(342 days)
No
The summary describes a mechanical circulatory support device with minor design modifications from a predicate. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies.
Yes
The device is intended for "partial circulatory support," which is a direct therapeutic intervention to improve or maintain bodily function.
No
The primary intended use of the device is for partial circulatory support. While it provides "pressure measurements which are useful in determining intravascular pressure," this function appears to be secondary and supportive to its main therapeutic purpose rather than its being a standalone diagnostic device. The device description and performance studies focus on its circulatory support capabilities and design updates related to flow, not on its role in diagnosing conditions.
No
The device description clearly states it is a catheter with physical components (inflow cannula, impeller, pump housing) and mentions electrical standards and safety testing, indicating it is a hardware device. While it interacts with a controller (likely containing software), the device itself is not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as providing "partial circulatory support" and "pressure measurements useful in determining intravascular pressure." These are functions performed within the body (in vivo), not on samples taken from the body (in vitro).
- Device Description: The description details a catheter and pump system designed to be placed within the circulatory system.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is mechanical support and pressure measurement within the circulatory system.
N/A
Intended Use / Indications for 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.
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.
Product codes
PBL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
SEP 6 2012
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: : 下
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.
1
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/ Axial | |
| inflow, tangential outflow, 14F. | Rotary axial flow pump/ Axial inflow, | |
| tangential outflow, 12F. | ||
| Motor Design, | ||
| Diameter | Hydrodynamic bearing with an | |
| integral stator winding, 14F | Hydrodynamic bearing with an | |
| integral 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.
2
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
3
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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Page 3 - Ms. Carolyn Pekar
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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Page 4 - Ms. Carolyn Pekar
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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