K Number
K972017
Device Name
BIOCOR SOFTSHELL VENOUS RESERVOIR (BIOCOR SVR)
Manufacturer
Date Cleared
1997-09-10

(103 days)

Product Code
Regulation Number
870.4400
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Biocor SVR Softshell Venous Reservoir is indicated for use in procedures requiring the dynamic storage of blood when used with a membrane oxygenator during procedures up to 6 hours in duration.
Device Description
Not Found
More Information

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Not Found

No
The summary describes a venous reservoir, a mechanical component for blood storage, and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.

No
The device is a reservoir for blood storage, used in conjunction with a membrane oxygenator, which are components of extracorporeal circulation systems (like heart-lung machines). While these systems support life, the reservoir itself is a component for blood management, not directly treating a disease or condition in a therapeutic sense.

No
The device is described as a "Venous Reservoir" used for "dynamic storage of blood" during procedures with a membrane oxygenator. This function relates to blood handling and storage during a medical procedure, not to diagnosing a disease or condition.

No

The intended use describes a "Venous Reservoir," which is a physical component used in medical procedures, not a software-only device.

Based on the provided information, the Biocor SVR Softshell Venous Reservoir is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use describes the device's function in procedures requiring the dynamic storage of blood during extracorporeal circulation (used with a membrane oxygenator). This is a function performed outside the body, but it's related to supporting a physiological process (oxygenation of blood) during surgery, not for diagnosing a condition based on analyzing a sample in vitro.
  • Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
    • Analyzing biological samples (blood, urine, tissue, etc.)
    • Detecting or measuring specific substances (analytes) in those samples
    • Providing information for diagnosis, monitoring, or screening of diseases or conditions.

The device is clearly intended for use in a surgical setting to manage blood flow during a procedure, which falls under the category of a medical device used for treatment or support, not diagnosis.

N/A

Intended Use / Indications for Use

The Biocor SVR Softshell Venous Reservoir is indicated for use in procedures requiring the dynamic storage of blood when used with a membrane oxygenator during cardiopulmonary bypass procedures up to 6 hours in duration.

Product codes

DTN

Device Description

Not Found

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)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

Not Found

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.

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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three distinct head shapes, suggesting a sense of care or protection.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

SEP 1 0 1997

Ms. Lynn Lueders Director, Regulatory Affairs Minntech Corporation 14605 28th Avenue North Minneapolis, Minnesota 55447

Re : K972017 Minntech Corporation's Biocor 200 Soft Shell Venous Reservoir Regulatory Class: II (Two) Product Code: DTN Dated: Auqust 27, 1997 Received: Auqust 29, 1997

Dear Ms. Lueders:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements

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Page 2 - Ms. Lynn Lueders

  • concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
    This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html."

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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  1. 4400 - DTN II -

510(k) Number (if known):

Venous Reserve

Indications for Use

K972017

Device Name:

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Biocor SVR Softshell Venous Reservoir

Indications for Use:

The Biocor SVR Softshell Venous Reservoir is indicated for use in procedures requiring I he Blocor SVR Solusion Venous Reed with a membrane oxygenator during
the dynamic storage of blood when used with a membrantian the dynamic storage of crood number of to 6 hours in duration.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Berta R. Lempesle

(Division Sign-Off) (Division Sign Of Cardiovascular, Respiratory, and Neurological Devices 6972017 510(k) Number.

Prescription Use X (Per 21 CFR 801.109) OR

Over-the-counter-use (Optional Format 1-2-96)

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