(21 days)
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.
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.
The provided document describes a Special 510(k) submission for the BMR1900 PH.I.S.I.O. device, a closed venous reservoir bag for cardiac surgical procedures. This submission focuses on demonstrating substantial equivalence to a predicate device (SMARxT BMR1900 Closed Venous Reservoir Bag) due to a modification in the blood-contacting coating.
The nature of this device (a medical device, not an AI/ML algorithm) means that many of the requested criteria related to AI/ML device evaluation (like sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types for AI models) are not applicable and therefore not present in the provided text.
Here's an analysis based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
The submission is for a medical device (a closed venous reservoir bag) and the "acceptance criteria" are related to biocompatibility and equivalent performance to a predicate device. The performance is demonstrated through in vitro testing.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility | Passed tests in accordance with ISO 10993-1 and FDA's May 1st, 1995 Memorandum. |
| Equivalence to Unmodified Device (SMARxT BMR1900) | Demonstrated through comparative in vitro testing. |
| Safety and Effectiveness | Met through in vitro testing, showing substantial equivalence to the predicate. |
| Material Properties (Coating) | Blood compatibility improved by PH.I.S.I.O. coating with the same claim of reduced platelet adhesion as SMARxT. |
| Operational Characteristics (unchanged from predicate) | Can be operated at flow rates up to 6 liters per minute, maximum operating volume 1900 mL, minimum operating volume 300 mL. |
| Sterility | Ethylene oxide sterilized. |
| Non-pyrogenic Fluid Path | Confirmed non-pyrogenic fluid path. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated as a number of "samples" in a clinical trial sense. The "test set" refers to physical devices used in in vitro testing. The document states "internal methods developed by the Manufacturer using sterilized devices aged up to 3 years." A specific number of devices tested is not provided.
- Data Provenance: The in vitro tests were carried out by the Manufacturer (Sorin Group Italia S.r.I.) using internal methods. The context implies these are laboratory tests performed within the company's facilities. This would be considered retrospective in the sense that it's testing manufactured devices, not prospective clinical data. Country of Origin: Italy (where Sorin Group Italia S.r.I. is located).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is not an AI/ML device where "ground truth" is established by expert review of data like images or patient records. The "ground truth" for this device's performance is derived directly from physical and chemical measurements during in vitro tests according to established standards (ISO 10993-1) and internal methods.
4. Adjudication method for the test set
- Not Applicable. As above, no expert adjudication process is described for in vitro laboratory test results.
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 medical device, not an AI system that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This device is hardware; it does not involve algorithms or AI performance.
7. The type of ground truth used
- For biocompatibility: Adherence to established international standards (ISO 10993-1) and FDA guidance for biological evaluation of medical devices.
- For performance equivalence: Quantitative physical and chemical measurements derived from in vitro comparative testing against the predicate device.
8. The sample size for the training set
- Not Applicable. This device does not use machine learning, so there is no "training set."
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.
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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 Italia86, Via Statale 12 Nord41037 Mirandola (MO) Italy |
|---|---|
| CONTACT PERSON: | Luigi VecchiPhone: 39 0535 29811Fax: 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 ReservoirBag (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.
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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.
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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
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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
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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
§ 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.