TANDEMHEART PUMP

K110493 · Cardiacassist, Inc. · KFM · Sep 20, 2011 · Cardiovascular

Device Facts

• Record ID: K110493
• Device Name: TANDEMHEART PUMP
• Applicant: Cardiacassist, Inc.
• Product Code: KFM · Cardiovascular
• Decision Date: Sep 20, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4360
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TandemHeart pump 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

TandemHeart System provides extracorporeal circulatory support; consists of Escort Controller and TandemHeart Blood Pump. Used in clinical settings during open surgical procedures; operated by trained medical professionals. Device pumps blood through extracorporeal circuit; supports full/partial cardiopulmonary bypass or temporary circulatory bypass. System allows integration of user-supplied oxygenator. Output provides hemodynamic support during planned circulatory pathway disruptions. Benefits include maintenance of blood flow during cardiac or vascular surgery. Healthcare providers monitor system performance to ensure adequate flow and pressure during procedures.

Clinical Evidence

Bench testing only. Risk assessment conducted to evaluate labeling changes. HQ (flow vs. pressure drop) testing performed to verify performance with an oxygenator. Results demonstrated adequate flow performance and substantial equivalence to the predicate AB-180 XC System.

Technological Characteristics

Non-roller type cardiopulmonary bypass blood pump. System comprises Escort Controller and blood pump. Supports extracorporeal circuit with optional user-supplied oxygenator. Design and construction identical to predicate AB-180 XC System.

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 less than 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

• CardiacAssist AB-180 XC System (K991783)
• Levitronix Centrimag Extracorporeal Blood Pumping System (K020271)
• Levitronix/Thoratec Centrimag Primary Console (K083340)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 17, 2016

CardiacAssist Incorporated c/o Mr. Robert Bollinger Director, Quality Assurance 240 Alpha Drive Pittsburg, PA 15238

Re: K110493

Trade/Device Name: TandemHeart System Regulation Number: 21 CFR 870.4360 Regulation Name: Non-Roller Type Cardiopulmonary Bypass Blood Pump Regulatory Class: Class II Product Code: KFM Dated: August 12, 2011 Received: August 15, 2011

Dear Mr. Bolinger:

This letter corrects our substantially equivalent letter of September 20, 2011.

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, 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.

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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 (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

# Eric E. Richardson -S

For Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| Form Approved: OMB No. 0910-0120 | | DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Expiration Date: January 31, 2017 | | Food and Drug Administration | |
| See PRA Statement below. | | <b>Indications for Use</b> | |
| 510(k) Number (if known) | K110493 | | |
| Device Name | TandemHeart System | | |
| Indications for Use (Describe) | The TandemHeart pump 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) | <table><tr><td><div style="display:inline-block; vertical-align:middle;"><img alt="checkbox" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAABCAQAAAC1HAwCAAAAC0lEQVR42mNkYAAAAAYAAjCB0C8AAAAASUVORK5CYII=" style="width:10px;height:10px;"/></div> Prescription Use (Part 21 CFR 801 Subpart D)</td></tr><tr><td><div style="display:inline-block; vertical-align:middle;"><img alt="checkbox" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAABCAQAAAC1HAwCAAAAC0lEQVR42mNkYAAAAAYAAjCB0C8AAAAASUVORK5CYII=" style="width:10px;height:10px;"/></div> Over-The-Counter Use (21 CFR 801 Subpart C)</td></tr></table> | <div style="display:inline-block; vertical-align:middle;"><img alt="checkbox" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAABCAQAAAC1HAwCAAAAC0lEQVR42mNkYAAAAAYAAjCB0C8AAAAASUVORK5CYII=" style="width:10px;height:10px;"/></div> Prescription Use (Part 21 CFR 801 Subpart D) | <div style="display:inline-block; vertical-align:middle;"><img alt="checkbox" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAABCAQAAAC1HAwCAAAAC0lEQVR42mNkYAAAAAYAAjCB0C8AAAAASUVORK5CYII=" style="width:10px;height:10px;"/></div> Over-The-Counter Use (21 CFR 801 Subpart C) |
| <div style="display:inline-block; vertical-align:middle;"><img alt="checkbox" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAABCAQAAAC1HAwCAAAAC0lEQVR42mNkYAAAAAYAAjCB0C8AAAAASUVORK5CYII=" style="width:10px;height:10px;"/></div> Prescription Use (Part 21 CFR 801 Subpart D) | | | |
| <div style="display:inline-block; vertical-align:middle;"><img alt="checkbox" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAABCAQAAAC1HAwCAAAAC0lEQVR42mNkYAAAAAYAAjCB0C8AAAAASUVORK5CYII=" style="width:10px;height:10px;"/></div> Over-The-Counter Use (21 CFR 801 Subpart C) | | | |

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Image /page/3/Picture/0 description: The image shows the logo for CardiacAssist, Inc. The logo consists of a circular graphic to the left of the company name. The graphic contains four arrows pointing in different directions, enclosed within two concentric circles. The company name, "CardiacAssist, Inc.", is written in a bold, sans-serif font.

# Section VIII 510(k) Summary

Date: 29 July 2015

# Applicant

CardiacAssist, Inc. 240 Alpha Drive Pittsburgh, PA 15238 Telephone: [phone] x266 Fax: [phone]

Contact: Greg Johnson

Title: Director of Regulatory Affairs e-mail: [e-mail]

# Device

Trade/Proprietary Name: TandemHeart System Common Name: TandemHeart System Controller and TandemHeart Pump Classification Name: Pump, Blood, Non-Roller Type Cardiopulmonary Bypass (21 CFR Part 870.4360 / Code 74 KFM)

# Predicate Devices

CardiacAssist AB-180 XC System (K991783) Levitronix Centrimag Extracorporeal Blood Pumping System (K020271) Levitronix/Thoratec Centrimag Primary Console (K083340)

#### Device Description

The TandemHeart System consists of two major components, the Escort Controller (K061369), and the TandemHeart Blood Pump (K991783), along with a number of accessory components required to setup and utilize the Pump. The system is intended for extracorporeal circulatory support using an extracorporeal bypass circuit.

#### Indications for Use

The TandemHeart pump 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.

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Image /page/4/Picture/0 description: The image shows the logo for CardiacAssist, Inc. The logo consists of a circular graphic to the left of the company name. The graphic contains a circle with arrows pointing in different directions. The company name is written in a blue, sans-serif font.

# Comparison of Technological Characteristics

The TandemHeart System is equivalent in design and construction to the predicate CardiacAssist AB-180 XC System. The labeling of the TandemHeart System is being revised to allow the use of a user supplied Oxygenator in the extracorporeal circuit. The labeling is also being revised to modify a warning statement. These revisions to the labeling result in labeling that is consistent with the labeling of the Levitronix Centrimag Extracorporeal Blood Pumping System (K020271), and Levitronix/Thoratec Centrimag Primary Console (K083340).

#### Performance Data

A risk assessment was conducted to determine the impact of the change to the labeling, and the appropriate testing to perform. Subsequent testing of the TandemHeart System was completed to verify flow vs. pressure drop (HQ) when utilized with an Oxygenator. The HQ testing results demonstrated adequate flow performance with the inclusion of an Oxygenator in the extracorporeal circuit, and that the flows were substantially equivalent to those provided by the predicate AB-180 XC System.

#### Conclusions

The CardiacAssist TandemHeart System is substantially equivalent to the predicate CardiacAssist AB-180 XC System in design characteristics, performance, materials, method of construction, and intended use. Changes to the labeling have no impact on device performance.