(79 days)
The NanoCross™ Elite 0.014" Over-the-Wire PTA Balloon 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 NanoCross catheter is an over-the-wire (OTW) coaxial lumen percutaneous transluminal angioplasty (PTA) balloon catheter compatible with 0.014"guidewires with a distally mounted semi-compliant inflatable balloon and an atraumatic tapered tip. The distal portion of the catheter has a lubricious 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 0.014". 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.
The NanoCross Elite catheter is available in balloon sizes ranging from 1.5 mm to 6 mm in diameter, and from 20 mm to 210 mm in length; reference labeling for introducer sheath compatibility.
The provided text describes a medical device, the NanoCross™ Elite 0.014" Over-the-Wire PTA Balloon Dilatation Catheter, and its substantial equivalence to predicate devices, rather than an AI/ML device with specific acceptance criteria and performance metrics. Therefore, many of the requested categories for AI/ML device studies are not applicable or cannot be extracted from this document.
However, I can extract information related to the device's performance testing and its acceptance criteria implicitly met through comparison to predicates.
Here's the information that can be extracted and how it relates to your request:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that "The NanoCross Elite catheter met all acceptance criteria for the bench testing with results similar to the predicates." It then lists the types of bench tests performed. The specific numerical acceptance criteria and precise performance results are not detailed in this summary. Instead, it relies on the concept of "similarity to predicates" and conformance to "requirements for its intended use."
| Acceptance Criteria Category (Implicit, based on tests performed) | Reported Device Performance (Summary) |
|---|---|
| Dimensional Verification: | Met all acceptance criteria with results similar to predicates. |
| - Crossing Profile | |
| - Balloon OD | |
| - Balloon Length | |
| - Tip/Lesion Entry Profile | |
| - Tip ID | |
| - Catheter Working Length | |
| Balloon Performance: | Met all acceptance criteria with results similar to predicates. |
| - Rated Burst Pressure | Notably, the device has "Identical balloon rated burst pressures" and "Identical balloon nominal pressure" to predicate devices. |
| - Rated Burst Pressure (In Stent) | |
| - Compliance | |
| - Fatigue | |
| - Inflation/Deflation Time | |
| Mechanical Properties & Usability: | Met all acceptance criteria with results similar to predicates. |
| - Radiopacity | |
| - Balloon Pull-back Force | |
| - Presence of Coating | The device has "A lubricious coating," similar to predicates. |
| - Pushability | |
| - Catheter Bond Strength | |
| - Wire Movement | |
| - Kink | |
| - Re-Insertion Force | |
| - Device Tracking | |
| - Insertion Force | |
| - Torque Strength | |
| - Particle Generation | |
| - Coating Durability | |
| Biocompatibility: | Met all acceptance criteria, leveraging tests from predicate devices. (Biocompatibility per ISO 10993-1) |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated for each individual bench test. The document mentions tests were performed "for one or more model sizes" or "leveraged from predicate devices for one or more model sizes." It does not provide specific numbers for units tested.
- Data Provenance: The testing was "Bench testing," meaning it was conducted in a laboratory setting, likely by the manufacturer (ev3 Inc.). It is not clinical data (retrospective or prospective). Country of origin is implied to be where ev3 Inc. operates (USA, as per address).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Not Applicable. This is a physical medical device (catheter), not an AI/ML diagnostic tool or image analysis software. "Ground truth" in this context refers to the verifiable physical properties and performance characteristics of the device, established through standardized engineering and materials testing, not through expert human interpretation of data.
4. Adjudication Method for the Test Set:
- Not Applicable. As above, the "test set" here refers to physical devices undergoing bench testing. The results are typically quantitative measurements against predefined specifications, not subjective assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, Not Applicable. This type of study assesses human reader performance with and without AI assistance, which is irrelevant for a physical medical device like a dilatation catheter.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, Not Applicable. There is no algorithm described for this physical device.
