COBE CLOSED VENOUS RESERVOIR BAGS WITH SMARX T, MODELS VRB 1200 AND VRB 1800 by COBE CARDIOVASCULAR, INC.

The COBE® Closed Venous Reservoir Bags With SMAR,T™ (Model Numbers VRB® 1200™ and The CODE Closed Transable be used in adult surgical procedures requiring extracorporeal support for periods of up to six hours.

Device Description

The COBE® Closed Venous Reservoir Bags With SMAR TT™, Model Numbers VRB® 1200™ and VRB® 1800™ are sterile devices with non-pyrogenic fluid pathways, for single use only, and are not to be resterilized by the user. The devices accomodate both systemic venous and cardiotomy return blood. A surface-modifying material is added to the primary blood contact surfaces of the device to improve the blood compatibility of the materials.

The VRB® 1200™ with SMAR,T consists of the bag with its basic ports (venous inlet, cardiotomy inlet, reservoir outlet, reservoir vent, venous sample ports) along with several additional user features. The reservoir bag is attached directly to a rigid backing plate that contains a three stopcock blood sampling system, a reservoir vent line with a one-way valve, and a front plate that is designed to exert pressure on the bag, squeezing it between the front and back plates to assist in air removal. There is a volume indicator tape on the back plate which provides an indication of the amount of blood in the bag. There is also a level sensing magnet on the outside of the reservoir bag and a sensor in the bracket which allows the VRB® 1200™ with SMAR,T to be used with the COBE® Air Emboli Protection System. The maximum volume of the reservoir bag is 1200 ml.

The VRB® 1800™ with SMAR,T is a simplified version of the VRB® 1200™ with SMAR,T. The VRB® 1800™ with SMAR, T consists of only the bag with its basic ports (venous inlet, cardiotomy inlet, reservoir outlet, reservoir vent, venous sample port, and auxillary ports). It does not have the additional user features listed above for the VRB® 1200™ with SMAR. T. The maximum volume of the reservoir bag is 1800 ml (the reservoir bag is identical to the VRB® 1200™ with SMART, but the maximum volume is greater in the VRB® 1800™ with SMAR, T because it is not attached to the rigid back plate).

AI/ML Overview

The provided 510(k) summary for the COBE® Closed Venous Reservoir Bags With SMAR, T™ is a pre-market notification for a medical device and not a study proving the device meets acceptance criteria in the manner typically associated with clinical trials or AI/software validation.

Instead, this document demonstrates substantial equivalence to a predicate device, as required for 510(k) clearance by the FDA. The "acceptance criteria" here are essentially the demonstration that the new device is as safe and effective as the predicate device, despite the modifications. The "study" refers to the testing performed to support this claim of substantial equivalence.

Therefore, the information below is interpreted within the context of a 510(k) submission, not a performance study as might be conducted for an AI or diagnostic device. Many of the requested fields (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this type of device clearance and the information provided.

Acceptance Criteria and Device Performance (in the context of 510(k) substantial equivalence)

The primary acceptance criterion for a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device. This means the device is as safe and effective as the predicate.

For the COBE® Closed Venous Reservoir Bags With SMAR, T™, the acceptance criteria revolve around showing that the addition of the surface-modifying material and the new 1800™ model (a simplified version) do not negatively impact safety or effectiveness compared to the predicate device (COBE® VRB® 1200™ Closed Venous Reservoir Bag).

Table of Acceptance Criteria (Inferred from the document) and Reported Device Performance:

Acceptance Criterion (Implicitly for Substantial Equivalence)	Reported Device Performance	Comments
Biocompatibility (Device materials are safe for biological contact)	Biocompatibility testing performed.	Concluded that the addition of surface-modifying material does not affect safety.
Mechanical Integrity (e.g., strength, leak resistance)	In-vitro testing performed.	Supports substantial equivalence.
Air Challenge (Ability to manage air, prevent air emboli)	In-vitro testing performed.	Supports substantial equivalence.
Bag Shutoff (Functionality of volume control/shutoff)	In-vitro testing performed.	Supports substantial equivalence.
Collapse Volume (How the bag collapses, residual volume)	In-vitro testing performed.	Supports substantial equivalence.
Blood Cell Damage (Minimizing harm to blood cells)	In-vitro testing performed.	Supports substantial equivalence. Specific focus on the impact of the surface-modifying material.
Surface-Modifying Material Leaching (No harmful substances leach into blood)	In-vitro testing performed.	Supports substantial equivalence.
Surface-Modifying Material Blood Compatibility (Interaction of SMAR,T™ with blood)	In-vitro and Ex-vivo testing performed.	This was a key focus given the primary modification.
Equivalent Intended Use (Same clinical application as predicate)	Stated to have the "same intended use." Used as blood reservoirs during adult cardiac surgical procedures requiring extracorporeal support for periods up to six hours.	Directly compared to the predicate device.
Equivalent Technological Characteristics (Similar design, materials, and operation principles, accounting for minor differences)	The document explicitly states the "only differences" are the surface-modifying material and the simplified VRB® 1800™ model. The testing performed addressed these differences.	The conclusion is that these differences do not affect safety and effectiveness.

