(128 days)
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.
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.
Here's a summary of the acceptance criteria and study information for the Sarns® Centrifugal Pump, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria/Test | Reported Device Performance |
|---|---|---|
| Flow Curves (performance of disposable pump with reusable adapter on Stöckert Centrifugal Pump System) | Back pressure ranges for proposed device configuration are within range of predicate device configuration. | 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 (lifetime use of 7 years) | Clipping mechanism rated for lifetime use of 7 years. | PASS: The reusable adapter has passed test meeting the lifetime use of 7 years. |
| Reusable Sarns® Centrifugal Pump Adapter change out time test (comparison to predicate device) | Change out time of pump on proposed device configuration similar to predicate device configuration. | PASS: The change out time between the predicate device configuration and the proposed device configuration showed no statistical difference. |
| Shipping and Durability test (Sarns® Centrifugal Pump Adapter) | No signs of damage after shipment and functions as intended. | PASS: Sarns® Centrifugal Pump Adapter showed no signs of damage and functioned as intended following testing. |
| Hemolysis test (effect on plasma free hemoglobin, white blood cell count, platelet count with/without reusable adapter) | No statistical difference in effect on plasma free hemoglobin, white blood cell count, and platelet count. | 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 (comparison to predicate device) | Force necessary to disconnect proposed device (with adapter) is similar or stronger than disconnecting from predicate. | 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 (interference with control and safety components of Stöckert system) | Usage of reusable Sarns® Centrifugal Pump Adapter does not interfere with control and safety components of the Stöckert system. | PASS: Usage of the reusable Sarns® Centrifugal Pump Adapter did not interfere with control and safety components of the Stöckert system. |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample sizes used for each test. The studies appear to be prospective in nature, as they involve testing the "proposed device" configuration against "predicate device" configurations or established standards. There is no information regarding the country of origin of the data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable. The studies described are engineering and performance validation tests, not clinical evaluations requiring expert interpretation of medical images or data to establish ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable. The studies described are engineering and performance validation tests with objective pass/fail criteria, not clinical evaluations requiring adjudication from multiple experts.
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 is a medical device (centrifugal pump) and not an AI-powered diagnostic or assistive technology that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This device is a mechanical pump, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for these tests is based on pre-defined performance standards, technical specifications, and comparisons to the legally marketed predicate device's established performance. For example:
- Flow curves: Comparison to predicate device's established flow characteristics.
- Clip fatigue: Designed lifetime use specification (7 years).
- Change out time: Statistical similarity to predicate device's change out time.
- Shipping and durability: Absence of damage and intended function, likely against internal or industry standards.
- Hemolysis: Absence of statistical difference in blood parameters compared to performance without the adapter.
- Disconnection force: Greater than or similar to predicate device.
- Interaction with HLM: No interference with control and safety components.
8. The sample size for the training set:
Not applicable. This device does not use machine learning or AI, so there is no "training set."
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of device.
