EMBOGUARD Balloon Guide Catheters are indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the neurovascular system. The balloon provides temporary vascular occlusion during angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for Retrieval Devices.

Device Description

EMBOGUARD Balloon Guide Catheter is a dual lumen, braid-reinforced, variable stiffness catheter with an eccentric inflation lumen, a radiopaque marker on the distal end and a bifurcated luer hub on the proximal end. A compliant balloon is mounted on the distal end. The distal end of the device shaft has a hydrophilic coating. Balloon Guide Catheter dimensions are indicated on the product label.

AI/ML Overview

The provided text is an FDA 510(k) summary for a medical device called the EMBOGUARD™ Balloon Guide Catheter (K233924). This document primarily focuses on establishing "substantial equivalence" of the new device to a previously cleared predicate device (K212340), rather than proving the device meets acceptance criteria through a traditional clinical study with defined performance metrics for AI/software.

The context of your request seems to imply the device might be an AI or software-based product given your detailed prompts about MRMC studies, ground truth, and expert adjudication. However, this FDA submission is for a physical medical device (catheter) and not an AI or software device. Therefore, many of the specific questions you've asked (e.g., sample size for test/training sets for AI, number of experts for ground truth, MRMC study, standalone algorithm performance) are not applicable to this type of device submission.

The "acceptance criteria" discussed in this document relate to bench testing, biocompatibility, and sterilization to demonstrate that the modified physical device performs as safely and effectively as its predicate.

Based on the provided text, here's what information is available and how it aligns (or doesn't align) with your request:

Device Type: Physical Medical Device (Balloon Guide Catheter), not an AI/software device.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes several performance tests with "Pass" results, indicating adherence to pre-determined acceptance criteria. However, quantitative acceptance criteria are generally not explicitly stated with specific numerical values in this summary, but rather implied by meeting internal specifications or relevant standards.

Here's a summary of the performance categories and their reported outcomes:

Performance Test Category	Acceptance Criteria (Implicit)	Reported Device Performance
Biocompatibility	Device should be non-cytotoxic, non-sensitizing, non-irritating, non-systemically toxic, non-pyrogenic, non-hemolytic, not activate complement, and demonstrate similar thromboresistance to control. (Per ISO 10993 series & ASTM F756-17)	Pass: All tests met pre-determined acceptance criteria. Non-cytotoxic, did not elicit sensitization, met intracutaneous reactivity, met systemic toxicity, non-pyrogenic, non-hemolytic, does not activate complement, demonstrates similar thromboresistance to control.
Sterilization	Achieve minimum sterility assurance level (SAL) of 10-6. Remain sterile for 1 year shelf life.	Pass: Sterilization process successfully validated to 10-6 SAL. Device and packaging remain functional and sterile for 1 year shelf life.
Bench Testing	Meet specifications for inflation/deflation time, fatigue, OD/compliance, concentricity, burst pressure, sheath compatibility, lumen integrity, deliverability, flexibility/kink resistance, torque durability, tensile strength, visual, particulates, tip stiffness.	Pass: All samples met pre-determined acceptance criteria for all listed tests (Inflation/Deflation Time, Balloon Fatigue, OD & Compliance, Concentricity, Burst, Sheath Compatibility (Insertion/Withdrawal & Re-insertion/Re-withdrawal), Inner Lumen Integrity (Pressure & Aspiration), Deliverability & Withdrawal Force, Flexibility & Kink Resistance, Kink to Failure (Characterization), Torque Durability, Torque to Failure, Visual Inspection, Particulates (Comparable to Predicate), Tensile Strength, Tip Stiffness (Comparable to Predicate)).

Note on Quantitative Data: For most bench tests, the summary states "All samples met the pre-determined acceptance criteria." without providing the specific numerical criteria or the actual measured values. For "Kink to Failure" and "Particulates", it's noted as "Characterization only" or "found comparable," indicating that precise numerical "pass/fail" limits might not have been applied as rigorously as for other tests, but rather assessed for equivalence to the predicate.

2. Sample Size for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated in the summary for each individual test. The document mentions "All samples" for the bench tests, implying a sufficient number were tested per internal protocols and relevant standards. For biocompatibility, it refers to standard test methods where sample sizes are typically defined by those standards.
Data Provenance: Not applicable in the context of patient data. The "data" here comes from laboratory bench testing and biological assays conducted according to established protocols and standards. The testing was conducted by or for Neuravi Ltd., based in Ireland.

