(202 days)
The Radical the Dude 7F Guide Catheter is indicated for the intravascular catheters into the peripheral, coronary, and neuro vasculature.
The Radical the Dude 7F Guide Catheter (Dude 7F Catheter) is a 7 French (Fr) guide catheter designed to aid the physician in accessing the target vasculature during interventional procedures. The Dude 7F Catheter has a usable length between 95 cm and 115 cm, and an outer diameter (OD) size designation of 7 Fr. The Dude 7F 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 7F Catheter has a hydrophilic coating. The Dude 7F Catheter is packaged with a rotating hemostasis valve (RHV) and a peel-away sheath.
The document provided is a 510(k) Summary for the Radical the Dude 7F Guide Catheter. It describes the device, its intended use, and a comparison to a predicate device to demonstrate substantial equivalence. This document does NOT describe the acceptance criteria and study for an AI/ML powered device.
The Radical the Dude 7F Guide Catheter is a medical device, specifically a guide catheter, and the submitted information pertains to its regulatory clearance as a physical medical device, not an AI/ML software device. As such, the information requested regarding AI/ML device performance (like test set sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, and training set details) is not applicable or present in this document.
The document mainly focuses on:
- Bench Testing: Mechanical and material property tests to ensure the device meets engineering specifications and is safe for its intended use.
- Biocompatibility Testing: To ensure the materials used in the device are safe for contact with the human body.
- Sterilization: Validation of the sterilization process.
- Shelf Life and Packaging: Testing to ensure the device maintains its integrity over time.
Therefore, I cannot provide the requested information for an AI/ML device based on this submission.
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November 30, 2023
Image /page/0/Picture/1 description: The image contains the logos of the 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, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Maduro Medical, Inc. Janice Kemp QA/RA Director 1731 Dell Avenue Campbell, California 95008
Re: K231393
Trade/Device Name: Radical the Dude 7F Guide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP, DQY Dated: November 1, 2023 Received: November 1, 2023
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.
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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approvals in the device master record (21 CFR 820.181).
Your device is also subject to, among other requirements, the Quality System (OS) 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
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
510(k) Number (if known) K231393
Device Name Radical the Dude 7F Guide Catheter
Indications for Use (Describe)
The Radical the Dude 7F 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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Image /page/3/Picture/0 description: The image shows a logo with the word "MADURO" in bold, purple letters at the bottom. Above the word is an image that resembles a brain, but it is made up 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 design.
510(k) SUMMARY
K231393
| Manufacturer/Sponsor: | Maduro Medical, Inc.1731 Dell AvenueCampbell, California 95008 | |
|---|---|---|
| Phone: (408) 600-2235 | ||
| Contact: | Janice KempQA/RA Director(408) 600-2235janice@maduromed.com | |
| Date Prepared: | November 29, 2023 | |
| Device Trade Name: | Radical the Dude® 7F Guide Catheter | |
| Common/Usual Name: | Catheter, Percutaneous, Neurovasculature | |
| Classification: | 21 CFR 870.1250, Percutaneous Catheter | |
| Class: | II | |
| Product Code: | QJP, DQY | |
| Predicate Device: | RIST Cath Radial Access Long Sheath (K191551) | |
| Device Attribute | Subject Device | Predicate Device |
| Product Name | Radical the Dude 7F GuideCatheter | RIST Cath Radial Access Long Sheath |
| 510(k) Number | K231393 | K191551 |
| Indications forUse | The Radical the Dude 7F GuideCatheter is indicated for theintroduction of intravascularcatheters into the peripheral,coronary, and neuro vasculature. | The RIST Cath Radial Access Long Sheathis indicated for the introduction ofinterventional devices into the peripheral,coronary, and neuro vasculature. |
| Product Code | QJP, DQY | DQY |
| Regulation No. | 21 CFR 870.1250 | 21 CFR 870.1250 |
| Classification | Class II | Class II |
| ComponentsSupplied | Catheter, Peel-away Sheath,Rotating Hemostasis Valve (RHV) | Sheath, Vessel Dilator, RHV |
| Materials | ||
| Catheter ShaftMaterial | Urethane (Tecoflex), Pebax,Nylon | Chronoflex/Polyblend (distal section)Chronoflex (PEBAX)Vestamid (proximal section) |
| Inner Liner | PTFE | Same |
| Hub Material | Nylon (Grilamid) | Polycarbonate (Makrolon) |
| Strain Relief | Polyolefin | Same |
| Catheter ShaftReinforcement | Braid: 304V Stainless SteelCoil: 304V Stainless Steel | Stainless Steel Coil (proximal)Nitinol Wire Coil (distal) |
