The Dideco Venomidicard and Midicard are hardshell blood collection reservoirs intended for use in CPB circuits and postoperative blood salvage procedures.

Device Description

The Venomidicard and Midicard are sterile, nonpyrogenic, disposable, hardshell reservoirs that contain an integral cardiotomy filter. Each device contains a polyurethane defoamer sponge and outer gross filter screen.

AI/ML Overview

The provided 510(k) summary for the Sorin Biomedical Inc. Venomidicard/Midicard describes a medical device, not an AI/ML algorithm. Therefore, many of the requested criteria (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable as they pertain to the evaluation of AI/ML software.

However, I can extract the relevant information regarding the device's acceptance criteria and the study that proves it meets those criteria based on the provided text.

Acceptance Criteria and Device Performance for Sorin Biomedical Inc. Venomidicard/Midicard

The acceptance criteria for the Venomidicard and Midicard reservoirs were based on their "substantial equivalence" to a legally marketed predicate device, the Sorin Hardshell Venous Reservoir (HSVRF), for the expanded use of chest drainage autotransfusion. Substantial equivalence was demonstrated through a comparison of technological characteristics and nonclinical test results.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Measured against predicate device - Sorin Hardshell Venous Reservoir)	Reported Device Performance (Venomidicard and Midicard)
Technological Characteristics:	Similar to predicate device:
Intended Use	Similar
Materials	Similar
Design	Similar
Performance Characteristics	Similar
Number of cardiotomy inlet ports	Similar
Filter elements	Similar
Setup and use for chest drainage	Similar
Nonclinical Test Results:	Similar performance characteristics to predicate device:
Physical Tests:
Vacuum Integrity	Test results show similar performance characteristics to the Sorin Hardshell Venous Reservoir.
Functional Tests:
Hemolysis	Test results show similar performance characteristics to the Sorin Hardshell Venous Reservoir.
Residual Volume	Test results show similar performance characteristics to the Sorin Hardshell Venous Reservoir.
Filter Pressurization	Test results show similar performance characteristics to the Sorin Hardshell Venous Reservoir.
Biocompatibility:	Acceptable for intended use:
Compatibility with blood-contacting materials (short term)	All test results comparable to negative control groups, indicating materials are acceptable for their intended use. (Previously performed on a finished, sterilized device in accordance with Tripartite Guidelines).

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

Sample Size: The document states that "All testing was conducted on nonaged, sterile devices." It does not specify the number of units tested for each physical and functional test.
Data Provenance: The tests were "in vitro physical and functional tests," meaning they were conducted in a laboratory setting. There is no mention of country of origin for the data or whether it was retrospective or prospective, as these terms are generally more applicable to clinical studies.

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

Not applicable. This device evaluation relies on objective physical and functional measurements, not expert interpretation of data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. This device evaluation relies on objective physical and functional measurements, not expert consensus or adjudication.

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:

Not applicable. This is a medical device (a physical reservoir), not an AI/ML algorithm or imaging diagnostic device.

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

Not applicable. This is a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The "ground truth" for this device's performance was established by comparing its physical and functional test results to those of the predicate device (Sorin Hardshell Venous Reservoir). The predicate device itself was presumably cleared based on its known performance and safety. Biocompatibility was assessed against established Tripartite Guidelines using negative control groups.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not an AI/ML algorithm that requires training data.

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

Not applicable. This is a physical medical device.

Summary

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K-6-1-1-1

510(k) Notification

Sorin Biomedical Inc. Venomidicard / Midicard

510(k) SUMMARY

Aug. 21, 1997

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

Date Summary was Prepared D.

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AUG 21 nat

510(k) SUMMARY (cont.)

Device Name E.

Trade or Proprietary Name:

Venomidicard	Pediatric Venous Reservoir with Integral Cardiotomy Filter
Midicard	Pediatric Cardiotomy Reservoir

Common Name:

Cardiotomy Reservoir, Venous Reservoir with Integral Cardiotomy Filter

Classification Name:

Cardiopulmonary Bypass Blood Reservoir Cardiopulmonary Bypass Cardiotomy Suction Line Blood Filter

Summary of Substantial Equivalence F.

The Venomidicard and Midicard reservoirs are 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). These device were designed for use in chest drainage and are marketed by DIDECO for that intended use outside the United States.

G. Device Description

H. Intended Use

The Venomidicard and Midicard reservoirs are intended to allow for the collection and autotransfusion of shed mediastinal blood following cardiopulmonary bypass procedures.

I. Summary of Comparison of Technological Characteristics

The technological characteristics of the Venomidicard and Midicard are 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.)

J. Summary of Nonclinical Tests

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 Venomidicard and Midicard 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 these devices are considered acceptable for their intended use.

K. Conclusions

Based upon the above information, Sorin Biomedical Inc. concludes that the Venomidicard Pediatric Venous Reservoir with Integral Cardiotomy Filter and the Midicard Pediatric Cardiotomy Reservoir are substantially equivalent to the Sorin Hardshell Venous Reservoir for use in chest drainage autotransfusion.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The text is in all caps and is written in a sans-serif font. The logo is black and white.

Food and Drug Administration 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

AUG 2 1 1997

K964907 Re: Venomidicard Pediatric Venous Reservoir with Integral Cardiotomy Filter Requlatory 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 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: (General requlation (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 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" (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. Callahion

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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Image /page/5/Picture/0 description: The image contains handwritten text. The text includes the number 870.4400, followed by "- DTN II - Cartictomy". The word "Reservoir" is also present in the image. The text appears to be part of a document or label.

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K984907

Device Name: CARDIOTOMY FILTER

Indications for Use:

The Dideco Venomidicard and Midicard are hardshell blood collection reservoirs intended for use in CPB circuits and postoperative blood salvage procedures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bette R. Lumperle

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number_

Image /page/5/Picture/10 description: The image shows the words "Prescription Use" in bold font, followed by the text "(Per 21 CFR 801.109)" in a smaller font size. The text is left-aligned and appears to be part of a document or label. There is also a symbol to the right of the text.

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.