The VRF40 Venous Reservoir with Integral Cardiotomy Filter is intended to allow for the collection and autotransfusion of shed mediastinal blood following cardiopulmonary bypass procedures or other procedures where shed blood is expected.
The VRF40 Venous Reservoir with Integral Cardiotomy Filter is intended for use in CPB circuits and postoperative blood salvage procedure

Device Description

The VRF40 is a sterile, nonpyrogenic, disposable, hardshell venous reservoir with an integral cardiotomy filter. It contains a polyurethane defoamer sponge and outer gross filter screen,

AI/ML Overview

The provided 510(k) summary for the Sorin Biomedical Inc. VRF40 Venous Reservoir with Integral Cardiotomy Filter (K964908) describes a substantial equivalence determination based on nonclinical (in vitro) testing. There is no mention of clinical studies, human reader performance, or AI systems.

Therefore, the response below reflects the information present in the document, and many of the requested sections (e.g., related to AI, human readers, experts, and training data) are not applicable or cannot be extracted from this type of regulatory submission.

Acceptance Criteria and Device Performance Study

The acceptance criteria for the VRF40 Venous Reservoir with Integral Cardiotomy Filter and the study proving its performance are based on a comparison to a predicate device, the Sorin Hardshell Venous Reservoir (HSVRF). The study primarily involved in vitro physical and functional tests to demonstrate substantial equivalence for the expanded use in chest drainage autotransfusion.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria with specific numerical targets. Instead, the acceptance was based on showing "similar performance characteristics" to the predicate device.

Test Type	Acceptance Criteria (Implied)	Reported Device Performance
Physical Tests
Vacuum Integrity	Performance comparable to predicate device	Similar performance characteristics to the Sorin Hardshell Venous Reservoir
Functional Tests
Hemolysis	Performance comparable to predicate device	Similar performance characteristics to the Sorin Hardshell Venous Reservoir
Residual Volume	Performance comparable to predicate device	Similar performance characteristics to the Sorin Hardshell Venous Reservoir
Filter Pressurization	Performance comparable to predicate device	Similar performance characteristics to the Sorin Hardshell Venous Reservoir
Biocompatibility	Acceptable for intended use (comparable to negative controls)	All test results were comparable to the negative control groups.

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

Sample Size for Test Set: The document states that "All testing was conducted on nonaged, sterile devices," but it does not specify the number of devices used in the physical and functional tests.
Data Provenance: The tests were "in vitro" and performed by Sorin Biomedical Inc. No information regarding country of origin of data or retrospective/prospective nature is applicable as it's not a clinical study.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This device is not an AI/diagnostic device that requires expert ground truth for its performance evaluation in this 510(k) submission.

4. Adjudication Method for the Test Set

Not applicable. This is not a clinical study requiring human adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is not a study involving human readers or AI assistance.

6. Standalone (Algorithm Only) Performance

Not applicable. This is not an algorithm or AI device.

7. Type of Ground Truth Used

The "ground truth" for demonstrating substantial equivalence was the established performance characteristics of the predicate device (Sorin Hardshell Venous Reservoir), as assessed through specific physical and functional in vitro tests.

8. Sample Size for the Training Set

Not applicable. This is a medical device, not a machine learning model requiring a training set.

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

Not applicable. There is no training set for this device.

Summary

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510(k) Notification

Sorin Biomedical Inc. VRF40 Venous Reservoir with Integral Cardiotomy Filter

K964908
Sept. 3, 1997

510(k) SUMMARY

Name and Address of Submitter A.

Sorin Biomedical Inc. 17600 Gillette Avenue Irvine, California 92614-5751

Telephone and Fax Numbers of Submitter B.

Telephone:	(714) 250-8320
Fax:	(714) 250-1524

Name of Contact Person C.

Richard J. DeRisio Vice President Quality & Regulatory Affairs

D. Date Summary was Prepared

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510(k) SUMMARY (cont.)

II. Device Name

Trade or Proprietary Name:

VRF 40 Venous Reservoir with Integral Cardiiotomy Filter

Common Name:

Cardiotomy Reservoir, Venous Reservoir with Integral Cardiotomy Filter

Classification Name:

Cardiopulmonary Bypass Blood Reservoir Cardiopulmonary Bypass Cardiotomy Suction Line Blood Filter

F. Summary of Substantial Equivalence

The VRF40 Venous Reservoir with Integral Cardiotomy Filter is judged to be substantially equivalent in intended use, materials, design, and performance characteristics to the Sorin Hardshell Venous Reservoir (HSVRF). The HSVRF was cleared for chest drainage on September 30, 1987 (K872719). The VRF40 was designed for use in chest drainage and is marketed by DIDECO for that intended use outside the United States.

G. Device Description

The VRF40 is a sterile, nonpyrogenic, disposable, hardshell venous reservoir with an integral cardiotomy filter. It contains a polyurethane defoamer sponge and outer gross filter screen,

H. Intended Use

The VRF40 is intended to allow for the collection and autotransfusion of shed mediastinal blood following cardiopulmonary bypass procedures or other procedures where shed blood is expected.

I. Summary of Comparison of Technological Characteristics

The technological characteristics of the VRF40 is similar to the Sorin Hardshell Venous Reservoir with respect to chest drainage autotransfusion. These devices have a similar number of cardiotomy inlet ports, have similar filter elements, and are similar in setup and use for chest drainage.

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510(k) SUMMARY (cont.)

Summary of Nonclinical Tests J.

Substantial equivalence was based on a comparison of test results from the following in vitro physical and functional tests:

Physical Tests Vacuum Integrity

Functional Tests Hemolysis Residual Volume Filter Pressurization

All testing was conducted on nonaged, sterile devices. Test results show similar performance characteristics between the VRF40 and the Sorin Hardshell Venous Reservoir with respect to the expanded use of chest drainage autotransfusion.

Biocompatibility

Biocompatibility testing was previously performed on a finished, sterilized device in accordance with the Tripartite Guidelines for Biocompatibility testing for short term blood contacting materials. All test results were comparable to the negative control groups. Therefore, the materials used in the VRF40 are considered acceptable for their intended use.

K. Conclusions

Based upon the above information, Sorin Biomedical Inc. concludes that the VRF40 Venous Reservoir with Integral Cardiotomy Filter is substantially equivalent to the Sorin Hardshell Venous Reservoir for use in chest drainage autotransfusion or any procedure where shed blood is expected.

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SORIN BIOMEDICAL INC. CONFIDENTIAL

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administra lon 9200 Corporate Boulevard Rockville MD 20856

Mr. Paul Butorac Manager, Quality Engineering Department Sorin Biomedical, Inc. 17600 Gillette Avenue P.O. Box 19503 Irvine, California 92713-9503 ················································································································································

SEP - 3 1997

Re: K964908 VRF40 Venous Reservoir with Integral Cardiotomy Filter Regulatory Class: II (Two) Product Code: 74 DTN Dated: June 10, 1997 Received: June 12, 1997

Dear Mr. Butorac:

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 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.

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Page 2 - Mr. Paul Butorac

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 requlation (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" (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.qov/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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510(k) Number (if known):_K964908

270 4400

ר.

Device Name: VRF40 Venous Reservoir with Integral Cardiotomy Filter

Indications for Use: The VRF40 Venous Reservoir with Integral Cardiotomy Filter is intended for use in CPB circuits and postoperative blood salvage procedure

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bera L. Remoule

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

510(k) Number

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

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.