For use in the peripheral and neuro vasculature where temporary occlusion is desired. The balloon catheter provides temporary vascular occlusion which is useful in selectively stopping or controlling blood flow. The balloon catheter also offers balloon assisted embolization of intracranial aneurysms.

For use in the peripheral vasculature for the delivery of diagnostic agents, such as contrast media, that have been approved or cleared for use in the peripheral vasculature and are compatible with the inner lumen of the Scepter Mini Occlusion Balloon Catheter.

For neurovascular use for the delivery of diagnostic agents, such as contrast media, and liquid embolic agents that have been approved or cleared for use in the neurovasculature and are compatible with the inner lumen of the Scepter Mini Occlusion Balloon Catheter.

Device Description

Scepter Mini Occlusion Balloon Catheter is a dual co-axial lumen balloon catheter. The catheter is designed to track over a steerable guidewire. The outer lumen is used for the inflation of the balloon independent of guidewire position. The inner lumen can be used to deliver diagnostic agents or liquid embolics to distal locations in tortuous anatomy. Radiopaque marker bands are located at each end of the balloon to facilitate fluoroscopic visualization. The outer surface of the catheter is coated with a hydrophilic polymer to increase lubricity. A luer fitting on the microcatheter hub is used for the attachment of accessories. The catheter is packaged sterile for single use only.

The Scepter Mini has similar indications for use as the predicates, however, incorporates several minor design differences. The Scepter Mini has a slightly longer length and a slightly smaller diameter. The balloon of the Scepter Mini is slightly shorter. The distal tip of the Scepter Mini extends a shorter distance from the distal end of the balloon than that of the Scepter C and XC. For the Scepter Mini, the purge hole is covered by a semi-permeable membrane designed to allow air to escape while preventing liquids from passing. The predicate Scepter C and XC incorporate 3 radiopaque marker bands, while the design of the Scepter Mini allows for visualization under fluoroscopy with only 2 radiopaque marker bands (due to shorter distal tip segment). All Scepter catheters have a hydrophilic coating.

AI/ML Overview

This document is a 510(k) Pre-market Notification for the Scepter Mini Occlusion Balloon Catheter, seeking to demonstrate its substantial equivalence to previously cleared predicate devices. The study detailed is a set of verification and validation tests, and a summary of an animal study, used to support this claim.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides a comprehensive table of "Verification Test Summary" where each test description implicitly defines the acceptance criteria by stating the desired outcome (e.g., "does not break," "does not leak," "pass") and then reports that the subject device "Pass"ed. For many tests, it explicitly states that the device "meets the same specification as predicates Scepter C/XC (K121785)."