3. Number of Experts and Qualifications for Ground Truth

Not Applicable: This is a physical device, not an AI/software system requiring expert interpretation of medical images. Ground truth for its performance is established through physical measurements, chemical assays, and mechanical tests according to engineering and biocompatibility standards.

4. Adjudication Method for the Test Set

Not Applicable: There is no "adjudication" in the sense of multiple human readers independently evaluating data for consensus, as would be done for an AI/software device. Performance is determined by objective measurements against predefined engineering specifications and biological safety limits.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No: This type of study is relevant for AI/software devices that assist human interpretation of medical data. It is not applicable to a physical catheter.

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

Not Applicable: As stated, this is a physical medical device, not an algorithm.

7. The type of ground truth used

Physical/Chemical Standards and Measurements: For biocompatibility, ground truth is based on established biological responses (e.g., cell viability for cytotoxicity, skin reaction for irritation, blood parameters for hemolysis) as defined by ISO 10993 series standards. For bench testing, ground truth is based on engineering specifications and mechanical properties (e.g., measured burst pressure, inflation time, pull strength, visual inspection against defects).

8. The sample size for the training set

Not Applicable: This is not an AI/software device that requires a training set. The device itself is manufactured, not "trained."

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

Not Applicable: No training set or ground truth in the context of machine learning. The "ground truth" for the device's design and manufacturing is based on established engineering principles, material science, and regulatory standards for medical devices.

Summary

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April 18, 2024

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Neuravi Ltd. Niall Fox Director of Regulatory Affairs Block 3, Ballybrit Business Park Galway H91 K5YD Ireland

Re: K233924

Trade/Device Name: EMBOGUARD Balloon Guide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP Dated: March 22, 2024 Received: March 22, 2024

Dear Niall Fox:

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" (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).

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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 QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) 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.

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).

Sincerely,

Naira Muradyan -S

Naira Muradyan, 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

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Indications for Use

510(k) Number (if known) K233924

Device Name EMBOGUARD™ Balloon Guide Catheter

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) Summarv

K233924

SUBMITTER: l.

510(k) Owner: Neuravi Ltd.

Block 3, Ballybrit Business Park, Galway H91 K5YD, Ireland

Contact Person: Niall Fox

Director of Regulatory Affairs

Tel: +353-91-394123

E-mail: nfox5@its.jnj.com

Date Prepared: April 16th 2024

II. DEVICE

Trade Name of Device: EMBOGUARD™ Balloon Guide Catheter

Common Name of Device: Catheter, Percutaneous, Neurovasculature

Classification Name: 21 CFR 870.1250 - Class II

Product Code: QJP

III. PREDICATE DEVICES

EMBOGUARD™ Balloon Guide Catheter (K212340)

IV. DEVICE DESCRIPTION

V. INDICATIONS FOR USE

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE VI.

A summary of the technological characteristics of the EMBOGUARD™ Balloon Guide Catheter device in comparison to those of the predicate device is presented below. The device specifications are unchanged in comparison to the predicate devices. There is a change in the shafts' Pebax jacket materials blend of Pebax, colorant mix and addition of colorant carrier. The forming process of the catheter inner lumen liner material has also changed.

