(195 days)
No
The summary describes a mechanical pump and controller with a microprocessor, but there is no mention of AI or ML capabilities in the device description, intended use, or performance studies.
Yes
The device is intended to pump blood for cardiopulmonary bypass or temporary circulatory bypass during open surgical procedures, which are therapeutic interventions.
No
The device is described as a system for pumping blood through an extracorporeal circuit to provide cardiopulmonary bypass or temporary circulatory bypass during surgical procedures. It does not mention any function related to diagnosing medical conditions.
No
The device description explicitly details hardware components: a sterile, single-use centrifugal pump and a microprocessor-based electromechanical pump drive system (Controller). While software is mentioned as part of the Controller's testing, the device is clearly a combination of hardware and software.
Based on the provided information, the LifeSPARC System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for pumping blood through an extracorporeal circuit for cardiopulmonary bypass or temporary circulatory bypass during surgical procedures. This involves directly interacting with the patient's blood flow outside the body for therapeutic purposes.
- Device Description: The description details a pump and a controller designed to physically move blood.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) in vitro (outside the living body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide information about a person's health. The LifeSPARC System's function is to support circulation during surgery, which is a therapeutic intervention, not a diagnostic test.
N/A
Intended Use / Indications for Use
The LifeSPARC System is intended 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.
Product codes
KFM, DWA
Device Description
The LifeSPARC Pump is a sterile, single-use, low prime volume centrifygal pump with an integrated motor and a single-point, pivot bearing. It is sterilized using ethylene oxide (EO) and sized to fit in the palm of the hand or to secure to the patient.
The LifeSPARC Controller provides the interface between pump and user, as well as the power and electrical signals to drive the pump. It is a microprocessor-based electromechanical pump drive system designed to operate on standard AC current (100/240 VAC, 50/60 Hz) or on internal, rechargeable batteries for intra-hospital transport.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Heart or great vessels, aorta or vena cava
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
Reliability, Hemolysis, Pressure/Flow Characteristics, Biocompatibility, Sterilization and Shelf Life, Software, Alarms, Electrical Safety, Electromagnetic Compatibility, Usability.
The pressure-flow test data demonstrate that the LifeSPARC Pump performs at all points within the pressure-flow operating envelope of the TandemHeart Pump.
The subject LifeSPARC Pump produces blood damage (hemolysis) at equivalent rates to the predicate TandemHeart Pump.
The remaining tests of the LifeSPARC Pump establish that it is reliable for the intended duration of use, biocompatible for the intended duration of use, and supplied sterile with a SAL of 10 °.
Testing of the LifeSPARC Controller demonstrates that no concerns regarding safety and effectiveness result from the changes and updates to the technology; specifically, test data is provided regarding Software, Usability, Alarms, Electrical Safety, and Electromagnetic Compatibility.
The subject LifeSPARC System performance is substantially equivalent to the legally marketed predicate TandemHeart System (K110493) in terms of pressure-flow characteristics and hemolysis. Additional test results listed above and described in this notification demonstrate that the differences in design between the subject LifeSPARC System and the predicate TandemHeart System do not raise new concerns regarding safety and effectiveness.
