(128 days)
No
The description focuses on the mechanical function of a centrifugal blood pump and an adapter, with no mention of AI or ML capabilities.
Yes
The device is described as an "extracorporeal blood pump for use in cardiopulmonary bypass procedures," which indicates it is used for medical treatment or therapy.
No
This device is described as an "extracorporeal blood pump" used during cardiopulmonary bypass procedures, indicating it is a therapeutic device for circulating blood, not a diagnostic device for identifying medical conditions.
No
The device description clearly details a physical, disposable pump and an adapter made of hard plastic, indicating it is a hardware device, not software only.
Based on the provided text, the Sarns® Centrifugal Pump is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's an "extracorporeal blood pump for use in cardiopulmonary bypass procedures." This involves pumping blood outside the body during surgery.
- Device Description: The description reinforces its function as a pump to move blood through an extracorporeal circuit.
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The Sarns® Centrifugal Pump does not perform any diagnostic testing on blood or other specimens. It is a mechanical device for moving blood.
Therefore, the Sarns® Centrifugal Pump is a medical device used in a surgical procedure, not an IVD.
N/A
Intended Use / Indications for Use
The Sarns® Centrifugal Pump (with or without X-Coating™) is a sterile, single use device, used as an extracorporeal blood pump for use in cardiopulmonary bypass procedures for up to 6 hours.
The pump is intended for use with the Sarns® Centrifugal Systems or may be used with Stöckert Centrifugal Pump Systems by attaching the Sarns® Centrifugal Pump Adapter.
Product codes
KFM
Device Description
The Sarns® Centrifugal Pump (with or without X-Coating™) is a single use, sterile and disposable device.
It is used to pump blood through the extracorporeal circuit during cardiopulmonary bypass surgery and may be used for up to 6 hours.
The pump has a priming volume of 48ml. The pump rotational speed is 0-3600 RPM resulting in a flow capacity of 0-9.9 LPM.
With this submission, the sterile disposable Sarns® Centrifugal pump may be used with Stöckert Centrifugal pump systems when the reusable Sarns® Centrifugal Pump Adapter is used. The Sarns® Centrifugal Pump Adapter is a device designed with geometries that mate the Stöckert centrifugal systems to the Sarns® Centrifugal pump. The housing is a hard plastic (acetal) that slides easily onto the Sarns® Centrifugal pump then clips into place. The adapted pump is then mounted onto the Stöckert Centrifugal pump systems.
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
Not Found
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)
Flow curves: A test that demonstrates the performance of the sterile disposable pump has not changed when used with the reusable Sarns® Centrifugal Pump adapter on the Stöckert Centrifugal Pump System. Results Summary: PASS: Back pressure ranges for the proposed device configuration are within range of the predicate device configuration.
Reusable Sarns® Centrifugal Pump Adapter clip fatigue test: Shows the clipping mechanism is rated for the lifetime use of 7yrs. Results Summary: PASS: The reusable adapter has passed test meeting the lifetime use of 7 years.
Reusable Sarns® Centrifugal Pump Adapter change out time test: To show that the change out time of the pump on the proposed device configuration is similar to the pump change out time of the predicate device configuration. Results Summary: PASS: The change out time between the predicate device configuration and the proposed device configuration showed no statistical difference.
Shipping and Durability test: Show that the Sarns® Centrifugal Pump Adapter show no signs of damage after shipment and functions as intended after shipment. Results Summary: PASS: Sarns® Centrifugal Pump Adapter showed no signs of damage and functioned as intended following testing.
Hemolysis test: To show that is there is no statistical difference of the effect on plasma free hemoglobin, white blood cell count and platelet count between the sterile disposable Sarns® Centrifugal Pump with reusable adapter and without reusable adapter. Results Summary: Pass: No adverse statistical differences found between plasma free hemoglobin, white blood cell count and platelet count while using the sterile disposable Sarns® Centrifugal Pump with or without adapter.
Reusable Sarns® Centrifugal Pump Adapter disconnection force: To show that the force necessary to disconnect the sterile disposable Sarns® Centrifugal Pump with or without X-Coating™ from the reusable Sarns® Centrifugal Pump Adapter is similar or stronger to disconnecting the pump from the predicate device configuration. Results Summary: PASS: The average disconnection force required to separate the Sarns® Centrifugal Pump from the reusable Sarns® Centrifugal Pump Adapter was greater than the force required to separate the predicate Sarns® Centrifugal Pump.
