(28 days)
Not Found
No
The device description explicitly states that the catheter is mechanical and contains no electrical components, and there is no mention of AI or ML in the summary.
Yes
The device is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature, which is a therapeutic action.
No
The device is described as an "Endovascular Catheter" intended for the "controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature." This indicates a therapeutic function (delivery of treatment), not a diagnostic one (identifying a condition or disease).
No
The device description explicitly states it is a mechanical catheter with no electrical components, and the performance studies focus on physical characteristics and usability of the hardware.
Based on the provided information, the Bashir™ S-B Endovascular Catheter is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the controlled and selective infusion of fluids into the peripheral vasculature. This is a direct intervention within the body, not a test performed on a sample taken from the body.
- Device Description: The device is a catheter designed for delivery and positioning within blood vessels. It's a mechanical device used for therapeutic delivery, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples (like blood, urine, tissue, etc.) to provide information about a patient's health status, diagnose a condition, or monitor treatment.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body. The Bashir™ S-B Endovascular Catheter is clearly an in vivo (within the body) device used for therapeutic purposes.
N/A
Intended Use / Indications for Use
The Bashir™ S-B Endovascular Catheter is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
Product codes (comma separated list FDA assigned to the subject device)
OEY, KRA
Device Description
The Bashir™ S-B Endovascular Catheter (Model 7101) is a continuous flush catheter designed to enable delivery of physician-specified fluids, including thrombolytics, into the peripheral circulation. The design of the Bashir™ S-B Endovascular Catheter allows for delivery and positioning of the catheter at the target peripheral location via a sheath, over a guidewire using fluoroscopic guidance. Depending on the target location, the infusion can be initiated 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. The physician-specified solution is delivered via multiple laser-drilled holes through the infusion limbs of the Bashir™ S-B Endovascular Catheter after placement. After the completion of solution delivery, the infusion limbs are collapsed to a straight position and then the Bashir™ S-B Endovascular Catheter is retracted into the sheath and removed.
The Bashir™ S-B Endovascular Catheter is comprised of common materials used in vascular catheters. The catheter is mechanical and contains no electrical components.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
interventional specialist
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: Performance testing was repeated to confirm that the device modifications did not adversely affect the device performance. The testing included an evaluation of: Trackability, advancement force, slider actuator force, catheter retraction, radial force, delivery flow rate, infusion pressure at various flow rates, infusion pressure with pulse spray, dimensional verification, joint tensile strengths and label legibility. The performance data demonstrate that the new device is substantially equivalent to the predicate device.
Sterilization and Shelf Life: The devices are sterilized using standard methods and the sterilization cycles have been validated following international standards. The shelf life of the devices was established through stability studies. The sterilization validation complied with ISO 11135: 2014. The sterilization cycle was validated to a sterility assurance level of 10. The shelf life of the Bashir Catheters was established through accelerated aging studies, and support a shelf life of 2 years.
Usability Testing: Usability testing was performed using the to-be-marketed modified device handle by ten (10) intended users and was found to be meet pre-defined acceptance criteria.
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).
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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, which is a blue square with the letters "FDA" in white. To the right of the blue square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 3, 2022
Thrombolex, Inc. % Diane Horwitz Regulatory Eminence Clinical Research Inc. 5 Lake Como Ct. Greenville. South Carolina 29609
Re: K192598
Trade/Device Name: Bashir S-B Endovascular Catheter, Ref. No. 7101 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 October 18, 2019. 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,
Image /page/0/Picture/9 description: The image shows a digital signature. The signature is for Gregory W. O'connell -S. The signature was created on February 3, 2022.
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
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October 18, 2019
Thrombolex, Inc. % Diane Horwitz, PhD Regulatory Consultant Eminence Clinical Research, Inc. 5 Lake Como Ct. Greenville, South Carolina 29609
Re: K192598
Trade/Device Name: Bashir™ S-B Endovascular Catheter, Ref. No. 7101 Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA Dated: September 19, 2019 Received: September 20, 2019
Dear Dr. Horwitz:
We have reviewed vour 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
2
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 Eleni by Eleni Whatley For Whatley 09:39:55 -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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K192598
Device Name
Bashir™ S-B Endovascular Catheter, Ref. No. 7101
Indications for Use (Describe)
The Bashir™ S-B Endovascular Catheter is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral 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) |
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Image /page/4/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, gray letters. The "X" in "THROMBOLEX" is stylized with a red line extending upwards and to the right, creating a visual emphasis. The trademark symbol is also present next to the word.
