(58 days)
No
The document describes a centrifugal blood 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 summary. The software verification and validation testing focuses on the functionality and safety of the software changes, not on AI/ML performance metrics.
Yes
The device is used for Extracorporeal Membrane Oxygenation (ECMO) and cardiopulmonary bypass to assist in the circulation and gas exchange of a patient's blood when other treatment options have failed, which are therapeutic interventions.
No
The device is described as a centrifugal blood pump system intended to assist in circulation and provide physiologic gas exchange. Its functions are therapeutic (ECMO, cardiopulmonary bypass) rather than diagnostic.
No
The device description explicitly details hardware components: a sterile, single-use centrifugal pump and a microprocessor-based electromechanical controller. While software is mentioned for verification and validation, the core device includes physical hardware.
Based on the provided text, the LifeSPARC System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes the device as a centrifugal blood pump system used in extracorporeal circuits to assist in the circulation and gas exchange of a patient's blood. This is a direct interaction with the patient's circulatory system, not the analysis of samples taken from the body.
- Device Description: The description details a blood pump and a controller, which are components of a system designed to move and manage blood flow outside 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 screening.
Therefore, the LifeSPARC System falls under the category of a medical device used for direct patient support, not an IVD.
N/A
Intended Use / Indications for Use
Extracorporeal Membrane Oxygenation
The LifeSPARC System is a centrifugal blood pump system intended to assist in circulation of the patient's blood when part of an extracorporeal circuit including physiologic gas exchange of the patient's blood in adult patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. These may include:
· Failure to wean from cardiopulmonary bypass following cardiac surgery in adult patients;
· ECMO-assisted cardiopulmonary resuscitation in adults.
Cardiopulmonary Bypass
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 (comma separated list FDA assigned to the subject device)
QNR, 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
Not Found
Indicated Patient Age Range
Adult patients
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)
Software Verification and Validation testing (including Cybersecurity) was completed for the Subject device with the new software. Testing of the LifeSPARC Controller demonstrates that no concerns regarding safety and effectiveness result from the software changes; specifically, software test data supports substantial equivalence of the Subject device to the Predicate and Reference devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.4100 Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure.
(a)
Identification. An extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary support (>6 hours) is a system of devices and accessories that provides assisted extracorporeal circulation and physiologic gas exchange of the patient's blood in patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. The main devices and accessories of the system include, but are not limited to, the console (hardware), software, and disposables, including, but not limited to, an oxygenator, blood pump, heat exchanger, cannulae, tubing, filters, and other accessories (e.g., monitors, detectors, sensors, connectors).(b)
Classification —Class II (special controls). The special controls for this device are:(1) The technological characteristics of the device must ensure that the geometry and design parameters are consistent with the intended use, and that the devices and accessories in the circuit are compatible;
(2) The devices and accessories in the circuit must be demonstrated to be biocompatible;
(3) Sterility and shelf-life testing must demonstrate the sterility of any patient-contacting devices and accessories in the circuit and the shelf life of these devices and accessories;
(4) Non-clinical performance evaluation of the devices and accessories in the circuit must demonstrate substantial equivalence of the performance characteristics on the bench, mechanical integrity, electromagnetic compatibility (where applicable), software, durability, and reliability;
(5) In vivo evaluation of the devices and accessories in the circuit must demonstrate their performance over the intended duration of use, including a detailed summary of the clinical evaluation pertinent to the use of the devices and accessories to demonstrate their effectiveness if a specific indication (patient population and/or condition) is identified; and
(6) Labeling must include a detailed summary of the non-clinical and in vivo evaluations pertinent to use of the devices and accessories in the circuit and adequate instructions with respect to anticoagulation, circuit setup, performance characteristics with respect to compatibility among different devices and accessories in the circuit, and maintenance during a procedure.
0
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January 19, 2024
CardiacAssist, Inc. Wendy Perreault Consultant 620 Alpha Drive Pittsburgh, Pennsylvania 15238
Re: K233736
Trade/Device Name: LifeSPARC System Regulation Number: 21 CFR 870.4100 Regulation Name: Extracorporeal Circuit And Accessories For Long-Term Respiratory/Cardiopulmonary Failure Regulatory Class: Class II Product Codes: QNR, KFM, DWA Dated: November 21, 2023 Received: November 22, 2023
Dear Wendy Perreault:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/medicaldevices/medical-device-safety/medical-device-reporting-mdr-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,
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: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
LifeSPARC System
Indications for Use (Describe)
Extracorporeal Membrane Oxygenation
The LifeSPARC System is a centrifugal blood pump system intended to assist in circulation of the patient's blood when part of an extracorporeal circuit including physiologic gas exchange of the patient's blood in adult patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. These may include:
· Failure to wean from cardiopulmonary bypass following cardiac surgery in adult patients;
· ECMO-assisted cardiopulmonary resuscitation in adults.
Cardiopulmonary Bypass
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
Date: 16-Jan-2024
Applicant:
CardiacAssist, Inc. (dba TandemLife) 620 Alpha Drive Pittsburgh, PA 15238 Telephone: 412-963-7770 Fax: 412-963-0800
Contact Person:
Wendy Perreault Title: Regulatory Affairs Consultant e-mail: tl.regulatory@livanova.com
Device:
| Trade/Proprietary Name: | LifeSPARC System |
|---|---|
| Common Name: | ECMO Pump and Controller/Cardiopulmonary Bypass System |
| Classification Name: | Extracorporeal Circuit and Accessories for Long-Term |
| Respiratory/Cardiopulmonary Failure (21 CFR 870.4100, Product | |
| Code QNR) | |
| Classification Name: | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type (21 CFR |
| 870.4360 / Product Code KFM) | |
| Classification Name: | Control, pump speed, cardiopulmonary bypass (21 CFR 870.4360 / |
| Product Code DWA) |
Primary Predicate Device:
LifeSPARC System (K211830)
Reference Device:
LifeSPARC System (K232132)
This is a bundled submission for the devices cleared under submissions K211830 and K232132. The same device is cleared for two different indications, under two different regulations.
4
TANDEM | LIFE
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.
Indications for Use:
Extracorporeal Membrane Oxygenation
The LifeSPARC System is a centrifugal blood pump system intended to assist in circulation of the patient's blood when part of an extracorporeal circuit including physiologic gas exchange of the patient's blood in adult patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. These may include:
- Failure to wean from cardiopulmonary bypass following cardiac surgery in adult patients
- ECMO-assisted cardiopulmonary resuscitation in adults
Cardiopulmonary Bypass
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 Predicate and Reference devices.
Summary of Non-clinical Testing:
Software Verification and Validation testing (including Cybersecurity) was completed for the Subject device with the new software.
5
TANDEM | LIFE
Substantial Equivalence Comparison:
Testing of the LifeSPARC Controller demonstrates that no concerns regarding safety and effectiveness result from the software changes; specifically, software test data supports substantial equivalence of the Subject device to the Predicate and Reference devices.
Conclusion:
Testing described in this notification demonstrates that the Subject LifeSPARC System performance is substantially equivalent to the legally marketed Predicate LifeSPARC System (K211830) and Reference device (K232132).