The En-Snare™ Endovascular Snare and Catheter is intended for use in the cardiovascular system or hollow viscous to retrieve and manipulate foreign objects. Manipulation procedures include indwelling venous catheter repositioning, indwelling venous catheter fibrin sheath stripping, and central venous access veni-puncture procedure assistance.

Device Description

The En-Snare™ Endovascular Snare and Catheter is comprised of stranded nitinol/platinum cables mechanically secured to a nitinol wire inserted into an intravascular catheter and manipulated by use of an external pin vise. The catheter is made from biocompatible FPE that has been used extensively in intravascular catheters.

AI/ML Overview

Here's an analysis of the provided text regarding the En-Snare™ Endovascular Snare and Catheter, focusing on acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Functional & Safety Testing)	Reported Device Performance
Capture Function	Comparable to predicate device
Tip Deflection	Comparable to predicate device
Torqueability	Comparable to predicate device
Tensile Strength	Comparable to predicate device
Flow Rate	Comparable to predicate device
Hub Leakage	Comparable to predicate device
Stiffness	Comparable to predicate device

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the sample size used for the functional and safety testing (test set). It only mentions "The En-Snare™ Endovascular Snare and Catheter were subjected to..." which implies a set of devices or tests. The data provenance is not specified, but it's implied to be internal testing conducted by Medical Device Technologies, Inc. and is retrospective as it refers to testing already completed.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:

The document does not mention the use of experts to establish a "ground truth" for the functional and safety testing in the typical sense of clinical or diagnostic performance. The ground truth for these engineering performance tests would be defined by established engineering standards and specifications.

4. Adjudication Method for the Test Set:

Not applicable. The "adjudication method" usually refers to a process for resolving discrepancies in expert opinion for clinical ground truth. For functional and safety engineering tests, the results would be objectively measured and compared against defined thresholds or the predicate device's performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

Not applicable. This is a medical device for retrieving and manipulating foreign objects, not an AI-powered diagnostic tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is irrelevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This is not an algorithm or AI device. The "standalone performance" concept doesn't apply to a physical medical device like an endovascular snare and catheter.

7. The Type of Ground Truth Used:

For the functional and safety testing, the "ground truth" was established by objective engineering measurements and comparison against the performance of the predicate device. The document states that the results "indicated that they are comparable to the predicate device."

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical device, not a machine learning model. Therefore, there is no "training set."

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for this type of device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for MDTECH. The logo is in black and white, with the letters "MDTECH" in a bold, sans-serif font. The letters are slightly stylized, with the "T", "E", "C", and "H" being outlined with dashed lines. There is a registered trademark symbol to the right of the "H".

3800 SW 47th Avenue May 13, 2002 Gainesville, Florida 32608 TEL: 352/338-0440 FAX: 352/338-0662 www.mdtech.com 510(k) SUMMARY KOZILOG Medical Device Technologies, Inc. APPLICANT: 3600 SW 47th Avenue Gainesville, FL 32608 Karl Swartz CONTACT: Quality Assurance Manager (352)338-0440 TELEPHONE: fax (352)338-0662 En-Snare™ Endovascular Snare and Catheter TRADE NAMES: Intravascular snare and catheter COMMON NAME: CLASSIFICATION NAME: Percutaneous Catheter, 21 CFR 870.1250 PRODUCT CODE: 78 DQY PANEL: Cardiovascular

SUBSTANTIAL EQUIVALENCE:

Company Name	Product Name	510(k) No.
Microvena	Amplatz Goose Neck Snare	K970668 and K972511

DESCRIPTION OF DEVICE:

INDICATIONS FOR USE:

MEDICAL DEVICE TECHNOLOGIES INC.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for MDTECH. The logo is in black and white, with the letters "MD" in bold, block letters. The letters "TECH" are in a thinner, outlined font. There is a registered trademark symbol in the upper right corner of the logo.

0 SW 47th Avenue Gainesville, Florida 32608 TEL: 352/338-0440 FAX: 352/338-0662 www.mdtech.com

FUNCTIONAL & SAFETY TESTING:

The En-Snare™ Endovascular Snare and Catheter were subjected to capture function, tip deflection, torqueability, tensile strength, flow rate, hub leakage, and stiffness tests. The results of the testing indicated that they are comparable to the predicate device.

May 13, 2002

TECHNICAL COMPARISON:

The following attributes of the En-Snare™ Endovascular Snare and Catheter were examined and found to be comparable to the predicate device:

CATHETER

Intended use 1.
French Sizes 2.
1. Length
Lumens 4.
Distal end configuration 5.
Intended anatomical location of distal end 6.
Proximal end configuration 7.
Materials 8.
Labeling 9.
Intended use 1.
1. Sizes
Length 3.
Distal end configuration 4.
Intended anatomical location of distal end న్.

SNARE

Proximal end configuration 6.
Materials 7.
1. Labeling

I-2

MEDICAL DEVICE TECHNOLOGIES Inc.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AN 31 2002

Medical Device Technologies, Inc c/o Mr. N.E. Devine, Jr. Entela, Inc. 3033 Madison Ave, SE Grand Rapids, MI 49548

Re: K021606

En-Snare™ Endovascular Snare and Catheter Regulation Number: 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II (two) Product Code: 74 MMX Dated: May 13, 2002 Received: May 16, 2002

Dear Mr. Devine:

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.

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);

{3}------------------------------------------------

Page 2 - Mr. N.E. Devine, Jr.

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Dalla Tull

Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for MDTECH. The logo is in black and white, with the letters "MDTECH" in a bold, sans-serif font. The letters are stacked on top of each other, with the "MD" on the top and the "TECH" on the bottom. There is a registered trademark symbol to the right of the logo.

3600 SW 47th Avenue Gainesville, Florida 32608 TEL: 352/338-0440 FAX: 352/338-0662 www.mdtech.com

Page 1 of 1

510(k) Number (if known):_____________________________________________________________________

Device Name: En-Snare™ Endovascular Snare and Catheter

Indications for Use:

The En-Snare™ Endovascular Snare and Catheter is intended for use in the cardiovascular system or hollow viscous to retrieve and manipulate foreign objects. Manipulation procedures include indwelling nonow viscous to retreve and mailipanter renous catheter fibrin sheath stripping, and central venous access veni-puncture procedure assistance.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) espiratory Devices Division 510(k) Number

Prescription Use_ (Per 21 CFR 801.109) OR

Over-The-Counter Use_

(Optional Format 1-2-96

J-1

MEDICAL DEVICE TECHNOLOGIES INC.

13

A member of The Marmon Group of companies

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).