(79 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a balloon catheter, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is used to perform balloon aortic valvuloplasty (BAV), a procedure to dilate a stenotic aortic valve, which is a therapeutic intervention.
No
Explanation: The device is a dilatant catheter used to widen a stenotic aortic valve, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly outlines a physical catheter with a balloon, guidewire lumen, and connectors, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "balloon aortic valvuloplasty," which is a procedure performed in vivo (within the body) to dilate a stenotic aortic valve.
- Device Description: The description details a catheter with an inflatable balloon designed for mechanical action within the body.
- 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 compatibility testing.
IVD devices are used to perform tests outside the body on biological samples. This device is used inside the body for a therapeutic procedure.
N/A
Intended Use / Indications for Use
The Ascendra Balloon Aortic Valvuloplasty Catheter is indicated for balloon aortic valvuloplasty.
Product codes (comma separated list FDA assigned to the subject device)
OZT
Device Description
The Edwards Ascendra Balloon Aortic Valvuloplasty Catheter is used for balloon aortic valvuloplasty. The device consists of a coaxial polyamide catheter with a distal inflatable polyamide balloon intended to dilate (perform valvuloplasty on) the stenotic aortic valve prior to implantation of a bioprosthesis. Two radiopaque marker bands indicate the dilating section of the balloon and aid in balloon placement. At the proximal end of the catheter, there is a standard "Y" connector for balloon inflation and a guidewire lumen. An inflation device may be connected directly or indirectly (using the supplied extension tubing) to the balloon inflation luer port of the catheter. The balloon is inflated by injecting a diluted contrast medium solution through the luer port (marked "BALLOON") on the "Y" connector. The device is supplied sterile for single use only. The BAVC is provided in a 20 mm size and is compatible with a 0.035" guidewire and a 14F sheath.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
aortic valve
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)
Non-clinical testing was completed to demonstrate that the Ascendra balloon aortic valvuloplasty catheter meets the established performance characteristics, and to verify that design requirements are satisfied. Testing included biocompatibility evaluation per ISO 10993-1, ethylene oxide sterilization validation, and package qualification. Device functional testing included surface/visual Inspection, dimensional inspection, radiopacity, balloon diameter, insertion force into sheath, balloon inflation time, balloon compliance, catheter kink test, balloon catheter retrieval force, balloon fatigue and burst, leakage test, bond testing. The conclusions drawn from the non-clinical tests demonstrated that the device is substantially equivalent to the predicate devices.
Clinical assessment for the Ascendra balloon aortic Valvuloplasty catheter consisted of a literature review, comparison to currently marketed devices and complaint analysis. The assessment concluded that the use of BAV to predilate the aortic valve prior to TAVR or as a bridge to percutaneous or surgical aortic valve replacement is feasible and safe. This analysis, in combination with the results of the clinical trials reviewed as part of PMA P110021 and P130009, provides reasonable assurance that the Ascendra balloon aortic Valvuloplasty catheter is safe and effective for its indicated use.
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
§ 870.1255 Balloon aortic valvuloplasty catheter.
(a)
Identification. A balloon aortic valvuloplasty catheter is a catheter with a balloon at the distal end of the shaft, which is intended to treat stenosis in the aortic valve when the balloon is expanded.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The device must be demonstrated to be biocompatible.
(2) Sterility and shelf life testing must demonstrate the sterility of patient-contacting components and the shelf life of these components.
(3) Non-clinical performance evaluation must demonstrate that the device performs as intended under anticipated conditions of use, including device delivery, inflation, deflation, and removal.
(4) In vivo evaluation of the device must demonstrate device performance, including the ability of the device to treat aortic stenosis.
(5) Labeling must include a detailed summary of the device-related and procedure-related complications pertinent to the use of the device.