Reusable Sarns® Centrifugal Adapter, Interaction with the Sorin Heart Lung Machine: To show that usage of the reusable Sarns® Centrifugal Pump Adapter does not interfere with the control and safety components of the Stöckert system. Results Summary: PASS: Usage of the reusable Sarns® Centrifugal Pump Adapter did not interfere with control and safety components of the Stöckert system.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.4360 Nonroller-type blood pump.
(a)
Nonroller-type cardiopulmonary and circulatory bypass blood pump —(1)Identification. A nonroller-type cardiopulmonary and circulatory bypass blood pump is a prescription device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either:(i) Full or partial cardiopulmonary bypass (
i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or(ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.
(2)
Classification —Class II (special controls). The special controls for this device are:(i) Non-clinical performance testing must perform as intended over the intended duration of use and demonstrate the following: Operating parameters, dynamic blood damage, heat generation, air entrapment, mechanical integrity, and durability/reliability;
(ii) The patient-contacting components of the device must be demonstrated to be biocompatible;
(iii) Sterility and shelf life testing must demonstrate the sterility of patient-contacting components and the shelf life of these components; and
(iv) Labeling must include information regarding the duration of use, and a detailed summary of the device- and procedure-related complications pertinent to use of the device.
(b)
Nonroller-type temporary ventricular support blood pump —(1)Identification. A nonroller-type temporary ventricular support blood pump is a prescription device that uses any method resulting in blood propulsion to provide the temporary ventricular assistance required for support of the systemic and/or pulmonary circulations during periods when there is ongoing or anticipated hemodynamic instability due to immediately reversible alterations in ventricular myocardial function resulting from mechanical or physiologic causes. Duration of use would be less than 6 hours.(2)
Classification. Class III (premarket approval).(c)
Date premarket approval application (PMA) or notice of completion of product development protocol (PDP) is required. A PMA or notice of completion of a PDP is required to be filed with FDA on or before September 8, 2015, for any nonroller-type temporary ventricular support blood pump that was in commercial distribution before May 28, 1976, or that has, on or before September 8, 2015, been found to be substantially equivalent to any nonroller-type temporary ventricular support blood pump that was in commercial distribution before May 28, 1976. Any other nonroller-type temporary ventricular support blood pump shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
0
Sarns® Centrifugal Pump
Section 6 – 510(k) Summary
510(K) Premarket Notification
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.
| Submitter Information | |
|---|---|
| Name | Terumo Cardiovascular Systems Corporation |
| Address | 6200 Jackson Road |
| Ann Arbor MI, 48103 | |
| Phone number | Tel: (734) 741-6113 |
| Fax number | Fax: (734) 741-6069 |
| Rebecca.andersen@terumomedical.com | |
| Establishment Registration | |
| Number | 1828100 |
| Name of contact person | Rebecca Andersen |
| Submission Co-Authors | Kevin Kong, RAC and Rebecca Andersen, PhD |
| Date prepared | 7/29/2011 |
| Name of Device | |
| Trade or proprietary name | Sarns® Centrifugal Pump (With or without X-Coating™ ) |
| Common or usual name | Centrifugal Pump |
| Classification name | Nonroller-type cardiopulmonary bypass blood pump |
| Classification panel | 74 Cardiovascular |
| Regulation | 21 CFR § 870.4360 |
| Product Code(s) | KFM |
| Legally marketed device(s) to | Sarns® Centrifugal Pump (With or without X-Coating™) |
| which equivalence is claimed | (K020998 & K915363) |
Section 6- Page 1 of 6
ERUMO
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Sams® Centrifugal Pump
Section 6 – 510(k) Summary
510(K) Premarket Notification
.
| Reason for 510(k) submission | This application seeks clearance for updates to the device and to
expand the indications for use. This application includes the
reusable Sarns® Centrifugal Pump Adapter which facilitates use of
the sterile disposable Sarns® Centrifugal pump with Stöckert
Centrifugal Pump Systems. |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device description | The Sarns® Centrifugal Pump (with or without X-Coating™) is a
single use, sterile and disposable device.
It is used to pump blood through the extracorporeal circuit during
cardiopulmonary bypass surgery and may be used for up to 6 hours.