| LubriciousCoating | Hydrophilic Coating | Hydrophilic Coating |
| RadiopaqueMarker Band | Platinum/Iridium | Same |
| Peel-away Sheath | PTFE | N/A |
| RHV | Polycarbonate, Silicone | Unknown |
| Dimensions | ||
| Working Length | 95, 105, 115 cm | 95, 100 cm |
| Inner Diameter | 0.082 inches | 0.079 inches |
| Outer Diameter | Distal shaft: 0.094 inchesDistal Tip OD, at marker band:0.098 inches max.Proximal OD: 0.098 inches max. | 0.093 inches |
| Device Attribute | Subject Device | Predicate Device |
| Product Name | Radical the Dude 7F GuideCatheter | RIST Cath Radial Access Long Sheath |
| Packaging | Tyvek/Nylon/polyethylene (PE)Pouch, PE tube, Packaging card,SBS carton | Same |
| Sterilization | Ethylene Oxide (EO) | Same |
| Pyrogenicity | Nonpyrogenic | Same |
| Number of Uses | Single Use | Same |
Indications for Use
The Radical the Dude 7F Guide Catheter is indicated for the introduction of intravascular catheters into the peripheral, coronary, and neuro vasculature.
Device Description
The Radical the Dude 7F Guide Catheter (Dude 7F Catheter) is a 7 French (Fr) guide catheter designed to aid the physician in accessing the target vasculature during interventional procedures. The Dude 7F Catheter has a usable length between 95 cm and 115 cm, and an outer diameter (OD) size designation of 7 Fr. The Dude 7F 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 7F Catheter has a hydrophilic coating. The Dude 7F Catheter is packaged with a rotating hemostasis valve (RHV) and a peel-away sheath.
Principles of Operation
The Radical the Dude 7F 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 7F 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 7F Catheter is advanced through the vasculature. Use of the Dude 7F Catheter relies on standard percutaneous interventional techniques,
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Image /page/4/Picture/0 description: The image shows a logo with a stylized brain shape at the top and the word "MADURO" in bold, sans-serif font below it. The brain shape is composed of interconnected figures in shades of orange, yellow, and purple, suggesting collaboration and community. The overall design is modern and conveys a sense of intelligence and connection.
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 7F 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 RIST Cath Radial Access Long Sheath cleared under K191551. The predicate and subject devices share the same intended use and basic technological characteristics as shown in Table 1.
Table 1: Comparison of Subject and Predicate Devices
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Image /page/5/Picture/0 description: The image shows a logo with the word "MADURO" in a bold, sans-serif font at the bottom. Above the word is a graphic that resembles a brain, but it is composed of interconnected human figures in shades of orange, yellow, and purple. The figures are arranged in a circular pattern, suggesting unity and collaboration.
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.
| Tests | Test Method/Applicable Standard | Result |
|---|---|---|
| Visual Inspection | Visual inspection completed for surface defects. | Pass |
| Dimensional Verification | Critical dimensions were verified. | Pass |
| Simulated Use Test (viaradial artery) | Simulated use in a bench anatomical modelwith radial artery access. | Pass |
| Simulated Use Test (viafemoral artery) | Simulated use in a bench anatomical model withfemoral artery access. | Pass |
| PTFE delamination | Assessed for PTFE delamination at distal tipfollowing simulated use testing. | Pass |
| Tensile Strength | Tensile strength measured along entire catheterlength. | Pass |
| Torque Strength | The distal end of the catheter was constrained frommovement while the proximal end was turned untilfailure in a simulated anatomy model. | Pass |
| Kink Resistance | Resistance to kink tested at various locations alongthe catheter shaft using successively smaller radii tochallenge 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 |
| Corrosion | Corrosion tested per ISO 10555-1. | Pass |
| Hydrophilic CoatingIntegrity | The integrity of the hydrophilic coating wasinspected before and after simulated use testing in anin vitro model. | Pass |
| Particulate Testing | During simulated use testing in an in vitro model theparticle size and count were analyzed using lightobscuration method and compared to the predicate. | Pass |
| Tip Stiffness | Compared the tip stiffness of the Dude 7F Catheterwith the predicate device. | Pass |
| Radiopacity | Radiopacity of the device was evaluated in ananimal model under fluoroscopy. | Pass |
Table 2: Bench Testing Summary
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Image /page/6/Picture/0 description: The image shows a logo with a stylized brain shape at the top. Inside the brain shape, there are several figures with their arms raised, colored in shades of orange, yellow, and purple. Below the brain shape, the word "MADURO" is written in a bold, sans-serif font. The logo appears to represent a concept related to intelligence, collaboration, or community.
