The Fogarty dilation atrioseptostomy catheter is indicated for enlarging interatrial openings for palliation of several congenital cardiac defects to increase mixing at atrial level or to decompress a hypertensive atrial chamber.

The Miller balloon atrioseptostomy catheter is indicated for enlarging interatrial openings for palliation of several congenital cardiac defects to increase mixing at atrial level or to decompress a hypertensive atrial chamber.

Device Description

The Fogarty dilation atrioseptostomy catheter is a 5 French single-lumen catheter (with 8F uninflated balloon OD) with a wire-wound shaft that may be visualized using fluoroscopy. A latex balloon with a maximum inflated diameter of 15mm is located at the distal end of the catheter. The distal tip has a nominal angulation of 35° to facilitate manipulation of the inter-atrial opening. A removable stylet is provided to increase catheter body stiffness and for temporary straightening of the 35° tip angulation during insertion. The catheter contains a gate valve in order to inflate and deflate the balloon. The catheter shaft has depth markings in 10 cm spacing.

The Miller balloon atrioseptostomy catheter is a 5 French single-lumen catheter (with 9F uninflated balloon OD) with a wire-wound shaft that may be visualized using fluoroscopy. A latex balloon with a maximum inflated diameter of 19mm is located at the distal end of the catheter. The distal tip has a nominal angulation of 35° to facilitate manipulation of the balloon through the inter-atrial opening. A removable stylet is provided to increase catheter body stiffness and for temporary straightening of the 35° tip angulation during insertion. The catheter contains a gate valve in order to inflate and deflate the balloon. The catheter shaft has depth markings in 5 cm spacing. The Miller catheter contains a plug for occluding the vein or percutaneous sheath to reduce venous leakage.

The Fogarty dilation atrioseptostomy catheter and Miller balloon atrioseptostomy catheter are packaged in an identical tube configuration.

AI/ML Overview

The provided text is a 510(k) summary for the Fogarty Dilation Atrioseptostomy Catheter and Miller Balloon Atrioseptostomy Catheter. It focuses on demonstrating substantial equivalence to a predicate device based on design descriptions, intended use, indications for use, and a summary of non-clinical (bench) testing.

This document describes a medical device (catheter) and its regulatory clearance, not an AI/ML powered device, therefore, the information requested about acceptance criteria and studies proving the device meets the criteria in the context of AI/ML performance (e.g., sample size for test/training sets, experts for ground truth, MRMC studies, standalone performance) is not applicable to the provided content.

The document details the device's physical characteristics, its intended use (enlarging interatrial openings for palliation of congenital cardiac defects), and asserts substantial equivalence to a predicate device based on common intended use and similar technological characteristics, with minor modifications.

Here's what can be extracted regarding "acceptance criteria" from the provided text, interpreted as performance tests for the physical catheter device:

1. Table of Acceptance Criteria and Reported Device Performance:

The document summarizes "Performance testing" which acts as the acceptance criteria for the physical device. Specific numerical "reported device performance" values are not provided in this summary; rather, it lists the types of tests performed. It states that the devices meet the established performance criteria.

Acceptance Criteria (Performance Test)	Reported Device Performance
Visual/Dimensional Inspection	Met established criteria
- Catheter length	Met established criteria
- Catheter tip angle	Met established criteria
- Depth marker spacing	Met established criteria
- Balloon nominal diameter	Met established criteria
Balloon pull force	Met established criteria
Deflation time	Met established criteria
Introducer compatibility	Met established criteria
Joint strength testing	Met established criteria
Air Leakage	Met established criteria
Biocompatibility	Met established criteria
Sterilization	Validated
Shelf life	Validated
Packaging (bubble leak) validations	Validated

Regarding the other aspects you asked about, they are not present in this document as it does not concern an AI/ML powered device impacting diagnostic performance:

Sample size used for the test set and data provenance: Not applicable. These are physical device bench tests.
Number of experts used to establish the ground truth for the test set and qualifications: Not applicable. Ground truth for a physical device's performance usually comes from engineering specifications and physical measurements.
Adjudication method: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This is for diagnostic systems.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for a physical catheter.
The type of ground truth used: For these non-clinical tests, the "ground truth" would be the engineering specifications and established test methodologies for mechanical, material, and sterility properties.
The sample size for the training set: Not applicable (no AI/ML training).
How the ground truth for the training set was established: Not applicable (no AI/ML training).