Study Details (in the context of 510(k) for this device)

Sample size used for the test set and the data provenance:
- Sample Size: Not specified for any of the in-vitro or ex-vivo tests. These are likely engineering and bench-top tests, often performed with a limited number of samples to demonstrate performance against specifications, rather than large statistical cohorts.
- Data Provenance: Not explicitly stated. Given it's a 510(k) submission by a U.S. manufacturer (COBE Cardiovascular, Inc.), the testing would typically be performed in a controlled laboratory environment, likely within the U.S. There is no indication of retrospective or prospective clinical data for human subjects for this clearance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. For this type of device (venous reservoir bag), "ground truth" isn't established by expert consensus on clinical images or diagnoses as it would be for AI. The "ground truth" for the tests performed (e.g., mechanical integrity) would be established by validated test methods and engineering specifications.
Adjudication method for the test set:
- N/A. Adjudication methods like 2+1 or 3+1 are used for expert consensus in diagnostic evaluations. This is not relevant to the engineering and bench testing performed for this device.
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 device is a passive medical device (venous reservoir bag), not an AI or diagnostic imaging device that involves human readers or AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is not an algorithm or software device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Engineering Specifications and Validation Standards. For in-vitro and ex-vivo tests, the "ground truth" is defined by established engineering specifications, performance standards (e.g., for blood compatibility, material properties), and validated test methods.
The sample size for the training set:
- N/A. There is no "training set" as this is not an AI/machine learning device.
How the ground truth for the training set was established:
- N/A. Not applicable for the same reason as above.

Summary

{0}------------------------------------------------

510(k) Pre-Market Notification: COBE® Closed Venous Reservoir Bags With SMAR, T™

K980786
20

AUG 24 1998

510(k) Summary

SUBMITTER:

COBE Cardiovascular, Inc. 14401 W. 65th Way Arvada, CO 80004

Lynne Leonard

CONTACT PERSON:

(303) 467-6429 Fax:

February 24, 1998 DATE PREPARED:

COBE® Closed Venous Reservoir Bags With SMAR TTM, DEVICE TRADE NAME: Model Numbers VRB® 1200™ and VRB® 1800™

Phone: (303) 467-6586

Venous Reservoir Bag COMMON/USUAL NAME:

Cardiopulmonary Bypass Blood Reservoir CLASSIFICATION NAME:

COBE® VRB® 1200™ Closed Venous Reservoir Bag PREDICATE DEVICE:

DEVICE DESCRIPTION:

{1}------------------------------------------------

INDICATIONS FOR USE

The COBE® Closed Venous Reservoir Bags With SMAR,T™ are closed, flexible reservoir bags intended to be used as blood reservoirs during adult cardiac surgical procedures requiring extracorporeal support for periods up to six hours.

STATEMENT OF TECHNICAL CHARACTERISTICS COMPARISON

The COBE® Closed Venous Reservoir Bags With SMAR T™ have the same intended use as the COBE® VRB® 1200™ Closed Venous Reservoir Bag. The only differences between the COBE® Closed Venous Reservoir Bags With SMAR TTM and the currently marketed VRB® 1200™ are 1) the COBE® Closed Venous Reservoir Bags With SMAR T™ contain the surface-modifying material; 2) Model VRB® 1800™ with SMAR,T is a simplified version of the VRB® 1200™, consisting only of the bag with its basic ports.

Biocompatibility testing, in-vitro testing, and ex-vivo testing were performed to demonstrate that the COBE® Closed Venous Reservoir Bags With SMAR, T™ are substantially equivalent to the currently marketed COBE® VRB® 1200™ Closed Venous Reservoir Bag.

In-vitro testing consisted of:

SEM Analysis Mechanical Integrity Air Challenge Bag Shutoff Collapse Volume Blood cell damage Surface-modifying material leaching Surface-modifying material blood compatibility

Ex-vivo testing consisted of:

Surface-modifying material blood compatibility

These data support that the COBE® Closed Venous Reservoir Bags With SMAR, T™ are substantially equivalent to the currently marketed COBE® VRB® 1200™ Closed Venous Reservoir Bag, and the addition of the surface-modifying material does not affect safety and effectiveness.

{2}------------------------------------------------

Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal, there is a stylized graphic of three human profiles facing to the right, one behind the other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 4 1998

Ms. Lynne Leonard Manager, Requlatory Submissions COBE Cardiovascular, Inc. 14401 W. 65th Way Arvada, CO 80004-3599

K980786 Re: COBE® Closed Venous Reservoir Bags with SMAR,T™ Regulatory Class: II (Two) DTN Product Code: Dated: June 10, 1998 Received: June 11, 1998

Dear Ms. Leonard:

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

{3}------------------------------------------------

Page 2 - Ms. Lynne Leonard

This letter will allow you to beqin 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" (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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahon

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

Enclosure

{4}------------------------------------------------

Indications For Use

510(k) Number (If known): _ K98 0786

COBE® Closed Venous Reservoir Bags With SMAR T™, Device Names: Model Numbers VRB® 1200™ and VRB® 1800™

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ben R. Russell
(Division Sign-Off)

Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number

Prescription Use
(Per 21 CFR 801.109) _/

Over-The-Counter Use

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.