(27 days)
Not Found
No
The device description explicitly states that the device is mechanical, contains no electrical components, and requires no capital equipment. There is no mention of software, algorithms, or data processing that would indicate the presence of AI/ML.
Yes.
The device is used for mechanical thrombolysis and infusion of physician-specified fluids (including thrombolytics) for the treatment of pulmonary embolism and venous thrombus, which are direct therapeutic actions.
No
This device is described as a "mechanical thrombolysis catheter" intended for the infusion of fluids, including thrombolytics, to treat pulmonary embolism and venous thrombus by restoring blood flow. Its function is to deliver treatment, not to diagnose a condition.
No
The device description clearly states it is a mechanical device composed of biocompatible materials, contains no electrical components, and requires no capital equipment. It is a physical catheter with an expandable basket for fluid infusion.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This testing is performed outside of the body (in vitro).
- Device Function: The BASHIR™ Endovascular Catheter is a device that is inserted into the patient's body (in vivo) to deliver fluids directly to a specific location (pulmonary arteries or peripheral vasculature) for therapeutic purposes (thrombolysis).
- Intended Use: The intended use clearly states the device is for "controlled and selective infusion of physician-specified fluids... into the pulmonary arteries" and "Infusion of physician-specified fluids... into the peripheral vasculature." This is a therapeutic intervention, not a diagnostic test performed on a specimen.
The device is a medical device used for treatment within the body, not for testing samples outside the body.
N/A
Intended Use / Indications 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.
Product codes
QEY, KRA
Device Description
The BASHIR™ .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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Pulmonary arteries, peripheral vasculature
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)
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
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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
1
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
2
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.
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
4
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 DEVICES
BASHIR™ .035 Endovascular
Catheter and
BASHIR™ S-B .035
Endovascular Catheter | PREDICATE DEVICES
BASHIR™ Endovascular
Catheter and
BASHIR™ S-B Endovascular
Catheter |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| 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 (basket
closed) | 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 |
5
| | SUBJECT DEVICES
BASHIR™ .035 Endovascular
Catheter and
BASHIR™ S-B .035
Endovascular Catheter | PREDICATE DEVICES
BASHIR™ Endovascular
Catheter and
BASHIR™ S-B Endovascular
Catheter |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| Biomaterials | Various biocompatible materials | Various biocompatible materials |
| Proximal Port | Flexible guidewire port with Luer
adapter (design change) | Fixed guidewire port and Luer
adapter |
| Infusion holes | Eight (8) laser-drilled holes
diameter 0.0020 in. in each of six
(6) infusion limbs of the infusion
basket | Eight (8) laser-drilled holes
diameter 0.0020 in. in each of six
(6) infusion limbs of the infusion
basket |
| Fluid injection, pulsed or
continuous | Pulsed or continuous | Pulsed or continuous |
| Bench Performance Tests | DV Testing of subject devices at
t=0, t=3 year accelerated | DV Testing of predicate devices at
t=0, t=3 year accelerated and real
time |
| 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
6
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.