K Number
K112771
Device Name
BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG
Date Cleared
2011-10-14

(21 days)

Product Code
Regulation Number
870.4400
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BMR1900 PH.I.S.I.O. is intended to be used in cardiac surgical procedures requiring extracorporeal support for periods of up to six hours.
Device Description
The BMR1900 PH.I.S.I.O. is a sterile, non-pyrogenic softshell reservoir designed for use in cardiac surgical procedures requiring extracorporeal support for periods of up to six hours. The BMR1900 PH.I.S.I.O. can be operated at flow rates up to 6 liters per minute. The maximum operating volume is 1900 mL. The minimum operating volume is 300 mL. The softshell reservoir has a blood inlet port with an integral cardiotomy inlet on one side of the bag and a blood outlet port on the opposite side of the bag with respect to the vertical axis. Integral to the blood inlet port are connectors for measuring the temperature and saturation/hematocrit of the incoming blood using external monitoring equipment. At the top edge of the bag it is located a dual four-way stopcock assembly that is used to manually purge air from the bag. The stopcock assembly may also be used for the administration of drugs or other solutions, as needed during the cardiopulmonary bypass procedure. 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 PH.I.S.I.O. is a modified version of the currently marketed SMARxT BMR1900 Closed Venous Reservoir Bag.
More Information

Not Found

No
The description focuses on the physical components and function of a blood reservoir bag for extracorporeal support, with no mention of AI or ML capabilities.

No
The device is a reservoir that holds blood during extracorporeal support and does not directly provide therapy; its function is supportive and mechanical, not therapeutic.

No

This device is a softshell reservoir used for extracorporeal support during cardiac surgical procedures. While it has ports for external monitoring equipment to measure temperature and saturation/hematocrit, the device itself does not perform diagnostic functions. It is a container and part of the circulatory support system.

No

The device description clearly outlines a physical, sterile, non-pyrogenic softshell reservoir with ports, filters, and stopcocks, indicating it is a hardware device used in cardiac surgery.

Based on the provided information, the BMR1900 PH.I.S.I.O. is not an IVD (In Vitro Diagnostic) device.

Here's why:

  • Intended Use: The intended use is for "cardiac surgical procedures requiring extracorporeal support." This describes a device used during a surgical procedure on a patient, not a device used to test samples outside of the body to diagnose a condition.
  • Device Description: The description details a "softshell reservoir" designed to hold blood during cardiopulmonary bypass. It mentions blood flow, volume, filtering, and ports for monitoring temperature and saturation/hematocrit. These are all characteristics of a device used in a surgical setting to manage blood flow and properties in vivo (within the living body).
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.) to provide diagnostic information. The monitoring mentioned (temperature, saturation/hematocrit) is related to the real-time status of the blood during the procedure, not for diagnostic purposes.

IVD devices are typically used to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The BMR1900 PH.I.S.I.O. is a device used during a medical procedure to support a patient's physiological functions.

N/A

Intended Use / Indications for Use

The BMR1900 PH.I.S.I.O. is intended to be used in cardiac surgical procedures requiring extracorporeal support for periods of up to six hours.

Product codes

DTN

Device Description

The BMR1900 PH.I.S.I.O. is a sterile, non-pyrogenic softshell reservoir designed for use in cardiac surgical procedures requiring extracorporeal support for periods of up to six hours.

The BMR1900 PH.I.S.I.O. can be operated at flow rates up to 6 liters per minute. The maximum operating volume is 1900 mL. The minimum operating volume is 300 mL.

The softshell reservoir has a blood inlet port with an integral cardiotomy inlet on one side of the bag and a blood outlet port on the opposite side of the bag with respect to the vertical axis.

Integral to the blood inlet port are connectors for measuring the temperature and saturation/hematocrit of the incoming blood using external monitoring equipment.

At the top edge of the bag it is located a dual four-way stopcock assembly that is used to manually purge air from the bag. The stopcock assembly may also be used for the administration of drugs or other solutions, as needed during the cardiopulmonary bypass procedure.

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 PH.I.S.I.O. is a modified version of the currently marketed SMARxT BMR1900 Closed Venous Reservoir Bag.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non Clinical Test Results: Applicable tests were carried out in accordance with the requirements of ISO 10993-1 and the FDA May 1st, 1995 Memorandum on the use of the ISO 10993 standard for biocompatibility testing of materials.

In Vitro Test Results: In vitro testing was carried out to demonstrate both the substantial equivalence with the unmodified device and also to comply with safety and effectiveness requirements. The tests were performed according to internal methods developed by the Manufacturer using sterilized devices aged up to 3 years.

Comparative testing was performed to demonstrate equivalent performance of the BMR 1900 PH.I.S.I.O and the SMARxT BMR1900.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K050111

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.

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OCT 1 4 2011

K11277/ pg 1 of 2

BMR1900 PH.I.S.I.O Sorin Group Italia S.r.I.

