The Neurescue device is intended for temporary occlusion of large vessels and blood pressure monitoring including patients requiring emergency control of hemorrhage.

Device Description

The NEURESCUE device is a large vessel occlusion catheter comprised of two main components: The NEURESCUE Catheter and the NEURESCUE Assistant.

The Catheter is an occlusion balloon catheter and the Assistant is a hub for interfacing with the operation of the Catheter. During normal use the device can be operated automatically. Alternatively, the device can be operated manually.

For manual use the interface consists of two Luer lock ports for:

Manual inflation and deflation of the balloon with saline -
-Flushing of the arterial FLUSH port with saline

Inflation and deflation of the balloon can be accomplished by an automatic filling and deflation function (automatic operation with a peristaltic pump) or manually.

Whether the filling is performed manually or automatically, the user is informed of the pressure at the tip of the Catheter. The device has a built-in alarms system.

AI/ML Overview

The provided text describes the 510(k) summary for the Neurescue device, which is a vascular clamp. It outlines performance testing (bench and in vivo) to support its safety and effectiveness and its substantial equivalence to a predicate device. However, it does not provide specific acceptance criteria or reported device performance in the format of a table, nor does it detail a clinical study with human subjects (multi-reader multi-case, standalone, etc.) that would prove the device meets acceptance criteria related to diagnostic or assistive performance with AI.

The document focuses on engineering and animal model testing to demonstrate the device's technical specifications and physical performance (e.g., balloon inflation, pressure sensing, material integrity) and its intended use for temporary occlusion of large vessels and blood pressure monitoring.

Therefore, many of the requested details, such as sample size for test sets, data provenance, number and qualifications of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and type of ground truth used for AI-related performance, are not applicable or not available in this FDA 510(k) summary because the device is a physical medical device (vascular clamp), not an AI-driven diagnostic or assistive software.

However, I can extract the information related to the acceptance criteria and performance testing that is mentioned, recognizing that it pertains to the device's physical and functional attributes rather than AI performance.

Acceptance Criteria and Device Performance (Based on Provided Text)

Given the nature of the device (a physical vascular clamp, not an AI software), the "acceptance criteria" discussed in the document are primarily related to its mechanical performance, functionality, and safety in in vitro (bench) and in vivo (animal) testing, rather than diagnostic accuracy or human reader improvement. The document summarizes categories of tests and states that the device "meets applicable design and performance requirements" or "demonstrate[s] that the NEURESCUE device has been designed for and tested to conform to its intended use," implying these were the acceptance criteria for each test.

