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)

K211061 · Thrombolex, Inc. · QEY · Jun 10, 2021 · Cardiovascular

Device Facts

• Record ID: K211061
• 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)
• Applicant: Thrombolex, Inc.
• Product Code: QEY · Cardiovascular
• Decision Date: Jun 10, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Endovascular catheters designed for controlled, selective infusion of physician-specified fluids (e.g., thrombolytics) into peripheral vasculature; used to restore blood flow in patients with venous thrombus. Device consists of infusion basket and shaft; delivered via sheath over guidewire under fluoroscopic guidance. Infusion basket expands within vessel to fragment clot and create channel; multiple laser-drilled holes in infusion limbs/shaft allow fluid delivery. BASHIR Plus models include second shaft port for additional infusion coverage (10-40 cm). Operated by interventional specialists in clinical settings. Mechanical device; no electrical components. Output is physical delivery of therapeutic fluids to target site; clinical benefit is restoration of blood flow via thrombus resolution.

Clinical Evidence

Real-world clinical data from 15 institutions; 45 patients with venous thrombus (primarily iliofemoral) treated with BASHIR/BASHIR Plus catheters. Results showed complete or partial resolution of venous thrombus with no reported bleeding or adverse events.

Technological Characteristics

Continuous flush catheter; mechanical design; no electrical components. Features infusion basket and shaft with laser-drilled holes for fluid delivery. Delivered via sheath over guidewire under fluoroscopic guidance. Materials are standard vascular catheter materials.

Indications for Use

Indicated for patients with venous thrombus requiring controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature to restore blood flow.

Regulatory Classification

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.

Predicate Devices

• BASHIR™ Endovascular Catheter (K183290)
• BASHIR™ Plus Endovascular Catheters (K193071)

Submission Summary (Full Text)

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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. [phone]. Gregory. [e-mail].

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

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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.

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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 ([e-mail]) or phone [phone] 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

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### 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) | |
|-------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="text-decoration: overline;"> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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K211061

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: [phone] Email: [e-mail]

#### 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

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# 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.

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## 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.