The COBE Cardiovascular ® SMAR x T ® VVR ™ 4000i Plus Filtered Hardshell Venous Reservoir is intended to be used in adult surgical procedures requiring cardiopulmonary bypass for periods of up to six hours, and for postoperative chest drainage collection and autotransfusion.

Device Description

The COBE SMARxT VVR4000i Plus is a sealed hardshell venous reservoir with a defoamer and integral cardiotomy filter. It is a sterile device with non-pyrogenic fluid pathways, for single use micgrar cardroionly micer. ilized by the user. Certain blood contact surfaces of the oxygenator only, and is not to be resterined by and dified to improve blood compatibility, resulting in reduced platelet adhesion on the treated surfaces.

AI/ML Overview

The provided text describes a 510(k) notification for the COBE Cardiovascular SMARxT VVR4000i Plus Filtered Hardshell Venous Reservoir. This is a notification for a medical device that is substantially equivalent to a predicate device, not a new type of study proving the device meets acceptance criteria in the way a clinical trial would for a new drug or algorithm.

Therefore, many of the requested categories are not applicable or cannot be extracted from this document, as this is a review of a Special 510(k) where the device is essentially an unmodified version with a surface-modifying material added. The "study" here refers to in-vitro tests demonstrating substantial equivalence, not a performance study against specific acceptance criteria for a new device's efficacy or accuracy.

Here's the breakdown based on the provided text, with N/A for information not present or not applicable to this type of submission:

Acceptance Criteria and Device Performance:

Acceptance Criteria (Stated Goal)	Reported Device Performance (Demonstrated by Study)
Substantial equivalence to the predicate device (COBE VVR4000 Filtered Hardshell Venous Reservoir) in design, method of operation, fundamental scientific technology, and intended use.	In-vitro tests were performed to demonstrate that the COBE Cardiovascular SMARxT VVR4000i Plus is substantially equivalent to the unmodified version (COBE VVR4000). The devices are identical in design, method of operation, and fundamental scientific technology. The only difference is a surface-modifying material to improve blood compatibility.
Improved blood compatibility (specifically, reduced platelet adhesion on treated surfaces).	The device contains a surface-modifying material that improves the blood compatibility of the device, resulting in reduced platelet adhesion on the treated surfaces. (Implied to be demonstrated through the in-vitro tests).

Study Details:

Sample size used for the test set and the data provenance:
- Sample Size: Not specified.
- Data Provenance: In-vitro tests. No information on country of origin. The study is laboratory-based (in-vitro), so retrospective/prospective does not apply in the typical clinical sense.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. This was an in-vitro substantial equivalence study, not a study requiring expert-established ground truth in a clinical context.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A. This was an in-vitro substantial equivalence study.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- N/A. This is a mechanical device, not an AI or imaging diagnostic device.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- N/A. This is a mechanical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this substantial equivalence submission would be the performance characteristics and design parameters of the predicate device, against which the modified device was compared using in-vitro testing. The effect of the surface modification (reduced platelet adhesion) would be measured directly, not against an expert consensus or pathology.
The sample size for the training set:
- N/A. This is a mechanical device, not a machine learning model requiring a training set.
How the ground truth for the training set was established:
- N/A. This is a mechanical device.

Summary

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DEC 1 1 2003

SPECIAL 510(K) NOTIFICATION COBE Cardiovascular Inc. SMAR,T VVR4000i Plus Filtered Hardshell Venous Reservoir

IX. 510(k) SUMMARY

SUBMITTER:	COBE Cardiovascular, Inc.14401 West 65th WayArvada, CO 80004 USA
CONTACT PERSON:	Lynne LeonardRegulatory Affairs, Submissionslynne.leonard@cobecv.comPhone: (303) 467-6214Fax: (303) 467-6529
DATE PREPARED:	November 6, 2003
DEVICE TRADENAME:	COBE Cardiovascular® SMARxT® VVR™ 4000i Plus FilteredHardshell Venous Reservoir
COMMON/USUALNAME:	Hardshell Venous Reservoir with Integral Cardiotomy Filter
CLASSIFICATIONNAME:	Cardiopulmonary Bypass Blood Reservoir with Defoamerand Cardiotomy Suction Line Blood Filter
PREDICATE DEVICE:	COBE Cardiovascular® VVR™ 4000 Filtered Hardshell VenousReservoir

DEVICE DESCRIPTION:

INDICATIONS FOR USE:

The COBE SMARxT VVR4000i Plus Sealed Hardshell Venous Reservoir is intended to be used in adult surgical procedures requiring cardiopulmonary bypass for periods up to six hours, and for postoperative chest drainage collection and autotransfusion.

