The BMR1900 PHISIO Closed Venous Reservoir Bag (hereinafter BMR1900) is a softshell, flexible, polyvinylchloride bag designed for use in cardiopulmonary bypass surgery for periods up to six hours. It is supplied sterile with non-pyrogenic fluid pathways, for single use only, and is not to be resterilized by the user. As for the unmodified device, the BMR1900 PHISIO. is composed of the following elements: - · A collapsible bag that serves as an in-line closed venous reservoir to contain blood volume. - · An integral 105 micron polyester filter screen which is mainly intended to facilitate the removal of large air bubbles from the blood. - A dual four-wav stopcock assembly used to manually purge the air captured by the filter screen or to administrate drugs or other solutions as needed during the cardiopulmonary bypass procedure. - A 1/2" venous blood inlet port and a 3/8" blood outlet port. - Connectors integral to the blood inlet port that are used to measure temperature and saturation/hematocrit of the incoming blood using external monitoring equipment, as needed. The BMR1900 PHISIO is designed with a 1900 mL maximum operating volume and a minimum operating volume equals to 300 mL and can be used at any flow rate up to 6 liter per minute. The venous blood inlet/outlet ports and the dual four-way stopcock assembly are opposite located with respect to the horizontal axis: the formers are placed in the bottom of the device while the latter at the top of the bag. Considering the vertical axis, both modified and unmodified devices present the blood inlet port with the integral cardiotomy inlet placed on one side of the bag while the blood outlet port is located on the opposite side of the bag. Blood enters the bag through the inlet port and passes through a polyester filter screen before exiting the bag through the outlet port. The purpose of the filter is to facilitate the removal of large air bubbles from the blood. The BMR1900 PHISIO will be available with two configurations that differ only for the orientation of the venous blood inlet. The BMR1900 PHISIO. has the connector of the venous blood inlet right oriented (figure 1) while the BMR1900 L PHISIO. has the connector of the venous blood inlet left oriented (figure 2) The modified device is modified version of the currently marketed BMR1900 PH.I.S.I.O product

AI/ML Overview

The provided text describes a 510(k) premarket notification for the BMR 1900 PHISIO Closed Venous Reservoir Bag, a medical device. This is a submission for a modified medical device, which is compared to its unmodified predicate device. The document focuses on demonstrating substantial equivalence rather than a device's initial performance study against clinical endpoints.

Therefore, the specific information requested in the prompt, such as acceptance criteria based on clinical outcomes, human reader improvement with AI, or detailed ground truth establishment for novel algorithms, is not applicable in this context. The study outlined here is a non-clinical performance study to show that the modified device is as safe and effective as the original, legally marketed device.

Here's the information that can be extracted and how it relates to the prompt's questions:

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

Since this is a substantial equivalence submission for a modified device, the "acceptance criteria" are effectively that the modified device performs equivalently to the unmodified predicate device across several non-clinical tests. The document states that the modified device "successfully met all acceptance criteria."

Acceptance Criteria Category	Specific Tests Conducted	Reported Device Performance
Physical Integrity	Blood Path integrity	Successfully met (equivalent to predicate)
	Connection Integrity	Successfully met (equivalent to predicate)
	Burst test	Successfully met (equivalent to predicate)
Functional Performance	Ease of prime	Successfully met (equivalent to predicate)
	Min/max blood volume	Successfully met (equivalent to predicate)
Material Biocompatibility	Biocompatibility tests (per ISO 10993-1)	Successfully met (equivalent to predicate)
Material Properties	Surface coverage coating test	Successfully met (equivalent to predicate)
	Leaching and flaking of coating test	Successfully met (equivalent to predicate)

2. Sample size 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 the sample size for each non-clinical test. The tests were performed on "sterile aged devices" equivalent to "at least 3 years" of aging. The provenance is not explicitly stated beyond the applicant being Sorin Group Italia S.R.L. and the tests being "in vitro testing." This implies laboratory-based tests rather than human patient data, and thus is more akin to prospective testing of manufactured devices.

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)

Not applicable. This is a non-clinical engineering and materials performance study, not a study involving human expert interpretation or ground truth establishment in a clinical sense.

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

Not applicable. This is a non-clinical engineering and materials performance study, not a study requiring adjudication of expert opinions.

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 non-clinical performance study for a physical medical device (a blood reservoir bag) and does not involve AI or human readers.

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

Not applicable. This device is not an algorithm or AI.

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

The "ground truth" in this context would be the established performance characteristics and safety profile of the unmodified BMR1900 PHISIO predicate device. The tests performed on the modified device aim to demonstrate that it functions identically to this established benchmark.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device, so there is no "training set."

