(205 days)
Affinity CVR Cardiotomy/ Venous Reservoir with filter (Avecor Cardlovascular), Sorin HSVRF Hardshell Venous Reservoir with Integral Cardiotomy Filter (Sorin Biomedical)
Not Found
No
The summary describes a physical medical device (a hardshell venous reservoir) and its performance and biocompatibility testing, with no mention of software, algorithms, image processing, AI, or ML.
No.
A therapeutic device is one that treats a medical condition or disease; this device is a reservoir for blood during a procedure, not a treatment in itself.
No
Explanation: The device is described as a storage reservoir for venous blood, and performance studies focus on its physical and biological compatibility, not on diagnosing medical conditions.
No
The device description explicitly states "Hardshell Venous Reservoir," indicating a physical, hardware-based device. The performance studies also focus on physical properties and interactions with blood, not software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "as a storage reservoir for venous blood and for blood recovered by intrathoracic suction." This describes a device used during a medical procedure (likely cardiopulmonary bypass, given the performance study context) to handle blood within the patient's circulatory system or immediately after recovery from the body.
- Device Description: "Hardshell Venous Reservoir" further supports its role in managing blood flow during a procedure.
- Lack of IVD Characteristics: IVD devices are used to examine specimens outside the body to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis or testing on the blood. It is a container for blood during a procedure.
- Performance Studies: The performance studies focus on the device's ability to handle blood physically (volume, flow, filtration, cell damage) and its biocompatibility, which are relevant for a device that interacts directly with blood during a procedure, not for an IVD.
Therefore, the description clearly indicates a device used in vivo or for handling blood during a procedure, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Biocor™ 200 Hardshell Venous Reservoir is safe and effective as a storage reservoir for venous blood and for blood recovered by intrathoracic suction.
Product codes
Not Found
Device Description
Blocor™ 200 Hardshell Venous Reservoir
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
Minntech Corporation has described the test plan for the Biocor™ 200 Hardshell Venous Reservoir and has provided the specific test results. The plan included a comparative analysis performance and structural integrity. Tests included volume callbration, dynamic priming volume, breakthrough volume, hold up volume, air removal/separation, particulate filtration efficiency, general performance assessment, and blood cell damage. Data support that the performance and integrity of the Biocor™ 200 Hardshell Venous Reservoir is suitable for its intended use and comparable to the Affinity CVR Cardiotomy/Venous Reservoir with filter (Avecor Cardiovascular) and the cardiopulmonary bypass indications of the Sorin HSVRF Hardshell Venous Reservoir with Integral Cardiotomy Filter (Sorin Biomedical).
Minntech Corporation has described the test plan for the Biocor™ 200 Hardshell Venous Reservoir and has provided the specific test results. The biocompatibility studies conducted were cytotoxicity, hemolysis. acute systemic, intracutaneous, sensitization AMES mutagenicity, in vitro hemocompatibility UPTT, PT, thrombosis formation and complement activation. Under the conditions of these studies, the Biocor™ 200 Hardshell Venous Reservoir was demonstrated to be non-cytotoxic, nonhemolytic, non-sensitizing, non-toxic and non-mutagenic. The Biocor™ 200 Hardshell Venous Reservoir is hemocompatibility and has acceptable clotting time and complement activation profiles. Thrombosis formation was not detected. Based on these results, the Biocor™ 200 Hardshell Venous Reservoir is safe for use in cardiopulmonary bypass procedures.
Key Metrics
Not Found
Predicate Device(s)
Affinity CVR Cardiotomy/ Venous Reservoir with filter (Avecor Cardlovascular), Sorin HSVRF Hardshell Venous Reservoir with Integral Cardiotomy Filter (Sorin Biomedical)
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
K953821
BIOCOR™ 200 HARDSHELL VENOUS RESERVOIR
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
Minntech Corporation has provided the following information to the US Food and Drug Administration to support that the Blocor™ 200 Hardshell Venous Reservoir is substantially equivalent to other devices currently in commercial distribution within the United States.
-
- Comparison to Another Device in Commercial Distribution within the United States
The Biocor™ 200 Hardshell Venous Reservoir is comparable in regards to its intended use and technological characteristics to other device in commercial distribution within the United States. Minntech Corporation has compared the similarities and difference of the Biocor™ 200 Hardshell Venous Reservoir to the Affinity CVR Cardiotomy/ Venous Reservoir with filter (Avecor Cardlovascular) and the cardiopulmonary bypass indications of the Sorin HSVRF Hardshell Venous Reservoir with Integral Cardiotomy Filter (Sorin Biomedical). This comparison supported comparability with respect to intended use, design features, and product specifications.
- Comparison to Another Device in Commercial Distribution within the United States
-
- Summary of Safety and Effectiveness
-
2.1 In-Vitro Performance Testing
Minntech Corporation has described the test plan for the Biocor™ 200 Hardshell Venous Reservoir and has provided the specific test results. The plan included a comparative analysis performance and structural integrity. Tests included volume callbration, dynamic priming volume, breakthrough volume, hold up volume, air removal/separation, particulate filtration efficiency, general performance assessment, and blood cell damage. Data support that the performance and integrity of the Biocor™ 200 Hardshell Venous Reservoir is suitable for its intended use and comparable to the Affinity CVR Cardiotomy/Venous Reservoir with filter (Avecor Cardiovascular) and the cardiopulmonary bypass indications of the Sorin HSVRF Hardshell Venous Reservoir with Integral Cardiotomy Filter (Sorin Biomedical).
1
2.2 Biocompatibility Studies
Minntech Corporation has described the test plan for the Biocor™ 200 Hardshell Venous Reservoir and has provided the specific test results. The biocompatibility studies conducted were cytotoxicity, hemolysis. acute systemic, intracutaneous, sensitization AMES mutagenicity, in vitro hemocompatibility UPTT, PT, thrombosis formation and complement activation. Under the conditions of these studies, the Biocor™ 200 Hardshell Venous Reservoir was demonstrated to be non-cytotoxic, nonhemolytic, non-sensitizing, non-toxic and non-mutagenic. The Biocor™ 200 Hardshell Venous Reservoir is hemocompatibility and has acceptable clotting time and complement activation profiles. Thrombosis formation was not detected. Based on these results, the Biocor™ 200 Hardshell Venous Reservoir is safe for use in cardiopulmonary bypass procedures.
Summary of Substantial Equivalence 3.
Minntech Corporation has provided the above information within the 510(k) Premarket Notification to support that the Biocor™ 200 Hardshell Venous Reservoir is safe and effective as a storage reservoir for venous blood and for blood recovered by intrathoracic suction. Additionally, the Biocorns 200 Hardshell Venous Reservoir has been shown to be comparable to other devices currently in commercial distribution. Data and information provided within this 510(k) Premarket Notification adequately support that the Biocor™ 200 Hardshell Venous Reservoir is substantially equivalent to other devices currently in commercial distribution.
188888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888
19 88:21 194 86-45-144 HOSTNATIN