(56 days)
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a guide catheter, with no mention of AI or ML technologies.
No
The device is a guide catheter used to introduce other intravascular catheters, not to deliver a therapy itself.
No
Explanation: The device description and intended use state that it is a "guide catheter" used for "introduction of intravascular catheters." It serves as a conduit for other devices and does not itself perform any diagnostic function like imaging, sensing, or measuring physiological parameters for diagnosis.
No
The device description clearly describes a physical catheter with specific dimensions, materials (hydrophilic coating, hybrid ribbon technologies), and included hardware components (RHV, peel-away sheath). The performance studies also focus on physical properties 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 intravascular catheters into the peripheral, coronary, and neuro vasculature. This describes a device used within the body for a procedural purpose (guiding other catheters), not for testing samples outside the body to diagnose or monitor a condition.
- Device Description: The description details a physical catheter designed for insertion into blood vessels. This aligns with an interventional device, not a diagnostic test kit or instrument.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely procedural and interventional.
N/A
Intended Use / Indications for Use
The Radical the Dude 8F Guide Catheter is indicated for the introduction of intravascular catheters into the peripheral, coronary, and neuro vasculature.
Product codes (comma separated list FDA assigned to the subject device)
QJP, DQY
Device Description
The Radical the Dude 8F Guide Catheter (Dude 8F Catheter) is an 8 French (Fr) guide catheter designed to aid the physician in accessing the target vasculature during interventional procedures. The Dude 8F Catheter has a usable length between 80 cm and 110 cm, and an outer diameter (OD) size designation of 8 Fr. The Dude 8F Catheter has variable stiffness along its length, incorporating hybrid ribbon technologies to maintain stability and vary stiffness along the device length. The distal portion of the Dude 8F Catheter has a hydrophilic coating. The Dude 8F Catheter is packaged with a rotating hemostasis valve (RHV) and a peel-away sheath.
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
Intended users for the Radical the Dude 8F Guide Catheter are physicians who have received appropriate training in interventional techniques.
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)
Nonclinical Performance Testing:
Bench Testing:
Visual Inspection - Pass
Dimensional Inspection - Pass
Simulated Use Test - Pass
PTFE Delamination - Pass
Tensile Testing - Pass
Torque Strength - Pass
Kink Resistance - Pass
Catheter Burst - Pass
Liquid Leak Test - Pass
Air Leak Test - Pass
Hydrophilic Coating Integrity - Pass
Particulate Testing - Pass
Tip Stiffness - Pass
Biocompatibility Testing:
Hemocompatibility: Partial Thromboplastin Time (PTT) - Pass, PTT similar to the reference device.
Thrombogenicity in Canine Model - Pass, Thrombogenicity similar to reference device.
Animal Study: An animal study was not deemed necessary to support the substantial equivalence of the subject device to the predicate device. Bench testing was determined sufficient to support substantial equivalence.
Clinical Study: The non-clinical performance and biocompatibility testing were determined to be sufficient to support the substantial equivalence of the subject device.
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.
Radical the Dude® 7F Guide Catheter (K231393)
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.
TracStar LDP Large Distal Platform (K240948), CEREBASE DA Guide Sheath (K192804), Neuron MAX System (K111380)
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 contains the logos of the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and 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.
January 14, 2025
Maduro Medical, Inc. Janice Kemp QA/RA Director 1731 Dell Avenue Campbell, California 95008
Re: K243577
Trade/Device Name: Radical the Dude 8F Guide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP, DQY Dated: December 16, 2024 Received: December 16, 2024
Dear Janice Kemp:
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.
1
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).
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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-regulatory
2
assistance/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
3
Indications for Use
510(k) Number (if known) K243577
Device Name Radical the Dude® 8F Guide Catheter
Indications for Use (Describe)
The Radical the Dude 8F Guide Catheter is indicated for the intravascular catheters into the peripheral, coronary, and neuro vasculature.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
| Manufacturer/Sponsor: | Maduro Medical, Inc.
1731 Dell Avenue
Campbell, California 95008
Phone: (408) 600-2235 |
|-----------------------|-------------------------------------------------------------------------------------------------|
| Contact: | Janice Kemp
QA/RA Director
(408) 600-2235
janice@maduromed.com |
| Date Prepared: | January 13, 2025 |
| Device Trade Name: | Radical the Dude® 8F Guide Catheter |
| Common/Usual Name: | Catheter, Percutaneous, Neurovasculature |
| Classification: | 21 CFR 870.1250, Percutaneous Catheter |
| Class: | II |
| Product Code: | QJP, DQY |
| Predicate Device: | Radical the Dude® 7F Guide Catheter (K231393) |
Indications for Use
The Radical the Dude 8F Guide Catheter is indicated for the introduction of intravascular catheters into the peripheral, coronary, and neuro vasculature.
