The HVR 4000 Filtered is intended for storage and filtration of blood during surgical procedures on adults requiring extracorporeal circulation for periods of up to six hours.

The HVR 4000 Nonfiltered is intended for storage of blood during surgical procedures on adults requiring extracorporeal circulation for periods of up to six hours.

Device Description

The HVR™ 4000 Filtered Hardshell Venous Reservoir is an open cardiopulmonary bypass blood reservoir with defoamer and cardiotomy suction filter. Used in coniunction with other ancillary equipment and disposable products, this device will satisfy an adult patient's blood storage and cardiotomy filtration requirements during surgical procedures.

The HVR™ 4000 Nonfiltered Hardshell Venous Reservoir is an open cardiopulmonary bypass blood reservoir with defoamer. Used in conjunction with other ancillary equipment and disposable products, this device will satisfy an adult patient's blood storage requirements during surgical procedures

The product is sterilized by ethylene oxide gas and has nonpyrogenic fluid pathways.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the COBE® HVR™ 4000 Filtered/Nonfiltered Hardshell Venous Reservoir, based on the provided 510(k) Premarket Notification:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Blood trauma characteristics comparable to predicate device (Maxima Hardshell Venous Reservoir)	The blood trauma characteristics of the HVR 4000 Filtered and the HVR 4000 Nonfiltered are not significantly different compared to the Maxima Hardshell Venous Reservoir.
Filtration efficiency meets specification (for Filtered model)	Filtration efficiency of the HVR 4000 Filtered meets specification.
Volume capacity meets specification (maximum operating volume)	Volume capacity of both COBE devices meet specification. The COBE devices' maximum operating volumes meet claims.
Volume capacity meets specification (minimum operating volume)	The COBE devices' minimum operating volumes meet claims.
Material biocompatibility meets requirements	Material biocompatibility for both COBE devices meet requirements.
Sterilization meets requirements	Sterilization for both COBE devices meet requirements.
Packaging meets requirements	Packaging for both COBE devices meet requirements.
All labeling claims are substantiated	All labeling claims for the COBE devices have been substantiated.
Expiration period of one year	The COBE HVR 4000 Hardshell Venous Reservoirs will be labeled with a one year expiration period.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated. The document mentions "in vitro testing" was performed, but specific sample sizes (e.g., number of devices tested, number of blood samples) are not provided.
Data Provenance: The testing was "in vitro," meaning it was conducted in a laboratory setting, not on human or animal subjects. The country of origin for the data is not specified, but the submitter is COBE Cardiovascular, Inc. in Arvada, CO, USA, suggesting the testing was likely conducted in the US or in a facility associated with the company. The study was retrospective in the sense that it was performed on existing device designs to demonstrate equivalence, but the testing itself would have been prospective (designed and executed to collect new data).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This device is a medical device (venous reservoir), not an AI/imaging device requiring expert interpretation for ground truth. Therefore, no experts were used to establish ground truth in this context. The "ground truth" for this device's performance is determined by established engineering specifications and performance benchmarks (e.g., blood cell damage levels, filtration rates, volume measurements).

4. Adjudication Method for the Test Set

Not applicable. Since the evaluation involved quantifiable performance metrics and not subjective interpretations, there was no need for an adjudication method by experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI systems that assist human readers in tasks like image interpretation. This device is a physical medical device, and its evaluation focuses on its physical and biological performance characteristics.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone study (in vitro testing) was done. The performance of the device was evaluated solely based on its own characteristics and against predetermined specifications, without human intervention in the device's operational performance during testing. The document states: "Safety and efficacy were determined by in vitro testing."

7. The Type of Ground Truth Used

The "ground truth" for this device's performance was based on engineering specifications and established performance benchmarks for safe and effective blood handling and filtration in cardiopulmonary bypass. This includes objective measurements such as:
- Blood trauma indicators (e.g., hemolysis levels).
- Filtration efficiency (e.g., particle removal size and percentage).
- Volume capacity (measured in milliliters).
- Biocompatibility standards.
- Sterilization efficacy standards.
- Packaging integrity standards.
- Comparison to the performance of the predicate device (Maxima Hardshell Venous Reservoir).

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical product, not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. (See #8).

Summary

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510(k) Premarket Notification

K971669

510(k) Summary

Jul 2 3 1997
COBE Cardiovascular, Inc. ® SUBMITTER: 14401 W. 65th Way Arvada, CO 80004
CONTACT PERSON: Mary L. Armstrong Phone:(303) 467-6521 Fax:

5/5/97 DATE PREPARED:

COBE® HVR™ 4000 Filtered Hardshell Venous Reservoir DEVICE TRADE NAME: COBE® HVR™ 4000 Nonfiltered Hardshell Venous Reservoir

Hardshell venous reservoir with integral cardiotomy filter COMMON NAME: Hardshell venous reservoir
CLASSIFICATION NAME: Cardiopulmonary bypass blood reservoir with defoamer and cardiotomy suction filter

Cardiopulmonary bypass blood reservoir with defoamer

PREDICATE DEVICE: Maxima Hardshell Venous Reservoir - Top Entry, Model MHR-T

DEVICE DESCRIPTION: The HVR™ 4000 Filtered Hardshell Venous Reservoir is an open cardiopulmonary bypass blood reservoir with defoamer and cardiotomy suction filter. Used in coniunction with other ancillary equipment and disposable products, this device will satisfy an adult patient's blood storage and cardiotomy filtration requirements during surgical procedures.

