AMPLATZ GOOSE NECK SNARE KIT/ CATHETER

K972511 · Microvena Corp. · DXE · Mar 6, 1998 · Cardiovascular

Device Facts

• Record ID: K972511
• Device Name: AMPLATZ GOOSE NECK SNARE KIT/ CATHETER
• Applicant: Microvena Corp.
• Product Code: DXE · Cardiovascular
• Decision Date: Mar 6, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5150
• Device Class: Class 2

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.

Device Story

Intravascular retrieval device; consists of braided nitinol loop attached to solid core nitinol guidewire; loop plane perpendicular to host wire; loop covered with gold-plated tungsten coil for radiopacity. Delivered via multi-purpose catheter with distal radiopaque marker band. Used by physicians in cardiovascular or hollow viscous procedures to retrieve or manipulate foreign objects, reposition catheters, or strip fibrin sheaths. Device provides mechanical retrieval capability; operator manipulates snare via catheter to capture objects. Benefits include minimally invasive foreign body removal and catheter management.

Clinical Evidence

No clinical data; device clearance based on functional and safety testing.

Technological Characteristics

Materials: Nitinol (loop and core wire), gold-plated tungsten (coil). Construction: Braided loop perpendicular to host wire. Delivery: Multi-purpose catheter with radiopaque marker. Sterilization: Not specified. Connectivity: None. Software: None.

Indications for Use

Indicated for use in the cardiovascular system or hollow viscous to retrieve and manipulate foreign objects, including indwelling venous catheter repositioning, fibrin sheath stripping, and central venous access venipuncture assistance.

Regulatory Classification

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.

Predicate Devices

• MICROVENA Amplatz Goose Neck Snare (K901502)

Submission Summary (Full Text)

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KA72511

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MAR - 6 1998

## 510(k) SUMMARY

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| Contact/Submitter: | Janell Colley, Regulatory Affairs Associate |
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| 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<br>Premarket Notification K901502 |
| Device Description: | The Amplatz Goose Neck Snare consists of a braided<br>nitinol loop attached to a solid core nitinol guidewire.<br>The plane of the loop is perpendicular to the host wire.<br>The loop is covered with a gold-plated tungsten coil to enhance<br>radiopaque. The shaft of the snare consists of a solid continuous<br>Nitinol core wire shaft. The loop snare is delivered in a multi-<br>purpose catheter. The catheter has a radiopaque marker band at its<br>distal tip.<br>The package configuration consists of a compact spiral<br>configuration, using hoops to contain the snare and<br>catheter. These spiral hoops are then double pouched in<br>Tyvek/mylar pouches. |
| Intended Use: | The Amplatz Goose Neck Snare is a Class II device intended<br>for use in the cardiovascular system or hollow viscous to<br>retrieve and manipulate foreign objects. Manipulation<br>procedures include indwelling venous catheter repositioning,<br>indwelling venous catheter fibrin sheath stripping, and central<br>venous access venipuncture procedure assistance. The Amplatz<br>Goose Neck Snare received clearance for market based on<br>functional and safety testing detailed in the original premarket<br>notification K901502. |
| Conclusion: | The Amplatz Goose Neck Snare is substantially equivalent<br>to the predicate devices based on design and indications for use. |

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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.

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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 [phone]. 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 [phone] or [phone] 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

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## 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 _

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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)