(69 days)
Not Found
No
The summary describes a mechanical aspiration catheter and its components. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities. The performance studies focus on mechanical and biological properties.
Yes
The device is used to remove thrombi/emboli from the peripheral arterial system, which is a therapeutic intervention.
No
The device is described as an aspiration catheter intended for the removal of thrombi/emboli, which is a therapeutic rather than diagnostic function.
No
The device description clearly outlines physical components like a catheter, adaptor, valve, dilator, and syringe, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for removal of fresh, soft thrombi/emboli from the peripheral arterial system." This describes a therapeutic procedure performed directly on the patient's body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is a catheter designed for physical removal of material from within the body. This is consistent with a medical device used for treatment, not an IVD used for diagnosis.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Intended for removal of fresh, soft thrombi/emboli from the peripheral arterial system.
Product codes
OEY, DXE
Device Description
The Flexor Evac Aspiration Catheter is hydrophilically coated, Flexor® material with a radiopaque band. The device is supplied with a Tuohy-Borst side-arm adaptor, stopcock valve, rapid exchange dilator, and a 30 mL vacuum syringe. This device is available in various lengths and French sizes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral arterial system
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
The Flexor Evac Aspiration Catheter was subjected to the following tests to assure reliable design and performance under specified testing parameters. These tests include: - Pressure Rating 1. - 2. Liquid Leakage - 3. Tensile Strength - Device Performance Animal Study 4. - 5. Biocompatibility The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as an aspiration catheter.
Key Metrics
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).
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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.
May 20, 2021
Cook, Inc. Karen Bradburn Senior Regulatory Affairs Specialist 750 Daniels Way P.O. Box 489 Bloomington, Indiana 47402
Re: K073627
Trade/Device Name: Flexor Evac Aspiration Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: OEY
Dear Karen Bradburn:
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 March 4, 2008. Specifically, FDA is updating this SE Letter 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,
Digitally signed by Gregory W. Gregory W. O'connell -S O'connell -S 10:10:10:15-04'00'
Gregory O'Connell Assistant Director Plaque Modification Devices Team 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/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular pattern around the symbol. The text is in all caps and is evenly spaced around the circle.
Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 4 2008
Cook, Inc. c/o Ms. Karen Bradburn Senior Regulatory Affairs Specialist 750 Daniels Way P.O. Box 489 Bloomington, IN 47402
Re: K073627
Trade/Device Name: Flexor Evac Aspiration Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II (Two) Product Code: DXE Dated: December 21, 2007 Received: December 26, 2007
Dear Ms. Bradburn:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
2
Page 2 -- Ms. Karen Bradburn
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complics 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket, Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Duma R. Vachner
( Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| 510(k) Number (if known): | K073627 |
|---|---|
| --------------------------- | --------- |
Flexor Evac Aspiration Catheter Device Name:
Intended for removal of fresh, soft thrombi/emboli from the Indications for Use: peripheral arterial system.
Prescription Use X (Per 21 CFR 801 Subpart D)
OR
Over-the-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
es R. de Luis
Discolor (Division Sign-Off) (Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K073627
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510(k) Summary
Submitted By:
MAR - 4 2008
Karen Bradburn, RAC Senior Regulatory Affairs Specialist Cook Incorporated 750 Daniels Way, PO Box 489 Bloomington. IN 47402 812-339-2235
Device:
Trade Name: Proposed Classification: Flexor Evac Aspiration Catheter Catheter, Embolectomy DXE (21 CFR §870.5150)
Indications for Use:
Intended for removal of fresh, soft thrombi/emboli from the peripheral arterial system.
Predicate Devices:
The Flexor Evac Aspiration Catheter is similar in terms of intended use, principles of operation, materials of construction and technological characteristics to predicate devices reviewed as devices for removal of fresh, soft thrombi/emboli from the peripheral arterial system. These devices include the Export XT Catheter (K061958) and the Pronto V3 Extraction Catheter (K063371).
Device Description:
The Flexor Evac Aspiration Catheter is hydrophilically coated, Flexor® material with a radiopaque band. The device is supplied with a Tuohy-Borst side-arm adaptor, stopcock valve, rapid exchange dilator, and a 30 mL vacuum syringe. This device is available in various lengths and French sizes.
Substantial Equivalence:
The Flexor Evac Aspiration Catheter is similar to catheters in commercial distribution used for removal of fresh, soft thrombi/emboli from the artery system.
The similar indications for use, principles of operation, technological characteristics and performance testing results for the Flexor Evac Aspiration Catheter as compared to the predicate device supports a determination of substantial equivalency.
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Test Data:
The Flexor Evac Aspiration Catheter was subjected to the following tests to assure reliable design and performance under specified testing parameters. These tests include:
- Pressure Rating 1.
-
- Liquid Leakage
-
- Tensile Strength
- Device Performance Animal Study 4.
-
- Biocompatibility
The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as an aspiration catheter.