Device Description
The Radical the Dude 8F Guide Catheter (Dude 8F Catheter) is an 8 French (Fr) guide catheter designed to aid the physician in accessing the target vasculature during interventional procedures. The Dude 8F Catheter has a usable length between 80 cm and 110 cm, and an outer diameter (OD) size designation of 8 Fr. The Dude 8F Catheter has variable stiffness along its length, incorporating hybrid ribbon technologies to maintain stability and vary stiffness along the device length. The distal portion of the Dude 8F Catheter has a hydrophilic coating. The Dude 8F Catheter is packaged with a rotating hemostasis valve (RHV) and a peel-away sheath.
Principles of Operation
The Radical the Dude 8F Guide Catheter may be used with support catheters to assist in accessing target vasculature. During use, the male luer of the RHV is attached to the proximal luer of the Dude 8F Catheter to create a continuous lumen through the catheter and to the RHV ports. The female luer of the RHV is typically connected to a saline drip line while the Dude 8F Catheter is advanced through the vasculature. Use of the Dude 8F Catheter relies on standard percutaneous interventional techniques,
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including access site preparation, introducing the catheter portion of the device, advancing the catheter under fluoroscopy, withdrawing the catheter, and closing the access site. Intended users for the Radical the Dude 8F Guide Catheter are physicians who have received appropriate training in interventional techniques. The devices are provided sterile, non-pyrogenic, and are intended for single use only.
Comparison of Technological Characteristics with the Predicate Device
The predicate device is the Radical the Dude 7F Guide Catheter, K231393. The subject and predicate devices have similar technological characteristics and the same intended use as shown in Table 1. The only differences being the larger inner and outer diameters and shorter length of the subject device. A comparison of the technological characteristics of the subject, predicate, and reference devices is shown in Table 1.
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| Device Attribute | Subject Device | Predicate Device | Reference Device | Reference Device | Reference Device |
|---|---|---|---|---|---|
| Product Name | Radical the Dude® 8F Guide | ||||
| Catheter | Radical the Dude® 7F | ||||
| Guide Catheter | TracStar LDP Large | ||||
| Distal Platform | CEREBASE DA Guide | ||||
| Sheath | Neuron MAX System | ||||
| 510(k) Number | K243577 | K231393 | K240948 | K192804 | K111380 |
| Indications for Use | The Radical the Dude 8F Guide | ||||
| Catheter is indicated for the | |||||
| introduction of intravascular | |||||
| catheters into the peripheral, | |||||
| coronary and neuro vasculature. | The Radical the Dude 7F | ||||
| Guide Catheter is indicated | |||||
| for the introduction of | |||||
| intravascular catheters into | |||||
| the peripheral, | |||||
| coronary, and neuro | |||||
| vasculature. | The TracStar LDP Large | ||||
| Distal Platform is | |||||
| indicated for the | |||||
| introduction of | |||||
| interventional devices | |||||
| into the peripheral, | |||||
| coronary, and neuro | |||||
| vasculature. | The CEREBASE DA Guide | ||||
| Sheath is indicated for the | |||||
| introduction of interventional | |||||
| devices into the neuro | |||||
| vasculature. | The Neuron MAX System | ||||
| is indicated for the | |||||
| introduction of | |||||
| interventional devices into | |||||
| the peripheral, coronary, | |||||
| and neuro vasculature. | |||||
| Product Code | QJP, DQY | QJP, DQY | QJP, DQY | QJP | DQY |
| Regulation No. | 21 CFR 870.1250 | 21 CFR 870.1250 | 21 CFR 870.1250 | 21 CFR 870.1250 | 21 CFR 870.1250 |
| Classification | Class II | Class II | Class II | Class II | Class II |
| Components | |||||
| Supplied | Catheter, Peel-away Sheath, | ||||
| Rotating Hemostasis Valve | |||||
| (RHV) | Same | RHV | RHV and Dilator | Hemostasis Valve Adapter | |
| (HVA), RHV, Dilator | |||||
| Materials | |||||
| Catheter Shaft | |||||
| Material | Urethane (Tecoflex), Pebax, | ||||
| Nylon | Same | Commonly used medical | |||
| grade polymers and | |||||
| metals with hydrophilic | |||||
| coating | Nylon, Pebax (nylon | ||||
| blend), and Polyurethane | |||||
| Segment(s) | Commonly used | ||||
| medical grade | |||||
| polymers and metals | |||||
| with hydrophilic | |||||
| coating | |||||
| Inner Liner | PTFE | Same | Commonly used medical | ||
| grade polymers | PTFE | Commonly used medical | |||
| grade polymers | |||||
