The Ballast 088 Long Sheath is a sterile, single lumen, variable stiffness Guide Catheter / Long Sheath that is designed for facilitating the introduction of appropriately sized interventional devices into target blood vessels in the peripheral, coronary, and neuro vasculature. The Ballast 088 Long Sheath consists of a lubricous inner liner made from Polytetrafluoroethylene (PTFE) reinforced by a stainless steel coil over the inner liner and stainless steel braid partially covering the inner coil layer. The outer jacket consists of thermoplastics ranging from thermoplastic polyurethane (TPU), polyether block amide (Pebax), and polyamide 12. The distal section of the Ballast 088 Long Sheath is coated with hydrophilic coating to provide lubricity during use. A Platinum/Iridium marker band is placed at the distal end of the catheter for maximum radiopacity. An introducer sheath, 9F hemostasis valve, 8F hemostasis valve adapter and a dilator are also provided with the device.

AI/ML Overview

This document is a 510(k) summary for the Ballast 088 Long Sheath, a medical device. It aims to demonstrate substantial equivalence to a predicate device, the Neuron MAX™ System. The document focuses on performance and biocompatibility testing.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Important Note: This document describes a medical device (a catheter) and its mechanical, material, and biological performance, not an AI/ML-based device. Therefore, many of the requested categories related to AI/ML (e.g., ground truth, experts, MRMC studies, training set data) are not applicable to this type of device submission. The acceptance criteria here are typically physical and biological performance metrics for a hardware device.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a formal "acceptance criteria" table with pass/fail thresholds for each test. Instead, it describes general test methods and states that "All test samples passed testing" or "The subject device is comparable to the predicate device." For biocompatibility, it states "Non-cytotoxic," "Did not elicit sensitization response," etc.

However, based on the "Performance Bench Testing and Animal Testing Summary" (Table 2) and "Biocompatibility Test Summary" (Table 3), we can infer the acceptance criteria and reported performance for key tests:

