(63 days)
Not Found
No
The description focuses on mechanical components and physical actions for thrombus removal, with no mention of AI/ML terms or functions.
Yes
The device is intended for the non-surgical removal of thrombi and emboli from the peripheral arterial vasculature, which is a therapeutic intervention.
No
The device is described as a "Thrombectomy System" intended for "non-surgical removal of thrombi and emboli." This indicates a therapeutic function, not a diagnostic one.
No
The device description clearly outlines multiple physical components (Delivery Catheter, Basket Wire, Funnel Catheter, cleaning tool accessories) and performance testing related to physical properties (Dimensional, Radial Force, Tensile Strength, etc.), indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the "non-surgical removal of thrombi and emboli from the peripheral arterial vasculature." This describes a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is a "percutaneous catheter system" designed for "mechanical thrombus removal." This involves physical intervention within the patient's circulatory system.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, tissue, etc.) outside of the body to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the human body to diagnose, monitor, or screen for diseases or conditions. This device is a therapeutic tool used to treat a condition within the body.
N/A
Intended Use / Indications for Use
The Pounce Thrombectomy System is intended for the non-surgical removal of thrombi and emboli from the peripheral arterial vasculature.
The Pounce LP Thrombectomy System is indicated for use in vessels ranging from 2 mm in diameter.
Product codes
QEW
Device Description
The Surmodics Pounce™ Thrombectomy System is a percutaneous catheter system designed to facilitate mechanical thrombus removal in the peripheral arterial vasculature. The system is comprised of three separate components: a Delivery Catheter, a Basket Wire, the Funnel Catheter, and cleaning tool accessories. The system contains radiopaque components to conduct the procedure and is intended to be introduced through appropriately sized guide sheath.
The Delivery Catheter is flexible and designed to deliver the Basket Wire to the location of the thrombus. Incorporated in the catheter is a radiopaque marker band located at the distal tip.
The Basket Wire is comprised of two distal self-expanding baskets mounted a core wire for capturing thrombus. The distal capture baskets have integral radiopaque markers mounted on the struts of the basket for basket visibility under fluoroscopy.
The Funnel Catheter is used for thrombus collection and retrieval in conjunction with the Basket Wire. The Funnel Catheter is comprised of an inner funnel catheter and an outer delivery catheter. The two catheters work together to allow unsheathing of the funnel using the slider button on the integrated handle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral arterial 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
Bench Testing:
- Dimensional
- Radial Force
- Tensile Strength
- Kink
- Air and Liquid Leak
- Basket Wire Fatigue
- Atraumatic Surfaces
- Simulated Use
- Removal Force
- Radiopacity
- Luer Compatibility
- Ancillary Device Compatibility
- Torque Strength
- Rated Burst Pressure
- Coating Integrity
- Packaging/Distribution
- Biocompatibility
No clinical studies were required.
Key Metrics
Not Found
Predicate Device(s)
Pounce™ Thrombectomy System (K220501)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the full name of the agency on the right. The symbol on the left is a stylized representation of a human figure, while the FDA acronym is in blue, followed by the full name of the agency, "U.S. Food & Drug Administration," in a smaller font size.
June 12, 2023
Surmodics Inc. Holly Ramirez Senior Staff Regulatory Affairs Specialist 7905 Golden Triangle Drive Suite 190 Eden Prairie, Minnesota 55344
Re: K231022
Trade/Device Name: Pounce™ Thrombectomy System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW Dated: April 10, 2023 Received: April 10, 2023
Dear Holly Ramirez:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ariel G. Ash- Digitally signed by
shakoor -S Ariel G. Ash-shakoor -S
Date: 2023.06.12
17:03:14 -04'00'
For
Gregory O'Connell 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
2
Indications for Use
510(k) Number (if known) K231022
Device Name Pounce™ Thrombectomy System
Indications for Use (Describe)
The Pounce Thrombectomy System is intended for the non-surgical removal of thrombi and emboli from the peripheral arterial vasculature.
The Pounce LP Thrombectomy System is indicated for use in vessels ranging from 2 mm in diameter.
