 3D™: Image Guidance System
Indications for Use (Describe)
The Envision 3D™: Image Guidance System is a stereotaxic image guidance system intended for the spationing 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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3
510(k) Summary of Safety and Effectiveness Envision 3D™: Image Guidance 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: August 23, 2016
-
- 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: | Envision 3D™: Image Guidance System |
These devices are classified as follows:
| Classification Name | 21 CFR Section | Product Code |
|---|---|---|
| Stereotaxic instrument | 21 CFR §882.4560 | OLO |
3. Substantially Equivalent Devices
7D Surgical believes the Envision 3D™: Image Guidance System is substantially equivalent to the following currently marketed devices:
| Product | 510(k) |
|---|---|
| Medtronic StealthStation System | K133444 |
The indications for use of the subject device Envision 3D™: Image Guidance System are equivalent to the predicate device K133444. Furthermore, the technological characteristics of the Envision 3D™: Image Guidance System are substantially equivalent. The differences in the technological characteristics do not raise new
4
Envision 3D™: Image Guidance System
questions of safety and effectiveness. Consequently, the subject is substantially equivalent to the predicate device.
4. Device Description and Technical Comparison to Predicate Devices
The 7D Surgical Envision 3D™: Image Guidance 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 Envision 3D™ integrated structured light scanner and/or user selected points. The system provides guidance data by displaying the locations of wireless optically tracked Envision 3D™ Spinal Instruments (examples include pedicle probe and awl) relative to the patient. Position and orientation data of tracked Envision 3D™ Spinal Instruments are linked to the preoperative scan data using the Envision 3D™ 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 Envision 3D™: Image Guidance System is comprised of 5 major components:
-
- Cart
-
- Arm
-
- Head
-
- Tracked surgical Envision 3D™ Spinal Instruments
-
- Software
The Cart of the system serves the following purposes:
- Easy movement of system with secure attachment of all moveable components to the cart.
- Space efficient storage of system, when not used.
- Allow stable positioning of the entire system when in use. •
- · Safe enclosure of the computer and electric supplies.
- . Allow user interaction and data-transfer to and from the computer workstation
The Arm of the system serves the following purposes:
- Link the cart and the head allowing easy positioning of the head by the sterile surgeon but is stable otherwise (no motion of the head after positioning)
- ・ Allow positioning of the head outside of the sterile field in all positions
- ・ Provides mechanisms for routing cables between the head and the cart
The Head of the system serves 3 main purposes:
5
- Capture 3D structured light images of the intraoperative patient anatomy to facilitate registration of patient preoperative data with the local surgical coordinate system to enable surgical navigation
- To passively track the location of Envision 3D™ Spinal Instruments awl, pedicle probe) and a reference frame within the surgical field and provide intraoperative guidance to the surgeon
- To illuminate the surgical field during navigated portions of the surgery. The incorporation of an illumination module into the system is driven by the fact that the use of standard surgical lighting during navigated parts of the procedure prevent the acquisition of structured light images due to saturation of cameras.
The Tracking System enables the surgeon to view the position and orientation of these Envision 3D™ Spinal Instruments relative to registered pre-operative image data while performing the surgical procedure. Each Envision 3D™ Instrument utilizes 4 commercially available passive reflective marker spheres [Manufactured by NORTHERN DIGITAL, INC.; 510(k) K033621] used to determine the position and orientation of each Envision 3D™ Instrument. Each Envision 3D™ Instrument 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.
5. Indications for Use
The Envision 3D™: Image Guidance 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. Safety Considerations
Electrical safety and EMC testing were conducted on Envision 3D™: Image Guidance System. The device complies with recognized electrical safety standards: IEC 60601-1
6
Envision 3D™: Image Guidance System
standard for electrical safety and IEC 60601-1-2 standard for electromagnetic compatibility.
The biocompatibility evaluation Envision 3D™: Image Guidance System instrumentation has been conducted in accordance with ISO 10993 standards and blue book memorandum #G95-1 entitled "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part-1: Evaluation and Testing", May 1, 1995. The evaluation reveals that biocompatibility requirements are met.
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 Envision 3D™ device:
- Non-Clinical System, Software, and Instrumentation Verification and Validation
- Non-Clinical Performance Surgical Simulations Conducted on Phantom Models .
- Surgeon Performed Human Cadaveric Workflow Study ●
- Cadaveric Porcine Study Performed on Reference Frame Clamp Stability
- . Compliance Conformity Assessments
- IEC 60601-1 Medical electrical equipment. General requirements for basic safety and essential performance, 2005, Amendment 1, 2012
- . IEC 60601-1-2 Medical Electrical Equipment – Part 1-2, General Requirements for Basic Safety and Essential Performance – Collateral Standard Electromagnetic Compatibility, 2007
- . IEC 60601-2-41 Medical electrical equipment - Part 2-41: Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis
- IEC 60601-1-6 Medical Electrical Equipment Part 1-6, General . Requirements for Basic Safety and Essential Performance - Usability
- . IEC 60825-1 Safety of laser products - Part 1: Equipment classification and requirements
- ISO 10993-1 Biological evaluation of medical devices.
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- . ISO 17665-1 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
- . AAMI / ANSI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, (Consolidated Text) Comprehensive Guide To Steam Sterilization And Sterility Assurance In Health Care Facilities. (Sterility)
- 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 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 Envision 3D™: Image Guidance System
| Verification and Validation | Description | Conclusion |
|---|---|---|
| System Verification | Scope of the test is to verify | |
| the design requirement | ||
| specifications of Envision 3D™ | ||
| 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 | ||
| Envision 3D™ System under | ||
| simulated use case situations. | Validation successful, all user | |
| needs met | ||
| Usability | This test is conducted to | |
| validate the Envision 3D™ | ||
| System with respect to use | ||
| errors. | Validation successful with | |
| respect to use errors | ||
| Safety regarding risk analysis | Implementation and | |
| effectiveness of all risk control | ||
| requirements specified in the | ||
| Envision 3D™ risk analysis are | ||
| tested and verified. | Risk Control requirements are | |
| effective and mitigate the | ||
| associated risks to an | ||
| acceptable level. | ||
| Product Safety standards | The Envision 3D™ 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 |
8
| Envision 3D™: Image Guidance System | |||||
|---|---|---|---|---|---|
| ------------------------------------- | -- | -- | -- | -- | -- |
| Verification and Validation | Description | Conclusion |
|---|---|---|
| Non Clinical Accuracy | System's accuracy is tested using the Envision 3D™ 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 |
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 Envision 3D™: Image Guidance System. Clinical validation is unnecessary as the Envision 3D™: Image Guidance System introduces no new indications for use, 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.
10. Conclusion
The Envision 3D™: Image Guidance System is substantially equivalent in safety and effectiveness to the predicate devices identified above:
- . The predicate devices and Envision 3D™ use essentially the same technologies
- The predicate devices and Envision 3D™ 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 Envision 3D™: Image Guidance System. The conclusions drawn from the nonclinical tests demonstrate that the Envision 3D™ 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 Envision 3D™ System is substantially equivalent to the predicate device with respect to its indications for use, technological characteristics and performance characteristics.