The Impella CP Introducer 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, Oscor Introducer set, Model Adelante-S2 Introducer (cleared under K122084).

AI/ML Overview

This document (K192769) outlines the 510(k) submission for the Impella CP Introducer. However, it explicitly states that no additional qualification testing was required for the substantial equivalence determination because the device is identical to its commercially available predicate device, the Oscor Introducer set, Model Adelante-S2 Introducer (cleared under K122084).

Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria is not present in this document, as such a study was deemed unnecessary for this submission.

Here's a breakdown of why this information isn't available based on the provided text:

A table of acceptance criteria and the reported device performance: This is not available because no new performance testing was conducted. The device is considered to perform identically to its predicate.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as no new test set was used.
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, as no new test set was used.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no new test set was used.
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 an introducer, not an AI or imaging device, so MRMC studies are irrelevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable, as no new testing or ground truth establishment was required.
The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
How the ground truth for the training set was established: Not applicable, as this is not an AI/machine learning device.

In summary, the K192769 submission for the Impella CP Introducer relies entirely on its substantial equivalence to a predicate device (Oscor Introducer set, Model Adelante-S2 Introducer, K122084) due to their identical design, manufacturing, and performance characteristics. Therefore, the document does not contain details about new acceptance criteria or a study to prove their fulfillment.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services USA logo. On the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.

November 18, 2019

Abiomed, Inc. Robert Stewart Regulatory Affairs Manager 22 Cherry Hill Drive Danvers, Massachusetts 01923

Re: K192769

Trade/Device Name: Impella CP Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: September 30, 2019 Received: September 30, 2019

Dear Robert Stewart:

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. 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

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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 (OS) 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,

for

Jessica Paulsen Director Cardiac Electrophysiology, Diagnostics, & 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) K192769

Device Name Impella CP Introducer

Indications for Use (Describe)

The Impella CP Introducer is intended for introduction of pacing leads or catheters into the body.

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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Impella CP Introducer 510(k) Summary

This summary of 510(k) safety and effectiveness 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:	September 27, 2019
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: Impella CP Introducer Common or Usual Name: Introducer, Catheter FDA Classification: Class II, DYB, 21 CFR- 870.1340 Requlation Description: Catheter Introducer Performance standards do not currently exist for these devices. Performance Standard: (i.e. none established under section 514 of the F D & C Act.)

C. Predicate Device:

Oscor Introducer set, Model Adelante-S2 Introducer, K122084

D. Device Description:

E. Intended Use:

The Impella CP Introducer is intended for introduction of pacing leads and catheters into the bodv.

F. Comparison of Required Technological Characteristics:

All technological characteristics of the Impella CP Introducer are identical to its commercially available predicate, including its design, packaging, manufacturing, sterilization, and labeling.

G. Comparison to Predicate Device:

The Impella CP Introducer is identical to its commercially available predicate device.

H. Qualification Testing:

Since the Impella CP Introducer 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).