0
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 29, 2014
Edwards Lifesciences % Ms. Susan Reynolds Regulatory Affairs Principal Project Manager One Edwards Way Irvine, California 92614
Re: K142199
Trade/Device Name: Ascendra Balloon Aortic Valvuloplasty Catheter Regulation Number: 21 CFR 870.1255 Regulation Name: Balloon Aortic Valvuloplasty Catheter Regulatory Class: Class II Product Code: OZT Dated: August 8, 2014 Received: August 11, 2014
Dear Ms. Susan Reynolds:
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
1
Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 (800) 638-2041 or (301) 796-7100 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" (21 CFR 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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
M.A. Hillebrand
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Ascendra Balloon Aortic Valvuloplasty Catheter
Indications for Use (Describe)
The Ascendra Balloon Aortic Valvuloplasty Catheter is indicated for balloon aortic valvuloplasty.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
| Submitter: | Edwards Lifesciences, LLC
One Edwards Way
Irvine, CA 92614 |
|----------------------|-------------------------------------------------------------------------------------|
| Contact: | Susan Reynolds, Phone: 949-756-4518, Fax: 949-809-5655 |
| Prepared: | August 8, 2014 |
| Trade Name: | Ascendra Balloon Aortic Valvuloplasty Catheter |
| Common Name: | Balloon aortic valvuloplasty catheter |
| Classification: | Balloon aortic valvuloplasty catheter, 21 CFR 870.1255,
Product Code OZT |
| Predicate Device(s): | Loma Vista Medical (BARD) TRUE Dilation Balloon Valvuloplasty
Catheter (K121083) |
| | NuMed Z-MED and Z-MED II™ Balloon Aortic Valvuloplasty Catheter
(K122012) |
Device Description:
The Edwards Ascendra Balloon Aortic Valvuloplasty Catheter is used for balloon aortic valvuloplasty. The device consists of a coaxial polyamide catheter with a distal inflatable polyamide balloon intended to dilate (perform valvuloplasty on) the stenotic aortic valve prior to implantation of a bioprosthesis. Two radiopaque marker bands indicate the dilating section of the balloon and aid in balloon placement. At the proximal end of the catheter, there is a standard "Y" connector for balloon inflation and a guidewire lumen. An inflation device may be connected directly or indirectly (using the supplied extension tubing) to the balloon inflation luer port of the catheter. The balloon is inflated by injecting a diluted contrast medium solution through the luer port (marked "BALLOON") on the "Y" connector. The device is supplied sterile for single use only. The BAVC is provided in a 20 mm size and is compatible with a 0.035" guidewire and a 14F sheath.
Indications for Use:
The Ascendra Balloon Aortic Valvuloplasty Catheter is indicated for balloon aortic valvuloplasty.
Comparison to Predicate:
The BAVC is substantially equivalent to Loma Vista Medical (BARD) TRUE Dilation Catheter, 510(k) No.: K121083 and the NuMed Z-MED and Z-MED II™ Balloon Aortic
4
Valvuloplasty Catheter, 510(k) No.: K122012 in intended use, design, technology and performance. The BAVC differs from the predicate devices in length.
Summary of Non-Clinical Testing:
Non-clinical testing was completed to demonstrate that the Ascendra balloon aortic valvuloplasty catheter meets the established performance characteristics, and to verify that design requirements are satisfied. Testing included biocompatibility evaluation per ISO 10993-1, ethylene oxide sterilization validation, and package qualification. Device functional testing included surface/visual Inspection, dimensional inspection, radiopacity, balloon diameter, insertion force into sheath, balloon inflation time, balloon compliance, catheter kink test, balloon catheter retrieval force, balloon fatigue and burst, leakage test, bond testing. The conclusions drawn from the non-clinical tests demonstrated that the device is substantially equivalent to the predicate devices.
Summary of Clinical Data:
Clinical assessment for the Ascendra balloon aortic Valvuloplasty catheter consisted of a literature review, comparison to currently marketed devices and complaint analysis. The assessment concluded that the use of BAV to predilate the aortic valve prior to TAVR or as a bridge to percutaneous or surgical aortic valve replacement is feasible and safe. This analysis, in combination with the results of the clinical trials reviewed as part of PMA P110021 and P130009, provides reasonable assurance that the Ascendra balloon aortic Valvuloplasty catheter is safe and effective for its indicated use.
Conclusion:
The Edwards Catheter is substantially equivalent to the predicate devices, Loma Vista Medical (BARD) TRUE Dilation Catheter and the NuMed Z-MED and Z-MED II™ Balloon Aortic Valvuloplasty Catheter.