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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 RoadAnn Arbor MI, 48103 |
| Phone number | Tel: (734) 741-6113 |
| Fax number | Fax: (734) 741-6069 |
| Rebecca.andersen@terumomedical.com | |
| Establishment RegistrationNumber | 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 toexpand the indications for use. This application includes thereusable Sarns® Centrifugal Pump Adapter which facilitates use ofthe sterile disposable Sarns® Centrifugal pump with StöckertCentrifugal Pump Systems. |
|---|---|
| Device description | The Sarns® Centrifugal Pump (with or without X-Coating™) is asingle use, sterile and disposable device.It is used to pump blood through the extracorporeal circuit duringcardiopulmonary bypass surgery and may be used for up to 6 hours.The pump has a priming volume of 48ml. The pump rotationalspeed is 0-3600 RPM resulting in a flow capacity of 0-9.9 LPM. |
| With this submission, the sterile disposable Sarns® Centrifugalpump may be used with Stöckert Centrifugal pump systems whenthe reusable Sarns® Centrifugal Pump Adapter is used. The Sarns®Centrifugal Pump Adapter is a device designed with geometries thatmate the Stöckert centrifugal systems to the Sarns® Centrifugalpump. The housing is a hard plastic (acetal) that slides easily ontothe Sarns® Centrifugal pump then clips into place. The adaptedpump is then mounted onto the Stöckert Centrifugal pump systems. | |
| Indications for use | The Sarns® Centrifugal Pump (with or without X-Coating™) is asterile, single use device, used as an extracorporeal blood pump foruse in cardiopulmonary bypass procedures for up to 6 hours.The pump is intended for use with the Sarns® Centrifugal Systemsor may be used with Stöckert Centrifugal Pump Systems byattaching the Sarns® Centrifugal Pump Adapter. |
| Intended use | The pump is intended for use with the Sarns® Centrifugal Systemsor may be used with Stöckert Centrifugal pump systems by attachingthe 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
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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
TERUMO
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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/FDAGuidance | Results Summary |
| Flow curves: A test that demonstratesthe performance of the steriledisposable pump has not changed whenused with the reusable Sarns®Centrifugal Pump adapter on theStöckert Centrifugal Pump System | Flow Curves PerformanceTest | PASS:Back pressure ranges for theproposed device configurationare within range of thepredicate device configuration |
| Reusable Sarns® Centrifugal PumpAdapter clip fatigue test: Shows theclipping mechanism is rated for thelifetime use of 7yrs | Reusable Centrifugal pumpadapter clip fatigue Test | PASS:The reusable adapter has passedtest meeting the lifetime use of7 years |
| Reusable Sarns® Centrifugal PumpAdapter change out time test: To showthat the change out time of the pumpon the proposed device configuration issimilar to the pump change out time ofthe predicate device configuration: | Reusable Centrifugal pumpadapter change out time test | PASS:The change out time betweenthe predicate deviceconfiguration and the proposeddevice configuration showed nostatistical difference |
| Shipping and Durability test: Show thatthe Sarns® Centrifugal Pump Adaptershow no signs of damage aftershipment and functions as intendedafter shipment | Shipping and DurabilityTest | PASS:Sarns® Centrifugal PumpAdapter showed no signs ofdamage and functioned asintended following testing |
| Characteristic | Standard/Test/FDA | Results Summary |
| Guidance | ||
| Hemolysis test: To show that isthere is no statistical differenceof the effect on plasma freehemoglobin, white blood cellcount and platelet count betweenthe sterile disposable Sarns®Centrifugal Pump with reusableadapter and without reusableadapter | Hemolysis testing for thereusable Sarns® CentrifugalAdapter | Pass:No adverse statistical differencesfound between plasma freehemoglobin, white blood cellcount and platelet count whileusing the sterile disposableSarns® Centrifugal Pump with orwithout adapter |
| Reusable Sarns® CentrifugalPump Adapter disconnectionforce: To show that the forcenecessary to disconnect thesterile disposable Sarns®Centrifugal Pump with orwithout X-Coating™ from thereusable Sarns® CentrifugalPump Adapter is similar orstronger to disconnecting thepump from the predicate deviceconfiguration | Centrifugal adapterdisconnection force | PASS:The average disconnection forcerequired to separate the Sarns®Centrifugal Pump from thereusable Sarns® CentrifugalPump Adapter was greater thanthe force required to separate thepredicate Sarns® CentrifugalPump |
| Reusable Sarns® CentrifugalAdapter, Interaction with theSorin Heart Lung Machine: Toshow that usage of the reusableSarns® Centrifugal PumpAdapter does not interfere withthe control and safetycomponents of the Stöckertsystem | Centrifugal Adapter Interactionwith a Heart Lung Machine | PASS:Usage of the reusable Sarns®Centrifugal Pump Adapter didnot interfere with control andsafety components of theStöckert 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
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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
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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.
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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
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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_
§ 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.