AMPLATZ THROMBECTOMY DEVICE(ATD 603,602,801,802)/FOOT PEDAL ASSEMBLY(AK 200)

K971984 · Microvena Corp. · MCW · Sep 19, 1997 · Cardiovascular

Device Facts

• Record ID: K971984
• Device Name: AMPLATZ THROMBECTOMY DEVICE(ATD 603,602,801,802)/FOOT PEDAL ASSEMBLY(AK 200)
• Applicant: Microvena Corp.
• Product Code: MCW · Cardiovascular
• Decision Date: Sep 19, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4875
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

The Amplatz Thrombectomy Device (ATD) is a percutaneous, rotational thrombectomy catheter used for mechanical thrombus dissolution in dialysis fistulae. The device consists of a polyurethane catheter containing a distal rotor housing with a recessed impeller attached to a drive shaft. The shaft connects to a disposable, high-speed, air-driven motor. An infusion line allows for saline delivery through the catheter. Operation requires a foot pedal/regulator assembly to control the air motor. The device is operated by a clinician to mechanically macerate thrombi, facilitating removal or dissolution. It is intended for use in clinical settings.

Clinical Evidence

Bench testing only. Testing included joint strengths, flow rate tests, burst tests, flexibility tests, device life tests, maceration capability tests, and material biocompatibility tests.

Technological Characteristics

Polyurethane catheter; distal rotor housing with recessed impeller; air-driven motor; foot pedal/regulator assembly; saline infusion line. Mechanical rotational principle.

Indications for Use

Indicated for the mechanical dissolution of acute and sub-acute 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

• MICROVENA Amplatz Thrombectomy Device

Submission Summary (Full Text)

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971984

## 510(k) Summary

SEP 1 9 1997

| Contact/Submitter: | Janell Colley, Regulatory Affairs Associate |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | September 8, 1997 |
| Trade Name: | The Amplatz Thrombectomy Device |
| Common Name: | Thrombectomy Catheter |
| Classification Name: | Percutaneous Catheter (per 21 CFR 870.1250) |
| Predicate Devices: | MICROVENA Amplatz Thrombectomy Device |
| Device Description: | The Amplatz Thrombectomy Device (ATD) is a percutaneous, rotational<br>thrombectomy device consisting of a polyurethane catheter. Inside the<br>catheter, a distal rotor housing contains a small diameter, recessed impeller,<br>attached to a drive shaft. The shaft is connected to a disposable, high speed,<br>air driven motor. An infusion line with luer connector, attached to the<br>proximal motor assembly, allows for infusion of saline through the catheter.<br>A foot pedal/regulator assembly is required to operate the air motor. |
| Intended Use: | The modified Amplatz Thrombectomy Device (ATD) is intended for use in<br>the mechanical dissolution of acute and sub-acute thrombus within dialysis<br>fistulae. |
| Functional/Safety<br>Testing: | The modified Amplatz Thrombectomy Device (ATD) device has successfully<br>undergone functional and safety testing of new design features, including<br>joint strengths, flow rate tests, burst tests, flexibility tests, device life tests,<br>maceration capability tests, and material biocompatibility tests. |
| Conclusion: | The modified Amplatz Thrombectomy Device (ATD) is substantially<br>equivalent to the predicate device. |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP | 9 ---

Ms. Janell Colley Microvena Corporation 1861 Buerkle Road 55110-5246 White Bear Lake, Minnesota

Re : K971984 Amplatz Thrombectomy Device Regulatory Class: II (two) Product Code: 74 MCW September 5, 1997 Dated: Received: September 9, 1997

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 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 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 requirement, 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 requlatory 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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Paqe 2 - Ms. Janell Colley

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" (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. Callehan

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 (if known):

Device Name:

Indications for Use:

The intended use for the device is the mechanical dissolution of acute and sub-acute thrombus within dialysis fistulae.

Ta A. R
(Division Sign-Off)

K971984

Amplatz Thrombectomy Device

. . . . . Of Cardiovascular, Respiratory, curological Device 510(k) Number.

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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)