(16 days)
No
The document describes a mechanical pump system with a microprocessor-based controller. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies.
Yes
The device is intended to provide full or partial 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 for bypass procedures. Its intended use and description focus on mechanical function and circulatory support, not on analyzing patient data to diagnose a condition.
No
The device description clearly outlines hardware components: a centrifugal pump (LifeSPARC Pump) and a microprocessor-based electromechanical pump drive system (LifeSPARC Controller). The performance studies also mention testing of the LifeSPARC Controller, further indicating hardware.
Based on the provided information, the LifeSPARC System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device's function as pumping blood through an extracorporeal circuit for circulatory bypass during surgical procedures. This is a direct intervention on the patient's circulatory system, not a test performed on samples taken from the body to diagnose or monitor a condition.
- Device Description: The description details a pump and a controller designed to physically move blood. This aligns with a medical device used for treatment or support, not for diagnostic testing.
- Lack of IVD Characteristics: There is no mention of the device analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's health status.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The LifeSPARC System's function falls outside of this definition.
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 centrifugal 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 (via extracorporeal circuit)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Intra-hospital transport (implied clinical use for surgical procedures)
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
Testing described in this notification demonstrates that the subject LifeSPARC System performance is substantially equivalent to the legally marketed predicate LifeSPARC System (K183623).
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 and Electromagnetic Compatibility.
Key Metrics
Not Found
Predicate Device(s)
LifeSPARC System (K183623)
Reference Device(s)
LifeSPARC System (K211830)
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
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August 3, 2023
CardiacAssist, Inc. Arielle Drummond Director of Regulatory Affairs 620 Alpha Drive Pittsburgh, Pennsylvania 15238
Re: K232132
Trade/Device Name: LifeSPARC System Regulation Number: 21 CFR 870.4360 Regulation Name: Nonroller-Type Blood Pump Regulatory Class: Class II Product Code: KFM, DWA Dated: July 17, 2023 Received: July 18, 2023
Dear Arielle Drummond:
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 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
1
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).
Sincerelv.
Nicole M. Gillette -S
Nicole Gillette 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
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission 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)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
TANDEM | LIFE
510(k) Summary 510(k) Special K232132
Date: 07/17/2023
Applicant
CardiacAssist, Inc. (dba TandemLife) 620 Alpha Drive Pittsburgh, PA 15238 Telephone: 412-963-7770 Fax: 412-963-0800
Contact person
Arielle Drummond, PhD Title: Director of Regulatory Affairs Phone: 412-889-9021 e-mail: arielle.drummond@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:
LifeSPARC System (K183623)
Reference Device:
LifeSPARC System (K211830)
Device Description
The LifeSPARC Pump is a sterile, single-use, low prime volume centrifugal 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
4
TANDEM LIFE
drive system designed to operate on standard AC current (100/240 VAC, 50/60 Hz) or on internal, rechargeable batteries for intra-hospital transport.
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 of this submission is an update to the software version of the currently-cleared device. All other aspects of the subject device are identical to the reference device.
Summary of Non-clinical Testing
Software Electromagnetic Compatibility
Substantial Equivalence Comparison
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 and Electromagnetic Compatibility.
Conclusion
Testing described in this notification demonstrates that the subject LifeSPARC System performance is substantially equivalent to the legally marketed predicate LifeSPARC System (K183623).