(7 days)
The PROWLER® SELECT™ (10, 14 and PLUS) 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.
The PROWLER® SELECT™ (10, 14 and PLUS) 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 .018" and smaller for PROWLER® SELECT™ PLUS, and of 0.014" and smaller for PROWLER® SELECT™ 10 and 14, 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.
The provided document describes a medical device, the PROWLER® SELECT™ Infusion Catheter, and its safety and effectiveness summary for a 510(k) submission. It does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of an AI/algorithm-based device.
The document discusses "Design verification testing" for the PROWLER® SELECT™ PLUS Infusion Catheters. This type of testing is standard for medical devices like catheters to ensure physical characteristics and performance align with design specifications. The tests listed are entirely related to the physical properties and functionality of the catheter itself, not to an algorithm's performance.
Therefore, I cannot provide the requested information for acceptance criteria and a study proving an AI device meets them based on the provided text. The document is for a physical medical device, not an AI or algorithmic device.
However, I can extract the information about the device verification testing that was performed for this specific catheter system:
Summary of Device Verification Testing (Not AI-related Acceptance Criteria)
| Acceptance Criteria (Measured Performance) | Reported Device Performance (as stated in document) |
|---|---|
| Outer Diameter Dimension Inspection (pre-coating) | Performed as intended |
| Visual Inspection | Performed as intended |
| Flexible Coil Length Inspection/Distal Zone Length Inspection | Performed as intended |
| Lateral Stiffness | Performed as intended |
| Trackability | Performed as intended |
| Joint Pull Test | Performed as intended |
| Static Burst Testing | Performed as intended |
| Biocompatibility | All materials used are biocompatible |
Regarding the other requested points (for an AI/algorithmic device):
The provided text does not contain any of the following information because it pertains to a physical medical device (catheter) and not an AI or algorithmic system:
- Sample size used for the test set and data provenance
- Number of experts used to establish ground truth for the test set and their qualifications
- Adjudication method for the test set
- Multi-reader multi-case (MRMC) comparative effectiveness study or effect size
- Standalone (algorithm only) performance
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
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MAY 2 2 2002
Attachment 4
.
12 11
0-000025
Summary of Safety and Effectiveness
| Submitter'sName/ContactPerson | 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) 313-6480May 14, 2002 |
|---|---|
| Trade Name /Common Name | Trade Name: PROWLER® SELECT™ (10, 14 and PLUS) Infusion Catheters with andwithout pre-shaped tipsCommon/Classification Name: Catheters, Continuous Flush |
| Classification | Class II |
| PerformanceStandards | The FDA under section 514 of the Food, Drug and Cosmetic Act has not establishedperformance standards. |
| Intended Use andDeviceDescription | The PROWLER® SELECT™ (10, 14 and PLUS) 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), forGuidewire Exchange/Support, and for superselective angiography of the peripheral andcoronary vasculatures. |
| DeviceDescription | The PROWLER® SELECT™ (10, 14 and PLUS) Infusion Catheters with and without pre-shaped tips are a single lumen catheter featuring a stiff proximal shaft and a flexible distalsection. The catheter's inner diameter accommodates guidewires of .018" and smaller forPROWLER® SELECT™ PLUS, and of 0.014" and smaller for PROWLER® SELECT™ 10and 14, depending on the catheter type. The catheter body is radiopaque with one or twodistinguishable marker(s) at the distal tip. It includes a hydrophilic coating on the outside ofthe shaft as well as a PTFE liner on the inner lumen. |
Continued on next page
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Summary of Safety and Effectiveness, Continued
0-000026
| Device | Company | 510 (k) Number | Product Code |
|---|---|---|---|
| PROWLER® InfusionCatheters | Cordis Neurovascular,Inc. | K965181K972518 | 74KRA |
| PROWLER® PLUSInfusion Catheters | Cordis Neurovascular,Inc. | K993266 | 74KRA |
| PROWLER® InfusionCatheters with pre-shapedtips | Cordis Neurovascular,Inc. | K003925 | 74KRA |
| PROWLER® SELECTTM10 and 14 InfusionCatheters with and withoutpre-shaped tips | Cordis Neurovascular,Inc. | K020680 / 3/27/02 | 74KRA |
The predicate devices are listed in the table below: Predicate Devices
Summary of Studies
Design verification testing demonstrated that the PROWLER® SELECT™ PLUS 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, 14 and PLUS) Infusion Catheters with and without pre-shaped tips are biocompatible.
Summary of Substantial Equivalence
The PROWLER® SELECT™ (10, 14 and PLUS) Infusion Catheters with and without preshaped tips are substantially equivalent to the predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 2 2002
Ms. Maritza Celaya Cordis Neurovascular, Inc. 14000 N.W. 57th Court Miami Lakes, FL 33014
Re: K021591
PROWLER® SELECT™ PLUS Infusion Catheters with and without pre-shaped tips Regulation Number: 870.1210 Regulation Name: Continous Flush Catheter Regulatory Class: Class II (two) Product Code: 74 KRA Dated: May 14, 2002 Received: May 15, 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.
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
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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,
N. Deetun
Donna-Bea Tillman, Ph.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 I of Effective Date: 11/15/00
Cordis
a fohnson-fohnson company
Page 1 of 1
510(k) Number (if known): Ko2159 |
Device Name: PROWLER® SELECT™ (10, 14 and PLUS) Infusion Catheters (with and without pre-shaped tips)
Indications for Use Statement
The PROWLER® SELECT™ (10, 14 and 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.
(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
Division of Cardiovascular & Respiratory Devices
510(k) Number K021597
OR
Prescription 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).