The PROWLER® SELECT™ Infusion Catheters are intended to be used as a mechanism for the infusion of various diagnostic, embolic, and therapeutic agents into the vascular systems (Neuro, Peripheral, Coronary), for Guidewire Exchange/Support, and for superselective angiography of the peripheral and coronary vasculatures.

Device Description

The PROWLER® SELECT™ 10 and 14 Infusion Catheters with and without pre-shaped tips are a single lumen catheter featuring a stiff proximal shaft and a flexible distal section. The catheter's inner diameter accommodates guidewires of .014" and smaller depending on the catheter type. The catheter body is radiopaque with one or two distinguishable marker(s) at the distal tip. It includes a hydrophilic coating on the outside of the shaft as well as a PTFE liner on the inner lumen.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the PROWLER® SELECT™ Infusion Catheters.

It's important to note that this document is a 510(k) Premarket Notification, which primarily demonstrates substantial equivalence to a legally marketed predicate device. This type of submission relies heavily on non-clinical performance data and often does not involve the extensive clinical trials or human reader studies typically associated with novel AI-powered diagnostic devices.

The information provided describes a medical device (infusion catheters), not an AI/ML-powered diagnostic device. Therefore, many of the requested categories related to AI/ML device studies (like MRMC efficacy, expert-established ground truth for AI, standalone algorithm performance, training set details) are not applicable to this document.

Acceptance Criteria and Study for PROWLER® SELECT™ Infusion Catheters

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list "acceptance criteria" in a quantified, pass/fail manner for each test. Instead, it states that "Design verification testing showed that the PROWLER® SELECT™ 10 and 14 Infusion Catheters with and without pre-shaped tips performed as intended" and "No new questions of safety and effectiveness were raised." This implies that the tests were performed and the results met the design specifications and internal performance requirements, which constitute the implicit acceptance criteria for such a device. These are primarily engineering and mechanical performance tests.

Acceptance Criteria (Implicit)	Reported Device Performance
Outer Diameter Dimension meets specifications (pre-coating)	Performed as intended (implies specifications were met).
Visual Inspection meets quality standards	Performed as intended (implies standards were met, e.g., no defects, correct markings).
Flexible Coil Length / Distal Zone Length meets specifications	Performed as intended (implies specifications were met).
Lateral Stiffness meets specifications	Performed as intended (implies specifications were met for proper navigation and support).
Trackability meets specifications	Performed as intended (implies specifications were met for smooth advancement through vascular pathways).
Joint Pull Strength meets safety specifications	Performed as intended (implies joints did not fail under specified force, preventing detachment of components).
Static Burst Pressure tolerance meets safety specifications	Performed as intended (implies the catheter can withstand internal pressure during infusion without bursting).
Biocompatibility	All materials used... are biocompatible (implies materials passed relevant biocompatibility tests as per ISO 10993 or equivalent).
Substantial Equivalence to Predicate Devices	The PROWLER® SELECT™ 10 and 14 Infusion Catheters with and without pre-shaped tips are substantially equivalent to the predicate devices. (This is the overarching acceptance criterion for the 510(k), demonstrated by the performance testing).

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document does not specify the exact sample sizes (number of units) used for each design verification test. It refers generally to "Design verification testing."
Data Provenance: The tests are described as "Design verification testing," which refers to in-house laboratory testing conducted by the manufacturer (Cordis Neurovascular, Inc.). This is retrospective data collected during the device's design and development phase for regulatory submission. There is no indication of country of origin for the data other than the manufacturer's location in Miami Lakes, Florida, USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not Applicable. This is a physical medical device (catheter), and the "ground truth" for its performance is established through engineering specifications, validated test methods, and industry standards, not by expert consensus on clinical data or images. The "experts" involved would be the design engineers, quality control personnel, and potentially materials scientists from Cordis Neurovascular, Inc.

4. Adjudication Method for the Test Set

Not Applicable. As the tests are non-clinical engineering and materials performance tests, there is no adjudication process involving multiple human evaluators or a consensus process in the sense of clinical decision-making. The results are based on objective measurements against pre-defined specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is not relevant to the evaluation of a physical medical device like an infusion catheter, as it is designed to assess the performance of diagnostic devices or algorithms with human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No. This is not an algorithm or AI-powered device, so standalone algorithm performance testing is not applicable.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on engineering specifications, validated test methods, and compliance with recognized industry standards (e.g., for biocompatibility, material properties, and mechanical performance). It is not pathology, outcomes data, or expert consensus in a clinical diagnostic sense. The ultimate "ground truth" for a 510(k) submission is substantial equivalence to a predicate device.

