(62 days)
No
The device description explicitly states that the catheters are mechanical and contain no electrical components, and there is no mention of AI or ML in the document.
Yes
The device is intended for the controlled and selective infusion of fluids to restore blood flow in patients with venous thrombus, indicating a therapeutic purpose.
No
The device is designed for the controlled and selective infusion of fluids like thrombolytics to restore blood flow, which is a therapeutic intervention, not a diagnostic one.
No
The device description explicitly states that the catheters are mechanical and contain no electrical components, indicating they are hardware devices, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The BASHIR™ Endovascular Catheter and BASHIR™ Plus Endovascular Catheters are physical devices designed to be inserted into the peripheral vasculature. Their function is to deliver fluids (like thrombolytics) directly to a thrombus (blood clot) within the vessel to help break it down and restore blood flow.
- Mechanism of Action: The device works mechanically by delivering a substance directly to the site of the problem within the body. It does not analyze a sample taken from the body to provide diagnostic information.
The device is an interventional medical device used for treatment, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The BASHIR™ Endovascular Catheter and the BASHIR™ Plus Endovascular Catheters (BASHIR™+10, BASHIR™+20, BASHIR™+30, BASHIR™+40) are intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature, enabling the restoration of blood flow in patients with venous thrombus.
Product codes
OEY, KRA
Device Description
The BASHIR™ Endovascular Catheter and the BASHIR™ Plus Endovascular Catheter are continuous flush catheters designed to enable delivery of physician-specified fluids, including thrombolytics, into the peripheral circulation. There is one model of the BASHIR™ Endovascular Catheter (Ref. No. 7201) and four models of the Bashir™ Plus Endovascular Catheter, (Ref. No. 7210, 7220, 7230, 7240). The design of the catheters allow for delivery and positioning of the catheter at the target peripheral location via a sheath, over a guidewire using fluoroscopic guidance. The infusion can be initiated into a distal infusion basket via the Basket Port either in the non-expanded position (for vessels with smaller diameters), or by controlled expansion of the infusion basket to a desired dimension inside the vessel by the interventional specialist under fluoroscopic guidance. When the infusion basket is expanded into a clot, the clot is fragmented and a channel created, providing an opportunity for restoration of endogenous blood flow. The physician-specified solution is delivered via multiple laser-drilled holes through the infusion limbs of the catheters after placement.
The BASHIR™ Plus Endovascular Catheters have a second Shaft Port, for delivery of infusion solutions into the shaft lumen adjacent to the infusion basket where multiple laserdrilled holes extend over 10 cm (BASHIR+10), 20 cm (BASHIR+20), 30 cm (BASHIR+30) or 40 cm (BASHIR+40) of shaft length.
After the completion of solution delivery, the infusion limbs are collapsed to a closed position and the BASHIR™ Endovascular Catheter and/or BASHIR™ Plus Endovascular Catheter are retracted into the sheath and removed.
The catheters are comprised of common materials used in vascular catheters are mechanical and contain no electrical components.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopic guidance
Anatomical Site
peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician-specified fluids
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
Clinical Evidence: Sequential case information from Real-World use of the BASHIR™ Endovascular Catheter and the range of BASHIR™ Plus Endovascular Catheters in 15 different institutions provides evidence for expanding the labeling to include the indication for use in patients with venous thrombus. The devices were used to successfully treat 45 patients with venous thrombus (primarily iliofemoral thrombus) with either complete or partial resolution of venous thrombus, with no bleeding or other adverse events.
