The NG Delivery Catheter is intended for general intravascular use, including the peripheral, coronary and neuro vasculature for the infusion of diagnostic agents, such as contrast media, and to assist in the delivery of interventional devices, such as distal access catheters, in the neurovasculature.

Device Description

The NG Delivery Catheter is a single lumen, variable stiffness, composite catheter. The design facilitates the advancement of the catheter and is intended to assist the delivery of interventional devices in the peripheral and neurovasculature. The outer surface of the NG Delivery Catheter is coated with a hydrophilic coating to increase lubricity. The proximal end of the NG Delivery Catheter incorporates a luer fitting for the attachment of accessories. Two radiopaque markers at the distal end help to facilitate fluoroscopic visualization. A Steam Shaping Mandrel and Peel-away Introducer Tube are included within the tray. The NG Delivery Catheter is provided sterile, non-pyrogenic, and is intended for single use only.

AI/ML Overview

This document is a 510(k) Pre-market Notification for a medical device (NG Delivery Catheter) and, as such, does not contain information about studies related to AI/ML device performance or acceptance criteria in the context of diagnostic accuracy. The data provided focuses on the physical and biological performance of the catheter itself, demonstrating substantial equivalence to predicate devices, rather than an AI component.

Therefore, I cannot provide the requested information regarding AI device acceptance criteria and study data. The document confirms that:

No clinical testing was conducted for the NG Delivery Catheter.
No animal testing was conducted for the NG Delivery Catheter.
The performance data provided is for bench testing of the physical device.

The tables in the document describe biocompatibility testing and performance bench testing for the NG Delivery Catheter, along with their respective results and conclusions (all samples passed acceptance criteria or were acceptable/comparable). These tests are relevant to the safety and functionality of the physical catheter, not an AI/ML component.

Summary

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September 13, 2023

Balt USA, LLC Catherine Chiou Specialist. Regulatory Affairs 29 Parker Irvine, California 92618

Re: K230609

Trade/Device Name: NG Delivery Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP, DQY Dated: August 17, 2023 Received: August 17, 2023

Dear Catherine Chiou:

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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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

Sincerely,

Naira Muradyan -S

Naira Muradyan, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K230609

Device Name NG Delivery Catheter

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary: K230609

Applicant:	Balt USA, LLC29 ParkerIrvine, CA 92618Registration No.: 3014162263
Contact Person:	Catherine ChiouSpecialist, Regulatory AffairsEmail: Catherine.chiou@baltgroup.com

Date SummaryPrepared:	September 13, 2023
Trade Name:	NG Delivery Catheter
Common Name:	Catheter, Percutaneous
Review Panel:	Neurology
Product Code:	QJP, DQY
Regulation Number:	21 CFR 870.1250
Device Classification:	Class II
Predicate Device:	Wedge Microcatheter510(k) #: K172014
Reference Device:	AXS Offset Delivery Assist Catheter510(k) #: K163259

Device Description:

A Steam Shaping Mandrel and Peel-away Introducer Tube are included within the tray. The NG Delivery Catheter is provided sterile, non-pyrogenic, and is intended for single use only.

Indications for Use:

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Device Comparison:

	Predicate Device:	Reference Device:	Subject Device:
	Wedge Microcatheter(K172014)	AXS Offset Delivery AssistCatheter (K163259)	NG Delivery Catheter(K230609)
DeviceClassification /Product Code	Class II/DQY(Percutaneous Catheters)	Same as K172014	Class II/QJP, DQY(Percutaneous Catheters)
Indications forUse	The Wedge Microcatheteris intended for generalintravascular use, includingthe peripheral, coronary andneuro vasculature for theinfusion of diagnostic agents,such as contrast media, and toassist in the delivery ofinterventional devices, such asthe SOFIA 6F Catheter, in theneurovasculature.	The AXS Offset DeliveryAssist Catheter is intended toassist in the delivery ofinterventional devices, such asdistal access catheters, in theneurovasculature.	The NG Delivery Catheteris intended for generalintravascular use, includingthe peripheral, coronary andneuro vasculature for theinfusion of diagnosticagents, such as contrastmedia, and to assist in thedelivery of interventionaldevices, such as distalaccess catheters, in theneurovasculature.
Catheter OD,Max	1.73 mm (0.068")	3.8F (1.27 mm; 0.05")	4.5F (1.50 mm; 0.059")-5.3F (1.75 mm; 0.069")
Catheter ID	0.53 mm (0.021")	0.53 mm (0.021")	Same as K172014
EffectiveLength	158 cm – 160 cm	150 cm	152 cm
Coating Length	110 cm – 115 cm	80 cm	60 cm
Packaging Configuration	Microcatheter is placed in adispenser hoop and accessorieson a mounting card that is theninserted into the pouch. Thepouch is then placed inside acarton box.	Catheter is placed in adispenser coil, then insertedinto a pouch and placedinside a carton box.	Same as K172014
Sterilization
Method	Ethylene Oxide	Same as K172014	Same as K172014
How Supplied	Sterile, Single Use	Same as K172014	Same as K172014

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Biocompatibility:
The following biocompatibility testing was conducted for the subject device, NG Delivery Catheter:

Test	Results	Conclusions
Cytotoxicity (ISO MEMElution Test)	The test article scored a ' 1' and isconsidered non-cytotoxic under theconditions of the test.	The test article isconsidered non-cytotoxic.
Sensitization (ISO Guinea PigMaximization Test)	None of the test animals challenged withthe test article extracts were observedwith a sensitization response greater than'O'.	The test article did notelicit a sensitizationresponse.
Intracutaneous Reactivity	The differences in the mean test andcontrol scores of the extract dermalobservations were 1.0 or less.	Requirements have beenmet by the test article.
Acute Systemic Toxicity	None of the animals in the study wereobserved with abnormal clinical signsindicative of toxicity during the 72-hourtest period. All were alive at the end ofthe 72-hour test duration and bodyweight changes were within acceptableparameters over the course of the study.	Requirements have beenmet by the test article.
Material-Mediated Pyrogenicity(ISO Materials Mediated RabbitPyrogen)	None of the rabbits administered withthe test article extract had a temperaturerise ≥ 0.5℃ at the required observationtime points.	The test article isconsidered non-pyrogenic.
Hemocompatibility -Hemolysis	The test article, in both extract and directmethod, met the criteria for assayvalidity and displayed an Average BlankCorrected Hemolytic Index above theNegative Control below 2.0%.	The test article isconsidered non-hemolytic.
Hemocompatibility -Complement Activation	The test article result was statisticallysignificantly lower (p<0.05) than that ofthe comparison article.	Test article performedbetter than the comparisonarticle under theconditions employed.
Hemocompatibility –Thrombogenicity (In vivo)	The test article has "normal" vesselobservations, and patency of "notoccluded" for both left/right externaljugulars.	Scores indicate lowthrombogenic potential forthe test device.
Hemocompatibility –Thrombogenicity (PartialThromboplastin Time)	The clotting time of the test article andthe comparison article are notsignificantly different.	Requirements have beenmet by the test article.
Hemocompatibility -Thrombogenicity (PlateletLeukocyte Count)	The test article platelet mean percentagevalue was between 80 to 120% and wasat least 30% above the positive control.	Requirements have beenmet by the test article.
Hemocompatibility -Thrombogenicity (ComparativeSurface Assessment)	Each device was inspected with zeronoted locations with rough surfaces ordefects.	Requirements have beenmet by the test article.

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Performance Data - Bench:

The following non-clinical bench testing was conducted to assess the performance of the subject device, NG Delivery Catheter:

Test	Test Method Summary	Results
Physical andDimensional	The physical and dimensional attributes weremeasured.	All samples passed theacceptance criteria.
Tensile Strength	The peak tensile force was obtained per ISO10555-1.	All samples passed theacceptance criteria.
Kink Resistance	Kink resistance was evaluated after subjecting thedevice to bending in a simulated use model.	All samples passed theacceptance criteria.
Liquid-Leakage	The device was exposed to a minimum liquidpressure for a minimum of 30 seconds. The devicewas inspected for leakage per ISO 10555-1.	All samples passed theacceptance criteria.
Air Leakage	The device was exposed to air pressure bysyringe. The device was inspected for leakage perISO 10555-1.	All samples passed theacceptance criteria.
Static Burst	The distal tip of the catheter was blocked, andfluid was injected into the lumen at increasingpressure until the catheter burst.	All samples passed theacceptance criteria.
Torque Strength	The device was evaluated for torque strength bymeasuring the number of catheter rotations untilfailure after tracking through a simulated usemodel.	All samples passed theacceptance criteria.
Catheter TipShapeability	Tip shapeability of the distal tip was measuredafter steam shaping.	All samples passed theacceptance criteria.
Hub Validation Testing	The luer connector was tested to functionalrequirements per ISO 80369-7 and non-interconnectability to other hubs per ISO 80369-1.	All samples passed theacceptance criteria.
Coating Adherence	The coating integrity was inspected undersimulated use conditions.	All samples passed theacceptance criteria.
Particulate Matter	The catheter underwent simulated use testing andparticulate testing was conducted including areference device for comparison.	All samples passed theacceptance criteria.
Tip Stiffness	The catheter stiffness profile was compared to thereference device.	The tip stiffness wascomparable.
Flow Rate	The flow rate of contrast media and associatedinjection pressures were evaluated.	Characterization only

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Test	Test Method Summary	Results
Saline and ContrastExposure	After the device was used to deliver saline andcontrast media, the device was inspected fordamage, and dimensional attributes were measured.	All samples passed theacceptance criteria.
Lubricity (FrictionForce)	The lubricity peak friction force was measured.	Characterization only
Radiopacity (Visibility)	The device was tested to demonstrate acceptableradiopacity.	Acceptable
Physician Usability	The devices were prepared in accordance withtheir respective instructions for use and metestablished acceptance criteria for deviceusability in a clinically relevant anatomicalmodel.	All samples passed theacceptance criteria.

Performance Data - Animal:

Balt USA, LLC did not conduct non-clinical animal testing. The differences in technological characteristics do not raise new questions of safety and effectiveness.

Performance Data - Clinical:

Balt USA, LLC did not conduct clinical testing. The differences in technological characteristics do not raise new questions of safety and effectiveness.

Conclusion:

The evidence presented in this 510(k) demonstrates substantial equivalence between the subject device and the predicate device. The subject and predicate devices have intended use and indications for use. The differences in technological characteristics do not raise new questions of safety and effectiveness. Non-clinical bench testing demonstrates the NG Delivery Catheter meets the specifications.

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).