· Controlled and selective infusion of physician-specified fluids, including thrombolytics, into the pulmonary arteries for treatment of pulmonary embolism.
· Infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature, enabling the restoration of blood flow in patients with venous thrombus.

Device Description

The BASHIRTM .035 Endovascular Catheter is a device intended for mechanical thrombolysis via expanding the distal infusion basket, allowing localized infusion of physician-specified fluids, including thrombolytics, into the peripheral or pulmonary vasculature. The distal infusion segment of the device is 12.50 cm (4.94 in.) long and consists of an expandable basket with a nitinol core surrounded by mini-infusion catheters, each with multiple infusion holes (hereafter referred to as the "infusion basket"). The infusion basket is expanded and closed using the red actuator located on the handle at the proximal end of the device. The BASHIR™ S-B .035 Endovascular Catheter is a second model intended for smaller anatomies, with an infusion basket that is 10.0 cm (3.94 in.). The devices are otherwise the same. The physician-specified fluid is then delivered via the basket infusion line located on the handle. Pulse sprays are followed by infusion through laser-drilled holes in the infusion limbs of the basket after placement in the peripheral vasculature or in the pulmonary artery. After the completion of fluid delivery, the infusion limbs are collapsed to a straight position and then the catheter is retracted into the sheath and removed from the patient. The BASHIR™ .035 Endovascular Catheter and BASHIR™ S-B .035 Endovascular catheters are composed of common biocompatible materials used in vascular catheters are mechanical and contain no electrical components and require no capital equipment.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (BASHIR™ .035 Endovascular Catheter and BASHIR™ S-B .035 Endovascular Catheter) seeking clearance for market, based on substantial equivalence to a predicate device (BASHIR™ Endovascular Catheter and BASHIR™ S-B Endovascular Catheter, K222095).

The document details performance testing for biocompatibility, sterility, bench performance, animal studies, and clinical studies. However, it does not explicitly present acceptance criteria for each of these tests in a quantifiable manner, nor does it provide a direct comparison of specific numerical performance metrics against predefined acceptance thresholds in a table format.

Instead, the document states that "All tests passed" for biocompatibility and sterility, and for bench performance, it indicates that the subject devices "meet product requirements and design specifications" and that simulated use studies "confirmed functionality." For animal studies, it notes "no adverse effects systemically, on gross or histopathology evaluation, and resulted in no animal mortality." For clinical studies, it mentions leveraging data from a "First in Human (FIH)" study with 9 patients and a "pivotal study with 109 patients."

Therefore, I cannot create the requested table of acceptance criteria and reported device performance with specific numerical values from the given text, as these are not explicitly provided in a comparative, quantitative format. The document focuses on demonstrating substantial equivalence by stating that various tests were performed and their outcomes were satisfactory or met requirements, rather than listing specific numerical criteria and results.

However, I can extract the information requested for other sections of your prompt based on the general descriptions of the studies.

1. A table of acceptance criteria and the reported device performance

As explained above, the document does not explicitly list quantitative acceptance criteria and corresponding reported device performance values in a table. It generally states that tests "passed" or "met requirements."

2. Sample size used for the test set and the data provenance

The document mentions several types of studies, some of which are leveraged from the predicate device.

Biocompatibility: Studies leveraged from the predicate device. Sample size not specified, but likely involved multiple samples for each test type (cytotoxicity, sensitization, etc.).
Sterility: Studies leveraged from the predicate device. Sample size not specified, but involved testing to achieve a Sterilization Assurance Level (SAL) of 10^-6 CFU.
Bench Performance Tests (Subject Devices): "Design verification bench performance testing conducted with the subject devices." Sample size not specified, but covered various mechanical and functional aspects such as kink radius, trackability, advancement force, etc.
Simulated Use Studies (Predicate Devices): Performed with predicate devices. Confirmed functionality over 20 hours. Sample size not specified.
In-Use Study (Predicate Devices): Performed with predicate devices to evaluate cumulative impact on a representative drug. Sample size not specified.
Animal Study (Predicate Device): A GLP animal study performed with the predicate device in a swine model. Sample size not specified, but implied to be sufficient for a GLP study.
Clinical Performance (Predicate Device):
- First in Human (FIH): 9 patients.
- Pivotal study: 109 patients.
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective for all studies). The clinical studies are implied to be prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The studies described are primarily technical performance, animal, and clinical outcome studies, not diagnostic interpretative studies requiring expert consensus on ground truth.

4. Adjudication method for the test set

This information is not provided in the document, as the studies described do not involve interpretative ground truth establishment that would require an adjudication method like 2+1 or 3+1.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There is no mention of an MRMC study or AI assistance in the provided text. The device is a mechanical thrombolysis catheter, not an AI-powered diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable as the device is a mechanical catheter and not an algorithm.

