(191 days)
No
The description focuses on the physical characteristics and mechanical performance of a delivery catheter, with no mention of AI or ML capabilities.
No
Explanation: The device is described as assisting in the delivery of interventional devices and the infusion of diagnostic agents. It does not exert a therapeutic effect itself.
No
The device is a delivery catheter intended for the infusion of diagnostic agents and to assist in the delivery of interventional devices, not to perform a diagnosis itself.
No
The device description clearly describes a physical catheter with various material and design features, including a luer fitting, radiopaque markers, and a hydrophilic coating. The performance studies also focus on physical characteristics and bench testing of a tangible device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "general intravascular use" for "infusion of diagnostic agents, such as contrast media, and to assist in the delivery of interventional devices." This describes a device used within the body for diagnostic imaging and procedural assistance, not for testing samples outside the body.
- Device Description: The description details a catheter designed for insertion into blood vessels, with features like a lumen for infusion, a hydrophilic coating for lubricity, and radiopaque markers for visualization during procedures. This aligns with an in-vivo medical device, not an in-vitro diagnostic.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples outside the body. The device's function is entirely focused on interacting with the patient's vasculature.
In summary, the NG Delivery Catheter is an in-vivo medical device used for procedures within the body, not an in-vitro diagnostic device used for testing samples outside the body.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
QJP, DQY
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.
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 Data - Bench:
The following non-clinical bench testing was conducted to assess the performance of the subject device, NG Delivery Catheter:
- Physical and Dimensional: All samples passed the acceptance criteria.
- Tensile Strength: All samples passed the acceptance criteria.
- Kink Resistance: All samples passed the acceptance criteria.
- Liquid-Leakage: All samples passed the acceptance criteria.
- Air Leakage: All samples passed the acceptance criteria.
- Static Burst: All samples passed the acceptance criteria.
- Torque Strength: All samples passed the acceptance criteria.
- Catheter Tip Shapeability: All samples passed the acceptance criteria.
- Hub Validation Testing: All samples passed the acceptance criteria.
- Coating Adherence: All samples passed the acceptance criteria.
- Particulate Matter: All samples passed the acceptance criteria.
- Tip Stiffness: The tip stiffness was comparable.
- Flow Rate: Characterization only
- Saline and Contrast Exposure: All samples passed the acceptance criteria.
- Lubricity (Friction Force): Characterization only
- Radiopacity (Visibility): Acceptable
- Physician Usability: All samples passed the acceptance 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.
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.
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).
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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
2
Indications for Use
510(k) Number (if known) K230609
Device Name NG Delivery Catheter
Indications for Use (Describe)
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.
| 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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Image /page/3/Picture/0 description: The image shows the logo for "balt". The logo consists of a green circle with three smaller white circles inside, connected to the word "balt" in lowercase letters. The word "balt" is written in a simple, sans-serif font and is also green. The overall design is modern and clean.
510(k) Summary: K230609
| 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: | 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 Microcatheter |
| 510(k) #: K172014 | |
| Reference Device: | AXS Offset Delivery Assist Catheter |
| 510(k) #: K163259 |
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.
Indications for Use:
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.
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Image /page/4/Picture/0 description: The image shows the logo for "balt". The logo consists of a green circle with a smaller circle attached to the top left, and a smaller circle inside the larger circle. The word "balt" is written in a sans-serif font to the right of the circle, with the same green color as the circle.
Device Comparison:
| Predicate Device: | Reference Device: | Subject Device: | |
|---|---|---|---|
| Wedge Microcatheter | |||
| (K172014) | AXS Offset Delivery Assist | ||
| Catheter (K163259) | NG Delivery Catheter | ||
| (K230609) | |||
| Device | |||
| Classification / | |||
| Product Code | Class II/DQY | ||
| (Percutaneous Catheters) | Same as K172014 | Class II/QJP, DQY | |
| (Percutaneous Catheters) | |||
| Indications for | |||
| Use | The Wedge Microcatheter | ||
| 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 | |||
| the SOFIA 6F Catheter, in the | |||
| neurovasculature. | The AXS Offset Delivery | ||
| Assist Catheter is intended to | |||
| assist in the delivery of | |||
| interventional devices, such as | |||
| distal access catheters, in the | |||
| neurovasculature. | 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. | |||
| 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 |
| Effective
Length | 158 cm – 160 cm | 150 cm | 152 cm |
| Coating Length | 110 cm – 115 cm | 80 cm | 60 cm |
| Packaging Configuration | Microcatheter is placed in a
dispenser hoop and accessories
on a mounting card that is then
inserted into the pouch. The
pouch is then placed inside a
carton box. | Catheter is placed in a
dispenser coil, then inserted
into a pouch and placed
inside 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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Image /page/5/Picture/0 description: The image shows the logo for "Balt". The logo consists of a green circle with three smaller circles inside, connected to the word "Balt" in a stylized font. The color scheme is primarily green, giving it a natural or organic feel.
Biocompatibility:
The following biocompatibility testing was conducted for the subject device, NG Delivery Catheter:
| Test | Results | Conclusions |
|---|---|---|
| Cytotoxicity (ISO MEM | ||
| Elution Test) | The test article scored a ' 1' and is | |
| considered non-cytotoxic under the | ||
| conditions of the test. | The test article is | |
| considered non-cytotoxic. | ||
| Sensitization (ISO Guinea Pig | ||
| Maximization Test) | None of the test animals challenged with | |
| the test article extracts were observed | ||
| with a sensitization response greater than | ||
| 'O'. | The test article did not | |
| elicit a sensitization | ||
| response. | ||
| Intracutaneous Reactivity | The differences in the mean test and | |
| control scores of the extract dermal | ||
| observations were 1.0 or less. | Requirements have been | |
| met by the test article. | ||
| Acute Systemic Toxicity | None of the animals in the study were | |
| observed with abnormal clinical signs | ||
| indicative of toxicity during the 72-hour | ||
| test period. All were alive at the end of | ||
| the 72-hour test duration and body | ||
| weight changes were within acceptable | ||
| parameters over the course of the study. | Requirements have been | |
| met by the test article. | ||
| Material-Mediated Pyrogenicity | ||
| (ISO Materials Mediated Rabbit | ||
| Pyrogen) | None of the rabbits administered with | |
| the test article extract had a temperature | ||
| rise ≥ 0.5℃ at the required observation | ||
| time points. | The test article is | |
| considered non-pyrogenic. | ||
| Hemocompatibility - | ||
| Hemolysis | The test article, in both extract and direct | |
| method, met the criteria for assay | ||
| validity and displayed an Average Blank | ||
| Corrected Hemolytic Index above the | ||
| Negative Control below 2.0%. | The test article is | |
| considered non-hemolytic. | ||
| Hemocompatibility - | ||
| Complement Activation | The test article result was statistically | |
| significantly lower (p |