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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Image /page/3/Picture/0 description: The image contains the word "SURMODICS" in a bold, sans-serif font. To the left of the word is a stylized logo. The logo is a geometric shape with two overlapping sections, one in a darker blue and the other in a lighter teal color.
510(k) Summary
Date Prepared: 10 April 2023
Submitters Name/Contact Person
510K Submitter and Contact for Routine Correspondence
Holly Ramirez Senior Staff Regulatory Affairs Specialist 7905 Golden Triangle Dr. Ste. 190 Eden Prairie, MN 88344 Phone (952)-500-7545 Email: hramirez@surmodics.com
510k Submitter Establishment Registration Number
3014687026
| General Information | |
|---|---|
| Trade Name: | Pounce™ LP Thrombectomy System |
| Common / Usual Name: | Thrombectomy Catheter |
| Classification Name | Embolectomy Catheter |
| Regulation/Product Code | 21 CFR 870.5150 |
| Device Panel | Cardiovascular |
| Regulatory Classification: | Class II |
| Product Code: | QEW |
| Predicate Device: | Pounce™ Thrombectomy System (K220501) |
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Image /page/4/Picture/0 description: The image shows the logo for Surmodics. The logo consists of a stylized blue and green icon to the left of the company name, "SURMODICS," which is written in a simple, sans-serif font. The icon appears to be an abstract representation of folded or layered shapes, with the blue color dominating and a touch of green at the bottom. The overall design is clean and modern.
Device Description
The Surmodics Pounce™ Thrombectomy System is a percutaneous catheter system designed to facilitate mechanical thrombus removal in the peripheral arterial vasculature. The system is comprised of three separate components: a Delivery Catheter, a Basket Wire, the Funnel Catheter, and cleaning tool accessories. The system contains radiopaque components to conduct the procedure and is intended to be introduced through appropriately sized guide sheath.
The Delivery Catheter is flexible and designed to deliver the Basket Wire to the location of the thrombus. Incorporated in the catheter is a radiopaque marker band located at the distal tip.
The Basket Wire is comprised of two distal self-expanding baskets mounted a core wire for capturing thrombus. The distal capture baskets have integral radiopaque markers mounted on the struts of the basket for basket visibility under fluoroscopy.
The Funnel Catheter is used for thrombus collection and retrieval in conjunction with the Basket Wire. The Funnel Catheter is comprised of an inner funnel catheter and an outer delivery catheter. The two catheters work together to allow unsheathing of the funnel using the slider button on the integrated handle.
Indication for Use
The Pounce™ Thrombectomy System is intended for the non-surgical removal of thrombi and emboli from the peripheral arterial vasculature.
The Pounce LP Thrombectomy System is indicated for use in vessels ranging from 2 mm to 4 mm in diameter.
Comparison of Technological Characteristics
The Pounce LP Thrombectomy System is substantially equivalent to the previous Pounce Thrombectomy System (K220501) in design, intended use, principles of use, biocompatibility, sterility, and labeling. Changes to the predicate device that have led to the submission of this new 510(k) are to extend the product line to include the use in vessels ranging from 2 mm. The smaller basket wire and catheter size has been verified through performance bench and biocompatibility testing and determined to be substantially equivalent.
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Image /page/5/Picture/0 description: The image shows the logo for Surmodics. The logo consists of a blue and green abstract shape on the left, followed by the word "SURMODICS" in a dark gray sans-serif font. The abstract shape appears to be a stylized ribbon or folded paper design, with the blue portion on top and the green portion underneath.
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 Pounce LP Thrombectomy System has been evaluated through the following tests:
- -Dimensional
- Radial Force -
- -Tensile Strength
- -Kink
- -Air and Liquid Leak
- Basket Wire Fatigue -
- -Atraumatic Surfaces
- -Simulated Use
- Removal Force -
- -Radiopacity
- -Luer Compatibility
- Ancillary Device Compatibility -
- Torque Strength -
- -Rated Burst Pressure
- -Coating Integrity
- Packaging/Distribution -
- -Biocompatibility
Clinical Studies and Testing
No clinical studies were required for the Pounce Thrombectomy System.
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 Pounce LP Thrombectomy System are substantially equivalent to the predicate device and the device will continue to function per its intended use.