7. The type of ground truth used

For the clinical performance data leveraged from the predicate device:

The ground truth would likely be clinical outcomes related to the treatment of pulmonary embolism and venous thrombus, such as thrombus reduction, restoration of blood flow, adverse events, etc., as assessed by clinical investigators and objective measurements (e.g., imaging studies, physiological parameters). The document does not specify the exact ground truth endpoints or how they were established, but medical device trials typically use objective clinical and imaging assessments.

For the bench, animal, biocompatibility, and sterility studies, the "ground truth" is established by adherence to predefined standards, specifications, and observed physical, chemical, and biological responses.

8. The sample size for the training set

This is not applicable. The device is a mechanical catheter, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

This is not applicable as the device is a mechanical catheter and not an AI/ML algorithm.

Summary

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July 3, 2023

Thrombolex, Inc. % Diane Horwitz Consultant Eminence Clinical Research Inc. 5 Lake Como Ct. Greenville, South Carolina 29609

Re: K231653

Trade/Device Name: BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEY, KRA Dated: June 5, 2023 Received: June 6, 2023

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.

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

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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 medical devices and radiation-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 -O'connell -S Date: 2023.07.03 11:20:26 -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 (if known) K231653

Device Name

BASHIR™ .035 Endovascular Catheter BASHIR™ S-B .035 Endovascular Catheter

Indications for Use (Describe)

The BASHIR™ .035 Endovascular Catheter and BASHIR™ S-B .035 Endovascular Catheter are mechanical thrombolysis catheters indicated for the:

· Controlled and selective infusion of physician-specified fluids, including thrombolytics, into the pulmonary arteries for treatment of pulmonary embolism.
· Infusion of physician-specified 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)

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Image /page/3/Picture/1 description: The image shows the word "THROMBOLEX" in large, bold, red letters. Below the word is the phrase "INNOVATIVE ENDOVASCULAR CATHETERS" in smaller, black letters. The "X" in "THROMBOLEX" is stylized with a red checkmark shape.

510(k) SUMMARY

1. GENERAL INFORMATION

1.1 Submitter and 510(k) Owner

Thrombolex, Inc. 75 Britain Dr. New Britain PA 18901

1.2 Official Correspondent

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

July 1, 2023

2. NAME OF THE DEVICE

2.1.1 Trade/Proprietary Name

BASHIR™ .035 Endovascular Catheter BASHIR™ S-B .035 Endovascular Catheter

Common/Usual Name 2.1.2

Mechanical Thrombolysis Catheter

2.1.3 Classification Information

Classification Name:	Mechanical Thrombolysis Catheter
Classification Regulation:	21 CFR 870.5150
Class:	2
Product Code:	QEY, KRA
Panel:	Cardiovascular

3. PREDICATE DEVICE

BASHIR™ Endovascular Catheter, BASHIR™ S-B Endovascular Catheter, K222095

DESCRIPTION OF THE DEVICE 4.

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of the device is 12.50 cm (4.94 in.) long and consists of an expandable basket with a nitinol core surrounded by mini-infusion catheters, each with multiple infusion holes (hereafter referred to as the "infusion basket"). The infusion basket is expanded and closed using the red actuator located on the handle at the proximal end of the device. The BASHIR™ S-B .035 Endovascular Catheter is a second model intended for smaller anatomies, with an infusion basket that is 10.0 cm (3.94 in.). The devices are otherwise the same.

The physician-specified fluid is then delivered via the basket infusion line located on the handle. Pulse sprays are followed by infusion through laser-drilled holes in the infusion limbs of the basket after placement in the peripheral vasculature or in the pulmonary artery. After the completion of fluid delivery, the infusion limbs are collapsed to a straight position and then the catheter is retracted into the sheath and removed from the patient.

The BASHIR™ .035 Endovascular Catheter and BASHIR™ S-B .035 Endovascular catheters are composed of common biocompatible materials used in vascular catheters are mechanical and contain no electrical components and require no capital equipment.

5. INTENDED USE / INDICATION FOR USE

The BASHIR™ .035 Endovascular Catheter and BASHIR™ S-B .035 Endovascular Catheter are mechanical thrombolysis catheters indicated for the:

Controlled and selective infusion of physician-specified fluids, including thrombolytics, ● into the pulmonary arteries for treatment of pulmonary embolism.
. Infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature, enabling the restoration of blood flow in patients with venous thrombus.

INTENDED USE COMPARED TO THE PREDICATE 6.

The intended use of the BASHIR™ .035 and the BASHIR™ S-B .035 Endovascular Catheters is the same as that of the predicate devices, BASHIR™ Endovascular Catheter and the BASHIRIM S-B Endovascular Catheters (K222095): They are mechanical thrombolysis catheters intended to infuse physician-specified fluids into a thrombus in either the peripheral or pulmonary circulation and for treatment of pulmonary embolism.

TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATE 7.

The BASHIR™ .035 and the BASHIR™ S-B .035 Endovascular Catheters have the same technological characteristics compared to the predicate device. The subject and predicate devices differ in the OD, which is 8Fr compared to 7Fr, with a commensurate slight increase in the ID to accommodate an 0.035 in. guidewire, and with addition of a flexible proximal guidewire port for improved handling.

