The RotaFlow Centrifugal Pump System is intended for use in an extracorporeal perfusion circuit to pump blood during short duration cardiopulmonary bypass procedures lasting 6 hours or less.

Device Description

The RotaFlow Centrifugal Pump System includes both hardware and disposables. The RotaFlow Centrifugal Pump System includes the following components:

Components to be used in combination with the RotaFlow Console:
1.1 Hardware: RotaFlow Console RFC 20-970, RotaFlow Drive Unit RFD 20-973, RotaFlow Emergency Drive RFE 20-976
1.2 Disposable: RotaFlow Centrifugal Pump RF-32
Components to be used in combination with the Bio-Medicus Console:
2.1 Hardware: Magnet Adapter MA-32
2.2 Disposables: RotaFlow Centrifugal Pump RF-32F, External Flow Probe FP-32E

AI/ML Overview

The provided document is a 510(k) summary for the RotaFlow Centrifugal Pump System. It focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel safety and effectiveness criteria through a new clinical study with acceptance criteria.

Therefore, the document does not contain the information requested in all sections of the prompt as it is a premarket notification for a device deemed substantially equivalent, not a new device requiring extensive de novo clinical trials and acceptance criteria in the typical sense for a novel technology.

However, I can extract information related to performance testing that supports its substantial equivalence.

Here's an attempt to answer based on the available information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" as pass/fail thresholds with specific numerical targets. Instead, it describes various tests performed to demonstrate "substantial equivalence" to predicate devices. The reported "performance" is implicitly that the device successfully met the requirements for substantial equivalence based on these tests.

Test Category	Test Performed	Reported Device Performance
Disposables	Function and Load testing (continuous & pulsatile)	Demonstrated substantial equivalence to predicate devices.
	Verification of flow-pressure curves	Demonstrated substantial equivalence to predicate devices.
	Mean Transit Time	Demonstrated substantial equivalence to predicate devices.
	Heat generation	Demonstrated substantial equivalence to predicate devices.
	Stagnant blood zones	Demonstrated substantial equivalence to predicate devices.
	Validation Flowprobe	Demonstrated substantial equivalence to predicate devices.
Magnet Adapter	Endurance Test	Demonstrated substantial equivalence to predicate devices.
	Heat Generation	Demonstrated substantial equivalence to predicate devices.
	Magnetic Clutch	Demonstrated substantial equivalence to predicate devices.
RotaFlow System (Hardware)	Clinical Assessment	Demonstrated substantial equivalence to predicate devices.
	Functional Safety	Demonstrated substantial equivalence to predicate devices.
	EMC	Demonstrated substantial equivalence to predicate devices.
	Construction Safety	Demonstrated substantial equivalence to predicate devices.
	Mains and Battery Operation	Demonstrated substantial equivalence to predicate devices.
	Interface Testing (Console with Jostra H-L Machine)	Demonstrated substantial equivalence to predicate devices.
	Emergency Unit Accuracy Testing	Demonstrated substantial equivalence to predicate devices.
	Software Validation	Demonstrated substantial equivalence to predicate devices.
Biocompatibility	Biocompatibility testing (G95-1, ISO 10993-1, USP)	Determined to be biocompatible and nontoxic, safe for intended use.
Blood Damage	Blood Damage Testing	Performed in comparison to the predicate device. (Implicitly passed for substantial equivalence)
Sterility	Sterilization validation (ANSI/AAMI/ISO 11135)	Validated to assure a sterility assurance level (SAL) of 10^-6.
EtO Residuals	EtO Residuals testing (ANSI/AAMI/ISO 10993-7)	Meets limits for EO (<25 ppm), ECH (<25 ppm), EG (<250 ppm).
Pyrogeans	Pyrogen testing (LAL method)	Meets product testing and release criteria (< 20 EU/ml) per FDA Guideline.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify sample sizes for the various tests, nor does it explicitly mention data provenance (country of origin, retrospective/prospective). The tests described are primarily bench and lab-based engineering and biological performance evaluations, not clinical studies in humans requiring patient-level data. The company is Jostra Medizintechnik AG, based in Germany, so it's likely the testing was conducted there or by affiliated labs.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable/provided. The ground truth for these types of engineering and biological performance tests is typically established through established scientific methods, standards, and validated equipment, not by expert consensus in a clinical diagnostic sense. While experts (e.g., engineers, toxicologists, microbiologists) would have conducted and interpreted the tests, their number and specific qualifications are not detailed in this summary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where human readers interpret medical images or data. These are not relevant for the types of engineering performance and biological safety tests described for this device.

