The Next Generation Access Catheter is a single-lumen, flexible, variable stiffness composite catheter. The distal tip of the catheter shaft includes a marker band while the proximal end of the catheter has a luer fitting to allow attachment of accessories and infusion of liguids through the system. The Next Generation Access Catheter distal shaft has an external hydrophilic coating which provides a lubricious surface during use. The Next Generation Access Catheter is visible under fluoroscopy. The Next Generation Access Catheter dimensions are included on the individual device label. The Next Generation Access Catheter is offered in various sizes to accommodate physician preferences and anatomical variations. A peelable split introducer sheath is provided in the package to provide support and facilitate the introduction of the distal tip of the Next Generation Access Catheter into an appropriate vascular sheath. The catheter and introducer sheath are provided sterile, non-pyrogenic, and are intended for single use only.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the "Next Generation Access Catheter" (K234074). This documentation focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing. It does not contain information about a study involving human readers with or without AI assistance, or any specific AI component that would require a ground truth established by experts. Therefore, many of the requested sections related to AI performance, sample sizes for test/training sets, expert qualifications, and adjudication methods are not applicable here.

Here's a summary of the available information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly list "acceptance criteria" for each test but rather states whether the device "Passed" or "Met requirements." The "Test Method Summary" implicitly defines the criteria being evaluated.

Test	Test Method Summary	Reported Device Performance (Results)
Biocompatibility
Cytotoxicity - MEM Elution	Tested in accordance with ISO 10993-5	Pass (Considered non-cytotoxic)
Hemocompatibility - Hemolysis (Direct Contact & Extract Method)	Tested in accordance with ISO 10993-4	Pass (Considered non-hemolytic)
Hemocompatibility - Complement Activation SC5b-9 Assay	Tested in accordance with ISO 10993-4	Pass (Requirements met)
Hemocompatibility - Partial Thromboplastin Time (PTT)	Tested in accordance with ASTM F2382-18	Pass (Requirements met)
Hemocompatibility – Blood Platelet and Leukocyte Count (PLC)	Tested in accordance with ASTM F2888-19	Pass (Requirements met)
Hemocompatibility - Comparative Surface Assessment	Visually inspected at more than 40x magnification.	Pass (Requirements met)
Hemocompatibility - Thrombogenicity in a Canine Model	Tested in accordance with ISO 10993-4	Pass (Performed similarly to comparator)
Pyrogenicity - Material-Mediated Rabbit Pyrogen	Tested in accordance with USP 151	Pass (Requirements met)
Sensitization - Guinea Pig Maximization Sensitization	Tested in accordance with ISO 10993-10	Pass (Did not elicit a sensitization response)
Systemic Toxicity - Acute Systemic Injection	Tested in accordance with ISO 10993-11	Pass (Requirements met)
Irritation - Intracutaneous Reactivity	Tested in accordance with ISO 10993-23	Pass (Requirements met)
Physical and Mechanical Performance
Dimensional Verification	Catheter outer diameter, inner diameter, usable length, tip length, and coating length were measured.	Pass
Surface Contamination	Visual inspection completed for surface defects.	Pass
Tensile Strength	Peak tensile force evaluated per ISO 10555-1 after preconditioning in a simulated use model.	Pass
Kink Resistance	Evaluated after preconditioning in a simulated use model.	Pass
Liquid Leakage	Exposed to liquid pressure for 30 seconds; inspected for leakage per ISO 10555-1.	Pass
Air Leakage	Tested for air leakage into the hub per ISO 10555-1.	Pass
Dynamic Burst	Verified ability to withstand internal liquid pressure under dynamic flow conditions with distal end open.	Pass
Torque Strength	Measured number of catheter rotations until failure after preconditioning in a simulated use model and compared to predicate.	Pass
Hub Validation Testing	Met established acceptance criteria per ISO 80369-7.	Pass
Particulate Matter	Underwent simulated use testing; particulate testing conducted including a reference device for comparison.	Pass
Tip Buckling	Maximum force to cause catheter tip buckling while constrained at varying distances was measured.	The tip stiffness was comparable to the predicate and other cleared catheters.
Corrosion	Tested per ISO 10555-1.	No evidence of corrosion and met requirements per ISO 10555-1.
Static Burst	Distal tip blocked, fluid injected at increasing pressure until burst (per ISO 10555-1); compared static burst pressure with maximum pressure generated with manual syringe injection.	Pass
Coating Integrity	Inspected before and after preconditioning through a simulated use model.	No evidence of surface damage or coating defects.
Saline and Contrast Exposure	After device use to deliver saline and contrast media, inspected for damage, and dimensional attributes measured.	No visual evidence of damage or dimensional changes.
Radiopacity (Visibility)	Tested to demonstrate acceptable radiopacity.	Marker radiopacity is comparable to the predicate.
Design Validation / Usability	Subject and predicate devices prepared per IFU and tested for usability in a clinically relevant anatomical model.	Device preparation, introduction, trackability, and retrieval were comparable to the predicate.