Acceptance Criteria Category/Test	Test Method Summary	Reported Device Performance (Implied Acceptance)
Mechanical/Physical Performance
Visual and Dimensional Inspection	Inspected dimensions (overall length, ID, OD, etc.).	All test samples passed testing.
Surface Contamination	Microscope inspection for particulates.	All test samples passed testing.
Catheter Compatibility	Verify compatibility with accessory devices, guidewires, dilators, inner guide/diagnostic catheters.	All test samples passed testing.
Simulated Use	In vitro performance in Bovine Aortic Arch vessel model.	All test samples passed testing.
Coating Integrity and Adherence	Dyed samples, simulated use, microscopic inspection.	All test samples passed testing.
Lubricity/Durability of Hydrophilic Coating	25 friction cycles with max 75g force.	All test samples passed testing.
Dynamic Burst	MEDRAD Mark V Plus Injection System.	All test samples passed testing.
Liquid Leakage at 46 psi	Per ISO 10555-1 and ISO 594-2.	All test samples passed testing.
Air Leakage	Per EN ISO 10555-1 and ISO 594-2.	All test samples passed testing.
Catheter Static Burst Test	Hydraulic Burst/Leak tester per ISO 10555-1.	All test samples passed testing.
Tensile Strength	Instron tensile tester, per ISO 10555-1.	All test samples passed testing.
Corrosion Resistance	Immersion in NaCl solution, then boiling water; visual inspection.	All test samples passed testing.
Torque Strength	Number of turns-to-failures, compared to predicate.	All test samples passed testing. Subject device comparable to predicate.
Kink Resistance Test	Tested against predicate in simulated use; wrapping around pin and microscopic examination.	All test samples passed testing. Subject device comparable to predicate.
Catheter Stiffness Testing	Instron tensile tester.	All test samples passed testing.
Fracture Resistance and Flexing Test	Resistance to damage by flexing/fracture per ISO 11070.	All test samples passed testing.
Particulate Matter Characterization	Quantified after simulated use.	All test samples passed testing.
Luer Dimensional Inspection	Per ISO 80369-7.	All test samples passed testing.
Separation Force (Luer)	Per ISO 594-1 and ISO 594-2.	All test samples passed testing.
Unscrewing Torque (Luer)	Per ISO 594-1 and ISO 594-2; remained attached.	All test samples passed testing.
Resistance to Overriding (Luer)	Per ISO 594-1 and ISO 594-2; no override of threads.	All test samples passed testing.
Stress Cracking (Luer)	Per ISO 594-1 and ISO 594-2; no cracks.	All test samples passed testing.
Subatmospheric-pressure Air Leakage (Luer)	Per ISO 80369-7.	All test samples passed testing.
Animal Testing (In Vivo Performance)
Animal Testing (GLP)	Evaluate in vivo performance in acute porcine model; assess trackability, handling, radiopacity, catheter compatibility. Compared to predicate device.	All test samples passed testing. Trackability, handling, radiopacity, and compatibility comparable to predicate device.
Biocompatibility (ISO 10993 Series)
Cytotoxicity – MEM Elution Test	ISO 10993-5 (48 hours).	Non-cytotoxic (average grade of 0).
Sensitization - Guinea Pig Kligman Maximization Test	ISO 10993-10.	Did not elicit sensitization response (0% sensitization).
Irritation or Intracutaneous - Rabbits	ISO 10993-10.	Non-irritant (difference between test and control mean score was 0.0).
Acute Systemic Toxicity - Mice	ISO 10993-11.	Non-toxic (no significant systemic toxicity or mortality).
Systemic Toxicity - Rabbit Pyrogen	ISO 10993-11.	Non-pyrogenic (no temperature rise >0.5℃).
Genotoxicity: Ames Test	ISO 10993-3; Salmonella typhimurium and Escherichia coli.	Non-mutagenic (no 2x or 3x increase in revertants).
Genotoxicity: Chromosomal Aberration Assay	ISO 10993; Chinese Hamster Ovary (CHO) cells.	Non-genotoxic.
Hemocompatibility – Hemolysis (Indirect/Direct)	ISO 10993-4 (ASTM Method).	Non-Hemolytic.
Hemocompatibility – Complement Activation	ISO 10993-4 (SC5b-9).	Passed (comparable to predicate).
Hemocompatibility – Partial Thromboplastin Time (PTT)	ISO 10993-4.	Passed (clotting times lengthened compared to predicate).
Hemocompatibility – Platelet and Leukocyte Count (PLC)	ISO 10993-4.	Passed (results for leukocyte and platelet counts within acceptable range, not statistically significant vs. reference material).
Hemocompatibility – Digital Optical Microscopy	40x images for surface morphology comparison.	Passed (no significant differences in geometry, surface morphology, or particulate contamination vs. predicate).
Sterilization & Packaging
Original Sterilization Validation and Adoption	EO sterilization (100% EO) to SAL 10-6, ISO 11135.	Validation study demonstrated capability to sterilize to SAL 10-6. Subject device successfully adopted to original validation.
EO and ECH Residuals	Measured per ISO 10993-7:2008.	Residual traces below specified limits.
Bacterial Endotoxin Levels	LAL testing per FDA guidance, USP<85>, European Pharmacopeia BET 2.6.14.	< 2.15 EU/device.
Shelf Life	Accelerated aging (1 year).	All acceptance criteria met. Device will perform as intended for 1 year.
Packaging Integrity Test	Visual Inspection, Seal Strength (ASTM F88/F88M), Bubble Immersion (ASTM F2096-11), Seal Integrity (ASTM F1886/F1886M-16). Validated for 1-year accelerated aging.	All test samples passed testing. Adequate and effective protection and sterile barrier provided for 1 year.

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

Sample Sizes: The document consistently states "All test samples passed testing" for the bench tests. However, it does not specify the exact number of samples used for each bench test. For animal testing, it refers to an "acute porcine model" but does not give the number of animals. For the biocompatibility tests, specific ISO standards are cited, which typically define minimum sample sizes for such tests, but the numbers are not explicitly stated in this summary.
Data Provenance:
- Country of Origin: Not specified in the provided text. It's an FDA submission, implying testing acceptable to US regulatory standards, but the physical location of labs is not mentioned.
- Retrospective or Prospective: These concepts are not applicable to the bench and animal testing described. These are controlled laboratory experiments and prospective animal studies, not data collected from human patients over time.

