The Edwards Balloon Catheter, is used for balloon aortic valvuloplasty. The device consists of a nylon balloon, a thermoplastic elastomer (Polyether block amide) multidurometer braided shaft with 130cm working length, platinum/iridium radio-detectable markers, and a polycarbonate y-connector that consists of a balloon inflation port and guidewire lumen. The effective length of the balloon is 4cm and is offered in 16mm, 20mm, 23mm and 25mm diameters. The balloon catheter is supplied sterilized by ethylene oxide for single use.

AI/ML Overview

The provided text is a 510(k) summary for the Edwards Balloon Catheter, intended for balloon aortic valvuloplasty. It details non-clinical testing performed to demonstrate performance. However, the document does not contain the specific acceptance criteria or a dedicated study explicitly proving the device meets these criteria in the format requested.

The summary describes general non-clinical testing and refers to a "Summary of Clinical Data" that involved a literature review, complaint analyses, and a review of post-market experience, as well as an IDE study (G030069) with a predicate device. This suggests that the clinical evidence for substantial equivalence was derived from existing data and comparisons rather than a new standalone clinical study with the specific Edwards Balloon Catheter.

Therefore, many of the requested fields cannot be filled directly from the provided text.

Here is an attempt to address the request based on the available information, noting where information is not present:

Acceptance Criteria and Device Performance Study for Edwards Balloon Catheter

The provided 510(k) summary for the Edwards Balloon Catheter does not explicitly state quantitative acceptance criteria or a dedicated clinical study designed to demonstrate the device meets those criteria. Instead, it relies on non-clinical performance testing, a literature review, complaint analyses, and a review of post-market experience, along with referencing the pivotal IDE study (G030069) conducted with a predicate device (RetroFlex Balloon Catheter). The underlying assumption is that if the non-clinical performance matches predicate devices and clinical history supports safety and effectiveness, then the device is substantially equivalent.

1. Table of Acceptance Criteria and Reported Device Performance

As specific quantitative "acceptance criteria" for demonstrating substantial equivalence for clinical performance are not delineated in the provided summary, a direct table cannot be constructed. The summary lists various non-clinical tests performed, and implicitly, the device passed these tests to demonstrate manufacturing quality and basic functionality.

Criterion Category (Non-Clinical)	Acceptance Criteria (Implicit - device met requirements)	Reported Device Performance
Biocompatibility	Per ISO 10993-1	Met ISO 10993-1
Sterilization	Validated Ethylene Oxide Sterilization	Validated
Package Qualification	Qualified	Qualified
Surface/Visual Inspection	Compliant with specifications	Passed
Dimensional Inspection (Catheter & Balloon)	Compliant with specifications	Passed
Balloon Inflation/Deflation Time	Within specified range	Met specifications
Balloon Maximum Inflation Pressure	Maintained nominal volume at max pressure	Met specifications
Balloon Diameter at Nominal Volume	Compliant with specifications	Met specifications
Balloon Catheter Retrieval Force	Within specified range	Met specifications
Balloon Fatigue and Burst	Withstood fatigue and burst pressure	Met specifications
Marker Band Bond Verification	Verified	Verified
Bond Strength (Shaft/Hub - Normal)	Compliant with specifications	Met specifications
Bond Strength (Shaft/Hub - Torque)	Compliant with specifications	Met specifications

Note: The "Acceptance Criteria" listed above are inferred as "met specifications" since no specific values are provided in the summary. The "Reported Device Performance" simply states that the tests were completed and presumably met the internal requirements for substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

Clinical Test Set: No specific clinical "test set" in the context of a prospective study for the Edwards Balloon Catheter is described. The "clinical assessment" relied on:
- Literature Review: Provenance unspecified.
- Complaint Analyses: For the Edwards Transfemoral Balloon Catheter and RetroFlex Balloon Catheter. Provenance is likely from post-market surveillance data, potentially global, but not specified.
- Review of Post-Market Experience: With the Edwards Transfemoral Balloon Catheter. Provenance is likely from post-market surveillance data, potentially global, but not specified.
- Pivotal IDE Study (G030069) with RetroFlex Balloon Catheter: This was a study for a predicate device. The sample size and provenance for this specific study are not detailed in the provided 510(k) summary, but it would have been prospective clinical data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the summary, as there was no standalone clinical study described for the Edwards Balloon Catheter that would involve experts establishing ground truth for efficacy or safety endpoints. The clinical assessment relies on aggregated literature, complaint data, and a predicate device's IDE study.

4. Adjudication Method for the Test Set

This information is not provided as there was no standalone clinical study for the Edwards Balloon Catheter involving a test set that would require adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was reported. The device is a physical medical device (balloon catheter) and not an imaging or diagnostic AI system, so an MRMC study comparing human readers with and without AI assistance would not be applicable here.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop)

Not applicable. This device is a physical, invasive medical device used for a therapeutic procedure, not an algorithm or AI system. Its performance inherently involves human interaction (a surgeon or interventional cardiologist).