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

The document does not specify exact sample sizes for each bench test conducted. The provenance of the data is from Balt USA, LLC and describes non-clinical bench testing. There is no mention of human data, so concepts like "country of origin of the data" or "retrospective or prospective" do not apply.

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

This section is not applicable. The tests performed are engineering and biocompatibility tests on a physical medical device, not a diagnostic algorithm requiring ground truth established by medical experts.

4. Adjudication Method for the Test Set

This section is not applicable. There was no human interpretation or subjective assessment that would require an adjudication method.

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 section is not applicable. This submission is for a physical medical device (catheter), not an AI-powered diagnostic tool, and therefore no MRMC study or AI assistance evaluation was conducted.

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

This section is not applicable. This submission is for a physical medical device, not a standalone algorithm.

7. The Type of Ground Truth Used

For the non-clinical performance tests, the "ground truth" is defined by established engineering standards (e.g., ISO, ASTM, USP) and the physical properties and performance characteristics of the device itself (e.g., directly measured dimensions, observed leakage, visual inspection for defects, comparison to a predicate device's performance).

8. The Sample Size for the Training Set

This section is not applicable. There is no "training set" as this is not an AI/machine learning device.

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

This section is not applicable. There is no "training set" as this is not an AI/machine learning device.

Summary

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July 2, 2024

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.

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

Re: K234074

Trade/Device Name: Next Generation Access Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP, DQY Dated: May 31, 2024 Received: June 3, 2024

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 (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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

Sincerely,

Naira Muradyan -S

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

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Indications for Use

Submission Number (if known)

K234074

Device Name

Next Generation Access Catheter

Indications for Use (Describe)

The Next Generation Access Catheter is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

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: K234074

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

Date SummaryPrepared:	June 28, 2024
Trade Name:	Next Generation Access Catheter
Common Name:	Catheter, Percutaneous
Review Panel:	Neurology, Cardiovascular
Product Code:	QJP, DQY
Regulation Number:	21 CFR 870.1250
Device Classification:	Class II
Predicate Device:	BENCHMARK BMX81 Access System510(k) #: K221822

Device Description:

A peelable split introducer sheath is provided in the package to provide support and facilitate the introduction of the distal tip of the Next Generation Access Catheter into an appropriate vascular sheath.

The catheter and introducer sheath are provided sterile, non-pyrogenic, and are intended for single use only.

Indications for Use:

The Next Generation Access Catheter is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

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Comparison of Technological Characteristics:

	Predicate Device	Subject Device
	BENCHMARK BMX81Access System(K221822)	Next Generation Access Catheter(K234074)
Indications for Use	The BENCHMARK BMX81 AccessSystem is indicated for the introduction ofinterventional devices into the peripheral,coronary, and neuro vasculature.	The Next Generation Access Catheter isindicated for the introduction ofinterventional devices into theperipheral, coronary, and neurovasculature.
Device Classification /Product Code	Class II / QJP, DQY(Percutaneous Catheter)	Same as K221822
Dimensional Specifications
Catheter OuterDiameter (OD)	7F (2.46 mm, 0.097")	6.F (2.11 mm, 0.083")7F (2.36 mm, 0.093")
Catheter InnerDiameter (ID)	0.081" (2.06 mm)	0.071" - 0.081" (1.80 mm - 2.06 mm)
Effective Length	95 cm, 105 cm, 115 cm	110 cm - 132 cm
Coating Length	18 cm	60 cm
Device Attributes
Catheter Materials	Commonly used medical grade plastics &stainless steel	Same as K221822
Coating	Hydrophilic	Same as K221822
Packaging Materials	Commonly used medical devicepackaging materials	Same as K221822
Sterilization
How Supplied	Sterile, Single Use	Same as K221822
Method	Ethylene Oxide	Same as K221822

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Performance Testing Summary:

Biocompatibility:

The following biocompatibility testing was conducted for the Next Generation Access Catheter:

Test	Test Method Summary	Results
Cytotoxicity - MEM Elution	Tested in accordance with ISO10993-5	PassThe test article is considerednon-cytotoxic.
Hemocompatibility -Hemolysis (Direct Contact &Extract Method)	Tested in accordance with ISO10993-4	PassThe test article is considerednon-hemolytic.
Hemocompatibility -Complement ActivationSC5b-9 Assay	Tested in accordance with ISO10993-4	PassRequirements have been met bythe test article.
Hemocompatibility - PartialThromboplastin Time (PTT)	Tested in accordance with ASTMF2382-18	PassRequirements have been met bythe test article.
Hemocompatibility – BloodPlatelet and Leukocyte Count(PLC)	Tested in accordance with ASTMF2888-19	PassRequirements have been met bythe test article.
Hemocompatibility -Comparative SurfaceAssessment	The test article was visuallyinspected at more than 40xmagnification.	PassRequirements have been met bythe test article.
Hemocompatibility -Thrombogenicity in a CanineModel	Tested in accordance with ISO10993-4	PassThe test article performedsimilarly to the comparator.
Pyrogenicity - Material-Mediated Rabbit Pyrogen	Tested in accordance with <usp151></usp	PassRequirements have been met bythe test article.
Sensitization - Guinea PigMaximization Sensitization	Tested in accordance with ISO10993-10	PassThe test article did not elicit asensitization response.
Systemic Toxicity - AcuteSystemic Injection	Tested in accordance with ISO10993-11	PassRequirements have been met bythe test article.
Irritation - IntracutaneousReactivity	Tested in accordance with ISO10993-23	PassRequirements have been met bythe test article.
Test	Test Method Summary	Results
DimensionalVerification	The catheter outer diameter, inner diameter, usablelength, tip length, and coating length were measured.	Pass
SurfaceContamination	Visual inspection completed for surface defects.	Pass
Tensile Strength	The peak tensile force was evaluated per ISO 10555-1after preconditioning in a simulated use model.	Pass
Kink Resistance	Kink resistance was evaluated after preconditioning in asimulated use model.	Pass
Liquid Leakage	The device was exposed to a liquid pressure for 30seconds. The device was inspected for leakage per ISO10555-1.	Pass
Air Leakage	The device was tested for air leakage into the hub perISO 10555-1.	Pass
Dynamic Burst	Tested to verify the device can withstand internal liquidpressure under dynamic flow conditions with the distalend open.	Pass
Torque Strength	The device was evaluated for torque strength bymeasuring the number of catheter rotations until failureafter preconditioning in a simulated use model andcompared to the predicate.	Pass
Hub ValidationTesting	The device shall meet the established acceptance criteriaper ISO 80369-7.	Pass
Particulate Matter	The catheter underwent simulated use testing andparticulate testing was conducted including a referencedevice for comparison.	Pass
Tip Buckling	The maximum force to cause catheter tip buckling whileconstrained at varying distances was measured.	The tip stiffness wascomparable to thepredicate and other clearedcatheters.
Corrosion	Corrosion tested per ISO 10555-1.	No evidence of corrosionand met requirements perISO 10555-1.
Static Burst	The distal tip of the catheter was blocked, and fluid wasinjected into the lumen at increasing pressure until thecatheter burst per ISO 10555-1 and the static burstpressure was compared with the maximum pressuregenerated with manual syringe injection.	Pass
Test	Test Method Summary	Results
Coating Integrity	The coating integrity was inspected before and after preconditioning through a simulated use model.	No evidence of surface damage or coating defects.
Saline andContrast Exposure	After the device was used to deliver saline and contrast media, the device was inspected for damage, and dimensional attributes were measured.	No visual evidence of damage or dimensional changes.
Radiopacity(Visibility)	The device was tested to demonstrate acceptable radiopacity.	Marker radiopacity is comparable to the predicate.
Design Validation/Usability	The subject and predicate devices were prepared in accordance with their respective instructions for use and tested for device usability in a clinically relevant anatomical model.	Device preparation, introduction, trackability, and retrieval were comparable to the predicate.

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Performance Data - Bench:

The following performance bench testing was conducted to assess the performance of the Next
Generation Access Catheter:

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Sterilization and Shelf-Life:

The Next Generation Access Catheters are sterilized using an ethylene oxide sterilization cycle that was verified to a sterility assurance level of 1 x 10° in accordance with ISO 11135. Accelerated aging testing for the Next Generation Access Catheter based on ASTM F1980 has established that the subject device and packaging remain functional for the labeled expiration date. Aging studies for packaging integrity, seal strength, and device functionality were performed and met the acceptance criteria.

Performance Data - Animal:

No animal study was conducted because bench performance testing was deemed sufficient for verification and validation and to support substantial equivalence.

Performance Data - Clinical:

No clinical study was conducted because bench performance testing was deemed sufficient for verification and validation and to support substantial equivalence.

Conclusion:

The evidence presented in this 510(k) submission 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. Nonclinical bench testing demonstrates the Next Generation Access Catheter meets the device specifications and perform as intended.

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).