	SUBJECT DEVICESBASHIR™ .035 EndovascularCatheter andBASHIR™ S-B .035Endovascular Catheter	PREDICATE DEVICESBASHIR™ EndovascularCatheter andBASHIR™ S-B EndovascularCatheter
French size	8 Fr (2.67 mm)	7 Fr (2.33 mm)
Companion Guidewire	.035 in. guidewire	.018 in. and .035 in. guidewire
Effective length (basketclosed)	92.5 cm (36.44 in.)	92.5 cm (36.44 in.)
Effective length (basket open)	90 cm (35.44 in)	90 cm (35.44 in)
Infusion basket length	12.50 cm (4.94 in.)	12.50 cm (4.94 in.)
	10 cm (3.94 in.)	10 cm (3.94 in.)
Infusion basket diameter	45 mm	45 mm

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	SUBJECT DEVICESBASHIR™ .035 EndovascularCatheter andBASHIR™ S-B .035Endovascular Catheter	PREDICATE DEVICESBASHIR™ EndovascularCatheter andBASHIR™ S-B EndovascularCatheter
Biomaterials	Various biocompatible materials	Various biocompatible materials
Proximal Port	Flexible guidewire port with Lueradapter (design change)	Fixed guidewire port and Lueradapter
Infusion holes	Eight (8) laser-drilled holesdiameter 0.0020 in. in each of six(6) infusion limbs of the infusionbasket	Eight (8) laser-drilled holesdiameter 0.0020 in. in each of six(6) infusion limbs of the infusionbasket
Fluid injection, pulsed orcontinuous	Pulsed or continuous	Pulsed or continuous
Bench Performance Tests	DV Testing of subject devices att=0, t=3 year accelerated	DV Testing of predicate devices att=0, t=3 year accelerated and realtime
Sterilization	Ethylene Oxide	Ethylene Oxide
Shelf Life	3-year shelf life	3-year shelf life
	39 mm	39 mm

8. PERFORMANCE TESTING

This 510(k) refers to bench and clinical performance data leveraged from the predicate devices to establish the substantial equivalence of the BASHIR™ .035 and the BASHIR™ S-B .035 Endovascular Catheters to the predicate devices.

Biocompatibility: Biocompatibility evaluation was leveraged from studies using the predicate device to show the finished, sterilized device is biocompatible for its intended use according to ISO 10993 and FDA Draft Guidance "Use of International Standard ISO 10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process." Testing included cytotoxicity, sensitization, intracutaneous toxicity, acute systemic toxicity, hemolysis, complement, and pyrogenicity testing. All tests passed.

Sterility: Sterilization validation studies were leveraged from studies using the predicate device with ethylene oxide sterilization to a Sterilization Assurance Level (SAL) of 10 ° CFU according to international standards. Bacteriostasis and fungistasis and ethylene oxide residual testing passed. All sterilization process parameters met the acceptance criteria and the requirements were satisfied.

Performance Testing - Bench: Thrombolex leveraged human factors testing conducted with the predicate devices and showed that the subject devices meet product requirements and design specifications. Simulated use studies conducted with the predicate devices over 20 hours confirmed functionality of the subject device over 20 hours.

Design verification bench performance testing conducted with the subject devices to support substantial equivalence included performance of: Kink radius, trackability, advancement force, slider actuator force, catheter retraction, radial force, delivery flow rate, infusion pressure through various lumens and at various flow rates, guidewire compatibility, dimensional verification, compliance of injection hubs, air leakage, fluid leakage, stress cracking, resistance to separation, torque strength, corrosion resistance, joint tensile strength and particulate generation.

Thrombolex leveraged an In-Use Study performed with the predicate devices to evaluate the cumulative impact of in-use materials and conditions on the product quality attributes of a

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representative drug, before vs. after the fluid was infused through the subject device at a rate and concentration representative of those used in clinical trials. Testing demonstrated no impact on the device or the pharmacological fluid.

Performance Testing - Animal: Thrombolex leveraged a GLP animal study performed with the predicate device with deployment of the device in the peripheral vasculature and the pulmonary artery in a swine model. The catheter had no adverse effects systemically, on gross or histopathology evaluation, and resulted in no animal mortality.

Performance Testing - Clinical: A First in Human (FIH) was leveraged using the predicate device with 9 patients, and a pivotal study with 109 patients was conducted. Please refer to published literature for appropriate use of the device in pulmonary endovascular cases.

CONCLUSIONS 9.

The information presented in this 510(k) submission demonstrates that the BASHIR™ .035 and the BASHIR™ S-B .035 Endovascular Catheters are substantially equivalent to the predicate device and supports the use of these devices in the pulmonary artery for treatment of pulmonary embolism and in the peripheral circulation for the restoration of blood flow in patients with venous thrombus.

Regulation Number and Section

§ 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).