LifeSPARC System

K232132 · Cardiacassist, Inc. · KFM · Aug 3, 2023 · Cardiovascular

Device Facts

• Record ID: K232132
• Device Name: LifeSPARC System
• Applicant: Cardiacassist, Inc.
• Product Code: KFM · Cardiovascular
• Decision Date: Aug 3, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4360
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

LifeSPARC System is a sterile, single-use, centrifugal blood pump with integrated motor and pivot bearing; used with a microprocessor-based electromechanical controller. System provides extracorporeal blood circulation for <6 hours during open surgical procedures. Controller drives pump via AC power or internal rechargeable batteries for intra-hospital transport. Clinicians operate system to provide cardiopulmonary or circulatory bypass. Output allows diversion of blood flow around surgical sites, supporting patient stability during cardiac or vascular procedures.

Clinical Evidence

Bench testing only. No clinical data provided. Testing focused on software verification and electromagnetic compatibility to support the software version update.

Technological Characteristics

Centrifugal blood pump with integrated motor and single-point pivot bearing. Sterile, single-use, low prime volume. Controller is microprocessor-based electromechanical system. Power: 100/240 VAC or internal rechargeable batteries. Sterilization: Ethylene oxide (EO).

Indications for Use

Indicated for patients undergoing open surgical procedures on the heart, great vessels, aorta, or vena cava requiring full or partial cardiopulmonary bypass or temporary circulatory bypass for <6 hours.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• LifeSPARC System (K183623)

Reference Devices

• LifeSPARC System (K211830)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.

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

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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 ([e-mail]) or phone [phone] 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

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# 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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# 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: [phone] Fax: [phone]

#### Contact person

Arielle Drummond, PhD Title: Director of Regulatory Affairs Phone: [phone] e-mail: [e-mail]

#### Device

| Trade/Proprietary Name: | LifeSPARC System |
|-------------------------|----------------------------------------------------------------------------------------------|
| Common Name: | Cardiopulmonary Bypass System |
| Classification Name: | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type (21 CFR<br>870.4360 / Product Code KFM) |
| | Control, pump speed, cardiopulmonary bypass (21 CFR 870.4360<br>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

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# 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).