The IMPELLA 5.0 Catheters are intended for circulatory support using an extracorporeal bypass control unit, for periods up to 6 hours. They are also intended to be used to provide circulatory support (for periods up to 6 hours) during procedures not requiring cardiopulmonary bypass.

The IMPELLA 5.0 Catheters also provide pressure measure-ments which are useful in determining intravascular pressure.

Device Description

The IMPELLA 5.0 catheter family (IMPELLA 5.0) is an extension of the IMPELLA Percutaneous Cardiac Support product line. The IMPELLA 5.0 is capable of providing up to 5 liters per minute blood flow. The IMPELLA 5.0 are catheter based pumps intended for placement in the left ventricle. There are currently two versions of IMPELLA 5.0 Catheters, one inserted through the femoral artery via cutdown (the IMPELLA 5.0 LP) and the other through the aorta (the IMPELLA 5.0 LD). The only difference between the two versions is the shape of the inflow cannula. The IMPELLA 5.0 catheters provide a means for temporary extracorporeal circulatory support that returns blood to the patient's systemic circulation.
Each IMPELLA 5.0 Catheter runs as a system comprised of: 1) a catheter which contains an integrated pump motor/ infusate lumen, integrated intravascular pressure sensor and integral cannula, 2) a controller/console and 3) infusion system designed to work together, and 4) accessories.

AI/ML Overview

The provided text describes the IMPELLA 5.0 Catheters, but it does not contain information about acceptance criteria or a specific study proving the device meets those criteria in the typical format requested. Instead, it focuses on demonstrating substantial equivalence to predicate devices through various tests and a general statement about clinical data.

Therefore, for aspects like "Acceptance Criteria," "Reported Device Performance," "Sample size used for the test set," "Number of experts," "Adjudication method," "MRMC study," "Standalone performance," and details about "Training set," the information is not available in the provided document.

However, I can extract information related to the pre-clinical and clinical testing performed to support the device's safety and effectiveness for its intended use, which indirectly serves to "prove" its suitability.

Here's a breakdown of the available information:

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

This information is not explicitly provided in the format of a table with specific acceptance criteria (e.g., "flow rate > X L/min," "biocompatibility pass/fail") and corresponding reported performance metrics. The document generally states that "All tests were acceptable" for in vitro performance and biocompatibility.

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

Test Set Sample Size (Clinical Data): A combination of 88 OUS (Outside US) and 17 US patients, totaling 105 patients.
Data Provenance: A combination of OUS (Outside US) and US patients. The document does not specify if the data was retrospective or prospective.

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):

This information is not available in the provided text. The clinical data is described as "a detailed analysis," but the method of establishing ground truth or the involvement and qualifications of experts are not mentioned.

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

This information is not available in the provided text.

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:

This information is not applicable/available. The device described is a medical pump (Extracorporeal Circulatory Support System), not an AI-powered diagnostic tool that would involve human readers.

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

This information is not applicable/available. The device is a physical pump, not an algorithm. However, in vitro performance testing ("ABIOMED conducted a full range of testing demonstrating that the IMPELLA 5.0 Catheters operate as intended") could be considered "standalone" technical performance testing of the device itself.

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

For the clinical data, the "ground truth" is implied to be patient safety and the device's ability to provide circulatory support as intended, analogous to outcomes data. However, the exact methods for defining and evaluating this "ground truth" are not detailed. For pre-clinical tests, the ground truth is against established standards for sterilization, biocompatibility, and in vitro performance.

8. The sample size for the training set:

This information is not applicable/available as the document describes a physical medical device and its validation, not an AI or algorithm that typically uses a "training set."

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

This information is not applicable/available as there is no mention of a training set for an algorithm.

Summary of Device Performance and Supporting Studies (as described in the document):

The device's performance is demonstrated through a combination of pre-clinical and clinical data, primarily aiming to show substantial equivalence to predicate devices.

