FLASH EVD System (10-0002)

K242480 · 7D Surgical ULC · HAW · Dec 27, 2024 · Neurology

Device Facts

• Record ID: K242480
• Device Name: FLASH EVD System (10-0002)
• Applicant: 7D Surgical ULC
• Product Code: HAW · Neurology
• Decision Date: Dec 27, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

FLASH EVD is a stereotactic image guidance system intended for the spatial positioning and orientation of neurosurgical instruments. The device is only indicated for cranial surgery where reference to a rigid anatomical structure can be identified, does not require rigid fixation of the patient, and does not require fixation of a navigated instrument guide to the patient.

Device Story

FLASH EVD is a stereotactic image-guided surgical navigation system used in OR, ICU, or ER settings by surgeons. It utilizes pre-operative 3D tomographic image data and intraoperative input from an integrated structured light scanner to perform patient registration. The system tracks navigation tools in real-time, linking their position and orientation to the preoperative image data via system software. The surgeon views the real-time display of tracked instruments relative to the patient's anatomy to guide the placement of EVD catheters. This provides continuous position feedback, replacing free-hand techniques, and assists in relieving elevated intracranial pressure caused by CSF flow disruption. The system benefits patients by improving the precision of catheter placement.

Clinical Evidence

No clinical data was required. Safety and effectiveness were demonstrated through non-clinical bench testing, including system verification and validation, surgical simulations on phantom models, and compliance with recognized standards (ISO 10993-1, ISO 11137, IEC 60601-1, ASTM F2554-10). Accuracy was verified using Target Registration Error (TRE) and Trajectory Angular Error (TAE) on phantom models.

Technological Characteristics

Stereotactic image guidance system; utilizes integrated structured light scanner for intraoperative data; real-time tracking of navigation tools. Materials assessed per ISO 10993-1. Single-use, pre-sterilized instrumentation (radiation sterilized per ISO 11137). Complies with IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), and ASTM F2554-10 (positional accuracy). Software developed per IEC 62304.

Indications for Use

Indicated for cranial surgery requiring spatial positioning and orientation of neurosurgical instruments, specifically for external ventricular drain (EVD) catheter placement. Applicable where rigid anatomical reference structures are identifiable; does not require patient fixation or navigated instrument guide fixation.

Regulatory Classification

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.

Predicate Devices

• 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application (K192945)

Submission Summary (Full Text)

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December 27, 2024

7D Surgical ULC Elena Marenny Regulatory Specialist 60 Scarsdale Road, Unit 118 Toronto, ON M3B 2R7 Canada

Re: K242480

Trade/Device Name: FLASH EVD System (10-0002) Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: November 27, 2024 Received: November 27, 2024

Dear Elena Marenny:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 ([e-mail]) or phone [phone] or 301-796-7100).

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Sincerely,

Adam D. Digitally signed by Adam D. Pierce -S Pierce -> 15:08:37 -05'00'

Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional, and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine 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) K242480

Device Name FLASH EVD System (10-0002)

### Indications for Use (Describe)

FLASH EVD is a stereotactic image guidance system intended for the spatial positioning and orientation of neurosurgical instruments. The device is only indicated for cranial surgery where reference to a rigid anatomical structure can be identified, does not require rigid fixation of the patient, and does not require fixation of a navigated instrument guide to the patient.

Type of Use (Select one or both, as applicable)

| | <span>☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> |
|--|-------------------------------------------------------------|
| | <span>☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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# 510(k) Summary of Safety and Effectiveness

FLASH EVD 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 ULC 60 Scarsdale Road, Unit 118 Toronto, ON, M3B 2R7, Canada Contact Person: Elena Marenny Regulatory Specialist 7D Surgical ULC 60 Scarsdale Road, Unit 118 Toronto, ON, M3B 2R7, Canada Phone: [phone] Email: elena.marenny(@seaspine.com

Date prepared: Nov 25, 2024

### 2. 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: FLASH EVD System

These devices are classified as follows:

| Classification Name | 21 CFR Section | Product Code |
|------------------------|------------------|--------------|
| Stereotaxic instrument | 21 CFR §882.4560 | HAW |

### 3. Substantially Equivalent Devices

7D Surgical believes FLASH EVD is substantially equivalent to the following currently marketed device:

| Product | 510(k) |
|-------------------------------------------------------------------------------------|---------|
| 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement<br>Application | K192945 |

The intended use of the subject device, FLASH EVD System, is equivalent to the predicate device K192945 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application. Furthermore, the technological characteristics of FLASH EVD are substantially equivalent to the 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application. 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.

The fundamental technology of FLASH EVD is equivalent to the predicate currently cleared 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application. Both Systems provide image

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registration between preoperatively acquired tomographic data captured intraoperatively from an integrated Structured Light scanner. Both Systems provide guidance data by displaying the locations of tracked navigation tools relative to the patient. Position and orientation data of the tracked navigation tools are linked to the preoperative image data using the system software. The differences in the characteristics do not raise new questions of safety and effectiveness. Consequently, the subject is substantially equivalent to the predicate device.

