(28 days)
Not Found
No
The summary describes a mechanical aspiration catheter and its accessories. There is no mention of software, algorithms, image processing, AI, or ML. The performance studies focus on mechanical properties and aspiration performance.
Yes
Explanation: The device is indicated for "the removal and thrombi from vessels" which is a therapeutic intervention aimed at treating medical conditions.
No
The device is designed for the removal of thrombi and emboli, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines a physical catheter with various components (shaft, ring marker, hub, strain relief, core wire, syringe kit, accessories) designed for mechanical aspiration, indicating it is a hardware device, not software-only.
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 removal of thrombi from vessels within the body (coronary and peripheral system). This is a therapeutic intervention performed in vivo (within a living organism).
- Device Description: The device is a catheter designed to be inserted into the body to physically aspirate and remove material. This is a medical device used for a procedure, not for analyzing samples in vitro (outside of a living organism).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.) outside of the body, detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely interventional and therapeutic.
N/A
Intended Use / Indications for Use
The Thrombuster II Aspiration Catheter is indicated for the removal and thrombi from vessels in the coronary and peripheral system. The Thrombuster II is not in the cerebral vasculature.
Product codes (comma separated list FDA assigned to the subject device)
QEZ
Device Description
Thrombuster II Aspiration Catheter [Thrombuster II] is a rapid exchange type of dual lumen catheter for embolectomy. The Thrombuster II has been commercially available in EU region, Asia including Japan and China, Oceania and Middle east countries.
The main body consists of a distal shaft, proximal shaft, ring marker, hub, and strain relief. The catheter working length is 1400 mm. This product includes a core wire to resist kink during delivery in clinical usage, syringe kit (extension tube, stopcock, and lock syringe) for connecting the catheter main body and aspiration of fresh, soft emboli and thrombi, and accessories (flushing needle and filter). After insertion of the catheter into a patient body, this product aspirates and removes emboli or thrombi from a target lesion by transmitting negative pressure generated by connected lock syringe to the distal end of the catheter.
The maximum compatible diameter of a guidewire used together with Thrombuster II in a procedure is 0.014 inches. Additionally, guiding catheters with a diameter of 6 or 7 Fr have been deemed to be compatible with Thrombuster II.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels in the coronary and peripheral system.
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)
To reduce risks identified in our risk analysis of the differences, and to demonstrate substantial equivalence of Thrombuster II to the predicate device, following tests were conducted using well-established methods:
- . Trackability test
- . Dimensional verification
- . Aspiration performance test
The results from these tests demonstrate that the technological characteristics and performance of the Thrombuster II are substantially equivalent to the predicate device.
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.
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 logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
October 26, 2021
Kaneka Medical America LLC % Takeaki Miyata Manager, Regulatory Affairs Team Kaneka Corporation 1-12-32 Akasaka Minato-ku, Tokyo 107-6028 Japan
Re: K213166
Trade/Device Name: Thrombuster II Aspiration Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEZ Dated: September 27, 2021 Received: September 28, 2021
Dear Takeaki Miyata:
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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K213166
Device Name Thrombuster II Aspiration Catheter
Indications for Use (Describe)
The Thrombuster II Aspiration Catheter is indicated for the removal and thrombi from vessels in the coronary and peripheral system. The Thrombuster II is not in the cerebral 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
K213166
Thrombuster II Aspiration Catheter
510(k) Submitter
Kaneka Medical America LLC 623 Fifth Avenue, New York NY, 10022, The United States Contact Person: Audra Bogucki Telephone: 917-628-9870 Email: Audra.boguchi@kaneka.com
Official Correspondent
Takeaki Miyata Manager, Regulatory Affairs Team KANEKA CORPORATION 1-12-32, Akasaka, Minato-ku, Tokyo 107-6028, Japan Phone: +81-3-5574-8023 Email: Takeaki.Miyata@kaneka.co.jp
Date Prepared: October 21, 2021
Subject Device Name:
| Trade Name | Thrombuster II Aspiration Catheter |
|---|---|
| Common or usual name | Aspiration Thrombectomy Catheter |
| Classification name | Embolectomy Catheter [21 CFR 870.5150; product code is |
| QEZ] | |
| Class | II |
| Classification Panel | Cardiovascular (74) |
Predicate Device:
- Xpress-Way RX [K101839 (Kaneka Corporation)]
4
The predicate device have not been subject to a design-related recall.
Device Description:
Thrombuster II Aspiration Catheter [Thrombuster II] is a rapid exchange type of dual lumen catheter for embolectomy. The Thrombuster II has been commercially available in EU region, Asia including Japan and China, Oceania and Middle east countries.
The main body consists of a distal shaft, proximal shaft, ring marker, hub, and strain relief. The catheter working length is 1400 mm. This product includes a core wire to resist kink during delivery in clinical usage, syringe kit (extension tube, stopcock, and lock syringe) for connecting the catheter main body and aspiration of fresh, soft emboli and thrombi, and accessories (flushing needle and filter). After insertion of the catheter into a patient body, this product aspirates and removes emboli or thrombi from a target lesion by transmitting negative pressure generated by connected lock syringe to the distal end of the catheter.
The maximum compatible diameter of a guidewire used together with Thrombuster II in a procedure is 0.014 inches. Additionally, guiding catheters with a diameter of 6 or 7 Fr have been deemed to be compatible with Thrombuster II.
Indications for Use
The Thrombuster II Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral system. The Thrombuster II is not intended for use in the cerebral vasculature.
Comparison of Indications for Use to Predicate Device
The Thrombuster II has the same intended use (removal of thrombus form the peripheral and/or coronary vasculature through aspiration) as the predicate device. The indications for use of the Thrombsuter II is also identical to that of the predicate device.
Comparison of Technological Characteristics to Predicate Device
Embolectomy or thrombectomy by aspiration is the technological principle for both Thrombuster II and the predicate device. These devices are used in Percutaneous Coronary Intervention (PCI) or peripheral intervention for the purpose of revascularization.
The subject device and predicate device are based on the following same technological elements:
- . Fundamental catheter design - rapid exchange type of dual lumen catheter
- . Catheter components - proximal shaft, distal shaft, wire lumen tube with radiopaque ring marker, hub, and hydrophilic coating
- . Product configuration - catheter main body, core wire, syringe kit, and accessories
5
- . Principle of operation - aspiration of emboli and thrombi from catheter tip due to negative pressure created by connected syringe
- . Dimensional specification - catheter working length, outer diameters of distal shaft and proximal shaft
- . Concomitant devices - a guidewire of 0.014 inches and a guiding catheter of 6Fr or 7Fr
There are following minor technological differences between Thrombuster II and the predicate device:
- . Aspiration opening shape at the distal end of catheter
- . Number of lock syringes
- . Filter shape
These differences do not affect common intended use, indications for use, fundamental scientific technology and performance specification in these devices.
Performance Testing
To reduce risks identified in our risk analysis of the differences, and to demonstrate substantial equivalence of Thrombuster II to the predicate device, following tests were conducted using well-established methods:
- . Trackability test
- . Dimensional verification
- . Aspiration performance test
The results from these tests demonstrate that the technological characteristics and performance of the Thrombuster II are substantially equivalent to the predicate device.
Biocompatibility:
The modifications do not affect the nature of body contact and do not change raw materials for the predicate device. Therefore, in the design control activities for the modifications, the original testing on the predicate device applies to the Thrombuster II.
Conclusions:
The Thrombuster II met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and customer inputs. The Thrombuster II is substantially equivalent to the predicate device.