K033641

p112

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SPECIAL 510(K) NOTIFICATION COBE Cardiovascular Inc. SMAR,T VVR4000i Plus Filtered Hardshell Venous Rescrvoir

STATEMENT OF TECHNICAL CHARACTERISTICS COMPARISON:

The COBE SMARxT VVR4000i Plus Venous Reservoir described in this submission is substantially equivalent to the unmodified version, the COBE VVR4000 Venous Reservoir. The devices are identical in design, method of operation, and fundamental scientific technology. Both devices are intended to be used in adult surgical procedures requiring cardiopulmonary bypass for deviods up to six hours, and for postoperative chest drainage collection and autotransfusion. The portodo ap to the the COBE SMARxT VVR4000i Plus Venous Reservoir contains a surfacemodifying material that improves the blood compatibility of the device.

TESTING TO DETERMINE SUBSTANTIAL EQUIVALENCE:

In-vitro tests were performed to demonstrate that the COBE Cardiovascular SMARxT VVR4000i m vide were were portionscribed in this submission is substantially equivalent to the unmodified version, the COBE VVR4000 Venous Reservoir.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three abstract shapes resembling waves or curves, stacked on top of each other.

DEC 1 1 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

COBE Cardiovascular, Inc. c/o Ms. Lynne Leonard 14401 W. 65th Way Arvada, CO 80004-3599

Re: K033641

COBE Cardiovascular® SMAR,T VVR™ 4000i Plus Filtered Hardshell Venous Reservoir Regulation Number: 21 CFR 870.4400 Regulation Name: Cardiopulmonary Bypass Venous Reservoir Regulatory Class: Class II (two) Product Code: DTN Dated: November 7, 2003 Received: November 20, 2003

Dear Ms. Leonard:

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 – Ms. Lynne Leonard

Please be advised that FDA's issuance of a substantial equivalence determination does not mean
ts of the Active in the simplies as a subsites semplies with other requirements Please be advised that FDA's issuance of a substantial complies with other requirements of the Act
that FDA has made a determination that your device Federal avencies. You that FDA has made a determination inal your development of ederal agencies. You must
or any Federal statutes and regulations administered by registration and listi or any Federal statutes and regulations and limited to: registration and listing (21)
comply with all the Act's requirements, including, but not hirements as set comply with all the Act s requirements, Mc.ian.ing practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); god in and 800); and if annlicable, the clection CFR Part 807); labeling (21 CFR Patl 601); good manufactaring phone if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and if appli forth in the quality systems (QS) regulation (2 - CFR of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections - ver decries on decribed in vour Section product radiation control provisions (Sections 31 care as described in your Section 510(k)
This letter will allow you to begin marketing your device as your device to a legal This letter will allow you to begin marketing your device of your device to a legally
premarket notification. The FDA finding of substantial equiralevice of your device premarket notification. The FDA inding of subsantal equivalence of .
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), please
rst the register and and 1904 - 114 - Also, masses note the regulation en If you desire specific advice for your device on but nacements (* (* ) = ) = (* )
contact the Office of Compliance at (301) 594-4646. Also, please noto the regulation contact the Office of Comphalice at (301) 571 101 (21CFR Part 807.97). You may obtain
"Misbranding by reference to premarket notification (21CFR Part 807.97). "Misbranding by reference to prematics nonification " (2) be Act from the Division of Small
other general information on your responsibilities under the Act from the (800) 63 other general information on your responsibilities and the reveal and the received or (301) 443-6597 or at its Internet address.

Sincerely yours,

CML

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k)Number(if known)	K033641
Device Name	COBE Cardiovascular ® SMAR x T ® VVR ™ 4000i Plus FilteredHardshell Venous Reservoir
Indicationsfor Use	The COBE Cardiovascular ® SMAR x T ® VVR ™ 4000i Plus FilteredHardshell Venous Reservoir is intended to be used in adult surgicalprocedures requiring cardiopulmonary bypass for periods of up to sixhours, and for postoperative chest drainage collection andautotransfusion.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use(Per 21 CFR 801. 109)	OR	Over-The-Counter Use
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(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number: K033641

Regulation Number and Section

§ 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.