The Edwards Balloon Catheter is used for balloon pulmonic valvuloplasty. The device consists of a nylon balloon, a thermoplastic elastomer (polyether block amide) multi-durometer braided shaft with 130 cm 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 4 cm and is offered in 16 mm, 20 mm, 23 mm and 25 mm diameters.

AI/ML Overview

The provided text does not contain information about specific acceptance criteria, reported device performance metrics, or a study that proves the device meets those criteria. The document is a 510(k) premarket notification for the Edwards Balloon Catheter, which primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing.

Here's an analysis based on the available information:

Acceptance Criteria and Reported Device Performance: This information is not present in the document. The document states that "Non-clinical testing was completed to demonstrate that the Edwards Balloon Catheter meets the established performance characteristics, and to verify that design requirements are satisfied," but it does not list these specific characteristics or the quantitative results.
Sample size used for the test set and the data provenance: Not applicable as no specific clinical or performance test sets with sample sizes are detailed. The testing mentioned is non-clinical (bench testing).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical test set requiring expert ground truth is described.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as no clinical test set requiring adjudication is described.
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 device is a medical catheter, not an AI-driven diagnostic or assistive device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a medical catheter, not an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The testing described is non-clinical (bench testing) to assess device integrity and function, not diagnostic accuracy against a ground truth.
The sample size for the training set: Not applicable as this is a physical medical device, not a machine learning algorithm requiring a training set.
How the ground truth for the training set was established: Not applicable as this is a physical medical device, not a machine learning algorithm.

Summary of Non-Clinical Testing (from the document):

The document lists the following non-clinical tests that were performed:

Biocompatibility evaluation per ISO 10993-1
Ethylene oxide sterilization validation
Package qualification
Device functional testing:
- Surface/visual Inspection
- Dimensional inspection
- Radiopacity
- Balloon diameter
- Insertion force into sheath
- Balloon inflation/deflation time
- Balloon compliance
- Catheter kink test
- Balloon catheter retrieval force
- Balloon fatigue and burst
- Leakage test
- Bond testing

The document concludes that "The Edwards Balloon Catheter is substantially equivalent to the predicate device, the NuMed Z-MED™ Balloon Dilatation Catheter" based on these non-clinical tests, and that "The differences between the subject and predicate devices do not have an adverse impact on safety or effectiveness, as demonstrated by bench testing." However, the specific quantitative acceptance criteria for each test and the precise performance results are not detailed in this public FDA letter.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing right, stacked on top of each other, with flowing lines beneath them.

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

January 07, 2016

Edwards Lifesciences LLC Mr. Chris Kennelly Regulatory Affairs Associate II One Edwards Way Irvine, California 92614

Re: K153069

Trade/Device Name: Edwards Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: OMZ Dated: October 21, 2015 Received: October 22, 2015

Dear Mr. Kennelly:

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 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.

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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. Hillebrenner

for

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) K153069

Device Name

Edwards Balloon Catheter

Indications for Use (Describe)

The Edwards Balloon Catheter is indicated for balloon pulmonic 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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510(k) Summary (K153069)

Submitter:	Edwards Lifesciences LLCOne Edwards WayIrvine, CA 92614
Contact:	Chris KennellyPhone: 949-250-2019Fax: 949-809-5655
Prepared:	October 20, 2015
Trade Name:	Edwards Balloon Catheter
Common Name:	Balloon valvuloplasty catheter
Classification:	Pulmonary (Pulmonic) Valvuloplasty Catheter, 21 CFR 870.1250Product Code: OMZ
Predicate Device:	NuMed Z-MEDTM Balloon Dilatation Catheter (K040830)

Device Description:

Indications for Use:

The Edwards Balloon Catheter is indicated for balloon pulmonic valvuloplasty.

Comparison to Predicate:

The Edwards Balloon Catheter is substantially equivalent to the predicate device in intended use, design, technology and performance. The Edwards Balloon Catheter differs from the predicate device in introducer size compatibility, rated burst pressure, catheter length, material composition and inflation method. The differences between the subject and predicate devices do not have an adverse impact on safety or effectiveness, as demonstrated by bench testing.

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Summary of Non-Clinical Testing:

Non-clinical testing was completed to demonstrate that the Edwards Balloon 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/deflation time, balloon compliance, catheter kink test, balloon catheter retrieval force, balloon fatigue and burst, leakage test, and bond testing.

Conclusion:

The Edwards Balloon Catheter is substantially equivalent to the predicate device, the NuMed Z-MED™ Balloon Dilatation Catheter.

Regulation Number and Section

§ 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).