The device is intended for dilatation of lesions in the renal, iliac, femoral, popliteal, tibial, and peroneal, 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 Armada 35/Armada 35 LL Percutaneous Transluminal Angioplasty (PTA) Catheter is a standard over-the-wire (OTW) balloon catheter to be used for percutaneous transluminal angioplasty (PTA). The dual-layer balloon (outer layer: Pebax L25, inner layer Pebax 7233D) will be available in lengths 20, 40, 60, 80, 100, 120, 150, 200 and 250 mm, with nominal diameters of 3, 4, 5, 6, 7, 8, 9, 10, 12 and 14mm. The balloon has a nominal diameter inflation pressure of 4, 6 and 8atm (depending on diameter) and a rated burst pressure between 7 to 28atm (depending on balloon size). Two swaged metal marker bands (PT/ IR) mark the working length of the balloons. The dual-lumen catheter shaft (Grilamid L25) has working lengths of 80 or 135 cm. The catheter shaft differs in outer diameter between 1.73 and 1.90 mm (depending on balloon size). One lumen is used for inflating the balloon and the second lumen allows access to the distal tip of the catheter for guide wire insertion. The inner member, which is constructed either of Grilamid L25 or ELG 6260 (depending on balloon size) will accept a 0.035" guide wire. The balloon, outer shaft of the catheter and the entire inner member is coated with silicone coating. The outer shaft has a polycarbonate y-arm luer adhesively bonded to the proximal end to allow for entry to the guide wire lumen and to allow for connection of the inflation device to the inflation/deflation lumen.

AI/ML Overview

The provided text describes a 510(k) summary for the Armada 35/Armada 35 LL PTA Catheter. This document details the device's characteristics, intended use, and performance data used to demonstrate substantial equivalence to predicate devices. However, it does not provide acceptance criteria in a structured, quantitative table, nor does it detail a study that explicitly proves the device meets such criteria with numerical performance metrics.

Instead, the document lists a series of performance tests that were "successfully completed" to support the claim of substantial equivalence. It is implied that the device's performance in these tests met internal (unspecified) acceptance criteria or demonstrated equivalence to the predicate devices.

Therefore, for the requested information, I will synthesize what is available and note where specific details are missing.

Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a table format, nor does it provide specific numerical performance metrics for the Armada 35/35 LL PTA Catheter to contrast against such criteria. The performance data section broadly indicates that various tests were "successfully completed."

Below is a table summarizing the tests, and where possible, general outcomes as implied by the submission:

