(90 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a standard balloon catheter, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended for the "dilatation of lesions" and "treatment of obstructive lesions," which are therapeutic actions. It is a "Percutaneous Transluminal Angioplasty (PTA) Catheter" used to open narrowed blood vessels.
No
Explanation: The device description states its intended use is for "dilatation of lesions" and "stent post-dilatation," which are therapeutic procedures, not diagnostic ones.
No
The device description clearly details physical components like a balloon, catheter shaft, lumens, marker bands, and a y-arm luer, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for dilating blood vessels and fistulae within the body. This is a therapeutic procedure performed directly on the patient.
- Device Description: The description details a balloon catheter, which is a physical tool used for mechanical intervention within the circulatory system.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. IVDs are typically reagents, instruments, or systems used in a laboratory or point-of-care setting to analyze these specimens.
In summary, this device is a therapeutic medical device used for interventional procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
LIT, DQY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
renal, iliac, femoral, popliteal, tibial, and peroneal, arteries; peripheral vasculature; 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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)
- 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)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Kiii899
p, 1 of 3
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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 Catheter |
| Armada 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 Dilatation |
| Catheter (K110319, cleared 04/14/11) | |
| • Invatec Admiral XTREME™ PTA Balloon | |
| Dilatation Catheter (K100921, cleared 04/30) |
· Abbott Vascular's FoxCross PTA Catheter (K090509, cleared 03/20/09)
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.
1
Indication for Use
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.
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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KII 1899
p. 3 of 3
- 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) ●
3
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.
4
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.
/L
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): 4-11 | 899
Armada 35/Armada 35 LL PTA Catheter Device Names:
Indications for Use:
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.
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
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