The pump has a priming volume of 48ml. The pump rotational
speed is 0-3600 RPM resulting in a flow capacity of 0-9.9 LPM. |
| | With this submission, the sterile disposable Sarns® Centrifugal
pump may be used with Stöckert Centrifugal pump systems when
the reusable Sarns® Centrifugal Pump Adapter is used. The Sarns®
Centrifugal Pump Adapter is a device designed with geometries that
mate the Stöckert centrifugal systems to the Sarns® Centrifugal
pump. The housing is a hard plastic (acetal) that slides easily onto
the Sarns® Centrifugal pump then clips into place. The adapted
pump is then mounted onto the Stöckert Centrifugal pump systems. |
| Indications for use | The Sarns® Centrifugal Pump (with or without X-Coating™) is a
sterile, single use device, used as an extracorporeal blood pump for
use in cardiopulmonary bypass procedures for up to 6 hours.
The pump is intended for use with the Sarns® Centrifugal Systems
or may be used with Stöckert Centrifugal Pump Systems by
attaching the Sarns® Centrifugal Pump Adapter. |
| Intended use | The pump is intended for use with the Sarns® Centrifugal Systems
or may be used with Stöckert Centrifugal pump systems by attaching
the Sarns® Centrifugal Pump Adapter. |
ﺔ ﺍﻟﻤﻮﺍﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﻮﺍﺻﻞ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ
TERUMO
2
Sarns® Centrifugal Pump
Section 6 – 510(k) Summary
510(K) Premarket Notification
PERFORMANCE D
| Summary of the technological characteristics of the device compared to the predicate device | ||
|---|---|---|
| Characteristic | Proposed Device: | |
| Sarns® Centrifugal Pump with or without X-Coating™ and reusable Sarns® Centrifugal Pump Adapter | Predicate: | |
| Sarns® Centrifugal Pump with(K020998) or without (K915363) X-Coating™ | ||
| Pump functionality | Propels blood through the extracorporeal circuit via centrifugal force created by an impeller. | Same |
| Pump Material: Housing | Polycarbonate (adapter housing is acetal) | Same |
| Pump Design | A polycarbonate case housing a magnetically driven acrylic vaned impeller which spins to create centrifugal force. This propels blood through the extracorporeal circuit. | Same |
| Pump Operating Principle/Technology | Movement of blood through the extracorporeal circuit via centrifugal force created by an impeller. The blood flows in to a pump chamber at the inlet port. It is moved by the impeller to the outlet port. | Same |
| Pump Prime Volume | 48 mL | Same |
| Pump Motor Interface | Magnetic Coupling (Adapter also couples magnetically) | Same |
| Pump Inlet/Outlet Port Diameters | 3/8 inch (9.5mm) | Same |
| Pump Sterilization | Ethylene Oxide (Adapter is non-sterile) | Same |
| Pump SAL | $10^{-6}$ (Adapter is non-sterile) | Same |
| Magnet | Ceramic Iron Ferrite (Adapter is NdFeB with Ni plating) | Ceramic Iron Ferrite |
Section 6- Page 3 of 6
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Section 6 – 510(k) Summary
510(K) Premarket Notification
| SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF | ||
|---|---|---|
| SUBSTANTIAL EQUIVALENCE* | ||
| Performance Test Summary-Proposed Device | ||
| Characteristic | Standard/Test/FDA | |
| Guidance | Results Summary | |
| Flow curves: A test that demonstrates | ||
| the performance of the sterile | ||
| disposable pump has not changed when | ||
| used with the reusable Sarns® | ||
| Centrifugal Pump adapter on the | ||
| Stöckert Centrifugal Pump System | Flow Curves Performance | |
| Test | PASS: | |
| Back pressure ranges for the | ||
| proposed device configuration | ||
| are within range of the | ||
| predicate device configuration | ||
| Reusable Sarns® Centrifugal Pump | ||
| Adapter clip fatigue test: Shows the | ||
| clipping mechanism is rated for the | ||
| lifetime use of 7yrs | Reusable Centrifugal pump | |
| adapter clip fatigue Test | PASS: | |
| The reusable adapter has passed | ||
| test meeting the lifetime use of | ||
| 7 years | ||
| Reusable Sarns® Centrifugal Pump | ||
| Adapter change out time test: To show | ||
| that the change out time of the pump | ||
| on the proposed device configuration is | ||
| similar to the pump change out time of | ||
| the predicate device configuration: | Reusable Centrifugal pump | |
| adapter change out time test | PASS: | |
| The change out time between | ||
| the predicate device | ||
| configuration and the proposed | ||
| device configuration showed no | ||
| statistical difference | ||
| Shipping and Durability test: Show that | ||