Test Name	Acceptance Criteria (Not explicitly stated in document)	Reported Device Performance (General, as implied by "successfully completed")
Balloon Preparation and Simulated Use (Trackability and Pushability)	(Implied: Meet functional requirements for catheter insertion and movement)	Successfully completed (device performed as intended)
Balloon Preparation and Simulated Use (Withdrawal)	(Implied: Meet functional requirements for catheter removal)	Successfully completed (device performed as intended)
Balloon Compliance (Diameter versus Pressure)	(Implied: Balloon inflates and reaches specified diameters at given pressures)	Successfully completed (balloon demonstrated expected compliance)
Balloon Dimensions (Tip Entry Profile +1mm)	(Implied: Meet specified dimensions for safe navigation)	Successfully completed (met dimensional specifications)
Balloon Dimensions (Lesion Crossing Profile)	(Implied: Meet specified dimensions for crossing lesions)	Successfully completed (met dimensional specifications)
Balloon Dimensions (Deflated Balloon Profile)	(Implied: Meet specified dimensions for ease of withdrawal)	Successfully completed (met dimensional specifications)
Balloon Inflation/ Deflation Time	(Implied: Meet specified times for clinical efficiency)	Successfully completed (demonstrated acceptable inflation/deflation times)
Longitudinal Growth of Balloon	(Implied: Within acceptable limits)	Successfully completed (balloon exhibited acceptable longitudinal growth)
Rated Burst Pressure (RBP)	(Implied: Meet or exceed specified burst pressures for safety)	Successfully completed (met or exceeded RBP specifications)
Balloon Fatigue	(Implied: Withstand specified number of inflation/deflation cycles)	Successfully completed (demonstrated resistance to fatigue)
RBP in Balloon-Expandable Stents	(Implied: Meet or exceed specified burst pressures for safety in stent environment)	Successfully completed (met or exceeded RBP specifications in stents)
RBP in Self-Expanding Stents	(Implied: Meet or exceed specified burst pressures for safety in stent environment)	Successfully completed (met or exceeded RBP specifications in stents)
Balloon Fatigue in Balloon-expandable Stent (Repeat Balloon Inflations in Stent)	(Implied: Withstand specified cycles without failure in stent environment)	Successfully completed (demonstrated resistance to fatigue in stents)
Balloon Fatigue in Self-expanding Stent (Repeat Balloon Inflations in Stent)	(Implied: Withstand specified cycles without failure in stent environment)	Successfully completed (demonstrated resistance to fatigue in stents)
Tensile strength distal balloon welding	(Implied: Meet or exceed minimum tensile strength)	Successfully completed (met tensile strength specifications)
Tensile strength proximal balloon welding	(Implied: Meet or exceed minimum tensile strength)	Successfully completed (met tensile strength specifications)
Tensile strength joint shaft/ manifold	(Implied: Meet or exceed minimum tensile strength)	Successfully completed (met tensile strength specifications)
Withdrawal force through introducer sheath –short sheath	(Implied: Within acceptable force limits)	Successfully completed (exhibited acceptable withdrawal force)
Withdrawal force through introducer sheath -long sheath	(Implied: Within acceptable force limits)	Successfully completed (exhibited acceptable withdrawal force)
Catheter Pullback Force into Short Sheath After Reinsertion	(Implied: Within acceptable force limits)	Successfully completed (exhibited acceptable pullback force)
Catheter Pullback Force into Long Sheath After Reinsertion	(Implied: Within acceptable force limits)	Successfully completed (exhibited acceptable pullback force)
Guide wire Lumen Collapse	(Implied: Resist collapse under specified conditions)	Successfully completed (lumen resisted collapse)
Flexibility & Kink Test	(Implied: Maintain integrity and function when flexed/kinked)	Successfully completed (demonstrated flexibility and kink resistance)
Torque strength	(Implied: Withstand specified torque without failure)	Successfully completed (met torque strength specifications)
Biocompatibility (various tests listed)	(Implied: Non-toxic, non-irritating, non-sensitizing, non-hemolytic, non-pyrogenic)	Successfully completed (device found to be biocompatible)
Packaging and Sterilization Validation	(Implied: Maintain sterility and packaging integrity)	Successfully completed (packaging and sterilization validated)
Shelf Life (Accelerated Aging)	(Implied: Maintain performance and integrity over specified shelf life)	Successfully completed (demonstrated expected shelf life)

Additional Information

Sample sizes used for the test set and the data provenance:
The document does not specify the sample sizes used for each of the performance tests. The data provenance is not explicitly stated in terms of country of origin; however, the tests appear to be laboratory-based engineering and biocompatibility tests, not clinical studies. Therefore, terms like "retrospective" or "prospective" are not applicable in the typical clinical study sense.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable. The performance testing described consists of laboratory and bench testing, not assessments requiring expert "ground truth" establishment in a clinical or imaging context.
Adjudication method for the test set:
This information is not applicable, as the tests are not clinical assessments requiring adjudication.
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:
This information is not applicable. The device is a physical medical device (PTA Catheter), not an AI diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not applicable, as the device is a physical medical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not applicable in the clinical sense. The "ground truth" for the engineering and biocompatibility tests would be the established scientific and engineering principles, material specifications, and regulatory standards against which the device's physical and functional properties are measured/tested.
The sample size for the training set:
This information is not applicable, as the device is a physical medical device and does not involve AI algorithms that require training sets.
How the ground truth for the training set was established:
This information is not applicable, as the device is a physical medical device and does not involve AI algorithms.

Summary

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Kiii899
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04/30/10)

510(k) Summary

The 510(k) Summary is submitted in accordance with 21 CFR §807.92 and the requirements of the Safe Medical Device Act (SMDA) of 1990.