Test Description	Acceptance Criteria (Implied / Explicit)	Reported Device Performance
Sterility	Meets sterility assurance level (SAL 10-6) per ISO 11135-1. EtO and ECH residual levels are ≤ 0.2 mg per device per ISO 10993-7. Bacterial endotoxin test results < 0.06 EU/mL (< 2.15 EU/Device) per USP <161>.	Pass
Physical Attributes	Meets design specifications.	Pass
Force at break	Does not break during use and meets same specification as predicates Scepter C/XC (K121785).	Pass
Freedom from Leakage – Fluids (low pressure, long duration)	Does not leak fluids at low pressure/long duration and meets same specification as predicates Scepter C/XC (K121785).	Pass
Freedom from Leakage – Air	Air does not leak into subject device meeting same specification as predicates Scepter C/XC (K121785).	Pass
Freedom from Leakage - Liquid (high pressure, short time)	Does not leak fluids at high pressure/short duration and meets same specification as predicates Scepter C/XC (K121785).	Pass
Burst Pressure of Catheter	Does not burst statically below rated burst pressure meeting same specification as predicates Scepter C/XC (K121785).	Pass
Gauging Test	Catheter luer compatible to other standard luer fittings. (Data leveraged from predicate Scepter C (K110741, K121785) due to the same hub design).	Pass
Separation Force	Catheter luer compatible to other standard luer fittings. (Data leveraged from predicate Scepter C (K110741, K121785) due to the same hub design).	Pass
Unscrewing Torque	Catheter luer compatible to other standard luer fittings. (Data leveraged from predicate Scepter C (K110741, K121785) due to the same hub design).	Pass
Ease of Assembly	Subject device luer mates together with other compatible fittings.	Pass
Resistance to Overriding	Catheter luer mates with other compatible fittings. (Data leveraged from predicate Scepter C (K110741, K121785) due to the same hub design).	Pass
Stress Cracking	Catheter hub does not leak. (Data leveraged from predicate Scepter C (K110741, K121785) due to the same hub design).	Pass
Durability of Hydrophilic Coating	Hydrophilic coating does not flake off during use, is of the same material and meets same specification as predicates Scepter C/XC (K121785).	Pass
Lubricity of Hydrophilic Coating	Hydrophilic coating is lubricious, of the same material and meets same specification as predicates Scepter C/XC (K121785).	Pass
Simulated Use	Demonstrated equivalent performance during simulated use with similar ratings to predicates Scepter C/XC (K121785).	Pass
Compatibility with device/agents: Embolic material, contrast media, dimethyl sulfoxide (DMSO).	Subject device is compatible with embolic material, contrast media, and DMSO, meeting same specification as predicates Scepter C/XC (K121785).	Pass
Dynamic Burst Pressure	Does not burst dynamically below rated burst pressure and meets same specification as predicates Scepter C/XC (K121785).	Pass
Radio-Detectability	Radiopaque marker bands are visualized under fluoroscopy.	Pass
Kink resistance	Does not kink during normal use meeting same specification as predicates Scepter C/XC.	Pass
Non-pyrogenic	Bacterial endotoxins level is less than 2.15 EU/device.	Pass
Simulated Shipping and Packaging Testing	No defects that compromise integrity of package, meets seal strength, creep to burst, and dye penetration specification.	Pass
Catheter Flexural Fatigue	Meets same specification as predicates Scepter C/XC (K121785) for flexural fatigue, pressure integrity, and hoop stress.	Pass
In Vivo Testing (Histopathology evaluation)	No significant differences between the Scepter C balloon catheter and the control catheter in categories of performance and histopathologic evaluation. No denudation, perforation, dissection, or clinicant injury to the target vasculature.	Pass
Balloon Rated Burst Volume	Does not burst during use meeting same specification as predicates Scepter C/XC (K121785).	Pass
Balloon Compliance (rated volume)	Consistently inflates to the desired OD meeting same specification as predicates Scepter C/XC (K121785).	Pass
Balloon Inflation/Deflation Times	Inflates and deflates within an acceptable time range meeting same specification as predicates Scepter C/XC (K121785).	Pass
Balloon Fatigue Test	Does not burst before acceptable minimum cycle(s) meeting same specification as predicates Scepter C/XC (K121785).	Pass
Torque Test	Maintains acceptable torque during use meeting same specification as predicates Scepter C/XC (K121785).	Pass
Packaging and Shelf Life	Sterile barrier is maintained during shelf life of product.	Pass
Insertion tool performance: Ease to enter RHV.	Ease to enter RHV rated 3 or higher in tested category meeting same specification as predicates Scepter C/XC (K121785).	Pass
Decay Test	Balloon maintains rated burst OD for a minimum of 30 min meeting same specification as predicates Scepter C/XC (K121785).	Pass
Surface Contamination	No Contamination (no uncured coating, particulate greater than 0.02 mm², sharp edges, and embedded particulate).	Pass
Corrosion Resistance	Metallic components show no signs of corrosion. (Data leveraged from reference device Headway 17 (K083343)).	Pass
Catheter Particle Testing	Less than 25 particles greater than 10 microns and less than 3 particles greater than 25 microns per 1mL meeting same specification as predicates Scepter C/XC (K121785).	Pass
Cytotoxicity - Medium Eluate Method	Non-cytotoxic (between no cell lysis (grade 0) to slight reactivity (grade 1)).	Non-cytotoxic
Sensitization: Maximization Test in Guinea Pigs	Non-sensitizer (no irritation present on test or negative control guinea pigs).	Non-sensitizer
Intracutaneous Reactivity	Non-irritating (no evidence of irritation (score 0.0)).	Non-irritating
Systemic Injection Test in Mice	Systemically non-toxic (no weight loss, mortality, or evidence of systemic toxicity).	Systemically non-toxic
Rabbit Pyrogen Test	Nonpyrogenic (rise of rabbit temperatures during three hours of observation did not exceed 0.5 ℃).	Nonpyrogenic
ASTM Blood Compatibility - Direct and Indirect Contact Hemolysis	Non-hemolytic (0.59% hemolysis in direct contact and 1.25% hemolysis in indirect contact).	Non-hemolytic
Unactivated Partial Thromboplastin Time Test	No effect on clotting (average clotting time of the test article showed no significant difference from the control).	No effect on clotting
Complement Activation	Non-activated (plasma exposed to test article for 90 minutes exhibited no statistically significant increase in SC5b-9).	Non-activated
In Vitro Hemocompatibility Test - Human Blood, Direct Contact	No effect on hematological parameters (concentration of White Blood Cells (WBC) and Platelets in human blood exposed to the test article was not statistically significantly decreased).	No effect on hematological parameters
Salmonella thvpimurium and Escherichia coli Reverse Mutation Assay	Non-mutagenic (test article extracts did not induce a statistically significant increase in the number of revertant colonies).	Non-mutagenic
Mouse Lymphoma Mutagenesis Assay	Non-mutagenic (increased mutant frequency (IMF) of the cells exposed to the test article extracts was less than the Global Evaluation Factor (GEF) 126 x 10^-6).	Non-mutagenic
Rodent Blood Micronucleus Assay	No clastogenic effect (test article did not result in a statistically significant increase in the percentage of reticulocytes containing micronuclei).	No clastogenic effect