8. The Sample Size for the Training Set

Not Applicable. This is not an AI/ML device, so there is no "training set." Device design and manufacturing processes are refined through iterative development and testing, rather than machine learning training.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. As there is no training set, this question is not relevant.

Summary

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Attachment 4

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MAR 2 7 2002

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Summary of Safety and Effectiveness

Submitter's Name/Contact Person	The submitter of this special 510(k) is:Cordis Neurovascular, Inc.14000 N.W. 57th CourtMiami Lakes, Florida 33014Establishment Registration No. 1058196Contact: Maritza CelayaSr. Regulatory Affairs AssociateTel: (786) 313-6546Fax: (786) 313-6480March 1, 2002
Trade Name / Common Name	Trade Name: PROWLER® SELECT™ 10 and 14 Infusion Catheters with and without pre-shaped tipsCommon/Classification Name: Catheters, Continuous Flush
Classification	Class II
Performance Standards	The FDA under section 514 of the Food, Drug and Cosmetic Act has not established performance standards.
Intended Use and Device Description	The PROWLER® SELECT™ Infusion Catheters with and without pre-shaped tips are intended to be used as a mechanism for the infusion of various diagnostic, embolic, and therapeutic agents into the vascular systems (Neuro, Peripheral, Coronary), for Guidewire Exchange/Support, and for superselective angiography of the peripheral and coronary vasculatures.
Device Description	The PROWLER® SELECT™ 10 and 14 Infusion Catheters with and without pre-shaped tips are a single lumen catheter featuring a stiff proximal shaft and a flexible distal section. The catheter's inner diameter accommodates guidewires of .014" and smaller depending on the catheter type. The catheter body is radiopaque with one or two distinguishable marker(s) at the distal tip. It includes a hydrophilic coating on the outside of the shaft as well as a PTFE liner on the inner lumen.

Continued on next page

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The predicate devices are listed in the table below: Predicate Devices

Device	Company	510 (k) Number	Product Code
PROWLER®Infusion Catheters	Cordis Neurovascular,Inc.	K965181 K972518	74KRA
PROWLER® PLUSInfusion Catheters	Cordis Neurovascular,Inc.	K993266	74KRA
PROWLER®Infusion Catheterswith pre-shaped tips	Cordis Neurovascular,Inc.	K003925	74KRA

Summary of Studies

Design verification testing showed that the PROWLER® SELECT™ 10 and 14 Infusion Catheters with and without pre-shaped tips performed as intended. No new questions of safety and effectiveness were raised. Design verification testing included:

. Outer Diameter Dimension Inspection (pre-coating)
Visual Inspection .
. Flexible Coil Length Inspection/Distal Zone Length Inspection
Lateral Stiffness .
. Trackability
Joint Pull Test .
Static Burst Testing .

All materials used in the PROWLER® SELECT™ 10 and 14 Infusion Catheters with and without pre-shaped tips are biocompatible.

Summary of Substantial Equivalence

The PROWLER® SELECT™ 10 and 14 Infusion Catheters with and without pre-shaped tips are substantially equivalent to the predicate devices.

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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 image of three human profiles facing right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 7 2002

Ms. Maritza Celaya Sr. Regulatory Affairs Associate Cordis Neurovascular, Inc. 14000 N.W. 57th Court Miami Lakes, FL 33014

Re: K020680

PROWLER® SELECT™ 10 and 14 Infusion Catheters with and without preshaped tips Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II (two) Product Code: KRA Dated: March 1, 2002 Received: March 4, 2002

Dear Ms. Celaya:

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 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 (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 - Ms. Maritza Celaya

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) 594-4586. 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 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,

Elias Mallis

Ron

Bram Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Cordis Franchise Form - CFF 20-014 Rev.01 Intended Use Statement

Page 1 of 10 - 0 0 0 Effective Date: 11/15/00

Page 1 of 1

510(k) Number (if known): K020680

Device Name: PROWLER® SELECT™ 10 and 14 Infusion Catheters (with and without pre-shapes)

Indications for Use Statement

The PROWLER® SELECT™ Infusion Catheters are intended to be used as a mechanism for the interiment of variousing of vailouire I he F N W HER SEELCY - Intelsion Catents into the vascular systems (Neuro, Peripheral, Coronary), for Guidewire diagnoste, ontoone, and therepount and ingraphy of the peripheral and coronary vasculatures.

Division of Cardiovascular & Respiratory Devices 510(k) Number 112200 mostis Kozo680

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ✓

Over-The-Counter Use

Regulation Number and Section

§ 870.1210 Continuous flush catheter.

(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).