The Medtronic Bio-Medicus Bio-Pump centrifugal blood pump is indicated for use only with the Medtronic Bio-Medicus Bio-Console to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours). It is also indicated for use in extracorporeal circulatory support systems (for periods up to six hours) not requiring complete cardiopulmonary bypass (e.g., valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants etc).

Device Description

The BPX-80 Bio-Pump centrifugal blood pump is a single use, disposable, non-pyrogenic device designed to move blood through the extracorporeal circuit by centrifugal force created by smooth rotating cones. Venous blood gravity drains into the inlet port of the Bio-Pump". The smooth cones rotate in the polycarbonate housing. As the cones rotate, energy in the form of pressure and velocity is transferred from the cones to the blood is gently accelerated toward the outlet of the pump. The Bio-Pump moves the blood through the circuit at a desired pressure and flow rate by increasing the speed of the rotating cones. This is accomplished by adjusting the Bio-Console's RPMs (revolutions per minute). Arterial blood is returned to the patient from the extracorporeal circuit.

The BPX-80 Bio-Pump consists of a housing and backplate, three smooth surface cones, a magnet, and a bearing/shaft assembly. The plastic components of the BPX-80 Bio-Pump are molded from polycarbonate. The joints are bonded with an ultraviolet light cured adhesive. The inlet port (3/8") is located at the top center of the Bio-Pump", and the outlet port (3/8") is located tangentially on the outer diameter. Notches on the backplate allow the BPX-80 Bio-Pump® to be securely locked onto the pump receptacle of the Bio-Console . The BPX-80 Bio-Pump is designed to be used only with Medtronic Bio-Medicus Bio-Consoles®

The BPX-80 Bio-Pump® centrifugal blood pump can be sterilized by either gamma radiation or ethylene oxide (EtO) gas. The Bio-Pump is also available with a heparin bonded (nonleaching) Carmeda® Bioactive Surface.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study that demonstrates the device meets them, based on the provided text:

BPX-80 Bio-Pump® Centrifugal Blood Pump

This document describes the safety and effectiveness summary for a medical device submitted for 510(k) clearance, which is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predicate device (i.e., substantially equivalent). The approval is based on demonstrating substantial equivalence, not necessarily meeting stringent, pre-defined acceptance criteria for novel devices.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a discrete table of acceptance criteria with specific numerical targets. Instead, it demonstrates substantial equivalence by comparing the BPX-80 Bio-Pump to predicate devices (BP-80 Bio-Pump and CBBP-80 Bio-Pump) across various in-vitro tests and demonstrating compliance with established standards for biocompatibility and sterilization. The "acceptance criteria" are implied by the performance of the predicate devices and relevant industry standards.

Acceptance Criteria (Implied)	Reported Device Performance (BPX-80 Bio-Pump)
Substantial Equivalence to Predicate Devices	In-vitro bench testing demonstrated that the BPX-80 Bio-Pump and CBBPX-80 Bio-Pump do not significantly affect safety and effectiveness and are substantially equivalent to other commercially distributed centrifugal blood pumps, specifically the BP-80 Bio-Pump and CBBP-80 Bio-Pump.
Hydraulic Performance (comparable to predicate)	Included in "In-vitro Bench Testing," implying comparable performance to predicate devices.
Priming Volume (comparable to predicate)	Included in "In-vitro Bench Testing," implying comparable performance to predicate devices.
Chemical Resistance (adequate for intended use)	Included in "In-vitro Bench Testing," implying acceptable resistance with new polycarbonate material.
Environmental Performance (adequate for intended use)	Included in "In-vitro Bench Testing," implying acceptable performance.
Carmeda® Coating Performance (if applicable)	Included in "In-vitro Bench Testing." For CBBPX-80 Bio-Pump, biocompatibility of Carmeda® surface substantiated by over 8 years of use on similar products with polycarbonate housings.
Complement Activation (acceptable levels)	Included in "In-vitro Bench Testing," implying acceptable levels.
Hemolysis (HIMA standard compliant)	"HIMA Hemolysis Testing" conducted, implying compliance with HIMA standards.
Biocompatibility (non-toxic, safe for intended use)	Determined to be biocompatible and nontoxic and, therefore, safe for its intended use, in accordance with FDA Blue Book Memorandum - #G95-1, ISO 10993-1, and USP - XXIII.
Sterility Assurance Level (SAL) (10⁻⁶)	Sterility validated to assure a SAL of 10⁻⁶. Gamma sterilization in accordance with ANSI/AAMI/ISO 11137. EtO sterilization in accordance with ANSI/AAMI/ISO 11135-1994.
EtO Residuals (<25ppm EO, <25ppm ECH, <250ppm EG)	Routine product release assures EtO sterilized Bio-Pumps meet the limits for residual concentrations of ethylene oxide (<25ppm), ethylene chlorohydrin (<25ppm), and ethylene glycol (<250ppm) as published in ANSI Standard Number ANSI/AAMI/ISO 10993-7.
Pyrogens (<0.5 EU/ml)	Routine Pyrogen Testing performed using the LAL method, with product testing and release criteria less than 0.5 EU/ml in accordance with December 1987 FDA Guideline.