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

Verification Tests: The document doesn't explicitly state the sample sizes for each individual mechanical or physical verification test. However, it indicates these tests were performed on the "subject device" (Scepter Mini Occlusion Balloon Catheter). The provenance of this data is MicroVention, Inc.'s internal testing/laboratories. This data is likely prospective, generated specifically for this submission.
Animal Study (In Vivo Testing): The animal study used for the "In Vivo Testing" was performed using the predicate device Scepter C in an "acute swine animal model." The exact number of swine used is not explicitly stated in this summary, but it implies multiple animals ("compared with a commercially equivalent device"). The data provenance is from this predicate device study. This would be prospective data for the predicate, but retrospective in its application to the subject device.

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

The document does not mention expert involvement in establishing ground truth for the mechanical, physical, or biocompatibility tests. These are objective, quantitative tests with defined pass/fail criteria.
For the animal study, the "histopathologic evaluation" implies assessment by a qualified pathologist. However, the exact number of experts or their specific qualifications (e.g., "veterinary pathologist with X years of experience") are not specified in this summary.

4. Adjudication Method for the Test Set:

For the technical verification tests, the results are objective (numerical values meeting specifications, or physical observations like "no leak," "no break"). An adjudication method is not applicable in the sense of expert consensus on ambiguous findings, as the tests produce clear pass/fail outcomes against predefined criteria.
For the animal study's histopathologic evaluation, it's not specified if multiple pathologists reviewed slides or if an adjudication method was used for discrepancies.

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 MRMC study was performed. This submission is for a physical medical device (balloon catheter), not an artificial intelligence (AI) or software as a medical device (SaMD) that typically relies on human reader performance. Therefore, there is no AI component, and no effect size regarding human reader improvement with AI assistance is relevant or reported.

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

Does not apply. This is a physical medical device; there is no AI algorithm to evaluate.

7. The Type of Ground Truth Used:

Verification Tests (Mechanical, Physical, Chemical): The ground truth for these tests is based on engineering specifications, industry standards (e.g., ISO), and regulatory requirements (e.g., USP). These are objective, measurable outcomes.
Biocompatibility Tests: Ground truth is established based on pre-defined biological responses (e.g., lack of cytotoxicity, non-irritating, non-pyrogenic) as per ISO 10993-1:2009 and FDA guidelines.
Animal Study (In Vivo Testing): The ground truth for the efficacy and safety during the in-vivo performance characteristics and histopathology evaluation is based on direct observation in the animal model and subsequent pathological examination of tissues for injury or adverse events. This could be considered pathology and in-vivo observational data.

8. The Sample Size for the Training Set:

Does not apply. This is a physical medical device, not a machine learning model; therefore, there is no "training set."

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

Does not apply. There is no training set for this type of device submission.