Special 510(k) September 22, 2011

510(k) SUMMARY

| SUBMITTER: | Sorin Group Italia
86, Via Statale 12 Nord
41037 Mirandola (MO) Italy |
|----------------------|-----------------------------------------------------------------------------|
| CONTACT PERSON: | Luigi Vecchi
Phone: 39 0535 29811
Fax: 39 0535 25229 |
| DATE PREPARED: | September 22, 2011 |
| DEVICE TRADE NAME: | BMR1900 PH.I.S.I.O. |
| COMMON NAME: | Closed Venous Reservoir Bag |
| CLASSIFICATION NAME: | Reservoir, Blood, Cardiopulmonary Bypass |
| UNMODIFIED DEVICES: | SMARxT BMR1900 Closed Venous Reservoir
Bag (K050111) |

DEVICE DESCRIPTION:

The BMR1900 PH.I.S.I.O. is a sterile, non-pyrogenic softshell reservoir designed for use in cardiac surgical procedures requiring extracorporeal support for periods of up to six hours.

The BMR1900 PH.I.S.I.O. can be operated at flow rates up to 6 liters per minute. The maximum operating volume is 1900 mL. The minimum operating volume is 300 mL.

The softshell reservoir has a blood inlet port with an integral cardiotomy inlet on one side of the bag and a blood outlet port on the opposite side of the bag with respect to the vertical axis.

Integral to the blood inlet port are connectors for measuring the temperature and saturation/hematocrit of the incoming blood using external monitoring equipment.

At the top edge of the bag it is located a dual four-way stopcock assembly that is used to manually purge air from the bag. The stopcock assembly may also be used for the administration of drugs or other solutions, as needed during the cardiopulmonary bypass procedure.

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 PH.I.S.I.O. is a modified version of the currently marketed SMARxT BMR1900 Closed Venous Reservoir Bag.

1

K112771 pg 2 of 2

Special 510(k) September 22, 2011

INDICATION FOR USE:

The BMR1900 PH.I.S.I.O. is intended to be used in cardiac surgical procedures requiring extracorporeal support for periods of up to six hours.

No change to the intended use has been made as a result of the modifications.

TECHNOLOGICAL CHARACTERISTICS:

The BMR1900 PH.I.S.I.O. has the same technological characteristics, principles of operation and control mechanisms as the unmodified device. The fundamental scientific technology is unchanged.

The blood contact surfaces are treated with a phosphorylcholine (PH.I.S.I.O.) coating rather than SMARxT as for the unmodified device. Both PH.I.S.I.O. and SMARxT treatments improve blood compatibility of the device and have the same claim of reduced platelet adhesion.

Instructions for use and labeling have been revised to reflect the change from a SMARxT to a PH.I.S.I.O. treatment.

The BMR1900 PH.I.S.I.O. is ethylene oxide sterilized and has a non-pyrogenic fluid path. It is for single use only.

NON CLINICAL TEST RESULTS:

Applicable tests were carried out in accordance with the requirements of ISO 10993-1 and the FDA May 1st, 1995 Memorandum on the use of the ISO 10993 standard for biocompatibility testing of materials.

IN VITRO TEST RESULTS:

In vitro testing was carried out to demonstrate both the substantial equivalence with the unmodified device and also to comply with safety and effectiveness requirements. The tests were performed according to internal methods developed by the Manufacturer using sterilized devices aged up to 3 years.

Comparative testing was performed to demonstrate equivalent performance of the BMR 1900 PH.I.S.I.O and the SMARxT BMR1900.

CONCLUSIONS:

The BMR1900 PH.I.S.I.O. has the same intended use, principles of operation and technological characteristics as the unmodified device. The testing performed demonstrates that the BMR1900 PH.I.S.I.O. is substantially equivalent to the SMARxT BMR1900.

2

Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services (HHS). The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with three lines forming the wings and a wavy line representing the staff. The text "U.S. Department of Health & Human Services" is arranged in a circular pattern around the caduceus.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Wenne Document Control Room -WO66-6609 Silver Spring, MI) 20093-0002

OCT 1 4 2011

Sorin Group USA, Inc. c/o Mr. Scott Light Regulatory Affairs Manager 14401 W. 65" Way Arvada, CO 80004

Re: K112771

Trade/Device Name: BMR 1900 Ph.I.S.I.O. Regulation Number: 21 CFR 370.4400 Regulation Name: Cardiopulmonary bypass blood reservoir Regulatory Class: Class II Product Code: DTN Dated: September 22, 2011 Received: September 23, 2011

Dear Mr. Light:

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. 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 fiability 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

3

Page 2 - Mr. Scon Light

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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.lda.gov/AboutFDA/CentersOfTices/CDRH/CDRHOffices/ucm115809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Pari 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH 's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Kuh

Bram D. Zuckerman. M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

4

BMR 1900 PH.I.S.I.O Sorin Group Italia S.r.I.

Special 510(k) September 22, 2011

510(k) Number (if known):

Device Name: BMR1900 PH.I.S.I.O. Indication for Use:

The BMR1900 PH.I.S.I.O. is intended to be used in cardiac surgical procedures requiring extracorporeal support for periods of up to six hours.

Prescription Use × (Part 21CFR 801 Subpart D)

Over-the- Counter Use AND/OR (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Cardiovascular Devices

510(k) Number K112711