The BMR™-4500 Filtered Venous Reservoir is indicated for use during cardiopulmonary bypass surgery in the extracorporeal circuit to collect, store, filter and defoam the patient's blood.

The BMR™-4500 GOLD® Hard Shell Venous Reservoir with Duraflo® treatment is indicated for use during cardiopulmonary bypass surgery in the extracorporeal circuit to collect, store, filter and defoam the patient's blood. The BMR-4500 GOLD® is further intended for use when a heparin treated blood path is desired.

Device Description

The BMR™-4500 GOLD® Filtered Venous Reservoir with Duraflo® Treatment is used during cardiopulmonary bypass surgery to collect, store, filter and defoam the patient's blood. All blood contacting surfaces of the device, with the exception of luer connectors, stopcock manifold and sample lines, are treated with Bentley's Duraflo® complex. This treatment is intended to enhance the blood compatibility of non-biological surfaces in the extracorporeal circuit.

Bentley's BMR™-4500 GOLD® will also be offered in a non-treated version. Designated BMR™-4500™, this device will not contain the Duraflo® complex. The indications for use for BMR™-4500™ are identical to the treated version of the device.

Bentley's BMR™-4500™ and BMR™-4500 GOLD® are intended to be used for blood flows of up to 7.0 LPM through the venous inlet, up to 5.0 LPM through the cardiotomy inlet or up to 7.0 LPM combined flow.

AI/ML Overview

The provided document describes the 510(k) premarket notification for the BMR™-4500 and BMR™-4500 GOLD® Filtered Venous Reservoirs. The submission focuses on demonstrating substantial equivalence to a predicate device, the Bentley HSR™-4000 Venous Reservoir.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list "acceptance criteria" in a quantitative, pass/fail manner with specific numerical thresholds. Instead, it states that the test results "demonstrated no remarkable differences between the proposed vs. predicate populations." This implies that the acceptance criterion was functional equivalence or "no remarkable differences" compared to the predicate device for each assessed parameter.

Parameter	Acceptance Criteria (Implied)	Reported Device Performance
Venous and Cardiotomy Blood Damage	No remarkable difference compared to predicate (HSR™-4000)	"no remarkable differences between the proposed vs. predicate populations"
Filtration Efficiency	No remarkable difference compared to predicate	"no remarkable differences between the proposed vs. predicate populations"
Venous and Cardiotomy Breakthrough Volume	No remarkable difference compared to predicate	"no remarkable differences between the proposed vs. predicate populations"
Venous and Cardiotomy Residual Volume	No remarkable difference compared to predicate	"no remarkable differences between the proposed vs. predicate populations"
Defoaming Capability	No remarkable difference compared to predicate	"no remarkable differences between the proposed vs. predicate populations"
Patency of One-Way Valve	No remarkable difference compared to predicate	"no remarkable differences between the proposed vs. predicate populations"
Heparin Leaching (for GOLD® version)	No remarkable difference compared to predicate (if applicable)	"no remarkable differences between the proposed vs. predicate populations"
Biocompatibility	Compliance with ISO-10993-1	"All components...were found to be biocompatible in compliance with ISO-10993-1."

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

Sample Size: The document states, "The number of devices tested was selected based on AAMI guidelines (AAMI OXY-D)." However, the specific number of devices tested is not provided.
Data Provenance: The study was in-vitro. The country of origin of the data is not explicitly stated but can be inferred as the USA, given Baxter Healthcare Corporation's location and the FDA submission.
Retrospective or Prospective: Not applicable as it's an in-vitro study.

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

Not applicable. The study is an in-vitro performance test of a medical device, not a diagnostic or AI algorithm requiring expert ground truth for interpretation.

4. Adjudication Method for the Test Set

Not applicable. This is an in-vitro performance study, not a clinical trial requiring adjudication of patient outcomes or interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This document describes an in-vitro performance study for a physical medical device, not an AI algorithm. Therefore, an MRMC comparative effectiveness study was not conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in a sense. The study describes the "standalone" performance of the BMR™-4500 and BMR™-4500 GOLD® devices themselves, as they are physical devices, not an AI algorithm. Their performance was evaluated independently in an in-vitro setting.

7. The Type of Ground Truth Used

The "ground truth" for this in-vitro study was essentially the measured performance parameters of the predicate device (Bentley HSR™-4000) under "worst case conditions," against which the performance of the proposed devices was compared. The implied ground truth is established industry standards and expected performance for such venous reservoirs.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning study, so there is no "training set."

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

Not applicable. There is no training set for this type of device submission.

Summary

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K974155

Submitter:	JAN 22 1998	Baxter Healthcare CorporationCardio Vascular GroupBentley Division17511 Armstrong AvenueIrvine California 92714 USA
Contact:		Tom HumphreyPhone: 714 756 4292Fax: 714 756 4021
Device Trade Name:		BMRTM-4500 Filtered Venous Reservoirand BMRTM-4500 GOLD® FilteredVenous Reservoir with Duraflo®Treatment
Common Name:		Cardiopulmonary bypass venous reservoirwith cardiotomy filter.
Classification:		Class II (Reference 21 CFR 870.4400)
Predicate or Legally Marketed Device:		Bentley HSRTM-4000 Venous Reservoirwith Cardiotomy Autotransfusion Filter.
Date Prepared:		11/3/97

510(k) Summary, Safety and Effectiveness

Device Description:

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Indications for Use:

The BMR™-4500 Filtered Venous Reservoir is indicated for use during cardiopulmonary bypass surgery in the extracorporeal circuit to collect, store, filter and defoam the patient's blood.

