The ECLIPSE 2L is indicated for use in the blood vessels of the peripheral and neurovasculature where temporary occlusion is desired. These catheters offer a vessel selective technique of temporary vascular occlusion which is useful in selectively stopping or controlling blood flow and for balloon assisted embolization of intracranial aneurysms.

ECLIPSE 2L is indicated for use in the peripheral vasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic devices, such as embolization coils.

ECLIPSE 2L is also indicated for neurovascular use for the infusion of diagnostic agents, such as contrast media, and therapeutic devices, such as DMSO based embolization materials, that have been approved for use in the neurovasculature and are compatible with the diameter of the ECLIPSE 2L.

Device Description

ECLIPSE 2L balloon catheters are catheters with dual lumen arranged in a parallel configuration. The guidewire lumen or the working lumen is DMSO compatible and can be used for infusion/delivery of diagnostic and therapeutic devices. The inflation lumen is used for the inflation and deflation of the balloon. The inflation of the balloon can be achieved independently of the presence of the guidewire. ECLIPSE 2L balloon catheter is equipped with a non-detachable low inflation pressure super compliant balloon welded to the distal end of the catheter.

The ECLIPSE 2L balloon catheter incorporates 3-4 radiopaque markers. The radiopaque marker bands are located at the distal end of the working lumen and at either end of the balloon to facilitate fluoroscopic visualization during procedure. The short nose (SN) variant has an additional proximal marker located 3 cm from the distal tip of the catheter to aid in positioning detachable coils. The ECLIPSE 2L also has distal purge air from the balloon prior to use. The catheter and the outer surface of the balloon is coated with hydrophilic coating to reduce friction and increase lubricity. An introducer sheath is provided with the device as an accessory.

