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.

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.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study proving device performance, based on the provided text:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

The provided text details various tests performed on the TOTAL across™ crossing support catheter. For each test, the general statement is made that "All of the pre-determined acceptance criteria were met and the testing passed." Specific numerical acceptance criteria are not explicitly stated in this summary, but the successful completion of each test implies adherence to predefined standards.

Test Category	Reported Device Performance
Surface Inspection and Device Dimensions	Met pre-determined acceptance criteria; testing passed.
Device Preparation	Met pre-determined acceptance criteria; testing passed.
Trackability	Met pre-determined acceptance criteria; testing passed.
Flexibility	Met pre-determined acceptance criteria; testing passed.
Kink test	Met pre-determined acceptance criteria; testing passed.
Introducer Sheath Compatibility	Met pre-determined acceptance criteria; testing passed.
Guidewire Compatibility	Met pre-determined acceptance criteria; testing passed.
Catheter Bond Strength	Met pre-determined acceptance criteria; testing passed.
Tip Pull	Met pre-determined acceptance criteria; testing passed.
Torque Strength	Met pre-determined acceptance criteria; testing passed.
Radiopacity	Satisfactory and comparable to predicate device's visibility.
Coating Evaluation	Met pre-determined acceptance criteria; testing passed.
Particulate evaluation	Met pre-determined acceptance criteria; testing passed.
Catheter Body Burst Pressure	Met pre-determined acceptance criteria; testing passed.
Contrast Media and Saline Flow Rate	Met pre-determined acceptance criteria; testing passed.
Hub Test (ISO 594-1:1986 & 594-2:1998)	Met pre-determined acceptance criteria; testing passed.
Crossability	Met pre-determined acceptance criteria; testing passed.
Biocompatibility Studies:
Cytotoxicity Study (ISO MEM Elution)	Met pre-determined acceptance criteria; testing passed.
ISO Guinea Pig Maximization Sensitization	Met pre-determined acceptance criteria; testing passed.
ISO Intracutaneous Study in Rabbits	Met pre-determined acceptance criteria; testing passed.
ISO Systemic Toxicity Study in Mice	Met pre-determined acceptance criteria; testing passed.
USP Pyrogen study	Met pre-determined acceptance criteria; testing passed.
Bacteria Reverse Mutation Study	Met pre-determined acceptance criteria; testing passed.
ASTM Hemolysis Study	Met pre-determined acceptance criteria; testing passed.
C3a Complement Activation Assay	Met pre-determined acceptance criteria; testing passed.
SC5b-9 Complement Activation Assay	Met pre-determined acceptance criteria; testing passed.
In-vivo Thromboresistance Study	Met pre-determined acceptance criteria; testing passed.
ASTM Partial Thromboplastin time	Met pre-determined acceptance criteria; testing passed.

2. Sample Size Used for the Test Set and Data Provenance

The document does not provide specific numerical sample sizes for the "test set" (bench testing or biocompatibility testing). It refers to the tests being conducted on "the TOTAL across" and "the finished TOTAL across," implying samples of the device were used.

The data provenance is described as "bench testing" and "biocompatibility testing." This typically implies laboratory-based, controlled studies, not human clinical trials. The country of origin of the data is not specified, but the applicant (Medtronic Vascular) is based in Santa Rosa, CA, USA, and an alternate contact is based in Roncadelle, ITALY. The testing was conducted in accordance with FDA guidance documents and ISO standards, which are internationally recognized. The studies are prospective in nature, as they involve testing new iterations of the device to ensure conformity to standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable to this submission. The "ground truth" for the performance and biocompatibility studies of a medical device like this catheter is based on established engineering principles, international standards (ISO, ASTM), and FDA guidance documents, not on human expert consensus derived from image interpretations or clinical assessments. The "experts" involved would be the engineers, scientists, and technicians conducting the testing and verifying the results against the predefined specifications. Their qualifications are inherent in their ability to perform and interpret these specialized tests.

4. Adjudication Method for the Test Set

This is not applicable to this type of device and testing. Adjudication methods like 2+1 or 3+1 are used in clinical trials or studies involving human assessment (e.g., image interpretation) where there might be disagreement among experts. For bench and biocompatibility testing, the results are typically quantitative and objective, measured against predefined acceptance criteria. Any discrepancies would be resolved through re-testing or thorough investigation of the testing methodology, not through expert adjudication in the traditional sense.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices that assist human readers in interpreting medical images or data. The TOTAL across™ is a physical medical device (a crossing support catheter), and its performance is evaluated through bench testing and biocompatibility studies, not through human-in-the-loop diagnostic tasks. Therefore, there is no AI component or human reader improvement effect size to report.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

A standalone performance evaluation (algorithm only) was not done as this device does not contain an AI algorithm. Its performance is assessed through its physical and material properties in a standalone manner (i.e., the device itself is tested without human intervention in its function, unlike, for example, a surgical tool where human skill is key to its performance).

