The CARD 43 is a cardiotomy reservoir specifically designed for cardiovascular procedures requiring cardiopulmonary by-pass. It defoams, filters and stores the blood from the operating field through thoracic, intracardiac and general suction. CARD 43 can be used postoperatively for chest drainage. The CARD 43 should not be used longer than 6 hours. Contact with blood for longer periods is not advised.

Device Description

The CARD 43 Cardiotomy Reservoir with phosphoryIcholine coating is intended for use in cardiovascular procedures requiring cardiopulmonary by-pass. It defoams, filters and stores the blood coming from the operating field through thoracic, intracardiac and general suction. The device is a modified version of the currently marketed Synthesis R (K022450). The design modifications consist of: eliminating the venous return inlet connector on the top of the reservoir lid. eliminating the venous section of the filtering system and updating of product specifications in the IFU. The modification enables the device to be suited for filtration, defoaming and collection only of blood aspirated from the operative field during cardiopulmonary bypass procedures or postoperatively during chest drainage. Other than this change the CARD 43 and the Synthesis R are similar in their intended use, materials and manufacturing processes.

AI/ML Overview

The Sorin Group Italia S.r.I. CARD 43 Cardiotomy Reservoir with phosphorylcholine coating (CARD 43) is a modified version of the previously marketed Synthesis R (K022450) and is intended for use in cardiovascular procedures requiring cardiopulmonary bypass. The modifications include eliminating the venous return inlet connector and the venous section of the filtering system, making it primarily suited for the collection and removal of microemboli or microaggregates from suctioned blood. The device's performance was evaluated through non-clinical and in vitro testing to demonstrate substantial equivalence to the unmodified device and compliance with safety and effectiveness requirements.

Here's an analysis of the acceptance criteria and study data:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the numerical sample size for individual tests. Instead, it refers to "a complete battery of tests" and "in vitro testing was carried out." The provenance of the data is not specified but is assumed to be from experiments conducted by Sorin Group Italia S.r.I. The studies are by nature prospective, as they evaluated the modified device's performance against predefined criteria.

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

This information is not provided in the document. The "ground truth" for these types of device performance studies is typically established by adhering to recognized international standards (ISO 10993-1:2003, ISO 15674:2001) and FDA guidance documents. The expertise would lie in the accredited labs and personnel performing the tests according to these standards, rather than a panel of clinical experts establishing ground truth in a diagnostic sense.

4. Adjudication Method for the Test Set

Not applicable. This is a non-clinical/in vitro device performance study, not a clinical study involving human assessment or diagnostic interpretation. The results are quantitative and compared against predefined technical specifications.

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 performance study, not a diagnostic AI study involving human readers or interpretation of medical images/data. The device is a physical product (cardiotomy reservoir), not an AI algorithm.

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

Not applicable, as this is a physical medical device and not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device modification acceptance is based on:

Established Specifications: Performance benchmarks derived from relevant international standards (ISO 10993-1:2003 for biocompatibility, ISO 15674:2001 for hardshell cardiotomies), FDA guidance documents ("Guidance for Blood Extracorporeal Blood Circuit Defoamer 510(k) Submission"), and prior validated performance of the predicate device (Synthesis R, K022450).
Scientific Principles: Underlying principles of engineering, material science, and blood-material interactions relevant to cardiotomy reservoirs.

8. The Sample Size for the Training Set

Not applicable. This is a device performance study, not an AI model requiring a training set.

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

Not applicable, as this is a device performance study and not an AI model.

Summary

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

Sorin Group Italia S.r.I. CARD 43 Cardiotomy Reservoir Special 510(k): Device Modificatio June 1, 2006

JUN 27 2006

510(k) SUMMARY

SUBMITTER:

CONTACT PERSON:

Luigi Vecchi Phone: 011 39 0535 29811 Fax: 011 39 0535 25229

June 1, 2006

Sorin Group Italia S.r.I.

