The Sorin C5 System is indicated for speed-controlled pumping of blood through the cardiopulmonary bypass circuit for durations of six (6) hours or less, left ventricular venting, cardiotomy suction, and administration of cardioplegia solution, when used by a qualified perfusionist who is experienced in the operation of the C5 System.

The C5 System has been qualified only for durations appropriate to cardiopulmonary bypass procedures and has not been qualified, through in vitro, in vivo, or clinical studies, for long term use as a bridge to transplant, pending recovery of the natural heart, or extracorporeal membrane oxygenation (ECMO) procedures.

Device Description

The Sorin C5 System modification consists of the addition of the mast pumps and the Electrical Venous Occluder (EVO) to the Sorin C5 System. The function of the modified Sorin C5 System is identical to that of the parent C5 system. Masts pumps expand the number of pumps available to the perfusionist. The Electrical Venous Occluder allows the perfusionist to respond more quickly to detections of air in the extracorporeal circuit. This Special 510(k) was submitted for the addition of optional components and accessories that are provided to assist the perfusionist in their conduct of cardiopulmonary bypass. The mast pumps allow for additional pumping for such activities as left ventricular venting, cardiotomy suction, and administration of cardioplegia solution. The EVO replaces a maximum of two manual tubing clamps and interfaces perfusionist-selected roller pumps to clamp the venous line when a pump alarm condition occurs.

AI/ML Overview

This 510(k) summary (K103762) for the Sorin C5 System is a Special 510(k) submission for modifications to an existing device rather than a new device with a comprehensive clinical or standalone performance study. Therefore, much of the requested information regarding acceptance criteria and detailed study designs for AI-powered devices is not directly applicable or available in this document.

The submission focuses on demonstrating substantial equivalence to a predicate device (Stöckert S5 System and the parent Sorin C5 System) for the modifications introduced, which are the addition of mast pumps and an Electrical Venous Occluder (EVO).

Here's an analysis based on the provided text, addressing the points where information is available or noting when it's not applicable:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics for the modified device in the way one would expect for an AI/algorithm-driven device. The "performance" assessment here is focused on demonstrating that the added components function as intended and do not negatively impact the overall system's safety and effectiveness compared to the predicate.

Acceptance Criteria (Inferred)	Reported Device Performance
Functionality of Mast Pumps: Ability to provide additional pumping for left ventricular venting, cardiotomy suction, and cardioplegia solution administration.	"The mast pumps allow for additional pumping for such activities as left ventricular venting, cardiotomy suction, and administration of cardioplegia solution." (Implied successful functionality through verification and validation testing).
Functionality of Electrical Venous Occluder (EVO): Ability to replace manual tubing clamps (max two) and interface with selected roller pumps to clamp the venous line upon pump alarm condition, allowing quicker response to air detection.	"The Electrical Venous Occluder allows the perfusionist to respond more quickly to detections of air in the extracorporeal circuit." (Implied successful functionality through verification and validation testing).
Overall System Safety (Electrical/Mechanical): Compliance with relevant safety standards (IEC 60601-1).	"safety testing (per IEC60601-1)" was conducted. (Implied compliance).
Overall System Electromagnetic Compatibility: Compliance with relevant EMC standards (IEC 60601-1-2).	"electromagnetic immunity and compatibility (per IEC 60601-1-2)" was conducted. (Implied compliance).
Integrated System Performance (Simulated/In Use): The modified system performs as expected in a simulated or "in-use" environment.	"simulated use/in use testing of the integrated system" was conducted. (Implied successful performance).
Substantial Equivalence: The modified Sorin C5 System performs according to specifications and is substantially equivalent to the predicate device.	"Based on the descriptive information and verification/validation /V testing provided... the modified Sorin C5 System performs according to specifications, demonstrating that there are no significant differences and that the devices are substantially equivalent."

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

The document does not provide details on specific "test set" sample sizes in the context of clinical data or AI model evaluation. The testing described is verification and validation (V&V) testing of hardware and integrated system functionality, not a clinical study with patient data.

Sample Size: Not applicable in the context of a "test set" for performance evaluation via clinical data. The V&V testing would involve a sufficient number of tests to confirm functionality and safety, but these are typically engineering tests, not patient data samples.
Data Provenance: Not applicable. No patient data or clinical data is mentioned as being used for performance evaluation of the modifications.

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. "Ground truth" in the context of expert consensus on diagnostic or prognostic outcomes is not relevant here as this is a hardware modification submission, not an AI or diagnostics device. The "ground truth" for the V&V testing would be engineering specifications and functional requirements.

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

Not applicable. This is not a study requiring adjudication of expert opinions on clinical cases.

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

Not applicable. No MRMC study was conducted, as this device is a hardware modification to a heart-lung machine, not an AI-assisted diagnostic or therapeutic tool.

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

Not applicable. This device is a console with added components, not a standalone algorithm. The EVO component has an automated function (clamping the venous line upon pump alarm), but its performance is verified through engineering tests, not an "algorithm only" study in the sense of AI.