The product is sterilized by ethylene oxide gas and has nonpyrogenic fluid pathways.

INDICATIONS FOR USE: The HVR 4000 Filtered is intended for storage and filtration of blood during surgical procedures on adults requiring extracorporeal circulation for periods of up to six hours.

The HVR 4000 Nonfiltered is intended for storage of blood during surgical procedures on adults requiring extracorporeal circulation for periods of up to six hours.

TECHNOLOGICAL CHARACTERISTICS: Comparing the HVR™ 4000 Filtered Hardshell Venous Reservoir and the HVR™ 4000 Nonfiltered Hardshell Venous Reservoir with the Maxima Hardshell Venous Reservoir, some similarities and differences are noted in the design and technology employed to accomplish their intended uses.

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510(k) Premarket Notification

All three devices use a knitted polyester fabric as the outer defoamer covering. In the filtered devices (i.e., the HVR 4000 Filtered and the Maxima Hardshell Venous Reservoir), filtration is accomplished through use of polyurethane foam for gross filtration and polyester depth media for fine filtration.

All three devices include the same functional types of porting in essentially the same numbers and sizes. For venting, the Maxima Hardshell Venous Reservoir uses a port on its cover where the COBE HVR 4000 Hardshell Venous Reservoirs use an open cover design. Both COBE devices use a one-piece, molded venous inlet port, whereas the Maxima device uses a two-piece inlet comprised of a rigid, injection molded port joined to a flexible, polyvinylchloride tube.

NONCLINICAL TEST RESULTS: The blood trauma characteristics of the HVR 4000 Filtered and the HVR 4000 Nonfiltered are not significantly different compared to the Maxima Hardshell Venous Reservoir. Filtration efficiency of the HVR 4000 Filtered meets specification. Volume capacity of both COBE devices meet specification. Material biocompatibility, sterilization and packaging of both COBE devices meet requirements. All labeling claims have been substantiated. The COBE HVR 4000 Hardshell Venous Reservoirs will be labeled with a one year expiration period.

CLINICAL TEST RESULTS: No clinical testing was performed. Safety and efficacy were determined by in vitro testing.

CONCLUSIONS:

1. The COBE devices' blood trauma characteristics are comparable to those of the predicate device.
1. The COBE devices' maximum operating volumes meet claims
1. The COBE devices' minimum operating volumes meet claims
The COBE devices' filtration efficiency meets claims 4.
1. Material biocompatibility, sterilization and packaging for the COBE devices meet requirements
1. All labeling claims for the COBE devices have been substantiated

COBE® and COBE Cardiovascular® are registered trademarks of COBE Laboratories, Inc. HVR™ is a trademark of COBE Laboratories, Inc.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

JUL 2 3 1997

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

Public Health Service

Ms. Mary L. Armstrong Regulatory Affairs Manager COBE Cardiovascular, Inc. 14401 W. 65th Way Arvada, Colorado 80004-3599

Re : K971669 COBE® HVR™ 4000 Reservoirs Requlatory Class: II (Two) Product Code: 74 DTN Dated: May 5, 1997 Received: May 6, 1997

Dear Ms. Armstrong:

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 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, 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.

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Page 2 - Ms. Mary L. Armstrong

This letter will allow you to begin 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) Additionally, for questions on the promotion and 594-4648. 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" (21 CFR 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/dsmamain.html."

Sincerely yours,

Thomas J. Callahan

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

Enclosure

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440 -

Reservoir

510(k) Premarket Notification

Indications For Use

510(k) Number (If known): ____________________________________________________________________________________________________________________________________________________

Device Name: COBE® HVR™ 4000 Filtered Hardshell Venous Reservoir COBE® HVR™ 4000 Nofiltered Hardshell-Venous Reservoir · ----------------------------------------------------------------------------------------------------------------------

Indications For Use:

The HVR 4000 Filtered is intended for storage and filtration of blood during surgical procedures on adults requiring extracorporeal circulation for periods of up to six hours.

The HVR 4000 Nonfiltered is intended for storage of blood during surgical procedures on adults requiring extracorporeal circulation 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)

Zote L. Lamperle

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 971669

ﻠ

Prescription Use x (Per 21 CFR 801.109) OR

510(k) Number

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.