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

An MRMC comparative effectiveness study is not applicable/provided. This device is a medical pump system, not an AI-powered diagnostic or assistive tool for human readers. Therefore, there's no "human reader improvement with AI" in this context. The "clinical assessment" mentioned in the hardware testing section likely refers to a review of design, use cases, and perhaps limited in-vivo (animal) or simulated clinical use observations for safety rather than a formal human clinical trial.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is a physical pump system, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The ground truth for the various tests would be based on:

Engineering specifications and standards: For functional, load, safety, EMC, and construction tests.
Physical measurements: For parameters like priming volume, pressure, surface area.
Standardized biological assays and chemical analysis: For biocompatibility, blood damage, sterility, EtO residuals, and pyrogen testing.
Industry benchmarks/predicate device performance: The "substantial equivalence" aspect implies that the device's performance was compared against established performance metrics of the legally marketed predicate devices.

8. The sample size for the training set

This information is not applicable/provided. This device does not use machine learning, so there is no concept of a "training set" in the context of an algorithm.

9. How the ground truth for the training set was established

This information is not applicable/provided for the same reason as point 8.

Summary

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AUG 3 1 2000

K991864 510/WBromark Notification JOSTRA MEDIZINTECHNIK AG - RotaFlow Centrifugal Pump System

SUMMARY OF SAFETY AND EFFECTIVENESS

510(k) SUMMARY

COMPANY NAME AND CONTACT PERSON

May 21, 1999

Jostra Medizintechnik AG Hechinger Straße 38 72145 Hirrlingen Germany

Kathy Johnson, Product Manager tel. (610)932-7365 fax (610)932-7366

DEVICE NAME

RotaFlow Centrifugal Pump System Magnet Adapter MA-32 RotaFlow Centrifugal Pump RF-32 / RF-32F Flowprobe FP-32E

COMMON NAME

Cardiopulmonary Bypass Pump Console, Magnet Adapter Centrifugal Blood Pump Cardiovascular Blood Flowprobe

CLASSIFICATION NAME

Control, Pump Speed, Cardiopulmonary Bypass, Adapter, Stopcock, Manifold, Fitting, Pump, Blood, Non-roller-type, Cardiopulmonary Bypass, Flowprobe, Blood, Cardiovascular

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PREDICATE DEVICE OR LEGALLY MARKETED DEVICE

Medtronic Bio-Medicus Bio-Console Model 550 Medtronic Bio-Medicus Bio-Pump Centrifugal Blood Pump BP 80 St. Jude Medical Pulse 2100 Centrifugal Pump Interface Medtronic Bio-Probe DP-38

DEVICE DESCRIPTION

......

The RotaFlow Centrifugal Pump System includes both hardware and disposables. The RotaFlow Centrifugal Pump System includes the following components:

RotaFlow Centrifugal Pump System (= RotaFlow System)
1. Components to be used in combination with the RotaFlow Console:
1.1 Hardware	RotaFlow Console RFC 20-970RotaFlow Drive Unit RFD 20-973RotaFlow Emergency Drive RFE 20-976
1.2 Disposable	RotaFlow Centrifugal Pump RF-32
2. Components to be used in combination with the Bio-Medicus Console:
2.1 Hardware	Magnet Adapter MA-32
2.2 Disposables	RotaFlow Centrifugal Pump RF-32FExternal Flow Probe FP-32E

INTENDED USE

The RotaFlow Centrifugal Pump System is intended for use in an extracorporeal perfusion circuit to pump blood during short duration cardiopulmonary bypass procedures lasting 6 hours or less.

