Radical the Dude 7F Guide Catheter

K231393 · Maduro Medical, Inc. · QJP · Nov 30, 2023 · Cardiovascular

Device Facts

• Record ID: K231393
• Device Name: Radical the Dude 7F Guide Catheter
• Applicant: Maduro Medical, Inc.
• Product Code: QJP · Cardiovascular
• Decision Date: Nov 30, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The Radical the Dude 7F Guide Catheter is indicated for the introduction of intravascular catheters into the peripheral, coronary, and neuro vasculature.

Device Story

The Radical the Dude 7F Guide Catheter is a 7 French guide catheter used by physicians to access target vasculature during interventional procedures. It features variable stiffness along its length using hybrid ribbon technologies and a hydrophilic coating on the distal portion. The device is used with support catheters; the physician attaches a rotating hemostasis valve (RHV) to the proximal luer to create a continuous lumen for saline infusion and device advancement. The catheter is advanced through the vasculature under fluoroscopic guidance using standard percutaneous techniques. By providing a stable conduit, it assists in the delivery of interventional devices to the target site, potentially improving procedural success and patient outcomes. It is provided sterile for single use.

Clinical Evidence

No clinical data was provided. Substantial equivalence was established through bench testing, including visual inspection, dimensional verification, simulated use (radial and femoral models), mechanical testing (tensile, torque, kink, burst), leak testing, coating integrity, particulate analysis, and radiopacity. Biocompatibility was confirmed per ISO 10993 standards (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, hemocompatibility, and canine thrombogenicity).

Technological Characteristics

7F guide catheter; 95-115 cm length. Materials: Urethane (Tecoflex), Pebax, Nylon shaft; PTFE liner; Nylon hub; Polyolefin strain relief; 304V Stainless Steel braid/coil reinforcement; Platinum/Iridium marker band. Features: Hydrophilic coating, variable stiffness hybrid ribbon technology. Sterilization: Ethylene Oxide (EO) per ISO 14937. Packaging: Tyvek/Nylon/PE pouch. Connectivity: None (mechanical device).

Indications for Use

Indicated for introduction of intravascular catheters into peripheral, coronary, and neuro vasculature in patients undergoing interventional procedures.

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

• RIST Cath Radial Access Long Sheath (K191551)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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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### 510(k) SUMMARY

### K231393

| Manufacturer/Sponsor: | Maduro Medical, Inc.<br>1731 Dell Avenue<br>Campbell, California 95008 | |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Phone: [phone] | |
| Contact: | Janice Kemp<br>QA/RA Director<br>[phone]<br>[e-mail] | |
| 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 Guide<br>Catheter | RIST Cath Radial Access Long Sheath |
| 510(k) Number | K231393 | K191551 |
| Indications for<br>Use | The Radical the Dude 7F Guide<br>Catheter is indicated for the<br>introduction of intravascular<br>catheters into the peripheral,<br>coronary, and neuro vasculature. | The RIST Cath Radial Access Long Sheath<br>is indicated for the introduction of<br>interventional devices into the peripheral,<br>coronary, and neuro vasculature. |
| Product Code | QJP, DQY | DQY |
| Regulation No. | 21 CFR 870.1250 | 21 CFR 870.1250 |
| Classification | Class II | Class II |
| Components<br>Supplied | Catheter, Peel-away Sheath,<br>Rotating Hemostasis Valve (RHV) | Sheath, Vessel Dilator, RHV |
| Materials | | |
| Catheter Shaft<br>Material | Urethane (Tecoflex), Pebax,<br>Nylon | Chronoflex/Polyblend (distal section)<br>Chronoflex (PEBAX)<br>Vestamid (proximal section) |
| Inner Liner | PTFE | Same |
| Hub Material | Nylon (Grilamid) | Polycarbonate (Makrolon) |
| Strain Relief | Polyolefin | Same |
| Catheter Shaft<br>Reinforcement | Braid: 304V Stainless Steel<br>Coil: 304V Stainless Steel | Stainless Steel Coil (proximal)<br>Nitinol Wire Coil (distal) |
| Lubricious<br>Coating | Hydrophilic Coating | Hydrophilic Coating |
| Radiopaque<br>Marker 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 inches<br>Distal Tip OD, at marker band:<br>0.098 inches max.<br>Proximal OD: 0.098 inches max. | 0.093 inches |
| Device Attribute | Subject Device | Predicate Device |
| Product Name | Radical the Dude 7F Guide<br>Catheter | RIST Cath Radial Access Long Sheath |
| Packaging | Tyvek/Nylon/polyethylene (PE)<br>Pouch, PE tube, Packaging card,<br>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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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 (via<br>radial artery) | Simulated use in a bench anatomical model<br>with radial artery access. | Pass |
| Simulated Use Test (via<br>femoral artery) | Simulated use in a bench anatomical model with<br>femoral artery access. | Pass |
| PTFE delamination | Assessed for PTFE delamination at distal tip<br>following simulated use testing. | Pass |
| Tensile Strength | Tensile strength measured along entire catheter<br>length. | Pass |
| Torque Strength | The distal end of the catheter was constrained from<br>movement while the proximal end was turned until<br>failure in a simulated anatomy model. | Pass |
| Kink Resistance | Resistance to kink tested at various locations along<br>the catheter shaft using successively smaller radii to<br>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 |
| Corrosion | Corrosion tested per ISO 10555-1. | Pass |
| Hydrophilic Coating<br>Integrity | The integrity of the hydrophilic coating was<br>inspected before and after simulated use testing in an<br>in vitro model. | Pass |
| Particulate Testing | During simulated use testing in an in vitro model the<br>particle size and count were analyzed using light<br>obscuration method and compared to the predicate. | Pass |
| Tip Stiffness | Compared the tip stiffness of the Dude 7F Catheter<br>with the predicate device. | Pass |
| Radiopacity | Radiopacity of the device was evaluated in an<br>animal model under fluoroscopy. | Pass |

