(29 days)
The Surmodics Microcatheter is intended to provide support to facilitate the placement of guidewires in the coronary and peripheral vasculatures and can be used to exchange one guidewire for another. This microcatheter is also intended to assist in the delivery of contrast media into the coronary and peripheral vasculatures.
Do not use this microcatheter other than for use in the coronary and peripheral vasculatures.
The Surmodics Microcatheter is a sterile, single use, percutaneous device intended to provide support to facilitate the placement of guidewires in the coronary and peripheral vasculature. Additionally, the microcatheter can be used for contrast media injection.
The catheter is a single-lumen microcatheter with a 1.9 Fr distal outer diameter, a 2.6 Fr proximal outer diameter and is compatible with a 0.014" guidewire. The proximal end of the catheter shaft has a larger inner diameter, outer diameter and wall thickness and tapers to the distal end. The catheter is available in working lengths of 135 cm and 150 cm to facilitate access to various target sites.
The provided text is a 510(k) clearance letter from the FDA for a microcatheter, not an AI/ML device. Therefore, it does not contain any of the information requested regarding acceptance criteria, study details, sample sizes, expert ground truth, or MRMC studies for an AI/ML device.
The document states:
- The device is a "Microcatheter" (Trade/Device Name).
- Its classification is "Percutaneous catheter" (Regulation Name, Class II, Product Code DQY).
- It's a medical device for use in coronary and peripheral vasculatures.
- "No clinical studies were required for the Surmodics Microcatheter." (Section 8.5)
- Performance testing focused on "Coating Integrity (Particulate, Track Force), Simulated Use (part of track force testing), Pinch testing lubricity, and Biocompatibility." (Section 8.4)
Since this document pertains to a physical medical device (microcatheter) and explicitly states no clinical studies were required, the questions regarding AI/ML device performance, ground truth, expert adjudication, and comparative effectiveness studies are not applicable and cannot be answered from this source.
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July 29, 2024
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Surmodics. Inc. Jodie Christe Regulatory Affairs Associate II 9924 West 74th Street Eden Prairie, Minnesota 55344
Re: K232647
Trade/Device Name: Microcatheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DQY
Dear Jodie Christe:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change for your device cleared on September 29, 2023. Specifically, FDA is updating this SE Letter because FDA inadvertently indicated that the SE determination also included review and clearance of a predetermined change control plan (PCCP). However, your 510(k) submission did not include a PCCP, so FDA is providing this administrative correction. Please see the attached revised clearance letter.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Lydia Glaw, OHT2: Office of Cardiovascular Devices, 301-796-1456, Lydia.Glaw(@fda.hhs.gov.
Sincerelv.
Samuel G. Raben -S
for Lydia Glaw Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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July 29, 2024
Image /page/1/Picture/1 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is a stylized depiction of an eagle, while the FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The logos are placed side-by-side, indicating a connection between the two organizations.
Surmodics. Inc. Jodie Christe Regulatory Affairs Associate II 9924 West 74th Street Eden Prairie, Minnesota 55344
Re: K232647
Trade/Device Name: Microcatheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DQY Dated: August 30, 2023 Received: August 31, 2023
Dear Jodie Christe:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change for your device cleared on September 29, 2023.
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/cdrb/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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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 OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) 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.
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-devices/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-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, Samuel G. Raben -S
for Lydia Glaw Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular 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) K232647
Device Name Microcatheter
Indications for Use (Describe)
The Surmodics Microcatheter is intended to provide support to facilitate the placement of guidewires in the coronary and peripheral vasculatures and can be used to exchange one guidewire for another. This microcatheter is also intended to assist in the delivery of contrast media into the coronary and peripheral vasculatures.
Do not use this microcatheter other than for use in the coronary and peripheral vasculatures.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
Date Prepared: August 30, 2023
Submitters Name/Contact Person
510(k) Submitter and Contact for Routine Correspondence
Jodie Christe Regulatory Affairs Associate II Surmodics, Inc. 9924 West 74th Street Eden Prairie, MN 55344 Phone (952)-500-7065 Email: jchriste(@surmodics.com
510(k) Submitter Establishment Registration Number
3001374820
| General Information | |
|---|---|
| Trade Name: | Microcatheter |
| Common / Usual Name: | Microcatheter |
| Classification Name | Cardiovascular |
| Regulation/Product Code | 21 CFR 870.5150 |
| Device Panel | Cardiovascular |
| Regulatory Classification: | Class II |
| Product Code: | DQY |
| Predicate Device: | Microcatheter (K173560) |
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Device Description 8.1
The Surmodics Microcatheter is a sterile, single use, percutaneous device intended to provide support to facilitate the placement of guidewires in the coronary and peripheral vasculature. Additionally, the microcatheter can be used for contrast media injection.
The catheter is a single-lumen microcatheter with a 1.9 Fr distal outer diameter, a 2.6 Fr proximal outer diameter and is compatible with a 0.014" guidewire. The proximal end of the catheter shaft has a larger inner diameter, outer diameter and wall thickness and tapers to the distal end. The catheter is available in working lengths of 135 cm and 150 cm to facilitate access to various target sites.
8.2 Indication for Use
The Surmodics Microcatheter is intended to provide support to facilitate the placement of guidewires in the coronary and peripheral vasculatures and can be used to exchange one guidewire for another. This microcatheter is also intended to assist in the delivery of contrast media into the coronary and peripheral vasculatures.
Do not use this microcatheter other than for use in the coronary and peripheral vasculatures.
8.3 Comparison of Technological Characteristics
The Surmodics Microcatheter device is substantially equivalent to the legally marketed predicate device in design, intended use, principles of operation, catheter materials, sizes and sterility. The Surmodics Microcatheter and the predicate device are intended to access discrete regions of the coronary and peripheral vasculature to facilitate the placement of or exchange of guidewires or to deliver contrast media. Both devices have similar dimensions and similar accessory compatibility. The only change from the predicate device is a modified lubricous hydrophilic coating. The modified hydrophilic top coat formulation, known as Preside, was developed to provide better customer experience.
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8.4 Performance Bench Testing
Results of design verification and biocompatibility testing demonstrates that the technological and material differences identified do not raise new questions of safety or effectiveness compared to the predicate device. The Surmodics Microcatheter has been evaluated through the following tests:
- Coating Integrity -
- -Particulate
- -Track Force
- Simulated Use (part of track force testing) -
- Pinch testing lubricity -
- -Biocompatibility
8:5 Clinical Studies and Testing
No clinical studies were required for the Surmodics Microcatheter.
8.6 Conclusion
Based on the device description, materials, technological characteristics, and accompanying performance and biocompatibility data it can be concluded that the device modifications made to the Surmodics Microcatheter are substantially equivalent to the predicate device and the device will continue to function per its intended use.
§ 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).