(28 days)
Not Found
No
The device description and performance studies focus on the physical components, materials, and biocompatibility of a venous reservoir bag used in cardiopulmonary bypass. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
No
Explanation: The device is a component of an extracorporeal circuit used during cardiopulmonary bypass surgery for blood management, not a device directly used to treat or cure a disease or condition. While it has a 'bioactive surface' to enhance blood compatibility, its primary function is to hold and direct blood within the circuit, not to provide therapy itself.
No
Explanation: The device is a venous reservoir bag used during cardiopulmonary bypass surgery to hold blood in an extracorporeal circuit. It does not perform any diagnostic functions.
No
The device description clearly describes a physical, single-use, sterile, nonpyrogenic variable volume device (a bag) used in conjunction with other hardware components (membrane oxygenator, pumps, etc.) during cardiopulmonary bypass surgery. It is sterilized using ethylene oxide and has a physical structure with an internal screen and stopcock. The performance studies also focus on the biocompatibility of a physical component (one-way stopcock).
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used during cardiopulmonary bypass surgery in an extracorporeal circuit. This involves handling blood outside the body for therapeutic purposes (oxygenation and circulation), not for diagnostic testing of samples.
- Device Description: The description details how the device handles blood flow from the patient, accommodates suctioned blood, and assists in air removal. This is consistent with a device used in a surgical procedure, not for analyzing biological samples for diagnostic information.
- Lack of Diagnostic Language: The text does not mention any analysis of biological samples, detection of analytes, or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on biocompatibility and functionality within the extracorporeal circuit, not on the accuracy or reliability of diagnostic measurements.
IVD devices are specifically designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device's function is to manage blood flow during surgery, which is a therapeutic intervention, not a diagnostic process.
N/A
Intended Use / Indications for Use
The MVR Venous Reservoir Bag is indicated for use during cardiopulmonary bypass surgery in an extracorporeal circuit utilizing a membrane oxygenator for up to 6 hours in duration. The MVR Holder (Model MVR-SH) is indicated for use with the MVR Collapsible Venous Reservoir Bag.
Product codes
DTN
Device Description
The MVR Venous Reservoir Bag, with or without Cortiva bioactive surface, is a single-use, sterile, nonpyrogenic variable volume device used in conjunction with a membrane oxygenator during cardiopulmonary bypass (CPB) surgery. It is sterilized using ethylene oxide. It is designed to accommodate blood from the patient and suctioned blood from the cardiotomy reservoir. The internal screen of the venous reservoir is designed to assist in tramping air, which may enter the venous reservoir during priming or perfusion on the inlet side of the reservoir. Air trapped in the venous reservoir bag can be removed using the one-way stopcock located at the top of the reservoir.
Blood that comes from the patient flows into the reservoir and is delivered through a pump to the oxygenator and other axillary devices, and back to the patient. The oxygenator can be connected to a heater/cooler device, recirculation circuit, cardioplegia circuit, and the main blood path.
Products coated with Cortiva bioactive surface include a "CB" prefix in the model number. The primary blood-contacting surfaces of the product are coated with Cortiva bioactive surface. This coated surface enhances blood compatibility and provides a blood-contacting surface that is thromboresistant. Cortiva bioactive surface contains nonleaching heparin derived from porcine intestinal mucosa.
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)
Biocompatibility evaluation has been performed to support evaluation of one-way stopcock component (M946844A001 - Female Luer to Male Luer with 2 Arrow Diverter) used with the MVR Venous Reservoir Bag after a material change in accordance with ISO 10993 and USA FDA Guidance Document on Use of ISO 10993-1.
The proposed one-way stopcock is used within Medtronic Surgical Innovations product, the Step™ Auto Suture™ Dilator and Cannula with Radially Expandable Sleeve 12mm / REF S101012. The Step™ Auto Suture™ Dilator and Cannula is used as the reference device in the biocompatibility evaluation since it is an external communicating device with limited tissue/bone contact and has undergone/passed cytotoxicity, sensitization (in vivo and in vitro), material-mediated pyrogenicity, and acute systemic toxicity testing. Since the one-way stopcock supplier, colorant, and sterilization process remain consistent for both the subject component and the reference component, the biocompatibility test data from the reference device component (Step™ Auto Suture™ Dilator and Cannula) can be applied to the subject device component (one-way stopcock of MVR® Venous Reservoir Bags). The identical contact duration ensures the consistent biocompatibility test methodology for shared tests between the subject device component and the reference device component, enabling the utilization of test data from the reference device for relevant biological endpoints.