Via Statale 12 Nord 41037 Mirandola (MO) Italy

DATE PREPARED:

DEVICE TRADE NAME:

COMMON NAME:

CLASSIFICATION NAME:

UNMODIFIED DEVICE

CARD 43 Cardiotomy Reservoir with phosphorvicholine coating (hereafter referred to as CARD 43)

Hardshell Cardiotomy Reservoir

Cardiopulmonary Bypass Blood Reservoir / Cardiopulmonary Bypass Defoamer

Synthesis R Hardshell Venous/Cardiotomy Reservoir Mimesys Treated with phosphoryIcholine coating (hereafter referred to as Synthesis R) (K022450)

DEVICE DESCRIPTION:

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

INDICATION FOR USE:

TECHNOLOGICAL CHARACTERISTICS:

The CARD 43 is similar to the Synthesis R unmodified device with respect to intended use, materials, biocompatibility and performance of the PC coating, operating principles, control mechanisms, fundamental scientific technology and manufacturing process. The hardshell cardiotomy/venous reservoir of both CARD 43 and Synthesis R share the same technological characteristics, operating principles, and materials except for the design change. The design modifications consist of: eliminating the venous return inlet connector on the top of the reservoir lid, eliminating the venous section of the filtering system and updating of product specifications in the IFU. These design changes make the CARD 43 primarily suited for the collection and removal of microemboli or microaggregates from suctioned blood. The use during cardiopulmonary procedures or postoperatively for chest drainage remains unchanged as a result of the modification. The CARD 43 is substantially equivalent to Synthesis R in intended use, patient population and performance specifications.

The coating of the CARD 43 is identical to the phosphorylcholine coating used on Synthesis R. The cardiotomy reservoir is ethylene oxide sterilized and has a nonpyrogenic fluid path. It is for single use only.

NON CLINICAL TEST RESULTS:

A complete battery of tests were carried out in accordance with the requirements of ISO 10993-1:2003 and the FDA May 1, 1995 Memorandum on the use of the ISO 10993 standard for biocompatibility testing on the raw materials. Testing was performed on the CARD 43. The aged device was tested for Hemolysis, Cytotoxicity, Irritation, Acute Systemic Toxicity and Mutagenicity, Sterility, Pyrogenicity, ETO residuals. Package integrity testing was also conducted. The results testing met established specifications.

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

IN VITRO TEST RESULTS:

In vitro testing was carried out in accordance with the requirements of "Guidance for Blood Extracorporeal Blood Circuit Defoamer 510(k) Submission" Final Guidance for industry and FDA issued on November 29, 2000 - and when applicable, following the ISO 15674 (2001) standard for "Cardiovascular Implants and Artificial Organs - Hardshell Cardiotomies/Venous Reservoirs Systems (with/without filter) and Soft Venous Reservoir Bags" for providing the data necessary to demonstrate both the substantial equivalence with the unmodified device and also for complying with safety and effectiveness requirements. The aged device was tested for in vitro hemolysis/cell depletion, structural integrity, mechanical integrity, breakthrough times and volumes, reservoir graduated scale accuracy, residual blood volume, defoaming capacity, filtration efficiency and flaking and leaching studies characterization. The results of these tests met established specifications. This 510(k) cross-references performance data previously submitted in the original Synthesis R 510(k) (K022450) as the above mentioned aspects are not affected by the modification.

CONCLUSIONS:

The CARD 43 device performs in a manner substantially equivalent to the unmodified device with respect to biocompatibility and the functional parameters in common with the unmodified device. Additional testing has also demonstrated the effectiveness of production techniques to assure that the device is sterile and non-pyrogenic.