7. The Type of Ground Truth Used:
- For the performance data listed (e.g., burst pressure, dimensions, fatigue): The ground truth is established through physical measurement against engineering specifications and international standards (like ISO 10993-1 for biocompatibility). The acceptance criteria are based on conformance to these specifications and demonstrated similarity to predicate devices that have prior FDA clearance.
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. No training set exists.
In summary of the provided text:
The NanoCross™ Elite catheter demonstrated conformance to established performance requirements and substantial equivalence through a series of bench tests (physical and material properties, mechanical performance in simulated use) and biocompatibility testing. The "acceptance criteria" were implicitly met by achieving "results similar to the predicates" and adhering to "the requirements for its intended use" as determined by internal risk analysis procedures and industry standards. The submission is focused on demonstrating that the new device is as safe and effective as equivalent legally marketed devices based on these non-clinical tests.
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K141118 p. 1 of 3
Image /page/0/Picture/1 description: The image shows the logo for "ev3", a company that specializes in endovascular products. The logo features the letters "ev3" in a stylized font, with three circles arranged in a triangular pattern above the letters. To the right of the logo, the text "Your endovascular company." is written in a smaller font.
JUL 1 8 2014
510(k) Summary
NanoCross™ Elite 0.014" Over-the-Wire PTA Balloon Dilatation Catheter
| 510(k) Summary | This 510(k) summary information is submitted in accordancewith the requirements of 21 CFR §807.92. | ||
|---|---|---|---|
| Applicant | ev3 Inc. | ||
| Submitter | ev3 Inc.3033 Campus DrivePlymouth, MN 55441-2651Tel: 763.398.7000Fax: 763.591.3248 | ||
| Contact Person | Laura J. Lind | ||
| Date Prepared | June 18, 2014 | ||
| Device Trade Name | NanoCross™ Elite0.014" Over-the-WirePTA Balloon Dilatation Catheter | ||
| Device Common Name | PTA Dilatation Catheter | ||
| Classification Name | Catheter, Angioplasty, Peripheral, Transluminal(21 CFR §870.1250, Product Code LIT) | ||
| Classification Panel | Cardiovascular | ||
| Predicate Devices | NanoCross™ Elite 0.014" Over-the-Wire PTA BalloonDilatation Catheter (K132777), PowerCross™ 0.018" OTW PTADilatation Catheter (K093286). | ||
| Intended use | The NanoCross™ Elite 0.014" Over-the-Wire PTA BalloonDilatation Catheter is intended to dilate stenoses in the iliac,femoral, ilio-femoral, popliteal, infra-popliteal, and renalarteries, and for the treatment of obstructive lesions of native orsynthetic arteriovenous dialysis fistulae. This device is alsoindicated for stent post-dilatation in the peripheral vasculature. | ||
| Device Description | The NanoCross catheter is an over-the-wire (OTW) coaxiallumen percutaneous transluminal angioplasty (PTA) ballooncatheter compatible with 0.014"guidewires with a distallymounted semi-compliant inflatable balloon and an atraumatictapered tip. The distal portion of the catheter has a lubriciouscoating. The manifold includes a lumen marked "THRU". Thisis the central lumen of the catheter, which terminates at the distal |
ev3 Corporate World Meadquarters / Peripheral Vascular - 3033 Carryus Drive, Plynouth, MN 55411, USA - Ph + 1 763 398 7000
ev3 Neurovascular - 9775 Toledo Way, Irvine, CA 92618 - Ph +1 949 837 3700
ev3 Europe / International Headquarters - 106/108 r.je La Boétie, 75008 Paris, France · Ph +33 156 88 59 10
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p. 2 of 3
NanoCross™ Elite 0.014" Over-the-Wire PTA Balloon Dilatation Catheter Summary
tip. This lumen is used to pass the catheter over a guidewire with a maximum diameter of 0.014". 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.
The NanoCross Elite catheter is available in balloon sizes ranging from 1.5 mm to 6 mm in diameter, and from 20 mm to 210 mm in length; reference labeling for introducer sheath compatibility.