Summary of Study:

The study was primarily an in-vitro bench testing and biocompatibility assessment comparing the modified BPX-80 Bio-Pump to its predicate devices. The modifications were material change (acrylic to polycarbonate), dimensional change (internal port dimensions), and UV adhesive in place of solvent bond. The study aimed to demonstrate that these changes did not negatively impact the safety and effectiveness, thus maintaining substantial equivalence.

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

Sample Size for Test Set: The document does not specify exact sample sizes for each in-vitro test (e.g., number of pumps tested for hydraulic performance). It broadly states "In-vitro bench testing" was conducted.
Data Provenance: The studies were conducted by Medtronic Bio-Medicus Inc. and are presumed to be prospective testing of the BPX-80 Bio-Pump and CBBPX-80 Bio-Pump. The country of origin for the data is not explicitly stated but is implied to be the United States, given the company's location (Eden Prairie, MN) and FDA submission.

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

This type of submission (510(k) for a mechanical device) does not typically involve "experts" establishing a "ground truth" in the way an AI diagnostic device would. Instead, the "ground truth" for the performance metrics is established by recognized engineering and biological standards and the performance of the predicate device.

No specific number of human "experts" with medical qualifications (like radiologists) were used to establish ground truth for this device's performance tests. The evaluation relies on established scientific methods and adherence to regulatory standards.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human interpretation of medical images or data requiring adjudication. The tests performed are objective laboratory measurements and adherence to specified standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices where human reader performance is a key metric. The BPX-80 Bio-Pump is a mechanical blood pump.

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

Yes, a standalone performance assessment was conducted in the sense that the device's technical specifications and performance were evaluated intrinsically without human intervention in its operation for the purpose of the tests described (e.g., hydraulic performance, biocompatibility). It's an "algorithm" in the sense of the physical properties and design of the pump, tested on its own.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on:

Performance of Legally Marketed Predicate Devices: The BP-80 Bio-Pump and CBBP-80 Bio-Pump, which set the standard for "substantially equivalent" performance.
Established Industry Standards and Regulations: Such as FDA Blue Book Memorandum - #G95-1, ISO 10993-1, USP - XXIII for biocompatibility, ANSI/AAMI/ISO 11137 and 11135-1994 for sterilization, ANSI/AAMI/ISO 10993-7 for EtO residuals, HIMA standards for hemolysis, and FDA guidelines for pyrogen testing.

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."

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

Not applicable, as there is no training set for this type of device.

Summary

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SUMMARY OF SAFETY AND EFFECTIVENESS

FEB 2 5 1998

510(k) SUMMARY

COMPANY NAME AND CONTACT PERSON

August 12, 1997

Medtronic Bio-Medicus Inc. 9600 West 76th Street Eden Prairie, MN 55344 tel. (612)944-7784 fax (612)944-7557

Thomas K. Johnsen Product Regulations Manager

DEVICE NAME

BPX-80 Bio-Pump®

COMMON NAME

Centrifugal Blood Pump

CLASSIFICATION NAME

Non-roller type cardiopulmonary bypass blood pump (21 CFR - 870.4360)

PREDICATE DEVICE OR LEGALLY MARKETED DEVICE

Medtronic Bio-Medicus, Inc. - BP-80 Bio-Pump® (K852698)

Medtronic Cardiopulmonary - CBBP-80 Bio-Pump® (K852698, K891687 and K896978)