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

Not Applicable. This is a hardware medical device. Ground truth, in the context of AI/ML, refers to human expert annotations or pathology for diagnostic accuracy. For this device, "ground truth" implicitly comes from physical measurements against engineering specifications and biological reactions governed by established scientific principles in highly controlled lab and animal environments (e.g., a specific tensile strength value must be met, a material must not induce a specific biological reaction). There is no "opinion-based" ground truth from human readers/experts in the way there would be for an AI-diagnostic algorithm.

4. Adjudication Method for the Test Set

Not Applicable. As above, this is for a hardware device. Adjudication methods (like 2+1, 3+1) are used to resolve discrepancies in human interpretations or diagnoses within AI/ML performance studies, which is not relevant here.

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

Not Applicable. This is a physical medical device, not an AI/ML diagnostic aid. Therefore, no MRMC study with human readers assisting AI was conducted.

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

Not Applicable. This is a physical medical device. There is no algorithm to test in isolation.

7. The Type of Ground Truth Used

For this device, the "ground truth" is established by:

Engineering Specifications/Standards: Each mechanical test (e.g., tensile strength, burst pressure, dimensions) has a defined acceptance range based on design specifications and relevant ISO or ASTM standards. "Passing" the test means meeting these predefined quantitative criteria.
Biological Standards/Regulatory Guidelines: For biocompatibility, the ground truth is whether the device materials elicit specific biological responses (e.g., cytotoxicity, sensitization, irritation, genotoxicity, hemolysis) that fall within acceptable limits defined by ISO 10993 standards. "Non-cytotoxic," "Non-irritant," etc., are the "ground truth" outcomes for these tests.
Comparative Performance to Predicate: For some tests (e.g., Torque Strength, Kink Resistance, Hemocompatibility), the "ground truth" for substantial equivalence is based on the subject device performing "comparable to" the already-cleared predicate device.
Validated Protocols: The methods used (e.g., in vitro models, animal models) are validated scientific/engineering protocols providing the "truth" of the device's performance under specific conditions.

8. The Sample Size for the Training Set

Not Applicable. This is a hardware medical device. There is no "training set" in the context of machine learning. The design and manufacturing process are typically developed and refined through engineering iterations, not by "training" an algorithm on data.

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

Not Applicable. As there is no training set for an AI/ML model, this question is irrelevant to this device description.

Summary

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Image /page/0/Picture/0 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 is in blue and includes the letters "FDA" in a square and the words "U.S. Food & Drug Administration".

March 21, 2019

Balt USA, LLC Charles Yang Senior Vice President, Quality Assurance and Regulatory Affairs 29 Parker Irvine, California 92618

Re: K182918

Device Name: Ballast 088 Long Sheath Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: February 15, 2019 Received: February 19, 2019

Dear Charles Yang:

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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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.

Lin Zheng

Digitally signed by
Xiaolin Zheng -S
Date: 2019.03.21
10:11:36 -04'00'

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) K182918

Device Name Ballast 088 Long Sheath

Indications for Use (Describe)

The Ballast 088 Long Sheath is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Ballast 088 Long Sheath 510(k) Summary

This 510(k) summary for Ballast 088 Long Sheath 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:	Charles Yang
	Senior Vice President, Quality Assurance and Regulatory Affairs
Telephone:	949-788-1443
E-mail:	charles.yang@balt-usa.com
Date prepared:	March 13, 2019

DEVICE [807.92(a)(2)]

Name of Device:	Ballast 088 Long Sheath
Common or Usual Name:	Guide Catheter / Long Sheath
Classification Name:	Catheter, Percutaneous
Product Code:	DQY
Regulatory Class:	Class II
Submission Type:	Traditional 510(k)
Regulation Number:	21 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)]

Neuron MAX System (K111380)

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DEVICE DESCRIPTION [807.92(a)(4)]

The Ballast 088 Long Sheath consists of a lubricous inner liner made from Polytetrafluoroethylene (PTFE) reinforced by a stainless steel coil over the inner liner and stainless steel braid partially covering the inner coil layer. The outer jacket consists of thermoplastics ranging from thermoplastic polyurethane (TPU), polyether block amide (Pebax), and polyamide 12.

