(21 days)
Not Found
No
The document describes a physical medical device (venous reservoir) and its intended use in cardiopulmonary bypass. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities. The "SMARxT" in the name appears to be a brand name, not indicative of smart technology in the AI/ML sense.
No
The device is a venous reservoir used during cardiopulmonary bypass to collect and filter blood, and for postoperative chest drainage and autotransfusion. It does not actively treat a disease or condition, but rather supports a surgical procedure.
No
Explanation: The device, a venous reservoir, is used in cardiopulmonary bypass procedures for blood management, not for detecting, diagnosing, or monitoring a disease or condition.
No
The device description clearly states it is a "sealed hardshell venous reservoir with a defoamer and integral cardiotomy filter," indicating it is a physical hardware device used in cardiopulmonary bypass procedures.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "adult surgical procedures requiring cardiopulmonary bypass" and "postoperative chest drainage collection and autotransfusion." This describes a device used during a medical procedure to support physiological function and manage blood, not a device used to perform tests on samples taken from the body to diagnose or monitor a condition.
- Device Description: The description details a "sealed hardshell venous reservoir with a defoamer and integral cardiotomy filter." This is a component of a cardiopulmonary bypass circuit, designed to handle blood flow and filtration during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) or to provide diagnostic information. The focus is on managing blood within the body during a procedure.
IVD devices are specifically designed to perform tests on samples in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device's function is entirely in vivo (within the body) during a surgical procedure.
N/A
Intended Use / Indications for Use
The COBE Cardiovascular® SMARxT® 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.
Product codes
DTN
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.
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
adult
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
COBE Cardiovascular® VVR™ 4000 Filtered Hardshell Venous Reservoir
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
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 Way
Arvada, CO 80004 USA |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Lynne Leonard
Regulatory Affairs, Submissions
lynne.leonard@cobecv.com
Phone: (303) 467-6214
Fax: (303) 467-6529 |
| DATE PREPARED: | November 6, 2003 |
| DEVICE TRADE
NAME: | COBE Cardiovascular® SMARxT® VVR™ 4000i Plus Filtered
Hardshell Venous Reservoir |
| COMMON/USUAL
NAME: | Hardshell Venous Reservoir with Integral Cardiotomy Filter |
| CLASSIFICATION
NAME: | Cardiopulmonary Bypass Blood Reservoir with Defoamer
and Cardiotomy Suction Line Blood Filter |
| PREDICATE DEVICE: | COBE Cardiovascular® VVR™ 4000 Filtered Hardshell Venous
Reservoir |
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.
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.
p112
1
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.
2
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.
3
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
4
Indications for Use Statement
:
:
| 510(k)
Number
| (if known) | K033641 |
|---|---|
| Device Name | COBE Cardiovascular ® SMAR x T ® VVR ™ 4000i Plus Filtered |
| Hardshell Venous Reservoir | |
| Indications | |
| for Use | 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. |
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 |
|---|---|---|
| ------------------------------------------- | ------------------------------------------ | ---------------------- |
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number: K033641