Summary

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Image /page/0/Picture/0 description: The image contains 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 10, 2019

MicroVention, Inc. Marina Emond Senior Manager, Regulatory Affairs 35 Enterprise Aliso Viejo, California 92656

Re: K182829

Device Name: Scepter Mini Occlusion Balloon Catheter Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: MJN, DQY Dated: June 7, 2019 Received: June 10, 2019

Dear Marina Emond:

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

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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 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 medical devices and radiation-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,

Xiaolin Zheng, 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) K182829

Device Name Scepter Mini Occlusion Balloon Catheter

Indications for Use (Describe) The Scepter Mini Occlusion Balloon Catheter is intended:

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

Trade Name:	Scepter Mini Occlusion Balloon Catheter
Generic Name:	Percutaneous Catheter
Classification:	Class II, 21 CFR 870.4450 (MJN) and 21 CFR 870.1250 (DQY)
Submitted By:	MicroVention, Inc.35 EnterpriseAliso Viejo, California 92656, USA
Contact:	Marina EmondSenior Manager, Regulatory AffairsMarina.Emond@Microvention.com(714) 247-8296
Date:	October 4, 2018
Predicate Device:	Scepter C Occlusion Balloon Catheter (K110741, K121785)
	Scepter XC Occlusion Balloon Catheter (K113698, K121785)
Reference Device:	Headway 17 Microcatheter (K083343)

Device Description:

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Scepter Mini is slightly shorter. The distal tip of the Scepter Mini extends a shorter distance from the distal end of the balloon than that of the Scepter C and XC. For the Scepter Mini, the purge hole is covered by a semi-permeable membrane designed to allow air to escape while preventing liquids from passing. The predicate Scepter C and XC incorporate 3 radiopaque marker bands, while the design of the Scepter Mini allows for visualization under fluoroscopy with only 2 radiopaque marker bands (due to shorter distal tip segment). All Scepter catheters have a hydrophilic coating.

Indications for Use:

The Scepter Mini Occlusion Balloon Catheter is intended:

Technological Characteristics and Product Feature Comparison:

The subject device, Scepter Mini Occlusion Balloon Catheter, is substantially equivalent to the predicate devices in terms of:

Intended use
· Scientific technology
Fundamental design
· Materials and processes for packaging and sterilization of devices

A tabular comparison of the technological characteristics between the predicate devices and subject device is provided below.

