BIOCOR 200 HARDSHELL VENOUS RESERVIOR
K953821 · Minntech Corp. · DTN · Mar 7, 1996 · Cardiovascular
Device Facts
| Record ID | K953821 |
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| Device Name | BIOCOR 200 HARDSHELL VENOUS RESERVIOR |
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| Applicant | Minntech Corp. |
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| Product Code | DTN · Cardiovascular |
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| Decision Date | Mar 7, 1996 |
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| Decision | SESE |
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| Submission Type | Traditional |
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| Regulation | 21 CFR 870.4400 |
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| Device Class | Class 2 |
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| Attributes | Therapeutic |
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Intended 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.
Device Story
Hardshell venous reservoir; stores venous blood and blood recovered via intrathoracic suction during cardiopulmonary bypass. Device functions as passive storage container; integrates cardiotomy filtration. Used in clinical settings (OR) by perfusionists/surgeons. Provides reservoir capacity for extracorporeal circulation; ensures blood volume management and filtration of debris/particulates during bypass. Benefits patient by maintaining hemodynamic stability and blood integrity during cardiac surgery.
Clinical Evidence
Bench testing only. In-vitro performance testing included volume calibration, dynamic priming volume, breakthrough volume, hold-up volume, air removal/separation, particulate filtration efficiency, and blood cell damage. Biocompatibility testing included cytotoxicity, hemolysis, acute systemic toxicity, intracutaneous reactivity, sensitization, AMES mutagenicity, in vitro hemocompatibility (PTT, PT), thrombosis formation, and complement activation. Results demonstrated non-cytotoxic, non-hemolytic, non-sensitizing, and non-toxic profile with acceptable clotting and complement activation.
Technological Characteristics
Hardshell reservoir design; includes integral cardiotomy filter. Materials demonstrated biocompatible per ISO/FDA standards. Functions as passive storage/filtration unit for extracorporeal circuits. No energy source or software components.
Indications for Use
Indicated for use as a storage reservoir for venous blood and blood recovered by intrathoracic suction during cardiopulmonary bypass procedures.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- Affinity CVR Cardiotomy/Venous Reservoir with filter (Avecor Cardiovascular)
- Sorin HSVRF Hardshell Venous Reservoir with Integral Cardiotomy Filter (Sorin Biomedical)
Related Devices
- K090534 — VENOUS HARDSHELL CARDIOTOMY RESERVIORS · Maquet Cardiopulmonary, AG · Dec 23, 2009
- K984456 — COBE HVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR · Cobe Cardiovascular, Inc. · Jan 11, 1999
- K991973 — CAPIOX SX10 HARDSHELL RESEVOIR · Terumo Medical Corp. · Sep 3, 1999
- K972017 — BIOCOR SOFTSHELL VENOUS RESERVOIR (BIOCOR SVR) · Minntech Corp. · Sep 10, 1997
- K981628 — BARD QUANTUM SVR MODEL NUMBER H-6440VR · C.R. Bard, Inc. · Aug 5, 1998
Submission Summary (Full Text)
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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 Biocor™ 200 Hardshell Venous Reservoir is substantially equivalent to other devices currently in commercial distribution within the United States.
1. 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 Cardiovascular) 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.
2. 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 calibration, 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).
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## 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, non-hemolytic, 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.
## 3. Summary of Substantial Equivalence
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 Biocor™ 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.
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FAX NO. 16125533387
MINNTECH
MAY-24-96 FRI 12:59 PM