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Characteristics	Predicate Device:EMBOGUARD™ Balloon GuideCatheter	Subject Device:EMBOGUARD™ Balloon GuideCatheter
510(k) Number	K212340	K233924
Classification	Class II, 21 CFR 870.1250	Same as Predicate Device
DeviceClassificationName	Catheter, Percutaneous,Neurovasculature	Same as Predicate Device
ClassificationProduct Code	QJP	Same as Predicate Device
Indications for Use	EMBOGUARD Balloon GuideCatheters are indicated for use infacilitating the insertion andguidance of an intravascularcatheter into a selected bloodvessel in the neurovascular system.The balloon provides temporaryvascular occlusion duringangiographic procedures. TheBalloon Guide Catheter is alsoindicated for use as a conduit forRetrieval Devices.	Same as Predicate Device
Materials	Commonly used medical gradeplastics (nylon, PTFE,polycarbonate, polyurethane,polyolefin, polyblend) and stainlesssteel	Same as Predicate Device
Shaft Outer JacketDistal Segment (1)Pebax 35D Jacket0.004" W/T	Pebax 3533 SA01 MEDTechmer Blue/Black (PM50167E1)Irganox 1010Tinuvin 622	Pebax 3533 SA01 MEDPebax 5533 SA01 MED(colorant carrier)CSRM016 Pigment Blue 36CSRM037 Pigment Violet 23CSRM035 Pigment Green 7Irganox 1010Tinuvin 622
Shaft Outer JacketDistal Segment (2)Pebax 35D Jacket0.005" W/T	Pebax 3533 SA01 MEDTechmer Blue/Black (PM50167E1)Irganox 1010Tinuvin 622	Pebax 3533 SA01 MEDPebax 5533 SA01 MED(colorant carrier)CSRM016 Pigment Blue 36CSRM037 Pigment Violet 23CSRM035 Pigment Green 7Irganox 1010Tinuvin 622
Shaft Outer JacketDistal Segment (3)Pebax 35/40DJacket	Pebax 4033 SA01 MEDPebax 3533 SA01 MEDTechmer Blue/Black (PM50167E1)Irganox 1010Tinuvin 622	Pebax 5533 SA01 MEDPebax 3533 SA01 MEDCSRM016 Pigment Blue 36CSRM037 Pigment Violet 23CSRM035 Pigment Green 7
Characteristics	Predicate Device:EMBOGUARD™ Balloon GuideCatheter	Subject Device:EMBOGUARD™ Balloon GuideCatheter
Shaft Outer JacketDistal Segment (4)Pebax 40D Jacket	Pebax 4033 SA01 MEDTechmer Blue/Black (PM50167E1)Irganox 1010Tinuvin 622	Irganox 1010Tinuvin 622Pebax 5533 SA01 MEDPebax 3533 SA01 MEDCSRM016 Pigment Blue 36CSRM037 Pigment Violet 23CSRM035 Pigment Green 7Irganox 1010Tinuvin 622
Shaft Outer JacketDistal Segment (5)Pebax 55D Jacket	Pebax 5533 SA01 MEDTechmer Blue/Black (PM50167E1)Irganox 1010Tinuvin 622	Pebax 5533 SA01 MEDCSRM016 Pigment Blue 36CSRM037 Pigment Violet 23CSRM035 Pigment Green 7Irganox 1010Tinuvin 622
Shaft Outer JacketDistal Segment (6)Pebax 72D Jacket	Pebax 7233 SA01 MEDTechmer Blue/Black (PM50167E1)Irganox 1010Tinuvin 622	Pebax 7233 SA01 MEDPebax 5533 SA01 MED(colorant carrier)CSRM016 Pigment Blue 36CSRM037 Pigment Violet 23CSRM035 Pigment Green 7Irganox 1010Tinuvin 622
Inner Lumen Liner	RAM extruded forming process;method by which the liner is formedinto its tubular shape	Film cast forming process; method bywhich the liner is formed into itstubular shape
ReinforcedCatheter Shaft	Stainless steel braid	Same as Predicate Device
RadiopaqueMarker Band	Distal tip Pt-Ir marker band	Same as Predicate Device
RadiopaqueMarker Locationfrom Distal Tip	1.3 mm	Same as Predicate Device
RadiopaqueMarker Length	0.031
Characteristics	Predicate Device:EMBOGUARD™ Balloon GuideCatheter	Subject Device:EMBOGUARD™ Balloon GuideCatheter
Balloon InflationLumen	Non-coaxial	Same as Predicate Device
Accessory DevicesProvided	Dilator (1)Rotating Hemostasis Valve (1)Peel Away Sheath (1)Luer-Activated Valve (1)	Same as Predicate Device
How Supplied	Sterile, Single Use	Same as Predicate Device
SterilizationMethod	EtO	Same as Predicate Device
Sterility AssuranceLevel	$10^{-6}$	Same as Predicate Device
Shelf Life	1 year	1 year

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VII. PERFORMANCE DATA Biocompatibility Testing:

The biocompatibility evaluation for the EMBOGUARD Balloon Guide Catheter device was conducted in accordance with ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process" and FDA biocompatibility guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"." The EMBOGUARD Balloon Guide Catheter device is categorized as an external communicating device with limited exposure with circulating blood (≤ 24 hours) per ISO 10993-1. All biocompatibility tests completed met the predetermined acceptance criteria as specified in the test protocol and in accordance with the requirements of the applicable standards. The biocompatibility evaluation included the following tests.