AI/ML Overview

The document provides acceptance criteria and study results for the ECLIPSE 2L device. Here is the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Performance Bench Testing
Corrosion Resistance	All test samples meet acceptance criteria.	All test samples met acceptance criteria.
Particulate Matter Characterization	All test samples meet acceptance criteria.	All test samples met acceptance criteria. Particulate matter characterization of the Subject Device was comparable to Predicate Device.
Coating Integrity and Adherence	All test samples meet acceptance criteria.	All test samples met acceptance criteria.
Compatibility and Coil Remodeling	No coating particulate shall be observed during and post simulated use.	All test samples met acceptance criteria.
Simulated Use/Coating Lubricity and Durability	No coating particulate shall be observed during and post simulated use. Overall performance comparable or better than competitor devices.	All test samples met the acceptance criteria. The overall performance of the Subject Device is equivalent or better than the Predicate Device.
Flow Rate	(For reference only)	Testing was conducted for reference only.
Dynamic Burst	Catheter hub and shaft junctions shall not burst.	All test samples met the acceptance criteria.
Liquid Leak	No liquid shall be leaking from hub and catheter shaft under pressure.	All test samples met the acceptance criteria.
Air Leak	Air bubbles shall not leak into the hub assembly during aspiration via syringe.	All test samples met the acceptance criteria.
Static Burst	Guidewire lumen shall not burst per specification.	All test samples met the acceptance criteria.
Torque Strength	Comparison of torque strength to Predicate Device.	All test samples met the acceptance criteria. The torque strength of the Subject Device is equivalent or better to the Predicate Device.
Physical Attributes	Dimensions inspect and measure per product specification.	All test samples met the acceptance criteria.
Dead Space Volume	(For reference only)	Testing was conducted for reference only.
Balloon Deflation Time	Determine time required to deflate balloon from rated burst volume.	All test samples met the acceptance criteria.
Balloon Compliance	Measure balloon OD while inflating incrementally to max rated inflation volume.	All test samples met the acceptance criteria.
Balloon Fatigue	No leakage or rupture after 20 inflation/deflation cycles to rated burst volume.	All test samples met the acceptance criteria.
Balloon Burst Volume	Determine burst volume by incrementally inflating until burst failure.	All test samples met the acceptance criteria.
Kink Resistance	No OD change or kinking when wrapped with appropriate pin gauge (180° turn), comparable to Predicate Device.	All test samples met the acceptance criteria. The kink resistance performance of the Subject Device is equivalent or better to the Predicate Device.
Surface Contamination	Entire catheter surface free of particulate under 2.5x magnification.	All test samples met the acceptance criteria.
Tensile Force	Peak tensile strength of distal tip ≥ 3N (for OD 0.55mm to 0.75mm); Peak tensile strength of catheter bonds ≥ 5N (for OD 0.75mm to 1.15mm).	All test samples met the acceptance criteria.
Gauge Test	Reference conical gauge and port opening align in limit planes; no rocking.	All test samples met the acceptance criteria.
Ease of Assembly	Satisfactory fit with inflation and guidewire ports and reference fittings.	All test samples met the acceptance criteria.
Unscrewing Torque	Port remains attached to reference fitting after specified unscrewing torque.	All test samples met the acceptance criteria.
Resistance to Overriding	Reference fitting does not override threads of port after specified torque.	All test samples met the acceptance criteria.
Separation Force	Port remains attached to reference fitting after specified max force.	All test samples met the acceptance criteria.
Stress Cracking	No evidence of stress cracks on the hub.	All test samples met the acceptance criteria.
Catheter Flexural Fatigue	Acceptable if Simulated Use, Dynamic Burst, Liquid Leakage, Air Leakage, Static Burst tests passed.	All test samples met the acceptance criteria.
DMSO Compatibility	Acceptable if Simulated Use, Dynamic Burst, Liquid Leakage, Air Leakage, Static Burst, Balloon Deflation, Balloon Compliance, Balloon Fatigue, Balloon Burst, Tensile Strength tests passed after DMSO Conditioning.	All test samples met the acceptance criteria.
Packaging Integrity Test
Visual Inspection	Packaging free of damage, seals free of defects, labels legible and intact.	All test samples met the acceptance criteria.
Bubble Leak Test	All samples must exhibit no leaks.	All test samples met the acceptance criteria.
Seal Strength	Perform seal strength test per ASTM F88/F88M-15.	All test samples met the acceptance criteria.
Performance Animal Testing
Animal Testing (GLP)	Evaluate in vivo performance, trackability, handling, radiopacity, and balloon occlusion, comparable to predicate devices.	All test samples met the acceptance criteria. Trackability and handling of the catheter, radiopacity, and the balloon test occlusion were comparable to predicate device.
Biocompatibility Testing
Cytotoxicity - Extraction	Average grade of 0 (no reactivity).	Non-cytotoxic
Sensitization - ISO Guinea Pig Maximization Sensitization Test	Sensitization response of “0”. No delayed sensitization.	Did not elicit sensitization response.
Irritation or Intracutaneous - ISO Intracutaneous Study in Rabbits	Differences in mean test and control scores of dermal observations ≤ 1.0.	Non-irritant
Acute Systemic Toxicity - ISO Acute Systemic Toxicity Study in Mice	No signs of toxicity, body weight changes within acceptable parameters.	Non-toxic
Systemic Toxicity - ISO Materials Mediated Rabbit Pyrogen	No temperature rise ≥ 0.5 °C.	Non-pyrogenic
Hemocompatibility-Hemolysis (Direct)	Test article in non-hemolytic range.	Non-Hemolytic
Hemocompatibility - ASTM Hemolysis (Extract Method)	Test article in non-hemolytic range.	Non-Hemolytic
Hemocompatibility – Complement Activation – SC5b-9	Statistically less activation than predicate device.	Passed
Hemocompatibility – Partial Thromboplastin Time (PTT)	Not statistically different from predicate device; clotting times similar. All acceptance criteria met.	Passed
Hemocompatibility – Platelet & Leukocyte Counts (PLC)	Not statistically significant (p>0.05) compared to comparison article.	Passed
Sterilization
Original Sterilization Validation and adoption	Validation demonstrated reliable and consistent sterilization to SAL of 10-6. Fractional, half, and full cycles met acceptance criteria. Subject device successfully adopted.	The validation study demonstrated that the sterilization process and equipment are capable of reliably and consistently sterilizing the devices to a minimum SAL of 10-6. Fractional cycles, half cycles, and full cycles met the acceptance criteria. The subject device was successfully adopted to the original sterilization validation by performing one (1) full cycle.
EO and ECH Residuals	Below limits specified in ISO 10993-7.	The residual traces of EO and ECH for the subject device are below the limits specified in ISO 10993-7.
Bacterial Endotoxin Levels	< 2.15 EU/device	< 2.15 EU/device
Shelf Life	All acceptance criteria met after accelerated aging.	All acceptance criteria were met after 1 year of accelerated aging.
Packaging	All acceptance criteria met after accelerated aging.	All acceptance criteria were met after 1 year of accelerated aging.

