The COBE® SMAR T™ HVR® 4000™ Surface Modified Hardshell Venous Reservoirs are intended to be used in adult surgical procedures requiring cardiopulmonary bypass for periods of up to six hours.

Device Description

The COBE® SMAR,T™ HVR® 4000™ Surface Modified Hardshell Venous Reservoirs are sterile devices with non-pyrogenic fluid pathways, for single use only, and are not to be resterilized by the user. The devices are open, hardshell, venous blood reservoirs intended to be used during adult cardiac surgical procedures requiring extracorporeal support for periods of up to six hours. Two configurations are available, one with an integral cardiotomy filter and one without the filter.

The filtered version of the COBE® SMAR.T™ HVR® 4000™ Surface Modified Venous Reservoir, in addition to receiving and storing the patient's venous blood and acting as blood volume buffer, is designed for receiving raw cardiotomy suction blood and filtering it to the circulating blood volume. Entrained air is removed from both the venous blood and cardiotomy suction blood by the defoamer.

The nonfiltered version of the COBE® SMAR,T" HVR® 4000" Surface Modified Venous Reservoir is designed for receiving and storage of the patient's venous blood and acting as blood volume buffer during cardiopulmonary bypass. The defoamer removes air entrained in the venous blood.

The major components of the filtered and nonfiltered COBE® SMAR.T™ HVR® 4000* Surface Modified Hardshell Venous Reservoirs are the bucket, the porting, the defoamer, and in the filtered version, the cardiotomy filter. The bucket serves both as a primary structural component of the device and as a transparent vessel to contain excess blood volume and to allow for the monitoring of changes in blood volume. The porting provides blood tubing connections between the reservoir and the patient, the defoamer serves to remove gross air from incoming venous and cardiotomy suction blood, and the filter removes particles from the cardiotomy suction return blood.

AI/ML Overview

The COBE® SMAR.T™ HVR® 4000™ Surface Modified Hardshell Venous Reservoirs are sterile devices with non-pyrogenic fluid pathways, for single use only. They are intended for use during adult cardiac surgical procedures requiring extracorporeal support for periods of up to six hours.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance	Study Type
Defoaming Capability	Demonstrated in performance tests	Performance Testing (In vitro)
Minimum Operating Volume	Demonstrated in performance tests	Performance Testing (In vitro)
Maximum Operating Volume	Demonstrated in performance tests	Performance Testing (In vitro)
Filtration Efficiency	Demonstrated in performance tests (for filtered version)	Performance Testing (In vitro)
Blood Trauma:
- Platelet reduction	Reduced platelet adhesion on treated surfaces (improved blood compatibility)	Performance Testing (In vitro)
- White blood cell reduction	Demonstrated in performance tests (improved blood compatibility)	Performance Testing (In vitro)
- Plasma free hemoglobin generation	Demonstrated in performance tests (improved blood compatibility)	Performance Testing (In vitro)
Biocompatibility	Improved blood compatibility due to surface modifying additive	In-vitro testing
Leach Test	Surface modifying additive does not leach from the device	Leach testing
Substantial Equivalence	Demonstrated to be substantially equivalent to the currently marketed COBE® HVR® 4000™ Filtered Hardshell Venous Reservoir	Comparison to Predicate Device, Performance Testing

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample size for the individual performance tests (i.e., defoaming capability, operating volumes, filtration efficiency, blood trauma). Neither is the data provenance explicitly stated (e.g., country of origin, retrospective or prospective). However, it is stated that "In-vitro testing was performed," suggesting that the tests were conducted in a laboratory setting.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The studies describe standard in-vitro performance and biocompatibility tests, which typically rely on established protocols and measurements rather than expert consensus on individual observations in the way diagnostic imaging studies might.

4. Adjudication method for the test set

This information is not provided. Given the nature of the tests (performance and biocompatibility), an adjudication method like 2+1 or 3+1, which is common in human-in-the-loop diagnostic studies, would not be applicable.

5. 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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a medical device (venous reservoir), not an AI-powered diagnostic tool, so such a study would not be applicable. The performance is assessed through direct physical and biological measurements.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This question is not applicable to the COBE® SMAR.T™ HVR® 4000™ Surface Modified Hardshell Venous Reservoir as it is a physical medical device, not an algorithm. The "standalone" performance refers to the device's inherent design and material properties.

7. The type of ground truth used

The ground truth for the performance tests was established by objective physical and biological measurements based on established scientific principles and industry standards for cardiopulmonary bypass equipment. For example, "filtration efficiency" would have a measurable output, and "platelet reduction" would be measured by quantifying platelet counts or adhesion. The "improved blood compatibility" and "non-leaching" of the surface modifying additive were also established through laboratory testing.

8. The sample size for the training set

This information is not applicable. The device is a physical medical device, not a machine learning model, so there is no "training set" in the context of AI.