7. The Type of Ground Truth Used

The "ground truth" for the performance tests relies on:

Established engineering specifications and design requirements: These are the inherent standards the device is designed to meet, such as specific dimensions, strength, flexibility, etc.
Applicable FDA guidance documents and ISO/ASTM standards: These provide the methodologies and acceptance criteria for evaluating various characteristics (e.g., ISO 594 for hub tests, ANSI/AAMI/ISO 10993 for biocompatibility).
Comparison to predicate devices: For some characteristics, the ground truth for "acceptable" performance is established by demonstrating comparability to legally marketed predicate devices. For example, radiopacity was considered "satisfactory and comparable to the predicate device's visibility."

8. The Sample Size for the Training Set

This is not applicable. The TOTAL across™ is a physical medical device and not an AI/machine learning model, so there is no "training set" in the context of data for an algorithm. The "training" in the manufacturing context refers to the manufacturing process that creates the device, but not a data set.

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the reasons stated in point 8. There is no training set for an AI algorithm.

Summary

{0}------------------------------------------------

MAR 2 6 2014 K133539 p. 1 of 4

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 Vascular3576 Unocal PlaceSanta Rosa, CA 95403Tel: 707-525-0111Fax: 707-566-1245Contact person: Diana Johnson, Regulatory Affairs Director
Official Contact Person:	Maddalena Pinsi, Sr. Regulatory Affairs SpecialistINVATEC, S.p.A.7, Via Martiri della LibertàRoncadelle, ITALY 25030.Tel: 707-591-2656Fax: 707-566-1245Email: maddalena.pinsi@medtronic.com
Alternate Contact:	Diana Johnson, Regulatory Affairs DirectorMedtronic Vascular3576 Unocal PlaceSanta Rosa, CA 95403Tel: 707-591-2656Fax: 707-566-1245Email: 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

Indications for Use

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

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 (<24hours).

Biocompatibility testing was conducted on the finished TOTAL across in accordance with the principles of the ANSI/AAMI/ISO 10993-1:2009 Biological evaluation of medical devices --Part 1: Evaluation and testing within a risk management process as specified in the FDA Blue Book Memorandum #G95-1 Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing' and in accordance with FDA 21 CFR Part 58: Good Laboratory Practice for Non clinical Laboratory Studies, and FDA guidance: Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (Sept 2010).

{3}------------------------------------------------

The biocompatibility testing performed for the TOTAL across device included the following:

Cytotoxicity Study using the ISO MEM Elution Method .
. ISO Guinea Pig Maximization Sensitization Test
. ISO Intracutaneous Study in Rabbits
ISO Systemic Toxicity Study in Mice .
. USP Pyrogen study - Material mediated
Bacteria Reverse Mutation Study .
. ASTM Hemolysis Study
. C3a Complement Activation Assay
. SC5b-9 Complement Activation Assay
In-vivo Thromboresistance Study in the Dog, Jugular Vein .
. ASTM Partial Thromboplastin time

All of the pre-determined acceptance criteria were met and the testing passed.

Assessment of non-clinical performance data for equivalence

Comparative and biocompatibility testing of the TOTAL across were performed in accordance with the relevant FDA guidance, ISO and ASTM standards. Results from these non-clinical testing demonstrates that the TOTAL across met the pre-determined acceptance criteria and results from the comparative testing also demonstrate that the subject device performs comparably to the predicate devices. No new type of safety or effectiveness issues were observed during the testing.

Conclusion

Results from the non-clinical performance testing demonstrate that the TOTAL across is substantially equivalent to the predicate devices in terms of safety, effectiveness and performance.

In conclusion, based on the considerations above, Medtronic believes that the TOTAL across is substantially equivalent to the predicate devices Quick Cross Extreme and Seeker in terms of indications for use, overall design, fundamental scientific technology (operating principle and mechanism of action) and performance characteristics, and that it does not raise new type of questions of safety and effectiveness. Therefore it is suitable for the Traditional 510(k) process.

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around it. Inside the circle is an emblem featuring three stylized human figures.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 26, 2014

Medtronic Vascular Ms. Diana Johnson Regulatory Affairs Director 3576 Unocal Place Santa Rosa, CA 95403

Re: K133539

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 SERVICESFood and Drug Administration	Form Approved: OMB No. 0910-012Expiration Date: December 31, 2012See 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)

Regulation Number and Section

§ 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).