(78 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and function of a standard balloon catheter, with no mention of AI/ML or related concepts like image processing, training/test sets, or performance metrics typically associated with AI/ML algorithms.
Yes.
The device is indicated to dilate stenoses in various arteries and for the treatment of obstructive lesions, which are therapeutic interventions.
No
The device is a balloon catheter used for percutaneous transluminal angioplasty (PTA) to dilate stenoses and treat obstructive lesions, which are therapeutic actions, not diagnostic ones.
No
The device description clearly describes a physical balloon catheter with various hardware components (balloon, catheter shaft, marker bands, y-arm fuer). The performance studies also focus on the physical properties and performance of this hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. These tests are performed outside the body.
- Device Description and Intended Use: The provided information clearly describes a catheter with a balloon used for percutaneous transluminal angioplasty (PTA). This is a procedure performed inside the body to dilate blood vessels.
- Lack of Diagnostic Testing: There is no mention of analyzing samples, performing tests on bodily fluids, or providing diagnostic information based on laboratory analysis.
The device is an interventional medical device used for a therapeutic procedure.
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 4.0 mm balloon diameters are also indicated for post-dilatation of balloon-expandable stents up to 40 mm and self-expanding stents up to 80 mm in the vessels listed above.
Product codes (comma separated list FDA assigned to the subject device)
LIT, DQY
Device Description
The Armada 14 PTA Catheter is a standard over-the-wire (OTW) balloon catheter to be used for percutaneous transluminal angioplasty (PTA). It is available in balloon lengths of 20 mm to 200 mm, with nominal diameters of 1.5 mm to 4.0 mm. The balloon has a nominal diameter inflation pressure of 8 atm and a rated burst pressure of 14 atm. Two polymer marker bands mark the working length of the balloons. The catheter shaft has working lengths of 90 and 150 cm. The inner lumen will accept a 0.014" guide wire. The outer shaft has a polycarbonate y-arm fuer 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
femoral, popliteal, infra popliteal and renal arteries
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 14 PTA Catheter. The following tests were conducted:
- Simulated Use (Pushability) .
- Balloon Compliance ●
- Delivery System Dimensions .
- . Balloon Dimensions
- Catheter Bond Tensile Testing ●
- Pullback Force into Sheath
- Balloon Inflation/Deflation Time .
- Catheter Body Burst Pressure
- Guide Wire Lumen Collapse
- Balloon Preparation and Flexibility and Kink Test ◆
- Torque Strength .
- Minimum Balloon Burst Strength (RBP) .
- . Balloon Fatigue (Repeat Balloon Inflations)
- Minimum Balloon Burst Strength in Stent .
- . Balloon Fatigue (Repeated Inflations) in Stent
- . Biocompatibility
- Cytotoxicity Qualitative (L929 MEM Elution Test- ISO) .
- . Irritation - Intracutaneous Irritation -- ISO
- Sensitization study -- Murine Local Lymph Node Assay -- ISO .
- . Acute Systemic Toxicity -- ISO
- Pyrogen - Study Material Mediated -- ISO
- Hemocompatibility Investigations Direct Method .
- Hemocompatibility Investigations Indirect method study .
- Complement Activation (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.
K072798, K050073, K052791, K083919
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
K102705 DEC - 7 2010
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.
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) 845-0688 (408) 845-3743 Laarni Ricafort September 14, 2010 Armada 14 PTA Catheter PTA Catheter Catheter, angioplasty, peripheral, transluminal VIATRAC 14 PLUS Peripheral Dilatation Catheter (K072798, cleared 01/21/08)
Amphirion Deep 0.014 OTW PTA Balloon Catheter (K050073 cleared 2/11/05, K052791 cleared 11/04/05, and K083919, cleared 03/13/09)
Device Description
The Armada 14 PTA Catheter is a standard over-the-wire (OTW) balloon catheter to be used for percutaneous transluminal angioplasty (PTA). It is available in balloon lengths of 20 mm to 200 mm, with nominal diameters of 1.5 mm to 4.0 mm. The balloon has a nominal diameter inflation pressure of 8 atm and a rated burst pressure of 14 atm. Two polymer marker bands mark the working length of the balloons. The catheter shaft has working lengths of 90 and 150 cm. The inner lumen will accept a 0.014" guide wire. The outer shaft has a polycarbonate y-arm fuer 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.
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 4.0 mm balloon diameters are also indicated for postdilatation of balloon-expandable stents up to 40 mm and self-expanding stents up to 80 mm in the vessels listed above.
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.
1
Performance Data
Performance testing was successfully completed on the Armada 14 PTA Catheter. The following tests were conducted:
- Simulated Use (Pushability) .
- Balloon Compliance ●
- Delivery System Dimensions .
- . Balloon Dimensions
- Catheter Bond Tensile Testing ●
- Pullback Force into Sheath �
- Balloon Inflation/Deflation Time .
- Catheter Body Burst Pressure �
- � Guide Wire Lumen Collapse
- Balloon Preparation and Flexibility and Kink Test ◆
- Torque Strength .
- Minimum Balloon Burst Strength (RBP) .
- . Balloon Fatigue (Repeat Balloon Inflations)
- Minimum Balloon Burst Strength in Stent .
- . Balloon Fatigue (Repeated Inflations) in Stent
- . Biocompatibility
- Cytotoxicity Qualitative (L929 MEM Elution Test- ISO) .
- . Irritation - Intracutaneous Irritation -- ISO
- Sensitization study -- Murine Local Lymph Node Assay -- ISO .
- . Acute Systemic Toxicity -- ISO
- Pyrogen - Study Material Mediated -- ISO
- Hemocompatibility Investigations Direct Method .
- Hemocompatibility Investigations Indirect method study .
- Complement Activation (C3a & SC5b9) .
- Packaging and Sterilization Validation .
- Shelf Life (Accelerated Aging) .
2
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
DEC - 7 2010
Re: K102705
Trade/Device Name: Armada 14 PTA Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT, DQY Dated: September 17, 2010 Received: September 20, 2010
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., Or re 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. However, we remind you 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.
3
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. 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 devicerelated 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/ucm115809.htm for 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" (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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
orma R. Valumer
Bram Zuckerman, M.D. - Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATION FOR USE STATEMENT
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Armada 14 PTA Catheter Device Names:
Indications The device is indicated to dilate stenoses in femoral, popliteal, infra for Use: popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The 2.0 to 4.0 mm balloon diameters are also indicated for post-dilatation of balloon-expandable stents up to 40 mm and self-expanding stents up to 80 mm in the vessels listed above.
Prescription Use_ X (Per 21 CFR 801.109)
Over-The-Counter (Optional Format 1-1-96)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duma R. V. Limes
Division Sign-Off) ാസ്ട്രാസ of Cardiovascular Devices
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