9. How the ground truth for the training set was established

This information is not applicable, as there is no "training set." The device's design and materials were developed and validated based on engineering principles and biomedical science.

Summary

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

510(k) Pre-Market Notification: COBE® SMAR,T™ HVR® 4000™ Surface Modified Venous F

DEC - 3 1999

510(k) Summary
SUBMITTER:	COBE Cardiovascular, Inc.14401 W. 65th WayArvada, CO 80004
CONTACT PERSON:	Lynne LeonardPhone: (303) 467-6586Fax: (303) 467-6429
DATE PREPARED:	September 2, 1999
DEVICE TRADE NAMES:	COBE® SMARxTM HVR® 4000TM Surface Modified HardshellVenous Reservoir, Filtered
	COBE® SMARxTM HVR® 4000TM Surface Modified HardshellVenous Reservoir, Nonfiltered
COMMON/USUAL NAMES:	Hardshell Venous Reservoir with Integral Cardiotomy FilterHardshell Venous Reservoir, Nonfiltered
CLASSIFICATION NAMES:	Cardiopulmonary Bypass Blood ReservoirCardiopulmonary Bypass DefoamerCardiopulmonary Bypass Cardiotomy Suction Line Blood Filter
PREDICATE DEVICE:	COBE® HVR® 4000TM Filtered Hardshell Venous Reservoir

DEVICE DESCRIPTION:

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

INDICATIONS FOR USE

The COBE® SMAR T™ HVR® 4000™ Surface Modified Hardshell Venous Reservoirs are intended to be used in adult surgical procedures requiring cardiopulmonary bypass for periods of up to six hours.

STATEMENT OF TECHNICAL CHARACTERISTICS COMPARISON

The COBE® SMAR, T™ HVR® 4000" Surface Modified Hardshell Venous Reservoirs have the same intended use as the predicate device, the COBE® HVR® 4000™ Fittered Hardshell Venous Reservoir. The primary difference between the COBE® SMAR.T™ HVR® 4000™ Surface Modified Hardshell Venous Reservoirs and the currently marketed COBE® HVR® 4000™ is the COBE® SMAR, T™ HVR® 4000™ Surface Modified Hardshell Venous Reservoirs contain a surface-modifying material which improves the blood compatibility of the device, resulting in reduced platelet adhesion on the treated surfaces.

Biocompatibility and performance tests demonstrate that the COBE® SMAR.T™ HVR® 4000" Surface Modified Hardshell Venous Reservoirs are substantially equivalent to the currently marketed COBE® HVR® 4000™ Filtered Hardshell Venous Reservoir.

Performance testing consisted of:

1. Defoaming Capability
1. Minimum Operating Volume
1. Maximum Operating Volume
Filtration Efficiency 4.
1. Blood trauma: platelet reduction, white blood cell reduction, and plasma free hemoglobin generation

In-vitro testing was performed to demonstrate improved blood compatibility of the materials containing the surface modifying additive and leach testing was conducted to show that the surface modifying additive does not leach from the device.

These data support that the COBE® SMAR T™ HVR® 4000™ Surface Modified Hardshell Venous Reservoirs are substantially equivalent to the currently marketed COBE® HVR® 4000™ Filtered Hardshell Venous Reservoir.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration

9200 Corporate Boulevard Rockville MD 20850

Image /page/2/Picture/2 description: The image is a black and white circular logo. The logo features a stylized eagle with its wings spread, facing to the left. The eagle is composed of three parallel lines that create the shape of the bird. Encircling the eagle is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the top and sides of the circle.

DEC -3 1999

Ms. Lynne Leonard Manager, Requlatory Submissions Cobe Cardiovascular, Inc. 14401 West 65th Way Aravada, CO 80004

Re: K993001 COBE® SMAR,T™ HVR® 4000™ Surface Modified Hardshell Venous Regulatory Class:III(3) Product Code: DTN Dated: September 3,1999 Received: September 7,1999

Dear Ms. Leonard:

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 requlations 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 Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General (QS) regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, the Food and Drug Administration (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 continue 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) 594-4639. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address

"http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

for Seitz. & Company.

Celia M. Witten, Ph.D., M.D. Acting Director Office of Device Evaluation Center for Devices and Radiological Health

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

Indications For Use

510(k) Number (If known): K993001

Device Names:

COBE® SMAR T™ HVR® 4000™ Surface Modified Hardshell Venous Reservoir, Filtered COBE® SMAR_T™ HVR® 4000" Surface Modified Hardshell Venous Reservoir, Nonfiltered

Indications For Use:

The COBE® SMAR T™ HVR® 4000™ Surface Modified Hardshell Venous Reservoirs are intended to be used in adult surgical procedures requiring cardiopulmonary bypass for periods of up to six hours.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Cardiovascular, Respiratory, and Neurological Devices

§10(k) Number 1<993001

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.