The FloPump 57mL Centrifugal Pump is a 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.

Device Description

The FloPump 57mL is a single use disposable centrifugal pump has an inlet that draws blood from a patient and an outlet that pushes the blood out, where it then passes through an oxygenator and back to the patient. The pump mates with the Sorin Group Stöckert Centrifugal Pump Console and rotates the internal impeller using a magnetic driver. The FloPump 57mL is a non-occlusive pump. The pump has a spinning rotor with flow channels which imparts rotary motion to the incoming blood, directing it through a spiral housing to the outflow port. The FloPump 57mL is part of the extracorporeal circuit, and is therefore in contact with the patient's blood while circulating. The FloPump 57mL does not have any other patient contact.

AI/ML Overview

This document describes the FloPump 57mL Centrifugal Pump, a non-roller type blood pump intended for use in extracorporeal circuits for periods less than 6 hours.

Here's an analysis of the acceptance criteria and supporting studies as presented in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list specific quantitative "acceptance criteria" with corresponding "reported device performance" in a structured table as might be expected for an AI/CAD device. Instead, it states that non-clinical testing was performed and the results were "Substantially equivalent to predicates" for a range of performance characteristics.

Performance Characteristic	Acceptance Criteria (Implicit)	Reported Device Performance
Flow curves	Substantially equivalent to predicate devices	Substantially equivalent to predicates
Heat generation	Substantially equivalent to predicate devices	Substantially equivalent to predicates
Prime volume	Substantially equivalent to predicate devices	Substantially equivalent to predicates
Air handling	Substantially equivalent to predicate devices	Substantially equivalent to predicates
Hemolysis	Substantially equivalent to predicate devices	Substantially equivalent to predicates
Reliability	Substantially equivalent to predicate devices	Substantially equivalent to predicates
Biocompatibility	Substantially equivalent to predicate devices	Substantially equivalent to predicates
Sterilization	Sterilization process results in a SAL of 10^-6	The sterilization process results in a SAL of 10^-6
Packaging durability	No signs of damage and functioned as intended following testing	No signs of damage and functioned as intended following testing
Shelf-life	No signs of damage and functioned as intended following testing	No signs of damage and functioned as intended following testing

2. Sample Size Used for the Test Set and Data Provenance:

The provided text does not contain any information regarding sample sizes for a standalone (test set) for clinical performance, as it explicitly states that clinical testing was not required. The testing mentioned is non-clinical, likely laboratory-based or bench testing. Therefore, there's no information on data provenance (country of origin, retrospective/prospective) related to a clinical test set.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Since no clinical testing was required or performed, there is no information on experts establishing ground truth for a clinical test set. The "ground truth" for the non-clinical tests would have been established by engineering specifications, validated test methods, and comparison against the performance of predicate devices.

4. Adjudication Method for the Test Set:

Given that no clinical testing requiring human interpretation or judgment was performed, there is no information on an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size:

No MRMC comparative effectiveness study was done as clinical testing was not required for this device. This device is a mechanical pump, not an AI/CAD diagnostic tool.

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

This is not applicable to the FloPump 57mL Centrifugal Pump. This device is a physical, mechanical blood pump, not an algorithm or AI system. The "standalone" performance here refers to the device's functional performance on its own, which was evaluated through the non-clinical tests listed.

7. The Type of Ground Truth Used:

For the non-clinical tests, the "ground truth" was based on:

Engineering specifications and design requirements: For parameters like priming volume, flow rates, and maximum rated pressure.
Established test methods and standards: For sterilization (SAL of 10^-6), biocompatibility, and perhaps reliability testing.
Performance of predicate devices: The primary method for proving substantial equivalence was demonstrating similar performance to legally marketed predicate devices for flow curves, heat generation, prime volume, air handling, hemolysis, and reliability. This implies that the accepted performance range of the predicate devices served as the "ground truth" for comparison.

8. The Sample Size for the Training Set:

Not applicable. This device is a mechanical blood pump, not an AI/ML algorithm that requires a "training set" of data.

9. How the Ground Truth for the Training Set was Established:

Not applicable. As stated above, this is a mechanical device, not an AI/ML system requiring a training set.

Summary

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March 10, 2021

International Biophysics Corporation Geoff Marcek VP Engineering and Quality 2101 E. St. Elmo Road Austin, Texas 78744

Re: K193663

Trade/Device Name: FloPump 57mL Centrifugal Pump Regulation Number: 21 CFR 870.4360 Regulation Name: Nonroller-Type Blood Pump Regulatory Class: Class II Product Code: KFM Dated: February 4, 2021 Received: February 5, 2021

Dear Geoff Marcek:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Fernando Aguel Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K193663

Device Name FloPump 57mL Centrifugal Pump

Indications for Use (Describe)

The FloPump 57mL Centrifugal Pump is a device that uses a method other than revolving rollers to pump the blood through an extracorpreal 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 necessary for open surgical procedures on the aorta or vena cava.

Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Date: November 19, 2020

Manufacturer: International Biophysics Corporation 2101 E. St. Elmo Road Austin, TX 78744

Contact Person: Geoff Marcek VP, Engineering and Quality Phone: (512) 814-0046 Email: gmarcek@biophysics.com

Product	Classification	Product Codes	Product Code	Regulation and Classification Name
FloPump 57mL Centrifugal Pump	Class II	KFM	KFM	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type per 21 CFR 870.4360

Description:

Specifications:
Model Numbers	6500S (Sterile), 6500N (Non-Sterile)
Priming Volume	Approx. 57 mL
Inlet/Outlet I.D.	9.5mm (3/8")
Max. rated pressure	750 mmHg
Flow rates	0 – 7 L/min
Materials
Pump Housing	Polycarbonate
Impeller and Magnet Housing	ABS
Bearings	HDPE
Shaft	Stainless steel
Magnet	Nylon NdFeB Blend

Indications for Use:

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.

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Primary Predicate Device: Sorin Revolution Blood Pump – K011835

Reference Devices:	IBC FloPump Centrifugal Pump – K983272IBC FloPump 32 Centrifugal Pump – K170029
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Comparable Features to Predicate Device(s): This device is comparable to the predicate devices in indications, material, design features, specifications, manufacturing methods, raw materials, intended use, packaging, labeling and sterilization.

Key Differences in Subject Device to Predicate: There are no key differences between the subject device and the predicate. The subject device has been designed and constructed to have the same technological characteristics as the predicate.

Non-Clinical Testing:

The following non-clinical testing was performed to determine substantial equivalence:

Testing	Results Summary
Flow curves	Substantially equivalent to predicates
Heat generation	Substantially equivalent to predicates
Prime volume	Substantially equivalent to predicates
Air handling	Substantially equivalent to predicates
Hemolysis	Substantially equivalent to predicates
Reliability	Substantially equivalent to predicates
Biocompatibility	Substantially equivalent to predicates
Sterilization	The sterilization process results in a SAL of 10-6
Packaging durability	No signs of damage and functioned as intended following testing
Shelf-life	No signs of damage and functioned as intended following testing

Clinical Testing: Clinical testing was not required

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.