Summary

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August 22, 2022

Edwards Lifesciences, LLC Mahvish Iqbal Senior Specialist, Regulatory Affairs One Edwards Way Irvine, California 92614

Re: K221528

Trade/Device Name: Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter Regulation Number: 21 CFR 870.5175 Regulation Name: Catheter, Septostomy Regulatory Class: Class II Product Code: DXF Dated: May 25, 2022 Received: May 26, 2022

Dear Mahvish Iqbal:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Rachel Neubrander Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K221528

Device Name

Fogarty Dilation Atrioseptostomy Catheter Miller Balloon Atrioseptostomy Catheter

Indications for Use (Describe)

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

Submitter:	Edwards Lifesciences LLCOne Edwards WayIrvine, CA 92614(949) 250-2500
Contact:	Mahvish Iqbal Phone: (949) 250-4994, Fax: (949) 809-5655
Prepared:	August 22, 2022
Trade Name:	Fogarty Dilation Atrioseptostomy Catheter, Model 830705F andMiller Balloon Atrioseptostomy Catheter, Model 830515F
Common Name:	Atrioseptostomy Catheter
Classification:	Catheter, Septostomy21 CFR 870.5175, Product Code DXF
Predicate Device:	Fogarty Dilation Catheter for Atrial Septostomy, Model 83-05-05F(Preamendment)

Device Description:

The Fogarty dilation atrioseptostomy catheter and Miller balloon atrioseptostomy catheter are packaged in an identical tube configuration.

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Intended Use:

The Fogarty dilation atrioseptostomy catheter and Miller balloon atrioseptostomy catheter are intended for use in atrioseptostomy procedures.

Indication:

Comparison to Predicate:

The Fogarty dilation and Miller balloon atrioseptostomy catheters are substantially equivalent to the predicate device. The subject devices' indications for use were clarified within the existing intended use and are similar to the preamendment device's indications for use. The subject devices have the same intended use as the predicate device.

The Fogarty dilation atrioseptostomy catheter has the same technological characteristics as the predicate device with the exception of minor modifications to the device packaging. The Miller balloon atrioseptostomy catheter has a larger balloon size, greater inflation volume and longer deflation time compared to the predicate device. These minor device differences do not introduce new issues of safety or effectiveness. The provided bench testing demonstrates the subject devices are substantially equivalent to the predicate.

Summary of Non-Clinical Testing:

Performance testing for the Fogarty dilation and Miller balloon atrioseptostomy catheters included the following:

. Design Verification
- o Visual/Dimensional Inspection
  - Catheter length .
  - . Catheter tip angle
  - . Depth marker spacing
  - Balloon nominal diameter
  - Balloon pull force o
  - Deflation time O
  - o Introducer compatibility
  - o Joint strength testing
  - o Air Leakage
Biocompatibility .

In addition, Edwards has performed sterilization, shelf life and packaging (bubble leak) validations.

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Conclusion:

Based on the performance testing and the technological characteristics, the Fogarty dilation atrioseptostomy catheter and Miller balloon atrioseptostomy catheter meet the established performance criteria and are substantially equivalent to the predicate device.

Regulation Number and Section

§ 870.5175 Septostomy catheter.

(a)
Identification. A septostomy catheter is a special balloon catheter that is used to create or enlarge the atrial septal defect found in the heart of certain infants.(b)
Classification. Class II (performance standards).