Table 2: Bench Testing Summary

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## 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 |
|-----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|-----------------|
| Cytotoxicity<br>MEM Elution (ISO 10993-5) | Grade=0 (Reactivity None) | Pass | Non-cytotoxic |
| Sensitization<br>Magnusson-Kligman Method<br>(ISO 10993-10) | Normal saline (NS) Extract:<br>Grade = 0<br>Sesame oil (SO) Extract:<br>Grade = 0 | Pass | Non-sensitizing |
| Irritation<br>Intracutaneous Reactivity<br>(ISO 10993-10) | NS Extract Difference = 0.0<br>SO Extract Diff. = 0.1 | Pass | Non-irritant |
| Acute Systemic Toxicity<br>Injection (ISO 10993-11) | No evidence of systemic<br>toxicity from sample extracts<br>(both NS and SO extracts):<br>• No deaths<br>• No signs consistent with<br>toxicity<br>• No weight loss > 10% | Pass | Non-toxic |
| Material-Mediated<br>Pyrogenicity (USP <151>) | No single animal showed a<br>temperature rise of 0.5°C or<br>more above its baseline<br>temperature. | Pass | Non-pyrogenic |
| Hemocompatibility:<br>Hemocompatibility:<br>Hemolysis<br>Direct and Indirect<br>(ISO 10993-4) | Direct Contact:<br>Hemolytic Index = -0.2%<br>Indirect Contact:<br>Hemolytic Index = 0.6% | Pass | Non-hemolytic |

Table 3: Biocompatibility Tests and Results

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| Tests | Results | Result | Conclusion |
|--------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|------------------------------------------------------------------------------------------------|
| Hemocompatibility:<br>Complement Activation<br>(ISO 10993-4) | The SC5b-9 concentration of<br>the test article sample was<br>lower than the activated<br>normal human serum (NHS)<br>and was similar to the<br>negative control. | Pass | Non-activator of<br>complement<br>system |
| Hemocompatibility:<br>Partial Thromboplastin Time (PTT) | The plasma exposed to the<br>test article had a final average<br>clotting time that was 90% of<br>the negative control. | Acceptable | No effect on the<br>PTT |
| Thrombogenicity in Canine model | An in vivo canine test to<br>evaluate the thrombogenic<br>potential of the subject device<br>compared to a comparator<br>device. | Pass | Non-thrombogenic |
| Platelet and Leukocyte Count | Average platelet count is<br>82.2% of the negative control.<br>Average leukocyte count is<br>83.5% of the negative control. | Pass | Subject device<br>counts are within<br>acceptable ranges<br>and are similar to<br>the 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.