(24 days)
No
The device description and intended use focus on the mechanical function of a balloon catheter for dilating stenoses. There is no mention of AI, ML, image processing, or any computational analysis of data.
Yes
The device is intended to dilate stenoses and treat obstructive lesions, which are therapeutic actions to treat a medical condition.
No
The provided text describes a PowerCross .018" OTW PTA Dilatation Catheter, which is used to dilate stenoses (narrowed sections) in arteries and treat obstructive lesions. This is a therapeutic intervention, not a diagnostic process. Diagnostic devices are used to identify or characterize a medical condition.
No
The device description clearly details a physical catheter with a balloon, lumens, and radiopaque markers, indicating it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the PowerCross .018" OTW PTA Dilatation Catheter is a device used to physically dilate (widen) narrowed arteries and treat lesions in fistulae. It is a physical intervention device used within the body.
- Lack of Biological Sample Analysis: There is no mention of this device analyzing any biological samples from a patient. Its function is mechanical.
Therefore, based on the provided information, this device is a therapeutic medical device used for interventional procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The PowerCrossTM .018" OTW PTA Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also intended for stent post-dilatation.
Product codes
LIT, DQY
Device Description
The PowerCrossTM .018" OTW PTA Dilatation Catheter is an over the wire (OTW) 0.018" coaxial catheter with a distally mounted semi-compliant inflatable balloon and an atraumatic tapered tip. The distal portion of the catheter has a hydrophilic coating. The manifold includes a lumen marked "THRU". This is the central lumen of the catheter, which terminates at the distal tip. This lumen is used to pass the catheter over a guidewire with a maximum diameter of 0.018". The lumen marked "BALLOON" is the balloon inflation lumen, which is used to inflate and deflate the dilatation balloon with a mixture of contrast medium and saline solution. The balloon has two radiopaque markers for positioning the balloon relative to the stenosis. The radiopaque marker bands indicate the dilating or working section of the balloon. On the 150 and 200 mm devices, two additional marker bands denote the middle of the balloon body. The PowerCross .018" OTW PTA Dilatation Catheter is available in multiple balloon sizes. Nominal balloon diameter and length are printed on the strain relief.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, arteriovenous dialysis fistulae, peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing was performed to support a determination of substantial equivalence. Results from this testing provide assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
NanoCrossTM .014" OTW PTA Dilatation Catheter (K090849), EverCrossTM .035" OTW PTA Dilatation Catheter (K082579)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
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510(k) Summary
געעים 3 ייעוץ
PowerCross™ .018" OTW PTA Dilatation Catheter
| 510(k) Summary | This summary of 510(k) safety and effectiveness information is
being submitted in accordance with the requirements of 21 CFR
§ 807.92. |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant | ev3 Inc. |
| Submitter | ev3 Inc.
3033 Campus Drive
Plymouth, MN 55441
Tel: 763-398-7000
Fax: 763-591-3248 |
| Contact Person | Sara Bakker
Regulatory Affairs Specialist |
| Date Prepared | October 16, 2009 |
| Device Trade Name | PowerCrossTM .018" OTW PTA Dilatation Catheter |
| Device Common Name | PTA Dilatation Catheter |
| Classification Name | Catheter, Percutaneous (21 CFR 870.1250, Product Code DQY) |
| Classification Panel | Cardiovascular |
| Predicate Device | NanoCrossTM .014" OTW PTA Dilatation Catheter (K090849)
EverCrossTM .035" OTW PTA Dilatation Catheter (K082579) |
| Intended use | The PowerCrossTM .018" OTW PTA Dilatation Catheter is
intended to dilate stenoses in the iliac, femoral, ilio-femoral,
popliteal, infra-popliteal, and renal arteries, and for the
treatment of obstructive lesions of native or synthetic
arteriovenous dialysis fistulae. This device is also intended for
stent post-dilatation. |
| Device Description | The PowerCrossTM .018" OTW PTA Dilatation Catheter is an
over the wire (OTW) 0.018" coaxial catheter with a distally
mounted semi-compliant inflatable balloon and an atraumatic
tapered tip. The distal portion of the catheter has a hydrophilic
coating. The manifold includes a lumen marked "THRU". This
is the central lumen of the catheter, which terminates at the
distal tip. This lumen is used to pass the catheter over a
guidewire with a maximum diameter of 0.018". The lumen
marked "BALLOON" is the balloon inflation lumen, which is
used to inflate and deflate the dilatation balloon with a mixture
of contrast medium and saline solution. The balloon has two
radiopaque markers for positioning the balloon relative to the
stenosis. The radiopaque marker bands indicate the dilating or
working section of the balloon. On the 150 and 200 mm devices,
two additional marker bands denote the middle of the balloon
body. The PowerCross .018" OTW PTA Dilatation Catheter is
available in multiple balloon sizes. Nominal balloon diameter
and length are printed on the strain relief. |
| Performance data | Bench testing was performed to support a determination of substantial equivalence. Results from this testing provide assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. |
| Summary of Substantial
Equivalence | The PowerCross .018" OTW PTA Dilatation Catheter has the following similarities to the legally marketed NanoCross .014" and EverCross .035" OTW PTA Dilatation Catheters:
Same indicated use as EverCross (K082579), Same operating principle, Same device materials as NanoCross (K090849), Same fundamental scientific technology, Same packaging and sterilization processes. |
| Conclusion | Based on the intended use, technological characteristics, safety and performance testing, the PowerCross .018" OTW PTA Dilatation Catheter has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the legally marketed NanoCross .014" OTW PTA Dilatation Catheter (K090849) and EverCross .035" OTW PTA Dilatation Catheter (K082854). |
ev3 Corporate World Headquarters / Peripheral Vascular ● 9609 5-1n Avenue Morth ● Plynouth, MN 55442 ● Page Vof 298 7000 ev3 Europe SAS • • 106/108 rue La Boette • • 75008 Paris, France • • PH •33 156 88 59 10
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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 an abstract image of an eagle or bird-like figure with outstretched wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
NOV 1 3 2009
ev3 Inc. c/o Ms. Sara Bakker 9600 54" Avenue North Plymouth, MN 55442
Re: K093286
PowerCross 0.018" OTW PTA Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT, DQY Dated: October 16, 2009 Received: October 20, 2009
Dear Ms. Bakker:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt have reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the onerosale) to regard) the enactment date of the Medical Device Amendments, or to Conninered price to this 20, 1978, and exacted with the provisions of the Federal Food, Drug, devices that have been require approval of a premarket approval application (PMA). and Costicule Act (71ct) that ao novice, subject to the general controls provisions of the Act. The 1 ou may, mercere, market the act include requirements for annual registration, listing of general controls provisions of ractice, 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 If your device is classified (boo aco re) existing major regulations affecting your device can be may be subject to additional confroit. "Entraling may areas on to 898. In addition, FDA may found in the Oods of reactions oncerning your device in the Federal Register.
3
Page 2 – Ms. Sara Bakker
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); medical device reporting (reporting of medical or re-rated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the qualisms by oversions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please rr you aboutFDA/CentersOffices/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part note the regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the I ou may of amall Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
er R. bihner
Bram Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1_of _1
Indications for Use Statement
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: PowerCross™ .018" OTW PTA Dilatation Catheter Indications for Use:
The PowerCross .018" OTW PTA Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
unger valmin
- Sign-Off) Connof Cardiovascular Devices
Number K093286