(232 days)
The Rist™ 079 Radial Access Guide Catheter is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
The Rist™ 071 Radial Access Guide Catheter is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
The Rist™ Radial Access Selective Catheter is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature. It can be used to facilitate introduction of diagnostic agents in the neuro vasculature. It is not intended to facilitate introduction of diagnostic agents in coronary or peripheral arteries.
The Rist™ Radial Access Selective Catheter is a flexible, single lumen catheter, with a radiopaque stainless-steel braid reinforced shaft to provide support. The distal tip of the catheter is shaped to have a smooth, rounded tip and is offered in two different distal segment shapes: Simmons 2 (SIM2) and Berenstein (BER). The braided, tapered shaft of the catheter is visible under fluoroscopy and has a luer connector in its proximal end for the attachment of accessories and the infusion of fluids. The Rist™ Radial Access Selective Catheter has no hydrophilic coating. The Rist™ Radial Access Selective Catheter is supplied sterile, non-pyrogenic, and intended for single use only.
The Rist™ 079 Radial Access Guide Catheter is a single lumen, variable stiffness catheter with a stainless steel and nitinol reinforced shaft to provide support. The catheter has a radiopaque marker band on the distal end to aid in visualization. The distal 25 cm of the Rist™ 079 Radial Access Guide Catheter has a hydrophilic coating which reduces the insertion force and allows the catheter to traverse the vasculature more easily. The Rist™ 079 Radial Access Guide Catheter has a PTFE-lined lumen to reduce friction with other devices introduced through the lumen. It is intended to provide access to the target site via transradial access and, once in place, provides a reinforcing conduit for other intravascular devices. A radial access dilator is included as an accessory. The Rist™ 079 Radial Access Guide Catheter is supplied sterile, non-pyrogenic, and intended for single use only.
The Rist™ 071 Radial Access Guide Catheter is a single lumen, variable stiffness catheter with a stainless steel and nitinol reinforced shaft to provide support. The embedded stainless-steel flat wire cross coil is in the proximal section of the catheter, which transitions to a nitinol round wire single coil in the distal end. The catheter has a radiopaque platinum/iridium marker band on to aid in visualization. The distal 25 cm of the Rist™ 071 Radial Access Guide Catheter has a hydrophilic coating which reduces the insertion force and allows the catheter to traverse the vasculature more easily. The Rist™ 071 Radial Access Guide Catheter has a PTFE- lined lumen to reduce friction with other devices introduced through the lumen. It is intended to provide access to the target site via transradial access and, once in place, provides a reinforcing conduit for other intravascular devices. A radial access dilator is included as an accessory. The Rist™ 071 Radial Access Guide Catheter is supplied sterile, non-pyrogenic, and intended for single use only.
Despite the request for a detailed description of acceptance criteria and study information, the provided text does not contain information related to specific acceptance criteria, device performance metrics, or a study report in the context of AI/ML device evaluation.
The document is an FDA 510(k) Premarket Notification for a medical device (catheters), not an AI/ML diagnostic or prognostic system. Therefore, the questions about sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details are not applicable to the content provided.
The document focuses on demonstrating substantial equivalence of the subject catheters to predicate devices, primarily based on design features, indications for use, and bench testing.
Here's a summary of what is available in the document, which addresses some points but not in the context of AI/ML performance evaluation:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that:
| Design Validation | Test Method Summary | Results |
|---|---|---|
| In-vitro Simulated Use Study - Bench | The devices were evaluated per ANSI/AAMI HE75:2009/(R) 2018. | The devices met the acceptance criteria. |
- Acceptance Criteria (Implied): The acceptance criteria are implicitly defined by the standards outlined in ANSI/AAMI HE75:2009/(R) 2018. The document does not provide the specific numerical or qualitative acceptance criteria used within this standard for the "In-vitro Simulated Use Study."
- Reported Device Performance: The reported performance is a high-level statement: "The devices met the acceptance criteria." Specific metrics, ranges, or quantitative results are not provided.
