(342 days)
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.
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.
This 510(k) summary describes a medical device, the Impella 2.5 Plus, which is an updated version of a previously cleared device, the Impella 2.5. The submission focuses on demonstrating substantial equivalence to the predicate device due to minor design modifications (increased diameters of the inflow cannula impeller and pump housing).
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state formal acceptance criteria with numerical targets. Instead, the "acceptance criteria" are implied to be substantially equivalent performance to the predicate device, the IMPELLA 2.5, and compliance with general design and safety standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence | |
| - Operate as intended | - DVV testing demonstrated that the Impella 2.5 Plus operated as intended. |
| - Substantial equivalence to predicate IMPELLA 2.5 | - DVV testing demonstrated that the Impella 2.5 Plus was substantially equivalent to the IMPELLA 2.5. |
| - Identical functional scientific technology | - The Impella 2.5 Plus employs identical functional scientific technology as the IMPELLA 2.5. |
| Power/Flow Performance | |
| - Maintain adequate flow (or improve upon predicate) | - Mean Flow: Up to 3.3 L/Min (60 mmHg differential pressure) - This is an improvement over the predicate's 2.5 L/Min. |
| - Appropriate pump speed | - Pump Speed: 46,000 RPM |
| Safety and Compatibility | |
| - No new risks from minor design differences | - Testing was completed to mitigate any possible new risks from the minor design differences. The results of bench testing demonstrated that the design changes did not raise any issues related to safety or effectiveness compared to the IMPELLA 2.5. |
| - Compatibility with IMPELLA Controller | - Software Verification testing was 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. |
| - Compliance with electrical safety standards | - Electrical Standards and Safety testing (IEEC 60601-1, Applied Part) was completed to verify compliance. |
| - Design modifications do not affect intended use or fundamental science | - Design modifications: do not affect the intended use of the device, AND do not alter the fundamental scientific technology of the device. |
| Biocompatibility/Material Integrity | - The predicate device and Impella 2.5 Plus have identical designs and materials of construction (e.g., Polyurethane for catheter, cannula, and pigtail). Implicitly, this implies that previous biocompatibility and material integrity assurances for the predicate apply, and no new testing beyond comparison was deemed necessary for these aspects due to identical materials. |
2. Sample Size Used for the Test Set and Data Provenance
The submission indicates that the studies conducted were bench tests and verification & validation (V&V) testing. It does not specify a "test set" in the context of patient data or clinical samples.
- Sample Size: Not applicable in the sense of patient-based test sets. The sample size would refer to the number of devices tested in bench experiments. This detail is not provided in the summary.
- Data Provenance: Not applicable in the sense of country of origin or retrospective/prospective clinical data for this type of submission. The performance data is derived from in vitro (bench) testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The ground truth for this device's performance is established through engineering and scientific measurements and comparisons against established specifications and the predicate device's performance. It does not involve expert image interpretation or clinical diagnosis.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical or image-based studies where expert consensus is required. This device relies on direct physical measurements and engineering verification.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers' Improvement with AI vs. Without AI Assistance
Not applicable. This device is a mechanical circulatory support device, not an AI-powered diagnostic or assistive tool for human readers.
6. If a Standalone (i.e., Algorithm-only without human-in-the-loop) Performance Study Was Done
Not applicable. This device is a physical medical device, not an algorithm. Its "standalone" performance is its bench-test performance as described.
7. The Type of Ground Truth Used
The "ground truth" for this submission is established by:
- Engineering specifications and design requirements: The device's ability to meet its intended design parameters.
- Performance of the predicate device (IMPELLA 2.5): The Impella 2.5 Plus is compared against the known performance characteristics of its legally marketed predecessor.
- International standards: Compliance with relevant standards like IEC 60601-1 for electrical safety.
- Functional operation: Verification that the device "operated as intended."
8. The Sample Size for the Training Set
Not applicable. This is a medical device, not an AI model, so there is no training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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SEP 6 2012
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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: 978-777-5692 E-mail: rstewart@abiomed.com
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,(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(60 mmHg differential pressure) | Up to 2.5 L/Min(60 mmHg differential pressure) |
| Pump Speed | 46,0000 RPM | 51,0000 RPM |
| Pump type/ Design,Diameter | Rotary axial flow pump/ Axialinflow, tangential outflow, 14F. | Rotary axial flow pump/ Axial inflow,tangential outflow, 12F. |
| Motor Design,Diameter | Hydrodynamic bearing with anintegral stator winding, 14F | Hydrodynamic bearing with anintegral stator winding, 12F |
| Cannula/ Pigtail tip(Material) | 14 F inflow cannula with 6F pigtail(Polyurethane) | 12 F inflow cannula with 6F pigtail(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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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 (800) 638-2041 or (301) 796-7100 or at its Internet address
(000) 036-2011 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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