IMPELLA 2.5 PLUS CATHETER

K112892 · Abiomed, Inc. · PBL · Sep 6, 2012 · CV

Device Facts

• Record ID: K112892
• Device Name: IMPELLA 2.5 PLUS CATHETER
• Applicant: Abiomed, Inc.
• Product Code: PBL · CV
• Decision Date: Sep 6, 2012
• Decision: SESU
• Submission Type: Special
• Attributes: Therapeutic

Intended Use

The IMPELLA 2.5 PLUS Catheter is intended for partial circulatory support using an extracorporeal bypass control unit, for periods up to 6 hours. It is also intended to be used to provide partial circulatory support (for periods up to 6 hours) during procedures not requiring cardiopulmonary bypass. The IMPELLA 2.5 PLUS Catheter also provides pressure measurements which are useful in determining intravascular pressure.

Device Story

Impella 2.5 Plus is a percutaneous rotary axial flow blood pump; provides partial circulatory support; used in clinical settings for up to 6 hours. Device consists of 14F inflow cannula, pump housing, and drive catheter; utilizes hydrodynamic bearing motor; inserted via Seldinger technique. Operates with external Impella Controller; provides real-time intravascular pressure measurements. Purge system uses dextrose/heparin solution to maintain seal. Physician-operated; output assists hemodynamic management during procedures. Design is scaled-up version of predicate Impella 2.5 (12F to 14F), resulting in ~30% higher flow (up to 3.3 L/min).

Clinical Evidence

Bench testing only. No clinical data provided. Verification and validation testing confirmed device performance met design requirements and was substantially equivalent to the predicate. Electrical safety and software verification testing were performed to ensure compatibility with the Impella Controller.

Technological Characteristics

Rotary axial flow pump; 14F diameter; polyurethane construction. Energy source: electric motor with hydrodynamic bearing. Connectivity: connects to external Impella Controller. Sterilization: Ethylene Oxide (EtO). Software: embedded firmware for controller integration. Technical specs: 3.3 L/min max flow at 60 mmHg differential pressure; 46,000 RPM.

Indications for Use

Indicated for patients requiring partial circulatory support for up to 6 hours during procedures not requiring cardiopulmonary bypass. Contraindicated for use in providing circulatory support for periods greater than 6 hours or for prophylactic hemodynamic support in patients with stable hemodynamics during high-risk coronary interventional procedures.

Predicate Devices

• IMPELLA 2.5 (K063723)

Reference Devices

• IMPELLA Controller (K110845)

Submission Summary (Full Text)

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K112892

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# Impella 2.5 Plus 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 5, 2012

Submitter's Name & Address:

ABIOMED, Inc. 22 Cherry Hill Drive Danvers, MA 01923

Contact Person:

Dr. Robert Stewart Manager, FDA Programs Ph: 978-646-1567 Fax: [phone] E-mail: [e-mail]

### B. Device Information:

Trade or Proprietary Name: Impella 2,5 Plus Common or Usual Name: Non-roller type Cardiopulmonary Blood Pump Classification Name: Class III, KFM, 21 CFR - 870.4360 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:

The IMPELLA 2.5 (K063723)

#### D. Device Description:

The Impella 2.5 Plus is an update to the design of the IMPELLA 2.5, which was cleared by the FDA in 2008 (under K063723). The predicate device, the IMPELLA 2.5, and the Impella 2,5 Plus have identical designs and materials of construction. The only design modifications made to the IMPELLA 2.5 for the Impella 2.5 Plus are slight increases in the diameters of the inflow can ula impeller and pump housing (from 12 F to 14 F). As a result of this increase, the Impella 2.5 Plus has approximately 30% higher flow than the IMPELLA 2.5.

### E. Intended Use:

The Impella 2.5 Plus is intended for partial circulatory support using an extracorporeal bypass control unit, for periods up to 6 hours. It is also intended to be used to provide partial circulatory support (for periods up to 6 hours) during procedures not requiring cardiopulmonary bypass.

The Impella 2.5 Plus also provides pressure measurements which are useful in determining intravascular pressure

#### F. Technological Characteristics:

The Impella 2.5 Plus design is a straight-forward iteration (scale-up) of the IMPELLA 2.5 design. The Impella 2.5 Plus employs identical functional scientific technology as the IMPELLA 2.5. The design modifications associated with the Impella 2.5 Plus (i.e. related to the IMPELLA 2.5):

- · do not affect the intended use of the device, AND
- · do not alter the fundamental scientific technology of the device.

