(29 days)
No
The 510(k) summary describes a mechanical device (a balloon catheter) and its physical characteristics and performance in in vitro tests. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes, this device is a therapeutic device.
Explanation: The device is intended to "dilate stenoses" and for "treatment of obstructive or synthetic arteriovenous dialysis fistulae," which are direct medical interventions to treat a condition.
No
Explanation: The device, a PTA Dilatation Catheter, is used to dilate stenoses and for stent post-dilatation, which are therapeutic interventions, not diagnostic procedures.
No
The device description clearly describes a physical catheter with a balloon, lumens, and a manifold, indicating it is a hardware device, not software-only.
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 fistulae. This is an in vivo application.
- Device Description: The description details a catheter with a balloon designed for insertion into the vascular system. This is consistent with an in vivo device.
- Anatomical Site: The specified anatomical sites are all within the human body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body, not to directly treat conditions within the body. The EverCross 0.889 mm (0.035 in) OTW PTA Dilatation Catheter is a therapeutic device used for interventional procedures.
N/A
Intended Use / Indications for Use
The EverCross 0.889 mm (0.035 in) OTW PTA Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, illofemoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.
Product codes
LIT, DOY
Device Description
EverCross 0.035" OTW PTA Dilatation Catheter is an over the wire (OTW) 0.035" dual lumen catheter with a distally mounted semi-compliant balloon and an atraumatic tapered tip. The distal portion of the catheter, proximal to the balloon, 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 0.035". The lumen marked "BALLOON" is the balloon inflation lumen, which is used to inflate and deflate the dilatation balloon. 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 EverCross 0.035" OTW PTA Dilatation Catheter is available in multiple balloon sizes and three catheter working lengths. 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, illofemoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive 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
To demonstrate substantial equivalence of the subject device, the EverCross™ 0.035" OTW PTA Dilatation Catheter to the predicate and reference devices, the technological characteristics and performance criteria were evaluated. Using FDA Guidance Documents "Deciding When to Submit a 510(k) for a Change to an Existing Device" and "Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters" on non-clinical testing of medical devices and internal Risk Analysis procedures, the following in vitro tests were performed:
- Kink
- Kink Extreme
- Inflation time ●
- Deflation Time/ No deflate
- Trackability
- Manifold Bond Tensile ●
- Torque to Failure
The results from these tests demonstrate that the technological characteristics and performance criteria of the EverCross™ 0.035" OTW PTA Dilatation Catheter are comparable to the predicate and reference devices, and that the subject device performs in a manner equivalent to the predicate and reference devices currently on the market for the same intended use.
Key Metrics
Not Found
Predicate Device(s)
EverCross™ .035'' OTW PTA Dilatation Catheter (K110319)
Reference Device(s)
Fortrex™ 0.035" OTW PTA Balloon Catheter (K142654)
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 23, 2019
Medtronic, Inc. Breanna Hessler Regulatory Affairs Specialist 3033 Campus Drive, Suite N550 Plymouth, MN 55441
Re: K190753
Trade/Device Name: EverCross™ 0.035" OTW PTA Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT, DOY Dated: March 22, 2019 Received: March 25, 2019
Dear Ms. Hessler:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmr/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Hajira F. Ahmad -S Ahmad For Date: 2019.04.23 14:25:19 -04 Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190753
Device Name EverCross™ 0.035" OTW PTA Dilatation Catheter
Indications for Use (Describe)
The EverCross 0.889 mm (0.035 in) OTW PTA Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, illofemoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
K190753
EverCross™ 0.035" OTW PTA Dilatation Catheter
| 510(k) Summary | This 510(k) summary is being submitted in accordance
with the requirements of 21 C.F.R § 807.92. |
|----------------------|---------------------------------------------------------------------------------------------------------------|
| Applicant/ Submitter | Medtronic, Inc.
3033 Campus Drive
Plymouth, MN 55441-2651
Tel: 763-398-7000 |
| Contact Person | Breanna Hessler
Regulatory Affairs Specialist
Tel: 763-591-3530
Email: Breanna.Hessler@medtronic.com |
| Date Prepared | March 22, 2019 |
| Device Trade Name | EverCross™ 0.035" OTW PTA Dilatation Catheter |
| Device Common Name | PTA Dilatation Catheter |
| Classification Name | Percutaneous catheter, Cardiovascular |
| Regulation Number | 21 CFR 870.1250 |
| Classification | Class II |
| Classification Panel | Cardiovascular |
| Product Code | LIT, DQY |
| Predicate Device | EverCross™ .035'' OTW PTA Dilatation Catheter
(K110319) |
4
- Reference Device Fortrex™ 0.035" OTW PTA Balloon Catheter (K142654)
- Indications for Use The EverCross 0.889 mm (0.035 in) 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.
- Device Description EverCross 0.035" OTW PTA Dilatation Catheter is an over the wire (OTW) 0.035" dual lumen catheter with a distally mounted semi-compliant balloon and an atraumatic tapered tip. The distal portion of the catheter, proximal to the balloon, 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 0.035". The lumen marked "BALLOON" is the balloon inflation lumen, which is used to inflate and deflate the dilatation balloon. 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 EverCross 0.035" OTW PTA Dilatation Catheter is available in multiple balloon sizes and three catheter working lengths. Nominal balloon diameter and length are printed on the strain relief.
- Performance data To demonstrate substantial equivalence of the subject device, the EverCross™ 0.035" OTW PTA Dilatation Catheter to the predicate and reference devices, the technological characteristics and performance criteria were evaluated. Using FDA Guidance Documents "Deciding When to Submit a 510(k) for a Change to an Existing Device" and "Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters" on non-clinical testing of medical devices and internal Risk Analysis procedures, the following in vitro tests were performed:
5
- Kink
- Kink Extreme
- Inflation time ●
- Deflation Time/ No deflate
- Trackability
- Manifold Bond Tensile ●
- Torque to Failure
The results from these tests demonstrate that the technological characteristics and performance criteria of the EverCross™ 0.035" OTW PTA Dilatation Catheter are comparable to the predicate and reference devices, and that the subject device performs in a manner equivalent to the predicate and reference devices currently on the market for the same intended use.
The subject EverCross™ 0.035" OTW PTA Dilatation Summary of Substantial Equivalence Catheter has the following equivalencies to the predicate device:
- Intended use ●
- Indications for use
- Fundamental scientific technology
- Operating principle
- Materials of construction ●
- Balloon design and rated burst pressure
- Sterilization method
- Conclusion Based on the intended use, technological characteristics and performance testing included in this submission and in previously cleared submissions for this product, Medtronic concludes the EverCross 0.035" OTW PTA Dilatation Catheter to be substantially equivalent to the EverCross .035" OTW PTA Dilatation Catheter, K110319 (predicate) and Fortrex™ 0.035" OTW PTA Balloon Catheter, K142654 (reference).