510(k) SUMMARY
GENERAL INFORMATION 1.
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
October 17, 2019
2. NAME OF THE DEVICE
2.1.1 Trade/Proprietary Name
Bashir™ S-B Endovascular Catheter, Ref. No. 7101
2.1.2 Common/Usual Name
Continuous Flush Catheter
Classification Information 2.1.3
| Classification Name: | Continuous Flush Catheter |
|---|---|
| Classification Regulation: | 21 CFR 870.1210 |
| Class: | 2 |
| Product Code: | KRA – Continuous Flush Catheter |
| Panel: | Cardiovascular |
3. PREDICATE DEVICE
The predicate device is the Bashir™ Endovascular Catheter, Reference No. 7201, K183290.
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4. DESCRIPTION OF THE DEVICE
The Bashir™ S-B Endovascular Catheter (Model 7101) is a continuous flush catheter designed to enable delivery of physician-specified fluids, including thrombolytics, into the peripheral circulation. The design of the Bashir™ S-B Endovascular Catheter allows for delivery and positioning of the catheter at the target peripheral location via a sheath, over a guidewire using fluoroscopic guidance. Depending on the target location, the infusion can be initiated 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. The physician-specified solution is delivered via multiple laser-drilled holes through the infusion limbs of the Bashir™ S-B Endovascular Catheter after placement. After the completion of solution delivery, the infusion limbs are collapsed to a straight position and then the Bashir™ S-B Endovascular Catheter is retracted into the sheath and removed.
The Bashir™ S-B Endovascular Catheter is comprised of common materials used in vascular catheters. The catheter is mechanical and contains no electrical components.
5. INDICATION FOR USE
The Bashir™ S-B Endovascular Catheter is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
6. COMPARISON OF THE INTENDED USE WITH THE PREDICATE DEVICE
The Bashir™ S-B Endovascular Catheter is intended to be used in the same interventional procedures in the same target population (patients with thrombosis in the peripheral vasculature) and have the same primary function of providing a conduit for infusion of solutions. The Bashir™ S-B Endovascular Catheter has an identical intended use/indications for use statement compared to the predicate device.
TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE 7. PREDICATE
The Bashir™ S-B Endovascular Catheter is substantially equivalent to the predicate device regarding its similar intended use, fluid infusion function, design, materials, packaging and sterility.
The parent device was modified to shorten the infusion basket from 12.5 cm to 10 cm to facilitate use in different anatomical size and/or locations within the peripheral vasculature to increase efficiency of exposure of the clot to thrombolytic solutions. Features of the handle were changed to improve ergonomics and torque resistance of the connector.
Through product testing, Thrombolex has demonstrated that the technological differences between the subject device and the predicate device do not raise different issues of safety or effectiveness.
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8. PERFORMANCE TESTING
This 510(k) notification provides performance data to establish the substantial equivalence of the Bashir™ S-B Endovascular Catheter to the predicate device. The following is a summary of the performance data repeated for the modified device.
Performance Testing - Bench: Performance testing was repeated to confirm that the device modifications did not adversely affect the device performance.
The testing included an evaluation of: Trackability, advancement force, slider actuator force, catheter retraction, radial force, delivery flow rate, infusion pressure at various flow rates, infusion pressure with pulse spray, dimensional verification, joint tensile strengths and label legibility. The performance data demonstrate that the new device is substantially equivalent to the predicate device.
Sterilization and Shelf Life: The devices are sterilized using standard methods and the sterilization cycles have been validated following international standards. The shelf life of the devices was established through stability studies. The sterilization validation complied with ISO 11135: 2014. The sterilization cycle was validated to a sterility assurance level of 10 . The shelf life of the Bashir Catheters was established through accelerated aging studies, and support a shelf life of 2 years.
Usability Testing: Usability testing was performed using the to-be-marketed modified device handle by ten (10) intended users and was found to be meet pre-defined acceptance criteria.
CONCLUSIONS 9.
The information presented in this 510(k) submission demonstrates that the Bashir™ Endovascular S-B Catheter is substantially equivalent to the predicate device.