(193 days)
Not Found
No
The device description and performance studies focus on the physical properties and mechanical performance of a catheter, with no mention of AI or ML capabilities.
No
Explanation: The device is an access catheter used to introduce other interventional devices into the vasculature. Its primary function is to facilitate the delivery of therapeutic devices or procedures, rather than providing therapy itself.
No
The device description and intended use state that it is for the "introduction of interventional devices" and describes it as a "catheter" used for physically accessing vasculature, not for diagnosis.
No
The device description clearly outlines a physical catheter with various material properties, dimensions, and accessories (introducer sheath). The performance studies focus on bench testing of physical characteristics and biocompatibility, not software validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the introduction of interventional devices into the vasculature. This is a procedural device used in vivo (within the body) to facilitate other medical procedures.
- Device Description: The description details a catheter designed for physical insertion into blood vessels. It mentions features like a lumen for introducing devices and infusing liquids, a hydrophilic coating for lubrication, and visibility under fluoroscopy. These are characteristics of devices used directly on the patient's anatomy.
- Lack of IVD Characteristics: An IVD device is used to examine specimens from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any analysis of biological samples.
Therefore, the Next Generation Access Catheter is a medical device used for interventional procedures within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Next Generation Access Catheter is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Product codes (comma separated list FDA assigned to the subject device)
QJP, DQY
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 liquids 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral, coronary, and neuro vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Testing Summary:
Biocompatibility:
- Cytotoxicity - MEM Elution: Tested in accordance with ISO 10993-5. Results: Pass, non-cytotoxic.
- Hemocompatibility - Hemolysis (Direct Contact & Extract Method): Tested in accordance with ISO 10993-4. Results: Pass, non-hemolytic.
- Hemocompatibility - Complement Activation SC5b-9 Assay: Tested in accordance with ISO 10993-4. Results: Pass, requirements met.
- Hemocompatibility - Partial Thromboplastin Time (PTT): Tested in accordance with ASTM F2382-18. Results: Pass, requirements met.
- Hemocompatibility – Blood Platelet and Leukocyte Count (PLC): Tested in accordance with ASTM F2888-19. Results: Pass, requirements met.
- Hemocompatibility - Comparative Surface Assessment: Visual inspection at more than 40x magnification. Results: Pass, requirements met.
- Hemocompatibility - Thrombogenicity in a Canine Model: Tested in accordance with ISO 10993-4. Results: Pass, performed similarly to the comparator.
- Pyrogenicity - Material-Mediated Rabbit Pyrogen: Tested in accordance with USP 151. Results: Pass, requirements met.
- Sensitization - Guinea Pig Maximization Sensitization: Tested in accordance with ISO 10993-10. Results: Pass, did not elicit a sensitization response.
- Systemic Toxicity - Acute Systemic Injection: Tested in accordance with ISO 10993-11. Results: Pass, requirements met.
- Irritation - Intracutaneous Reactivity: Tested in accordance with ISO 10993-23. Results: Pass, requirements met.
Performance Bench Testing:
- Dimensional Verification: Catheter outer diameter, inner diameter, usable length, tip length, and coating length were measured. Results: Pass.
- Surface Contamination: Visual inspection completed for surface defects. Results: Pass.
- Tensile Strength: Peak tensile force evaluated per ISO 10555-1 after preconditioning in a simulated use model. Results: Pass.
- Kink Resistance: Evaluated after preconditioning in a simulated use model. Results: Pass.
- Liquid Leakage: Device exposed to liquid pressure for 30 seconds; inspected for leakage per ISO 10555-1. Results: Pass.
- Air Leakage: Device tested for air leakage into the hub per ISO 10555-1. Results: Pass.
- Dynamic Burst: Tested to verify the device can withstand internal liquid pressure under dynamic flow conditions with the distal end open. Results: Pass.
- Torque Strength: Evaluated by measuring the number of catheter rotations until failure after preconditioning in a simulated use model and compared to the predicate. Results: Pass.
- Hub Validation Testing: Device met established acceptance criteria per ISO 80369-7. Results: Pass.
- Particulate Matter: Catheter underwent simulated use testing and particulate testing including a reference device for comparison. Results: Pass.
- Tip Buckling: Maximum force to cause catheter tip buckling while constrained at varying distances was measured. Results: The tip stiffness was comparable to the predicate and other cleared catheters.
- Corrosion: Tested per ISO 10555-1. Results: No evidence of corrosion and met requirements per ISO 10555-1.
- Static Burst: Distal tip of catheter blocked, fluid injected into lumen at increasing pressure until catheter burst per ISO 10555-1 and compared with maximum pressure generated by manual syringe injection. Results: Pass.
- Coating Integrity: Inspected before and after preconditioning through a simulated use model. Results: No evidence of surface damage or coating defects.
- Saline and Contrast Exposure: After device used to deliver saline and contrast media, device inspected for damage, and dimensional attributes measured. Results: No visual evidence of damage or dimensional changes.
- Radiopacity (Visibility): Device tested to demonstrate acceptable radiopacity. Results: Marker radiopacity is comparable to the predicate.
- Design Validation/Usability: Subject and predicate devices prepared in accordance with respective instructions for use and tested for device usability in a clinically relevant anatomical model. Results: Device preparation, introduction, trackability, and retrieval were comparable to the predicate.
Sterilization and Shelf-Life:
- Sterilization: Ethylene oxide sterilization cycle verified to a sterility assurance level of 1 x 10^-6 in accordance with ISO 11135.
- Shelf-Life: Accelerated aging testing based on ASTM F1980 established 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.
Animal Study: No animal study was conducted.
Clinical Study: No clinical study was conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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)
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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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 |