Technology Comparison

With exception to the addition of rotatable venous and cardiotomy inlets and supplemental luer fittings, the BMR™-4500, BMR™-4500 GOLD® and HSR™-4000 are essentially the same. The only difference between the BMR™-4500 and BMRTM. 4500 GOLD® is the inclusion of Bentley's Duraflo® complex in the "GOLD®" version.

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Test Summary, In-vitro

The untreated BMR™-4500 and Duraflo® treated BMR™-4500 GOLD® Reservoirs were evaluated in-vitro for functional performance. The results were compared with those of the untreated HSR™-4000. The number of devices tested was selected based on AAMI guidelines (AAMI OXY-D). AAMI standards for autologous transfusion devices (AAMI AT6R-D) were also considered in the performance evaluation. The parameters under which the device was tested were considered worst case conditions.

Performance evaluation included the following tests:

Venous and Cardiotomy Blood Damage .
. Filtration Efficiency
. Venous and Cardiotomy Breakthrough Volume
. Venous and Cardiotomy Residual Volume
. Defoaming Capability
Patency of One-Way Valve .
. Heparin Leaching

The test results demonstrated no remarkable differences between the proposed vs. predicate populations.

Test Summary, In-vivo:

Clinical testing was not conducted. Safety and efficacy has been established via in-vitro analyses and historical experience with similar devices.

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Test Summary, Biocompatibility:

All components of the BMR™-4500 and BMR™-4500 GOLD® were found to be biocompatible in compliance with ISO-10993-1.

Rational for Substantial Equivalence Determination

The coated and uncoated versions of Bentley's BMR™-4500 are either functionally identical or substantially equivalent to the predicate device, Bentley's HSR™-4000. The primary raw materials, principal of operation, developmental technology, functionality, intended use and labeling claims are essentially the same for all products referenced under this notification. The only notable differences between the proposed vs. predicate device are the autotransfusion function of the HSR™-4000 and addition of Bentley's Duraflo Filtered Venous Reservoir complex to the blood contacting surfaces of the GOLD® version of the device.

Bentley's Duraflo® Treatment is utilized as a biocompatible surface treatment on several devices manufactured and distributed by Baxter Healthcare corporation, Bentley Division. Numerous Duraflo treated devices have been previously "cleared" by FDA.

The results of the above referenced analyses demonstrate no remarkable differences between the proposed and predicate populations. In addition to in-vitro assessment, the device materials, intended use and technological characteristics of the proposed vs. predicate devices are largely identical. The test results and strong similarities in raw materials and intended use between the BMR™-4500, BMR™-4500 GOLD® and HSR™-4000, combined with Bentley's historical experience in developing similar products, provide strong rational for substantial equivalence between the proposed and predicate devices.

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Image /page/4/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is composed of three curved lines that form the head, body, and wings. The text is in a simple, sans-serif font.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Tom Humphrey Sr. Requlatory Affairs Specialist Baxter Healthcare Corporation 17221 Red Hill Avenue (Irvine) P.O. Box 11150 Santa Ana, California 92711-1150

JAN 2 2 1998

Re : K974155 BMR™-4500 Filterted Venous Reservoir and BMR™-4500 GOLD® Filtered Venous Reservoir with Duraflo® Treatment Requlatory Class: II (Two) Product Code: DTN Dated: November 3, 1997 November 4, 1997 Received:

Dear Mr. Humphrey:

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 (for the indications for use stated in the enclosure) 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 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 (Premarket Approval), it may be subject to such Existing major requlations affecting your device additional controls. 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 Regulation (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 - Mr. Tom Humphrey

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/dsmamain.html."

Sincerely yours,

Thomas J. Callahon

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

Enclosure

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DIN II -870. 4400 -

Venous

Reservoir

510(k) Number (if known): K974155

Device Name: BMR™-4500 and BMR™-4500 GOLD® Filtered Venous Reservoir with Duraflo® Treatment --

Indications For Use:

The BMR™-4500 Filtered Venous Reservoir is indicated for use during cardiopulmonary bypass surgery in the extracorporeal circuit to collect, store, filter and defoam the patient's blood.

The BMR™-4500 GOLD® Hard Shell Venous Reservoir with Duraflo® treatment is indicated for use during cardiopulmonary bypass surgery in the extracorporeal circuit to " collect, store, filter and defoam the patient's blood. The BMR-4500 GOLD® is further intended for use when a heparin treated blood path is desired.

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

Concurrence of CDRH, Office OF Device Evaluation (ODE)

Bura G. Remmersle

Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

K974155 510(k) Number_

Prescription Use

Over-The-Counter Use_

(Per 21 CFR 801.109) --------------

(Optional Format 1-2-96)

Regulation Number and Section

§ 870.4400 Cardiopulmonary bypass blood reservoir.

(a)
Identification. A cardiopulmonary bypass blood reservoir is a device used in conjunction with short-term extracorporeal circulation devices to hold a reserve supply of blood in the bypass circulation.(b)
Classification. Class II (special controls), except that a reservoir that contains a defoamer or filter is classified into the same class as the defoamer or filter. The device, when it is a cardiopulmonary bypass blood reservoir that does not contain defoamers or blood filters, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.