A separate design assessment was conducted which concluded that the change has no impact on the final product functionality or performance and as a result, no design verification or validation testing is warranted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
| Biological Endpoint / Extraction Condition | Result |
|---|---|
| ISO MEM Elution Cytotoxicity / 1x MEM with 5% serum, 2% antibiotics, and 1% L-glutamine at 37°C for 24hrs | Pass |
| Guinea Pig Maximization Sensitization / Normal Saline and Sesame Oil at 50°C for 72hrs | Pass |
| Intracutaneous Reactivity / Normal Saline and Sesame Oil at 50°C for 72hrs | Pass |
| In Vitro Skin Irritation / Phosphate Buffered Saline and Sesame Oil at 50°C for 72hrs | Pass |
| Acute Systemic Toxicity / Normal Saline and Sesame Oil at 50°C for 72hrs | Pass |
| Material-mediated Pyrogenicity / Sterile, Non-Pyrogenic 0.9% Normal Saline at 50°C for 72hrs | Pass |
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 15, 2024
Medtronic Cardiac Surgery Yidi Hou Senior Regulatory Affairs Specialist 8200 Coral Sea Street NE Mounds View, Minnesota 55112
Re: K241053
Trade/Device Name: MVR™ Venous Reservoir Bag 800 mL; MVR™ Venous Reservoir Bag 1600 mL; MVR™ Venous Reservoir Bag with Cortiva™ BioActive Surface 800 mL; MVR™ Venous Reservoir Bag with Cortiva™ BioActive Surface 1600 mL Regulation Number: 21 CFR 870.4400 Regulation Name: Cardiopulmonary bypass blood reservoir Regulatory Class: Class II Product Code: DTN Dated: April 17, 2024 Received: April 17, 2024
Dear Yidi Hou:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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,
Nicole M. Gillette -S
Nicole Gillette 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
2
Indications for Use
Submission Number (if known)
Device Name
MVR™ Venous Reservoir Bag 800 mL
MVR™ Venous Reservoir Bag 1600 mL
MVR™ Venous Reservoir Bag with Cortiva™ BioActive Surface 800 mL
MVR™ Venous Reservoir Bag with Cortiva™ BioActive Surface 1600 mL
Indications for Use (Describe)
MVR™ Venous Reservoir Baq, with or without Cortiva™ BioActive Surface Models MVR800, MVR1600, CBMVR800, CBMVR1600
The MVR Venous Reservoir Bag is indicated for use during cardiopulmonary bypass surgery in an extracorporeal circuit utilizing a membrane oxygenator for up to 6 hours in duration. The MVR Holder (Model MVR-SH) is indicated for use with the MVR Collapsible Venous Reservoir Bag.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Attachment 13 - 510(k) Summary
| Date Prepared: | May 15, 2024 |
|---|---|
| Submitter: | Medtronic, Inc. |
| Medtronic Perfusion Systems | |
| 7611 Northland Drive | |
| Minneapolis, MN 55428 | |
| Establishment Registration Number: 2184009 | |
| Contact Person: | Yidi Hou |
| Sr. Regulatory Affairs Specialist | |
| Medtronic Perfusion Systems | |
| Phone: +16513990486 | |
| Email: yidi.hou@medtronic.com | |
| Alternate Contact: | Megan Schlichting |
| Regulatory Affairs Manager | |
| Medtronic Perfusion Systems | |
| Phone: +16519554743 | |
| Email: megan.schlichting@medtronic.com | |
| Device Name | |
| Trade Name | MVR TM Venous Reservoir Bag 800 mL |
| MVR TM Venous Reservoir Bag 1600 mL | |
| MVR TM Venous Reservoir Bag with Cortiva TM BioActive Surface 800 mL | |
| MVR TM Venous Reservoir Bag with Cortiva TM BioActive Surface 1600 mL | |
| 1600 mL | |
| Common Name | Cardiopulmonary bypass blood reservoir. |
| Collapsible venous reservoir bag. |
Device Class
| Classification | II |
|---|---|
| Regulation Number | 21 CFR 870.4400 |
| Classification Panel | Cardiovascular |
| Product Code | DTN |
4
Predicate Device Information
| Model | Description | Predicate
510(k) |