2. Sample size used for the test set and the data provenance:
Not applicable, as this was a bench test and not an AI/ML study involving patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth establishment for medical images by experts is not relevant to this bench testing of physical catheter devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable.
5. 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:
Not applicable. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI algorithm.
7. The type of ground truth used:
For the "In-vitro Simulated Use Study," the "ground truth" would be the successful completion of tasks or performance within acceptable parameters as defined by the ANSI/AAMI HE75:2009/(R) 2018 standard for simulated use. This is a technical performance standard, not a clinical ground truth.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established:
Not applicable. This is not an AI/ML device.
In summary, the provided text describes regulatory approval for physical medical devices (catheters) based on substantial equivalence and bench testing, not an AI/ML-driven device that would require the in-depth data and performance metrics requested in the prompt.
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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services logo. The logo on the right is the FDA logo, which stands for U.S. Food & Drug Administration. The FDA logo is in blue.
January 2, 2025
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Vesselina Clayton Senior Regulatory Affairs Specialist 9775 Toledo Way Irvine, California 92618
Re: K241388
Trade/Device Name: Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist Radial Access Selective Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP, DQY, DQO Dated: December 3, 2024 Received: December 4, 2024
Dear Vesselina Clayton:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database 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 medical devices and radiation-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) K241388
Device Name Rist™ 079 Radial Access Guide Catheter Rist™ 071 Radial Access Guide Catheter Rist TM Radial Access Selective Catheter
Indications for Use (Describe)
The Rist™ 079 Radial Access Guide Catheter is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
The Rist™ 071 Radial Access Guide Catheter is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
The Rist™ Radial Access Selective Catheter is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature. It can be used to facilitate introduction of diagnostic agents in the neuro vasculature. It is not intended to facilitate introduction of diagnostic agents in coronary or peripheral arteries.
| 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 K241388
| 510(k) Owner: | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
|---|---|
| 9775 Toledo Way | |
| Irvine, CA 92618, USA | |
| Establishment Registration: 2029214 | |
| Contact Person: | Vesselina Clayton |
| Senior Regulatory Affairs Specialist | |
| Telephone: (651) 707-5314 | |
| Email: vessa.clayton@medtronic.com | |
| Date SummaryPrepared: | 30 December 2024 |
| Trade Name of Devices: | Rist™ Radial Access Selective Catheter |
| Rist™ 071 Radial Access Guide Catheter | |
| Rist™ 079 Radial Access Guide Catheter | |
| Common Name ofDevice: | Percutaneous Catheter, Neurovasculature |
| Review Panel: | Neurovascular |
| Medical Specialty: | Cardiovascular |
| Product Code: | QJP, DQY – Applicable to Rist™ 079 Radial Access Guide Catheter, Rist™Radial Access Selective Catheter, Rist™ 071 Radial Access Guide Catheter |
| DQO - Applicable to Rist™ Radial Access Selective Catheter | |
| Regulation Number: | 21 CFR 870.1250, 21 CFR 870.1200 |
| Regulation Name: | Percutaneous Catheter; Diagnostic Intravascular Catheter |
| Device Classification | Class II |
| Predicate Devices: | K191551 (RIST Cath Radial Access Long Sheath) |
| K211990 (Rist™ 071 Radial Access Guide Catheter) | |
| K201682 (RIST Radial Access Catheter) |
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Device Description:
The Rist™ Radial Access Selective Catheter is a flexible, single lumen catheter, with a radiopaque stainless-steel braid reinforced shaft to provide support. The distal tip of the catheter is shaped to have a smooth, rounded tip and is offered in two different distal segment shapes: Simmons 2 (SIM2) and Berenstein (BER). The braided, tapered shaft of the catheter is visible under fluoroscopy and has a luer connector in its proximal end for the attachment of accessories and the infusion of fluids. The Rist™ Radial Access Selective Catheter has no hydrophilic coating. The Rist™ Radial Access Selective Catheter is supplied sterile, non-pyrogenic, and intended for single use only.