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

The "ground truth" for this submission refers to:

Engineering Specifications: Functional requirements for the mast pumps and EVO.
Safety Standards: Compliance with IEC 60601-1 and IEC 60601-1-2.
Predicate Device Performance: The established safety and effectiveness of the existing Sorin C5 System and the predicate Stöckert S5 System.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."

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

Not applicable. As there is no training set mentioned.

Summary

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K103762

510(k) Summary (per 21 CFR 807.92) Sorin C5 System

JAN 2 0 2011

1. SPONSOR

Sorin Group Deutschland GmbH Lindberghstrasse 25 80939 Munich Germany Contact Person: Renate Goebert 011 49 89 323 010 Telephone:

Date Prepared: December 20, 2010

2. DEVICE NAME

Proprietary Name:	Sorin C5 System
Common/Usual Name:	Heart lung machine console
Classification Name:	Cardiopulmonary bypass console

3. PREDICATE DEVICES

Parent Device:	Sorin C5 System
Predicate Device:	Stöckert S5 System

4. DEVICE DESCRIPTION

. Physical description

The Sorin C5 System modification consists of the addition of the mast pumps and the Electrical Venous Occluder (EVO) to the Sorin C5 System.

How the device functions .

The function of the modified Sorin C5 System is identical to that of the parent C5 system. Masts pumps expand the number of pumps available to the perfusionist. The Electrical Venous Occluder allows the perfusionist to respond more quickly to detections of air in the extracorporeal circuit.

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. Scientific concepts that form the basis for the device

The scientific concepts of the modified Sorin C5 System are identical to those of the parent Sorin C5 System, and the predicate Stöckert S5 System; they provide artificial circulation in a cardiopulmonary bypass circuit.

. Significant physical and performance characteristics of the device, such as device design, material used, and physical properties

This Special 510(k) was submitted for the addition of optional components and accessories that are provided to assist the perfusionist in their conduct of cardiopulmonary bypass. The mast pumps allow for additional pumping for such activities as left ventricular venting, cardiotomy suction, and administration of cardioplegia solution. The EVO replaces a maximum of two manual tubing clamps and interfaces perfusionist-selected roller pumps to clamp the venous line when a pump alarm condition occurs.

5. INTENDED USE/INDICATION FOR USE

The C5 System has been qualified only for durations appropriate to cardiopulmonary bypass procedures and has not been qualified, through in vivo, or clinical studies, for long term use as a bridge to transplant, pending recovery of the natural heart, or extracorporeal membrane oxygenation (ECMO) procedures.

6. SUMMARY OF TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATE DEVICE/S

A detailed comparison of the fundamental design, technology, and performance specifications of the modified Sorin C5 System, the parent Sorin C5 System, and the predicate Stöckert S5 System demonstrates their substantial equivalence.

7. SUMMARY OF NON-CLINICAL PERFORMANCE TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE

Substantial equivalence of the modified Sorin C5 System, the parent Sorin C5 Systems, and the predicate Stöckert S5 System was based on intended use, indications for use, the

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fundamental design, technology, and performance specifications. No non-clinical testing was used as the basis for substantial equivalence. Verification and validation testing included in this Special 510(k) consisted of function testing; electromagnetic immunity and compatibility (per IEC 60601-1-2); safety testing (per IEC60601-1); and simulated use/in use testing of the integrated system.

8. SUMMARY OF CLINICAL TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE

Clinical testing on the modified Sorin C5 System was not required or provided. Therefore, this section does not apply.

9. SUMMARY OF OTHER INFORMATION

No information other than that described was provided.

10. CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL TESTS

Based on the descriptive information and verification/validation /V testing provided in this Special 510(k), the modified Sorin C5 System performs according to specifications, demonstrating that there are no significant differences and that the devices are substantially equivalent.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

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

JAN 2 0 201

Medical Device Consultants, Inc. c/o Ms. Rosina Robinson Principal Consultant, Regulatory Services 49 Plain Street North Attleboro, MA 02760

K103762 Sorin C5 System Regulation Number: 21 CFR 870.4220. Regulation Name: Console, Heart-Lung Machine, Cardiopulmonary Bypass Regulatory Class: Class II (two) Product Code: DTQ Dated: December 20, 2010 Received: December 23, 2010

Dear Ms. Robinson:

Re:

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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Page 2 - Ms. Rosina Robinson

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

0.11an.2007/MedicalDevices/ResourceCenter/PolicyGuidance/default.htm

Sincerely vours.

Dina R. Vohuner

(

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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510(k) Number (if known):

Device Name: Sorin C5 System

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duma R. V. James

(Division Sian-Off) Division of Cardiovascular Devices

510(k) Number_K103376 Z

Regulation Number and Section

§ 870.4220 Cardiopulmonary bypass heart-lung machine console.

(a)
Identification. A cardiopulmonary bypass heart-lung machine console is a device that consists of a control panel and the electrical power and control circuitry for a heart-lung machine. The console is designed to interface with the basic units used in a gas exchange system, including the pumps, oxygenator, and heat exchanger.(b)
Classification. Class II (performance standards).