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.
| • Dimensional Verification:Crossing Profile | • Dimensional Verification:Balloon OD |
|---|---|
| • Balloon Rated Burst Pressure | • Balloon Rated Burst Pressure (In Stent) |
| • Balloon Compliance | • Radiopacity |
| • Balloon Pull-back Force | • Presence of Coating |
| • Dimensional Verification:Balloon Length | • Dimensional Verification:Tip/Lesion Entry Profile |
| • Inflation/Deflation Time | • Pushability |
| • Balloon Fatigue | • Dimensional Verification: Tip ID |
| • Catheter Bond Strength | • Wire Movement |
| • Kink | • Re-Insertion Force |
| • Device Tracking | • Catheter Working Length |
| • Insertion Force | • Torque Strength |
| • Particle Generation | • Coating Durability |
Using internal Risk Analysis procedures, the following tests were performed for one or more model sizes:
Using the same Risk Analysis procedures, the following tests were leveraged from predicate devices for one or more model sizes:
Biocompatibility per ISO 10993-1
The NanoCross Elite catheter met all acceptance criteria for the bench testing with results similar to the predicates. Based on the bench test results, comparison to legally marketed predicates, and non-clinical test results, the NanoCross Elite catheter is determined to perform as safely and effectively as the predicates for its intended use.
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r
NanoCross™ Elite 0.014" Over-the-Wire PTA Balloon Dilatation Catheter Summary
| Summary ofSubstantialEquivalence | The NanoCross Elite catheter has the following similarities toone or more of the predicate devices:Same fundamental scientific technology Identical intended use Same operating principle Identical balloon rated burst pressures Identical balloon nominal pressure Similar balloon diameters Similar balloon lengths Identical catheter lengths A lubricious coating Packaged with the same materials and processes Same sterility assurance level and sterilization method |
|---|---|
| The devices are compatible with 0.014" guidewires. All deviceshave similar construction and principles of operation. Alldevices are used by the physician in a similar manner typical ofPTA balloon catheters.The NanoCross Elite catheter and the predicates have the sameintended use - all devices are intended to treat peripheral arteries.All devices are intended to treat the same target population. Themanner in accessing and treating lesions is the same. | |
| Conclusion | Based on the intended use, technological characteristics, andresults from safety and performance testing, the modifiedNanoCrossTM Elite 0.014" Over-the-Wire PTA BalloonDilatation Catheter is considered substantially equivalent to thelegally marketed predicate devices NanoCrossTM Elite 0.014"Over-the-Wire PTA Balloon Dilatation Catheter (K132777) andPowerCrossTM .018" OTW PTA Dilatation Catheter (K093286). |
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Image /page/3/Picture/1 description: The image shows a circular logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which consists of a stylized human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the emblem in a circular fashion. The image is black and white.
Food and Drug Administration 0903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 18, 2014
ev3 Inc. Ms. Brenda Johnson Regulatory Affairs Manager 3033 Campus Drive Suite N550 Plymouth, MN 55441
Re: K141118
Trade/Device Name: NanoCross Elite 0.014" Over-the-Wire PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 871.1250 Regulation Name: Catheter, Angioplasty, Peripheral, Transluminal Regulatory Class: Class II Product Code: LIT Dated: June 18, 2014 Received: June 19, 2014
Dear Ms. Johnson,
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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Page 2 - Ms. Brenda Johnson
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 Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions 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 Division of Industry and Consumer Education 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
Kenneth J. Cavanaugh -S
for
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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Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017 See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) ה/a
Device Name
NanoCross™ Elite 0.014" Over-the-Wire PTA Balloon Dilatation Catheter
Indications for Use (Describe)
The NanoCross™ Elite 0.014" Over-the-Wire PTA Balloon Dilatation Catheter is intended to dilate stenoses in the illias, femoral, ilio-femoral, 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.
| CONSULERS CONNUIL I AN AN AND LINE LINE LE LE SENSIO LEBE | Income of experience of the property of the property of the program and |
|---|---|
| Type of Use (Select one or both, as applicable) |
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY J. 3"
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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§ 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).