The Rist™ 079 Radial Access Guide Catheter is a single lumen, variable stiffness catheter with a stainless steel and nitinol reinforced shaft to provide support. The catheter has a radiopaque marker band on the distal end to aid in visualization. The distal 25 cm of the Rist™ 079 Radial Access Guide Catheter has a hydrophilic coating which reduces the insertion force and allows the catheter to traverse the vasculature more easily. The Rist™ 079 Radial Access Guide Catheter has a PTFE-lined lumen to reduce friction with other devices introduced through the lumen. It is intended to provide access to the target site via transradial access and, once in place, provides a reinforcing conduit for other intravascular devices. A radial access dilator is included as an accessory. The Rist™ 079 Radial Access Guide Catheter is supplied sterile, non-pyrogenic, and intended for single use only.
The Rist™ 071 Radial Access Guide Catheter is a single lumen, variable stiffness catheter with a stainless steel and nitinol reinforced shaft to provide support. The embedded stainless-steel flat wire cross coil is in the proximal section of the catheter, which transitions to a nitinol round wire single coil in the distal end. The catheter has a radiopaque platinum/iridium marker band on to aid in visualization. The distal 25 cm of the Rist™ 071 Radial Access Guide Catheter has a hydrophilic coating which reduces the insertion force and allows the catheter to traverse the vasculature more easily. The Rist™ 071 Radial Access Guide Catheter has a PTFE- lined lumen to reduce friction with other devices introduced through the lumen. It is intended to provide access to the target site via transradial access and, once in place, provides a reinforcing conduit for other intravascular devices. A radial access dilator is included as an accessory. The Rist™ 071 Radial Access Guide Catheter is supplied sterile, non-pyrogenic, and intended for single use only.
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Indications for Use
| The Rist™ Radial Access Catheters Device Family Indications for Use | ||
|---|---|---|
| CustomerFacingNumbers(CFNs) | Trade Name | Indications for Use |
| 105F-BER-120 | Rist™ RadialAccess SelectiveCatheter | The Rist™ Radial Access Selective Catheter is indicated for theintroduction of interventional devices into the peripheral,coronary, and neuro vasculature. It can be used to facilitateintroduction of diagnostic agents in the neuro vasculature. It isnot intended to facilitate introduction of diagnostic agents incoronary or peripheral arteries. |
| 105F-BER-130 | ||
| 105F-SIM-120 | ||
| 105F-SIM-130 | ||
| 106F-071-095 | Rist™ 071 RadialAccess GuideCatheter | The Rist™ 071 Radial Access Guide Catheter is indicated for theintroduction of interventional devices into the peripheral,coronary, and neuro vasculature. |
| 106F-071-100 | ||
| 106F-071-105 | ||
| 107F-079-095 | Rist™ 079 RadialAccess GuideCatheter | The Rist™ 079 Radial Access Guide Catheter is indicated for theintroduction of interventional devices into the peripheral,coronary, and neuro vasculature. |
| 107F-079-100 | ||
| 107F-079-105 |
Proposed Change:
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular requests clearance for commercialization of the Rist™ Radial Access Selective Catheter, Rist™ 071 Radial Access Guide Catheter and Rist™ 079 Radial Access Guide Catheter with revised labeling that introduces additional Warnings, Precautions, and Complications to the Instructions for Use, as well as clarifications throughout the Directions for Use.
