(128 days)
Not Found
No
The summary does not mention AI, ML, or related terms, and the performance studies focus on traditional accuracy metrics for image-guided surgery systems.
No
The device aids in the spatial positioning and orientation of neurosurgical instruments and guides surgeons, but it does not directly treat a disease or condition itself.
No
Explanation: The device is a surgical navigation system intended for the spatial positioning and orientation of neurosurgical instruments during cranial procedures. It assists in guiding surgeons for external ventricular drainage (EVD) catheter placement. Its purpose is to aid in treatment (surgery), not to diagnose a condition.
No
The device description explicitly states "FLASH EVD System is a stereotactic image guided surgical navigation system". The performance studies include "Instrumentation Verification and Validation" and "Sterilization and Packaging Validation Studies", indicating the presence of hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "spatial positioning and orientation of neurosurgical instruments" during cranial surgery. This is a surgical guidance system, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description reinforces its role as a "stereotactic image guided surgical navigation system" to assist surgeons during procedures.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are specifically designed to perform tests on samples taken from the body to help diagnose diseases or conditions. This device's function is to guide surgical instruments based on pre-operative imaging.
N/A
Intended Use / 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.
Product codes
HAW
Device Description
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
3D pre-operative exam
Anatomical Site
cranial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Operating Room (OR)
Intensive Care Unit (ICU)
Emergency Room (ER)
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 Performance Surgical Simulations Conducted on Phantom Models to verify the absolute accuracy and repeatability of the device and navigation accuracy according to ASTM F2554-10. Target Registration Error (TRE) and Trajectory Angular Error (TAE) were used to evaluate clinical accuracy on phantom models in a simulated clinical environment. All accuracy specifications have been met.
System Verification: Verification successful, all design requirements have been fulfilled.
System Validation: Validation successful, all user needs met.
Usability: Validation successful, device safe and effective with respect to use errors.
Safety regarding risk analysis: Risk Control requirements are effective and mitigate the associated risks to an acceptable level.
Biocompatibility: Compliance with recognized standards has been established.
Sterilization Validation: Compliance with recognized standards has been established.
Accelerated Aging, Real Time Aging, Distribution Validation, and Sealing Validation: Compliance with recognized standards has been established.
Product Safety standards: Compliance with recognized standards has been verified.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Linear Placement Error:
§ 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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
| ☑ 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
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: +1(416) 471-2569 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 | |
| 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
5
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
Ventricular Catheter Placement
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
for precisely locating anatomical structures in
either open or percutaneous neurosurgical and
orthopedic procedures. | FLASH EVD System is intended to aid the
placement of external ventricular drain (EVD)
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)
Intensive Care Unit (ICU)
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: