(28 days)
The Prowler Plus 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.
The Prowler Plus is a single lumen catheter featuring a stiff proximal shaft and a flexible distal section. The catheter's inner diameter accommodates guidewires of .018" and smaller. The catheter body is radiopaque with a distinguishable marker 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.
The provided text describes the Prowler Plus Infusion Catheter and its summary of safety and effectiveness, including a statement of substantial equivalence to predicate devices. However, it does not contain specific acceptance criteria with numerical targets, nor does it detail a study with reported device performance against such criteria in the format typically used for medical device efficacy or AI performance evaluation. The information provided is for a traditional medical device (catheter), not an AI/ML-enabled device.
Therefore, many of the requested sections (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set size) are not applicable or cannot be extracted from the given document, as these pertain to studies typically conducted for AI/ML device validation.
Based on the provided text, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria. Instead, it states that "Design verification testing showed that the Prowler Plus Infusion Catheter performs as well or better than the predicate devices tested." This implies an equivalence or non-inferiority standard, but specific numerical targets are not provided. The performance is described qualitatively as meeting this standard.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Performs as well as or better than predicate devices (Cordis Endovascular Systems, Inc. Prowler Infusion Catheter, and Rapid Transit Infusion Catheter) | Performs as well or better than the predicate devices tested. No new questions of safety and effectiveness were raised. |
The design verification tests included:
- Pull Strength Test
- Trackability Test
- Dimensional Testing (Tip OD, ID, Body OD, Joint OD, Length Assembly, Hub Taper)
- Static Burst Pressure Test
- Alternative Flow Rate Calculation
- Air Aspiration
- Linear Stiffness Test (Boink)
- Shapeability Test
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the document. The "Summary of Studies" only lists the types of tests performed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not applicable and not provided. The device is a physical catheter, and its performance is evaluated through engineering design verification tests, not clinical studies requiring expert ground truth or AI/ML model evaluation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable and not provided. It relates to studies typically conducted for AI/ML device validation.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC study was not done, as this is a physical medical device (catheter), not an AI/ML system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study a it is a physical medical device (catheter), not an AI/ML system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for a physical device like a catheter is the engineering specification and performance standards derived from predicate devices, verified through physical and mechanical testing.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical device.
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Attachment 4
Summary of Safety and Effectiveness
| GeneralProvisions | Trade Name: Prowler Plus Infusion CatheterCommon/Classification Name: Infusion Catheter |
|---|---|
| Name ofPredicateDevices | Cordis Endovascular Systems, Inc. Prowler Infusion Catheter, and RapidTransit Infusion Catheter. |
| Classification | Class II |
| PerformanceStandards | The FDA under section 514 of the Food, Drug and Cosmetic Act has not establishedperformance standards. |
| Intended Useand DeviceDescription | The Prowler Plus Infusion Catheters are intended to be used as a mechanism for theinfusion of various diagnostic, embolic, and therapeutic agents into the vascularsystems (Neuro, Peripheral, Coronary), for Guidewire Exchange/Support, and forsuperselective angiography of the peripheral and coronary vasculatures.The Prowler Plus is a single lumen catheter featuring a stiff proximal shaft and aflexible distal section. The catheter's inner diameter accommodates guidewires of |
| Summary ofStudies | .018" and smaller. The catheter body is radiopaque with a distinguishable marker atthe distal tip. It includes a hydrophilic coating on the outside of the shaft as well as aPTFE liner on the inner lumen.Design verification testing showed that the Prowler Plus Infusion Catheter performs as well orbetter than the predicate devices tested. No new questions of safety and effectiveness wereraised. Design verification testing included:• Pull Strength Test• Trackability Test• Dimensional Testing (Tip OD, ID, Body OD, Joint OD, Length Assembly, Hub Taper)• Static Burst Pressure Test• Alternative Flow Rate Calculation• Air Aspiration• Linear Stiffness Test (Boink)• Shapeability Test |