2. Sample sizes used for the test set and the data provenance
The document does not explicitly state specific sample sizes for each test in the acceptance criteria, nor does it specify data provenance (country of origin, retrospective/prospective). It generally states "All test samples" met the criteria. For animal testing, it mentions evaluation in an "acute porcine model."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The tests seem to rely on objective measurements and established standards (e.g., ISO, ASTM) rather than expert consensus on a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. The testing described involves bench and animal studies with objective measurements against predefined criteria, not diagnostic interpretation requiring adjudication.

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
This information is not applicable and not provided. The device (ECLIPSE 2L) is a physical medical device (occlusion balloon catheter), not an AI-powered diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided, as the device is a physical medical instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the performance and biocompatibility studies, the "ground truth" is based on:

Established industry standards: ISO, ASTM specifications (e.g., ISO 10555-1 for static burst, ISO 594 for gauge testing, ISO 10993 for biocompatibility, ISO 11135 for sterilization).
Predefined acceptance criteria: Specific quantitative and qualitative thresholds for various physical, chemical, and biological properties.
Comparison to predicate devices: For several performance aspects (e.g., particulate matter, simulated use, torque strength, kink resistance, animal testing trackability).
Direct measurement: For various physical attributes like dimensions, flow rates, burst volumes, and deflation times.
In vivo observation: For animal testing.

8. The sample size for the training set
This information is not applicable and not provided. The device is a physical product and does not involve a "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established
This information is not applicable and not provided, as there is no "training set" for this type of medical device.

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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 30, 2019

Balt USA, LLC Nancy Xu Regulatory Affairs Manager 29 Parker Irvine, California 92618

Re: K183045

Device Name: ECLIPSE 2L Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: MJN, DQY Dated: March 29, 2019 Received: April 1, 2019

Dear Nancy Xu:

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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K183045

Device Name ECLIPSE 2L

Indications for Use (Describe)

The ECLIPSE 2L is indicated for use in the blood vessels of the periovasculature where temporary occlusion is desired. These catheters offer a vessel selective technique of temporary vascular occlusion which is useful in selectively stopping or controlling blood flow and for balloon assisted embolization of intracranial aneurysms.

ECLIPSE 2L is indicated for use in the peripheral vasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic devices, such as embolization coils.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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ECLIPSE 2L 510(k) Summary

This 510(k) summary for ECLIPSE 2L is submitted in accordance with the requirements of 21 CFR 807.87(h) and 807.92 and following the recommendation outlined in FDA Guidance, The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notification [510(k)], dated 28 July, 2014.

SUBMITTER [807.92(a)(1)]

Balt USA, LLC 29 Parker Irvine CA 92618

Contact Person:	Nancy Xu
	Director of Regulatory Affairs
Telephone:	949-788-1443
E-mail:	nancy.xu@balt-usa.com
Date prepared:	April 29, 2019

DEVICE [807.92(a)(2)]

Name of Device:	ECLIPSE 2L
Common or Usual Name:	Occlusion Balloon Catheter
Classification Name:	Vascular ClampPercutaneous Catheter
Product Code:	MJNDQY
Regulatory Class:	Class II
Submission Type:	Traditional 510(k)
Regulation Number:	21 C.F.R. 870.445021 C.F.R. 870.1250
Reviewing Product Branch:	Division of Neurological and Physical Medicine Devices (Office ofDevice Evaluation, CDRH)