1. Table of Acceptance Criteria and Reported Device Performance

Category / Test Name	Acceptance Criteria (Implied)	Reported Device Performance (Summary)
Performance Testing - Bench	Device meets design and performance requirements for the specified tests.
Catheter Dimensional	Conformance to specified dimensions (lumen size, balloon leg distance, tip size, etc.).	Verified.
Radiopacity	Catheter visible on fluoroscopy by real users.	Verified with real users and human cadavers.
Tensile strength	All adhesive bonds and catheter tip meet tensile strength requirements.	Verified.
Compliance, rated burst volume & freedom from Fragmentation	Balloon inflates to burst without fragmentation and meets specified dimensions.	Verified.
Balloon Fatigue	Balloon and catheter maintain mechanical endurance after repeated use.	Verified through repeated use (inflation, deflation, insertion).
Flexibility and kink resistance	Catheter demonstrates acceptable flexibility and kink resistance.	Verified.
Torque Strength	Catheter maintains integrity and strength when twisted.	Verified through twisting multiple turns.
Preparation, Deployment and Retraction	Reliable performance during simulated preparation, deployment, and retraction in clinical environment.	Verified through repeated simulated use testing under clinically relevant environment.
Minimum/Maximum vessel occlusion diameter	Device achieves and maintains occlusion for specified vessel sizes.	Verification of status of occlusion for maximum and minimum vessel sizes performed.
Balloon Regulation	System accurately controls balloon pressure.	Verified.
Inflation and deflation time	Manual and automated inflation/deflation times meet specifications.	Verified.
1-hour occlusion test	Device sustains clinically relevant occlusion for 1 hour.	Verified that the device is able to sustain a clinically relevant occlusion over 1 hour.
Pressure sensor accuracy	Pressure sensors maintain accuracy across temperature range, accounting for hysteresis.	Verified throughout a temperature range taking hysteresis behavior into account.
Systolic and diastolic pressure accuracy	Device accurately calculates and displays systolic and diastolic pressure.	Verified.
Branch vessel indicator alarm	Alarm mechanism correctly identifies and signals balloon inflation in a branch vessel.	Verified.
Occlusion time alarm	Alarm mechanism correctly times and notifies user of excessive occlusion duration.	Verified.
Pressure relief system	Mechanical pressure relief system prevents excessive balloon pressure.	Verified.
Battery life time	Device battery operates for the specified duration.	Verified.
Peel-away cover testing	Properties of the peel-away tube meet specifications.	Verified.
Free Fall	Device and packaging withstand specified free fall tests.	Verified through typical drop tests.
Interface integrity testing	Connection interface between Assistant and Catheter maintains integrity.	Verified.
Introducer sheath compatibility	Device is compatible with recommended introducer sheaths.	Verified.
Software Testing	Software meets all requirements, risk control measures, and is validated according to standards.	All software requirements and risk control measures implemented in software are tested and verified. Developed according to IEC 62304 and FDA guidance, and validated.
Software unit testing	Full set of software unit tests (static code analysis, function testing, code coverage).	Verified as part of release process.
Software system testing	Software and hardware perform together as expected (pump performance, catheter pairing).	Verified through extensive tests.
Software validation	Software validated according to IEC 62304 and FDA guidance.	Verified.
Electromagnetic Compatibility & Electrical Safety	Device meets electrical safety and EMC standards.	Tested and verified according to ANSI AAMI ES60601-1:2005 and IEC 60601-1-2:2014.
Electromagnetic immunity	Device maintains performance under specified EMC conditions.	Tested for EMC according to IEC 60601-1-2:2014.
Defibrillation	Device shows immunity to defibrillation.	Tested for immunity according to IEC 60601-1-2:2014.
Electrostatic discharge	Device is protected against electrostatic discharge.	Compliance according to ANSI AAMI ES60601-1:2005 and IEC 60601-1-2:2014 concluded and verified.
Packaging, sterilization, shelf life & biocompatibility	Device properties and packaging maintain integrity through aging and sterilization.	Verified.
Packaging, sterilization	Performance after accelerated aging, transit testing. Sterilization methods validated.	Verified. Includes bioburden and endotoxin testing.
Accelerated aging	All relevant tests (cover tube removal, vessel occlusion, pressure sensor accuracy, etc.) maintain performance after aging.	Verified through repeat testing of relevant performance parameters after accelerated aging.
Marker bands integrity and depth markers legibility testing	Marker bands integrity and legibility of position/depth markers maintained on aged products.	Verified.
Biocompatibility testing	Device components demonstrate biocompatibility.	Verified for Cytotoxicity, Irritation / intracutaneous reactivity, Sensitization, Acute systemic toxicity, Material-mediated pyrogenicity, and Hemocompatibility.
In Vivo Testing (Animal Model)	Device performs as intended in a relevant animal model.	A GLP Study was conducted to Evaluate the Performance of the NEURESCUE Catheter in the Aorta of an Acute Naïve Porcine Model. (Results stated as supporting substantial equivalence.)

2. Sample Size Used for the Test Set and Data Provenance

Bench Testing: The specific sample sizes for each in vitro (bench) test are not provided in this summary. The tests are described as being "carried out" or "verified," implying sufficient samples were used to meet internal validation requirements.
In Vivo Testing: One "GLP Study to Evaluate the Performance of the NEURESCUE Catheter in the Aorta of an Acute Naïve Porcine Model" was conducted. The exact number of porcine models (sample size) is not specified.
Data Provenance: The tests are part of the premarket notification (510k) submission by Neurescue Aps, located in Copenhagen, Denmark. The data would thus originate from their internal testing or contracted testing facilities. All testing described is of a prospective nature (designed and conducted specifically for this submission). No reference to retrospective data is made.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

For the technical and performance testing (bench and in vivo), "ground truth" is established by engineering specifications, physical measurements, and observed functional performance rather than expert (e.g., radiologist) interpretation.
The radiopacity test mentions "real users" with human cadavers; however, the number or qualifications of these users/experts are not specified. Their role seemed to be to confirm visibility, not to establish a diagnostic ground truth.

4. Adjudication Method for the Test Set

Not applicable as the testing involves objective measurements, mechanical performance, and animal studies, not human interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for AI-driven diagnostic or assistive devices where human reader performance is a key outcome. The Neurescue device is a physical medical device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone study (in the context of AI performance) was not done. The device's "automatic inflation and deflation function" and "built-in alarm system" are functionalities of the device itself, not an AI algorithm that makes diagnostic predictions. Performance of these automated functions would be part of the bench and software testing, but not a standalone AI performance study.

