(24 days)
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.
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.
The provided document, K093286, is a 510(k) Summary for the PowerCross™ .018" OTW PTA Dilatation Catheter. This type of submission is for medical device clearance, demonstrating substantial equivalence to a legally marketed predicate device, rather than a clinical study evaluating AI performance. Therefore, many of the requested criteria related to AI studies, like sample sizes for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable to this document.
The document primarily focuses on bench testing to support the claim of substantial equivalence.
Here's a breakdown of the applicable information:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device (a PTA Dilatation Catheter), the "acceptance criteria" are typically the successful completion of various bench tests demonstrating physical and performance characteristics, and the "reported device performance" is the successful outcome of those tests, showing the device meets its design specifications and is comparable to predicate devices. Specific quantitative criteria and results are generally not detailed in the 510(k) summary but would be found in the full 510(k) submission.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Bench Testing | Conformance to requirements for its intended use, demonstrating substantial equivalence to predicate devices. Specific tests would include (but are not limited to) burst pressure, guidewire compatibility, shaft tensile strength, balloon inflation/deflation, tip tensile strength, bond strength, flexural rigidity, marker band visibility, lubricity, etc. The summary states "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." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the 510(k) summary, as this refers to bench testing of the device itself, not a clinical study involving a test set of data. The "test set" in this context would be the physical devices manufactured and subjected to various engineering tests.
- Data Provenance: Not applicable in the context of data used for an AI algorithm. The performance data is from bench testing of the manufactured medical device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth as typically defined for AI algorithms (e.g., expert labels on images) is not relevant to a 510(k) summary for a physical medical device based on bench testing. The "ground truth" for device performance is typically engineering specifications and established test methodologies.
4. Adjudication method for the test set
- Not applicable. "Adjudication method" usually refers to reconciling differences among expert annotators in an AI study. This submission is about a physical device and its engineering performance.
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
- No. An MRMC study is specific to AI-assisted interpretation tasks. This submission is for a physical medical device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No. This applies to AI algorithms, not a PTA dilatation catheter.
7. The type of ground truth used
- The "ground truth" for this device's performance is established by engineering specifications and validated bench test methods. For example, a balloon must inflate to a certain diameter at a certain pressure without bursting, and this is verified through specific tests.
8. The sample size for the training set
- Not applicable. There is no AI training set involved in this submission.
9. How the ground truth for the training set was established
- Not applicable. There is no AI training set involved in this submission.
Summary of the Study (Bench Testing):
The study was not a clinical trial or an AI performance study. It was a series of bench tests conducted to evaluate the physical and functional performance of the PowerCross™ .018" OTW PTA Dilatation Catheter. The purpose of these tests was to demonstrate that the proposed device performs as intended and is "substantially equivalent" to already legally marketed predicate devices (NanoCrossTM .014" OTW PTA Dilatation Catheter (K090849) and EverCrossTM .035" OTW PTA Dilatation Catheter (K082579)). The 510(k) summary states that "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." The specific details of these bench tests (e.g., number of devices tested for each parameter, the exact test protocols) are not included in the provided summary but would be part of the full 510(k) submission.
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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 isbeing submitted in accordance with the requirements of 21 CFR§ 807.92. |
|---|---|
| Applicant | ev3 Inc. |
| Submitter | ev3 Inc.3033 Campus DrivePlymouth, MN 55441Tel: 763-398-7000Fax: 763-591-3248 |
| Contact Person | Sara BakkerRegulatory 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 isintended to dilate stenoses in the iliac, femoral, ilio-femoral,popliteal, infra-popliteal, and renal arteries, and for thetreatment of obstructive lesions of native or syntheticarteriovenous dialysis fistulae. This device is also intended forstent post-dilatation. |
| Device Description | The PowerCrossTM .018" OTW PTA Dilatation Catheter is anover the wire (OTW) 0.018" coaxial catheter with a distallymounted semi-compliant inflatable balloon and an atraumatictapered tip. The distal portion of the catheter has a hydrophiliccoating. The manifold includes a lumen marked "THRU". Thisis the central lumen of the catheter, which terminates at thedistal tip. This lumen is used to pass the catheter over aguidewire with a maximum diameter of 0.018". The lumenmarked "BALLOON" is the balloon inflation lumen, which isused to inflate and deflate the dilatation balloon with a mixtureof contrast medium and saline solution. The balloon has tworadiopaque markers for positioning the balloon relative to thestenosis. The radiopaque marker bands indicate the dilating orworking section of the balloon. On the 150 and 200 mm devices,two additional marker bands denote the middle of the balloonbody. The PowerCross .018" OTW PTA Dilatation Catheter isavailable in multiple balloon sizes. Nominal balloon diameterand 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 SubstantialEquivalence | 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.
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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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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)
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Number K093286
§ 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).