PREDICATE DEVICE [807.92(a)(3)]

Scepter C/XC Occlusion Balloon Catheter (K121785)

REFERENCE DEVICE

HyperGlide and HyperForm Occlusion Balloons (K101570)

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DEVICE DESCRIPTION [807.92(a)(4)]

INDICATIONS FOR USE [807.92(a)(5)]

ECLIPSE 2L is indicated for use in the peripheral vasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic devices, such as embolization coils.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS [807.92(a)(6)]

The technological characteristics of the ECLIPSE 2L is highly analogous to the technological characteristics of the Scepter C/XC Occlusion Balloon Catheter (K121785) and HyperGlide and HyperForm Occlusion Balloons (K101570). Substantial equivalence is determined based on the following similarities:

similar intended use/indications for use
Same principles of operation ●

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Same fundamental scientific technology .
Incorporate similar basic balloon catheter design .
Incorporate similar balloon catheter construction material .

Table 1 comprises the comparison between ECLIPSE 2L (Subject Device), Scepter C/XC Occlusion Balloon Catheter (Predicate Device, K121785) and HyperGlide and HyperForm Occlusion Balloons (Reference Device, K101570).

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Feature	Scepter C/XC Occlusion BalloonCatheter	HyperGlide and HyperFormOcclusion Balloons	ECLIPSE 2L
	[PREDICATE DEVICE][K121785]	[REFERENCE DEVICE][K101570]	[SUBJECT DEVICE]
Product Code	MJNDQY	MJN	Same as Predicate Device
Regulatory Class	Class II	Class II	Same as Predicate Device andReference Device
Regulation Number	21 CFR 870.445021 CFR 870.1250	21 CFR 870.4450	Same as Predicate Device
Regulation Name	Vascular ClampPercutaneous Catheter	Vascular Clamp	Same as Predicate Device
Generic Name	Occlusion Balloon Catheter	Occlusion Balloon Catheter	Same as Predicate Device andReference Device

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Indications for UseStatement
	For use in the blood vessels of theperipheral and neurovasculature wheretemporary occlusion is desired. Thesecatheters offer a vessel selectivetechnique of temporary vascularocclusion which is useful in selectivelystopping or controlling blood flow andfor balloon assisted embolization ofintracranial aneurysms.For use in the peripheral vasculature forthe infusion of diagnostic agents, suchas contrast media, and therapeuticagents, such as embolization materials.For neurovascular use for the infusionof diagnostic agents, such as contrastmedia, and therapeutic agents, such asembolization materials, that have beenapproved or cleared for use in theneurovasculature and are compatiblewith the diameter of the Scepter C/XCBalloon Catheter.	The ev3 Occlusion BalloonCatheters are indicated for use inblood vessels of the peripheral andneuro vasculature where temporaryocclusion is desired. These cathetersoffer a vessel selective technique oftemporary vascular occlusion, whichis useful in selectively stopping orcontrolling blood flow; theOcclusion Balloon Catheters mayalso be used in balloon-assistedembolization of intracranialaneurysms.	The ECLIPSE 2L is indicated foruse in the blood vessels of theperipheral and neurovasculaturewhere temporary occlusion isdesired. These catheters offer avessel selective technique oftemporary vascular occlusion whichis useful in selectively stopping orcontrolling blood flow and forballoon assisted embolization ofintracranial aneurysms.ECLIPSE 2L is indicated for use inthe peripheral vasculature for theinfusion of diagnostic agents, suchas contrast media, and therapeuticdevices, such as embolization coils.ECLIPSE 2L is also indicated forneurovascular use for the infusionof diagnostic agents, such ascontrast media, and therapeuticdevices, such as DMSO basedembolization materials, that havebeen approved for use in theneurovasculature and arecompatible with the diameter of theECLIPSE 2L.
Feature	Scepter C/XC Occlusion BalloonCatheter	HyperGlide and HyperFormOcclusion Balloons	ECLIPSE 2L
	[PREDICATE DEVICE][K121785]	[REFERENCE DEVICE][K101570]	[SUBJECT DEVICE]
Intended Use	For use in the blood vessels of theperipheral and neurovasculature wheretemporary occlusion is desired. Thesecatheters offer a vessel selectivetechnique of temporary vascularocclusion which is useful in selectivelystopping or controlling blood flow andalso offers balloon assistedembolization of intracranial aneurysms.For general intravascular use, includingthe peripheral and neurovasculature, forthe infusion of diagnostic agents, suchas contrast media, and therapeuticagents, such as embolization materials.	The ev3 Occlusion BalloonCatheters are intended for use in theperipheral and neuro vasculaturewherever temporary occlusion isdesired as well as for balloon-assisted embolization of intracranialaneurysms.	Same as Predicate Device.

