JOSTRA VENOUS HARDSHELL CARDIOTOMIC RESERVOIR VHK 4200

K982136 · Schiff & Co. · DTN · Mar 24, 1999 · Cardiovascular

Device Facts

• Record ID: K982136
• Device Name: JOSTRA VENOUS HARDSHELL CARDIOTOMIC RESERVOIR VHK 4200
• Applicant: Schiff & Co.
• Product Code: DTN · Cardiovascular
• Decision Date: Mar 24, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Jostra Venous Hardshell Cardiotomy Resevoir VHK 4200 is intended for use in adult cardiopulmonary bypass procedures of short duration of 6 hours or less.

Device Story

The Jostra Venous Hardshell Cardiotomy Reservoir VHK 4200 is a sterile, single-use extracorporeal blood reservoir used during cardiopulmonary bypass (CPB) surgery. It functions as a venous blood collection vessel and cardiotomy filter, receiving venous blood from the patient and suctioned blood from the surgical field. The device facilitates air removal and filtration of debris before blood is returned to the oxygenator. It is operated by perfusionists in the operating room during open-heart procedures. By managing venous return and filtering cardiotomy suction, the device supports the maintenance of extracorporeal circulation, helping to ensure hemodynamic stability and minimize embolic risk to the patient during short-term bypass.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Hardshell reservoir design; integrated cardiotomy filter; sterile, single-use; intended for extracorporeal circulation; class II device.

Indications for Use

Indicated for use in adult patients undergoing cardiopulmonary bypass procedures of short duration (6 hours or less).

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 4 1999

Ms. Kathy Johnson Product Manager Jostra U.S.A. 8403 Cross Park Drive Suite 3-G Austin, TX 78754

K982136 Re : Jostra Venous Hardshell Cardiotomic Reservoir VHK 4200 Regulatory Class: II (Two) Product Code: 74 DTN December 10, 1998 Dated: Received: December 29, 1998

Dear Ms. Johnson

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 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). 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 Regulations, 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 Requlation (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 requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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.

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## Page 2 - Ms. Kathy Johnson

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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html."

Sincerely yours,

Thomas J. Callahon

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

Enclosure

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Page__________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known):K982136

Device Name:Jostra Venous Hardshell Cardiotomy Resevoir VHK 4200

Indications For Use:

The Jostra Venous Hardshell Cardiotomy Resevoir VHK 4200 is intended for use in adult cardiopulmonary bypass procedures of short duration of 6 hours or less.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K182136

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use

(Optional Format 1-2-96)

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