| the Sarns® Centrifugal Pump Adapter | ||
| show no signs of damage after | ||
| shipment and functions as intended | ||
| after shipment | Shipping and Durability | |
| Test | PASS: | |
| Sarns® Centrifugal Pump | ||
| Adapter showed no signs of | ||
| damage and functioned as | ||
| intended following testing | ||
| Characteristic | Standard/Test/FDA | Results Summary |
| Guidance | ||
| Hemolysis test: To show that is | ||
| there is no statistical difference | ||
| of the effect on plasma free | ||
| hemoglobin, white blood cell | ||
| count and platelet count between | ||
| the sterile disposable Sarns® | ||
| Centrifugal Pump with reusable | ||
| adapter and without reusable | ||
| adapter | Hemolysis testing for the | |
| reusable Sarns® Centrifugal | ||
| Adapter | Pass: | |
| No adverse statistical differences | ||
| found between plasma free | ||
| hemoglobin, white blood cell | ||
| count and platelet count while | ||
| using the sterile disposable | ||
| Sarns® Centrifugal Pump with or | ||
| without adapter | ||
| Reusable Sarns® Centrifugal | ||
| Pump Adapter disconnection | ||
| force: To show that the force | ||
| necessary to disconnect the | ||
| sterile disposable Sarns® | ||
| Centrifugal Pump with or | ||
| without X-Coating™ from the | ||
| reusable Sarns® Centrifugal | ||
| Pump Adapter is similar or | ||
| stronger to disconnecting the | ||
| pump from the predicate device | ||
| configuration | Centrifugal adapter | |
| disconnection force | PASS: | |
| The average disconnection force | ||
| required to separate the Sarns® | ||
| Centrifugal Pump from the | ||
| reusable Sarns® Centrifugal | ||
| Pump Adapter was greater than | ||
| the force required to separate the | ||
| predicate Sarns® Centrifugal | ||
| Pump | ||
| Reusable Sarns® Centrifugal | ||
| Adapter, Interaction with the | ||
| Sorin Heart Lung Machine: To | ||
| show that usage of the reusable | ||
| Sarns® Centrifugal Pump | ||
| Adapter does not interfere with | ||
| the control and safety | ||
| components of the Stöckert | ||
| system | Centrifugal Adapter Interaction | |
| with a Heart Lung Machine | PASS: | |
| Usage of the reusable Sarns® | ||
| Centrifugal Pump Adapter did | ||
| not interfere with control and | ||
| safety components of the | ||
| Stöckert system |
.
Section 6- Page 4 of 6
TTERUMO
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Sarns® Centrifugal Pump
Section 6 – 510(k) Summary
510(K) Premarket Notification
(TERUMO
5
Sarns® Centrifugal Pump
Section 6 – 510(k) Summary
510(K) Premarket Notification
Summary of Non clinical tests conducted for determination of substantial equivalenc
The Sams® Centrifugal Pumps passed all the testing criteria and are shown to have the same level of performance when used with the adapter on Stöckert Centrifugal Pump Systems. Therefore the devices used with the adapter on a Stöckert Centrifugal Pump System are substantially equivalent to the devices when used on Sams® Centrifugal Pump systems.
ERUM
6
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines that suggest the head, body, and tail feathers.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DEC - 9 2011
Terumo Cardiovascular Systems c/o Rebecca Andersen, Ph.D. Director, Global Regulatory Affairs 6200 Jackson Road Ann Arbor, MI 48103
Re: K112229
Sarn Centrifugal Pump Regulation Number: 21 CFR 870.4360 Regulation Name: Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type Regulatory Class: Class III (three) Product Code: KFM Dated: December 2, 2011 Received: December 5, 2011
Dear Dr. Andersen:
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 (see 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.
7
Page 2 - Rebecca Andersen, Ph.D.
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) premarket 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
M. A. Killebrew
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
Indications for Use
510(k) Number (if known): K12229
Device Name:
Sarns® Centrifugal Pump with or without adapter
Indications for Use:
The Sarns® Centrifugal Pump with or without X-Coating™ is a sterile, single use device, used as an extracorporeal blood pump for use in cardiopulmonary bypass procedures for up to 6 hours.
The pump is intended for use with the Sarns® Centrifugal Systems or may be used with Stöckert Centrifugal Pump Systems by attaching the Sarns® Centrifugal Pump Adapter.
Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
.f. Hillebrand
(Division Sign-Off) Division of Cardiovascular Devices
KII2229 510(k) Number_