The Amulet™ Steerable Delivery Sheath is designed to provide a pathway through which a device may be delivered. The sheath is provided in one size (14F), with a working length of 75 cm and a bi-directional distal tip to provide positioning in the cardiac anatomy. The handle is equipped with a deflection knob to deflect the tip clockwise 120° and counterclockwise 0°. The body of the sheath is radiopaque for visibility under fluoroscopy and has a marker band located in the distal tip. The dilator eases penetration of tissue. The sheath and dilator utilize a dual curve in two dimensions, resulting in a three-dimensional geometry. The 14F flush adapter facilitates the attachment of additional components.

AI/ML Overview

This document is a 510(k) clearance letter for a medical device called the "Amulet™ Steerable Delivery Sheath." The purpose of a 510(k) is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This process does not typically involve comprehensive clinical studies or complex AI performance evaluations.

Based on the provided text, the changes to the device are primarily related to manufacturing processes:

"The difference between the subject device and predicate is the in-process solvent used to prepare the surface of the distal tip PEBAX extrusions."
"Additionally, a tip bond tensile specification and in-process tensile test method are being implemented."

Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to non-clinical performance testing designed to show that these manufacturing changes do not negatively impact the device's function or safety, and that the new device remains substantially equivalent to the predicate. There is no mention of AI, human-in-the-loop studies, multi-reader multi-case studies, or complex ground truth establishment in this document.

Here's a breakdown of the information that can be extracted or inferred from the provided text, presented in the requested format, while acknowledging the severe limitations of this specific document for an "AI" type of study.

Acceptance Criteria and Device Performance for Amulet™ Steerable Delivery Sheath

Summary of Device Modification: The primary difference between the subject device and the predicate device is the "in-process solvent used to prepare the surface of the distal tip PEBAX extrusions." Additionally, a new "tip bond tensile specification and in-process tensile test method are being implemented." The submitted 510(k) is a "Special 510(k)," which is used for modifications to a manufacturer's own legally marketed device where the modified device does not raise new questions of safety and effectiveness.

Study Type: Non-clinical (benchtop) performance testing, process qualifications, and re-evaluation of biocompatibility and sterilization profiles for substantial equivalence demonstration. This is not a clinical study involving human patients, nor an AI performance study.

Table of Acceptance Criteria and Reported Device Performance (Non-Clinical):

Acceptance Criteria Category	Specific Acceptance Criteria (Inferred from testing purpose)	Reported Device Performance (as stated or implied)
Process Qualification	The device must maintain its intended performance characteristics despite changes in manufacturing solvent and the addition of a new tensile test.	"Product performance qualification (PPQ) testing was conducted to demonstrate that the Amulet Steerable Delivery Sheath met performance specifications impacted by these changes."
Occluder Retrievals	Capable of facilitating the specified number of occluder retrievals without compromise.	Met performance specifications; further details not provided, but implies successful performance.
Delivery Sheath & Implant Damage	No damage to the delivery sheath or the implant during simulated use that would compromise safety/efficacy.	Met performance specifications; implies no unacceptable damage observed.
Tensile Bonds During Handoff/Advancement	Tip bond strength must meet the new tensile specification to prevent separation or failure during use.	Met performance specifications, including the new tip bond tensile specification.
Biocompatibility	The modified device must remain biocompatible with patient contact type and duration equivalent to the predicate.	"No new materials of construction were introduced... Potential risks identified with changing the surface preparation chemical present negligible risk... no further testing was required." Implies prior biocompatibility data is still valid.
Sterilization & Microbiology	Maintain a Sterility Assurance Level (SAL) of 10⁻⁶ and demonstrate no increased microbiological or sterilization risk due to changes.	"The currently established SAL of 10⁻⁶ is not impacted by this change." "No increased microbiological or sterilization risk."

Important Note: The provided document is for a medical device modification, not an AI or diagnostic device. Therefore, many of the requested bullet points regarding AI-specific evaluation are not applicable. I will address them by stating their non-applicability.

Sample sizes used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a numerical value (N) for each test. For "Process Qualification," it refers to "Product performance qualification (PPQ) testing." This typically involves a defined number of units tested per batch or according to a statistical sampling plan (e.g., AQL tables), but the specific numbers are not disclosed in this summary.
- Data Provenance: This is non-clinical benchtop testing conducted by the manufacturer, Abbott Medical, in a laboratory setting. It is not patient data; therefore, "country of origin of the data" and "retrospective or prospective" are not applicable in their clinical sense. The testing is essentially "prospective" in that it's performed on newly manufactured samples of the modified device prior to marketing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is non-clinical benchtop testing of a physical medical device. "Ground truth" in the context of expert review (e.g., for AI image analysis) is not relevant here. Performance is measured against engineering specifications and industry standards by qualified engineers and technicians.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. As this is non-clinical engineering testing, there are no human "readers" or clinical "adjudication" in the sense of consensus on medical findings. Test results are compared against predefined acceptance criteria from engineering specifications.
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 document describes the clearance of a physical medical delivery sheath, not an AI-powered diagnostic device or a device intended for clinical interpretation improvement. No human reader studies or AI assistance are mentioned or relevant to this 510(k).
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device; there is no "algorithm only" performance to evaluate.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Engineering Specifications and Standardized Test Methods: The "ground truth" for this device's performance is established by predefined engineering specifications (e.g., tensile strength values, deflection angles, number of cycles) and adherence to recognized industry standards (e.g., ISO, ASTM). For biocompatibility, it's based on ISO 10993 standards and the assessment of material properties. For sterilization, it's based on ISO 11135 and a Sterility Assurance Level (SAL).
The sample size for the training set:
- Not Applicable. This device is not an AI model requiring a training set. The "training" for the device's performance is its design and manufacturing process, and its "experience" is validated through the non-clinical tests described.
How the ground truth for the training set was established:
- Not Applicable. As there is no AI training set, this question is not relevant. The device's foundational "ground truth" (its design and intended performance) is established through extensive engineering design, development, and risk assessment processes preceding this specific 510(k) modification.