The distal section of the Ballast 088 Long Sheath is coated with hydrophilic coating to provide lubricity during use. A Platinum/Iridium marker band is placed at the distal end of the catheter for maximum radiopacity. An introducer sheath, 9F hemostasis valve, 8F hemostasis valve adapter and a dilator are also provided with the device.

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

The Ballast 088 Long Sheath is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

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

The technological characteristics of the Ballast 088 Long Sheath are highly analogous to the technological characteristics of the Neuron MAX™ System previously cleared (K111380). Substantial equivalence is determined based on the following similarities:

Same intended use/indications for use
Same principles of operation ●
Same fundamental scientific technology ●
Incorporate similar basic Guide Catheter / Long Sheath design .
. Incorporate similar Guide Catheter / Long Sheath construction material

Table 1 comprises the comparison between Ballast 088 Long Sheath (Subject Device) and Neuron MAXTM System (Predicate Device, K111380).

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Feature	Neuron MAX™ System	Ballast 088 Long Sheath
	[PREDICATE DEVICEK111380]	[SUBJECT DEVICE]
Product Code	DQY	Same
Regulatory Class	Class II	Same
Regulation Number	21 CFR 870.1250	Same
Regulation Name	Catheter, Percutaneous	Same
Generic Name	Guide Catheter / Long Sheath	Same
Indications for UseStatement	The Neuron MAX™ System isindicated for the introduction ofinterventional devices into theperipheral, coronary, and neurovasculature.	Same
Function	Guide Catheter / Long Sheath forfacilitating the introduction ofappropriately sized interventionaldevices into target blood vessels inthe peripheral, coronary, and neurovasculature	Same
Principle of Operation	The steerable Guide Catheter / LongSheath is used to facilitate theselective placement of interventionaldevices	Same
Anatomical Location	Peripheral, coronary, and neurovasculature.	Same
Visualization	Visible under radiographic imaging	Same
Feature	Neuron MAX™ System	Ballast 088 Long Sheath
	[PREDICATE DEVICEK111380]	[SUBJECT DEVICE]
Configurations	PNML6F088804(Usable Length 80, Straight TipShape)PNML6F088804M(Usable Length 80, MultipurposeTip Shape)PNML6F088904(Usable Length 90, Straight TipShape)PNML6F088904M(Usable Length 90, MultipurposeTip Shape)	Ballast80(Usable Length 80 cm)Ballast90(Usable Length 90 cm)Ballast100(Usable Length 100 cm)Ballast105(Usable Length 105 cm)
Tip Shape	Straight,Multipurpose	Straight
Overall Length	80 cm - 90 cm	80 cm - 105cm
Proximal OuterDiameter	8F	Same
Distal Outer Diameter	8F	Same
Internal Diameter	0.088"	Same
Coil Length	Not Listed	77 cm - 102 cm
Length fromRadiopaque markerband to distal tip	Not Listed	0.025"
Braided Shaft Length	Not Listed	9 cm from distal tip
Feature	Neuron MAX™ System	Ballast 088 Long Sheath
	[PREDICATE DEVICEK111380]	[SUBJECT DEVICE]
Coil	Not Listed	Stainless Steel
Inner Liner	Not Listed	PTFE
Braid	Stainless Steel	Same
Radiopaque Marker	Not Listed	Platinum/Iridium
Coating	Hydrophilic Coating	Same
Hydrophilic CoatingLength	Not Listed	20 cm
Method of supply	Sterile and single use	Same
Sterilization method	Ethylene oxide gas	Same
Accessories	Rotating Hemostasis Valve (RHV)	Introducer sheath
	Hemostasis valve adapter (HVA)	9F rotating hemostasis valve
	Dilator	8F hemostasis valve adapter
		Dilator
Package configuration	Placed into a packaging card,Tyvek pouch and Carton box.	Same

Table 1: Predicate Device vs. Subject Device Comparison Table

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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 Ballast 088 Long Sheath (Subject Device) meets established performance requirements and is substantially equivalent for its intended use.

