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 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.

AI/ML Overview

The provided document is a 510(k) summary for the TandemHeart System, a non-roller type cardiopulmonary bypass blood pump. This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. As such, it focuses on comparing the new device to existing ones rather than presenting a standalone study with detailed acceptance criteria and performance metrics in the way one might expect for a novel AI/software medical device.

Based on the available text, here's what can be extracted and what cannot:

A table of acceptance criteria and the reported device performance
- Acceptance Criteria (Implicit): The primary acceptance criterion for a 510(k) submission is "substantial equivalence" to a predicate device. For the specific performance test mentioned, the implicit acceptance criterion was that the TandemHeart System demonstrate "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."
- Reported Device Performance:
  - "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."
Table:

Acceptance Criteria (Implicit)	Reported Device Performance
Adequate flow performance with an Oxygenator in the extracorporeal circuit.	Demonstrated (implied by "adequate flow performance").
Flow performance substantially equivalent to the predicate AB-180 XC System when an Oxygenator is included.	Flows were "substantially equivalent to those provided by the predicate AB-180 XC System" with an Oxygenator.
Device design, construction, performance, materials, and method of construction are substantially equivalent to the predicate.	The TandemHeart System is "substantially equivalent to the predicate CardiacAssist AB-180 XC System in design characteristics, performance, materials, method of construction, and intended use." (This is a general statement of equivalence as required for 510(k)).

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. The document mentions "subsequent testing of the TandemHeart System" for "flow vs. pressure drop (HQ)," but does not provide details on the number of units tested, the duration of tests, or any patient data sample sizes.
- Data Provenance: Not specified. As the testing was to verify performance, it's likely internal lab testing, but specific country or retrospective/prospective nature regarding patient data is not applicable/provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This device is a mechanical blood pump, not an AI/diagnostic imaging device. "Ground truth" in the context of expert review or clinical outcomes is not pertinent to the "flow vs. pressure drop" testing described.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is not a study involving expert adjudication for diagnostic accuracy. The performance testing described (flow vs. pressure drop) would likely involve objective measurements against engineering specifications or comparative measurements with a predicate, not expert adjudication.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is not an AI-assisted diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a mechanical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the "flow vs. pressure drop (HQ)" testing, the ground truth would be based on physical measurements and engineering principles, likely comparing the device's performance against established specifications or the performance of the predicate device. It's not based on expert consensus, pathology, or outcomes data.
The sample size for the training set
- Not applicable. This is not an AI/machine learning device that requires a training set.
How the ground truth for the training set was established
- Not applicable. As above, this is a mechanical device, not an AI system.

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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.		Indications for Use
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)	Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)	Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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FORM FDA 3881 (8/14)

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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: 412-963-7770 x266 Fax: 412-963-0800

Contact: Greg Johnson

Title: Director of Regulatory Affairs e-mail: gjohnson@tandemheart.com

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

Indications for Use

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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.

Regulation Number and Section

§ 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.