The Amplatzer Steerable Delivery Sheath is a sterile (EO), single use sheath designed to provide a pathway through which a device may be delivery sheath is available in one size, 14F. The sheath will be used to deliver an Amplatzer Amulet™ Left Atrial Appendage Occluder. The Amplatzer™ Steerable Delivery Sheath is comprised of three components: a sheath to deliver the device, a dilator to ease penetration of tissue, and a 2X to 1X Flush Adapter to facilitate connection of additional device components.

The sheath is comprised of the distal tip, sheath body and sheath handle. The distal tip design utilizes a dual fixed curve in two dimensions, resulting in a three-dimensional geometry. The sheath body is radiopague for visibility under fluoroscopy and includes a marker band located in the distal tip to aid with visualization during device deployment and recapture. The Steerable Sheath device has been designed with a bi-directional distal tip which is controlled by pull-wires along the sheath body connected to the device handle to provide better co-axial alignment between the appendage and sheath, allowing for more accurate device placement. Additionally, a hemostasis valve and side port are integrated in the device handle to support improved procedural hemostasis control and ease of use. The sheath has an effective length of 75 cm and 98.5 cm overall length. The sheath is compatible with a 0.35" guidewire and a 19F introducer.

This Special 510(k) is being submitted to add additional precautions and updated procedural steps to the Instructions for Use (IFU) of the Amplatzer Steerable Delivery Sheath.

AI/ML Overview

This appears to be a 510(k) summary for the Amplatzer™ Steerable Delivery Sheath. Based on the provided text, the submission is a "Special 510(k)" to add additional precautions and updated procedural steps to the Instructions for Use (IFU).

Crucially, the document states: "There are no changes in technological characteristics from the predicate device." and "As there are no changes in the indication for use, intended use, technological characteristics, the Amplatzer Steerable Delivery Sheath is substantially equivalent to the primary predicate device (K212026)."

This means that the provided document does not contain the full details of the original acceptance criteria and the study that proved the device met those criteria, as it refers back to the predicate device (K212026) for the substantial equivalence. The current submission only addresses the safety and effectiveness of the updated IFU, primarily through a Human Factors evaluation.

Therefore, I cannot fully complete the requested table and answer all questions based solely on the provided text. I can only infer what kind of testing would have been done for the original clearance based on typical medical device regulations and what is mentioned about the current submission.

Here's what can be extracted and inferred from the provided text regarding this specific 510(k) submission:

Device: Amplatzer™ Steerable Delivery Sheath

Reason for this 510(k) Submission (K220340): To add additional precautions and updated procedural steps to the Instructions for Use (IFU).

Key Statement: "There are no changes in technological characteristics from the predicate device."

Acceptance Criteria and Device Performance (Based on this Special 510(k) submission)

Acceptance Criteria	Reported Device Performance
Updated IFU does not introduce new user-device interactions that compromise safety or effectiveness.	"It was concluded that use of the Amplatzer Steerable Delivery Sheath with the updated IFU remains safe and effective for the intended users, uses, and use environments." (Based on Human Factors evaluation)

Study Information (Based on this Special 510(k) submission):

Sample size used for the test set and the data provenance: Not explicitly stated, but the study type is a "Human Factors evaluation." These typically involve a relatively small number of representative users performing tasks with the device and new IFU. The provenance is likely within a controlled lab environment.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not explicitly stated. For a Human Factors study, "ground truth" relates to identifying usability issues and risks. Experts might include human factors specialists, clinicians, and engineers.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not explicitly stated. For Human Factors, this would involve systematic observation and analysis of user performance, errors, and feedback.
If a multi reader multi case (MRMC) comparative effectiveness study was done: No, not for this specific 510(k) submission. This is a Human Factors evaluation, not a clinical effectiveness trial for the device's diagnostic or therapeutic performance.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No, this is a physical medical device. The "standalone" concept applies more to AI/software.
The type of ground truth used: For a Human Factors study, the "ground truth" is the observed user behavior, identified use errors, and subjective feedback compared against expected safe and effective use.
The sample size for the training set: Not applicable, as this is a Human Factors study, not an AI/ML model.
How the ground truth for the training set was established: Not applicable.

Information that would be in the original K212026 submission:

To fully answer your request regarding the original acceptance criteria and proof of device performance (e.g., mechanical, electrical, biocompatibility, and potentially clinical performance) for the Amplatzer™ Steerable Delivery Sheath, one would need to review the predicate device's 510(k) submission (K212026). That submission would contain:

Detailed performance testing (e.g., tensile strength, steerability, torqueability, burst pressure, fatigue, material compatibility, dimensional stability, etc.) directly linked to the device's design specifications and intended use.
Biocompatibility testing
Sterilization validation
Potentially, pre-clinical (in-vitro or in-vivo) or clinical studies if substantial changes were made from its own predicate, or if it was the first of its kind. Given it's a catheter delivery system, comparative bench testing and possibly animal studies would be typical.

Conclusion:

This specific 510(k) (K220340) demonstrates continued safety and effectiveness through a Human Factors evaluation of updated Instructions for Use. It relies on the substantial equivalence to its predicate (K212026) for the fundamental performance claims of the Amplatzer™ Steerable Delivery Sheath itself. Therefore, the detailed performance data and acceptance criteria for the device proper (not just its IFU) would be found in the K212026 submission.

Summary

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March 9, 2022

Abbott Medical Emily Jallen Regulatory Affairs Specialist II 5050 Nathan Lane N Plymouth, Minnesota 55442

Re: K220340

Trade/Device Name: Amplatzer™ Steerable Delivery Sheath Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DQY Dated: February 2, 2022 Received: February 7, 2022

Dear Emily Jallen:

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) K220340

Device Name Amplatzer™ Steerable Delivery Sheath

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the Abbott logo. The logo consists of a stylized letter "a" in a blue box on the left, followed by the word "Abbott" in bold, black font on the right. The logo is simple and modern, and the colors are eye-catching.

510(k) Summary

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.

SUBMITTER INFORMATION -

Submitter Name: Abbott Medical

Submitter Address:	5050 Nathan Lane North
	Plymouth, MN 55442
	USA
Phone:	+1 (651) 756-3583
Contact Person:	Emily Jallen
Date Prepared:	February 2, 2022

DEVICE ll.

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

111. PREDICATE DEVICES

Primary Predicate: Amplatzer™ Steerable Delivery Sheath (K212026, cleared September 27.2021)

IV. DEVICE DESCRIPTION

This Special 510(k) is being submitted to add additional precautions and updated procedural steps to the Instructions for Use (IFU) of the Amplatzer Steerable Delivery Sheath.

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V. INDICATION FOR USE

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

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

There are no changes in technological characteristics from the predicate device.

VII. SUMMARY OF NON-CLINICAL PERFORMANCE TESTING

A Human Factors evaluation of the Amplatzer Steerable Delivery Sheath was performed to confirm that the updated IFU did not introduced any new user-device interactions per the requirements of ANSI/AAMI/IEC 62366-1. It was concluded that use of the Amplatzer Steerable Delivery Sheath with the updated IFU remains safe and effective for the intended users, uses, and use environments.

VIII CONCLUSION

As there are no changes in the indication for use, intended use, technological characteristics, the Amplatzer Steerable Delivery Sheath is substantially equivalent to the primary predicate device (K212026). The Amplatzer 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).