(29 days)
Not Found
No
The description focuses on mechanical components and physical manipulation for thrombus removal, with no mention of AI or ML for analysis, decision-making, or image processing.
Yes.
Explanation: The device is intended for the non-surgical removal of thrombi and emboli from the peripheral arterial vasculature, which directly addresses a medical condition (thrombi/emboli) to restore or improve health.
No
Explanation: The device is intended for the non-surgical removal of thrombi and emboli, which is a therapeutic function, not a diagnostic one. It is used to treat a condition rather than identify or characterize it.
No
The device description clearly outlines physical components (catheter, basket wire, funnel catheter) and performance studies focus on physical properties and functionality, 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 for 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 description details a percutaneous catheter system designed for mechanical thrombus removal. This involves physical intervention within the patient's circulatory system.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This device does not perform such testing on specimens.
The Pounce™ Thrombectomy System is a medical device used for a therapeutic intervention within the body, not for diagnostic testing of samples outside 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.
Product codes (comma separated list FDA assigned to the subject device)
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 with a preloaded loading tool, and the Funnel Catheter. The system contains radiopaque components to conduct the procedure and is intended to be introduced through a minimum 7Fr guide sheath.
The Delivery Catheter is a flexible 5Fr catheter 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 and sheathing 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
fluoroscopy
Anatomical Site
peripheral arterial vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
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 Thrombectomy System has been evaluated through the following tests:
- -Dimensional
- -Tensile Strength
- Air and Liquid Leak -
- -Handle Split Force
- Retention Force -
- Atraumatic Surfaces -
- Assembled Functionality -
- Torque Strength -
- -Lock and Unlock Force
- -Tensile Strength
- Packaging/Distribution -
- Biocompatibility -
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Pounce™ Thrombectomy System (K211492)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the image is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue rectangle with the letters "FDA" in white. To the right of the rectangle is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 23, 2022
Surmodics Inc. Holly Ramirez Senior Staff Regulatory Affairs Specialist 7905 Golden Triangle Drive Suite 190 Eden Prairie, Minnesota 55344
Re: K220501
Trade/Device Name: Pounce Thrombectomy System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW Dated: February 21, 2022 Received: February 22, 2022
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,
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) K220501
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.
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
Date Prepared: 18 March 2022
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™ 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 (K211492) |
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1 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 with a preloaded loading tool, and the Funnel Catheter. The system contains radiopaque components to conduct the procedure and is intended to be introduced through a minimum 7Fr guide sheath.
The Delivery Catheter is a flexible 5Fr catheter 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 and sheathing of the funnel using the slider button on the integrated handle.
2 Indication for Use
The Pounce™ Thrombectomy System is intended for the non-surgical removal of thrombi and emboli from the peripheral arterial vasculature.
3 Comparison of Technological Characteristics
The Pounce Thrombectomy System is substantially equivalent to the previous Pounce Thrombectomy System (K211492) 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 ergonomic and branding in nature, including a new handle design, new packaging to accommodate the handle, and updated coloring. All characteristics that were not identical to the predicate device were verified through performance bench and biocompatibility testing and determined to be substantially equivalent.
5
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 Pounce Thrombectomy System has been evaluated through the following tests:
- -Dimensional
- -Tensile Strength
- Air and Liquid Leak -
- -Handle Split Force
- Retention Force -
- Atraumatic Surfaces -
- Assembled Functionality -
- Torque Strength -
- -Lock and Unlock Force
- -Tensile Strength
- Packaging/Distribution -
- Biocompatibility -
5 Clinical Studies and Testing
No clinical studies were required for the Pounce Thrombectomy System.
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 Pounce Thrombectomy System are substantially equivalent to the predicate device and the device will continue to function per its intended use.