The Abiomed 23 Fr Sheath is packaged as a sterile kit, which includes an introducer sheath (consisting of sheath with sideport tubing, stopcock and hemostasis valve assembly), and dilators, and a guidewire. It is identical to the commercially available predicate device, the Oscor 23 Fr Adelante-S2 Introducers, K122084.

AI/ML Overview

The provided text is related to an FDA 510(k) premarket notification for a medical device called the "Abiomed 23 Fr Sheath." It is a regulatory document affirming that the device is substantially equivalent to a legally marketed predicate device.

Crucially, this document does not describe the acceptance criteria or a study that proves the device meets specific performance criteria. Instead, it states that the device is identical to a previously cleared predicate device, and therefore, no additional qualification testing was required for substantial equivalence.

Therefore, I cannot provide the requested information from the given text as it explicitly states that no such studies or acceptance criteria comparisons were performed for this specific 510(k) submission.

Here's a breakdown based on the information provided, and why most of your questions cannot be answered from this document:

1. A table of acceptance criteria and the reported device performance

Not Applicable. The document explicitly states: "Since the Abiomed 23 Fr Sheath is identical to its commercially available predicate device, no additional qualification testing was required for the substantial equivalence determination." Therefore, no new acceptance criteria or reported device performance data is presented.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. No new testing was performed for this 510(k) submission. The substantial equivalence is based on the device being identical to the predicate.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. No new ground truth establishment or expert review was part of this submission, as no new testing was conducted.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. No test set was generated for this 510(k) submission.

5. 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 catheter introducer sheath, not an AI or imaging device, so MRMC studies are not relevant. This document is a regulatory clearance for a physical medical device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not Applicable. This is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable. No new ground truth was established for this submission.

8. The sample size for the training set

Not Applicable. This is not an AI algorithm.

9. How the ground truth for the training set was established

Not Applicable. This is not an AI algorithm.

Summary from the provided text:

The Abiomed 23 Fr Sheath obtained 510(k) clearance (K201116) by demonstrating substantial equivalence to a predicate device, the Oscor Adelante-S Introducer Series (K122084).

The basis for this substantial equivalence is that the Abiomed 23 Fr Sheath is identical to its commercially available predicate device in terms of "design, packaging, manufacturing, sterilization, and labeling." Because of this asserted identity, no additional qualification testing was required for this specific 510(k) submission. Therefore, the document does not contain information about new acceptance criteria or studies performed to demonstrate performance.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 15, 2020

Abiomed Inc. Sandy Fowler Regulatory Affairs Specialist 22 Cherry Hill Drive Danvers, Massachusetts 01923

Re: K201116

Trade/Device Name: Abiomed 23 Fr Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: April 24, 2020 Received: April 27, 2020

Dear Sandy Fowler:

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.

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.

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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-regulatoryinformation/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 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 mediation-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,

Hetal Odobasic Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K201116

Device Name Abiomed 23 Fr Sheath

Indications for Use (Describe) The Abiomed 23 Fr Sheath is intended for introduction of pacing leads or catheters.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Abiomed 23 Fr Sheath 510(k) Summary

This summary of 510(k) information is being submitted in accordance with the Safe Medical Devices Act (SMDA) of 1990 and Title 21 of the Code of Federal Regulations, Part 807.92.

A. Application Information:

Date Prepared:	April 24th, 2020
Submitter's Name & Address:	ABIOMED, Inc.22 Cherry Hill DriveDanvers, MA 01923
Contact Person:	J. Kenneth RyderSenior Director, Global Regulatory AffairsPh: 978-646-1707E-mail: kryder@abiomed.com

B. Device Information:

Trade or Proprietary Name:	Abiomed 23 Fr Sheath
Common or Usual Name:	Introducer, Catheter
FDA Classification:	Class II, DYB, 21 CFR- 870.1340
Regulation Description:	Catheter Introducer
Performance Standard:	Performance standards do not currently exist for these devices.(i.e. none established under section 514 of the F D & C Act.)

ﻥ Predicate Device:

Oscor Adelante-S Introducer Series, K122084

D. Device Description:

E. Intended Use:

The Abiomed 23 Fr Sheath is intended for introduction of pacing leads and catheters into the body.

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F. Comparison of Required Technological Characteristics:

All technological characteristics of the Abiomed 23 Fr Sheath are identical to its commercially available predicate, including its design, packaging, manufacturing, sterilization, and labeling,

G. Comparison to Predicate Device:

The Abiomed 23 Fr Sheath is identical to its commercially available predicate device.

H. Qualification Testing:

Since the Abiomed 23 Fr Sheath is identical to its commercially available predicate device, no additional qualification testing was required for the substantial equivalence determination.

Regulation Number and Section

§ 870.1340 Catheter introducer.

(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).