(28 days)
Not Found
No
The summary describes a mechanical system with added components (mast pumps, EVO) to assist the perfusionist. There is no mention of AI, ML, or any data-driven decision-making or learning capabilities. The focus is on hardware modifications and their functional equivalence to existing systems.
Yes
The device actively pumps blood and cardioplegia solution, and performs left ventricular venting and cardiotomy suction during cardiopulmonary bypass procedures, all of which are direct interventions to support or restore physiological function.
No
Explanation: The device is described as a system for speed-controlled pumping of blood through a cardiopulmonary bypass circuit, left ventricular venting, cardiotomy suction, and administration of cardioplegia solution. These are therapeutic and support functions, not diagnostic ones.
No
The device description clearly states the addition of "mast pumps and the Electrical Venous Occluder (EVO)" which are hardware components. The submission is for modifications to a physical system, not a standalone software application.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device's function as pumping blood through a cardiopulmonary bypass circuit, left ventricular venting, cardiotomy suction, and administering cardioplegia solution. These are all procedures performed on the patient's body during surgery, not tests performed on samples taken from the body.
- Device Description: The description focuses on the mechanical components (pumps, occluder) and their role in managing blood flow during bypass. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information about a patient's health status
- Using reagents or assays
The Sorin C5 System is a medical device used in a surgical setting to support a patient's circulatory system during a procedure. It does not perform in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
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 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.
Product codes
DTQ
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.
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified perfusionist who is experienced in the operation of the C5 System
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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.
Clinical testing on the modified Sorin C5 System was not required or provided. Therefore, this section does not apply.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Stöckert S5 System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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.
1
. 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 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 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
2
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.
3
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:
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.
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