Sorin VVR 4000i and Sorin VVR 4000i SMARxT filtered hardshell reservoirs are intended to be used in surgical procedures requiring cardiopulmonary bypass for periods up to six hours.

Device Description

SORIN VVR 4000i and SORIN VVR 4000i SMARxT Filtered Hardshell Venous Reservoirs are sealed hardshell venous blood reservoirs with a defoamer and integral cardiotomy filter. The devices are supplied ethylene oxide sterilized with non-pyrogenic fluid pathways and are for single use only. They defoam, filter and store the blood coming from the operating field through thoracic, intracardiac and general suction. The devices are a modified version of the currently marketed COBE VVR 4000 COBE SMARXT VVR 4000 Filtered Hardshell Venous Reservoirs and (#K004046). The differences in design consist of the addition of a 41 micron pore size polvester net in the filtering section for enhanced defoaming capability and the addition of two ports (one female luer lock port and one cardiotomy luer lock port) on the reservoir lid for user convenience. Notwithstanding the modification, no new materials have been used since the added polyester net consists of the same polyester sock which constitutes the filter housing. Another modification concerns the transfer of the manufacturing site from Sorin Group USA, Inc. to Sorin Group Italia S.r.l. As a consequence of these three minor modifications, the labeling has to be updated.

AI/ML Overview

The provided document describes a Special 510(k) submission for the Sorin VVR 4000i and VVR 4000i SMARxT Filtered Hardshell Venous Reservoirs. This submission is for modifications to an existing device (COBE VVR 4000 / SMARxT VVR 4000, K004046), not for a new device requiring extensive de novo clinical or standalone studies. Therefore, many of the requested elements regarding sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies are not applicable or not detailed in this type of submission.

The "study" in this context refers to the non-clinical and in-vitro testing performed to demonstrate substantial equivalence to the predicate device and to confirm the safety and effectiveness of the modifications.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance results in a clear, quantitative format. Instead, it states that "The results of these tests met established specifications." These specifications are implicitly derived from the predicate device and relevant guidance documents.

Acceptance Criteria (General Categories)	Reported Device Performance (Summary)
Substantial Equivalence to Unmodified Device	Achieved; identical in intended use, materials, biocompatibility, SMA treatment performance, operating principles, control mechanisms, fundamental scientific technology and manufacturing process.
Compliance with "Guidance for Blood Extracorporeal Blood Circuit Defoamer 510(k) Submission"	Tests carried out in accordance, results met established specifications.
Biocompatibility	Not re-tested due to no new blood-contacting materials; cross-referenced predicate device (K004046).
Package Integrity	Not re-tested due to unchanged packaging; cross-referenced predicate device (K004046).
In-vitro Pressure Drop	Met established specifications.
Haemolysis/Cell Depletion	Met established specifications.
Wetting Volume (Breakthrough times/volumes & Priming volume (static))	Met established specifications.
Filter Flow Rate Capacity	Met established specifications.
Defoaming Efficiency	Met established specifications; enhanced by new polyester net modification.
Dynamic Priming Volume (Hold-up volumes)	Met established specifications.
Sterility	Demonstrated effectiveness of production techniques.
Non-pyrogenicity	Demonstrated effectiveness of production techniques.

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

Sample Size for Test Set: Not explicitly stated. The document refers to "in vitro testing" performed on the "aged device" but does not specify the number of units tested for each parameter.
Data Provenance: The tests were conducted internally by the manufacturer, Sorin Group Italia S.r.l. (Mirandola, Italy). The context indicates these were laboratory-based in vitro tests.

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

Not Applicable. For this type of 510(k) submission, ground truth typically refers to objective measurements and established specifications for the device's physical and functional performance, rather than expert consensus on interpretive data (e.g., medical image analysis). The "ground truth" here is determined by engineering and performance specifications.

4. Adjudication Method for the Test Set

Not Applicable. As the ground truth is based on objective measurements against established specifications, an adjudication method by human experts is not relevant.