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TECHNOLOGICAL CHARACTERISTICS

Table 1. Comparison between RotaFlow System (Hardware) and Medtronic Bio-Medicus Bio-Console Type 550

Name of Product	RotaFlow System(Hardware)	Medtronic Bio-MedicusBio-Console Model 550
Power supply Mains	230 V~/ 50 Hz StandAlone	220-240 Vac with 50-60Hz
Batteries Console:	+ 24 V, NiCd	Two, series connected,12 Vdc lead-acid gel;rechargeable
Weight	app. 14.400 kg Console	23.000 kg (50 lbs.)
MeasurementsLxWxH/Size	179 x 385 x 243 mmConsole	420 x 230 x 360 mm

Table 2. Comparison between RotaFlow Centrifugal Pump RF-32 / RF-32F and Medtronic Bio-Medicus Bio-Pump Centrifugal Blood Pump BP 80

Name of Product	RotaFlow CentrifugalPump RF-32 / RF-32F	Bio-Pump CentrifugalBlood Pump BP-80
Priming Volume	32 ml	80 ml
Inlet/Outlet I. D.	9,5 mm (3/8 inches)	9,5 mm (3/8 inches)
Maximum OperatingPressure	750 mmHg	900 mmHg
Surface Area	190 cm²	590 cm²
Rotor Diameter	50 mm	79 mm
System	Flowchannel	Vortex rotors
Connectors	3/8"	3/8"

SOOR

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Name of Product	RotaFlow CentrifugalPump RF-32 / RF-32F	Bio-Pump CentrifugalBlood Pump BP-80
materials:
Housing	polycarbonate	polyacryl
Rotor	polycarbonate	polyacryl
Connector	polycarbonate	polyacryl
Callote	polyethylene	unknown
Ball	sapphire	unknown
Magnet	neodymium	unknown
in. - and outlet caps 3/8"	HDPE	unknown

SUMMARY OF PERFORMANCE DATA

The following tests were performed to demonstrate substantial equivalence between the RotaFlow Centrifugal Pump System and predicate devices (Medtronic, St. Jude):

Disposables:

Function and Load testing in continuous and pulsatile mode
Verification of the flow-pressure curves
Mean Transit Time
Heat generation
Stagnant blood zones
Validation Flowprobe

Magnet Adapter:

Endurance Test
Heat Generation
Magnetic Clutch

RotaFlow System (Hardware):

Clinical Assessment
Functional Safety
EMC
Construction Safety
Mains and Battery Operation
Interface Testing Console with Jostra Heart-Lung Machine
Emergency Unit Accuracy Testing
Software Validation

The above listed testings demonstrated that the RotaFlow Centrifugal Blood Pump System is substantial equivalent to the compared predicate devices from Medtronic and St. Jude.

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Biocompatibility and Blood Damage Testing:

Biocompatibility testing of the RotaFlow Centrifugal Pump was performed in accordance with the FDA Blue Book Memorandum - #G95-1 and Biological Evaluation of Medical Devices Guidance – International Standard ISO 10993-1, and in accordance with United States Pharmacopeia - XXIII.

Based on the results of the biocompatibility testing performed, the RotaFlow Centrifugal Pump was determined to be biocompatible and nontoxic and, therefore, safe for its intended use.

Blood Damage Testing has also been performed in comparison to the predicate device.

Sterility:

Sterilization of the RotaFlow Centrifugal Pump and Flowprobe have been validated to assure a sterility assurance level (SAL) of 106

EtO sterilized RotaFlow Pump is sterilized in accordance with the American National Standards Institute, Inc. (ANSI) standard ANSI/AAMI/ISO 11135-1994 (Medical Devices -Validation and Routine Control of Ethylene Oxide Sterilization).

EtO Residuals:

RotaFlow Centrifugal Pump meets the limits for residual concentrations of ethylene oxide (<25 ppm), ethylene chlorohydrin (<25 ppm), and ethylene glycol (< 250 ppm) as published in ANSI Standard Number ANSI/AAMI/ISO 10993-7 (Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals).

Pvrogens:

Routine pyrogen testing is performed using the Limulus Amebocyte Lysate (LAL) method. Product testing and release criteria (less than 20 EU/ml) is in accordance to the December 1987 Guideline issued by the Food and Drug Administration, office of Compliance ( Guideline on Validation of the Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices").

