AMPLATZ THROMBECTOMY DEVICE MODELS ATD 601, ATD 602, ATD 801, ATD 802, FOOT PEDAL ASSEMBLY MODEL AK 100

K982657 · Microvena Corp. · MCW · Nov 18, 1998 · Cardiovascular

Device Facts

• Record ID: K982657
• Device Name: AMPLATZ THROMBECTOMY DEVICE MODELS ATD 601, ATD 602, ATD 801, ATD 802, FOOT PEDAL ASSEMBLY MODEL AK 100
• Applicant: Microvena Corp.
• Product Code: MCW · Cardiovascular
• Decision Date: Nov 18, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4875
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Amplatz Thrombectomy Device (ATD) is intended for use in the mechanical dissolution of acute and subacute thrombus within dialysis fistulae.

Device Story

Percutaneous thrombectomy device; consists of catheter, distal housing with small diameter impeller, and driveshaft. Operates via disposable, high-speed, air-driven motor connected to driveshaft; requires external foot pedal/regulator assembly. Infusion line allows saline delivery during operation. Used by clinicians in clinical setting to mechanically dissolve thrombi in dialysis fistulae; restores patency to access site.

Clinical Evidence

Bench testing only. Functional and safety testing performed on new design features, including joint strengths, flow rate tests, flexibility tests, and material biocompatibility tests.

Technological Characteristics

Percutaneous catheter system; impeller-based mechanical thrombectomy; air-driven motor; saline infusion capability; foot pedal/regulator control. Materials biocompatibility verified.

Indications for Use

Indicated for mechanical dissolution of acute and subacute thrombus within dialysis fistulae.

Regulatory Classification

Identification

An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)

Predicate Devices

• Amplatz Thrombectomy Device (K982657)

Submission Summary (Full Text)

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NOV 1 8 1998

K982657

510(k) Summary

## 510(K) SUMMARY

| SUBMITTER: | MICROVENA Corporation |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Tonya Weigel<br>MICROVENA Corporation<br>1861 Buerkle Road<br>White Bear Lake, MN 55110 |
| DATE PREPARED: | July 29, 1998 |
| TRADE NAME: | Amplatz Thrombectomy Device |
| CLASSIFICATION NAME<br>and NUMBER: | Peripheral Atherectomy Catheter<br>Class II, 21 CFR 870.4875 |
| PRODUCT CODE: | 74MCW |
| PREDICATE DEVICE(S): | MICROVENA Corporation's Amplatz Thrombectomy Device |
| DEVICE DESCRIPTION: | The Amplatz Thrombectomy Device (ATD) is a percutaneous,<br>thrombectomy device consisting of a catheter, a small diameter<br>impeller encased in a distal housing, and a driveshaft. The driveshaft is<br>the connection between the impeller and a disposable, high speed, air<br>driven motor. An infusion line with luer connector, attached to the<br>proximal motor housing, allows infusion of saline. A foot<br>pedal/regulator assembly is required to operate the air motor. |
| INTENDED USE: | The Amplatz Thrombectomy Device (ATD) is intended for use in the<br>mechanical dissolution of acute and subacute thrombus within<br>dialysis fistulae. |
| FUNCTIONAL &<br>SAFETY TESTING: | The Amplatz Thrombectomy Device (ATD) device has successfully<br>undergone functional and safety testing of new design features,<br>including joint strengths, flow rate tests, flexibility tests, and material<br>biocompatibility tests. |
| CONCLUSION: | The Modified Amplatz Thrombectomy Device (ATD) is substantially<br>equivalent to the Predicate ATD. |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around the eagle. The eagle is depicted in black and white, and the text is also in black.

Food and Drug Administration Rockville MD 20857

NOV 1 8 1998

Ms. Tonya L. Weigel Regulatory Affairs Associate MICROVENA Corporation 1861 Buerkle Road White Lake, MN 55110-5246

Re: K982657 Trade Name: Amplatz Thrombectomy Device Regulatory Class: II Product Code: MCW Dated: October 27, 1998 Received: October 28, 1998

Dear Ms. Weigel:

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 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug 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 Reqister. Please note: this response to your premarket notification submission does not affect any obligation

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Page 2 - Ms. Tonya Weigel

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 requlations.

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 [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callehan

Thomas J. Callan 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 (if known): K99 2657

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

The Amplatz Thrombectomy Device is intended for use in the mechanical dissolution of acute and subacute thrombus within dialysis fistulae.

## Concurrence of CDRH, Office of Device Evaluation (ODE)

Cid Dale Gutt Jr. TJ Callahan
(Division Sigh Off)

Division of Cardiovascular, Respir. and Neurological Devices 510(k) Number