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.
Biocompatibility
The subject Radical the Dude 7F Guide Catheter is categorized as a limited exposure (<24 hours), externally communicating device with circulating blood contact in accordance with ISO 10993-1 and FDA guidance, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"." The subject device is constructed using materials that are commonly used in the medical device industry.
All patient contacting components of the subject device have been evaluated for biocompatibility using the following tests (Table 3).
| Tests | Results | Result | Conclusion |
|---|---|---|---|
| CytotoxicityMEM Elution (ISO 10993-5) | Grade=0 (Reactivity None) | Pass | Non-cytotoxic |
| SensitizationMagnusson-Kligman Method(ISO 10993-10) | Normal saline (NS) Extract:Grade = 0Sesame oil (SO) Extract:Grade = 0 | Pass | Non-sensitizing |
| IrritationIntracutaneous Reactivity(ISO 10993-10) | NS Extract Difference = 0.0SO Extract Diff. = 0.1 | Pass | Non-irritant |
| Acute Systemic ToxicityInjection (ISO 10993-11) | No evidence of systemictoxicity from sample extracts(both NS and SO extracts):• No deaths• No signs consistent withtoxicity• No weight loss > 10% | Pass | Non-toxic |
| Material-MediatedPyrogenicity (USP <151>) | No single animal showed atemperature rise of 0.5°C ormore above its baselinetemperature. | Pass | Non-pyrogenic |
| Hemocompatibility:Hemocompatibility:HemolysisDirect and Indirect(ISO 10993-4) | Direct Contact:Hemolytic Index = -0.2%Indirect Contact:Hemolytic Index = 0.6% | Pass | Non-hemolytic |
Table 3: Biocompatibility Tests and Results
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Image /page/7/Picture/0 description: The image shows a logo with the word "MADURO" in purple, block letters at the bottom. Above the text is a graphic that resembles a brain shape, filled with interconnected figures in shades of orange and white. The figures are stylized and appear to be holding hands, creating a sense of unity or collaboration within the brain-shaped form.
| Tests | Results | Result | Conclusion |
|---|---|---|---|
| Hemocompatibility:Complement Activation(ISO 10993-4) | The SC5b-9 concentration ofthe test article sample waslower than the activatednormal human serum (NHS)and was similar to thenegative control. | Pass | Non-activator ofcomplementsystem |
| Hemocompatibility:Partial Thromboplastin Time (PTT) | The plasma exposed to thetest article had a final averageclotting time that was 90% ofthe negative control. | Acceptable | No effect on thePTT |
| Thrombogenicity in Canine model | An in vivo canine test toevaluate the thrombogenicpotential of the subject devicecompared to a comparatordevice. | Pass | Non-thrombogenic |
| Platelet and Leukocyte Count | Average platelet count is82.2% of the negative control.Average leukocyte count is83.5% of the negative control. | Pass | Subject devicecounts are withinacceptable rangesand are similar tothe control. |
Per the completed biocompatibility testing, the requirements and performance specifications for the subject device were met, as the device was shown to be non-cytotoxic, non-irritant, non-toxic, non-pyrogenic, non-hemolytic, and non-thrombogenic.
Sterilization
The subject Radical the Dude 7F Guide Catheter will be sterilized using a validated EO process with a sterility assurance level (SAL) of 106. The validation will be conducted using the overkill method according to ISO 14937:2009 "Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices."
Shelf Life and Packaging
Accelerated aging testing based on ASTM F1980 was conducted to verify packaged device performance. Accelerated aging equivalent to 1-year of real time shelf life was used to support the 1year shelf-life claim. Device performance was verified by functional and performance testing.
Clinical Testing
A clinical study was not deemed necessary for this submission. Substantial equivalence of the subject device to the predicate has been established through the results of nonclinical testing.
Conclusion
The subject Radical the Dude 7F Guide Catheter has similar intended use, indications for use, principles of operation, and technological characteristics as the predicate device. The technological differences identified do not raise new questions of safety or effectiveness between the subject and predicate devices. Performance testing demonstrates that the Radical the Dude 7F Guide Catheter is substantially equivalent to the predicate device.
§ 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).