The Arrow-Trerotola™ Percutaneous Thrombolytic Device (PTD™) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous fistulae and synthetic dialysis grafts.

Device Description

The Arrow-Trerotola™ PTD™ Catheter Assembly consists of two components, an outer cover sheath and an inner flexible torque cable with a self-expanding fragmentation basket attached to its distal end. The PTD™ fragmentation basket is constructed of four wires that are formed into a helical cage with a soft, flexible tip located on its distal end. The PTD™ catheter is designed to be used in conjunction with the Arrow Rotator Drive Unit that spins the basket at approximately 3000rpm. A drive hub on the proximal end of the catheter assembly mates with a drive gear in the Rotator Drive Unit. The cable stop on the catheter assembly secures the PTD™ Catheter to the Rotator Unit during operation.

The PTD™ outer sheath moves relative to the inner torque cable and is used to collapse and expand the fragmentation basket. The catheter is placed inside the clotted fistula with the basket in the closed position. After insertion, the basket is fully deployed inside the fistula to conform to the fistula wall. The basket is then rotated which pulverizes the clot; the clot is aspirated from the graft through an introducer sheath.

The PTD™ catheter is manufactured in two lengths, 65cm and 120cm, with a basket diameter of 9mm. It is also available in an Over-The-Wire (OTW) version, which allows the device to be passed over a guidewire.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided documents. Please note that the documents are primarily a 510(k) summary and FDA clearance letters, which focus on demonstrating substantial equivalence to a predicate device rather than providing detailed clinical trial results with specific performance metrics and rigorous statistical analysis often seen in PMAs or later clinical studies.

Therefore, much of the requested information (like specific effect sizes for human readers, detailed ground truth establishment for training sets, or exact sample sizes for training) is not explicitly stated in these 510(k) documents.

Acceptance Criteria and Reported Device Performance

The documentation focuses on demonstrating substantial equivalence to a predicate device for an expanded indication for use (native arterio-venous fistulae). The implication is that if the device performs comparably to the predicate for this new indication, it meets the acceptance criteria for safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Safe and effective for mechanical declotting	As safe and effective as the legally marketed predicate device.
Comparable technological characteristics to predicate device	The proposed device has the same technological characteristics as the predicate device.
Performance for expanded indication (native AV fistulae)	Clinical data presented in the performance section supports this indication.

Explanation of Implied Criteria: In a 510(k) submission, the primary "acceptance criterion" is often demonstrating substantial equivalence to a device already legally marketed. This means showing that the new device is as safe and effective as the predicate, often through comparable technological characteristics and, if necessary, performance data supporting any expanded or modified indications. Specific numerical performance metrics (like sensitivity, specificity, accuracy) are less common in 510(k)s unless there's a significant technological change or a new "unmet need" being addressed that requires new performance endpoints.

Study Details

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not explicitly stated in these documents. The submission mentions "clinical data presented in the performance section," but does not provide the specific number of patients or cases used.
Data Provenance: Not explicitly stated. It's generally assumed to be retrospective analysis of existing clinical experience or a prospective study, but the document doesn't specify. The country of origin is also not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not explicitly stated. The 510(k) summary refers to "clinical data," implying expert interpretation and assessment, but details about the number and qualifications of experts involved in establishing ground truth for this clinical data are absent.

4. Adjudication method

Not explicitly stated. Given the nature of a 510(k) submission and the focus on "clinical data," it's plausible that standard clinical practice and expert consensus would have been used to determine outcomes, but the specific adjudication method is not described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done

No, not specified. The document does not mention an MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. The device described (Arrow-Trerotola PTD) is a mechanical device, not an AI-powered diagnostic tool, so an MRMC study in the context of "human readers improve with AI" would not be relevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

N/A. This device is a physical, mechanical thrombolytic device. It does not have an "algorithm-only" or "standalone AI" component in the way a diagnostic AI software would. Its performance is intrinsically linked to human execution and interaction.