Performance Bench Testing
Tests	Test Method Summary	Results
Visual and DimensionalInspection	Inspected dimensions for overall length,total length of proximal hub and strainrelief, inner diameter, outer diameter (distaland proximal).	All test samples passed testing.
Surface Contamination	A microscope was used to inspect thecatheter surface for the presence ofparticulates.	All test samples passed testing
Catheter Compatibility	Verify the compatibility of the Ballast 088Long Sheath with the following:- Accessory devices- Guidewire- 6F dilator and guidewire- Inner guide catheter and guidewire- Inner diagnostic catheter andguidewire	All test samples passed testing.
Simulated Use	Verify the in vitro performance of the testarticle under simulated use conditionsusing Type III, Bovine Aortic Arch vesselmodel.	All test samples passed testing.
Coating Integrity andAdherence	Test samples were dyed and gone throughsimulated use testing. The coating quality	All test samples passed testing
	of the dyed test articles were inspectedunder a microscope.
Lubricity/Durability ofHydrophilic Coating	Test samples underwent 25 friction cycleswith a maximum friction force of 75 gramsto determine the lubricity and durability ofthe catheter coating.	All test samples passed testing.
Dynamic Burst	A MEDRAD Mark V Plus InjectionSystem was used to measure catheterdynamic burst test of the test samples.	All test samples passed testing.
Liquid Leakage at 46 psi	Determined whether liquid leaks from thecatheter under a pressure of 46 psi per ISO10555-1 and ISO 594-2.	All test samples passed testing.
Air Leakage	Determined whether air leaks into the hubassembly during aspiration per EN ISO10555-1 and ISO 594-2.	All test samples passed testing.
Catheter Static Burst Test	A hydraulic Burst/Leak tester was used totest the static burst resistance of the testsamples per ISO 10555-1.	All test samples passed testing.
Tensile Strength	Measured the catheter shaft peak tensileforce and the hub to shaft peak tensileforce using an Intron tensile tester per theguidelines in ISO 10555-1.	All test samples passed testing.
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 passed testing.
Torque Strength	Torque strength was determined by numberof turns-to-failures. Torque strength of thesubject device was compared to thepredicate device.	All test samples passed testing.The Torque Strength of thesubject device is comparable tothe predicate device.
Kink Resistance Test	The kink resistance of the test samples wastested against the predicate device insimulated use. In addition, kink resistanceof the test samples was tested against thepredicate device by wrapping the devicearound a pin and examining the device forkinks by using a microscope.	All test samples passed testing.The Kink Resistance of thesubject device is comparable tothe predicate device.
Catheter Stiffness Testing	An Instron tensile tester was used tocharacterize the stiffness profile of thedevice.	All test samples passed testing.
Fracture Resistance andFlexing Test	Testing was conducted to determine theGuide Catheter's resistance to damage byflexing and resistance to fracture per ISO11070.	All test samples passed testing.
Particulate MatterCharacterization	Particulate matter in injections of thedevice were quantified after simulated use.	All test samples passed testing.
Luer DimensionalInspection	Inspected the luer dimensions per ISO80369-7.	All test samples passed testing.
Separation Force	Verified mating parts separation force perISO 594-1 and ISO 594-2.	All test samples passed testing.
Unscrewing Torque	Verified that the catheter luer remainedattached after applying an unscrewingtorque, per ISO 594-1 and ISO 594-2.	All test samples passed testing.
Resistance to Overriding	Verified that the catheter luer did notoverride reference fitting threads, per ISO594-1 and ISO 594-2.	All test samples passed testing.
Stress Cracking	Verified that there were no stress cracks onmicrocatheter hub, per ISO 594-1 and ISO594-2.	All test samples passed testing.
Subatmospheric-pressureAir Leakage	ISO 80369-7	All test samples passed testing.
	The fittings were assembled by applying anaxial force while rotating the testconnector.The test connector and reference connectorassembly were secured to the test port onthe pressure decay leak tester and thepressure decay rates were recorded.
Separation Force	ISO 80369-7The fittings were assembled by applying anaxial force while rotating the testconnector. An axial force is applied in thedirection away from the test connection.	All test samples passed testing.
Stress Cracking	ISO 80369-7The fittings were assembled by applying anaxial force while rotating the testconnector. The test connector isdisconnected from the reference connectorand is reassembled again.With the axis of the lock fitting horizontal,the assembly outlet is sealed and theinternal water pressure is brought to aneffective pressure and maintained for a	All test samples passed testing.
Unscrewing Torque	specific time.ISO 80369-7The fittings were assembled by applying anaxial force while rotating the testconnector. A screwing torque was appliedfor a certain hold period.	All test samples passed testing.
Resistance to Overriding	ISO 80369-7The fittings were assembled by applying anaxial force while rotating the testconnector. Using a torque watch with noaxial load, a torque is applied for a specifichold period.	All test samples passed testing.