#### Purpose of Submission 4.

The objective of this submission is to introduce FLASH EVD for image guided placement of external ventricular drainage (EVD) catheters. Standard external ventricular drain (EVD) catheter placement relies on a free-hand technique using anatomical landmarks. Image guided navigation systems, both the predicate 7D Surgical System K192945 and FLASH EVD, address these limitations by providing continuous position feedback using tracked navigation tools and targeted workflows tailored specifically for procedures. The newly proposed FLASH EVD System's intended use and technological characteristics are similar to the validated predicate 7D Surgical System while adopting a system design, workflow, and instrumentation for image guided placement of EVD catheters.

### 5. Indications for Use

FLASH EVD is a stereotactic image guidance system intended for the spatial positioning and orientation of neurosurgical instruments. The device is only indicated for cranial surgery, where reference to a rigid anatomical structure can be identified, does not require rigid fixation of the patient, and does not require fixation of a navigated instrument guide to the patient.

#### Device Description and Technical Comparison to Predicate Devices 6.

FLASH EVD System is a stereotactic image guided surgical navigation system during cranial procedures. The FLASH EVD software assists in guiding surgeons during external ventricular drainage (EVD) catheter placement procedure, also known as a ventriculostomy, is prescribed to relieve elevated intracranial pressure when there is a disruption in the normal flow of cerebrospinal fluid (CSF) within the brain.

| Trade Name | 7D Surgical System Cranial Biopsy and<br>Ventricular Catheter Placement<br>Application (K192945) | FLASH EVD System |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | 7D Surgical ULC | 7D Surgical ULC |
| 510(K) Number | K192945 | Pending |
| Common Name | Computer-assisted surgical device | Same as K192945 |
| Classification Name | Instrument, Stereotaxic | Same as K192945 |
| Product Code | HAW | Same as K192945 |
| Class | Class II | Class II |
| Regulation Number | 21 CFR § 882.4560 | Same as K192945 |
| Classification Panel | Neurological | Same as K192945 |
| Intended Use | The 7D Surgical System is intended as an aid<br>for precisely locating anatomical structures in<br>either open or percutaneous neurosurgical and<br>orthopedic procedures. | FLASH EVD System is intended to aid the<br>placement of external ventricular drain (EVD)<br>catheters. |
| 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 cranial surgery where reference to a rigid anatomical structure can be identified. | FLASH EVD is a stereotactic image guidance system intended for the spatial positioning and orientation of neurosurgical instruments. The device is only indicated for cranial surgery where reference to a rigid anatomical structure can be identified, does not require rigid fixation of the patient, and does not require fixation of a navigated instrument guide to the patient. |
| Where used | Operating Room (OR) | Operating Room (OR)<br>Intensive Care Unit (ICU)<br>Emergency Room (ER) |
| General device description | Image guidance system assisting the surgeon in manual guidance of navigated neurosurgical instruments. | Same as K192945 |
| System Accuracy Requirement | Linear Placement Error: <2.0 mm to 99% Confidence Interval (CI) Angular Placement Error: <2° to 99% Confidence Interval (CI) | Same as K192945 |
| Principle of operation | Pre-operative imaging; Patient registration; Trajectory planning; Real-time tracking of navigated instruments | Same as K192945 |
| Input images | 3D pre-operative exam | Same as K192945 |
| Real time display of the instrument position | Yes | Same as K192945 |
| Associated equipment | Reflective sterile spheres Navigation instrumentation Ventricular catheter | Single-Use procedural kits containing navigation instrumentation<br>EVD catheter |
| Cranial Fixation Modality | Skull clamp | None (no fixation) |
| Sterilization | Reprocess and store multi-use tools in a provided sterilization tray. | Presterilized single-use tools in a sealed procedural kit with a shelf life of 1 years. |

### Substantial Equivalence (SE) Comparison:

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FLASH EVD System

### 7. Technological Characteristics

FLASH EVD System makes use of equivalent technological characteristics and functionality and is intended for equivalent surgical procedures as compared to the predicate device.