7. Type of Ground Truth Used

Given the context of a medical device 510(k) for a balloon catheter, "ground truth" would typically refer to clinical outcomes (e.g., successful valvuloplasty, adverse event rates, hemodynamic improvements). However, for the Edwards Balloon Catheter, the summary indicates that substantial equivalence was demonstrated through:

Non-clinical testing: Demonstrating that the physical device functions as intended and meets design specifications (e.g., burst pressure, inflation/deflation time).
Clinical assessment by proxy: Relying on the established safety and effectiveness of predicate devices (including the pivotal IDE G030069 for the RetroFlex Balloon Catheter), literature, and post-market surveillance data. The "ground truth" for the predicate device's IDE study would have been defined clinical outcomes (e.g., patient survival, complication rates, hemodynamic improvements assessed by objective measures) relevant to balloon aortic valvuloplasty.

8. Sample Size for the Training Set

Not applicable/Not provided. This is not an AI/algorithm-based device that would typically have a "training set" in the computational sense. The "training" for the design and manufacturing of the device would come from engineering principles, predicate device experience, and manufacturing processes.

9. How the Ground Truth for the Training Set Was Established

Not applicable/Not provided. As stated above, this is not an AI/algorithm-based device. For the predicate device's IDE study, the ground truth would have been established through standard clinical trial methodologies, including patient enrollment, clinical follow-up, and objective measurements of outcomes.

Summary

{0}------------------------------------------------

	510(k) Summary
--	----------------

JUL 0 3 2014

Submitter:	Edwards Lifesciences, LLCOne Edwards WayIrvine, CA 92614
Contact:	Eric Carrier, Phone: 949-250-6443, Fax: 949-809-5655
Prepared:	January 28, 2014
Trade Name:	Balloon Catheter
Common Name:	Percutaneous Catheter
Classification:	Catheter Introducer21 CFR 870.1250, Product Code OZT
PredicateDevice(s):	Loma Vista Medical (BARD) TRUE Dilation Balloon ValvuloplastyCatheter (K121083), and the Z-MED and Z-MED II™ Balloon AorticValvuloplasty & Percutaneous Transluminal Valvuloplasty Catheter(K122012).

Device Description:

Indication:

The Edwards Balloon Catheter is indicated for balloon aortic valvuloplasty.

Comparison to Predicate:

The Edwards Balloon Catheter is substantially equivalent to Loma Vista Medical (BARD) TRUE Dilation Catheter, 510(k) No .: K121083 and the Z-MED and Z-MED II™ Balloon Apric Valvuloplasty & Percutaneous Transluminal Valvuloplasty Catheter, 510(k) No.: K122012.

Summary of Non-Clinical Testing:

Non-clinical testing was completed to demonstrate that the Edwards Balloon Catheter met 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: Catheter and Balloon Working Length, Balloon

{1}------------------------------------------------

K140241 page 2 of 2

Inflation/Deflation Time, Balloon Maximum Inflation Pressure for Nominal Volume, Balloon Diameter at Nominal Volume, Balloon Catheter Retrieval Force, Balloon Fatigue and Burst, Marker Band Bond Verification, Bond Strength: Catheter Shaft/Hub, and Bond Strength: Catheter Shaft/Hub (Torque).

Summary of Clinical Data:

Clinical assessment for the Edwards Transfemoral Balloon Catheters consisted of a literature review, complaint analyses for the Edwards Transfemoral Balloon Catheter and RetroFlex Balloon Catheter, and review of post-market experience with the Edwards Transfemoral Balloon Catheter. This data, in combination with the results of the pivotal IDE G030069 (with the RetroFlex Balloon Catheter) reviewed as part of PMA P100041, provides reasonable assurance that the Edwards Transfemoral Balloon 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 the Z-MED and Z-MED II™ Balloon Aortic Valvuloplasty & Percutaneous Transluminal Valvuloplasty Catheter.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 20, 2015

Edwards Lifesciences, LLC. Eric Carrier Sr. Manager, Regulatory Affairs One Edwards Way Irvine, CA 92614

Re: K140241

Trade/Device Name: Edwards Balloon Catheter Regulation Number: 21 CFR 870.1255 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: OZT Dated: June 4, 2014 Received: June 5, 2014

Dear Mr. Carrier:

This letter corrects our substantially equivalent letter of July 3, 2014.

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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

{3}------------------------------------------------

Page 2 - Mr. Eric Carrier

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 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" (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 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,

Nicole G. Ibrahim -S

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

K140241

Indications For Use Statement

510(k) Number (if known)
Device Name	Edwards Balloon Catheter
Indications for Use	The Edwards Balloon Catheter is indicated for balloon aortic valvuloplasty.

PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

M.A. Zillaham

Prescription Use メ (Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

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.