Key Metrics
Not Found
Predicate Device(s)
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
February 3, 2022
Thrombolex, Inc. % Diane Horwitz Regulatory Consultant Eminence Clinical Research Inc. 5 Lake Como Ct. Greenville. South Carolina 29609
Re: K211061
Trade/Device Name: BASHIR Endovascular Catheter, Reference No. 7201 and BASHIR Plus Endovascular Catheter, Reference No. 7210, 7220, 7230, 7240 (BASHIR+10, BASHIR+20, BASHIR+30, BASHIR+40) Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: OEY, KRA
Dear Diane Horwitz:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated June 10, 2021. Specifically, FDA is updating this SE Letter as an administrative correction because FDA has created a new product code to better categorize your device technology.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Gregory O'Connell. OHT2: Office of Cardiovascular Devices. (301) 796-6075. Gregory. Oconnell@FDA.HHS.gov.
Sincerely,
Gregory W. Digitally signed by
Gregory W. Gregory W. O'connell -S O'connell -S Date: 2022.02.03
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
1
Image /page/1/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 10, 2021
Thrombolex, Inc. % Diane Horwitz Regulatory Consultant Eminence Clinical Research Inc. 5 Lake Como Ct. Greenville, South Carolina 29609
Re: K211061
Trade/Device Name: BASHIR Endovascular Catheter (Ref. 7201), BASHIR Plus 10 Endovascular Catheter (Ref. 7210), BASHIR Plus 20 Endovascular Catheter (Ref. 7220), BASHIR Plus 30 Endovascular Catheter (Ref. 7230), BASHIR Plus 40 Endovascular Catheter (Ref. 7240) Regulation Number: 21 CFR 870.1210
Regulation Name: Continuous flush catheter Regulatory Class: Class II Product Code: KRA Dated: April 8, 2021 Received: April 9, 2021
Dear Diane Horwitz:
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.
2
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 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 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,
Digitally signed by Gregory W. Gregory W. O'connell -S O'connell -S Pate: 2021.06.10
12:43:23 -04'00'
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
3
Indications for Use
510(k) Number: K211061
Device Name
BASHIR™ Endovascular Catheter and BASHIR™ Plus Endovascular Catheters (BASHIR™+20, BASHIR™+30, BASHIR™+40)
Indications for Use (Describe)
The BASHIR™ Endovascular Catheter and the BASHIR™ Plus Endovascular Catheters (BASHIR™+10, BASHIR™+20, BASHIR™+30, BASHIR™+40) are intended for the controlled and selective infusion of physicianspecified fluids, including thrombolytics, into the peripheral vasculature, enabling the restoration of blood flow in patients with venous thrombus.
| 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."
4
Image /page/4/Picture/1 description: The image contains the logo for THROMBOLEX. The logo is red and has a stylized X at the end. Below the logo, the text "INNOVATIVE ENDOVASCULAR CATHETERS" is written in a smaller font.
510(k) Summary
1. GENERAL INFORMATION
Submitter and 510(k) Owner 1.1
Thrombolex, Inc. 75 Britain Dr. New Britain PA 18901
Official Correspondent 1.2
Diane Horwitz, Ph.D. 5 Lake Como Ct. Greenville, SC 29609 Telephone: 703.307.2921 Email: dhorwitz@ecr-inc.com
1.3 Date of Preparation
April 8, 2021
2. NAME OF THE DEVICE
2.1.1 Trade/Proprietary Name
BASHIR™ Endovascular Catheter, Reference No. 7201 BASHIR™ Plus Endovascular Catheter, Reference No. 7210, 7220, 7230, 7240 (BASHIRTM +10, BASHIR™+20, BASHIR™+30, BASHIR™+40)
2.1.2 Common/Usual Name
Continuous Flush Catheter
2.1.3 Classification Information
| Classification Name: | Continuous Flush Catheter |
|---|---|
| Classification Regulation: | 21 CFR 870.1210 |
| Class: | II |
| Product Code: | KRA – Continuous Flush Catheter |
| Panel: | Cardiovascular |
3. PREDICATE DEVICE
The predicate devices are the BASHIR™ Endovascular Catheter, K183290 and the BASHIR™ Plus Endovascular Catheters, K193071.