Key Metrics
Not Found
Predicate Device(s)
TandemHeart System (K110493)
Reference Device(s)
TandemHeart Pump (K991783), Escort Controller (K061369)
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue rectangle with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 9, 2019
CardiacAssist Inc Greg Johnson Director of Regulatory Affairs 620 Alpha Drive Pittsburgh, Pennsylvania 15238
Re: K183623
Trade/Device Name: LifeSPARC Pump, LifeSPARC Controller Regulation Number: 21 CFR 870.4360 Regulation Name: Nonroller-type blood pump Regulatory Class: Class II Product Code: KFM, DWA Dated: June 5, 2019 Received: June 6, 2019
Dear Greg Johnson:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Fernando Aguel Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name LifeSPARC System
Indications for Use (Describe)
The LifeSPARC System is intended 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.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
TANDEM LIFE
Section 5 510(k) Summary 510(k) Traditional
Date: 5/29/2019
Applicant
CardiacAssist, Inc. (dba TandemLife) 620 Alpha Drive Pittsburgh, PA 15238 Telephone: 412-963-7770 Fax: 412-963-0800
Contact person
Greg Johnson, PhD Title: Director of Regulatory Affairs Phone: 412-963-7770 x266 e-mail: greg.johnson@livanova.com
Device
| Trade/Proprietary Name: | LifeSPARC System |
|---|---|
| Common Name: | Cardiopulmonary Bypass System |
| Classification Name: | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type (21 CFR 870.4360 / Product Code KFM) |
| Control, pump speed, cardiopulmonary bypass (21 CFR 870.4360 / Product Code DWA) |
Predicate Device:
TandemHeart System (K110493)
Reference Devices:
TandemHeart Pump (K991783) Escort Controller (K061369)
Device Description
The LifeSPARC Pump is a sterile, single-use, low prime volume centrifygal pump with an integrated motor and a single-point, pivot bearing. It is sterilized using ethylene oxide (EO) and sized to fit in the palm of the hand or to secure to the patient.
The LifeSPARC Controller provides the interface between pump and user, as well as the power and electrical signals to drive the pump. It is a microprocessor-based electromechanical pump drive system designed to operate on standard AC current (100/240 VAC, 50/60 Hz) or on internal, rechargeable batteries for intra-hospital transport.
4
TANDEM LIFE
Indications for Use
The LifeSPARC System is intended 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.
Comparison of Technological Characteristics
The subject LifeSPARC Pump and the predicate TandemHeart Pump have the same Indications for Use, the same principle of operation, the same tubing connections, and the same operating flow rate range. The LifeSPARC Pump is lighter in weight and has a larger priming volume. Technological differences between the subject LifeSPARC Pump and the predicate TandemHeart Pump are the bearing design, blood flow pathways, and materials of construction.
The subject LifeSPARC Controller has the identical function as the predicate Escort Controller; specifically, it energizes the brushless DC motor that powers the pump while providing device monitoring, alarms and interface with the user. The two controllers have the same principles of operation and are similar in design. Technological differences between the two units include:
- LifeSPARC does not include purge pump and system (LifeSPARC pump does not require); ●
- LifeSPARC Controller incorporates updated batteries; ●
- LifeSPARC dock / control unit configuration adds portability / flexibility and additional battery charging capability compared to predicate Escort Controller;
- LifeSPARC Controller has updated electronics and enclosure design;
- LifeSPARC Controller has updated software / user interface technology.
Summary of Non-clinical Testing
Reliability Hemolysis Pressure/Flow Characteristics Biocompatibility Sterilization and Shelf Life Software Alarms Electrical Safety Electromagnetic Compatibility Usability
5
TANDEM LIFE
Section 5 510(k) Summary 510(k) Traditional
Substantial Equivalence Comparison
The pressure-flow test data demonstrate that the LifeSPARC Pump performs at all points within the pressure-flow operating envelope of the TandemHeart Pump.
The subject LifeSPARC Pump produces blood damage (hemolysis) at equivalent rates to the predicate TandemHeart Pump.
The remaining tests of the LifeSPARC Pump establish that it is reliable for the intended duration of use, biocompatible for the intended duration of use, and supplied sterile with a SAL of 10 °.
Testing of the LifeSPARC Controller demonstrates that no concerns regarding safety and effectiveness result from the changes and updates to the technology; specifically, test data is provided regarding Software, Usability, Alarms, Electrical Safety, and Electromagnetic Compatibility.
Conclusion
Testing described in this notification demonstrates that the subject LifeSPARC System performance is substantially equivalent to the legally marketed predicate TandemHeart System (K110493) in terms of pressure-flow characteristics and hemolysis. Additional test results listed above and described in this notification demonstrate that the differences in design between the subject LifeSPARC System and the predicate TandemHeart System do not raise new concerns regarding safety and effectiveness.