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

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.

AI/ML Overview

The provided text describes the 7D Surgical FLASH EVD System and its 510(k) submission for clearance. However, it does not contain the detailed information necessary to fully answer all aspects of your request, particularly regarding specific acceptance criteria metrics and a multi-reader, multi-case (MRMC) comparative effectiveness study.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application, K192945) through non-clinical testing.

Here's a breakdown of what can be extracted and what information is missing based on your prompts:

1. Table of Acceptance Criteria and Reported Device Performance

The document specifies "System Accuracy Requirement" for the predicate device, which the FLASH EVD System also adopts as "Same as K192945." These are the closest things to acceptance criteria mentioned.

Acceptance Criteria	Reported Device Performance
Linear Placement Error: <2.0 mm to 99% Confidence Interval (CI)	"All accuracy specifications have been met." (Implies <2.0 mm at 99% CI)
Angular Placement Error: <2° to 99% Confidence Interval (CI)	"All accuracy specifications have been met." (Implies <2° at 99% CI)

Note: The document states that "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." It also mentions "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." However, the specific numerical results for these tests are not provided in the summary, only a general "All accuracy specifications have been met." conclusion.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Test Set Sample Size: Not explicitly stated. The testing was described as "Non-Clinical Performance Surgical Simulations Conducted on Phantom Models."
Data Provenance: The testing was conducted on "phantom models" in a "clinical simulated environment." The origin of data for clinical performance (i.e., human subject data) is not applicable as a clinical trial was not required. The manufacturer is 7D Surgical ULC, located in Toronto, ON, Canada, which suggests the development and non-clinical testing likely occurred there.
Retrospective or Prospective: Not applicable, as the testing was on phantom models, not patient data in a retrospective or prospective manner.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided. The ground truth for the non-clinical accuracy testing (TRE and TAE on phantom models) would typically be established through precise physical measurements or a CAD model of the phantom, rather than expert consensus on medical images.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are primarily used for reviewing patient images by multiple experts to establish ground truth for AI model performance. Since the testing was non-clinical on phantom models, this type of adjudication is not relevant.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was explicitly NOT done. The document states: "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."
Therefore, there is no information on how much human readers improve with or without AI assistance, as AI assistance in the context of improving human reader performance on imaging interpretation does not appear to be the primary function or study objective of this surgical navigation system. The system guides surgeons, but it's not described as an AI diagnostic aid for image interpretation.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, the "Non-Clinical Accuracy" testing (System accuracy, TRE, TAE) on phantom models represents a form of standalone performance evaluation of the device's navigation capabilities. The results concluded that "All accuracy specifications have been met."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the "Non-Clinical Accuracy" tests, the ground truth was based on:
- Physical measurements/known phantom geometry: "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."
- ASTM F2554-10 Standard: This standard provides a method for objectively measuring positional accuracy.

8. The sample size for the training set

Not applicable/Not provided. This device is a surgical navigation system, not an AI/ML model for image interpretation that typically requires a large training set of labeled images. While the system uses "preoperatively acquired tomographic data," this is for patient-specific registration and navigation, not for training a generalizable AI model in the typical sense of deep learning. The document describes it as "displaying the locations of tracked navigation tools relative to the patient" and linking "Position and orientation data of the tracked navigation tools to the preoperative image data."

9. How the ground truth for the training set was established

Not applicable/Not provided for the reasons stated in point 8.

Summary

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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 (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)

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 PlacementApplication	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.

Trade Name	7D Surgical System Cranial Biopsy andVentricular Catheter PlacementApplication (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 aidfor precisely locating anatomical structures ineither open or percutaneous neurosurgical andorthopedic procedures.	FLASH EVD System is intended to aid theplacement 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: <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 instrumentationEVD 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 designrequirement specifications of FLASHEVD under test case protocols.	Verification successful, all designrequirements have been fulfilled.
System Validation	Scope of the test is to validate theIndications 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 undersimulated use case situations.
Usability	This test is conducted to validate FLASHEVD with respect to use errors.	Validation successful, device safe andeffective with respect to use errors.
Safety regarding risk analysis	Implementation and effectiveness of allrisk control requirements specified inFLASH EVD risk analysis is tested andverified.	Risk Control requirements are effectiveand mitigate the associated risks to anacceptable level.
Biocompatibility	FLASH EVD Navigation Tools wereassessed to the following recognizedstandards: ISO 10993-1	Compliance with recognized standardshas been established.
Sterilization Validation	FLASH EVD Navigation Tools wereassessed to the following recognizedstandards: ISO 11137-1, ISO 11137-2	Compliance with recognized standardshas been established.
Accelerated Aging, Real TimeAging, Distribution Validation, andSealing Validation	FLASH EVD Navigation Tools wereassessed to the following recognizedstandards: ISO 11607-1, ISO 11607-2	Compliance with recognized standardshas been established.
Product Safety standards	FLASH EVD was tested to the followingrecognized standards: IEC 60601-1, IEC60601-1-2, IEC 60601-1-6	Compliance with recognized standardshas been verified.
Non-Clinical Accuracy	System's accuracy is tested using FLASHEVD on phantom models following theASTM F2554-10 Standard Practice forMeasurement of Positional Accuracy ofComputer Assisted Surgical Systems inaddition to Target Registration Error andAngular Trajectory Error	All accuracy specifications have beenmet.

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.

Regulation Number and Section

§ 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).