(53 days)
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.
The device is a 5 Fr. X 65cm sterile, single use rotatable catheter with a 9mm fragmentation basket. 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 The rotator is then activated and the spinning basket is withdrawn through the graft to macerate the thrombus.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.
Acceptance Criteria and Study for Arrow-Trerotola™ Percutaneous Thrombolytic Device (PTD) Modification
This document outlines the acceptance criteria and study proving the modified Arrow-Trerotola™ Percutaneous Thrombolytic Device (PTD) meets those criteria, based on the provided text.
The device modification is a "Special 510(k)" submission, which typically focuses on demonstrating that a modified device is as safe and effective as its legally marketed predicate device, rather than establishing de novo effectiveness against a clinical outcome. Therefore, the "acceptance criteria" here refer to the performance requirements demonstrating equivalence, and the "study" is a series of laboratory tests.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this Special 510(k) are implicitly defined by the safety and effectiveness profile of the predicate device. The performance tests conducted aimed to demonstrate that the modified device maintains this same profile. The reported performance is that the results of the laboratory tests demonstrated that the device modification is as safe, and as effective as the legally marketed predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Material Strength and Integrity:- Basket cap tensile/torque strength not reduced.- Basket wires tensile/torque strength not reduced.- Basket sleeve tensile/torque strength not reduced.- Torque cable tensile/torque strength not reduced.- Torque cable drive hub tensile/torque strength not reduced.- Outer catheter sleeve mold tensile strength not reduced.- Outer catheter extrusion tensile/torque strength not reduced.- Extrusion tip tensile strength not reduced. | All tests (tensile/torque, friction) demonstrated that the device modification is as safe and effective as the legally marketed predicate device. |
| Durability and Functionality:- Basket/cable fatigue performance maintained.- Cable torque transmission efficiency maintained.- Cable/catheter friction within acceptable limits.- Basket speed in radius maintained.- Basket abrasion characteristics maintained. | All simulated use tests (fatigue, torque transmission, friction, speed, abrasion) demonstrated that the device modification is as safe and effective as the legally marketed predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for each individual test. The phrasing "The performance test information in the submission includes" a list of 13 tests, implying that each test was conducted on a sufficient number of samples to generate reliable results.
- Data Provenance: The tests were laboratory-based ("The results of the laboratory tests demonstrated..."), conducted by Arrow International, Inc.
- Country of Origin: United States (company address is Reading, PA).
- Retrospective or Prospective: Prospective (tests were conducted specifically for this submission).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable for this type of submission. The ground truth for these engineering performance tests would be defined by established manufacturing specifications, engineering standards, and direct comparison to the predicate device, not by expert consensus in the medical sense.
4. Adjudication Method for the Test Set
Not applicable. The "adjudication" would involve engineering review and comparison to established specifications, rather than a clinical adjudication method like 2+1 or 3+1.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This submission is for a device modification and relies on engineering performance testing to demonstrate substantial equivalence to a predicate device, not a comparative effectiveness study involving human readers or clinical outcomes.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a mechanical medical device, not an AI algorithm.
7. The Type of Ground Truth Used
The ground truth used was based on engineering specifications and performance data of the legally marketed predicate device. The modified device's performance in the listed tests had to meet or exceed the performance of the predicate to demonstrate substantial equivalence in safety and effectiveness.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" as this is a mechanical device, not an AI or machine learning algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set or associated ground truth establishment process for this device as it is not an AI algorithm.
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5/4/99
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:
-
Basket cap -- basket wires tensile/torque test
-
Basket sleeve -- basket wires tensile/torque test
-
Basket sleeve - torque cable tensile/torque test
-
Torque cable tensile/torque test
-
Torque cable drive hub tensile/torque test
-
Outer catheter sleeve mold tensile test
-
Outer catheter extrusion tensile/torque test
-
Extrusion tip tensile test
-
Basket/cable fatigue simulated use test
-
Cable torque transmission test
-
Cable/catheter friction tensile test
-
Basket speed in radius simulated use test
-
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 (301) 594-4586. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
(610) 378-0131 FAX: (610) 374-5360
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
§ 870.4875 Intraluminal artery stripper.
(a)
Identification. An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)(b)
Classification. Class II (performance standards).