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## G. Comparison to Predicate Device:

The Table below provides a comparison of the overall design properties of the Impella 2.5 Plus to the predicate IMPELLA 2.5.

| Design Property | Impella 2.5 Plus | IMPELLA.2.5 (K063723) |
|-------------------------------------|----------------------------------------------------------------------|-------------------------------------------------------------------|
| Drive console | IMPELLA Controller (identical to that cleared under (K110845) | |
| Insertion Method | Percutaneous via the Seldinger technique. | |
| Packaging | Polystyrene tray in double Tyvek Pouch | |
| Sterilization | Ethylene Oxide (EtO) | |
| Drive catheter, Size,<br>(Material) | Contains drive line, pressure lumen, purge lumen, 9F, (Polyurethane) | |
| Seal (Purge Fluid) | Fluid Bearing (Dextrose solution with Heparin) | |
| Purge Fluid Rate | 2-30 cc/hr | |
| Mean Flow | Up to 3.3 L/Min<br>(60 mmHg differential pressure) | Up to 2.5 L/Min<br>(60 mmHg differential pressure) |
| Pump Speed | 46,0000 RPM | 51,0000 RPM |
| Pump type/ Design,<br>Diameter | Rotary axial flow pump/ Axial<br>inflow, tangential outflow, 14F. | Rotary axial flow pump/ Axial inflow,<br>tangential outflow, 12F. |
| Motor Design,<br>Diameter | Hydrodynamic bearing with an<br>integral stator winding, 14F | Hydrodynamic bearing with an<br>integral stator winding, 12F |
| Cannula/ Pigtail tip<br>(Material) | 14 F inflow cannula with 6F pigtail<br>(Polyurethane) | 12 F inflow cannula with 6F pigtail<br>(Polyurethane) |

| Design Specifications Comparison Table | | |
|----------------------------------------|--|--|
| | | |

#### H. Summary of Performance Data:

The Impella 2.5 Plus was developed under design controls. Testing was completed to mitigate any possible new risks from the minor design differences (from the predicate IMPELLA 2.5), and to verify the Impella 2.5 Plus met its design requirements. Testing included:

- Design and Verification & Validation (DVV) testing, which demonstrated that the Impella 2.5 . Plus operated as intended and was substantially equivalent to the IMPELLA 2.5.
- Software Verification testing was also completed to verify the Impella 2.5 Plus could be . used with the IMPELLA Controller.
- Electrical Standards and Safety testing (IEEC 60601-1, Applied Part) was completed to . verify compliance for use of the Impella 2.5 Plus with the IMPELLA Controller.

The results of the bench testing demonstrated that the design changes associated with the Impella 2.5 Plus did not raise any issues related its safety or effectiveness compared to its predicate, the IMPELLA 2.5.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

SEP - 6 2012

Abiomed, Inc. c/o Ms. Carolyn Pekar 22 Cherry Hill Drive Danvers, MA 01923

Re: K112892

Trade Name: IMPELLA 2.5 PLUS Catheter Regulation Number: 21CFR 870.4360 Regulation Name: Non-roller type cardiopulmonary bypass blood pump Regulatory Class: Class III (three) Product Code: PBL Dated: September 29, 2011 Received: September 30, 2011

Dear Ms. Pekar:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your been wined 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 connifered pror to May 20, 1976, the eccordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls and Cosment 1xc (rice). " Fou may ans described below. The general controls provisions of the provisions of the Act and the mixel registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

The Office of Device Evaluation has determined that there is a reasonable likelihood that this The Office of Device Evaluation has association the proposed labeling and that such use device will be used for an mendou acc moce with Section 513(i)(1)(E) of the Act, the following Could Cause nami. "Therefore, Warnings section of the] device's labeling:

The safety and effectiveness of this device has not been established for use in providing I he salely and criceliveness of ans aculation for periods of greater than 6 hours, or for

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Page 2 - Ms. Carolyn Pekar

providing prophylactic hemodynamic support, for example, in patients with stable hemodynamics during percutaneous interventional procedures of high risk coronary artery lesions and/or anatomy.

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.

The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.

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 (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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You may obtain other general information on your responsibilities under the Act from the You may ootain other general incomations on Jone Jone Assistance at its toll-free number [phone] or [phone] or at its Internet address

[phone] 01 (3 MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Christy Foreman

Christy Foreman Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: JIMPELLA 2.5 PLUS

Indications For Use:

The IMPELLA 2.5 PLUS Catheter is intended for partial circulatory support using an extracorporeal bypass control unit, for periods up to 6 hours. It is also intended to be used to extracorpored bypass control will (for periods up to 6 hours) during procedures not requiring cardiopulmonary bypass.

The IMPELLA 2.5 PLUS Catheter also provides pressure measurements which are useful in determining intravascular pressure.

Prescription Use _ X (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)

UM R. Hilliker

(Division Sian-Off) Division of Cardiovascular Dences

510(k) Number_K (1 299 2

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