(48 days)
The Sorin Centrifugal Pump (CP5) is a cardiopulmonary bypass speed control device indicated for use exclusively with the Sorin Revolution®, for speedcontrolled pumping through the cardiopulmonary bypass circuit for typical durations of six hours or less.
The CP5 has been qualified only for typical durations of six hours or less, 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.
The Sorin CP5 is intended for use as a component part of or optional accessory for the Sorin heart lung machine consoles and with the Stöckert Air Purge (APC) the Borin heads they System. The Sorin CP5 consists of the drive unit, a mounting receptacle for the Dystein. The Cretaining key, splash protection, and a 3-joint mast holder with fast clamp connector. It integrates the functional capabilities of the SCP, the SCP Plus, and the Sorin Pulse Mode Control within a single device.
The Sorin CP5 consists of hardware, firmware, and electronics that are used to drive the centrifugal pump for surgical procedures requiring cardiopulmonary bypass for typical durations of six (6) hours or less. The SCP drive unit uses magnetic coupling with the disposable centrifugal pump.
The Sorin CP5 with the loaded centrifugal pump recirculates the contents of the extracorporeal circuit during cardiopulmonary bypass.
The design, materials, and physical properties of the CP5 are essentially unchanged from that of the parent/predicate devices already reviewed and cleared by the FDA.
The provided text describes a 510(k) summary for the Sorin Centrifugal Pump (CP5). However, it explicitly states that no clinical testing and no comparative nonclinical testing served as the basis for substantial equivalence. The summary focuses on technological characteristics compared to predicate devices and internal validation.
Therefore, the requested information regarding an acceptance criteria table, detailed study parameters, ground truth establishment, expert involvement, and MRMC studies cannot be extracted from the provided text, as such studies were not performed or are not reported.
Here's what can be extracted based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states: "Testing of the Sorin Centrifugal Pump (CPS) demonstrates that the CP5 fulfills prospectively defined performance criteria and meets user needs." However, the specific quantitative or qualitative acceptance criteria and the corresponding reported device performance values are not detailed in this summary.
2. Sample size used for the test set and the data provenance:
Not applicable. The document states: "No comparative nonclinical testing served as the basis for substantial equivalence." and "No clinical testing served as the basis for substantial equivalence." The testing performed involved "integration testing of hardware and firmware, functional testing, testing of organized (IEC 60601-1 including deviations for the US) and associated tooling, success (IEC 60601-1-2), and validation testing (simulated use and in use)." This describes internal validation, not a test set based on patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as no external test set with ground truth established by experts is described.
4. Adjudication method for the test set:
Not applicable, as no external test set requiring adjudication is described.
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. This device is a cardiopulmonary bypass centrifugal pump, not an AI-assisted diagnostic tool for human readers. No MRMC study was performed or is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device is a hardware component (centrifugal pump) with firmware, not a standalone algorithm. Performance testing was internal validation of the hardware and firmware.
7. The type of ground truth used:
Not applicable in the context of clinical or diagnostic performance. The "ground truth" for the internal validation would be the design specifications and expected functional behavior.
8. The sample size for the training set:
Not applicable, as this is not an AI/machine learning device with a training set.
9. How the ground truth for the training set was established:
Not applicable, as this is not an AI/machine learning device with a training set.
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510(k) Summary for the Sorin Group Deutschland GmbH Sorin Centrifugal Pump (CP5)
(21 CFR 807.92 and http://www.fdagov/MedicalDevices/DevicesRegulationandGuidance/default.html
1. SPONSOR/APPLICANT
| Sorin Group Deutschland GmbH | |
|---|---|
| Lindberghstrasse 25 | |
| D-80939 Munich | |
| Germany | |
| Contact Person: | Renate Goebert |
| Telephone: | 011 +49 (0)89 323 01 153 |
September 1, 2011 Date Prepared:
2. DEVICE NAME
| Proprietary Name: | Sorin Centrifugal Pump (CP5) |
|---|---|
| Common/Usual Name: | Cardiopulmonary bypass centrifugal pump |
| Classification Name: | Cardiopulmonary bypass speed control device (21 CFR 870.4380; Product Code: DWA) |
3. PREDICATE DEVICE/S
- · Stöckert Centrifugal Pump System Plus for the S5/C5 System (K103468)
- · Pulse Mode Control for the S5 System (K071318)
4. DEVICE DESCRIPTION
· Physical description
The Sorin CP5 is intended for use as a component part of or optional accessory for the Sorin heart lung machine consoles and with the Stöckert Air Purge (APC) the Borin heads they
System. The Sorin CP5 consists of the drive unit, a mounting receptacle for the Dystein. The Cretaining key, splash protection, and a 3-joint mast holder with fast clamp connector. It integrates the functional capabilities of the SCP, the SCP Plus, and the Sorin Pulse Mode Control within a single device.
