(28 days)
Not Found
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on speed-controlled pumping and basic/optional components, with no mention of AI/ML functionalities.
Yes
The device's intended use clearly states its function in cardiopulmonary bypass, left ventricular venting, cardiotomy suction, and cardioplegia administration, all of which are direct medical interventions aimed at treating or supporting physiological functions during surgery.
No
The device is described as a system for pumping blood and administering solutions during cardiopulmonary bypass, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states it is a "System" comprising "basic components and optional components," which strongly implies hardware. The intended use also describes "pumping of blood," which is a hardware function.
Based on the provided information, the Sorin C5 System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device's function as a blood pump for cardiopulmonary bypass, left ventricular venting, cardiotomy suction, and cardioplegia administration. These are all procedures performed on the patient's body, not on samples taken from the patient's body for diagnostic purposes.
- Device Description: The description focuses on the mechanical components and their function in circulating blood.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Sorin C5 System's function is entirely focused on supporting physiological processes during surgery.
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 System.
Product codes (comma separated list FDA assigned to the subject device)
DTQ
Device Description
The Sorin C5 System is a modification of the modular S5 System that comprises basic components and optional components. Optional components/accessories that have been cleared by the FDA for use as part of the S5 System are also compatible with the C5 · System.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified perfusionist
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing of the Sorin CS System has demonstrated that the System fulfills prospectively defined performance criteria and that the modified System meets user needs.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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).
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510(k) Summary (per 21 CFR 807.92) Sorin C5 System
1. SPONSOR
JAN 1 5 2010
Sorin Group Deutschland GmbH Lindberghstrasse 25 80939 Munich Germany Contact Person: Renate Goebert Telephone: 011 49 89 323 010
Date Prepared: December 1, 2009
2. DEVICE NAME
| Proprietary Name: | Sorin C5 System |
|---|---|
| Common/Usual Name: | Heart lung machine console and integrated roller pumps |
| Classification Name: | Cardiopulmonary bypass console, (with integrated roller-type |
| cardiopulmonary bypass pumps |
3. PREDICATE DEVICES
Parent Device: Stöckert S5 System
4. DEVICE DESCRIPTION
The Sorin C5 System is a modification of the modular S5 System that comprises basic components and optional components. Optional components/accessories that have been cleared by the FDA for use as part of the S5 System are also compatible with the C5 · System.
5. 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 System.
1
6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
The Sorin C5 System is a modification of the Stockert S5 System. The modified Stöckert S5 System is substantially equivalent to the parent Stöckert S5 System based on intended use, indication for use, operational characteristics, fundamental technological characteristics and performance specifications.
7. PERFORMANCE TESTING
Testing of the Sorin CS System has demonstrated that the System fulfills prospectively defined performance criteria and that the modified System meets user needs.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus or a representation of human services.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Sorin Group Deutschland Gmbh c/o Ms. Rosina Robinson Medical Device Consultants, Inc. 49 Plain Street North Attleboro, MA 02760
JAN 1 5 2010
Re: K093882
Trade/Device Name: Sorin C5 System, Model 58-00-00 Regulation Number: 21 CFR 870.4220 Regulation Name: Cardiopulmonary Bypass Heart Lung Machine Console Regulatory Class: II Product Code: DTQ Dated: December 15, 2009 Received: December 18, 2009
Dear Ms. Robinson:
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.
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
3
Page 2 - Ms. Rosina Robinson
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/CDRH0ffices/ucml 15809.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.
Sincerely vours.
D.nna R. Valine
Image /page/3/Picture/7 description: The image contains a handwritten signature on the left and the letters 'B' and 'D' on the right. The signature is illegible, but it appears to be written in cursive. The letters 'B' and 'D' are in a simple, sans-serif font. The image is black and white.
C 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.
Ko93882
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)
Duna P. Watkins
n of Cardiovascular Devices
510(k) Number_Ko93882