| Biocompatibility | All materials used in the Prowler Plus Infusion Catheters are biocompatible. |
| Summary ofSubstantialEquivalence | The Prowler Plus Infusion Catheters are substantially equivalent to the previouslycleared Prowler and Rapid Transit Infusion Catheters. |
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes representing the department's mission of promoting health, well-being, and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 8 1999
Ms. Maritza Celaya Sr. Regulatory Affairs Specialist Cordis Endovascular SystemS, Inc. p.o. Box 025700 Ct. Miami Lakes, FL 33102-5700
Re: K993266 K993266
Trade Name: Prowler Plus Infusion Catheter Regulatory Class: II Product Code: KRA Dated: September 29, 1999 September 30, 1999 Received:
Dear Ms. Celaya:
We have reviewed your Section 510(k) notification of intent to market the f
actived by the becale boys determined the device is We have reviewed your securer state determined the device is device referenced above and we nave associons for use stated in the substantially equivalent (10) the indites marketed in interstate enclosure) to legally marketed breatment date of the Medical Device commerce prior to May 28, 1976, the encements assisted in accordance with Amendments, or to devices that nave been, and Cosmetic Act (Act). You
the provisions of the Federal Food, Drug, and Cosmeral controls the provisions of the rederal rood, bray and the general controls
may, therefore, market the device, subject to the Act may, therefore, market the device, busferols provisions of the Act
provisions of the Act. The general controls provisions of provisions of the Act. The general concross productions of devices, good
include requirements for annual registration, against misbranding include requirements for annual registration, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special If your device is classified (see aboro), it may be subject to such Controls) or class III (reliminer regions affecting your device additional controls. Extrema Requires Title 21, Parts 800 to
can be found in the Code of Federal Requires compliance with e found in the Code of rederal Requirement compliance with 895. 895. A substantially equivalence active requirements, as set forth in the Current General regulation the Current Good Manufacturing Frassis al Devices: General regulation Quality System Regulation (QS) Lockidations inspections, the Food and (21 CFR Part 820) and that, through percula assumptions . Failure to comply
Drug Administration (FDA) will verify such assumptions. In addition, Drug Administration (FDA) will versily bagulatory action. In addition,
with the GMP regulation may result in regulation your device in the with the GMP regulation may rebare in concerning your device in the
FDA may publish further announcements concern to your premarket FDA may publish further announces to your premarket.
Federal Register. Please note: this response thirstion you might rederal Rediscer. Prease noce. Enterespection you might have
notification submission does not affect any for douices notification basmissions of the Act for devices
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Paye 2 - Ms. Maritza Celaya
under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in This fecter will arrow you oo begin to the FDA finding of substantial your 510(k) prematics. I legally marketed prodicate device results
equivalence of your device to a legally marketed with mown device to equivalence of your device to a regulary
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 in II you desire speciele additionally 809.10 for in vitro diagnostic (21 CFR Part over and addressions)
devices), please contact the Office of Compliance at (301) 594-4586. devices), prease concacions on the promotion and advertising of your Additionally, for questions on the primeses (301) 594-4639. Also, as a regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on premarket nocification (arch over may be obtained from the Division of your responsibilities under ens tool -----------------------------------------------------------------------------------------------------------------------------------------(301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
At. A. LiachowsL.
Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Attachment 2
| 510(k) Number(if known) | The 510(k) number has not yet been assigned. |
|---|---|
| Device Name | Prowler Plus Infusion Catheters. |
| Indications forUse | The Prowler Plus Infusion Catheters are intended to be used as a mechanism for theinfusion of various diagnostic, embolic, and therapeutic agents into the vascularsystems (Neuro, Peripheral, Coronary), for Guidewire Exchange/Support, and forsuperselective angiography of the peripheral and coronary vasculatures. |
Indications for Use Statement
PLEASE DO NOT WRITE BEI.OW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEFDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Christopher Witten.
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K993266
× Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
§ 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).