(128 days)
Not Found
No
The device description and performance studies focus on the physical and mechanical properties of a crossing support catheter, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as a "crossing support catheter" intended to "guide and support a guidewire during the access of peripheral arteries, allow for wire exchanges, and provide a conduit for the infusion of saline solutions or diagnostic contrast agents." This functionality is supportive and diagnostic, not therapeutic. Therapeutic devices are those that treat or cure a disease or condition.
No
The device is a crossing support catheter intended to guide and support a guidewire, allow for wire exchanges, and provide a conduit for infusion. While it can deliver diagnostic contrast agents, its primary function is not to diagnose a condition, but rather to facilitate other procedures.
No
The device description clearly outlines a physical catheter with specific material components (spiral hypotube, hub, flexible part, radiopaque markers) and physical characteristics (dimensions, coating, guidewire compatibility). The performance studies focus on bench testing of these physical attributes and biocompatibility, not software validation.
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 in vivo (within the body) to guide and support a guidewire in peripheral arteries, allow for wire exchanges, and provide a conduit for infusing solutions. This is a procedural device used during medical interventions.
- Device Description: The description details a physical catheter designed for insertion into blood vessels.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests outside the body on biological samples. This device is used inside the body during a medical procedure.
N/A
Intended Use / Indications for Use
The TOTAL across™ crossing support catheter is intended to guide and support a guidewire during the access of peripheral arteries, allow for wire exchanges, and provide a conduit for the infusion of saline solutions or diagnostic contrast agents.
Product codes
DQY
Device Description
The TOTAL across is an over the wire (OTW) single lumen catheter composed of a spiral hypotube which provides a smooth transition from proximal to distal part, a proximal female hub and a distal flexible part with an atraumatic tapered tip.
The distal end of the catheter features a lubricious, hydrophilic coating and 2 radiopaque markers. The TOTAL across is 0.014" (0.36mm) guidewire compatible, and features working lengths of 100cm and 150cm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral arteries
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)
Comparative testing was also conducted with the subject device and the predicate devices. The bench test results demonstrated that the subject device met the acceptance criteria and that the predicate devices and the subject device are comparable with respect to the performance characteristics.
Summary of Bench Testing: The TOTAL across was thoroughly tested on the bench to evaluate and verify that it meets the required performance specifications. The bench testing plan was developed with the consideration of the recommendations outlined in the applicable FDA guidance documents and ISO standards. Testing performed on the TOTAL across device included the following:
- Surface Inspection and Device Dimensions
- Device Preparation, Trackability, Flexibility and Kink test
- Introducer Sheath and Guidewire Compatibility
- Catheter Bond Strength
- Tip Pull
- Torque Strength
- Radiopacity
- Coating Evaluation
- Particulate evaluation
- Catheter Body Burst Pressure
- Contrast Media and Saline Solution Flow Rate
- Hub Test according to ISO 594-1:1986 - Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements and to ISO 594-2:1998 - Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment – Part 2: Lock fittings
- Crossability
All of the pre-determined acceptance criteria were met and the testing passed.
Summary of Biocompatibility Testing: The TOTAL across is an externally communicating device, which contacts circulating blood for the limited contact duration (
§ 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).
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MAR 2 6 2014 K133539 p. 1 of 4
3
3.0 510(k) Summary
This 510(k) Summary is submitted in accordance with the requirements of 21 CFR Part 807, Section 807.92(c).
| Applicant/Submitter: | Medtronic Vascular
3576 Unocal Place
Santa Rosa, CA 95403
Tel: 707-525-0111
Fax: 707-566-1245
Contact person: Diana Johnson, Regulatory Affairs Director |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact Person: | Maddalena Pinsi, Sr. Regulatory Affairs Specialist
INVATEC, S.p.A.
7, Via Martiri della Libertà
Roncadelle, ITALY 25030.
Tel: 707-591-2656
Fax: 707-566-1245
Email: maddalena.pinsi@medtronic.com |
| Alternate Contact: | Diana Johnson, Regulatory Affairs Director
Medtronic Vascular
3576 Unocal Place
Santa Rosa, CA 95403
Tel: 707-591-2656
Fax: 707-566-1245
Email: diana.j.johnson@medtronic.com |
| Date Prepared: | November 15, 2013 |
| Device Information: | |
| Trade Name: | TOTAL acrossTM |
| Common Name: | Crossing Support Catheter |
| Regulation Name: | Percutaneous Catheter |
| Classification: | Class II |
| Classification Panel: | Cardiovascular |
| Regulation Number: | 21 CFR 870.1250 |
| Product Code: | DQY |
Medtronic Vascular
TOTAL across™
K____ Traditional 510(k)
1
Predicate Devices
- Quick Cross Extreme Support Catheter (K082561 SE- December 1010, 2008 and K092396 . SE- September 4th, 2009)
- Seeker™ Crossing Support Catheter (K103367 SE- December 8th, 2010) .