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Lumen Configuration	Dual coaxial lumen	Single lumen	Dual Lumen (parallel)
Guidewire LumenInner Diameter	0.0165"	Not Listed	0.0161" (guidewire lumen innerdiameter)
Outer Diameter	2.6-2.8F	Not Listed	Major OD: 3.3 F (1.1mm)Minor OD: 2.7 F (0.9mm)
Balloon Diameter	4 mm	3-7 mm	6 mm
Balloon Length	10-20 mm	7-30 mm	7-20 mm
Material	Polyether block amide, polyolefin,stainless steel, PTFE, polyurethaneelastomeric alloy, Pt alloy,polypropylene	Not Listed	Polyamide, Polyether BlockAmide, Estane, PTFE, TPE, Gold
Introducer Sheath	Yes	Not Listed	Same as Predicate Device
Shaping Mandrel	Yes	Not Listed	No
Distal Tip Shaping	Yes	Not Listed	No
GuidewireCompatibility	0.014" wire or smaller	0.010" wire	0.014" max
Method of Supply	Sterile and single use	Sterile and single use	Same as Predicate Device andReference Device

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PERFORMANCE DATA [807.92(b)]

Performance Bench Testing and Animal Testing: Results of the performance bench testing and animal testing (Table 2) indicate that ECLIPSE 2L (Subject Device) meets established performance requirements and is substantially equivalent for its intended use.