Conclusion

Performance, functional, and biocompatibility testing demonstrated that the RotaFlow Centrifugal Pump System is substantially equivalent to the named predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 31 2000

Jostra Incorporated c/o Ms. Kathy Johnson Product Manager 2035 Sunset Lake Road Newark, DE 19702

Re: K991864 Rotaflow Centrifugal Pump System Regulatory Class: III (three) Product Code: KFM Dated: August 14, 2000 Received: August 15, 2000

Dear Ms. Johnson:

We have reviewed your Section 510 (k) notification of intent to market is We have reviewed your section Juvis hourseaving the device is the device referenced and we indications for use stated in the
substantially equivalent (for the indications for use stated in substantially equivalenc (tor the 1976, the enactment date enclosure) to legally marketed predicate actroso macment date of the interstate commerce prior to May 26, 1970, cho bare been reclassified
Medical Device Amendments, or to devices that have been reclassified Medical Device Amendments, or co creat food, Drug, and in accordance with the provisions of the readed be device, subject to
Cosmetic Act (Act). You may, therefore, market the device, subject to Cosmetic Act (Act). You ilay, chefore marmers on and controls the general controls provisions of the for annual registration,
provisions of the Act include requirements for annual mand provisions of the Act Incrude requiring practice, labeling, and
listing of devices, good manufacturing and adulteration, listing of devices, good manazation of adulteration.

If your device is classified (see above) into either class II (Special If your device is classified (see above) it may be subject to such Controls) or class III (Premarket Applovar) required on the may bevice
additional controls Existing major regulations Title 21, Parts 800 additional controls. Existing Mary regulations, Title 21, Parts 800
can be found in the Code of Federal Regulations, Title 21, Parts 800 ound in the Code of Federal Regardion assumes compliance
A substantially equivalent determination assumes as set to 895. A substantially equivarient actorization requirements, as set
with the Current Good Manufacturing VCS, for Medical Devices: to 895. with the Current Good Manufaccuring raddS) for Medical Devices:
forth in the Quality System Regulation (OS) for Medical periodic forth in the Quality System Regulation that, through periodic QS
General regulation (21 CFR Part 2010) will verify su General regulation (21 Cra rare edo) and time (FDA) will verify such inspections, the Food and Drug Administration may result in assumptions. Failure to compry with the ourcher announcements
regulatory action. In addition, FDA may publish further and regulatory action. In addition, from my pare. Please note: this concerning your device in the rederal submission does not affect any
response to your premarket not samission does of the Act response to your premarket notification 531 through 542 of the Act
obligation you might have under sections 531 through provision obligation you might have under sections of the may of the most on trol provisions,
for devices under the Electronic Product Radiation Control provisions, for devices arral laws or regulations.

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Page 2 - Ms. Kathy Johnson

This letter will allow you to begin marketing your device as described inis recei will arrow you co icention. The FDA finding of substantial in your Sront, promodevice to a legally marketed predicate device equivalence or your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling II you desire Specific and additionally 809.10 for in vitro reguration (21 crr), please contact the Office of Compliance at GraynoStre actrees), promotions on the promotion and (301) 354 4646. haarermally, same contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, a (Misbranding by reference to premarket notification" (21CFR 807.97). MESDIanana by Formation on your responsibilities under the Act may other general inform Division of Small Manufacturers Assistance at its be obtained from 2000) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

James E. Dillard

James E. Dillard III Director Division of Cardiovascurar and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

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Page 1 of 1

510(k) Number (if known): not assigned

Device Name: RotaFlow Centrifugal Pump System

Indications for Use "RotaFlow Centrifugal Pump System":

indications for boo jjitugal Pump System is intended for use in an extracorporeal The Kotal low Sonthluga Famp by during short duration cardiopulmonary bypass procedures lasting 6 hours or less.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Besse R. Kimberlin (Optional Format 3-10-98)

(Division Sign-Off)
Division of Cardiovascular, Respiratory.
and Neurological Devices
510(k) Number K991864

Regulation Number and Section

§ 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.