(43 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 document.
Yes
The device is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature, which directly treats a medical condition (e.g., blood clots with thrombolytics).
No
The device is described as an infusion catheter for delivering fluids into the peripheral vasculature, not for diagnosing medical conditions.
No
The device description clearly states it is a mechanical catheter made of common vascular catheter materials and contains no electrical components. It is a physical device for delivering fluids.
Based on the provided information, the Bashir™ Plus Endovascular Catheter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside the body (in vitro).
- The Bashir™ Plus Endovascular Catheter is a medical device used inside the body (in vivo) to deliver fluids directly into the peripheral vasculature. Its purpose is therapeutic (delivering thrombolytics) and procedural (controlled infusion), not diagnostic testing of bodily specimens.
The description clearly outlines its function as a catheter for delivering substances within the body, guided by fluoroscopy. This is characteristic of an interventional medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Bashir™ Plus Endovascular Catheters are 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™ Plus Endovascular Catheter is a continuous flush catheter designed to enable delivery of physician-specified fluids, including thrombolytics, into the peripheral circulation. There are four models of the Bashir™ Plus Endovascular Catheter, (Ref. No. 7210, 7220, 7230, 7240). The design of the Bashir™ Plus 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 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. The physician-specified solution is delivered via multiple laserdrilled holes through the infusion limbs of the Bashir™ Plus Endovascular Catheter after placement.
The Bashir™ Plus Endovascular Catheter has a second Shaft Port, for delivery of infusion solutions into the shaft lumen where multiple laser-drilled holes cover 10 cm of length (Ref. No. 7210), 20 cm (Ref. No. 7220), 30 cm (Ref. No. 7230) or 40 cm (Ref. No. 7240).
After the completion of solution delivery, the infusion limbs are collapsed to a straight position and then the Bashir™ Plus Endovascular Catheter is retracted into the sheath and removed.
The Bashir™ Plus 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
fluoroscopic guidance
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)
Not Found
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).
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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "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: K193071
Trade/Device Name: Bashir Plus Endovascular Catheter 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 December 17, 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,
Gregory W. Digitally signed by Gregory W. O'connell -S O'connell -S Date: 2022.02.03
14:31:39 -05'00'
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
1
Image /page/1/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right, the FDA logo is displayed in blue, with the words "U.S. FOOD & DRUG" on one line and "ADMINISTRATION" on the line below.
December 17, 2019
Thrombolex, Inc. % Diane Horwitz Regulatory Eminence Clinical Research Inc. 5 Lake Como Ct. Greenville, South Carolina 29609
Re: K193071
Trade/Device Name: Bashir Plus Endovascular Catheter Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA Dated: November 1, 2019 Received: November 4, 2019
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 mav, 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
2
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 (OS) 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,
Gregory W. Digitally signed by
Gregory W. Gregory W. O'connell -S O'connell -S Date: 2019.12.17
15:11:09 -05:00' 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 (if known) K193071
Device Name Bashir™ Plus Endovascular Catheter
Indications for Use (Describe)
The Bashir™ Plus Endovascular Catheters are 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)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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K193071 Page 1
Image /page/4/Picture/1 description: The image shows the logo for THROMBOLEX. The logo is in red and features the company name in bold, sans-serif font. Below the company name is the tagline "INNOVATIVE ENDOVASCULAR CATHETERS" in a smaller, sans-serif font.
510(k) SUMMARY
1. GENERAL INFORMATION
Submitter and 510(k) Owner 1.1
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
November 1, 2019
2. NAME OF THE DEVICE
2.1.1 Trade/Proprietary Name
Bashir™ Plus Endovascular Catheter, Reference No. 7210, 7220, 7230, 7240
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: | 2 |
| Product Code: | KRA - Continuous Flush Catheter |
| Panel: | Cardiovascular |
3. PREDICATE DEVICE
The predicate device is the Bashir™ Endovascular Catheter, Reference No. 7201, K183290.
5
DESCRIPTION OF THE DEVICE
The Bashir™ Plus Endovascular Catheter is a continuous flush catheter designed to enable delivery of physician-specified fluids, including thrombolytics, into the peripheral circulation. There are four models of the Bashir™ Plus Endovascular Catheter, (Ref. No. 7210, 7220, 7230, 7240). The design of the Bashir™ Plus 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 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. The physician-specified solution is delivered via multiple laserdrilled holes through the infusion limbs of the Bashir™ Plus Endovascular Catheter after placement.
The Bashir™ Plus Endovascular Catheter has a second Shaft Port, for delivery of infusion solutions into the shaft lumen where multiple laser-drilled holes cover 10 cm of length (Ref. No. 7210), 20 cm (Ref. No. 7220), 30 cm (Ref. No. 7230) or 40 cm (Ref. No. 7240).
After the completion of solution delivery, the infusion limbs are collapsed to a straight position and then the Bashir™ Plus Endovascular Catheter is retracted into the sheath and removed.
The Bashir™ Plus 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™ Plus Endovascular Catheters are 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™ Plus 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™ Plus Endovascular Catheter has an identical intended use/indications for use statement compared to the predicate device.
TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATE
'he Bashir™ Plus Endovascular Catheter is substantially equivalent to the predicate device regarding its similar intended use, fluid infusion function, design, materials, packaging and sterility.