7. The type of ground truth used

Implied Clinical Outcomes/Diagnosis: The "clinical data" likely refers to patient outcomes and successful declotting as determined by clinical assessment (e.g., patency of the fistula, resolution of symptoms, absence of complications). This would be based on expert medical diagnosis and follow-up.

8. The sample size for the training set

N/A. There is no "training set" in the context of an AI/machine learning model, as this is a mechanical device. The development process would involve engineering design, bench testing, and potentially pre-clinical (animal) studies, followed by clinical evaluation.

9. How the ground truth for the training set was established

N/A. As above, no training set in the AI sense. The "ground truth" for the device's design and engineering would be based on principles of fluid mechanics, material science, and medical best practices for thrombus removal, established through engineering validation and pre-clinical testing.

Summary

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October 8, 2021

Arrow Intl., Inc. Thomas Nickel Vice President RA 2400 Bernville Rd. Reading, Pennsylvania 19605

Re: K011056

Trade/Device Name: Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEW

Dear Thomas Nickel:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated October 24. 2001. Specifically, FDA is updating this SE Letter as an administrative correction because FDA has created a new product code to better categorize your device technology.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Gregory O'Connell, OHT2: Office of Cardiovascular Devices, (301) 796-6075, Gregory.Oconnell(@FDA.HHS.gov.

Sincerely,

Digitally signed by Gregory W. Gregory W. O'connell - o'connell -s Date: 2021.10.08 S 10:17:52 -04'00'

Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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OCT 2 4 2001

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: K011056

Trade Name: Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II (two) Product Code: DXE Dated: July 27, 2001 Received: July 31, 2001

Dear Mr. Nickel:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The rou may, increase or visions 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Thomas D. Nickel

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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 regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,

R. James E. Dillard III

James B. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Premarket Notification: Arrow-Trerotola™ Percutaneous Thrombolytic Device

SECTION 12. INDICATIONS FOR USE STATEMENT

KO11056 510(k) Number

Device Name: Arrow-Trerotola™ Percutaneous Thrombolytic Device (PTD™)

Indications For Use: The Arrow-Trerotola™ Percutaneous Thrombolytic Device (PTD™) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous fistulae and synthetic dialysis grafts.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number K011056

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KOII056

OCT 2 4 2001

510(k) Premarket Notification: Arrow-Trerotola™ Percutaneous Thrombolytic Device

SECTION 2. 510(K) SUMMARY

P.O. Box 12888 Reading, PA 19612

ARROW
INTERNATIONAL

Submitter

Arrow International 2400 Bernville Road Reading, PA 19605

Research/Engineering 2400 Bernville Road Reading, PA 19605

(610) 378-0131 FAX: (610) 478-3188

Contact person:

Thomas D. Nickel Vice President, Regulatory Affairs and Quality Assurance Phone: (610) 478-3137 (610) 478-3172 Fax: E-mail: tom.nickel@arrowintl.com

04/03/01 Date summary prepared:

Arrow-Trerotola™ Percutaneous Thrombolytic Device (PTD™) Device trade name:

Thrombolytic device, thrombolytic catheter and PTD™ Device common name:

Class II at 21 CFR 870.5150, Embolectomy catheter Device classification

name:

Legally marketed devices to which the device is substantially equivalent:

Arrow-Trerotola™ Percutaneous Thrombolytic Device K990829

Description of device

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510(k) Premarket Notification: Arrow-Trerotola™ Percutaneous Thrombolytic Device

Intended use of the device:

Technological characteristics:

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

Performance tests:

The expanded indications for use to include native arterio-venous fistulae is based on the clinical data presented in the performance section of the submission.

Conclusions:

The Arrow-Trerotola™ PTD™ is as safe and effective as the legally marketed predicate device for the mechanical declotting of native arterio-venous fistulae.

Regulation Number and Section

§ 870.5150 Embolectomy catheter.

(a)
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.(b)
Classification. Class II (performance standards).