(532 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like neural networks, deep learning, or algorithms that would typically indicate the presence of AI/ML. The performance studies focus on standard medical device testing (sterilization, biocompatibility, software validation, EMC, in vitro performance, and clinical data analysis) without any mention of AI/ML model training or evaluation.
Yes.
The device provides "partial circulatory support," which is a treatment for a medical condition, namely cardiac insufficiency.
Yes
The system provides "pressure measurements which are useful in determining intravascular pressure," which is a diagnostic function.
No
The device description explicitly states that the system is comprised of a catheter with an integrated pump motor, a controller/console, and an infusion system, in addition to accessories. This indicates significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "partial circulatory support" and "provide partial circulatory support during procedures." This describes a device that directly interacts with the patient's circulatory system to provide mechanical assistance.
- Device Description: The description details a "catheter which contains an integrated pump motor/infusate lumen," a "controller/console," and an "infusion system." These are components of a system designed for direct intervention within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing. IVDs typically involve analyzing biological samples outside the body.
- Anatomical Site: The anatomical site is "Cardiac," indicating direct interaction with the heart and circulatory system.
Therefore, the IMPELLA RECOVER® LP 2.5 Percutaneous Cardiac Support System is a medical device used for direct patient treatment and support, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The IMPELLA RECOVER® LP 2.5 Percutaneous Cardiac Support System 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 RECOVER® LP 2.5 Percutaneous Cardiac Support System also provides pressure measurements which are useful in determining intravascular pressure.
Product codes
KFM, DWF, DQO
Device Description
The IMPELLA RECOVER® LP 2.5 Percutaneous Cardiac Support System (IMPELLA RECOVER LP 2.5 System) provides circulatory support with the ability to deliver anticoagulant through an infusion system. The System is comprised of: 1) a catheter which contains an integrated pump motor/infusate lumen, integrated intravascular pressure lumen and integral cannula, 2) a controller/console and 3) infusion system designed to work together, and 4) accessories.
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
Prescription Use
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
Pre - Clinical:
In vitro testing, sterilization validation, software testing (compliance with FDA 2005 guidance), electromagnetic compatibility and electrical safety testing (in accordance with EN 60601 and EN 61000), In vitro performance testing.
Clinical :
Detailed analysis based on a clinical data collected from a combination of 109 OUS and 20 US patients used to address patient safety.
Key Metrics
Not Found
Predicate Device(s)
K991783, K052570, K924642, K924643, K050168
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Public Health Service
Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper half of the circle, with the words separated by dots.
MAY 19 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Abiomed, Inc. c/o Mr. Robert T. Kung 22 Cherry Hill Drive Danvers, MA 01923
Re: K063723 Impella® Recover® LP 2.5 Percutaneous Cardiac Suppport System Regulation Number: 21 CFR 870.4360 Regulation Name: Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type Catheter, Cannula and Tubing Vascular, Cardiopulmonary Bypass Catheter, Intravascular, Diagnostic Regulatory Class: Class III (three) Product Code: KFM, DWF, DQO Dated: May 15, 2008 Received: May 19, 2008
Dear Mr. Kung:
This letter corrects our substantially equivalent letter of May 30, 2008.
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. Iisting 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.
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Page 2 -- Mr. Robert T. Kung
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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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. Vahner
A Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosur
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ABIOMED, Inc.
IMPELLA RECOVER® LP 2.5 Perculaneous Cardiac Support System Traditional 510(k)
Indications for Use
510{k) Number (if known): K063723
Device Name: IMPELLA RECOVER® LP 2.5 Percutaneous Cardiac Support System
Indications for Use:
The IMPELLA RECOVER® LP 2.5 Percutaneous Cardiac Support System 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 RECOVER® LP 2.5 Percutaneous Cardiac Support System also provides pressure measurements 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)
Division of Carmovascular Devices
510(k) Number_Ko63723
Page 1 of 1
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K063723
MAY 30 2008
510(k) Summary (Prepared in accordance with 21 CFR Part 807.92)
a. Submitted
| Applicant Name: | ABIOMED, Inc. |
|---|---|
| 22 Cherry Hill Drive, Danvers, MA 01923 | |
| Contact Person: | William J. Bolt |
| Date Summary | |
| Prepared: | May 15, 2008 |
| b. Device Information | |
| Trade Name: | IMPELLA RECOVER® LP 2.5 Percutaneous |
| Cardiac Support System | |
| Common Name: | Percutaneous Cardiac Support System |
| Classification | |
| Name: | Pump, Blood, Cardiopulmonary Bypass, non rolle |
| type (classified under 870.4360) | |
| Catheter, Cannula and Tubing, Vascular, | |
| Cardiopulmonary Bypass (classified under | |
| 870.4210) | |
| Diagnostic intravascular catheter (classified under | |
| 870.1200) | |
| Product Code: | 74KFM, 74DWF, 74DQO |
c. Legally Marketed Predicate Devices
- TandemHeart PTVA System K991783, K052570 K924642 , K924643 .
- Vascular Solutions Langston Dual Lumen Catheter K050168 .
d. Device Description:
The IMPELLA RECOVER® LP 2.5 Percutaneous Cardiac Support System (IMPELLA RECOVER LP 2.5 System) provides circulatory support with the ability to deliver anticoagulant through an infusion system. The System is comprised of: 1) a catheter which contains an integrated pump motor/infusate lumen, integrated intravascular pressure lumen and integral cannula, 2) a controller/console and 3) infusion system designed to work together, and 4) accessories.
e. Intended Use:
The IMPELLA RECOVER® LP 2.5 Percutaneous Cardiac Support System 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 RECOVER® LP 2.5 Percutaneous Cardiac Support System also provides pressure measurements which are useful in determining intravascular pressure.
4
f. Technological Characteristics and Comparison to Predicate Device(s):
The technological characteristics of the IMPELLA RECOVER® LP 2,5 are the same as the TANDEM HEART systems and the Vascular solutions Langston catheter with the exception of the following differences:
- · pump location
- certain materials of construction .
- . pump speed
g. Test Results:
Pre - Clinical:
To validate the device design of the IMPELLA RECOVER® Percutaneous Cardiac Support System, ABIOMED performed the following in vitro testing:
With regard to sterilization, packaging, and shelf-life, the IMPELLA RECOVER® LP 2.5 Percutaneous Cardiac Support System 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-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing". All testing results are acceptable.
The design and testing validation of the software contained in the IMPELLA MCS was conducted in compliance with the FDA 2005 guidance document entitled "Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
With regard to electromagnetic compatibility and electrical safety, the IMPELLA RECOVER® LP 2.5 Percutaneous Cardiac Support System was tested in accordance with EN 60601 and EN 61000 and their applicable subparts. The testing results demonstrate that the device is in conformance with these FDA recognized standards.
With regard to In vitro performance testing, ABIOMED conducted a full range of testing demonstrating that the entire IMPELLA RECOVER® LP 2.5 System operates as intended. All tests were acceptable.
Clinical :
Abiomed provided a detailed analysis based on a clinical data collected from a combination of 109 OUS and 20 US patients used to address patient safety.
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h. Conclusion:
。
The ABIOMED IMPELLA RECOVER® LP 2.5 Percutaneous Cardiac Support System is substantially equivalent to the TandemHeart PTVA System and Control system (K991783), the TandemHeart Transseptal Cannula (K052570), the Medtronic Biomedicus 15F arterial cannula and introducer (K924642, K924643) and the Vascular Solutions Langston Dual Lumen Catheter – K050168