(56 days)
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 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.
The provided FDA 510(k) summary (K243577) describes a medical device, the Radical the Dude 8F Guide Catheter, and its substantial equivalence to a predicate device. However, this document does not describe a study involving AI or software performance evaluation with human-in-the-loop scenarios.
Therefore, most of the questions regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typically relevant for assessing the performance of AI/software medical devices, cannot be answered based on the provided text.
The 510(k) pertains to a physical catheter device and details traditional bench testing and biocompatibility assessments to establish substantial equivalence with a previously cleared device.
Based on the provided document, here's what can be extracted, and where limitations exist:
-
A table of acceptance criteria and the reported device performance
The document provides a summary of "Nonclinical Performance Testing" (Bench Testing and Biocompatibility). The acceptance "criteria" are implied by the "Pass" result for each test.
Table of Acceptance Criteria and Reported Device Performance
| Test | Test Method/Applicable Standard | Acceptance Criteria (Implied by "Pass") | Reported Device Performance |
|---|---|---|---|
| Visual Inspection | Visual inspection completed for surface defects. | No surface defects | Pass |
| Dimensional Inspection | Critical dimensions were verified. | Critical dimensions met specifications | Pass |
| Simulated Use Test | Simulated use in a bench anatomical model with femoral artery access. | Successful use in simulated anatomical model | Pass |
| PTFE Delamination | Assessed for PTFE delamination at distal tip following simulated use testing. | No PTFE delamination | Pass |
| Tensile Testing | Tensile strength measured along entire catheter length. | Tensile strength met specifications | 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. | Torque strength met specifications | Pass |
| Kink Resistance | Resistance to kink was tested at various locations along the catheter shaft using successively smaller radii to challenge the catheter. | Acceptable kink resistance | Pass |
| Catheter Burst | Catheter burst tested per ISO 10555-1. | Met ISO 10555-1 burst requirements | Pass |
| Liquid Leak Test | Liquid leak tested per ISO 10555-1. | Met ISO 10555-1 liquid leak requirements | Pass |
| Air Leak Test | Air leak tested per ISO 10555-1. | Met ISO 10555-1 air leak requirements | Pass |
| Hydrophilic Coating Integrity | The integrity of the hydrophilic coating was inspected before and after simulated use testing in an in vitro model. | Hydrophilic coating integrity maintained | 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. | Particle size and count comparable to reference device | Pass |
| Tip Stiffness | Compared the tip stiffness of the Dude 8F Catheter with the reference device. | Tip stiffness comparable to reference device | Pass |
| Biocompatibility: | |||
| Hemocompatibility: Partial Thromboplastin Time (PTT) | The test article average clotting time was higher and was not statistically significant when compared to the negative control. The test article average clotting time was lower and was not statistically significant when compared to the vehicle control. | PTT similar to the reference device | Pass |
| Thrombogenicity in Canine Model | An in vivo canine test to evaluate the thrombogenic potential of the subject device compared to a comparator device. | Thrombogenicity similar to reference device | Pass |
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Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document describes bench testing and biocompatibility testing. Specific sample sizes for each bench test are not specified in this summary.
- For the "Thrombogenicity in Canine Model", it used an in vivo canine test, implying an animal study. The exact number of animals or the test setup details are not provided in this summary.
- There is no mention of "test sets" in the context of clinical data or patient data, as this is a device for physical performance and biocompatibility.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. The tests are physical or chemical evaluations (e.g., visual inspection, dimensional inspection, tensile strength, PTT). "Ground truth" in the context of expert review for diagnostic accuracy is not relevant here.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is not a study requiring adjudication of expert opinions for a test set.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. An MRMC study was not done, as this is neither an AI device nor does it involve human readers interpreting images.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an algorithm or AI device.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For bench testing, the "ground truth" is established by adherence to engineering specifications, relevant ISO standards (e.g., ISO 10555-1), and comparison to the predicate/reference device's performance. For biocompatibility, it's based on standard biological evaluation methods and comparison to controls or reference devices.
-
The sample size for the training set
- Not applicable. This is not an AI/ML device employing a training set.
-
How the ground truth for the training set was established
- Not applicable. There is no training set for this device.
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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.
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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
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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
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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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Image /page/4/Picture/0 description: The image shows a logo with a brain-shaped design at the top and the word "MADURO" in bold, purple letters at the bottom. The brain design is composed of interconnected figures in shades of orange and yellow, creating a sense of unity and collaboration. The overall design is clean and modern, with a focus on the brain as a symbol of intelligence or innovation.