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Device Comparison:
| Design Feature | Legally Marketed Predicate Devices(K191551, K211990, K201682) | Subject Devices(K241388) | ||
|---|---|---|---|---|
| Indicationsfor Use | Rist™ 079 Radial Access Guide Catheter (K191551): TheRist™ 079 Radial Access Guide Catheter is indicated for theintroduction of interventional devices into the peripheral,coronary, and neuro vasculature.Rist™ 071 Radial Access Guide Catheter (K211990): TheRist™ 071 Radial Access Guide Catheter is indicated for theintroduction of interventional devices into the peripheral,coronary, and neuro vasculature.Rist™ Radial Access Selective Catheter (K201682): The Rist™Radial Access Selective Catheter is indicated for theintroduction of interventional devices into the peripheral,coronary, and neuro vasculature. It can be used to facilitateintroduction of diagnostic agents in the neuro vasculature. It isnot intended to facilitate introduction of diagnostic agents incoronary or peripheral arteries. | Same | ||
| Design Feature | Rist™ 079 RadialAccess GuideCatheter (K191551) | Rist™ 071 RadialAccess GuideCatheter (K211990) | Rist™ RadialAccess SelectiveCatheter (K201682) | Subject Devices(K241388) |
| Outer Diameter(OD) | 7F0.093"2.37 mm | 6FMax 0.087"2.21 mm | 5.5F0.070"1.78 mm | Same |
| Inner Diameter(ID) | 0.079"2.00 mm | 0.071"1.80 mm | 0.040"1.02 mm | Same |
| Effective Length | 95 cm100 cm105 cm | 95 cm100 cm105 cm | 120 cm130 cm | Same |
| Tip Shape | N/A | Berenstein (BER)Simmons2 (SIM2) | Same | |
| CompatibleCatheter OD | 6F0.078"1.99 mm | 5.5F0.070"1.78 mm | N/A | Same |
| CompatibleRadialIntroducerSheath ID | 7F0.093"2.37 mm | 6F0.087"2.21 mm | N/A | Same |
| Dilator Max.Guidewire | 0.037"0.94 mm | 0.038"0.97 mm | N/A | Same |
| CompatibleGuide CatheterID | N/A | 0.070"1.78 mm | Same | |
| Max. Guidewire | N/A | 0.038"0.97 mm | Same | |
| Catheter Body | Polyether Block Amide (PEBAX) and BaSO4 | Same | ||
| CatheterReinforcementLayer | Stainless Steel Coil (Proximal)Nitinol Wire Coil (Distal) | Stainless SteelBraid | Same | |
| Strain Relief | Polyolefin Hub;Polycarbonate | Same | ||
| Marker Band | Platinum/Iridium Radiopaque Marker Band | Same | ||
| Coating | Hydrophilic Coating; distal 25 cm | N/A | Same | |
| PackagingConfiguration | Nylon/Tyvek® pouch, polyethylene support tube, packagingcard, SBS carton | Same | ||
| Radial Dilator | Yes | No | Same | |
| SterilizationMethod | Ethylene Oxide (EO) | Same | ||
| Pyrogenicity | Non-pyrogenic | Same |
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Biocompatibility:
There is no change to the biocompatibility of the products associated with the proposed labeling changes.
Performance Data - Bench:
Non-clinical bench testing was conducted to evaluate the performance of the Rist™ Radial Access Selective Catheter and the Rist™ 079 Radial Access Guide Catheter in a clinically representative radial access model. The successful results of the testing demonstrated that the changes do not raise new questions of safety and effectiveness, supporting the substantial equivalence to the respective predicate devices.
The following non-clinical bench tests were conducted:
| Design Validation | ||
|---|---|---|
| Test | Test Method Summary | Results |
| In-vitro Simulated Use Study -Bench | The devices were evaluated perANSI/AAMI HE75:2009/(R)2018. | The devices met the acceptancecriteria. |
Performance Data - Animal:
The determination of substantial equivalence is based upon non-clinical bench testing as there is no change to the indications for use, fundamental scientific technology, or materials of construction.
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Performance Data - Clinical:
The determination of substantial equivalence is based upon non-clinical bench testing as there is no change to the indications for use, fundamental scientific technology, or materials of construction.
Conclusion:
There is no change to the indications for use, design, materials, fundamental scientific technology, or principles of operations of the Rist™ Radial Access Selective Catheter, Rist™ 071 Radial Access Guide Catheter, and Rist™ 079 Radial Access Guide Catheter in comparison to the respective predicate devices. The revised labeling which introduces additional Warnings, Precautions, and Complications to the Instructions for Use, as well as clarifications throughout the Directions for Use do not raise new questions of safety and effectiveness as demonstrated through non-clinical bench testing. The information provided in this submission supports a determination of substantial equivalence of the Rist™ Radial Access Selective Catheter, Rist™ 071 Radial Access Guide Catheter, and Rist™ 079 Radial Access Guide Catheter to the respective predicate devices.
§ 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).