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.

AI/ML Overview

The provided document is a 510(k) summary for the DIVER C.E. Catheter, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness or specific performance metrics against pre-defined clinical acceptance criteria.

Therefore, the document does not contain the requested information regarding acceptance criteria, study details (sample sizes, ground truth establishment, expert qualifications, adjudication methods), or comparative effectiveness studies (MRMC).

The section "Summary of Testing" states: "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."

However, the specific acceptance criteria and the detailed results of the study that "prove" the device meets them are not provided in this document. The document primarily focuses on demonstrating substantial equivalence through comparison of technological characteristics and intended use, and confirming sterilization validation and general performance testing.

Here's a breakdown of what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance:

Missing. The document states that "established acceptance criteria" were met, but does not list them or the specific performance values.

2. Sample sized used for the test set and the data provenance:

Missing. The document mentions "verification testing" but does not provide details on sample sizes, country of origin, or whether the study was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Missing. No information on experts or ground truth establishment for a test set is provided. This type of detail is typically not part of a 510(k) summary focused on substantial equivalence.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Missing. Not applicable given the document's content.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Missing. This device is a catheter, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to AI assistance is not applicable.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Missing. Not applicable as this is a physical medical device (catheter), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Missing. The document refers to "verification testing" and equivalence to predicate devices, not clinical ground truth establishment in the context of diagnostic accuracy.

8. The sample size for the training set:

Missing. Not applicable to this type of device and submission.

9. How the ground truth for the training set was established:

Missing. Not applicable to this type of device and submission.

In summary, the provided 510(k) summary for the DIVER C.E. Catheter confirms that verification testing was conducted and met "established acceptance criteria," but it does not disclose the details of those criteria or the study methodology (sample sizes, ground truth, expert involvement, etc.) as these are not typically required for a 510(k) demonstrating substantial equivalence for a device of this nature.

Summary

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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 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

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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.

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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)

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

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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 TechnologiesVia Martiri della Libertà, 725030 Roncadelle (BS) ItalyTel: +39 030 258 93 11Fax: +39 030 258 93 12
Submitter's Name:	ev3 Inc.4600 Nathan Lane NorthPlymouth, MN 55442Tel: (763) 398-7000Fax: (763) 398-7200
Official Contact:	Stephanie K. Isgrigg RobinsonRegulatory Affairs Specialistev3 Inc.4600 Nathan Lane NorthPlymouth, MN 55442Tel: (763) 398-7487Fax: (763) 398-7200srobinson@ev3.net
Summary Preparation Date:	July 15, 2005
Device Name and Classification:Trade Name:Common Name/Usual Name:Classification Name:Class:	DIVERTM C.E. CatheterCatheter, EmbolectomyCatheter, EmbolectomyClass II, 21 CFR 870.5150
Predicate Devices:	DIVERTM C.E. Catheter – K050276Vascular Solutions Inc. PRONTOTM Extraction Catheter – K032763VacLokTM Syringe - K994253

Hi-Flex™ High Pressure Tubing - K883718 Stopcock (One-port Manifold) - K934123

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Device Description:

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.

Regulation Number and Section

§ 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).