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· How the device functions
The Sorin CP5 consists of hardware, firmware, and electronics that are used to drive the centrifugal pump for surgical procedures requiring cardiopulmonary bypass for typical durations of six (6) hours or less. The SCP drive unit uses magnetic coupling with the disposable centrifugal pump.
· Scientific concepts that form the basis for the device
The Sorin CP5 with the loaded centrifugal pump recirculates the contents of the extracorporeal circuit during cardiopulmonary bypass.
- · Significant physical and performance characteristics of the device, such as device design, material used, and physical properties
The design, materials, and physical properties of the CP5 are essentially unchanged from that of the parent/predicate devices already reviewed and cleared by the FDA.
5. INTENDED USE/INDICATION FOR USE
The Sorin Centrifugal Pump (CP5) is a cardiopulmonary bypass speed control device indicated for use exclusively with the Sorin Revolution®, for speed-controlled pumping through the cardiopulmonary bypass circuit for typical durations of six hours or less.
The CP5 has been qualified only for typical durations of six hours or less, 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.
6. SUMMARY OF TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATE DEVICE/S
The technological characteristics of the Sorin CP5 described in this Special 510(k): Device Modification are substantially equivalent to cited parent/predicate devices previously reviewed and cleared by the FDA. Characteristics unchanged from the parent/predicate devices include the following: firmware control; magnetic coupling with disposable pump head; speed control with shaft encoder; data transfer via CAN bus; mast mounted drive unit with fast clamp connector; hosing materials; motor; DC power supply from HLM; microcontroller; programming language; and tools for code implementation. Minor differences include the following: panel hosing and mounting; control keys; data connection to drive unit; use of an OTS operating system and user
Sorin Group Deutschland GmbH
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interface; complier; CAN bus identifiers and identification method; and addition of ramp down function and inlet pressure measurement.
7. SUMMARY OF NON-CLINICAL PERFORMANCE TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE
No comparative nonclinical testing served as the basis for substantial equivalence. Testing consisted of integration testing of hardware and firmware, functional I csting ocusioned of moganized (IEC 60601-1 including deviations for the US and acceptained tooling, success (1EC 60601-1-2), and validation testing (simulated use and in use).
8. SUMMARY OF CLINICAL TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE
No clinical testing served as the basis for substantial equivalence.
9. SUMMARY OF OTHER INFORMATION
No "other information" was included in this 510(k).
10. Conclusions Drawn From Non-clinical and Clinical Tests
Testing of the Sorin Centrifugal Pump (CPS) demonstrates that the CP5 fulfills prospectively defined performance criteria and meets user needs.
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Image /page/3/Picture/1 description: The image shows a black and white logo. The logo features a stylized bird-like figure with three curved lines representing its body or wings. The bird is oriented diagonally within the frame. Encircling the bird is a circular arrangement of text, although the text is not clearly legible due to the image quality.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -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
SEP 20 2011
Re: K112225
Trade/Device Name: Sorin Centrifugal Pump (CP5) Regulation Number: 21 CFR 870.4380 Regulation Name: Cardiopulmonary bypass pump speed control Regulatory Class: II Product Code: DWA Dated: September 1. 2011 Received: September 2, 2011
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 introtate 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 misbrandi, 1rsund 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 migleding.
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 comply with all the Act's requirements, including, but not limited to: registration and histing (21
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Page 2 – Ms. Rosina Robinson
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical er it i art 607), mooning (21 CFR 803); good manufacturing practice requirements as set de receithated develos events) (2) CFR Part 820); and if applicable, the electronic form in the quant) by oversions (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 n you desire specific advice for your conters Offices/CDRH/CDRHOffices/ucm115809.htm for go to migories and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part note the regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/Reportal?roblem/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 Tou may obtain only. generational 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/ResourcesforYou/Industry/default.htm.
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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Indications for Use Statement
112225 510(k) Number (if known):
Sorin Centrifugal Pump (CP5) Device Name:
Indications for Use:
The Sorin Centrifugal Pump (CP5) is a cardiopulmonary bypass speed control device indicated for use exclusively with the Sorin Revolution®, for speedcontrolled pumping through the cardiopulmonary bypass circuit for typical durations of six hours or less.
The CP5 has been qualified only for typical durations of six hours or less, 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 IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sigh-Off) Division of Cardiovascular Devices 510(k) Number_ (< 11222 S
§ 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).