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

Not applicable. There is no training set. The "ground truth" for the non-clinical comparisons is the performance of the previously cleared predicate device, which would have been established through its own initial premarket submission and subsequent clinical use.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.

June 10, 2023

Sorin Group Italia S.R.L. Luigi Vecchi Director, Regulatory Affairs Via Statale 12 Nord, 86 Mirandola, Modena 41037 Italy

Re: K223361

Trade/Device Name: BMR 1900 PHISIO Closed Venous Reservoir Bag Regulation Number: 21 CFR 870.4400 Regulation Name: Cardiopulmonary Bypass Blood Reservoir Regulatory Class: Class II Product Code: DTN Dated: May 17, 2023 Received: May 17, 2023

Dear Luigi Vecchi:

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

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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); 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 medical devices and radiation-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,

Eric E. Richardson -S & Digitally signed by Eric E. Richardson -S
Poate: 2023.06.10 09:46:2023.06.10 09:46:41 -04'00'

for Kathleen Grunder Acting 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K223361

Device Name BMR 1900 PHISIO Closed Venous Reservoir Bag

Indications for Use (Describe) The BMR1900 PHISIO Closed Venous Reservoir Bag is intended to be used in cardiopulmonary bypass procedures for periods of up to six hours.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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510(k) Summary

(in accordance with 21 CFR 807.92)

510(k) Number: K223361

l. Applicant Information

APPLICANT:	Sorin Group Italia S.r.l.86, Via Statale 12 Nord41037 Mirandola (MO) ITALY
CONTACT PERSON:	Luigi VecchiPhone: +39 0535 29957e-mail: luigi.vecchi@livanova.com
APPLICATION CORRESPONDANT:	Sorin Group Italia S.r.l.86, Via Statale 12 Nord41037 Mirandola (MO) ITALY
CONTACT PERSON:	Luigi VecchiPhone: +39 0535 29957e-mail: luigi.vecchi@livanova.com
DATE PREPARED:	October 1st 2022

II. Subject Devices Identification

PROPRIETARY NAME:	BMR 1900 PHISIO Closed VenousReservoir Bag
COMMON/ USUAL NAME:	BMR 1900 PHISIO
CLASSIFICATION NAME:	Reservoir, Blood, CardiopulmonaryBypass
REGULATION NUMBER:	21 CFR 870.4400
CLASSIFICATION PRODUCT CODE:	DTN
CLASSIFICATION:	Class II
CLASSIFICATION PANEL;	Cardiovascular

III. Predicate Devices

The BMR 1900 PHISIO Closed Venous Reservoir Bag is substantially equivalent to the following cleared predicate device. All models have the same fundamental scientific technology and intended use

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510(k) NUMBER:	K112771
PROPRIETARY NAME:	BMR 1900 PHISIO Closed Venous ReservoirBag
COMMON/ USUAL NAME:	BMR 1900 PHISIO
CLASSIFICATION NAME:	Reservoir, Blood, Cardiopulmonary Bypass
REGULATION NUMBER:	21 CFR 870.4400
CLASSIFICATION:	Class II
CLASSIFICATION PANEL;	Cardiovascular

IV. Device Description

As for the unmodified device, the BMR1900 PHISIO. is composed of the following elements:

· A collapsible bag that serves as an in-line closed venous reservoir to contain blood volume.
· An integral 105 micron polyester filter screen which is mainly intended to facilitate the removal of large air bubbles from the blood.
A dual four-wav stopcock assembly used to manually purge the air captured by the filter screen or to administrate drugs or other solutions as needed during the cardiopulmonary bypass procedure.
A 1/2" venous blood inlet port and a 3/8" blood outlet port.
Connectors integral to the blood inlet port that are used to measure temperature and saturation/hematocrit of the incoming blood using external monitoring equipment, as needed.

The BMR1900 PHISIO is designed with a 1900 mL maximum operating volume and a minimum operating volume equals to 300 mL and can be used at any flow rate up to 6 liter per minute.

The venous blood inlet/outlet ports and the dual four-way stopcock assembly are opposite located with respect to the horizontal axis: the formers are placed in the bottom of the device while the latter at the top of the bag.

Considering the vertical axis, both modified and unmodified devices present the blood inlet port with the integral cardiotomy inlet placed on one side of the bag while the blood outlet port is located on the opposite side of the bag.

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Blood enters the bag through the inlet port and passes through a polyester filter screen before exiting the bag through the outlet port. The purpose of the filter is to facilitate the removal of large air bubbles from the blood.

The BMR1900 PHISIO will be available with two configurations that differ only for the orientation of the venous blood inlet.

