(103 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and performance of a balloon catheter, with no mention of AI or ML technology.
Yes
The device is indicated to dilate stenoses in various arteries and for the treatment of obstructive lesions, which directly addresses a medical condition rather than just providing diagnostic information.
No
Explanation: The device's intended use is to dilate stenoses and treat obstructive lesions, which are therapeutic actions, not diagnostic ones. The description details a balloon catheter used for mechanical intervention.
No
The device description clearly details a physical catheter with a balloon, guide wire lumen, and other hardware components. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used to physically dilate blood vessels and fistulae. This is an in vivo procedure (performed within the living body).
- Device Description: The description details a catheter with a balloon designed for mechanical dilation. This aligns with an interventional medical device, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely mechanical and interventional.
N/A
Intended Use / Indications for Use
The device is indicated to dilate stenoses in femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The 2.0 to 5.0 mm balloon diameters are also indicated for post-dilatation of balloon-expandable stents.
Product codes
LIT, DQY
Device Description
The Armada 14 XT PTA Catheter is an over-the-wire co-axial design with a balloon at the distal tip. The balloon segment expands to a known diameter and length at a specific inflation pressure and has radiopaque marker(s) under the balloon to aid in positioning the balloon in a stenosis. The co-axial shaft consists of a tubular inner and outer member. The inner lumen permits the use of a guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. The outer lumen provides for inflation and deflation of the balloon with contrast fluid. Along the proximal portion of the shaft are brachial and femoral markers to aid in gauging the catheter's position relative to the guiding catheter tip when introducing the catheter through the guiding catheter. An adaption arm is located at the proximal end to provide access to the inflation lumen and guide wire lumen and allows connection with an inflation device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral, popliteal, infra popliteal and renal arteries and native or synthetic arteriovenous dialysis fistulae.
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
Bench and biocompatibility testing. The following tests were conducted: Balloon Crossing Profile, Refolded Balloon Profile, Guide wire Lumen ID, Total Catheter Length, Minimum Balloon Burst Strength (Rated Burst Pressure, RBP), Balloon Compliance (Diameter vs. Pressure), Balloon Inflation/ Deflation Time, Balloon Fatigue (Repeat Balloon Inflations), Tensile strength - Proximal Adaptation, Tensile strength - Proximal Balloon Seal, Tensile strength Distal Outer Member to Proximal Shaft, Tensile strength Soft Tip to Inner Member Seal, Catheter Flexibility & Kink Test, Torque Strength, Radiopacity, Minimum Balloon Burst Strength (RBP) Within Stent, Balloon Fatigue Within Stent (Repeat Balloon Inflations in Stent), Shelf Life (Accelerated Aging). Biocompatibility testing included cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, hemolysis, pyrogen, and complement activation. The tests demonstrated that the Armada 14 XT PTA Catheters met all acceptance criteria and performed similarly to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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.
AUG 1 5 2012
Submitter's Name Submitter's Address Telephone Fax Contact Person Date Prepared Device Trade Name Device Common Name Device Classification Name Predicate Device Names
Abbott Vascular 3200 Lakeside Drive, Santa Clara, CA 95054 (408) 845-0682 (408) 845-3743 Ivalee Cohen May 2, 2012 Armada 14 XT PTA Catheter PTA Catheter Catheter, angioplasty, peripheral, transluminal, LIT • Abbott Vascular TREK OTW & MINI TREK OTW Coronary Dilatation Catheter (K103011, cleared 1/10/11 and K110617, cleared 6/2/11)
· Abbott Vascular Armada 14 PTA Catheter (K102705, cleared 12/7/10)
Device Description
The Armada 14 XT PTA Catheter is an over-the-wire co-axial design with a balloon at the distal tip. The balloon segment expands to a known diameter and length at a specific inflation pressure and has radiopaque marker(s) under the balloon to aid in positioning the balloon in a stenosis. The co-axial shaft consists of a tubular inner and outer member. The inner lumen permits the use of a guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. The outer lumen provides for inflation and deflation of the balloon with contrast fluid. Along the proximal portion of the shaft are brachial and femoral markers to aid in gauging the catheter's position relative to the guiding catheter tip when introducing the catheter through the guiding catheter. An adaption arm is located at the proximal end to provide access to the inflation lumen and guide wire lumen and allows connection with an inflation device.
Indication for Use
The device is indicated to dilate stenoses in femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The 2.0 to 5.0 mm balloon diameters are also indicated for postdilatation of balloon-expandable stents.
1
Technological Characteristics
The subject Armada 14 XT PTA Catheter has the same fundamental scientific technology (operating principle) and indication for use as the Armada 14 predicate device and shares the same materials, design, labeling, packaging materials, shelf life and sterilization process as the TREK and MINI-TREK predicate devices.
Performance Data
Performance testing was successfully completed on the Armada 14 XT PTA Catheter.
The following tests were conducted:
- . Balloon Crossing Profile
- Refolded Balloon Profile .
- Guide wire Lumen ID .
- . Total Catheter Length
- Minimum Balloon Burst Strength (Rated Burst Pressure, RBP) .
- Balloon Compliance (Diameter vs. Pressure) .
- . Balloon Inflation/ Deflation Time
- Balloon Fatigue (Repeat Balloon Inflations) ●
- . Tensile strength - Proximal Adaptation
- . Tensile strength - Proximal Balloon Seal
- Tensile strength Distal Outer Member to Proximal Shaft .
- Tensile strength Soft Tip to Inner Member Seal ●
- Catheter Flexibility & Kink Test
- Torque Strength .
- . Radiopacity
- Minimum Balloon Burst Strength (RBP) Within Stent �
- Balloon Fatigue Within Stent (Repeat Balloon Inflations in Stent) ●
- Shelf Life (Accelerated Aging)
Biocompatibility testing included cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, hemolysis, pyrogen, and complement activation.
Conclusion
The in vitro bench and biocompatibility tests demonstrated that the Armada 14 XT PTA Catheters met all acceptance criteria and performed similarly to the predicate devices. No new safety or effectiveness issues were raised during the testing program and, therefore, these devices may be considered substantially equivalent to the predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
AUG 15 2012
Abbott Vascular c/o Ivalee Cohen 3200 Lakeside Drive Santa Clara, CA 95054
Re: K121352
Trade/Device Name: Armada 14 XT PTA Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT, DQY Dated: May 02, 2012 Received: May 04, 2012
Dear Ms. Cohen:
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 provisions of the Federal rood, Drily, 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 informations against missianuly and 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 offecting 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.
3
Page 2 - Ms. Ivalee Cohen
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 modical 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 electionic 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,htmfor for for for for for for for for for for for for for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, Jease 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 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.
.s.kiel
Go 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
K121352 510(k) Number (if known):
Device Names:
、
Armada 14 XT PTA Catheter
Indications for Use:
The device is indicated to dilate stenoses in femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The 2.0 to 5.0 mm balloon diameters are also indicated for post-dilatation of balloon-expandable stents.
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)
Cuañillele
(Division Sign-Off) Division of Cardiovascular Devices
Page 1 of
化1252 510(k) Number_