Performance Bench Testing
Tests	Test Method Summary	Results
Corrosion Resistance	The test article is immersed in sodiumchloride solution before being placed inboiling distilled or deionized water.Subsequently, the test article is examinedvisually for evidence of corrosion.	All test samples met acceptancecriteria.
Particulate MatterCharacterization	Particulate matter in injections of thesterilized device were quantified after pre-conditioning per IFU and simulated use.Particulate matter characterization of theSubject Device was compared to thePredicate Device.	All test samples met acceptancecriteria. Particulate mattercharacterization of the SubjectDevice was comparable toPredicate Device.
Coating Integrity andAdherence	Test samples were dyed and gone throughsimulated use testing. Inspect the coatingquality of the dyed catheter under amicroscope.	All test samples met acceptancecriteria.
Compatibility and CoilRemodeling	The compatibility of 6F Guide catheterwith microcatheter, balloon coiling and theuse of stent was evaluated and rated. Nocoating particulate shall be observed duringand post simulated use.	All test samples met acceptancecriteria.
Simulated Use/CoatingLubricity and Durability	The clinical use of the device in vitro usinga cerebrovascular benchtop model and thelubricity/durability of the coating wasevaluated and rated. No coating particulateshall be observed during and post	All test samples met theacceptance criteria. The overallperformance of the SubjectDevice is equivalent or betterthan the Predicate Device.
	simulated use. The overall performancewas compared to the competitor devices.
Flow Rate	The injection flow rate of saline andcontrast media of the device is measured.The flow rate is measured for reference.	Testing was conducted forreference only.
Dynamic Burst	Catheter hub and shaft junctions shall notburst when injected with saline andcontrast media under hydrostatic pressureby using an injection system.	All test samples met theacceptance criteria.
Liquid Leak	Devices were tested for liquid leakage. Noliquid shall be leaking from hub andcatheter shaft under pressure.	All test samples met theacceptance criteria.
Air Leak	Devices were tested for air leakage. Airbubbles shall not leak into the hubassembly during aspiration via syringe.	All test samples met theacceptance criteria.
Static Burst	Perform static burst testing per ISO 10555-1. The guidewire lumen shall not burst perspecification.	All test samples met theacceptance criteria.
Torque Strength	Torque strength was determined by numberof turns-to-failures. Torque strength of theSubject Device was compared to thePredicate Device.	All test samples met theacceptance criteria. The torquestrength of the Subject Deviceis equivalent or better to thePredicate Device.
Physical Attributes	Inspect and measure dimensions for boththe catheter and the balloon per productspecification.	All test samples met theacceptance criteria.
Dead Space Volume	Determine the dead space volume for boththe guidewire lumen and inflation lumenby using syringe and syringe pump.	Testing was conducted forreference only.
Balloon Deflation Time	Perform balloon deflation time testing bydetermining the time required to deflate theballoon from the rated burst volume.	All test samples met theacceptance criteria.
Balloon Compliance	Perform balloon compliance testing bymeasuring the balloon OD while inflatingincrementally to the max rated inflationvolume.	All test samples met theacceptance criteria.
Balloon Fatigue	Perform balloon fatigue testing byevaluating the integrity of the test sampleafter repeated inflation cycles. No leakageor rupture shall be observed after 20 cycles(inflation/deflation) to rated burst volume.	All test samples met theacceptance criteria.
Balloon Burst Volume	Determine the burst volume of the testsamples by incrementally inflating theballoon with solution until burst failure.	All test samples met theacceptance criteria.
Kink Resistance	Perform kink resistance testing bywrapping the test point with an appropriatepin gauge to achieve a full 180° turn.Verify the OD has not changed and thecatheter is not kinked using a microscope.Kink resistance of the Subject Device wascompared to the Predicate Device.	All test samples met theacceptance criteria. The kinkresistance performance of theSubject Device is equivalent orbetter to the Predicate Device.
Surface Contamination	Test samples were visually inspected forsurface contamination under 2.5xmagnification. The entire catheter surfaceshould be free of presence of particulate.	All test samples met theacceptance criteria.
Tensile Force	Perform tensile force testing per ISO10555-1.Peak tensile strength of distal tipshould be ≥ 3N (OD ≥.55mm <.75mm) Peak tensile strength of catheter bondsshould be ≥ 5N (OD ≥.75mm < 1.15mm)	All test samples met theacceptance criteria.
Gauge Test	Perform gauge testing per ISO 594-1.Reference conical gauge and theinflation port opening should align inthe limit planes. No rocking should beevident between the reference gaugeand the fitting	All test samples met theacceptance criteria.
	Reference conical gauge and theguidewire port opening should align inthe limit planes. No rocking should beevident between the reference gaugeand the fitting.
Ease of Assembly	Perform ease of assembly testing per ISO594-2.A satisfactory fit is achieved with theinflation port and reference fitting.A satisfactory fit is achieved with theguidewire port and reference fitting.	All test samples met theacceptance criteria.
Unscrewing Torque	Perform unscrewing torque testing per ISO594-2.Inflation port shall remain attached tothe reference fitting after applying anunscrewing torque of $0.02+0/-0.002$Nm for 10 seconds minimum.Guidewire port shall remain attachedto the reference fitting after applyingan unscrewing torque of $0.02+0/-0.002$Nm for 10 seconds minimum.	All test samples met theacceptance criteria.
Resistance to Overriding	Perform resistance to overriding testing perISO 594-2.The reference fitting shall not overridethe threads of the inflation port afterapplying a minimum torque of 0.15Nm for 5 seconds.The reference fitting shall not overridethe threads of the guidewire port afterapplying a minimum torque of 0.15Nm for 5 seconds.	All test samples met theacceptance criteria.
Separation Force	Perform separation force testing per ISO594-2.Inflation port shall remain attached tothe reference fitting after applying amax force of 35N for 10 secondsminimum.	All test samples met theacceptance criteria.
	Guidewire port shall remain attached to the reference fitting after applying a max force of 35N max for 10 seconds minimum.
Stress Cracking	Perform stress cracking testing per ISO 594-2.There shall be no evidence of stress cracks on the hub.	All test samples met the acceptance criteria.
Catheter Flexural Fatigue	The catheter flexural fatigue should be acceptable if the following tests passed:Simulated Use Dynamic Burst Liquid Leakage Air Leakage Static Burst	All test samples met the acceptance criteria.
DMSO Compatibility	The device is DMSO Compatible if the following tests passed after DMSO Conditioning:Simulated Use Dynamic Burst Liquid Leakage Air Leakage Static Burst Balloon Deflation Balloon Compliance Balloon Fatigue Balloon Burst Tensile Strength	All test samples met the acceptance criteria.
Packaging Integrity Test
Visual Inspection	Visually inspect packaging for any signs of damage. All seals shall be free of incomplete seals, voids, channels, wrinkles, foreign material in the seal and/or over heated sections. Labels shall be legible and intact, with no damage or delamination.	All test samples met the acceptance criteria.
Bubble Leak Test	Perform bubble leak test per ASTMF2096-11. All samples must exhibit noleaks.	All test samples met theacceptance criteria.
Seal Strength	Perform seal strength test per ASTMF88/F88M-15.	All test samples met theacceptance criteria.
Performance Animal Testing
Animal Testing (GLP)	Animal testing is to evaluate the in vivoperformance of the device in an acuteporcine model. Trackability and handlingof the catheter, radiopacity, and the balloontest occlusion were assessed. Subjectdevice was compared to predicate devices.	All test samples met theacceptance criteria.Trackability and handling of thecatheter, radiopacity, and theballoon test occlusion werecomparable to predicate device.