1
5
4. DESCRIPTION OF THE DEVICE
The BASHIR™ Endovascular Catheter and the BASHIR™ Plus Endovascular Catheter are continuous flush catheters designed to enable delivery of physician-specified fluids, including thrombolytics, into the peripheral circulation. There is one model of the BASHIR™ Endovascular Catheter (Ref. No. 7201) and four models of the Bashir™ Plus Endovascular Catheter, (Ref. No. 7210, 7220, 7230, 7240). The design of the catheters allow for delivery and positioning of the catheter at the target peripheral location via a sheath, over a guidewire using fluoroscopic guidance. The infusion can be initiated into a distal infusion basket via the Basket Port either in the non-expanded position (for vessels with smaller diameters), or by controlled expansion of the infusion basket to a desired dimension inside the vessel by the interventional specialist under fluoroscopic guidance. When the infusion basket is expanded into a clot, the clot is fragmented and a channel created, providing an opportunity for restoration of endogenous blood flow. The physician-specified solution is delivered via multiple laser-drilled holes through the infusion limbs of the catheters after placement.
The BASHIR™ Plus Endovascular Catheters have a second Shaft Port, for delivery of infusion solutions into the shaft lumen adjacent to the infusion basket where multiple laserdrilled holes extend over 10 cm (BASHIR+10), 20 cm (BASHIR+20), 30 cm (BASHIR+30) or 40 cm (BASHIR+40) of shaft length.
After the completion of solution delivery, the infusion limbs are collapsed to a closed position and the BASHIR™ Endovascular Catheter and/or BASHIR™ Plus Endovascular Catheter are retracted into the sheath and removed.
The catheters are comprised of common materials used in vascular catheters are mechanical and contain no electrical components.
5. INTENDED USE / INDICATION FOR USE
The BASHIR™ Endovascular Catheter and the BASHIR™ Plus Endovascular Catheters (BASHIR™+10, BASHIR™+20, BASHIR™+30, BASHIR™+40) are intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature, enabling the restoration of blood flow in patients with venous thrombus.
6. COMPARISON OF THE INTENDED USE WITH THE PREDICATE DEVICE
The Intended Use statement is identical to that of the predicate devices with the exception of adding a specific indication for use, as an example of the types of patients that can be treated with the BASHIR™ Endovascular Catheter and the BASHIR™ Plus Endovascular Catheters. The modification, addition of the wording the restoration of blood flow in patients with venous thrombus," is an example of the patient population to be treated.
6
TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATE
The BASHIR™ Endovascular Catheter and the BASHIR™ Plus Endovascular Catheters are lentical in design, operational and technological characteristics and supports that no new safety concerns are being raised by change in the Intended Use/Indications for Use statement and thus raises no new issues of safety or effectiveness.
PERFORMANCE TESTING
The BASHIR™ Endovascular Catheter and the BASHIR™ Plus Endovascular Catheters were previously subjected to a comprehensive test program that included animal and bench testing, biocompatibility, sterilization and packaging testing. Clinical data for the treatment of venous thrombus, already included in the intended use of the device, support the additional wording in the intended use statement as summarized below:
Tlinical Evidence: Sequential case information from Real-World use of the BASHIR™ indovascular Catheter and the range of BASHIR™ Plus Endovascular Catheters in 15 ifferent institutions provides evidence for expanding the labeling to include the indication for use in patients with venous thrombus. The devices were used to successfully treat 45 patients with venous thrombus (primarily iliofemoral thrombus) with either complete or partial resolution of venous thrombus, with no bleeding or other adverse events.
9. CONCLUSIONS
n summary, the Real-World clinical information presented in this 510(k) submission upports the additional indications for use wording for the BASHIR™ Endovascular Catheter and the BASHIR™ Plus Endovascular Catheters to restore blood flow in patients with venous thrombus, and raises no new issues of safety or effectiveness, leading to the conclusion of substantial equivalence to the predicate devices.