7. The Type of Ground Truth Used

Engineering Specifications and Physical Measurements: For bench tests (e.g., dimensions, tensile strength, burst volume, pressure accuracy, inflation time, battery life).
Observed Functional Performance: For tests like kink resistance, deployment, occlusion, and alarm functions.
Biocompatibility Standards: For biocompatibility tests.
Animal Physiological Response/Survival: For the in vivo GLP study in porcine models, performance would be assessed against physiological parameters and outcomes in the animal model.
User Observation/Feedback: For radiopacity testing ("real users with human cadavers").

8. The Sample Size for the Training Set

Not applicable. This device is not an AI-driven system that requires a "training set" in the context of machine learning. The software testing mentioned refers to traditional software development and validation (unit testing, system testing, software validation) for controlling the device's functions, not for training a predictive model.

9. How the Ground Truth for the Training Set Was Established

Not applicable. See point 8.

Summary

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May 21, 2021

Neurescue Aps % H. Semih Oktay President CardioMed Device Consultants, LLC 1783 Forest Drive. Suite 254 Annapolis, Maryland 21401

Re: K210358

Trade/Device Name: Neurescue device Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: MJN, DQY, DQO Dated: April 23, 2021 Received: April 23, 2021

Dear H. Semih Oktay:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

for Carmen Johnson, Ph.D. Assistant Director DHT2B: Division of Circulatory Support. Structural and Vascular Devices OHT2: Office of Cardiovascular 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) K210358

Device Name Neurescue Device

Indications for Use (Describe)

The Neurescue device is intended for temporary occlusion of large vessels and blood pressure monitoring including patients requiring emergency control of hemorrhage.

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

The following section is being provided in accordance with 21 CRF 807.92 and contains the 510(k) summary for the NEURESCUE device:

Applicant name and contact information

Name: Neurescue Aps Address: Købmagergade 53, 2., 1150, Copenhagen, Denmark Official contact: Habib Frost, M.D. Contact Telephone: +45 53 53 67 60

Date Prepared: May 15, 2021

Device name and classification

Trade name: NEURESCUE® device Common name: Occlusion balloon catheter Classification name: Vascular clamp Device classification: Class II, 870.4450, 870.1250, 870.1200 Product code: MJN, DQY, DQO

Predicate device

The NEURESCUE device is claimed to be substantially equivalent to the Prytime™ ER-REBOA™ Catheter (K170411).

Device description

The NEURESCUE device is a large vessel occlusion catheter comprised of two main components: The NEURESCUE Catheter and the NEURESCUE Assistant.

For manual use the interface consists of two Luer lock ports for:

Manual inflation and deflation of the balloon with saline -
-Flushing of the arterial FLUSH port with saline

Inflation and deflation of the balloon can be accomplished by an automatic filling and deflation function (automatic operation with a peristaltic pump) or manually.

Whether the filling is performed manually or automatically, the user is informed of the pressure at the tip of the Catheter. The device has a built-in alarms system.

Intended Use

The NEURESCUE device is intended for temporary occlusion of large vessels and blood pressure monitoring.

Comparison of Technological Characteristics

The NEURESCUE device is identical to the predicate device in terms of intended use and similar in basic characteristics, including:

-A large vessel occlusion balloon
-A hub with Luer lock access to the balloon
Pressure monitoring capabilities -

The NEURESCUE device has the following primary differences from the predicate device:

Built-in an automatic inflation and deflation function -

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-Built-in alarms system
Performance bench and in vivo testing were performed to support the safety and effectiveness of these differences. The results of these tests demonstrate that the NEURESCUE device has been designed for and tested to conform to its intended use.

Performance Testing

The following in vitro tests were performed to demonstrate that the NEURESCUE device meets applicable design and performance requirements and is therefore equivalent to the predicate device:

Test name / area	Summary
Performance Testing - Bench	Below are listed specific performance testing carried out:
Catheter Dimensional	Dimensional aspects of the Catheter verified, as lumen size, balloon leg distance, peel away cover tube diameters, tip sensor opening dimensions, tip size, catheter effective length and balloon length and diameter.
Radiopacity	Testing with real users with human cadavers that the catheter is visible on fluoroscopy.
Tensile strength	Tensile strength of all adhesive bonds and catheter tip is verified.
Compliance, rated bust volumeand freedom from Fragmentation	Test of balloon inflation to burst while observing dimensions and failure mode.
Balloon Fatigue	Repeated use (inflation, deflation and insertion) carried out to verify balloon and catheter mechanical endurance.
Flexibility and kink resistance	Flexibility and kink resistance of the catheter verified.
Torque Strength	Catheter twisted multiple turns to verify torque strength.
Preparation, Deployment andRetraction	Repeated simulated use of catheter testing performed under clinically relevant environment.
Minimum/Maximum vesselocclusion diameter	Verification of status of occlusion for maximum and minimum vessel sizes.
Balloon Regulation	The ability of the system to control the balloon pressure accurately is verified.
Inflation and deflation time	Manual and automated inflation and deflation time is verified.
1-hour occlusion test	Verification that the device is able to sustain a clinically relevant occlusion over 1 hour.
Pressure sensor accuracy	Accuracy of the pressure sensors are carried out, throughout a temperature range taking hysteresis behavior into account.
Systolic and diastolic pressureaccuracy	The ability of the device to calculate and show the systolic and diastolic pressure is verified.
Branch vessel indicator alarm	The alarm mechanism to identify inflation of the balloon in a branch vessel to the aorta is verified.
Occlusion time alarm	The alarm mechanism of timing and notifying the user of excessive duration of occlusion is verified.
Pressure relief system	The device incorporates mechanical means of preventing excessive balloon pressure, which is verified.
Battery life time	Testing of the battery operating time for the device is carried out.
Peel-away cover testing	The properties of the peel-away tube covering the balloon is verified.
Free Fall	The device and the device box are tested for free fall (drop test).
Interface integrity testing	Verification of the integrity of the connection interface between the Assistant and the Catheter.
Introducer sheath compatibility	Testing to verify compatibility with the recommended introducer sheaths.
Software Testing	All software requirements and risk control measures implemented in software are tested and verified.
Software unit testing	Part of the release process of every software part, both during development and release, is a full set of software unit test. Included is static code analysis, function testing of units and code coverage tests.
Software system testing	An extensive set of tests are performed verifying aspects of the device where software and hardware are acting together. Everything from pump performance to catheter pairing.
Software validation	Software developed according to IEC 62304 and FDA guidance on "General Principles of Software Validation". The software is validated.
Electromagnetic Compatibility& Electrical Safety
Electromagnetic Compatibility	Electrical safety testing (primarily) according to ANSI AAMI ES60601-1:2005tested and verified.
Electromagnetic Compatibility	Electromagnetic compatibility according to IEC 60601-1-2:2014 verified.
Electromagnetic immunity	Tested for EMC according to IEC 60601-1-2:2014.
Defibrillation	Tested for immunity according to IEC 60601-1-2:2014.
Electrostatic discharge	Compliance according to ANSI AAMI ES60601-1:2005 concluded andverified.
Packaging, sterilization andshelf life and biocompatibility	Tested for ESD according to ANSI AAMI ES60601-1:2005 and IEC 60601-1-2:2014.
Packaging, sterilization	Testing to verify performance with respect to biocompatibility, acceleratedaging, the packaging's ability to protect the device through the lifetime of thedevice and the adequacy of the sterilization processes.
Accelerated aging	Packaging testing for (accelerated) aged products and products put throughtransit testing carried out. Validation of the two sterilization methods used fortwo different parts performed (EO and E-BEAM). This includes bioburdenand endotoxin testing.
Marker bands integrity and depthmarkers legibility testing	Accelerated aging and relevant testing to verify performance has beencarried out. The test suite is a repeat of the relevant tests also carried outprior to aging; cover tube removal, vessel occlusion, pressure sensoraccuracy, inflation and deflation time test, flexibility and kink, torque strength,balloon volume vs diameter to burst, battery lifetime, pump regulation, watercontainer burst test and water container diffusion.
Biocompatibility testing	Verification of marker bands integrity and verification of the legibility of theposition and depth markers on aged products.
	Biocompatibility testing carried out for Cytotoxicity, Irritation / intracutaneousreactivity, Sensitization, Acute systemic toxicity, Material-mediatedpyrogenicity and Hemocompatibility.

Summary of in vitro testing

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The following in vivo tests were performed to demonstrate that the NEURESCUE device meets applicable design and performance requirements and is therefore substantially equivalent to the predicate device:

A GLP Study to Evaluate the Performance of the NEURESCUE Catheter in the Aorta of an - Acute Naïve Porcine Model

Conclusion

The NEURESCUE device is substantially equivalent to the identified predicate device.

Regulation Number and Section

§ 870.4450 Vascular clamp.

(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).