Summary

FDA 510(k) Clearance Letter - Amulet™ Steerable Delivery Sheath

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.07.05

April 25, 2025

Abbott Medical
Meghann Kayoum
Senior Regulatory Affairs Specialist
177 County Road B East
St. Paul, Minnesota 55117

Re: K250426
Trade/Device Name: Amulet™ Steerable Delivery Sheath
Regulation Number: 21 CFR 870.1250
Regulation Name: Percutaneous Catheter
Regulatory Class: Class II
Product Code: DQY
Dated: February 13, 2025
Received: February 14, 2025

Dear Meghann Kayoum:

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 (the 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 available 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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K250426 - Meghann Kayoum Page 2

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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K250426 - Meghann Kayoum Page 3

assistance/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,

LYDIA S. GLAW -S
Digitally signed by LYDIA S. GLAW -S
Date: 2025.04.25 16:45:22 -04'00'

Lydia Glaw
Assistant Director
DHT2C: Division of Coronary and
Peripheral Intervention Devices
OHT2: Office of Cardiovascular Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

Page 4

FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.

510(k) Number (if known)
K250426

Device Name
Amulet™ Steerable Delivery Sheath

Indications for Use (Describe)
The Amulet™ Steerable Delivery Sheath is indicated to facilitate the delivery of the Amplatzer™ Amulet™ Left Atrial Appendage Occluder.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Page 5

510(k) SUMMARY

Amulet™ Steerable Delivery Sheath
Special 510(k)

Confidential
Page 1 of 2

The 510(k) summary is submitted in accordance with 21 CFR 807.92 and the requirements of the Safe Medical Device Act (SMDA) of 1990.

I. SUBMITTER INFORMATION

Submitter Name: Abbott Medical
Submitter Address: 177 County Road B East
St. Paul, MN 55117 USA
Phone: (651) 756-5833
Contact Person: Meghann Kayoum
Date Prepared: 13 February 2025

II. DEVICE

Name of Device: Amulet™ Steerable Delivery Sheath
Common Name: Catheter Delivery Sheath
Classification Name: Catheter, Percutaneous (21 CFR 870.1250)
Device Class: II
Product Code: DQY

III. PREDICATE DEVICES

Primary Predicate: Amulet™ Steerable Delivery Sheath (K232690, cleared 29 September 2023)

IV. DEVICE DESCRIPTION

V. INDICATIONS FOR USE

The Amulet™ Steerable Delivery Sheath is indicated to facilitate the delivery of the Amplatzer™ Amulet™ Left Atrial Appendage Occluder.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

The Amulet Steerable Delivery Sheath incorporates substantially equivalent design, function, packaging, sterilization process, materials, fundamental technology, indication for use, and operating principles as those shared by the predicate Amulet Steerable Delivery Sheath (K232690).

A comparison of the proposed Amulet Steerable Delivery Sheath and the predicate Amulet Steerable Delivery Sheath show these devices have substantially equivalent design characteristics, including a deflectable sheath, dilator, and adapter. The difference between the subject device and predicate is the in-process solvent used to prepare the surface of the distal tip PEBAX extrusions. Additionally, a tip bond tensile specification and in-process tensile test method are being implemented. The tip bond tensile specification aligns with currently defined product requirements.

K250426

Page 6

Amulet™ Steerable Delivery Sheath
Special 510(k)

510(k) SUMMARY

Confidential
Page 2 of 2

VII. SUMMARY OF NON-CLINICAL PERFORMANCE TESTING

The following testing was provided in support of a substantial equivalence determination.

Process Qualification

Product performance qualification (PPQ) testing was conducted to demonstrate that the Amulet Steerable Delivery Sheath met performance specifications impacted by these changes, including:

Number of Occluder Retrievals
Delivery Sheath and Implant Damage
Tensile Bonds During Handoff/Advancement

Biocompatibility

A biocompatibility safety evaluation of the Amulet Steerable Delivery Sheath was conducted in accordance with the FDA Guidance: Use of International Standard ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (2023), ISO 10993-1, ISO 14971, and ASTM F2475. No new materials of construction were introduced with this change, and the subject device has identical patient contact types and durations and the predicate device. Potential risks identified with changing the surface preparation chemical present negligible risk to the established biocompatibility profile of the device, and no further testing was required.

Sterilization and Microbiology

The Amulet Steerable Delivery Sheath is intended for single use only and is provided sterile via ethylene oxide (EO) gas to achieve a Sterility Assurance Level (SAL) of 10⁻⁶ per ISO 11135. There are no proposed changes to the sterilization method, sterilization facilities, packaging system, product design, or materials of construction with this change. A microbiology product assessment evaluated the microbiological impact of this change and determined there is no increased microbiological or sterilization risk. The currently established SAL of 10⁻⁶ is not impacted by this change.

VIII. CONCLUSION

Based on the indication for use, technological characteristics, and non-clinical performance testing provided, the subject Amulet Steerable Delivery Sheath device is substantially equivalent to the predicate Amulet Steerable Delivery Sheath (K232690). The Amulet Steerable Delivery Sheath should perform as intended in the specified use conditions.

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).