(246 days)
No
The device description and intended use focus on the mechanical function of a snare for retrieving and manipulating objects, with no mention of AI or ML capabilities.
No
The device is used to retrieve and manipulate foreign objects within the body, which are primarily diagnostic or interventional procedures rather than therapeutic ones.
No
The device description indicates its purpose is to "retrieve and manipulate foreign objects" and assist in procedures like "catheter repositioning" and "venipuncture." These are interventional and manipulative actions rather than diagnostic ones. There is no mention of analysis, measurement, or imaging for the purpose of diagnosis.
No
The device description clearly details physical components such as a braided nitinol loop, solid core nitinol guidewire, gold-plated tungsten coil, and a multi-purpose catheter. This indicates it is a hardware 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 the device is for use in the cardiovascular system or hollow viscous to retrieve and manipulate foreign objects. This is an in vivo (within a living organism) application.
- Device Description: The description details a physical device (snare, guidewire, catheter) used for physical manipulation within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) outside of the body to diagnose a condition. IVDs are designed for laboratory or point-of-care testing of biological specimens.
Therefore, the Amplatz Goose Neck Snare is a medical device used for interventional procedures within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Amplatz Goose Neck Snare is a Class II device 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 venipuncture procedure assistance.
Product codes
74 DXE
Device Description
The Amplatz Goose Neck Snare consists of a braided nitinol loop attached to a solid core nitinol guidewire. The plane of the loop is perpendicular to the host wire. The loop is covered with a gold-plated tungsten coil to enhance radiopaque. The shaft of the snare consists of a solid continuous Nitinol core wire shaft. The loop snare is delivered in a multi-purpose catheter. The catheter has a radiopaque marker band at its distal tip. The package configuration consists of a compact spiral configuration, using hoops to contain the snare and catheter. These spiral hoops are then double pouched in Tyvek/mylar pouches.
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
The Amplatz Goose Neck Snare received clearance for market based on functional and safety testing detailed in the original premarket notification K901502.
Key Metrics
Not Found
Predicate Device(s)
MICROVENA Amplatz Goose Neck Snare Premarket Notification K901502
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
KA72511
Image /page/0/Picture/1 description: The image shows the logo for Microvena Corporation. The logo consists of a stylized "M" symbol made of two overlapping zig-zag lines, followed by the word "MICROVENA" in a bold, sans-serif font. Below "MICROVENA" is the word "CORPORATION" in a smaller font size.
MAR - 6 1998
510(k) SUMMARY
(
(
| Contact/Submitter: | Janell Colley, Regulatory Affairs Associate |
|---|---|
| Date Prepared: | January 13, 1998 |
| Trade Name: | The Amplatz Goose Neck Snare |
| Common Name: | Intravascular Retrieval Device |
| Classification Name: | Percutaneous Retrieval Device |
| Predicate Devices: | MICROVENA Amplatz Goose Neck Snare |
| Premarket Notification K901502 | |
| Device Description: | The Amplatz Goose Neck Snare consists of a braided |
| nitinol loop attached to a solid core nitinol guidewire. | |
| The plane of the loop is perpendicular to the host wire. | |
| The loop is covered with a gold-plated tungsten coil to enhance | |
| radiopaque. The shaft of the snare consists of a solid continuous | |
| Nitinol core wire shaft. The loop snare is delivered in a multi- | |
| purpose catheter. The catheter has a radiopaque marker band at its | |
| distal tip. | |
| The package configuration consists of a compact spiral | |
| configuration, using hoops to contain the snare and | |
| catheter. These spiral hoops are then double pouched in | |
| Tyvek/mylar pouches. | |
| Intended Use: | The Amplatz Goose Neck Snare is a Class II device 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 venipuncture procedure assistance. The Amplatz | |
| Goose Neck Snare received clearance for market based on | |
| functional and safety testing detailed in the original premarket | |
| notification K901502. | |
| Conclusion: | The Amplatz Goose Neck Snare is substantially equivalent |
| to the predicate devices based on design and indications for use. |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes extending from its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 6 1998
Ms. Janell Colley Regulatory Affairs Associate Microvena Corporation 1861 Buerkle Road White Bear Lake, MN 55110-5246
Re: K972511 Amplatz Goose Neck Snare Kit/Catheter Regulatory Class: II (two) Product Code: 74 DXE Dated: January 13, 1998 Received: January 14, 1998
Dear Ms. Colley:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 - Mr. Dennis (Dan) Reigle
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-Also, please note the regulation entitled, "Misbranding by 4639. reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number: K972511
Device Name:
Indications for Use:
The Amplatz Goose Neck Snare is a Class II device 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 venipuncture procedure assistance.
Tht R
(Division Sign-Off) Division of Canavascular, Respiratory, and Neurologica, Jevices K 972611 510(k) Number _
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Amplatz Goose Neck Snare
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-the-Counter Use
(Optional Format 1-2-96)