|-----------|-------------------------------------------------------------------------------|---------------------|
| MVR800 | MVR TM Venous Reservoir Bag 800 mL | |
| MVR1600 | MVR TM Venous Reservoir Bag 1600 mL | K920774 |
| CBMVR800 | MVR TM Venous Reservoir Bag with Cortiva TM BioActive Surface 800 mL | |
| CBMVR1600 | MVR TM Venous Reservoir Bag with Cortiva TM BioActive Surface 1600 mL | |
Device Description
The MVR Venous Reservoir Bag, with or without Cortiva bioactive surface, is a single-use, sterile, nonpyrogenic variable volume device used in conjunction with a membrane oxygenator during cardiopulmonary bypass (CPB) surgery. It is sterilized using ethylene oxide. It is designed to accommodate blood from the patient and suctioned blood from the cardiotomy reservoir. The internal screen of the venous reservoir is designed to assist in tramping air, which may enter the venous reservoir during priming or perfusion on the inlet side of the reservoir. Air trapped in the venous reservoir bag can be removed using the one-way stopcock located at the top of the reservoir.
Blood that comes from the patient flows into the reservoir and is delivered through a pump to the oxygenator and other axillary devices, and back to the patient. The oxygenator can be connected to a heater/cooler device, recirculation circuit, cardioplegia circuit, and the main blood path.
Products coated with Cortiva bioactive surface include a "CB" prefix in the model number. The primary blood-contacting surfaces of the product are coated with Cortiva bioactive surface. This coated surface enhances blood compatibility and provides a blood-contacting surface that is thromboresistant. Cortiva bioactive surface contains nonleaching heparin derived from porcine intestinal mucosa.
Principle of Operation
The MVR Venous Reservoir Bag is designed to be part of a cardiopulmonary heart lung bypass circuit. It is used to accommodate blood from the patient and suctioned blood from the cardiotomy reservoir, allows for blood temperature monitoring, and remove air from the patient's blood.
The MVR Venous Reservoir Bag is connected to cannula, suckers, vents, and other auxiliary devices to collect and filter blood from the patient, which is then delivered through a pump to an oxygenator, arterial filter or other auxiliary devices, and back to the patient. The internal screen of the Venous Reservoir Bag is designed to assist in trapping air, which may enter the venous
5
reservoir during priming or perfusion on the inlet side of the reservoir. Air trapped in the Venous Reservoir Bag can be removed using the one-way stopcock located at the top of the reservoir.
In the perfusion circuit, blood travels from the Venous Reservoir Bag to a pump, an oxygenator and then an arterial filter. The oxygenator transfers oxygen to the blood to support the patient's metabolic load. It also removes carbon dioxide, a product of metabolism, from the patient's blood so that the carbon dioxide levels are normal once the blood is returned to the patient.
Indications for Use
The MVR Venous Reservoir Bag is indicated for use during cardiopulmonary bypass surgery in an extracorporeal circuit utilizing a membrane oxygenator for up to 6 hours in duration. The MVR Holder (Model MVR-SH) is indicated for use with the MVR Collapsible Venous Reservoir Bag.
Contraindications
Use the device only as indicated.
Comparison to Predicate Devices
The modified MVR Venous Reservoir Bag (which includes the subject one-way stopcock component built with the same resin with an addition of a colorant) have the following similarities to the predicate device which previously received FDA clearance per K920774.