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

Image /page/3/Picture/11 description: The image shows a logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized, curved lines that appear to be stacked on top of each other.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 7 2006

Sorin Group Italia S.R.L. c/o Mr. Barry Sall Principal Consultant 200 West Street Waltham, MA 02451

Re: K061527

CARD 43 Cardiotomy Reservoir with PhosphoryIcholine Coating Regulation Number: 21 CFR 870.4400 Regulation Name: Cardiopulmonary Bypass Reservoir Regulatory Class: Class II (Two) Product Code: DTN Dated: June 1. 2006 Received: June 2, 2006

Dear Mr. Sall:

We have reviewed your Section 510(k) premarket notification of intent to market the referenced above and have determined the device is substantially equivalent (for the use stated in the enclosure) to legally marketed predicate devices marketed in interstat prior to May 28, 1976, the enactment date of the Medical Device Amedical Ministant Mar have been reclassified in accordance with the provisions of the Federal Food. Drug, or crud ( osme to Act (Act) that do not require approval of a premarket approval application (PMA). Tour Close therefore, market the device, subject to the general controls provisions of the Act. The sector. controls provisions of the Act include requirements for annual registration. Institions good manufacturing practice. labeling, and prohibitions against misbranding and additeration.

If your device is classified (see above) into cither class II (Special Controls) or class III (PM. A. it may be subject to such additional controls. Existing major regulations affècting your levyce an be found in the Code of Federal Regulations. Title 21. Paris 800 to 898. In addition, FDA may partish further announcements concerning your device in the Federal Register.

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

Page 2 - Mr. Barry Sall

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Duna R. Virdner

Image /page/4/Picture/6 description: The image shows a signature on the left and the letters 'B' and 'D' on the right. The signature is illegible, but it appears to be written in cursive. The letters 'B' and 'D' are in a simple, sans-serif font. The image is simple and contains only a few elements.

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the logo for Sorin Group, a medical technology company. The logo features a stylized graphic to the left of the company name. Below the company name is the tagline "At the heart of medical technology". The logo is simple and professional, and it conveys the company's focus on medical technology.

Sorin Group Italia S.r.I.

510(k) Number (if known): K661527

Device Name: CARD 43 Cardiotomy Reservoir with PhosphoryIcholine Coating Indications for Use:

The CARD 43 is a cardiotomy reservoir specifically designed for cardiovascular procedures requiring cardiopulmonary by-pass. It defoams, filters and stores the blood from the operating field through thoracic, intracardiac and general suction. CARD 43 can be used postoperatively for chest drainage. The Card 43 should not be used longer than 6 hours. Contact with blood for longer periods is not advised.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-the-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duna R. Vichnes
sign-Off

levices

Number K061527

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.

Acceptance Criteria Category	Specific Test	Acceptance Criteria (Implicit from "met established specifications")	Reported Device Performance
Biocompatibility (Non-Clinical)	Hemolysis	Met established specifications	Met established specifications
	Cytotoxicity	Met established specifications	Met established specifications
	Irritation	Met established specifications	Met established specifications
	Acute Systemic Toxicity	Met established specifications	Met established specifications
	Mutagenicity	Met established specifications	Met established specifications
	Sterility	Met established specifications	Met established specifications
	Pyrogenicity	Met established specifications	Met established specifications
	ETO residuals	Met established specifications	Met established specifications
	Package integrity	Met established specifications	Met established specifications
Functional Performance (In Vitro)	In vitro hemolysis/cell depletion	Met established specifications	Met established specifications
	Structural integrity	Met established specifications	Met established specifications
	Mechanical integrity	Met established specifications	Met established specifications
	Breakthrough times and volumes	Met established specifications	Met established specifications
	Reservoir graduated scale accuracy	Met established specifications	Met established specifications
	Residual blood volume	Met established specifications	Met established specifications
	Defoaming capacity	Met established specifications	Met established specifications
	Filtration efficiency	Met established specifications	Met established specifications
	Flaking and leaching studies characterization	Met established specifications	Met established specifications
Material Equivalence	PC coating performance	Equivalent to Synthesis R	Identical to phosphorylcholine coating used on Synthesis R