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DeviceCharacteristics	Scepter C OcclusionBalloon Catheter(K110741, K121785)	Scepter XC OcclusionBalloon Catheter(K113698, K121785)	Scepter Mini OcclusionBalloon Catheter(Subject Device)
DeviceClassification/Product Code	Class II/ DQY(Percutaneous catheters)	Class II/ DQY(Percutaneous catheters)	Class II/ DQY(Percutaneous catheters)
Intended Use	Intended for use in the blood vessels of the peripheraland neurovasculature where temporary occlusion isdesired. These catheters offer a vessel selectivetechnique of temporary vascular occlusion which isuseful in selectively stopping or controlling blood flowand for balloon assisted embolization of intracranialaneurysms.Intended for use in the peripheral vasculature for theinfusion of diagnostic agents, such as contrast media,and therapeutic agents, such as embolization materials.It is intended for neurovascular use for the infusion ofdiagnostic agents, such as contrast media, andtherapeutic agents, such as embolization materials, thathave been approved or cleared for use in theneurovasculature and are compatible with the innerdiameter of the Scepter C/XC Occlusion BalloonCatheters.	Intended for use in the blood vessels of the peripheraland neurovasculature where temporary occlusion isdesired. These catheters offer a vessel selectivetechnique of temporary vascular occlusion which isuseful in selectively stopping or controlling blood flowand for balloon assisted embolization of intracranialaneurysms.Intended for use in the peripheral vasculature for theinfusion of diagnostic agents, such as contrast media,and therapeutic agents, such as embolization materials.It is intended for neurovascular use for the infusion ofdiagnostic agents, such as contrast media, andtherapeutic agents, such as embolization materials, thathave been approved or cleared for use in theneurovasculature and are compatible with the innerdiameter of the Scepter C/XC Occlusion BalloonCatheters.	Similar Intended UseFor use in the peripheral andneuro vasculature wheretemporary occlusion is desired.The balloon catheter providestemporary vascular occlusionwhich is useful in selectivelystopping or controlling bloodflow. The balloon catheter alsooffers balloon assistedembolization of intracranialaneurysms.For use in the peripheralvasculature for the delivery ofdiagnostic agents, such ascontrast media, that have beenapproved or cleared for use inthe peripheral vasculature andare compatible with the innerlumen of the Scepter MiniOcclusion Balloon Catheter.For neurovascular use for thedelivery of diagnostic agents,such as contrast media, andliquid embolic agents that havebeen approved or cleared foruse in the neurovasculature andare compatible with the innerlumen of the Scepter MiniOcclusion Balloon Catheter.
Catheter OD	Proximal = 2.8 FrDistal = 2.6 Fr	Proximal = 2.8 FrDistal = 2.6 Fr	Proximal = 2.8 FrDistal = 1.6 Fr
DeviceCharacteristics	Scepter C OcclusionBalloon Catheter(K110741, K121785)	Scepter XC OcclusionBalloon Catheter(K113698, K121785)	Scepter Mini OcclusionBalloon Catheter(Subject Device)
Inner Lumen	0.0165"	0.0165"	0.0100" - 0.0155"
Diameter	(0.419 mm)	(0.419 mm)	(0.254 mm - 0.394 mm)
(Distal toProximal)	Un-tapered inner lumen	Un-tapered inner lumen	Tapered inner lumen
			The Scepter Mini's inner lumenincorporates a taper in order toachieve a 1.6F distal OD, whilethe inner lumen of Scepter Cand XC is straight.
Lumenconfiguration	Dual coaxial lumen	Dual coaxial lumen	Same
Balloon Type	Compliant, Polyurethane	Extra Compliant,	Compliant, Polyurethane
	Elastomeric	Polyurethane Elastomeric	Elastomeric
BalloonDiameter	4 mm	4 mm	2.2 mm
Balloon Length	10, 15, 20 mm	11 mm	9 mm
Working Length	150 cm	150 cm	165 cm
RadiopaqueMarker Bands	3	3	2The predicate Scepter C andXCincorporate 3 radiopaquemarker bands, while theScepter Mini allows forvisualization under fluoroscopywith 2 radiopaque markerbands (due to the shorter distaltip segment).
Air Purge	Purge hole	Purge hole	The air purge hole is covered bya semi-permeable membranedesigned to allow the removalof air from the balloon whilepreventing escape of inflationliquids.
Shaping Mandrel	Included in singlecatheter package	Included in single catheterpackage	NoneThe Scepter Mini distal tip isnotshapeable therefore noshaping mandrel is provided.
Introducer sheath	Included in singlecatheter package	Included in single catheterpackage	Same
GuidewireCompatibility	0.014" wire or smaller	0.014" wire or smaller	0.008" or smaller
DeviceCharacteristics	Scepter C OcclusionBalloon Catheter(K110741, K121785)	Scepter XC OcclusionBalloon Catheter(K113698, K121785)	Scepter Mini OcclusionBalloon Catheter(Subject Device)
Coating	Hydrophilic Coating	Hydrophilic Coating	Same
Hub	2 port design	2 port design	Same
Strain Relief	Dynaflex material	Dynaflex material	Pebax material
PackagingMaterial	Dispenser hoop: PolyethyleneMounting card: PolyethylenePouch: TyvekCarton Box: Bleached Sulfate	Dispenser hoop: PolyethyleneMounting card: PolyethylenePouch: TyvekCarton Box: Bleached Sulfate	Same packaging with anadditional stylet inserted in theguide wire lumen for support ofthe catheter while beinginserted in the packaging hoop.The stylet is removed anddisposed of before use of thecatheter.
PackageConfiguration	Microcatheter is placed in a dispenser hoop andaccessories on a mounting card that is then insertedinto the pouch. The pouch is then placed inside acarton box.	Microcatheter is placed in a dispenser hoop andaccessories on a mounting card that is then insertedinto the pouch. The pouch is then placed inside acarton box.	Same packaging with anadditional stylet inserted in theguide wire lumen for support ofthe catheter while beinginserted in the packaging hoop.The stylet is removed anddisposed of before use of thecatheter.
Method ofSupplying	Sterile and single use	Sterile and single use	Same
Method ofSterilization	Ethylene oxide	Ethylene oxide	Same

Technological Characteristics Comparison of Subject Device with Predicate Device

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Verification Test Summary:

The results of verification and validation testing conducted on the subject device demonstrate that it performs as intended and are summarized as follows:

Test Description	Result
Sterility	Subject device is processed under the same sterilizationmethod (Ethylene Oxide) and meets the same sterilityassurance level (SAL 10-6) as predicates Scepter C/XC(K121785).Validation of the EtO sterilization method for Scepter Miniwas conducted in accordance with requirements of ISO11135-1, using the overkill method.The EtO and ECH residual levels were 0.2 mg per devicerespectively, meeting the residual levelrequirements per ISO 10993-7.The bacterial endotoxin test results were <0.01 EU/mLmeeting the specification of <0.06 EU/mL(<2.15 EU/Device) per USP <161>
Physical Attributes	PassPhysical dimensions of subject device meet designspecifications.
Force at break	PassSubject device does not break during use and meets samespecification for force at break as predicates Scepter C/XC(K121785).
Freedom from Leakage – Fluids (lowpressure, long duration)	PassSubject device does not leak fluids at low pressure/longduration and meets same specification for freedom fromleakage as predicates Scepter C/XC (K121785).
Freedom from Leakage – Air	PassAir does not leak into subject device meeting samespecification as predicates Scepter C/XC (K121785).
Freedom from Leakage - Liquid (highpressure, short time)	PassSubject device does not leak fluids at high pressure/shortduration and meets same specification for freedom fromleakage as predicates Scepter C/XC (K121785).
Test Description	Result
Burst Pressure of Catheter	PassSubject device does not burst statically below rated burstpressure meeting same specification as predicates ScepterC/XC (K121785).
Gauging Test	PassCatheter luer compatible to other standard luer fittings.Data leveraged from predicate Scepter C (K110741,K121785) due to the same hub design.
Separation Force	PassCatheter luer compatible to other standard luer fittings.Data leveraged from predicate Scepter C (K110741,K121785) due to the same hub design.
Unscrewing Torque	PassCatheter luer compatible to other standard luer fittings.Data leveraged from predicate Scepter C (K110741,K121785) due to the same hub design.
Ease of Assembly	PassSubject device luer mates together with other compatiblefittings.
Resistance to Overriding	PassCatheter luer mates with other compatible fittings.Data leveraged from predicate Scepter C (K110741,K121785) due to the same hub design.
Stress Cracking	PassCatheter hub does not leak.Data leveraged from predicate Scepter C (K110741,K121785) due to the same hub design.
Durability of Hydrophilic Coating	PassHydrophilic coating does not flake off during use, is of thesame material and meets same specification as predicatesScepter C/XC (K121785).
Test Description	Result
Lubricity of Hydrophilic Coating	PassHydrophilic coating is lubricious, of the same material andmeets same specification as predicates Scepter C/XC(K121785).
Simulated Use	PassSubject device demonstrated equivalent performanceduring simulated use with similar ratings to predicatesScepter C/XC (K121785).
Compatibility with device/agents:Embolic material, contrast media,dimethyl sulfoxide (DMSO).	PassSubject device is compatible with embolic material,contrast media, and DMSO, meeting same specification aspredicates Scepter C/XC (K121785).
Dynamic Burst Pressure	PassSubject device does not burst dynamically below ratedburst pressure and meets same specification as predicatesScepter C/XC (K121785).
Radio-Detectability	PassRadiopaque marker bands are visualized underfluoroscopy.
Kink resistance	PassSubject device does not kink during normal use meetingsame specification as predicates Scepter C/XC.
Non-pyrogenic	PassSubject device bacterial endotoxins level is lessthan 2.15 EU/device.
Simulated Shipping and PackagingTesting	PassSubject device showed no defects that compromiseintegrity of package, met seal strength, creep to burst, anddye penetration specification.
Catheter Flexural Fatigue	PassSubject device met same specification as predicatesScepter C/XC (K121785) for flexural fatigue, pressureintegrity, and hoop stress.
Test Description	Result
In Vivo Testing· In vivo performance characteristics• Histopathology evaluation	PassData from the predicate device Scepter C(K110741 ) used to support safety and performance of the subjectdevice due to its larger OD profile, higher stiffness andtrackability force.
Balloon Rated Burst Volume	PassBalloon does not burst during use meeting samespecification as predicates Scepter C/XC (K121785).
Balloon Compliance (rated volume)	PassBalloon consistently inflates to the desired OD meetingsame specification as predicates Scepter C/XC (K121785).
Balloon Inflation/Deflation Times	PassBalloon inflates and deflates within an acceptable timerange meeting same specification as predicates ScepterC/XC (K121785).
Balloon Fatigue Test	PassBalloon does not burst before acceptable minimumcycle(s) meeting same specification as predicates ScepterC/XC (K121785).
Torque Test	PassSubject device maintains acceptable torque during usemeeting same specification as predicates Scepter C/XC(K121785).
Packaging and Shelf Life	PassSterile barrier is maintained during shelf life of product.
Insertion tool performance: Ease toenter RHV.	PassEase to enter RHV rated 3 or higher in tested categorymeeting same specification as predicates Scepter C/XC(K121785).
Decay Test	PassBalloon maintains rated burst OD for a minimum of 30min meeting same specification as predicates ScepterC/XC (K121785).
Test Description	Result
Surface Contamination	PassSubject device samples were inspected for surfacecontamination for uncured coating, particulate greater than0.02 mm², sharp edges, and embedded particulate. Allsamples passed the acceptance criteria ofNo Contamination.
Corrosion Resistance	PassMetallic components show no signs of corrosion.Data leveraged from reference device Headway 17(K083343) as the metal components are of the samematerial.
Catheter Particle Testing	PassSubject device demonstrated less than 25 particles greaterthan 10 microns and less than 3 particles greater than 25microns per 1mL meeting same specification as predicatesScepter C/XC (K121785).

