Who is the manufacturer of Next Generation Access Catheter?

Balt USA, LLC filed the 510(k) submission for Next Generation Access Catheter (K234074).

What is the FDA product code for Next Generation Access Catheter?

QJP. It is classified under 21 CFR 870.1250 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for Next Generation Access Catheter?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Next Generation Access Catheter?

BENCHMARK BMX81 Access System (K221822).

Who can help prepare an FDA 510(k) submission like Next Generation Access Catheter?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Next Generation Access Catheter

K234074 · Balt USA, LLC · QJP · Jul 2, 2024 · Cardiovascular

Device Facts

Record ID	K234074
Device Name	Next Generation Access Catheter
Applicant	Balt USA, LLC
Product Code	QJP · Cardiovascular
Decision Date	Jul 2, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1250
Device Class	Class 2

Intended Use

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

Device Story

Single-lumen, flexible, variable stiffness composite catheter; distal tip includes marker band; proximal end features luer fitting for accessory attachment and liquid infusion. Distal shaft has external hydrophilic coating for lubricity; visible under fluoroscopy. Provided with peelable split introducer sheath to facilitate vascular entry. Used in clinical settings by physicians for navigating peripheral, coronary, and neuro vasculature to deliver interventional devices. Device provides access path; enables physician to perform procedures; benefits patient by facilitating minimally invasive interventions.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including biocompatibility (ISO 10993 series), mechanical performance (tensile strength, kink resistance, leakage, burst, torque), and usability in a clinically relevant anatomical model.

Technological Characteristics

Single-lumen composite catheter; medical grade plastics and stainless steel; hydrophilic coating. Dimensions: 6F-7F OD, 1.80-2.06 mm ID, 110-132 cm length. Sterilization: Ethylene Oxide (ISO 11135). Standards: ISO 10993 (biocompatibility), ISO 10555-1 (catheter performance), ISO 80369-7 (hub), ASTM F1980 (shelf-life).

Indications for Use

Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature in patients requiring such access.

Regulatory Classification

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.

Predicate Devices

BENCHMARK BMX81 Access System (K221822)

Related Devices

K230609 — NG Delivery Catheter · Balt USA, LLC · Sep 13, 2023
K252569 — Carrier XL Delivery Catheter · Balt USA, LLC · Oct 22, 2025
K231218 — Distal Access Catheter · Accumedical Beijing , Ltd. · Jan 19, 2024
K253032 — AXS Lift Intracranial Base Catheter · Stryker Neurovascular · Feb 11, 2026
K140080 — ENVOY DISTAL ACCESS (DA) GUIDING CATHETER, 6F, 95CM & 105CM, STRAIGHT & XB, MPD & XB, MPC & XB · Codman & Shurtleff, Inc. · Apr 24, 2014

Submission Summary (Full Text)

{0}------------------------------------------------ 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). {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ### 510(k) Summary: K234074 | Applicant: | Balt USA, LLC 29 Parker Irvine, CA 92618 Registration No.: 3014162263 | |-----------------|-------------------------------------------------------------------------------------------| | Contact Person: | Catherine Chiou Specialist, Regulatory Affairs Email: Catherine.chiou@baltgroup.com | | Date Summary Prepared: | 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 System 510(k) #: K221822 | #### Device Description: 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. #### Indications for Use: The Next Generation Access Catheter is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature. {4}------------------------------------------------ Comparison of Technological Characteristics: | | Predicate Device | Subject Device | |-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | BENCHMARK BMX81 Access System (K221822) | Next Generation Access Catheter (K234074) | | Indications for Use | The BENCHMARK BMX81 Access System is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature. | The Next Generation Access Catheter is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature. | | Device Classification / Product Code | Class II / QJP, DQY (Percutaneous Catheter) | Same as K221822 | | Dimensional Specifications | | | | Catheter Outer Diameter (OD) | 7F (2.46 mm, 0.097") | 6.F (2.11 mm, 0.083") 7F (2.36 mm, 0.093") | | Catheter Inner Diameter (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 device packaging materials | Same as K221822 | | Sterilization | | | | How Supplied | Sterile, Single Use | Same as K221822 | | Method | Ethylene Oxide | Same as K221822 | {5}------------------------------------------------ ### 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 ISO 10993-5 | Pass The test article is considered non-cytotoxic. | | Hemocompatibility - Hemolysis (Direct Contact & Extract Method) | Tested in accordance with ISO 10993-4 | Pass The test article is considered non-hemolytic. | | Hemocompatibility - Complement Activation SC5b-9 Assay | Tested in accordance with ISO 10993-4 | Pass Requirements have been met by the test article. | | Hemocompatibility - Partial Thromboplastin Time (PTT) | Tested in accordance with ASTM F2382-18 | Pass Requirements have been met by the test article. | | Hemocompatibility – Blood Platelet and Leukocyte Count (PLC) | Tested in accordance with ASTM F2888-19 | Pass Requirements have been met by the test article. | | Hemocompatibility - Comparative Surface Assessment | The test article was visually inspected at more than 40x magnification. | Pass Requirements have been met by the test article. | | Hemocompatibility - Thrombogenicity in a Canine Model | Tested in accordance with ISO 10993-4 | Pass The test article performed similarly to the comparator. | | Pyrogenicity - Material- Mediated Rabbit Pyrogen | Tested in accordance with <usp 151></usp | Pass Requirements have been met by the test article. | | Sensitization - Guinea Pig Maximization Sensitization | Tested in accordance with ISO 10993-10 | Pass The test article did not elicit a sensitization response. | | Systemic Toxicity - Acute Systemic Injection | Tested in accordance with ISO 10993-11 | Pass Requirements have been met by the test article. | | Irritation - Intracutaneous Reactivity | Tested in accordance with ISO 10993-23 | Pass Requirements have been met by the test article. | | Test | Test Method Summary | Results | | Dimensional Verification | The 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 | The peak tensile force was evaluated per ISO 10555-1 after preconditioning in a simulated use model. | Pass | | Kink Resistance | Kink resistance was evaluated after preconditioning in a simulated use model. | Pass | | Liquid Leakage | The device was exposed to a liquid pressure for 30 seconds. The device was inspected for leakage per ISO 10555-1. | Pass | | Air Leakage | The device was tested for air leakage into the hub per ISO 10555-1. | Pass | | Dynamic Burst | Tested to verify the device can withstand internal liquid pressure under dynamic flow conditions with the distal end open. | Pass | | Torque Strength | The device was evaluated for torque strength by measuring the number of catheter rotations until failure after preconditioning in a simulated use model and compared to the predicate. | Pass | | Hub Validation Testing | The device shall meet the established acceptance criteria per ISO 80369-7. | Pass | | Particulate Matter | The catheter underwent simulated use testing and particulate testing was conducted including a reference device for comparison. | Pass | | Tip Buckling | The 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 | Corrosion tested per ISO 10555-1. | No evidence of corrosion and met requirements per ISO 10555-1. | | Static Burst | The distal tip of the catheter was blocked, and fluid was injected into the lumen at increasing pressure until the catheter burst per ISO 10555-1 and the static burst pressure was compared with the maximum pressure generated 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 and Contrast 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. | {6}------------------------------------------------ ## Performance Data - Bench: The following performance bench testing was conducted to assess the performance of the Next Generation Access Catheter: {7}------------------------------------------------ ### 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.