Table 2: Performance Bench Testing and Animal Testing Summary

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Biocompatibility: Results of the biocompatibility testing (Table 3) indicate that ECLIPSE 2L (Subject Device) is biocompatible and is substantially equivalent for its intended use.

Test	Results	Conclusion
Cytotoxicity - ExtractionISO 10993-5	The test article extract showed no evidenceof lysed cells or intracytoplasmic granules,with an average grade of 0 (no reactivity).	Non-cytotoxic
Sensitization - ISO Guinea PigMaximization SensitizationTest-(2 Extracts)ISO 10993-10	The normal saline extract of the testmaterial had a sensitization response of “0”under valid test condition.The sesame oil extract of the test materialhad a sensitization response of “0” undervalid test condition.The test article did not elicit a sensitizationresponse. The topical application of thesesame oil extract evaluated at aconcentration of 100% did not inducedelayed sensitization in the guinea pig(grade 0).	Did not elicit sensitizationresponse
Irritation or Intracutaneous –ISO Intracutaneous Study inRabbits – Two ExtractsISO 10993-10	The differences in the mean test and controlscores of the extract dermal observationswere 1.0 or less, indicating that therequirements of the ISO IntracutaneousReactivity Test have been met by the testarticle	Non-irritant
Acute Systemic Toxicity – ISOAcute Systemic Toxicity Studyin Mice – Two Extracts	The vehicle control treated animals had nosigns of toxicity at any of the observationperiods and no animals lost weight in excessof 10%, indicating a valid test.	Non-toxic
ISO 10993-11	None of the test article treated animals wereobserved with clinical signs consistent withtoxicity at any of the observation periods.Body weight changes were withinacceptable parameters over the course of thestudy. These findings indicate that therequirements of the ISO Acute SystemicInjection Test have been met by the testarticle.	Non-toxic
Systemic Toxicity –ISO Materials Mediated RabbitPyrogenISO 10993-11	During the 3-hour observation period, noneof the rabbits administered with the testarticle extract had a temperature rise ≥ 0.5°C at the required observation time points.This response did not exceed the USP limitand meets the requirements for this test.Therefore, these results indicate that the testarticle was determined to be non-pyrogenic.	Non-pyrogenic
Hemocompatibility-Hemolysis(Direct)ISO 10993-4	The difference between the hemolyticindexes of the test article and the negativecontrol equals 0.00 percent. This resultplaced the test article in the non-hemolyticrange.	Non-Hemolytic
Hemocompatibility - ASTMHemolysis(Extract Method)ISO 10993-4	The difference between the hemolyticindexes of the test article and the negativecontrol equals 0.00 percent. This resultplaced the test article in the non-hemolyticrange.	Non-Hemolytic
Hemocompatibility –Complement Activation –SC5b-9ISO 10993-4	The test article result reported there wasstatistically less activation than that of thepredicate device.	Passed
Hemocompatibility – PartialThromboplastin Time (PTT)ISO 10993-4	The test article and the predicate devicewere not statistically different. The clottingtimes exhibited by the test article weresimilar when compared to the clotting timesexhibited by the predicate device. All theacceptance criteria were met.	Passed
Hemocompatibility – Platelet &Leukocyte Counts (PLC)ISO 10993-4	The platelet and leukocyte count of the testarticle were not statistically significant(one-way ANOVA, p>0.05) whencompared to the comparison article.Therefore, the statistical analysis indicatesthat the test article is comparable to thecomparison article.	Passed