- Same intended use/indications for all devices in scope
- Same finished device operating principles for all devices in scope
- Same shelf life for all devices in scope
- Blood-contacting devices are packaged and sterilized using identical materials and ● processes
- Did not require clinical data to verify safety and efficacy ●
- . Did not alter the sterilization process or reduce the sterilization requirements
When compared to the predicate device, the modified MVR Venous Reservoir Bag (which includes the subject one-way stopcock component built with the same resin with an addition of a colorant) presented in this submission have the following resin differences:
6
| Materials within Stopcock | Current Formulation | Proposed Formulation |
|---|---|---|
| Stopcock Housing | 100% Makrolon 3158 550115 | |
| Polycarbonate Resin Clear | 96% Makrolon 3158 550115 | |
| Polycarbonate Resin Clear + 4% | ||
| Teknor, 41,988WCPC BLUE | ||
| Concentrate Polycarbonate | ||
| Stopcock Diverter | 100% INEOC HDPE, T60-800-119 | |
| Natural White | 100% INEOC HDPE, T60-800-119 | |
| Natural White | ||
| Lubricant | Dow Corning 360 Medical Fluid 350 | Dow Corning 360 Medical Fluid 350 |
In summary, based upon the examination of the comparison with the predicate devices, and the information presented in this submission demonstrates that the modified MVR Venous Reservoir Bag (which includes the subject one-way stopcock component built with the same resin with an addition of a colorant) is substantially equivalent to the legally marketed predicate devices.
Summary of Testing
Biocompatibility evaluation has been performed to support evaluation of one-way stopcock component (M946844A001 - Female Luer to Male Luer with 2 Arrow Diverter) used with the MVR Venous Reservoir Bag after a material change in accordance with ISO 10993 and USA FDA Guidance Document on Use of ISO 10993-1.
The proposed one-way stopcock is used within Medtronic Surgical Innovations product, the Step™ Auto Suture™ Dilator and Cannula with Radially Expandable Sleeve 12mm / REF S101012. The Step™ Auto Suture™ Dilator and Cannula is used as the reference device in the biocompatibility evaluation since it is an external communicating device with limited tissue/bone contact and has undergone/passed cytotoxicity, sensitization (in vivo and in vitro), material-mediated pyrogenicity, and acute systemic toxicity testing. Since the one-way stopcock supplier, colorant, and sterilization process remain consistent for both the subject component and the reference component, the biocompatibility test data from the reference device component (Step™ Auto Suture™ Dilator and Cannula) can be applied to the subject device component (one-way stopcock of MVR® Venous Reservoir Bags). The identical contact duration ensures the consistent biocompatibility test methodology for shared tests between the subject device component and the reference device component, enabling the utilization of test data from the reference device for relevant biological endpoints.
| Biological Endpoint / Extraction Condition | Result |
|---|---|
| ISO MEM Elution Cytotoxicity / | |
| 1x MEM with 5% serum, 2% antibiotics, and 1% L-glutamine at 37°C for 24hrs | Pass |
| Guinea Pig Maximization Sensitization / | |
| Normal Saline and Sesame Oil at 50°C for 72hrs | Pass |
| Intracutaneous Reactivity / | |
| Normal Saline and Sesame Oil at 50°C for 72hrs | Pass |
| In Vitro Skin Irritation / | |
| Phosphate Buffered Saline and Sesame Oil at 50°C for 72hrs | Pass |
| Acute Systemic Toxicity / | |
| Normal Saline and Sesame Oil at 50°C for 72hrs | Pass |
| Material-mediated Pyrogenicity / | |
| Sterile, Non-Pyrogenic 0.9% Normal Saline at 50°C for 72hrs | Pass |
7
The supplier provided certificate of regulatory compliance for material used in the one-way stopcock, which stated "an identical formulation of resin with higher levels of additives and colorants was used to determine biocompatibility according to ISO 10993-1 and USP class VI. Tests conducted in accordance with 'Good Laboratory Practice' include: USP Class VI Evaluation, USP Systemic Toxicity Injection Test, USP Intracutaneous Reactivity Test, USP Muscle Implantation Test - Saline and 95% Ethanol extracts, Blood Compatibility Evaluation (direct contact), Blood Compatibility Evaluation (saline extract), MEM Elution Test Evaluation, Guinea Pig Maximization, Pyrogen Test ... ", which indicates that a test article representative of the one-way stopcock body impregnated with 4% 988WCPC blue colorant underwent/passed genotoxicity and hemocompatibility testing, respectively.
A separate design assessment was conducted which concluded that the change has no impact on the final product functionality or performance and as a result, no design verification or validation testing is warranted.
Conclusion
In conclusion, the information included in this submission demonstrates that the modified MVR Venous Reservoir Bag (which includes the subject one-way stopcock component built with the same resin with an addition of a colorant), are substantially equivalent to the legally marketed predicate devices.