(219 days)
Not Found
No
The device description and performance studies focus on the physical components and mechanical performance of a blood reservoir bag, with no mention of AI or ML.
Yes
The device is described as "intended to be used in cardiopulmonary bypass procedures" and designed to contain blood volume, remove large air bubbles from the blood, and assist in drug administration during the procedure, all of which are actions taken to support or restore normal physiological function.
No
The BMR1900 PHISIO Closed Venous Reservoir Bag is a medical device used in cardiopulmonary bypass procedures to contain blood volume, filter air bubbles, and allow for drug administration. While it has ports for external monitoring equipment to measure temperature and blood saturation/hematocrit, the device itself does not perform diagnostic functions; it is a component of a larger system that facilitates blood management during surgery. Its primary function is therapeutic and supportive, not diagnostic.
No
The device description clearly outlines a physical, hardware-based medical device (a bag, filter, stopcock, ports, and connectors) used in cardiopulmonary bypass procedures. There is no mention of software as the primary or sole component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to be used in cardiopulmonary bypass procedures for periods of up to six hours." This describes a device used during a medical 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 bag for containing blood volume during bypass surgery, including a filter for air bubbles and ports for blood flow and monitoring. This aligns with a surgical device, not a diagnostic test.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze blood or other samples to provide diagnostic information about a patient's health status. The monitoring mentioned is for temperature and saturation/hematocrit of the incoming blood, which are parameters relevant to the bypass procedure itself, not for diagnosing a disease.
- Performance Studies: The performance studies focus on the physical and functional integrity of the bag and its components in relation to blood flow and handling, not on the accuracy or reliability of diagnostic results.
In summary, the BMR1900 PHISIO Closed Venous Reservoir Bag is a medical device used in a surgical procedure, not a device used for in vitro diagnostic testing.
N/A
Intended Use / 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.
Product codes
DTN
Device Description
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
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
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)
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.
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.
Key Metrics
Not Found
Predicate Device(s)
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.
0
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
1
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
2
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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3
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 Nord
41037 Mirandola (MO) ITALY |
|----------------------------|------------------------------------------------------------------------------------|
| CONTACT PERSON: | Luigi Vecchi
Phone: +39 0535 29957
e-mail: luigi.vecchi@livanova.com |
| APPLICATION CORRESPONDANT: | Sorin Group Italia S.r.l.
86, Via Statale 12 Nord
41037 Mirandola (MO) ITALY |
| CONTACT PERSON: | Luigi Vecchi
Phone: +39 0535 29957
e-mail: luigi.vecchi@livanova.com |
| DATE PREPARED: | October 1st 2022 |
II. Subject Devices Identification
| PROPRIETARY NAME: | BMR 1900 PHISIO Closed Venous
Reservoir Bag |
|------------------------------|------------------------------------------------|
| COMMON/ USUAL NAME: | BMR 1900 PHISIO |
| CLASSIFICATION NAME: | Reservoir, Blood, Cardiopulmonary
Bypass |
| 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
4
| 510(k) NUMBER: | K112771 |
|---|---|
| PROPRIETARY NAME: | BMR 1900 PHISIO Closed Venous Reservoir |
| Bag | |
| 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
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.
5
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
6
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.
-
- The material of tubes, film and connectors is changed. Specifically, in the tubing the plasticizer (phthalate) and additive (polyester modified
7
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)
-
- 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
- The Instructions for Use was revised to reflect the changes above and improve readability.
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) ●
8
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.