Biocompatibility Testing
Test	Test Method Summary	Results
Cytotoxicity Study	Tested in accordance with ISO 10993-5, Biological Evaluation of Medical Devices - Part 5: Tests for in vitro Cytotoxicity.	PassNon-cytotoxic according to the pre-determined acceptance criteria.
SensitizationStudy	Tested in accordance with ISO 10993-10, Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization, Kligman and Magnusson Maximisation Test.	Pass,Did not elicit a sensitization response according to the pre-determined acceptance criteria.
IntracutaneousIrritation	Tested in accordance with ISO 10993-10,Biological Evaluation of Medical Devices -Part 10: Tests for Irritation and SkinSensitization.	PassTest requirements forintracutaneous reactivity weremet according to the pre-determined acceptancecriteria.
Acute SystemicToxicity	Tested in accordance with ISO 10993-11,Biological Evaluation of Medical Devices -Part 11: Tests for Systemic Toxicity.	PassTest requirements for systemictoxicity were met according tothe pre-determined acceptancecriteria.
Pyrogenicity -Material-MediatedRabbit Pyrogen	Tested in accordance with ISO 10993-11,Biological Evaluation of Medical Devices -Part 11: Tests for Systemic Toxicity andUSP <151> Pyrogen Test.	PassNon-pyrogenic, met the pre-determined acceptancecriteria.
Hemolysis Study	Tested in accordance ASTM F756-17,Standard Practice for Assessment ofHemolytic Properties of Materials and ISO10993-4, Biological Evaluation of MedicalDevices - Part 4: Selection of Tests forInteractions with Blood, Tests forHemolytic Properties, Direct and IndirectMethods.	PassNon-hemolytic, met the pre-determined acceptancecriteria.
SC5b-9 ComplementActivation Study	Tested in accordance with ISO 10993-4,Biological Evaluation of Medical Devices -Part 4: Selection of Tests for Interactionswith Blood, SC5b-9 ComplementActivation.	PassDoes not activate thecomplement system, met thepre-determined acceptancecriteria.
ASTM PartialThromboplastin Time(PTT)	Tested in accordance with ISO 10993-4,Biological Evaluation of Medical Devices -Part 4: Selection of Tests for Interactionswith Blood.	PassDemonstrates similarthromboresistancecharacteristic as the controldevice, met the pre-determined acceptancecriteria.
Platelet andLeukocyte Count	Tested in accordance with ISO 10993-4,Biological Evaluation of Medical Devices -Part 4: Selection of Tests for Interactionswith Blood.	PassDemonstrates similarthromboresistancecharacteristic as the controldevice, met the pre-determined acceptancecriteria.

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Sterilization and Shelf Life:

The EMBOGUARD Balloon Guide Catheter device is labelled as a single-use, sterile device, with a shelf life of 1 year. Previous testing with the predicate device has demonstrated that the sterilization process for the EMBOGUARD Balloon Guide Catheter device has been successfully validated and process monitoring controls are in place to assure that the device is EO-sterilized to achieve a minimum sterility assurance level (SAL) of 10-6. The changes made to the EMBOGUARD Balloon Guide Catheter do not impact its sterilization.

Shelf-life studies have been conducted on the EMBOGUARD Balloon Guide Catheter device and established that the product and packaging remain functional and sterile for the shelf-life period of 1 year.

In Vitro (Bench) Testing:

Performance bench testing was conducted according to existing test methods previously reviewed by FDA in the predicate submission (K212340). A description of each performance test used to support substantial equivalence determination is presented below.

