The TandemHeart Escort Controller is intended to be used with the TandemHeart PTVA System. The TandemHeart PTVA System consists of the TandemHeart PTVA Blood Pump, a single use, disposable device; The TandemHeart Escort (T.H.E.) Controller, a reusable control system for the TandemHeart PTVA Blood Pump; and disposable accessory items used in conjunction with the TandemHeart PTVA System. In the U.S., the TandemHeart PTVA System is intended for extracorporeal circulatory support using an extracorporeal bypass circuit. Intended duration of use is for periods appropriate to cardiopulmonary bypass, up to six hours. It is also intended to be used as an extracorporeal circulatory support system (for periods up to six hours) for procedures not requiring complete cardiopulmonary bypass (e.g., valvuloplasty, mitral valve reoperation, surgery of the vena cava and/or aorta, liver transplant, etc.)

Device Description

The TandemHeart Escort (T.H.E) Controller is a microprocessor-based pump motor drive and infusion system. It is designed to operate on AC current (110/240 VAC, 50/60 Hz) or on internal, rechargeable batteries for intra-hospital transport. The T.H.E Controller generates the signals required to power the drive motor of the TandemHeart Blood Pump, which turns the impeller to propel blood through the Pump. The system works independently of the heart. The Controller also serves to deliver the infusate into the TandemHeart Blood Pump and to provide information regarding system performance including measured flow. It is portable and designed to be pole mounted, hung from a horizontal bed rail, or placed on a table top. It is simple to use, with an integral backup motor control circuit, and backup batteries for redundant operation.

AI/ML Overview

The provided text is a 510(k) summary for the TandemHeart Escort Controller, a medical device used for cardiopulmonary bypass. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study for meeting specific acceptance criteria on clinical performance. Therefore, many of the requested elements (e.g., sample sizes, expert qualifications, adjudication methods, MRMC studies, ground truth details) are not applicable or cannot be extracted from this document as no clinical performance study is described.

Here's an attempt to answer the questions based only on the provided text, indicating when information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (What was measured/verified)	Reported Device Performance (How the device performed against criteria)
Conformance to CardiacAssist performance specifications established for the device	Performance characteristics "were tested and compared with CardiacAssist performance specifications established for the device." (No specific quantitative performance metrics are provided, but the statement implies successful conformance.)
Conformance to voluntary standards for EMC (Electromagnetic Compatibility)	Performance characteristics "were tested and compared with... voluntary standards for EMC." (Implied conformance to these standards.)
Conformance to voluntary standards for Electrical Safety	Performance characteristics "were tested and compared with... voluntary standards for... Electrical Safety." (Implied conformance to these standards.)
Equivalence to the commercially available predicate device (AB-180 XD Blood Pump Controller)	The T.H.E. Controller "employs the same functional scientific technology as its predicate device." It has "the same intended use and indications for use as its predicate." Its "primary function... remains the same as its predicate, which is to supply Blood Pump motor power and motor control." The changes (Color LCD, smaller case, optional blood flow sensor) "raise no new safety or effectiveness issues." Based on these comparisons, the FDA determined the device is "substantially equivalent" to legally marketed predicate devices.

2. Sample size(s) used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not applicable / Not provided. This document describes a comparison to design specifications and predicate device characteristics, not a clinical study on a patient sample.
Data Provenance: Not applicable / Not provided.

3. 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 / Not provided. No test set requiring expert-established ground truth is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable / Not provided.

5. 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

No MRMC comparative effectiveness study was done or reported. This device is a pump speed controller, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is hardware with integrated software for pump control, not a standalone algorithm in the typical sense of AI/ML. The performance review focused on the device's conformance to its specifications and equivalence to a predicate.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable / Not provided. The "truth" used for comparison was CardiacAssist's own performance specifications, voluntary standards (EMC, electrical safety), and the established characteristics of the predicate device.

8. The sample size for the training set

Not applicable / Not provided. As no AI/ML clinical performance study is described for this device, there is no "training set" in that context.

9. How the ground truth for the training set was established

Not applicable / Not provided.

Summary

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K061369
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TandemHeart Escort Controller 510(k) Summary

AUG 2 2 2006

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the Safe Medical Devices Act (SMDA) of 1990 and Title 21 of the Code of Federal Regulations, Part 807, and in particular §807.92.

Application Information: A.

