(32 days)
The NanoCross 0.014" 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.
The NanoCross .014" OTW PTA Dilatation Catheter is an over the wire (OTW) 0.014" coaxial lumen catheter with a distally mounted semi-compliant inflatable balloon and an atraumatic, tapered tip. The distal portion of the catheter shaft and the balloon has a hydrophilic coating. The manifold includes a lumen marked "THRU". This is the central lumen of the catheter that terminates at the distal tip. This lumen is used to pass the catheter over a guidewire with a maximum outer diameter of 0.014". The lumen marked "BALLOON" is used to inflate and deflate the dilatation balloon with a solution of contrast medium and saline. 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. The 210mm balloon contains two additional radiopaque marker bands that denote the middle of the balloon body.
The provided 510(k) summary for the "NanoCross™ .014" OTW PTA Dilatation Catheter" indicates that this is a medical device clearance application, not an AI/ML-driven diagnostic device. Therefore, the information requested regarding acceptance criteria, performance metrics like sensitivity/specificity, ground truth establishment, expert adjudication, MRMC studies, and sample sizes for training/test sets is not applicable to this submission type.
Instead, this submission seeks substantial equivalence to a predicate device (NanoCrossTM .014" OTW PTA Dilatation Catheter (K082854)) based on device characteristics and bench testing.
Here's an analysis based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria in terms of performance metrics like sensitivity or specificity, as it's not a diagnostic AI/ML device. Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to a legally marketed predicate device (K082854).
The reported device performance is described as conformance to requirements for its intended use through "bench testing."
| Acceptance Criteria Category (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Substantial Equivalence | Demonstrated by similarities to predicate (K082854) across: |
| - Indicated Use | Same |
| - Operating Principle | Same |
| - Device Materials | Same |
| - Basic Catheter Design | Same |
| - Shelf Life | Same |
| - Packaging and Sterilization Processes | Same |
| Functional Performance | Bench testing performed |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This device is not an AI/ML diagnostic and therefore does not have a "test set" of patient data in the typical sense for performance evaluation. The "testing" refers to bench testing of the physical catheter.
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)
Not applicable. There is no concept of "ground truth" established by experts for this type of medical device submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no expert adjudication for a test set in this context.
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
Not applicable. This is not an AI-assisted device, so MRMC studies are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. "Ground truth" as a concept for performance evaluation of diagnostic or AI/ML systems is not relevant here. The evaluation relies on engineering principles and similarity 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.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.
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MAY - 1 2009
:
510(k) Summary
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ev3 Corporate
Image /page/0/Picture/3 description: The image shows the logo for "ev3". The logo consists of the letters "ev3" in a bold, sans-serif font. Above the letters are three circular shapes arranged in a triangular pattern. The "3" has a registered trademark symbol next to it.
NanoCross™ .014* 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.9600 54th Ave NPlymouth, MN 55442Tel: 763-398-7000Fax: 763-398-7200 |
| Contact Person | Sara BakkerRegulatory Affairs Specialist |
| Date Prepared | March 27, 2009 |
| Device Trade Name | NanoCross .014" 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 (K082854) |
| Intended use | The NanoCross .014" 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. |
| Device Description | The NanoCross .014" OTW PTA Dilatation Catheter is an overthe wire (OTW) 0.014" coaxial lumen catheter with a distallymounted semi-compliant inflatable balloon and an atraumatic,tapered tip. The distal portion of the catheter shaft and theballoon has a hydrophilic coating. The manifold includes alumen marked "THRU". This is the central lumen of the catheterthat terminates at the distal tip. This lumen is used to pass thecatheter over a guidewire with a maximum outer diameter of0.014". The lumen marked "BALLOON" is used to inflate anddeflate the dilatation balloon with a solution of contrast mediumand saline. The balloon has two radiopaque markers forpositioning the balloon relative to the stenosis. The radiopaquemarker bands indicate the dilating or working section of theballoon. The 210mm balloon contains two additionalradiopaque marker bands that denote the middle of the balloonbody. |
| Performance data | Bench testing was performed to support a determination ofsubstantial equivalence. Results from this testing provideassurance that the proposed device has been designed and testedto assure conformance to the requirements for its intended use. |
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Summary of Substantial Equivalence
The 210mm NanoCross .014" OTW PTA Dilatation Catheter has the following similarities to the legally marketed NanoCross .014" OTW PTA Dilatation Catheter:
- Same indicated use, t
- Same operating principle, . ●
- · · Same device materials,
- . Same basic catheter design,
- Same shelf life, .
- Same packaging and sterilization processes. .
Based on the intended use, technological characteristics, safety and performance testing, the 210mm NanoCross .014" 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 (K082854).
Conclusion
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 1 2009
ev3 Inc. c/o Ms. Sara Bakker Regulatory Affairs Specialist 9600 54" Avenue North Plymouth, MN 55442
Re: K090849
NanoCross .014" OTW PTA Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DQY Dated: April 22, 2009 Received: April 23, 2009
Dear Ms. Bakker:
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 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. 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 device-related 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 product radiation control provisions (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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Dma R. be Ames
Bram D. 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): K090849
Device Name: NanoCross™ .014" OTW PTA Dilatation Catheter Indications for Use:
The NanoCross 0.014" 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.
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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Division of Cardiovascular Devices
510(k) Number_ko90849
§ 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).