ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD, MODELS PT-45509 (CATHETER KIT WITH INTRODUCER SHEATHS),PT-65

K990829 · Arrow Intl., Inc. · MCW · May 4, 1999 · Cardiovascular

Device Facts

• Record ID: K990829
• Device Name: ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD, MODELS PT-45509 (CATHETER KIT WITH INTRODUCER SHEATHS),PT-65
• Applicant: Arrow Intl., Inc.
• Product Code: MCW · Cardiovascular
• Decision Date: May 4, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4875
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Arrow-Trerotola™ Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit (PT-03000-R), permits mechanical declotting of synthetic dialysis grafts.

Device Story

The Arrow-Trerotola PTD is a sterile, single-use 5 Fr. x 65cm rotatable catheter featuring a self-expanding 9mm fragmentation basket. It connects to a hand-held, disposable Arrow Rotator Drive Unit (PT-03000-R) operating at 3000 RPM. The device is inserted into a thrombosed synthetic dialysis graft via an introducer sheath. Upon deployment, the basket expands to conform to the graft wall. Activation of the rotator spins the basket, which is then withdrawn through the graft to macerate the thrombus. The resulting homogenized clot is subsequently aspirated from the graft through the introducer sheath. The device is intended for use by clinicians in a clinical setting to restore graft patency, potentially benefiting patients by avoiding more invasive surgical interventions.

Clinical Evidence

Bench testing only. Performance testing included basket/cable tensile and torque tests, fatigue testing, cable torque transmission, friction testing, and simulated use testing for basket speed and abrasion.

Technological Characteristics

5 Fr. outer sheath; inner cable; self-expanding fragmentation basket. Energy source: hand-held disposable rotator drive unit (3000 RPM). Sterile, single-use. Mechanical fragmentation principle.

Indications for Use

Indicated for mechanical declotting of synthetic dialysis grafts in patients requiring thrombus removal.

Regulatory Classification

Identification

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

Predicate Devices

• Arrow-Trerotola™ Percutaneous Thrombolytic Device (PTD)

Submission Summary (Full Text)

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5/4/99

K990829

Special 510(k): Device Modification Arrow-Trerotola™ Percutaneous Thrombolytic Device

## ATTACHMENT 1 - 510(K) SUMMARY

Submitter

Arrow International, Inc. 2400 Bernville Road Reading. PA 19605 610-378-0131

Contact Person:

Thomas D. Nickel Vice President, Regulatory Affairs and Quality Assurance 610-478-3137

Summary prepared: March 10, 1999

Device Name

Arrow-Trerotola™ Percutaneous Thrombolytic Device or "PTD" - Class II at 21 CFR 870.5150, Embolectomy catheter.

Legally marketed predicate device

Arrow-Trerotola™ Percutaneous Thrombolytic Device or "PTD".

Device description

The device is a 5 Fr. X 65cm sterile, single use rotatable catheter with a 9mm fragmentation basket.

Intended use of the device

The Arrow-Trerotola™ Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit (PT-03000-R), permits mechanical declotting of synthetic dialysis grafts.

Technological characteristics

The design of the Arrow-Trerotola PTD™ consists of a 5 Fr. outer sheath with and inner cable connected to a self-expanding fragmentation basket. The device is attached to a hand-held, disposable rotator drive unit that spins at 3000-RPM. The catheter is placed into the thrombosed graft via an introducer sheath. Once placed inside the clotted graft, the basket is deployed to expand and conform to the graft wall. The rotator is then activated and the spinning basket is withdrawn through the graft to macerate the thrombus. The homogenized clot can then be aspirated from the graft via the introducer sheaths.

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## Special 510(k): Device Modification Arrow-Trerotola™ Percutaneous Thrombolytic Device

The modified device has the same technological characteristics as the predicate.

The performance test information in the submission includes:

1) Basket cap -- basket wires tensile/torque test

2) Basket sleeve -- basket wires tensile/torque test

3) Basket sleeve - torque cable tensile/torque test

4) Torque cable tensile/torque test

5) Torque cable drive hub tensile/torque test

6) Outer catheter sleeve mold tensile test

7) Outer catheter extrusion tensile/torque test

8) Extrusion tip tensile test

9) Basket/cable fatigue simulated use test

10) Cable torque transmission test

11) Cable/catheter friction tensile test

12) Basket speed in radius simulated use test

13) Basket abrasion simulated use test

The results of the laboratory tests demonstrated that the device modification is as safe, and as effective as the legally marketed predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird with three horizontal lines forming the body and two curved lines representing the legs or feet.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

4 1999 MAY

Mr. Thomas D. Nickel Vice President Regulatory Affairs and Quality Assurance Arrow International, Inc. 2400 Bernville Road Reading, PA 19605

Re: K990829 Trade Name: Arrow-Trerotola™ PTD Percutaneous Thrombolytic Device Regulatory Class: II Product Code: MCW Dated: April 16, 1999 Received: April 20, 1999

Dear Mr. Nickel:

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 Requlation (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 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

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Paqe 2 - Mr. Thomas D. Nickel

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 leqally 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 requlation (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 requlation 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. Callahon

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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P.O. Box 12888 Reading, PA 19612

Image /page/4/Picture/2 description: The image shows the logo for Arrow International. The word "ARROW" is in large, bold, sans-serif font. Below it, in a smaller font, is the word "INTERNATIONAL". The logo is in black and white.

2400 Bernville Road Reading, PA 19605

[phone] FAX: [phone]

## SECTION 12 -- INDICATIONS FOR USE STATEMENT

Device Name

Arrow-Trerotola™ Percutaneous Thrombolytic Device (PTD) Catheter.

Indications for Use

The Arrow-Trerotola™ Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit (PT-03000-R), permits mechanical declotting of synthetic dialysis grafts.

J. Gabriel for Slocen

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices GJITY 510(k) Number