510(k) SUMMARY
| Manufacturer/Sponsor: | Maduro Medical, Inc.1731 Dell AvenueCampbell, California 95008Phone: (408) 600-2235 |
|---|---|
| Contact: | Janice KempQA/RA Director(408) 600-2235janice@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 GuideCatheter | Radical the Dude® 7FGuide Catheter | TracStar LDP LargeDistal Platform | CEREBASE DA GuideSheath | Neuron MAX System |
| 510(k) Number | K243577 | K231393 | K240948 | K192804 | K111380 |
| Indications for Use | The Radical the Dude 8F GuideCatheter is indicated for theintroduction of intravascularcatheters into the peripheral,coronary and neuro vasculature. | The Radical the Dude 7FGuide Catheter is indicatedfor the introduction ofintravascular catheters intothe peripheral,coronary, and neurovasculature. | The TracStar LDP LargeDistal Platform isindicated for theintroduction ofinterventional devicesinto the peripheral,coronary, and neurovasculature. | The CEREBASE DA GuideSheath is indicated for theintroduction of interventionaldevices into the neurovasculature. | The Neuron MAX Systemis indicated for theintroduction ofinterventional devices intothe 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 |
| ComponentsSupplied | Catheter, Peel-away Sheath,Rotating Hemostasis Valve(RHV) | Same | RHV | RHV and Dilator | Hemostasis Valve Adapter(HVA), RHV, Dilator |
| Materials | |||||
| Catheter ShaftMaterial | Urethane (Tecoflex), Pebax,Nylon | Same | Commonly used medicalgrade polymers andmetals with hydrophiliccoating | Nylon, Pebax (nylonblend), and PolyurethaneSegment(s) | Commonly usedmedical gradepolymers and metalswith hydrophiliccoating |
| Inner Liner | PTFE | Same | Commonly used medicalgrade polymers | PTFE | Commonly used medicalgrade polymers |
| Hub Material | Nylon (Grilamid) | Same | Unknown | Polycarbonate (yellow) | Nylon, Polyurethane |
| Strain Relief | Polyolefin | Same | Unknown | Unknown | Unknown |
| Catheter ShaftReinforcement | Braid: 304V Stainless SteelCoil: 304V Stainless Steel | Same | Reinforced with metalsand polymers | 304 Stainless Steel braid | Stainless Steel Braid |
| Lubricious Coating | Hydrophilic Coating | Same | Same | Same | Same |
| Radiopaque MarkerBand | 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 markerband: 0.110 inches max.Proximal OD: 0.110 inchesmax. | Distal shaft: 0.094inches.Distal tip OD, at markerband: 0.098 inches max.Proximal OD: 0.098 inchesmax. | Distal: 0.106 inchesProximal: 0.110 inches | 8F (0.105 inches) | 8F (0.112 inches max) |
| Packaging | Tyvek/Nylon/Polyethylene(PE) pouch, PE tube, packagingcard, SBS carton | Same | PE tube, PE packagingcard, pouch, shelf cartonbox | PET/ LDPE Tyvek pouchPolypropylene tubing, SBSmounting card, SBS carton | Tyvek/Nylon pouch, PEsupport tube, packagingcard. 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 arteryaccess. | Pass |
| PTFE Delamination | Assessed for PTFE delamination at distal tipfollowing 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 movementwhile the proximal end was turned until failure in a simulatedanatomy model. | Pass |
| Kink Resistance | Resistance to kink was tested at various locations along the cathetershaft 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 CoatingIntegrity | The integrity of the hydrophilic coating was inspected before andafter simulated use testing in an in vitro model. | Pass |
| Particulate Testing | During simulated use testing in an in vitro model the particle size andcount were analyzed using light obscuration method and comparedto the reference device. | Pass |
| Tip Stiffness | Compared the tip stiffness of the Dude 8F Catheter with thereference device. | Pass |
Table 2: Bench Testing Summary
Biocompatibility
The subject Radical the Dude 8F 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. The subject device uses the same materials and manufacturing processes as the predicate device. Therefore, based on risk analysis, the following tests were performed to confirm biocompatibility of the subject device (Table 3).
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Image /page/9/Picture/0 description: The image shows a logo for MADURO. The logo features a stylized brain shape with figures holding hands inside, colored in shades of orange and yellow. The word "MADURO" is written in bold, purple letters below the brain graphic.
| Table 3: Biocompatibility Tests and Results | |
|---|---|
| --------------------------------------------- | -- |
| Tests | Output | Result | Conclusion |
|---|---|---|---|
| Hemocompatibility:Partial Thromboplastin Time (PTT) | The test article average clotting timewas higher and was not statisticallysignificant when compared to thenegative control.The test article average clotting timewas lower and was not statisticallysignificant when compared to thevehicle control. | Pass | PTT similar to thereference device. |
| Thrombogenicity in Canine Model | An in vivo canine test to evaluatethe thrombogenic potential of thesubject device compared to acomparator device. | Pass | Thrombogenicitysimilar to referencedevice. |
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.
Sterilization and Shelf Life
The Radical the Dude 8F Guide Catheter is sterilized using a validated ethylene oxide (EO) process with a sterility assurance level of 1x106. The sterilization method is identical for the subject and predicate devices.
The subject device's shelf life and packaging configuration remain identical to that of the predicate device. Therefore, no shelf life testing or packaging validation was deemed necessary to support the device and packaging shelf life.
Clinical Study
The non-clinical performance and biocompatibility testing were determined to be sufficient to support the substantial equivalence of the subject device.
Conclusion
The subject Radical the Dude 8F 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 and biocompatibility testing demonstrates that the Dude 8F 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).