### 8. Non-clinical 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.

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### 510(k) Premarket Notification

### FLASH EVD System

7D Surgical performed the following testing to ensure the safety and effectiveness of FLASH EVD:

- Non-Clinical System, Software, and Instrumentation Verification and Validation ●
- . Non-Clinical Performance Surgical Simulations Conducted on Phantom Models
- Sterilization and Packaging Validation Studies ●
- Compliance Conformity Assessments .
- ISO 10993-1 Biological evaluation of medical devices. o
- ISO 11607-1- Packaging for terminally sterilized medical devices -- Part 1: Requirements for O materials, sterile barrier systems, and packaging systems
- ISO 11607-2- Packaging for terminally sterilized medical devices Part 2: Validation O requirements for forming, sealing and assembly processes
- ISO 11137-1- Sterilization of health care products -- Radiation -- Part 1: Requirements for o development, validation and routine control of a sterilization process for medical devices
- ISO 11137-2- Sterilization of health care products -- Radiation -- Part 2: Establishing the O sterilization dose
- IEC 62366-1- Medical devices -- Part 1: Application of usability engineering to medical O devices
- ANSI/AAMI HE75- Human factors engineering -- Design of medical devices O
- ASTM F2554-10 Standard Practice for Measurement of Positional Accuracy of Computer O Assisted Surgical Systems
- IEC 62304, Medical device software -software life-cycle processes O
- IEC 60601-1 Medical electrical equipment -- Part 1: General requirements for basic safety O and essential performance. This standard sets out the general requirements for the basic safety and essential performance of medical electrical equipment, including image-guided stereotactic systems.
- IEC 60601-1-2- Medical electrical equipment -- Part 1-2: General requirements for basic O safety and essential performance -- Collateral standard: Electromagnetic compatibility --Requirements and tests. This standard sets out the requirements for electromagnetic compatibility (EMC) testing of medical electrical equipment, including image-guided stereotactic systems.
- IEC 60601-1-6- Medical electrical equipment -- Part 1-6: General requirements for basic o safety and essential performance -- Collateral standard: Usability
- ISO 14971 Medical devices Application of risk management to medical devices O

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 Trajectory Angular Error (TAE) have been used to evaluate the clinical accuracy of the system on phantom models in a clinical simulated environment. TRE and TAE evaluate the error discrepancy between the position reported by the image guided surgery system and the ground truth position measured physically or otherwise.

| Verification and Validation | Description | Conclusion |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| System Verification | Scope of the test is to verify the design<br>requirement specifications of FLASH<br>EVD under test case protocols. | Verification successful, all design<br>requirements have been fulfilled. |
| System Validation | Scope of the test is to validate the<br>Indications for Use and Customer | Validation successful, all user needs met. |

### Summary of Non-clinical Performance Testing:

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| Verification and Validation | Description | Conclusion |
|-------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| Requirements of FLASH EVD under<br>simulated use case situations. | | |
| Usability | This test is conducted to validate FLASH<br>EVD with respect to use errors. | Validation successful, device safe and<br>effective with respect to use errors. |
| Safety regarding risk analysis | Implementation and effectiveness of all<br>risk control requirements specified in<br>FLASH EVD risk analysis is tested and<br>verified. | Risk Control requirements are effective<br>and mitigate the associated risks to an<br>acceptable level. |
| Biocompatibility | FLASH EVD Navigation Tools were<br>assessed to the following recognized<br>standards: ISO 10993-1 | Compliance with recognized standards<br>has been established. |
| Sterilization Validation | FLASH EVD Navigation Tools were<br>assessed to the following recognized<br>standards: ISO 11137-1, ISO 11137-2 | Compliance with recognized standards<br>has been established. |
| Accelerated Aging, Real Time<br>Aging, Distribution Validation, and<br>Sealing Validation | FLASH EVD Navigation Tools were<br>assessed to the following recognized<br>standards: ISO 11607-1, ISO 11607-2 | Compliance with recognized standards<br>has been established. |
| Product Safety standards | FLASH EVD was tested to the following<br>recognized standards: IEC 60601-1, IEC<br>60601-1-2, IEC 60601-1-6 | Compliance with recognized standards<br>has been verified. |
| Non-Clinical Accuracy | System's accuracy is tested using FLASH<br>EVD on phantom models following the<br>ASTM F2554-10 Standard Practice for<br>Measurement of Positional Accuracy of<br>Computer Assisted Surgical Systems in<br>addition to Target Registration Error and<br>Angular Trajectory Error | All accuracy specifications have been<br>met. |

### 9. Clinical Data

A clinical trial was not required to demonstrate the safety and effectiveness of FLASH EVD. Clinical validation is unnecessary as FLASH EVD does not introduce 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.

### 10. Conclusion

FLASH EVD is substantially equivalent in safety and effectiveness to the predicate device identified above:

- . The predicate devices and FLASH EVD use essentially the same technologies.
- . The predicate devices and FLASH EVD instrumentation have essentially the same performance requirements.
- The predicate devices and FLASH EVD are designed and manufactured to similar electrical and physical safety standards.

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510(k) Premarket Notification

FLASH EVD System

The non-clinical verification and validation performed support the safety and effectiveness of FLASH EVD. The conclusions drawn from the nonclinical tests demonstrate that FLASH EVD 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 FLASH EVD is substantially equivalent to the predicate device with respect to its indications for use, technological characteristics, and performance characteristics.