Table 3: Biocompatibility Test Summary

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Shelf life: The accelerated shelf life testing for ECLIPSE 2L has been conducted (T=1 years accelerated aging) with test results confirmed that all acceptance criteria were met. No new questions of safety or effectiveness are raised. Based on the results, we can conclude that ECLIPSE 2L will perform as intended to the Design Specification. ECLIPSE 2L will be labeled for 1-year shelf life.

Packaging: The packaging validation, T=1 year accelerated aging was performed on the ECLIPSE 2L. The results from packaging testing conducted on ECLIPSE 2L showed that the acceptance criteria were met. Therefore, we can conclude the ECLIPSE 2L packaging will provide the adequate and effective protection and sterile barrier requirements.

Sterilization: ECLIPSE 2L is sterilized using 100% Ethylene Oxide (EO) gas in the same manner as FDA cleared predicate device, Scepter C/XC Occlusion Balloon Catheter (K121785) and HyperGlide and HyperForm Occlusion Balloons (K101570). ECLIPSE 2L is sold sterile, for single use and single patient only. The sterilization was performed and documented. The sterilization validation results showed that the sterilization dose and routine sterilization process was validated to achieve a SAL of 106 for the ECLIPSE 2L.

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Test Description	Test Summary	Results
Original SterilizationValidation and adoption	100% EO is used to sterilizethe device to achieve aminimum SAL of 10-6. Thevalidation was conducted inaccordance with ISO 11135.The original validation of theEO sterilization cycle of aworst-case device family wasperformed using one (1)fractional exposure cycle,three (3) half exposure cyclesand one (1) full exposurecycle, overkill approachdescribed in ISO 11135. Thesubject device was adopted tothe original validatedsterilization cycle byperforming one (1) full cycle.	The validation studydemonstrated that thesterilization process andequipment are capable ofreliably and consistentlysterilizing the devices to aminimum SAL of 10-6.Fractional cycles, half cycles,and full cycles met theacceptance criteria. Thesubject device wassuccessfully adopted to theoriginal sterilizationvalidation by performing one(1) full cycle.
EO and ECH Residuals	EO and ECH residuals weremeasured per ISO 10993-7:2008.	The residual traces of EO andECH for the subject deviceare below the limits specifiedin ISO 10993-7.
Bacterial Endotoxin Levels	LAL testing was conducted inaccordance with FDAguidance document (June2012), USP<85>, andEuropean Pharmacopeia BET2.6.14	< 2.15 EU/device

CONCLUSIONS

The ECLIPSE 2L met all specified criteria. We conclude that the Subject Device, ECLIPSE 2L, is substantially equivalent in its intended use, design, material, performance, and the underlying fundamental scientific technology used, to the Predicate Device, Scepter C/XC Occlusion Balloon Catheter and the Reference Device, HyperGlide and HyperForm Occlusion Balloons.

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).