Armada 18 PTA Catheter

K151317 · Abbott Vascular · LIT · Jul 6, 2015 · Cardiovascular

Device Facts

• Record ID: K151317
• Device Name: Armada 18 PTA Catheter
• Applicant: Abbott Vascular
• Product Code: LIT · Cardiovascular
• Decision Date: Jul 6, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

Armada 18 PTA Catheter is an over-the-wire, 0.018" guide wire compatible catheter for percutaneous transluminal angioplasty. Device features single-layer balloon (2.0-6.0 mm diameter; 20-200 mm length) and catheter shaft (90 or 150 cm). Radiopaque marker bands facilitate balloon positioning relative to stenosis. Proximal adaptation arm with luer-lock connects to inflation device. Physician operates device in clinical setting to dilate arterial stenoses or dialysis fistulae, or post-dilate stents. Inflation of balloon via side port expands balloon to specific diameter at controlled pressures. Device is single-use and ethylene oxide sterilized.

Clinical Evidence

Bench testing only. Testing included dimensional verification, catheter preparation/delivery/retraction, rated burst pressure, fatigue, balloon compliance, inflation/deflation time, tensile strength, flexibility, kink test, torque strength, particulate evaluation, coating integrity, and accelerated aging. Biocompatibility testing included cytotoxicity, sensitization, acute systemic toxicity, material-mediated pyrogen, hemolysis, coagulation, and complement activation. All tests met acceptance criteria.

Technological Characteristics

Over-the-wire PTA catheter; 0.018" guide wire compatible. Single-layer balloon; 2.0-6.0 mm diameter; 20-200 mm length. Shaft lengths 90/150 cm. Radiopaque marker bands for positioning. Luer-lock inflation port. Ethylene oxide sterilization. Single-use.

Indications for Use

Indicated for patients requiring dilation of stenosis in femoral, popliteal, and renal arteries, treatment of obstructive lesions in native or synthetic arteriovenous dialysis fistulae, and post-dilatation of balloon-expandable and self-expanding stents.

Regulatory Classification

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.

Predicate Devices

• Armada 14 PTA Catheter (K102705)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

Type of Use (Select one or both, as applicable)

| <div> <span> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|-------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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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 | [phone] |
| 4. | Fax | [phone] |
| 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<br>(21 CFR 870.1250, LIT) |
| 10. | Predicate Device Name | Armada 14 PTA Catheter (K102705, cleared on<br>December 7, 2010) |

## 11. 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.

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#### 12. Indication for Use

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.

### 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.