Packaging Integrity Test
Visual Inspection(Product carton)	Visually inspected packaging for any signsof damage.	All test samples passed testing.
Seal strength	Perform seal strength test per ASTMF88/F88M.	All test samples passed testing.
Bubble Immersion	Perform Bubble Immersion test per ASTMF2096-11. No bubbles observedattributable to leaks and no test fluidattributable to leaks inside the devicepackaging.	All test samples passed testing.
Visual Inspection(Seal Integrity)	Visual inspection testing was performedper ASTM F1886/F1886M-16 to visuallydetect channel defects in package seals.	All test samples passed testing.
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 guide catheter, radiopacity, andcatheter compatibility were assessed.Subject device was compared to predicatedevice.	All test samples passed testing.Trackability and handling ofthe guide catheter, radiopacity,and catheter compatibility withmicrocatheter were comparableto predicate device.
Test	Results	Conclusion
Cytotoxicity – MEM Elution Test– 48 hoursISO 10993-5	Test Article extract showed no evidence oflysed cells or cytotoxicity to L-929 cells,with an average grade of 0 (no reactivity).	Non-cytotoxic
Sensitization - ISO Guinea PigKligman Maximization TestISO 10993-10	The 0.9% Sodium Chloride for injection(NaCl) and Cottonseed Oil (CSO) extractsdid not induce delayed sensitization in theguinea pig (0% Sensitization).	Did not elicit sensitizationresponse
Irritation or Intracutaneous - ISOIntracutaneous Study in Rabbits -Two ExtractsISO 10993-10	The difference between the test and thecontrol mean score was 0.0.	Non-irritant
Acute Systemic Toxicity - ISOAcute Systemic Toxicity Study inMice – Two ExtractsISO 10993-11	There was no evidence of significantsystemic toxicity or mortality after testarticle extracts injection.	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℃at the required observation time points. Thisresponse did not exceed the USP limit andmeets the requirements for this test.Therefore, these results indicate that the testarticle was determined to be non-pyrogenic.	Non-pyrogenic
Genotoxicity: Ames Test (Solids),2 extracts, 4 strains of Salmonellatyphimurium and one strain ofEscherichia coliISO 10993-3	The test article extracts did not produce atwo-fold or a three-fold increase in thenumber of revertants in any of the 5 testerstrains. The spot tests showed no zone ofincreased reversion or of toxicity.Therefore, the test article is considered non-mutagenic.	Non-mutagenic
Genotoxicity: ChromosomalAberration Assay in ChineseHamster Ovary (CHO) cells, 2extracts, OECD 473ISO 10993	The cytotoxicity data showed no reactivityto the test article solutions when placed onCHO cells. The polyploid,endoreduplication rate, and the mitoticindex of the test article solutions showed nosignificant difference from the controls.Therefore, the test article is not consideredto be genotoxic when exposed to CHO cells.	Non-genotoxic
Hemocompatibility-Hemolysis,ASTM Method (Indirect)ISO 10993-4	The difference between the hemolyticindexes of the test article and the negativecontrol equals 0.15%, placing the test articlein the non-hemolytic range according to theHemolytic Grade scale	Non-Hemolytic
Hemocompatibility-Hemolysis,ASTM Method (Direct)ISO 10993-4	The difference between the hemolyticindexes of the test article and the negativecontrol equals 0.00%, placing the test articlein the non-hemolytic range according to theHemolytic Grade scale	Non-Hemolytic
Hemocompatibility -Complement Activation, SC5b-9ISO 10993-4	The results of the complement activationtesting performed on the test article indicatethat it has a complement activationcomparable to the predicate device.	Passed
Hemocompatibility - PartialThromboplastin Time (PTT)ISO 10993-4	The clotting times exhibited by the testarticle were lengthened when compared tothe clotting times exhibited by the predicatedevice.	Passed
Hemocompatibility - Platelet andLeukocyte Count (PLC)ISO 10993-4	The triplicate test article replicates werewithin 25% of their average. The test articleresults for the leukocyte and platelet countswere 86.9% and 117.7%, respectively, ofthe negative control. The platelet counts ofthe test article were not statisticallysignificant (p>0.05) when compared to thereference material.	Passed
Hemocompatibility -40x Digital Optical Microscopy -comparative analysis of surfacemorphology	40x images were taken from multiplelocations along the entire length of thesubject device and the predicate controldevice to assess differences in surfacecharacteristics and/or geometry.	Passed
	Although the catheters differed in color andtransparency, there were no significantdifferences in geometry, surfacemorphology, or particulate contamination.
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 two (2) fullcycles.	The validation studydemonstrated that thesterilization process andequipment are capable ofreliably and consistentlysterilizing the devices to aminimum SAL of 10-6. TheBI results confirm theacceptable lethality of thesterilization cycle to achievethe required SAL of 10-6.Fractional cycles, half cycles,and full cycles met theacceptance criteria. Thesubject device wassuccessfully adopted to theoriginal sterilizationvalidation.
EO and ECH Residuals	EO and ECH residuals weremeasured per ISO 10993-7:2008.	The residual traces of EO andECH for the subject device arebelow the limits specified inISO 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