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DEVICE DESCRIPTION

INTENDED USE

The Medtronic Bio-Medicus Bio-Pump® centrifugal blood pump is indicated for use only with the Medtronic Bio-Medicus Bio-Console to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours). It is also indicated for use in extracorporeal circulatory support systems (for periods up to six hours) not requiring complete cardiopulmonary bypass (e.g., valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants etc). . 我在

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TECHNOLOGICAL CHARACTERISTICS

The technological characteristics are identical to the BP-80 Bio-Pump®, with the exception of the following modifications; material change (acrylic to polycarbogate), dimensional change (internal dimensions of the port), and UV adhesive in place of solvent bond. The packaging material, sterilization methods/cycles, optional heparin bonding (Carmeda® Coating), drive magnet, bearing assembly, internal seal and component specifications are identical to the currently marketed BP-80 Bio-Pump®.

SUMMARY OF PERFORMANCE DATA

In-vitro Bench Testing:

In-vitro bench testing demonstrated that when compared to the predicate devices (BP-80 Bio-Pump and CBBP-80 Bio-Pump"), the BPX-80 Bio-Pump and CBBPX-80 Bio-Pump do not significantly affect safety and effectiveness and are substantially equivalent to other commercially distributed centrifugal blood pumps. The in-vitro bench testing included analysis of:

Hydraulic Performance and Priming Volume Tests .
Chemical Resistance Tests .
Environmental Tests .
Carmeda® Coating Tests .
Complement Activation .
HIMA Hemolysis Testing �

Biocompatibility:

Biocompatibility testing of the BPX-80 Bio-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 Pharmacopoeia - XXIII.

Based on the results of the biocompatibility testing performed, the BPX-80 Bio-Pump was determined to be biocompatible and nontoxic and, therefore, safe for its intended use. Biocompatibility on the CBBPX-80 Bio-Pump has been substantiated by over 8 years of the Carmeda Bioactive Surface being applied to Cardiopulmonary bypass products, many of which have polycarbonate housing materials.

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Sterilization:

Sterilization of the BPX-80 Bio-Pump® has been validated to assure a sterility assurance level (SAL) of 10°.

Gamma radiated Bio-Pumps® are sterilized in accordance with ANSI/AAMI/ISO 11137 - Method 1, Sterilization of Health Care Product Requirements for Validation and Routine Control - Radiation Sterilization.

EtO sterilized Bio-Pumps are 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:

EtO dissipation curves are used for routine product release to assure EtO sterilized Bio-Pumps meet the limits for residual concentrations of ethylene oxide (<25ppm), ethylene chlorohydrin (<25ppm), and ethylene glycol (<250ppm) as published in ANSI Standard Number ANSI/AAMI/ISO 10993-7 (Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals).

Pyrogens:

Routine Pyrogen Testing is performed using the Limulus Amebocyte Lysate (LAL) method. Product testing and release criteria (less than .5 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

BPX-80 Bio-Pump® is substantially equivalent to the BP-80 Bio-Pump®. Performance, functional, and biocompatibility testing demonstrated that there are no new safety and effectiveness questions raised by the modifications made to the currently marketed BP-80 Bio-Pump®.

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Image /page/4/Picture/2 description: The image shows a logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized, curved shapes that resemble abstract human figures or waves, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

FEB 2 5 1998

Mr. Thomas K. Johnsen Product Regulation Manager Medtronic Cardiac Surgery Medtronic Bio-Medicus, Inc. 9600 West 76th Street Eden Prairie, MN 55344

Re : K973011 BPX-80 Bio-Pump Centrifugal Blood Pump Regulatory Class: III Product Code: KFM Dated: November 25, 1997 November 28, 1997 Received:

Dear Mr. Johnsen:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent to 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). You may, therefore, market the device, subject to the general controls provisions of the The general controls provisions of the Act include Act. 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Thomas K. Johnsen

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html."

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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INDICATIONS FOR USE

CONFIDENTIAL

K 973011 510(k) Number: __

BPX-80 Bio-Pump® Centrifugal Blood Pump Device Name:

Indications for use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

	K973011
	(Division Sign-Off)
	Division of Cardiovascular, Respiratory,
	and Nemalogical Devices
Prescription Use (Per 21 CFR 801.109	X
OR	Over-The-Counter-Use ________

(Optional Format 1-2-96)

Medtronic Bio-Medicus, Inc.	510(k) Notification - BPX-80 Bio-Pump®	Confidential
-----------------------------	----------------------------------------	--------------

signature

August 12, 1997

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.