The Armada 18 is indicated to dilate stenosis in femoral, popliteal, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. In addition, the device is also indicated for post-dilatation of balloon-expandable and self-expanding stents.

The Armada 18 is indicated to dilate stenosis in femoral, popliteal, infra-popliteal, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. In addition, the device is also indicated for post-dilatation of balloonexpandable and self-expanding stents.

Device Description

The Armada 18 is a 0.018" guide wire compatible and Over-the-Wire catheter used for Percutaneous Transluminal Angioplasty (PTA) procedures. The single-laver balloon is available in lengths of 20 to 200 mm with nominal diameters of 2.0 to 6.0 mm. The catheter shaft has working lengths of 90 or 150 cm.

There are two radiopaque marker bands for positioning the balloon relative to the stenosis. The radiopaque marker bands indicate the dilating section of the balloon and help in balloon placement.

An adaption arm is provided on the proximal end of the dilatation catheter to provide access to the inflation lumen and the guide wire lumen. It is designed with a luer-lock fitting for connection with an inflation device. The balloon is inflated using the side port, at which point the balloon expands to a known diameter at specific pressures. The working pressure range for the balloon is between the nominal pressure and the rated burst pressure. All balloons distend to diameters above the nominal diameter when inflated to pressures greater than the nominal pressure.

The Armada 18 PTA Catheter is sterilized with ethylene oxide (EO) and is intended for single use.

AI/ML Overview

This document is a 510(k) summary for the Armada 18 PTA Catheter, a medical device used for percutaneous transluminal angioplasty (PTA) procedures. It describes the device, its intended use, and the performance testing conducted to demonstrate its substantial equivalence to a predicate device.

Here's an analysis based on your request, highlighting what information is available and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists the types of performance tests conducted and states that the device "met all acceptance criteria." However, it does not provide a specific table detailing the acceptance criteria for each test or the exact performance values achieved against those criteria. It's a high-level summary confirming compliance.

Acceptance Criteria (Example based on typical device testing)	Reported Device Performance
Dimensional Verification:	"met all acceptance criteria"
Balloon length within tolerance	(Not specified)
Balloon diameter within tolerance	(Not specified)
Catheter shaft length within tolerance	(Not specified)
Catheter Preparation, Delivery, Deployment and Retraction:	"met all acceptance criteria"
Smooth advancement and retraction	(Not specified)
No kinking or damage during deployment	(Not specified)
Rated Burst Pressure:	"met all acceptance criteria"
Exceeds specified pressure without bursting	(Not specified)
Rated Burst Pressure In Stent:	"met all acceptance criteria"
Exceeds specified pressure in stented conditions	(Not specified)
Fatigue:	"met all acceptance criteria"
Withstands specified number of inflation/deflation cycles	(Not specified)
Fatigue In Stent:	"met all acceptance criteria"
Withstands specified number of inflation/deflation cycles in stented conditions	(Not specified)
Balloon Compliance:	"met all acceptance criteria"
Inflation to expected diameter at specific pressures	(Not specified)
Balloon Inflation and Deflation Time:	"met all acceptance criteria"
Within specified time limits	(Not specified)
Catheter Tensile Strength:	"met all acceptance criteria"
Withstands specified tensile force	(Not specified)
Flexibility and Kink Test:	"met all acceptance criteria"
Demonstrates adequate flexibility and kink resistance	(Not specified)
Torque Strength:	"met all acceptance criteria"
Withstands specified torque	(Not specified)
Particulate Evaluation:	"met all acceptance criteria"
Meets particulate limits	(Not specified)
Coating Integrity:	"met all acceptance criteria"
Maintains coating integrity	(Not specified)
Accelerated Aging:	"met all acceptance criteria"
Maintains performance after accelerated aging	(Not specified)
Biocompatibility: (Cytotoxicity, Sensitization, Acute Systemic Toxicity, Material Mediated Pyrogen, Hemolysis, Coagulation and Complement Activation)	"met all acceptance criteria"
No adverse biological reactions	(Not specified)

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

The document does not specify the sample size used for any of the performance tests. It only lists the types of tests conducted.

The provenance of the data is in vitro bench testing, meaning tests conducted in a controlled laboratory environment on the device itself. It is not patient data, so there is no country of origin or retrospective/prospective distinction in this context.

