(15 days)
Not Found
No
The device description and performance studies focus on mechanical properties and function, with no mention of AI/ML or related concepts like image processing, training/test sets, or performance metrics typically associated with AI/ML algorithms.
No.
The device is used to retrieve and manipulate foreign objects or assist in procedures, which are interventional or diagnostic in nature, not therapeutic treatments for a disease or condition.
No
Explanation: The device is intended for retrieving and manipulating foreign objects within the body, which are therapeutic or interventional procedures, not diagnostic ones.
No
The device description explicitly states it is comprised of physical components like cables, wires, and a catheter, manipulated by an external pin vise. This indicates a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for retrieving and manipulating foreign objects within the cardiovascular system or hollow viscous. This is an in vivo procedure, meaning it is performed within a living organism.
- Device Description: The description details a physical device (snare and catheter) used for mechanical manipulation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVDs are used to perform tests on samples taken from the body, not to directly interact with structures within the body in the way this snare and catheter does.
N/A
Intended Use / 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 venous catheter repositioning, indwelling venous catheter fibrin sheath stripping, and central venous access veni-puncture procedure assistance.
Product codes
78 DQY, 74 MMX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiovascular system or hollow viscous
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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).
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:
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.
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 venous catheter repositioning, indwelling venous catheter fibrin sheath stripping, and central venous access veni-puncture procedure assistance.
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.
-
- 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.
-
- Sizes
- Length 3.
- Distal end configuration 4.
- Intended anatomical location of distal end న్.
SNARE
- Proximal end configuration 6.
- Materials 7.
-
- Labeling
I-2
MEDICAL DEVICE TECHNOLOGIES Inc.
1
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);
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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
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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.
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A member of The Marmon Group of companies