(58 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a microcatheter, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as facilitating the infusion/delivery of "therapeutic agents" into the vasculature, which directly relates to treatment.
Yes
The "Intended Use / Indications for Use" section states that the device "may be used to facilitate...subselectively infuse/deliver diagnostic and therapeutic agents." The mention of delivering "diagnostic agents" indicates a diagnostic function for the device.
No
The device description clearly details a physical catheter with various configurations, lengths, and coatings, indicating it is a hardware medical device. The performance studies also focus on physical properties and biocompatibility, not software validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used within the body (in vivo) to access and facilitate procedures in the coronary and peripheral vasculature. IVDs are used to examine specimens from the body (in vitro) to provide diagnostic information.
- Device Description: The description details a catheter designed for insertion into blood vessels, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, tissue, or other biological samples, which is the core function of an IVD.
The device described is a medical device used for interventional procedures, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The SuperCross microcatheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary and/or peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and to subselectively infuse/deliver diagnostic and therapeutic agents.
Product codes
DQY
Device Description
The SuperCross microcatheters are single lumen catheters designed for use in the coronary and/or peripheral vasculature. The SuperCross microcatheters provide guidewire support during interventional procedures and allows for the exchange of one distally located guidewire for another while maintaining access to distal vasculature. The SuperCross microcatheters are available in various tip configurations (straight, flexible, angled) and two working lengths (130cm, 150cm). The distal 40cm of the straight tip catheters and the distal 72 cm of the angled tip catheters has a hydrophilic coating. The proximal end of the catheter incorporates a strain relief and a luer-lock adapter for flushing. The SuperCross microcatheters are compatible with .014" guidewires and 5F guide catheters.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary and/or peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The device performance was verified through the following tests:
- . Deliverability
- Hydrophilic Coating Evaluation
- Structural Integrity
- . ISO 10555-1 Verification
- . ISO 594 Hub Verification
Device samples passed the following biocompatibility tests performed in accordance with ISO 10993-1:
- . Cytotoxicity
- . Sensitization
- Irritation
- . Systemic Toxicity
- . Material Mediated Pyrogenicity
- Hemolysis
- Complement Activation ●
- . Thrombogenicity
The results of the verification tests met the specified acceptance criteria and did not raise new questions of safety or effectiveness; therefore, the SuperCross microcatheters are substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
April 30. 2021
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services USA seal. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below.
Vascular Solutions LLC Steph Pahl Regulatory Product Specialist 6464 Sycamore Court North Minneapolis, Minnesota 55369
Re: K210647
Trade/Device Name: SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DQY Dated: March 1, 2021 Received: March 3, 2021
Dear Steph Pahl:
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 located 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.
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
1
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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@)tda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Image /page/1/Picture/5 description: The image shows the name "Lydia S. Glaw -S" in a large, bold font. The text is arranged in two lines, with "Lydia S." on the first line and "Glaw -S" on the second line. The background is a light blue color with a faint, geometric pattern.
Digitally signed by Lydia S. Glaw -S Date: 2021.04.30 12:22:30 -04'00'
Lydia Glaw Assistant Director DHT2C: Division of Coronary and Peripheral Interventional Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210647
Device Name
SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheter
Indications for Use (Describe)
The SuperCross microcatheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary and/or peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and to subselectively infuse/deliver diagnostic and therapeutic agents.
| 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
[As required by 21 CFR 807.92]
Date Prepared: March 1, 2021
Submitter's Name / Contact Person
Manufacturer Vascular Solutions LLC 6464 Sycamore Court North Minneapolis, MN 55369 USA Establishment Registration # 2134812
Contact Person
Steph Pahl Regulatory Product Specialist Tel: 763-762-2641 Fax: 763-251-0363
General Information
| Trade Name | SuperCross microcatheter
SuperCross FT microcatheter
SuperCross AT microcatheter |
|---------------------|----------------------------------------------------------------------------------------|
| Common / Usual Name | Catheter |
| Classification Name | 21 CFR 870.1250, DQY, Percutaneous catheter, Class II |
| Predicate Device | K101659, SuperCross microcatheter (Vascular Solutions, Inc.) |
Device Description
The SuperCross microcatheters are single lumen catheters designed for use in the coronary and/or peripheral vasculature. The SuperCross microcatheters provide guidewire support during interventional procedures and allows for the exchange of one distally located guidewire for another while maintaining access to distal vasculature. The SuperCross microcatheters are available in various tip configurations (straight, flexible, angled) and two working lengths (130cm, 150cm). The distal 40cm of the straight tip catheters and the distal 72 cm of the angled tip catheters has a hydrophilic coating. The proximal end of the catheter incorporates a strain relief and a luer-lock adapter for flushing. The SuperCross microcatheters are compatible with .014" guidewires and 5F guide catheters.
Intended Use
The SuperCross microcatheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary and/or peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and to subselectively infuse/deliver diagnostic and therapeutic agents.
Technological Characteristics Comparison
The key technological differences between the SuperCross microcatheters and the predicate device are the addition of flexible and angled tip versions and a change to the hub and markerbals.
4
Substantial Equivalence and Summary of Studies
The technological differences between the subject and predicate devices have been evaluated through performance and biocompatibility tests to provide evidence of substantial equivalence for the Supercross microcatheters.
The device performance was verified through the following tests:
- . Deliverability
- Hydrophilic Coating Evaluation
- Structural Integrity
- . ISO 10555-1 Verification
- . ISO 594 Hub Verification
Device samples passed the following biocompatibility tests performed in accordance with ISO 10993-1:
- . Cytotoxicity
- . Sensitization
- Irritation
- . Systemic Toxicity
- . Material Mediated Pyrogenicity
- Hemolysis
- Complement Activation ●
- . Thrombogenicity
The results of the verification tests met the specified acceptance criteria and did not raise new questions of safety or effectiveness; therefore, the SuperCross microcatheters are substantially equivalent to the predicate device.