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

This information is not applicable as the document describes bench testing of a physical medical device, not a diagnostic algorithm that requires expert-established ground truth from patient data.

4. Adjudication Method for the Test Set

This is not applicable for the same reason as point 3. Bench testing results are typically based on predefined physical and material science metrics, not expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

This is not applicable. The document describes in vitro bench testing of a physical device, not an AI/medical imaging algorithm requiring an MRMC study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This is not applicable. The document describes in vitro bench testing of a physical device. There is no algorithm involved in the performance testing described.

7. The Type of Ground Truth Used

For the performance tests described, the "ground truth" would be the predefined engineering specifications, international standards, and internal quality control metrics for the physical characteristics and performance of the catheter. For example, a burst pressure test would have a "ground truth" of a minimum pressure the balloon must withstand. Biocompatibility testing compares results against established biological safety standards.

8. The Sample Size for the Training Set

This is not applicable. The document describes in vitro bench testing of a physical device. There is no "training set" in the context of device performance testing; rather, it refers to the batches/samples of the manufactured device tested. The number of units tested per batch or for validation is not provided.

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

This is not applicable for the same reason as point 8.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines suggesting hair or wings above them. The profiles are arranged in a row, slightly overlapping each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.

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

July 6, 2015

Abbott Vascular Shu Chi Hsu Project Manager, Regulatory Affairs 3200 Lakeside Drive Santa Clara, CA 95054

Re: K151317

Trade/Device Name: Armada 18 PTA Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: June 19, 2015 Received: June 22, 2015

Dear Shu Chi Hsu:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in 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" (21CFR 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.

M.A. Hilleman

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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Indications for Use

510(k) Number (if known) K151317

Device Name

Armada 18 PTA Catheter

Indications for Use (Describe)

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)

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510(k) Summary

The 510(k) Summary is submitted in accordance with 21 CFR 8807.92 and the requirements of the Safe Medical Device Act (SMDA) of 1990.

1.	Submitter's Name	Abbott Vascular
2.	Submitter's Address	3200 Lakeside Dr. Santa Clara, CA 95054
3.	Telephone	(408) 845-1256
4.	Fax	(408) 845-3743
5.	Contact Person	Shu Chi Hsu
6.	Date Prepared	May 14, 2015
7.	Device Trade Name	Armada 18 PTA Catheter
8.	Device Common Name	PTA Catheter
9.	Device Classification Name	Catheter, angioplasty, peripheral, transluminal(21 CFR 870.1250, LIT)
10.	Predicate Device Name	Armada 14 PTA Catheter (K102705, cleared onDecember 7, 2010)

11. Device Description

There are two radiopaque marker bands for positioning the balloon relative to the stenosis. The radiopaque marker bands indicate the dilating section of the balloon and help in balloon placement.

The Armada 18 PTA Catheter is sterilized with ethylene oxide (EO) and is intended for single use.

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12. Indication for Use

13. Technological Characteristics

Comparison of the new device and predicate device demonstrate that the technological characteristics such as product performance, design (with minor modifications) and indications for use are substantially equivalent to the current marketed predicate device.

14. Performance Data

Performance testing was successfully completed on the Armada 18 PTA Catheter. The following tests were conducted:

Dimensional Verification ●
Catheter Preparation, Delivery, Deployment and Retraction ●
Rated Burst Pressure, Rated Burst Pressure In Stent ●
Fatigue, Fatigue In Stent ●
Balloon Compliance
Balloon Inflation and Deflation Time
Catheter Tensile Strength
Flexibility and Kink Test
Torque Strength ●
Particulate Evaluation
Coating Integrity ●
. Accelerated Aging

Biocompatibility testing included cytotoxicity, sensitization, acute systemic toxicity, material mediated pyrogen, hemolysis, coagulation and complement activation.

15. Conclusions

Test results from the in vitro bench testing conducted on the subject device demonstrate that the Armada 18 PTA Catheter met all acceptance criteria and performed similarly to the predicate device and that no new safety or effectiveness issues were raised during the testing program. Therefore, the Armada 18 PTA Catheter may be considered substantially equivalent to the predicate device.

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).