Pre-Clinical Studies:

Sterilization, Packaging, and Shelf-life:
- Method: EtO gas sterilization with SAL of 10-6. Validated using EN 550.
- Performance: EtO sterilization residual values for EO and ECH were within allowable limits of ISO 10993-7. LAL test used for pyrogen-free determination. Packaging material integrity validated.
- Acceptance Criteria/Outcome: All results acceptable.
Biocompatibility Testing:
- Method: Testing of all patient-contacting materials on finished sterilized devices. Conducted in accordance with ISO 10993, Part 1.
- Performance: Not specified in detail, but stated all testing results were acceptable.
- Acceptance Criteria/Outcome: All results acceptable.
In Vitro Performance Testing:
- Method: A full range of testing conducted.
- Performance: Demonstrated that the IMPELLA 5.0 Catheters operate as intended.
- Acceptance Criteria/Outcome: All tests were acceptable. This demonstrates the device can achieve its stated flow rate of up to 5 liters per minute and other operational parameters.

Clinical Study:

Purpose: To address patient safety.
Sample Size: 105 patients (88 OUS, 17 US).
Provenance: Combination of OUS and US data.
Outcome: ABIOMED provided a "detailed analysis" based on this data, which was part of the submission to demonstrate substantial equivalence and acceptable patient safety for the intended use and duration (up to 6 hours). No specific performance metrics or statistical results from this clinical analysis are provided in the summary.

Conclusion stated by the manufacturer: The IMPELLA 5.0 catheters are substantially equivalent to the listed predicate devices. This implies that the performance data (pre-clinical and clinical) supported this claim to the FDA's satisfaction.

Summary

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510(k) SUMMARY – IMPELLA 5.0 (Prepared in accordance with 21 CFR Part 807.92)

Applicant Name:	ABIOMED, Inc.22 Cherry Hill DriveDanvers, MA 01923
Contact Person:	Robert Stewart
	APR 16 2009
Date Prepared:	April 15, 2009
Device Trade Name:	IMPELLA 5.0 Catheters
Device Common Name:	Extracorporeal Circulatory Support System
Classification Name:	Non-roller Type Cardiopulmonary Bypass (CPB) Blood Pump
Predicate Devices:	IMPELLA 2.5 (K063723)Estech 21 Fr RAP Cannula (K032632)Estech 21 Fr RAP Femoral Cannula (K990573)Estech Easy Flow Aortic Cannulae (K060101)Calmed 18-24 Fr Aortic Arch Cannulae (K943934)Sarn's Delpin Centrifugal Pump (K913176)
Device Description:	The IMPELLA 5.0 catheter family (IMPELLA 5.0) is anextension of the IMPELLA Percutaneous Cardiac Supportproduct line. The IMPELLA 5.0 is capable of providing up to 5liters per minute blood flow. The IMPELLA 5.0 are catheterbased pumps intended for placement in the left ventricle.There are currently two versions of IMPELLA 5.0 Catheters,one inserted through the femoral artery via cutdown (theIMPELLA 5.0 LP) and the other through the aorta (theIMPELLA 5.0 LD). The only difference between the twoversions is the shape of the inflow cannula. The IMPELLA 5.0catheters provide a means for temporary extracorporealcirculatory support that returns blood to the patient's systemiccirculation.Each IMPELLA 5.0 Catheter runs as a system comprised of:1) a catheter which contains an integrated pump motor/infusate lumen, integrated intravascular pressure sensor andintegral cannula, 2) a controller/console and 3) infusionsystem designed to work together, and 4) accessories.
Intended Use:	The IMPELLA 5.0 Catheters are intended for circulatorysupport using an extracorporeal bypass control unit, forperiods up to 6 hours. They are also intended to be used toprovide circulatory support (for periods up to 6 hours) duringprocedures not requiring cardiopulmonary bypass.The IMPELLA 5.0 Catheters also provide pressure measure-ments which are useful in determining intravascular pressure.
4/8/2009	Page 1 of 2

ABIOMED, Confidential

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Device Technological Characteristics and Comparison to Predicate Device(s):

Performance Data:

The technological characteristics of the IMPELLA 5.0 are the same as the IMPELLA 2.5, with the exception of a larger pump to permit a higher flow rate and insertion techniques, and minor differences in the impeller blade design and construction material. The IMPELLA 5.0 flow range, up to 5 liters per minute and insertion techniques are equivalent to the listed predicate aortic perfusion cannulae (K032632, K060101, K943934, K990573), when they are used with a cleared CPB system, such as the Sarns Delphin Centrifugal Pump (K913176).