Table 2: Performance Bench Testing and Animal Testing Summary

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Biocompatibility: Results of the biocompatibility testing (Table 3) indicate that the Ballast 088 Long Sheath (Subject Device) is biocompatible and is substantially equivalent for its intended use.

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Table 3: Biocompatibility Test Summary

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Shelf life: The accelerated shelf life testing for Ballast 088 Long Sheath has been conducted (T=1 year 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 Ballast 088 Long Sheath will perform as intended to the Design Specification. Ballast 088 Long Sheath will be labeled for 1-year shelf life.

Packaging: The packaging validation, T=1 year accelerated aging was performed on the Ballast 088 Long Sheath. The results from packaging testing conducted on Ballast 088 Long Sheath showed that the acceptance criteria were met. Therefore, we can conclude the Ballast 088 Long Sheath packaging will provide the adequate and effective protection and sterile barrier requirements.

Sterilization: Ballast 088 Long Sheath is sterilized using 100% Ethylene Oxide (EtO) gas in the same manner as FDA cleared predicate device, Neuron MAXIM System (K111380). Ballast 088 Long Sheath is sold sterile, for single use and single patient only. The sterilization was performed and is documented. The sterilization validation results showed that the sterilization dose and routine sterilization process was validated to achieve a SAL of 10-6 for the Ballast 088 Long Sheath.

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CONCLUSIONS

The Ballast 088 Long Sheath met all specified criteria. We conclude that the subject device, Ballast 088 Long Sheath, is substantially equivalent in its intended use, design, material, performance,

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and the underlying fundamental scientific technology used, to the predicate device, Neuron MAX™ System.

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).