Date Prepared:	May 12, 2006
Submitter's Name & Address:	CardiacAssist, Inc.240 Alpha DrivePittsburgh, PA 15238
Contact Person:	Mr. Robert BollingerDirector of Quality AssurancePh: 412-963-7770 x229Fax: (412) 963-0800e-mail: RBollinger@cardiacassist.com
B. Device Information:
Trade or Proprietary Name:	TandemHeart Escort Controller
Common or Usual Name:	Cardiopulmonary bypass pump speed control
Classification Name:	Class II, DWA, 21 CFR - 870.4380Control, Pump Speed, Cardiopulmonary Bypass
Performance Standard:	Performance standards do not currentlyexist for these devices. None established undersection 514 of the Food, Drug and Cosmetic Act.
C. Predicate Device:	CardiacAssist Model AB-180 XD Blood PumpController, K991783, found substantially equivalentNovember 1, 2000. Name changed to TandemHeartPTVA Controller
D. Device Description:	The TandemHeart Escort (T.H.E) Controller is amicroprocessor-based pump motor drive and infusionsystem. It is designed to operate on AC current (110/240VAC, 50/60 Hz) or on internal, rechargeable batteries forintra-hospital transport.

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്ത് CardiacAssist, Inc.

KC61369
Page 2 of 3

The T.H.E Controller generates the signals required to power the drive motor of the TandemHeart Blood Pump, which turns the impeller to propel blood through the Pump. The system works independently of the heart. The Controller also serves to deliver the infusate into the TandemHeart Blood Pump and to provide information regarding system performance including measured flow. It is portable and designed to be pole mounted, hung from a horizontal bed rail, or placed on a table top. It is simple to use, with an integral backup motor control circuit, and backup batteries for redundant operation.

In the U.S., the TandemHeart PTVA System is intended for extracorporeal circulatory support using an extracorporeal bypass circuit. Intended duration of use is for periods appropriate to cardiopulmonary bypass, up to six hours. It is also intended to be used as an extracorporeal circulatory support system (for periods up to six hours) for procedures not requiring complete cardiopulmonary bypass (e.g., valvuloplasty, mitral valve reoperation, surgery of the vena cava and/or aorta, liver transplant, etc.)

F. Technological Characteristics:

The TandemHeart Escort Controller employs the same functional scientific technology as its predicate device.

G. Comparison to Predicate Device

The TandemHeart Escort (T.H.E.) Controller has the same intended use and indications for use as its predicate, the AB-180 XD Blood Pump Controller. The primary function of the T.H.E. Controller remains the same as its predicate, which is to supply Blood Pump motor power and motor control. The T.H.E Controller has been designed to provide improved portability using the same technology as the AB-180 XD Controller.

E. Intended Use:

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്ത് CardiacAssist, Inc.

KCG1369
Page 3 of 3

The AB-180 XD (TandemHeart PTVA) Controller utilized a monochromatic display for the display of operational information whereas the T.H.E. Controller upgraded the display to a Color LCD. Other changes include a smaller case for the controller hardware while utilizing the same blood pump, and an optional blood flow sensor. The equivalency of the indications for use, the design features and the functional characteristics raise no new safety or effectiveness issues.

H. Summary of Performance Data:

The performance characteristics of the TandemHeart Escort Controller were tested and compared with CardiacAssist performance specifications established for the device, voluntary standards for EMC, Electrical Safety and with the commercially available predicate device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 2 2006

Cardiac Assist, Inc. c/o Mr. Robert Bollinger Director of Quality Assurance 240 Alpha Drive Pittsburgh, PA 15238

Re: K061369

TandemHeart Escort (T.H.E.) Controller Regulation Number: 21 CFR 870.4380 Regulation Name: Cardiopulmonary Bypass Pump Speed Control Regulatory Class: Class II (two) Product Code: DWA Dated: August 1, 2006 Received: August 2, 2006

Dear Mr. Bollinger:

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.

If your device is classified (sec above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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Page 2 -- Mr. Robert Bollinger

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) rremarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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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്ത്യം CardiacAssist, Inc.

Indications for Use Statement

K061369 510(k) Number CardiacAssist TandemHeart Escort Controller Device Name The TandemHeart Escort Controller is intended to Indication for Use be used with the TandemHeart PTVA System. The TandemHeart PTVA System consists of the TandemHeart PTVA Blood Pump, a single use, disposable device; The TandemHeart Escort (T.H.E.) Controller, a reusable control system for the TandemHeart PTVA Blood Pump; and disposable accessory items used in conjunction with the TandemHeart PTVA System. In the U.S., the TandemHeart PTVA System is intended for extracorporeal circulatory support using an extracorporeal bypass circuit. Intended duration of use is for periods appropriate to cardiopulmonary bypass, up to six hours. It is also intended to be used as an extracorporeal circulatory support system (for periods up to six hours) for procedures not requiring complete cardiopulmonary bypass (e.g., valvuloplasty, mitral valve reoperation, surgery of the vena cava and/or aorta, liver transplant, etc.)

× Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division/Sign-Off)
Division of Cardiovascular Devices
510(k)	Kbb1369

Regulation Number and Section

§ 870.4380 Cardiopulmonary bypass pump speed control.

(a)
Identification. A cardiopulmonary bypass pump speed control is a device used that incorporates an electrical system or a mechanical system, or both, and is used to control the speed of blood pumps used in cardiopulmonary bypass surgery.(b)
Classification. Class II (performance standards).