The BMR1900 PHISIO. has the connector of the venous blood inlet right oriented (figure 1) while the BMR1900 L PHISIO. has the connector of the venous blood inlet left oriented (figure 2)

Image /page/5/Figure/3 description: This image is a diagram of a reservoir bag outlet with labels. There are 10 labels in total, starting with the reservoir vent stopcock and auxiliary vent stopcock at the top of the image, labeled 1 and 2 respectively. The diagram also includes labels for mounting holes, auxiliary female luer lock port, cardiotomy inlet, reservoir bag outlet, SAT/HCT fitting, venous inlet, venous temperature probe fitting, and venous sampling female luer lock port.

Figure 1 BMR1900 PHISIO

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Image /page/6/Figure/0 description: This image shows a diagram of a reservoir bag outlet. The diagram includes labels with numbers 1-10 pointing to different parts of the bag. Some of the parts labeled are the reservoir vent stopcock and the reservoir bag outlet. The diagram is a technical drawing and is likely from a manual or instruction guide.

- ous sampling female luer

Image /page/6/Figure/8 description: This image contains the text "Figure 2 BMR1900 L PHISIO". The text is written in a bold, sans-serif font. The figure number is "2", followed by the identifier "BMR1900 L PHISIO".

The modified device is modified version of the currently marketed BMR1900 PH.I.S.I.O product

V. Indications for use

The BMR1900 PHISIO Closed Venous Reservoir Bag is intended to be used in cardiopulmonary bypass procedures for periods of up to six hours.

VI. Summary of technical characteristics

The BMR1900 PHISIO subject device has the same principles of operation and control mechanisms as the BMR1900 PHISIO unmodified device. The BMR1900 PHISIO subject device and the BMR1900 PHISIO unmodified device share the same fundamental technological characteristics except for some modifications that do not affect the basic device function. These differences are summarized below and do not raise any new issues of safety and effectiveness.

1. The material of tubes, film and connectors is changed. Specifically, in the tubing the plasticizer (phthalate) and additive (polyester modified

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siloxane based Tegomer® H-Si 6441) have been removed from the PVC and sub substituted with Tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate(TOTM). The PVC material of the film is changed substituting the plasticiser (phthalate) with Tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate(TOTM) The MABS of connectors is changed with a MABS without polyester modified siloxane based additive (Tegomer® H-Si 6441)

1. The Instructions for Use was revised to reflect the changes above and improve readability.
  No change to the intended use has been made as a result of these modifications. Also, there are no differences in packaging type and sterilization method between BMR1900 PHISIO and BMR 1900 unmodified device. Both modified and unmodified devices are for single use only, ethylene oxide sterilized and has a non-pyrogenic fluid path

VII. Substantial equivalence discussion

Based on equivalent intended use and technological characteristics, as well as on equivalent performance testing, the BMR1900 PHISIO can be deemed to be substantially equivalent to its predicate device, the unmodified BMR1900 PHISIO The BMR1900 PHISIO as designed and manufactured, does not raise new questions regarding safety and effectiveness as compared to its predicate device and is determined to be substantially equivalent to its predicate device. the unmodified BMR1900 PHISIO

VIII. Non clinical performance data

The subject device was tested to ensure that it can provide all the capabilities necessary to operate safely and effectively. Applicable tests were carried out in accordance with the requirements of ISO 10993-1 standard as well as in compliance with the FDA guidance document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" of September 4, 2020.

In vitro testing was performed to evaluate the impact of the different materials in the modified BMR1900 PHISIO version, specifically the following tests were carried on:

Blood Path integrity
Ease of prime ●
Min/max blood volume ●
Connection Integrity ●
Burst test
Surface coverage coating test
Leaching and flacking of coating test ●
Biocompatibility tests (listed and described in section 011) ●

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This performance testing was conducted on sterile aged devices; accelerated aging for a period of time equivalent to at least 3 years as per device labeling The modified device successfully met all acceptance criteria.

The results of in vitro studies demonstrate that the subject BMR1900 PHISIO performs in a manner substantially equivalent to the Unmodified BMR1900 PHISIO predicate device with respect to the relevant functional parameters.

IX. Clinical performance data

No clinical testing was conducted in support of the BMR1900 PHISIO, as the indications for use are equivalent to those of their respective predicates, which have been on the market for many years. The non-clinical testing summarized in this submission supports the substantial equivalence of these devices with their respective predicates in relation to the changes subject of this submission.

Statement of Substantial Equivalence X.

As designed and manufactured and based on the intended use, technological characteristics, and performance testing, the modified BMR1900 PHISIO do not raise new questions regarding their safety and effectiveness as compared to their predicates devices and are determined to be substantially equivalent to the predicate devices.

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.