Device Description
The TOTAL across is an over the wire (OTW) single lumen catheter composed of a spiral hypotube which provides a smooth transition from proximal to distal part, a proximal female hub and a distal flexible part with an atraumatic tapered tip.
The distal end of the catheter features a lubricious, hydrophilic coating and 2 radiopaque markers. The TOTAL across is 0.014" (0.36mm) guidewire compatible, and features working lengths of 100cm and 150cm.
Indications for Use
The TOTAL across™ crossing support catheter is intended to guide and support a guidewire during the access of peripheral arteries, allow for wire exchanges, and provide a conduit for the infusion of saline solutions or diagnostic contrast agents.
The indications for use for the TOTAL across are equivalent and covered by the currently cleared predicate devices, Quick Cross® Extreme Support Catheter (hereinafter referred to as "Quick Cross Extreme") and Seeker"14 Crossing Support Catheter referred to as "Seeker").
Technological Characteristics
The overall design and the fundamental scientific technology (operating principle and mechanism of action) of the TOTAL across device (hereinafter referred to also as "subject device") are substantially equivalent to the currently cleared predicate devices, Quick Cross Extreme and Seeker.
The subject device has a guidewire compatibility of 0.014", as the Quick Cross Extreme and the Seeker predicate devices (which also have additional platforms having 0.018" and 0.035" guidewire compatibilities).
The TOTAL across has an introducer sheath compatibility of 4F, which is the same as the Quick Cross Extreme and Seeker predicate devices introducer sheath compatibility for the 0.014" platform.
The TOTAL across usable lengths (100cm and 150cm) are within the Quick Cross Extreme and Seeker predicate devices' range (from 65cm to 150cm).
The distal end of the subject device features a lubricious, hydrophilic coating as are the predicate devices Ouick Cross Extreme and Seeker.
The subject device features two radiopaque markers per device, while the Quick Cross Extreme predicate device features three radiopaque markers per device. The visibility of the subject device markerbands has been considered satisfactory and comparable to the predicate device's visibility.
Refer to Section 9.4 and to Section 10.0 for a detailed description of the subject device and for its comparison to the predicate devices.
- Medtronic Vascular TOTAL across TM K ... Traditional 510(k)
2
K133539 p. 3 of 4
5
Comparative testing was also conducted with the subject device and the predicate devices. The bench test results demonstrated that the subject device met the acceptance criteria and that the predicate devices and the subject device are comparable with respect to the performance characteristics.
Summary of Bench Testing
The TOTAL across was thoroughly tested on the bench to evaluate and verify that it meets the required performance specifications. The bench testing plan was developed with the consideration of the recommendations outlined in the applicable FDA guidance documents and ISO standards. Testing performed on the TOTAL across device included the following:
- Surface Inspection and Device Dimensions .
- . Device Preparation, Trackability, Flexibility and Kink test
- . Introducer Sheath and Guidewire Compatibility
- . Catheter Bond Strength
- Tip Pull ●
- . Torque Strength
- . Radiopacity
- . Coating Evaluation
- . Particulate evaluation
- . Catheter Body Burst Pressure
- Contrast Media and Saline Solution Flow Rate .
- . Hub Test according to ISO 594-1:1986 - Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements and to ISO 594-2:1998 - Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment – Part 2: Lock fittings
- . Crossability
All of the pre-determined acceptance criteria were met and the testing passed.
Summarv of Biocompatibility Testing
The TOTAL across is an externally communicating device, which contacts circulating blood for the limited contact duration ( Trade/Device Name: TOTAL across Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY Dated: February 21, 2014 Received: February 24, 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 that + DAT has I 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
5
Page 2 - Ms. Diana Johnson
the quality systems (OS) 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 Small Manufacturers. International and Consumer Assistance at its tollfree 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 Small 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/Resourcesfor You/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
6
CONFIDENTIAL
May not be reproduced without written permission from Medtronic, Inc.
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | Form Approved: OMB No. 0910-012
Expiration Date: December 31, 2012
See PRA Statement on last page. |
|-------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| Indications for Use | |
| 510(k) Number (if known) | K133539 |
| Device Name | |
TOTAL across™
Indications for Use (Describe)
The TOTAL across™ crossing support cather: is intended to guide and support a guide wire during the access of peripheral arents.
| 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) |
|---|---|
| ------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Kenneth J. Cavanaugh -S
| FORM FDA 3881 (9/13) | Page 1 of 2 |
|---|---|
| ---------------------- | ------------- |
Medtronic, Inc. TOTAL across K133539, Traditional 510(k)