OCT - 3 2011

Submitter's Name	Abbott Vascular
Submitter's Address	3200 Lakeside Drive, Santa Clara, CA 95054
Telephone	(408) 845-0688
Fax	(408) 845-3743
Contact Person	Laarni Ricafort
Date Prepared	July 1, 2011
Device Trade Name	Armada 35 PTA CatheterArmada 35 LL PTA Catheter
Device Common Name	PTA Catheter
Device Classification Name	Catheter, angioplasty, peripheral, transluminal
Predicate Device Names	• ev3 Inc's EverCross™ OTW PTA DilatationCatheter (K110319, cleared 04/14/11)• Invatec Admiral XTREME™ PTA BalloonDilatation Catheter (K100921, cleared 04/30)

· Abbott Vascular's FoxCross PTA Catheter (K090509, cleared 03/20/09)

Device Description

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Indication for Use

This device is also indicated for stent post-dilatation in the peripheral vasculature.

Technological Characteristics

Comparisons to the predicate devices show that the technological characteristics such as product performance, design and intended use are substantially equivalent to the current marketed predicate devices.

Performance Data

Performance testing was successfully completed on the Armada 35/35 LL PTA Catheter. The following tests were conducted:

Balloon Preparation and Simulated Use (Trackability and Pushability) .
Balloon Preparation and Simulated Use (Withdrawal) .
Balloon Compliance (Diameter versus Pressure) �
. Balloon Dimensions (Tip Entry Profile +1mm)
Balloon Dimensions (Lesion Crossing Profile)
Balloon Dimensions (Deflated Balloon Profile) ●
Balloon Inflation/ Deflation Time .
. Longitudinal Growth of Balloon
. Rated Burst Pressure (RBP)
. Balloon Fatigue
RBP in Balloon-Expandable Stents .
RBP in Self-Expanding Stents .
. , Balloon Fatigue in Balloon-expandable Stent (Repeat Balloon Inflations in Stent)
Balloon Fatigue in Self-expanding Stent (Repeat Balloon Inflations in Stent)
. Tensile strength distal balloon welding
Tensile strength proximal balloon welding
. Tensile strength joint shaft/ manifold
. Withdrawal force through introducer sheath –short sheath
Withdrawal force through introducer sheath -long sheath .
Catheter Pullback Force into Short Sheath After Reinsertion ●
Catheter Pullback Force into Long Sheath After Reinsertion .
Guide wire Lumen Collapse .
Flexibility & Kink Test .
Torque strength .
Biocompatibility .
- · Cytotoxicity Qualitative (L929 MEM Elution Test- ISO) .

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Irritation Intracutaneous Irritation -- ISO .
Sensitization study Kligman Maximization Test ISO .
Acute Systemic Toxicity Systemic Injection Test -ISO .
Pyrogen Test Material Mediated ISO .
Hemolysis Rabbit Blood ASTM Direct and Indirect Contact .
In Vitro Hemocompatibility Assay -- ISO, Indirect Contract .
Complement Activation Assay (C3a & SC5b9) .
Packaging and Sterilization Validation ●
Shelf Life (Accelerated Aging) ●

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in capital letters. The text is arranged around the circle, following its curvature.

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

Abbott Vascular c/o Laarni Ricafort Regulatory Affairs Associate 3200 Lakeside Drive Santa Clara, CA 95054

OCT - 3 2011

Re: K111899

Trade/Device Name: Armada 35/35LL PTA Catheters Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT, DQY Dated: July 01, 2011 Received: July 05, 2011

Dear Ms. Ricafort:

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.

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Page 2 - Ms. Laarni Ricafort

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. Your 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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm1118001/ppef.com the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFF) 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 fire 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.

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): 4-11 | 899

Armada 35/Armada 35 LL PTA Catheter Device Names:

Indications for Use:

This device is also indicated for stent post-dilatation in the peripheral vasculature.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter_ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Z.M.2.

(Division Sign-Off) Division of Čardiovascular Devices

510(k) Number_k111899

Page 1 of 1

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).