(24 days)
No
The device description and performance data focus on the mechanical aspects of the catheter and its accessories for thrombus removal. There is no mention of AI, ML, image processing, or any data-driven algorithms.
Yes
The device is described as an aspiration catheter indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system, which directly addresses a medical condition to restore normal function.
No
Explanation: The device is an aspiration catheter designed for the removal of emboli and thrombi from vessels, which is a therapeutic intervention, not a diagnostic one. While it includes a filter basket for post-procedure examination of removed material, this does not make the device itself diagnostic.
No
The device description clearly outlines a physical catheter with lumens, a hub, a tip, a radiopaque marker band, and compatibility with guide wires. It also includes accessories like an extension line, stopcock, syringe, and filter basket. This 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 the removal of emboli and thrombi from vessels in the arterial system. This is a therapeutic procedure performed in vivo (within the body).
- Device Description: The description details a catheter designed for aspiration and removal of material from blood vessels. This is a medical device used for intervention, not for testing samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information based on testing samples. The included filter basket is for examining the removed material, not for performing a diagnostic test on it.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to physically remove material from the body.
N/A
Intended Use / Indications for Use
The DIVER C.E. Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system.
Product codes
QEZ, DXE
Device Description
The DIVER C.E. Catheter is an aspiration catheter indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system. The catheter features an aspiration lumen running through the full length of the catheter. A luer lock type hub in the proximal end allows the connection of the catheter to the extension line (High Pressure Tubing), stopcock, and syringe that are included in the catheter package. The DIVER C.E. Catheter has a central aspiration lumen and a soft, atraumatic tip. The smooth, soft, atraumatic tip has a radiopaque marker band located at 1mm from its distal end. The DIVER C.E. Catheter is available in two configurations - with and without sideholes. The catheter is a rapid exchange design, with the guide wire lumen running from the distal tip to 22.7 cm proximally in the catheter body, where the exit port is located. The catheter is compatible with guide wires with a maximum diameter of 0.014". Additionally, a 40u filter basket is also included to allow the physician to perform a post-procedure examination of the aspirated thrombi/emboli material removed during the procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels in the 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
Sterilization: Results of sterilization validation demonstrate that the DIVER C.E. Catheter and its accessories are adequately sterilized.
Performance Data: The results of verification testing demonstrated that the DIVER C.E. Catheter and its accessories met the established acceptance criteria and performs in a manner equivalent to the predicate devices. No new safety or effectiveness issues were raised during the testing program.
Key Metrics
Not Found
Predicate Device(s)
DIVERTM C.E. Catheter – K050276, Vascular Solutions Inc. PRONTOTM Extraction Catheter – K032763, VacLokTM Syringe - K994253
Reference Device(s)
Hi-Flex™ High Pressure Tubing - K883718, Stopcock (One-port Manifold) - K934123
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
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.
October 8, 2021
Invatec Innovative Technologies Stephanie Isgrigg Robinson Regulatory Affairs Specialist 4600 Nathan Lane North Plymouth, Minnesota 55442
Re: K051917
Trade/Device Name: Diver C.E. Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEZ
Dear Stephanie Isgrigg Robinson:
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 August 8, 2005. 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 Date: 2021.10.08
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
Public Health Service
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 8 - 2005
Invatec Innovative Technologies, S.R. c/o Ms. Stephanie Isgrigg Robinson Regulatory Affairs Specialist 4600 Nathan Lane North Plymouth, MN 55442
Re: K051917 DIVER C.E. Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II (two) Product Code: DXE Dated: July 14, 2005 Received: July 15, 2005
Dear Ms. Robinson:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your be 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
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 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 Office of Compliance at (301) 594-4648. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Bhimma for
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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Indications For Use
510(k) Number (if known): K051917
DIVER™ C.E. Catheter Device Name: Device Name
Indications for Use:
The DIVER C.E. Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system.
Prescription Use Over-The-Counter Use X AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
x
Page 1 of 1
almanian and the many of the may be the may be the may be the may be the may be the may be the may sion Sign-Off) Division of Cardiovascular Devices 510(k) Number_
DIVERTM C.E. Catheter Traditional 510(k)
Confidential Document
4
AUG 8 - 2005 510(k) Summary DIVERTM C.E. Catheter
510(k) Number: 4051917
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR $807.92.
| Submitter/Contact Person:
Applicant
(Manufacturer): | Invatec Innovative Technologies
Via Martiri della Libertà, 7
25030 Roncadelle (BS) Italy
Tel: +39 030 258 93 11
Fax: +39 030 258 93 12 |
|-------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter's Name: | ev3 Inc.
4600 Nathan Lane North
Plymouth, MN 55442
Tel: (763) 398-7000
Fax: (763) 398-7200 |
| Official Contact: | Stephanie K. Isgrigg Robinson
Regulatory Affairs Specialist
ev3 Inc.
4600 Nathan Lane North
Plymouth, MN 55442
Tel: (763) 398-7487
Fax: (763) 398-7200
srobinson@ev3.net |
| Summary Preparation Date: | July 15, 2005 |
| Device Name and Classification:
Trade Name:
Common Name/Usual Name:
Classification Name:
Class: | DIVERTM C.E. Catheter
Catheter, Embolectomy
Catheter, Embolectomy
Class II, 21 CFR 870.5150 |
| Predicate Devices: | DIVERTM C.E. Catheter – K050276
Vascular Solutions Inc. PRONTOTM Extraction Catheter – K032763
VacLokTM Syringe - K994253 |
Hi-Flex™ High Pressure Tubing - K883718 Stopcock (One-port Manifold) - K934123
5
Device Description:
The DIVER C.E. Catheter is an aspiration catheter indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system. The catheter features an aspiration lumen running through the full length of the catheter. A luer lock type hub in the proximal end allows the connection of the catheter to the extension line (High Pressure Tubing), stopcock, and syringe that are included in the catheter package. The DIVER C.E. Catheter has a central aspiration lumen and a soft, atraumatic tip. The smooth, soft, atraumatic tip has a radiopaque marker band located at 1mm from its distal end. The DIVER C.E. Catheter is available in two configurations - with and without sideholes. The catheter is a rapid exchange design, with the guide wire lumen running from the distal tip to 22.7 cm proximally in the catheter body, where the exit port is located. The catheter is compatible with guide wires with a maximum diameter of 0.014". Additionally, a 40u filter basket is also included to allow the physician to perform a post-procedure examination of the aspirated thrombi/emboli material removed during the procedure.
Intended Use:
The DIVER C.E. Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system.
Summary of Testing:
Sterilization: Results of sterilization validation demonstrate that the DIVER C.E. Catheter and its accessories are adequately sterilized.
Performance Data: The results of verification testing demonstrated that the DIVER C.E. Catheter and its accessories met the established acceptance criteria and performs in a manner equivalent to the predicate devices. No new safety or effectiveness issues were raised during the testing program.
Statement of Equivalence:
The DIVER C.E. Catheter and its accessories are substantially equivalent to the currently marketed DIVER C.E. Catheter (K050276), VacLokTM Syringe (K994253), Hi-Flex™ High Pressure Tubing (K883718) Stopcock (One-port Manifold) (K934123) and Vascular Solutions Pronto™ Extraction Catheter (K032763) in intended use, performance, technological characteristics and materials.