THE V BAG, CATALOG NUMBER VB1800; VAC-BOX FOR VACUUM ASSISTED VENOUS DRAINAGE, CATALOG NUMBER VACBOX1500

K012942 · Circulatory Technology, Inc. · DTN · Nov 5, 2001 · Cardiovascular

Device Facts

• Record ID: K012942
• Device Name: THE V BAG, CATALOG NUMBER VB1800; VAC-BOX FOR VACUUM ASSISTED VENOUS DRAINAGE, CATALOG NUMBER VACBOX1500
• Applicant: Circulatory Technology, Inc.
• Product Code: DTN · Cardiovascular
• Decision Date: Nov 5, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

V-Bag™ with the Vac-Box™ are designed for use in an extracorporeal circuit to provide a volume reservoir, compliance, and assist in removing air from the blood, or vacuum assisted venous drainage operating mode.

Device Story

V-Bag and Vac-Box system functions as a component of an extracorporeal circuit during cardiopulmonary bypass. Device provides volume reservoir, compliance, and air removal capabilities. System supports vacuum-assisted venous drainage (VAVD) operating mode. Used in clinical settings (OR) by perfusionists or surgeons. Device manages venous blood flow and pressure regulation to assist in drainage. Benefits include improved venous return and air management during bypass procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Extracorporeal blood reservoir system. Components include V-Bag and Vac-Box. Designed for vacuum-assisted venous drainage. Mechanical device; no software or electronic components.

Indications for Use

Indicated for use in extracorporeal circuits to provide volume reservoir, compliance, air removal, and vacuum-assisted venous drainage (VAVD) 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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 0 5 2001

Mr. Yehuda Tamari President Circulatory Technology Inc. 21 Singworth Street Oyster Bay, NY 11771

Re: K012942

> Trade Name: The V-Bag and Vac-Box for Vacuum Assisted Venous Drainage Regulation Number: 21 CFR 870.4400 Regulation Name: Cardiopulmonary bypass blood reservoir Regulatory Class: II (two) Product Code: DTN Dated: August 30, 2001 Received: August 31, 2001

Dear Mr. Tamari

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 (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. 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Yehuda Tamari

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r todo oo actives made a determination that your device complies with other requirements of the Act or that I Dr. I has mutes 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); good manufacturing practice requirements as set forth in the quality labeling (21 CFR Part 820), and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally premailed nodicate 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 [phone]. Additionally, for questions on the promotion and advertising of Compliance at [phone] of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

,

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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KD129442 Page A10-1

Attachment 10 V-Bag™ and Vac-Box™ for VAVD Indications for Use

510(k) Number Device Name: Indications for Use: K01_294 レ V-Bag™ with the Vac-Box™ V-Bag™ with the Vac-Box™ are designed for use in an extracorporeal The V-Dag - und the vac Doservoir, compliance, and assist in removing air cheun to provide a volume rose. For, occar, or vacuum assisted venous drainage operating mode.

NOV 0 5 2001

Division of Cardiovascular & Respiratory Devices
510(k) Number K012947