Pre - Clinical:

To validate the device design of the IMPELLA 5.0, ABIOMED performed the following in vitro testing:

With regard to sterilization, packaging, and shelf-life, the . IMPELLA 5.0 is sterilized using EtO gas with a SAL of 10-6. The sterilization method/cycle was validated using EN 550 "Sterilization of Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization." The EtO sterilization residual values for EO and ECH and are within the allowable limits of ISO 10993-7. The LAL test was used to ensure a pyrogen free determination. The packaging material has been validated to ensure its integrity.
Biocompatibility testing of all patient contacting materials was conducted on the finished sterilized devices in accordance with ISO-1 0993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing". All testing results are acceptable.
With regard to In Vitro performance testing, ABIOMED . conducted a full range of testing demonstrating that the IMPELLA 5.0 Catheters operate as intended. All tests were acceptable.

Clinical:

ABIOMED provided a detailed analysis based on a clinical data collected from a combination of 88 OUS and 17 US patients used to address patient safety.

For the purposes of 510(k) clearance, the IMPELLA 5.0 catheters are substantially equivalent to the IMPELLA 2.5 (K063723), Estech 21 Fr RAP Cannula (K032632), Estech 21 Fr RAP Femoral Cannula (K990573), Estech Easy Flow Aortic Cannulae (K060101), the Calmed 24 Fr Aortic Arch Cannulae (K943934), and the Sarns Delphin Centrifugal Pump (K913176).

umer R. la. Ames

Division Si . Off) Division of Cardiovascular Devices

510(k) Number K083111
2/28/2009

Conclusion:

ABIOMED. Confidential

Page 2 of 2

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" encircling the eagle. The text is arranged in a circular fashion around the eagle, with "DEPARTMENT OF HEALTH & HUMAN SERVICES" at the bottom and "USA" at the top.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 6 2009

......

Abiomed, Inc. c/o Mr. Robert B. Stewart Manager, FDA Programs 22 Cherry Hill Drive Danvers, MA 01923

Re: K083111

IMPELLA® 5.0 Catheter Family Regulation Number: 21 CFR 870.4360 Regulation Name: Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type Regulatory Class: Class III Product Code: KFM Dated: March 14, 2009 Received: March 16, 2009

Dear Mr. 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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

{3}------------------------------------------------

Page 2 - Mr. Robert B. Stewart

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from , the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

R. Weiner

A Bram D. Zuckerman, M.D. Division Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K083111

Device Name: IMPELLA 5.0 Catheters

Indications for Use:

The IMPELLA 5.0 Catheters also provide pressure measure-ments which are useful in determining intravascular pressure.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)on of Caralovascular Devices

Page 1 of 1

Regulation Number and Section

§ 870.4360 Nonroller-type blood pump.

(a)
Nonroller-type cardiopulmonary and circulatory bypass blood pump —(1)Identification. A nonroller-type cardiopulmonary and circulatory bypass blood pump is a prescription device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either:(i) Full or partial cardiopulmonary bypass (
i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or(ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.
(2)
Classification —Class II (special controls). The special controls for this device are:(i) Non-clinical performance testing must perform as intended over the intended duration of use and demonstrate the following: Operating parameters, dynamic blood damage, heat generation, air entrapment, mechanical integrity, and durability/reliability;
(ii) The patient-contacting components of the device must be demonstrated to be biocompatible;
(iii) Sterility and shelf life testing must demonstrate the sterility of patient-contacting components and the shelf life of these components; and
(iv) Labeling must include information regarding the duration of use, and a detailed summary of the device- and procedure-related complications pertinent to use of the device.
(b)
Nonroller-type temporary ventricular support blood pump —(1)Identification. A nonroller-type temporary ventricular support blood pump is a prescription device that uses any method resulting in blood propulsion to provide the temporary ventricular assistance required for support of the systemic and/or pulmonary circulations during periods when there is ongoing or anticipated hemodynamic instability due to immediately reversible alterations in ventricular myocardial function resulting from mechanical or physiologic causes. Duration of use would be less than 6 hours.(2)
Classification. Class III (premarket approval).(c)
Date premarket approval application (PMA) or notice of completion of product development protocol (PDP) is required. A PMA or notice of completion of a PDP is required to be filed with FDA on or before September 8, 2015, for any nonroller-type temporary ventricular support blood pump that was in commercial distribution before May 28, 1976, or that has, on or before September 8, 2015, been found to be substantially equivalent to any nonroller-type temporary ventricular support blood pump that was in commercial distribution before May 28, 1976. Any other nonroller-type temporary ventricular support blood pump shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.