| Hub Material | Nylon (Grilamid) | Same | Unknown | Polycarbonate (yellow) | Nylon, Polyurethane |
| Strain Relief | Polyolefin | Same | Unknown | Unknown | Unknown |
| Catheter Shaft | |||||
| Reinforcement | Braid: 304V Stainless Steel | ||||
| Coil: 304V Stainless Steel | Same | Reinforced with metals | |||
| and polymers | 304 Stainless Steel braid | Stainless Steel Braid | |||
| Lubricious Coating | Hydrophilic Coating | Same | Same | Same | Same |
| Radiopaque Marker | |||||
| Band | Platinum/Iridium | Same | Unknown | Metal Marker Band | Same |
| Peel-away Sheath | PTFE | Same | N/A | N/A | N/A |
| RHV | Polycarbonate, Silicone | Same | Unknown | Unknown | Unknown |
| Dimensions | |||||
| Working Length | 80, 90, 95, 100, 105, 110 cm | 95, 105, 115 cm | 80-105 cm | 70, 80, 90, and 95 cm | 80 and 90 cm |
| Inner Diameter | 0.094 inches | 0.082 inches | 0.088 inches | 0.090 inches | 0.088 inches |
| Outer Diameter | Distal shaft: 0.105 inches. | ||||
| Distal tip OD, at marker | |||||
| band: 0.110 inches max. | |||||
| Proximal OD: 0.110 inches | |||||
| max. | Distal shaft: 0.094 | ||||
| inches. | |||||
| Distal tip OD, at marker | |||||
| band: 0.098 inches max. | |||||
| Proximal OD: 0.098 inches | |||||
| max. | Distal: 0.106 inches | ||||
| Proximal: 0.110 inches | 8F (0.105 inches) | 8F (0.112 inches max) | |||
| Packaging | Tyvek/Nylon/Polyethylene | ||||
| (PE) pouch, PE tube, packaging | |||||
| card, SBS carton | Same | PE tube, PE packaging | |||
| card, pouch, shelf carton | |||||
| box | PET/ LDPE Tyvek pouch | ||||
| Polypropylene tubing, SBS | |||||
| mounting card, SBS carton | Tyvek/Nylon pouch, PE | ||||
| support tube, packaging | |||||
| card. SBS carton | |||||
| Sterilization | Ethylene Oxide (EO) | Same | Same | Same | Same |
| Pyrogenicity | Nonpyrogenic | Same | Same | Same | Same |
| Number of Uses | Single Use | Same | Same | Same | Same |
Table 1: Comparison of Subject, Predicate, and Reference Devices
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Image /page/7/Picture/0 description: The image shows the logo for Maduro. The logo consists of a stylized brain shape with multiple figures holding hands within the brain. The figures are colored in shades of orange and yellow. Below the brain shape, the word "MADURO" is written in bold, capital letters.
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Image /page/8/Picture/0 description: The image shows a logo with the word "MADURO" in bold, dark blue letters at the bottom. Above the text is an abstract design resembling a brain, composed of interconnected figures in shades of orange, yellow, and purple. The figures appear to be holding hands, creating a sense of unity and collaboration within the brain-shaped form.
Nonclinical Performance Testing
The following nonclinical performance testing was conducted to demonstrate substantial equivalence.
Bench Testing
Table 2 lists the bench testing performed to demonstrate substantial equivalence.
| Test | Test Method/Applicable Standard | Result |
|---|---|---|
| Visual Inspection | Visual inspection completed for surface defects. | Pass |
| Dimensional Inspection | Critical dimensions were verified. | Pass |
| Simulated Use Test | Simulated use in a bench anatomical model with femoral artery | |
| access. | Pass | |
| PTFE Delamination | Assessed for PTFE delamination at distal tip | |
| following simulated use testing. | Pass | |
| Tensile Testing | Tensile strength measured along entire catheter length. | Pass |
| Torque Strength | The distal end of the catheter was constrained from movement | |
| while the proximal end was turned until failure in a simulated | ||
| anatomy model. | Pass | |
| Kink Resistance | Resistance to kink was tested at various locations along the catheter | |
| shaft using successively smaller radii to challenge the catheter. | Pass | |
| Catheter Burst | Catheter burst tested per ISO 10555-1. | Pass |
| Liquid Leak Test | Liquid leak tested per ISO 10555-1. | Pass |
| Air Leak Test | Air leak tested per ISO 10555-1. | Pass |
| Hydrophilic Coating | ||
| Integrity | The integrity of the hydrophilic coating was inspected before and | |
| after simulated use testing in an in vitro model. | Pass | |
| Particulate Testing | During simulated use testing in an in vitro model the particle size and | |
| count were analyzed using light obscuration method and compared | ||
| to the reference device. | Pass | |
| Tip Stiffness | Compared the tip stiffness of the Dude 8F Catheter with the | |
| reference device. | Pass |
Table 2: Bench Testing Summary
Biocompatibility
The subject Radical the Dude 8F Guide Catheter is categorized as a limited exposure (