(79 days)
Not Found
No
The description focuses on the physical characteristics and function of a balloon catheter for angioplasty and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes
The device is a PTA balloon catheter intended to dilate stenoses in various arteries and treat obstructive lesions, which are therapeutic actions.
No
The device description and intended use clearly state that it is a balloon dilatation catheter used for dilating stenoses and post-dilatation, which are therapeutic interventions, not diagnostic procedures.
No
The device description clearly details a physical medical device (catheter with a balloon) and its components, not a software-only product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used within the body to dilate blood vessels and treat lesions. This is an interventional procedure, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a physical catheter with a balloon designed for insertion into the vascular system. This is consistent with a medical device used for treatment, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue), reagents, or any other components typically associated with in vitro diagnostics.
In summary, the NanoCross™ Elite 0.014" Over-the-Wire PTA Balloon Dilatation Catheter is a therapeutic medical device used for interventional procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
LIT
Device Description
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.
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, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
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.
Using internal Risk Analysis procedures, the following tests were performed for one or more model sizes:
- Dimensional Verification: Crossing Profile
- Balloon Rated Burst Pressure
- Balloon Compliance
- Balloon Pull-back Force
- Dimensional Verification: Balloon Length
- Inflation/Deflation Time
- Balloon Fatigue
- Catheter Bond Strength
- Kink
- Device Tracking
- Insertion Force
- Particle Generation
- Dimensional Verification: Balloon OD
- Balloon Rated Burst Pressure (In Stent)
- Radiopacity
- Presence of Coating
- Dimensional Verification: Tip/Lesion Entry Profile
- Pushability
- Dimensional Verification: Tip ID
- Wire Movement
- Re-Insertion Force
- Catheter Working Length
- Torque Strength
- Coating Durability
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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).
0
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 accordance
with the requirements of 21 CFR §807.92. | | |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Applicant | ev3 Inc. | | |
| Submitter | ev3 Inc.
3033 Campus Drive
Plymouth, MN 55441-2651
Tel: 763.398.7000
Fax: 763.591.3248 | | |
| Contact Person | Laura J. Lind | | |
| Date Prepared | June 18, 2014 | | |
| Device Trade Name | NanoCross™ Elite
0.014" Over-the-Wire
PTA 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 Balloon
Dilatation Catheter (K132777), PowerCross™ 0.018" OTW PTA
Dilatation Catheter (K093286). | | |
| Intended use | 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. | | |
| Device Description | 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 | | |
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
1
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.
2
r
NanoCross™ Elite 0.014" Over-the-Wire PTA Balloon Dilatation Catheter Summary
| Summary of
Substantial
Equivalence | The NanoCross Elite catheter has the following similarities to
one 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 devices
have similar construction and principles of operation. All
devices are used by the physician in a similar manner typical of
PTA balloon catheters.
The NanoCross Elite catheter and the predicates have the same
intended use - all devices are intended to treat peripheral arteries.
All devices are intended to treat the same target population. The
manner in accessing and treating lesions is the same. |
| Conclusion | Based on the intended use, technological characteristics, and
results from safety and performance testing, the modified
NanoCrossTM Elite 0.014" Over-the-Wire PTA Balloon
Dilatation Catheter is considered substantially equivalent to the
legally marketed predicate devices NanoCrossTM Elite 0.014"
Over-the-Wire PTA Balloon Dilatation Catheter (K132777) and
PowerCrossTM .018" OTW PTA Dilatation Catheter (K093286). |
.
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ーPage 3 of 3
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3
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
4
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
5
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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