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.

AI/ML Overview

This document is a 510(k) summary for the Ascendra Balloon Aortic Valvuloplasty Catheter. It does not describe an AI/ML device or algorithm. Therefore, many of the requested fields are not applicable.

Here's an analysis based on the provided text, focusing on the device and its assessment, and stating "Not Applicable" for AI-specific questions:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (General Categories)	Reported Device Performance and Assessment
Biocompatibility	Met per ISO 10993-1.
Sterilization Efficacy	Ethylene oxide sterilization validated.
Packaging Integrity	Package qualification performed.
Device Functional Performance (e.g., integrity, dimensions, inflation, strength)	Non-clinical 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 (All concluded to demonstrate substantial equivalence)
Clinical Safety and Effectiveness	Literature review, comparison to currently marketed devices, and complaint analysis concluded that the use of Balloon Aortic Valvuloplasty (BAV) for predilation prior to TAVR or as a bridge to percutaneous/surgical aortic valve replacement is feasible and safe. This was supported by clinical trials reviewed as part of PMAs P110021 and P130009.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Test Set Sample Size: Not explicitly stated for non-clinical or clinical assessment. For non-clinical tests, it would refer to the number of devices tested for each functional criterion. For the clinical assessment, it
refers to a "literature review, comparison to currently marketed devices and complaint analysis" and the results of clinical trials (P110021 and P130009), but specific sample sizes of patients/cases used in the literature review or complaint analysis are not provided in this summary.
Data Provenance: Not specified in this 510(k) summary (e.g., country of origin). The clinical assessment relies on literature and existing PMA clinical trials.
Retrospective/Prospective: The literature review and complaint analysis would inherently involve retrospective data. The PMA clinical trials (P110021 and P130009) would have been prospective studies, but details are not provided here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not Applicable. This is a medical device (catheter), not an AI/ML diagnostic or image analysis device that requires expert-established ground truth for a test set. The clinical assessment relies on scientific literature, comparison to predicate devices, and results from pre-market approval (PMA) clinical trials.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not Applicable, as this is not an AI/ML device relying on human expert adjudication for image interpretation or diagnosis.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This is a medical device, not an AI/ML reading assistance tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not Applicable. This is a physical medical device (catheter), not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical testing, the "ground truth" would be established engineering specifications, ISO standards, and predicate device performance. For the clinical assessment, the "ground truth" on safety and feasibility is derived from comprehensive clinical outcomes data from literature reviews, comparison with predicate devices, complaint analysis, and the results of clinical trials (P110021 and P130009) that likely involved patient outcomes, physiological measurements, and possibly pathology or imaging interpretation in the context of valuloplasty.

8. The sample size for the training set

Not Applicable. This device does not use a training set as it is not an AI/ML algorithm.

9. How the ground truth for the training set was established

Not Applicable. This device does not use a training set.

Summary

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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

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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

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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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary

Submitter:	Edwards Lifesciences, LLCOne Edwards WayIrvine, 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 ValvuloplastyCatheter (K121083)
	NuMed Z-MED and Z-MED II™ Balloon Aortic Valvuloplasty Catheter(K122012)

Device Description:

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

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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.

Regulation Number and Section

§ 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.