Performance Bench Testing
Test	Description	Reference Standard	Results
Balloon Inflation / Deflation Time	To demonstrate the balloon meets the inflation and deflation time specifications.	FDA guidance Certain PTCA Catheters:2010; §VIII.A6 Balloon Inflation and Deflation Time	Pass All samples met the pre-determined acceptance criteria.
Balloon Fatigue	To demonstrate that there is no leakage or damage to the balloon after 20 inflation cycles.	FDA guidance Certain PTCA Catheters:2010; §VIII.A4 Balloon Fatigue (Repeat Balloon Inflations)	Pass All samples met the pre-determined acceptance criteria.
Balloon Outer Diameter (OD) and Compliance	To demonstrate that the product meets the maximum recommended inflation volume vs. balloon diameter specifications.	FDA guidance Certain PTCA Catheters:2010; §VIII.A5 Balloon Compliance (Diameters vs. Pressure)	Pass All samples met the pre-determined acceptance criteria.
BalloonConcentricity	To demonstrate that theproduct meets the balloondiameter specification oneach side at therecommended inflationvolume when rotated 360°.	FDA guidance Certain PTCACatheters:2010; §VIII.A5 BalloonCompliance (Diameter vs. Pressure)	PassAll samples met thepre-determinedacceptance criteria.
Balloon Burst	To demonstrate that theballoon is capable ofwithstanding an injectionvolume of 2x and 2.5xrecommended inflationvolume.	N/A	PassAll samples met thepre-determinedacceptance criteria.
Introducer SheathCompatibility(Insertion andWithdrawal)	To demonstrate thatthe product meets therequired insertion andwithdrawal force withoutproduct damage.	N/A	PassAll samples met thepre-determinedacceptance criteria.
Introducer SheathCompatibility (Re-insertion and Re-withdrawal)	To demonstrate deviceintegrity is maintained postre-insertion and re-withdrawal.	N/A	PassAll samples met thepre-determinedacceptance criteria.
Inner LumenIntegrity - Pressure	To demonstrate that theproduct meets the pressurerequirements.	ISO 10555-1:2013 Intravascular catheters- Sterile and single-use catheters - Part 1:General requirementsFDA guidance Certain PTCACatheters:2010; §VIII.B.1 Catheter BodyBurst Pressure	PassAll samples met thepre-determinedacceptance criteria.
Inner LumenIntegrity -Aspiration	To demonstrate that theproduct meets theaspiration air leakagerequirements and will notcollapse under aspiration.	ISO 10555-1:2013 Intravascular catheters- Sterile and single-use catheters - Part 1:General requirementsFDA guidance Certain PTCACatheters:2010; §VIII.B.1 Catheter BodyBurst Pressure	PassAll samples met thepre-determinedacceptance criteria.
CatheterDeliverabilityandWithdrawal Force	To demonstrate that devicemeets the required trackingforce specification.	N/A	PassAll samples met thepre-determinedacceptance criteria.
Flexibility andKink Resistance	To demonstrate thatthe product hasacceptable flexibility andkink resistance whenwrapped around a seriesof mandrels.	FDA guidance Certain PTCACatheters:2010; §VIII.A.9 Flexibility andKink Test	PassAll samples met thepre-determinedacceptance criteria.
Kink to Failure	To determine the bendradius at which catheterkink occurs, as it is bentaround mandrels ofdecreasing radii.	Characterization onlyFDA guidance Certain PTCACatheters:2010; §VIII.A.9 Flexibility andKink Test	PassAll samples met thepre-determinedacceptance criteria.
Torque Durability	To demonstrate thattheproduct is capable of360degrees of rotation of thehub while the distal tip is fixedin position.	FDA guidance Certain PTCACatheters:2010; §VIII.A.10 TorqueStrengthFDA guidance "Coronary, Peripheraland Neurovascular Guidewires -Performance Tests and RecommendedLabeling":2019	PassAll samples met thepre-determinedacceptance criteria.
Torque to failure	The number of rotations of theproximal hub requiredtoinitiate device failure, includingseparation, when the distal endis held stationary.	FDA guidance "Coronary, Peripheral andNeurovascular Guidewires – PerformanceTests and Recommended Labeling":2019FDA guidance Certain PTCACatheters:2010; §VIII.A.10 TorqueStrength	PassAll samples met thepre-determinedacceptance criteria.
Visual Inspection	To demonstrate the productsatisfies the visual surfacerequirements.	ISO 10555-1:2013 Intravascular Catheters-Sterile and single-use catheters - Part 1:General requirements	PassAll samples met thepre-determinedacceptance criteria.
Particulates	This study was conducted todetermine the quantity andsize of particles generatedduring simulated use.	Characterization only	PassThe particulates fromthe subject deviceand the predicatewere evaluated andfound comparable.
Tensile Strength	To demonstrate the productsatisfies the tensile strengthrequirements for bonds andtip pull test.	ISO 10555-1:2013 Intravascular Catheters-Sterile and single-use catheters - Part 1:General requirements.FDA guidance Certain PTCA Catheters:2010;§VIII.A.7 Catheter Bond Strength, §VIII.A.8Tip Pull Test	PassAll samples met thepredeterminedacceptance criteria.
Tip Stiffness	To demonstrate that thestiffness of the distal end ofthe product is similar topredicate device.	N/A	PassThe tip deflectionforce of the subjectdevice wasevaluated andfound comparableto the predicate

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Animal Studies:

No animal study was deemed necessary to evaluate the changes to the subject device and demonstrate substantial equivalence to the predicate device.

Clinical Studies:

No clinical study was deemed necessary to demonstrate substantial equivalence between the subject and predicate device.

VIII. CONCLUSIONS

The subject device has the same intended use and similar technological characteristics as the predicate device. The differences in technological characteristics do not raise new questions of safety and effectiveness. Non-clinical studies conducted demonstrate that the EMBOGUARD™ Balloon Guide Catheter Device is substantially equivalent to the predicate device.

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).