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Animal Testing Summary:

Evaluation of the in-vivo performance characteristics of the MicroVention Scepter balloon catheters was performed using the predicate device Scepter C in an acute swine animal model compared with a commercially equivalent device. There were no significant differences between the Scepter C balloon catheter and the control catheter in categories of performance and histopathologic evaluation. There was no denudation, perforation, dissection, or clinicant injury to the target vasculature where the test device and the control device maneuvered through the swine anatomy. The Scepter C is considered the worst case for the Scepter Balloon Catheters in terms of in-vivo performance characteristics due to its larger OD profile, higher stiffness and trackability force. The proposed Scepter Mini device has smaller outer diameter profile and, based on the stiffness data, is softer, easier to track, and is less traumatic to the vessel. Therefore, the animal study results were leveraged from the predicate device.

Biocompatibility Evaluation:

The in vitro and in vivo biocompatibility safety studies performed on the Scepter Mini Occlusion Balloon Catheter have demonstrated the biocompatibility of the proposed device and support compliance with the ISO 10993-1:2009 and FDA guidelines. The device was determined to be nonsensitizing, intracutaneously non-irritating, systemically non-toxic, non-pyrogenic (material-mediated),

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non-hemolytic, non-complement activating, non-mutagenic, have no effect on clotting and hematological parameters, and have no clastogenic effect. The results of biocompatibility evaluation are summarized as follows:

Test	Test Summary	Conclusions
Cytotoxicity -Medium EluateMethod	The test article extract exhibited between no cell lysis(grade 0) to slight reactivity (grade 1).	Non-cytotoxic
Sensitization:Maximization Testin Guinea Pigs	No irritation was present on any of the test or negativecontrol (0% sensitized) guinea pigs.	Non-sensitizer
IntracutaneousReactivity	No evidence of irritation (score 0.0).	Non-irritating
Systemic InjectionTest in Mice	No weight loss, mortality, or evidence of systemictoxicity from the extract exposure to the mice wasobserved.	Systemicallynon-toxic
Rabbit Pyrogen Test	The rise of rabbit temperatures during the three hoursof observation did not exceed 0.5 ℃.	Nonpyrogenic
ASTM BloodCompatibility -Direct and IndirectContact Hemolysis	The test article demonstrated 0.59% hemolysis in directcontact and 1.25% hemolysis in indirect contact.	Non-hemolytic
Unactivated PartialThromboplastinTime Test	An average clotting time of the test article showed nosignificant difference from the control.	No effect onclotting
ComplementActivation	The plasma exposed to the test article for 90 minutes wasfound to exhibit no statistically significant increase inSC5b-9.	Non-activated
In VitroHemocompatibilityTest -Human Blood,Direct Contact	The concentration of White Blood Cells (WBC) andPlatelets in human blood exposed to the test article wasnot statistically significantly decreased.	No effect onhematologicalparameters
Salmonellathvpimurium andEscherichia coliReverse MutationAssay	The test article extracts did not induce a statisticallysignificant increase in the number of revertant colonies.	Non-mutagenic
Mouse LymphomaMutagenesis Assay	The increased mutant frequency (IMF) of the cellsexposed to the test article extracts was less thanthe Global Evaluation Factor (GEF) 126 x 10-6.	Non-mutagenic
Rodent BloodMicronucleus Assay	The test article did not result in a statistically significant increase inthe percentage of reticulocytes containing micronuclei.	No clastogeniceffect

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Summary of Substantial Equivalence:

The information presented in this 510(k) demonstrates the substantial equivalence between the predicates and the Scepter Mini Occlusion Balloon Catheter with regard to the design, construction materials, operating principle and intended use.

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).