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

No. An MRMC study is not mentioned or relevant for this type of device (venous reservoir) or submission. These studies are typically used for diagnostic devices where human interpretation of results is involved.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes (implicit). The in vitro tests performed are considered "standalone" in the sense that they evaluate the device's performance directly, independent of a human operator's cognitive input. The device itself (the reservoir) is the "algorithm" in this context, demonstrating its physical and functional parameters.

7. Type of Ground Truth Used

Engineering and Performance Specifications / Predicate Device Data: The ground truth for the in vitro tests was based on established specifications referenced from the "Guidance for Blood Extracorporeal Blood Circuit Defoamer 510(k) Submission" (November 29, 2000) and the demonstrated performance of the predicate device (COBE VVR 4000 / SMARxT VVR 4000, K004046). Biocompatibility and packaging integrity ground truth were entirely cross-referenced to the predicate device due to no changes in materials or packaging.

8. Sample Size for the Training Set

Not Applicable. This is a physical medical device, not a machine learning algorithm. Therefore, there is no "training set" in the computational sense. The design and manufacturing process are informed by established engineering principles and prior experience with similar devices (the predicate).

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

Not Applicable. See point 8.

Summary

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VVR 4000i and VVR 4000i SMARxT Filtered Hardshell Venous Reservoirs Sorin Group Italia S.r.l.

Special 510(k) July 29, 2009

510(k) SUMMARY

SUBMITTER:

Sorin Group Italia S.r.I. 86. Via Statale 12 Nord 41037 Mirandola (MO) Italy AUG ] 2 2009

CONTACT PERSON:

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

July 29, 2009

DATE PREPARED:

DEVICE TRADE NAME:

Sorin VVR 4000i and Sorin VVR 4000i SMARxT (hereafter referred to ક્ષક Modified VVR 4000i)

COMMON NAME:

Sealed Filtered Hardshell Venous Reservoir with Integral Cardiotomy Filter

CLASSIFICATION NAME:

Cardiopulmonary Bypass Blood Reservoir with Defoamer

Cardiopulmonary Bypass Cardiotomv Suction Line Blood Filter

UNMODIFIED DEVICE

COBE VVR 4000 and COBE SMARxT VVR 4000 Filtered Hardshell Venous Reservoirs (hereafter referred to as Unmodified VVR 4000i) (#K004046)

DEVICE DESCRIPTION:

SORIN VVR 4000i and SORIN VVR 4000i SMARxT Filtered Hardshell Venous Reservoirs are sealed hardshell venous blood reservoirs with a defoamer and integral cardiotomy filter.

The devices are supplied ethylene oxide sterilized with non-pyrogenic fluid pathways and are for single use only. They defoam, filter and store the blood coming from the operating field through thoracic, intracardiac and general suction. The devices are a modified version of the currently marketed COBE VVR 4000 COBE SMARXT VVR 4000 Filtered Hardshell Venous Reservoirs and

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VVR 4000i and VVR 4000i SMARxT Filtered Hardshell Venous Reservoirs	Special 510(k)
Sorin Group Italia S.r.l.	July 29, 2005

(#K004046). The differences in design consist of the addition of a 41 micron pore size polvester net in the filtering section for enhanced defoaming capability and the addition of two ports (one female luer lock port and one cardiotomy luer lock port) on the reservoir lid for user convenience. Notwithstanding the modification, no new materials have been used since the added polyester net consists of the same polyester sock which constitutes the filter housing. Another modification concerns the transfer of the manufacturing site from Sorin Group USA, Inc. to Sorin Group Italia S.r.l. As a consequence of these three minor modifications, the labeling has to be updated.

The design modification enables the device to better defoam the blood suctioned from the operative field during cardiopulmonary bypass procedures. The Modified VVR4000i and Unmodified VVR4000i are similar in their intended use, materials and manufacturing processes.

INDICATION FOR USE:

Sorin VVR 4000i and Sorin VVR 4000i SMARxT are intended to be used in surgical procedures requiring cardiopulmonary bypass for periods up to six hours.

TECHNOLOGICAL CHARACTERISTICS:

The Modified VVR 4000i is identical to the Unmodified VVR 4000i with respect to intended use, materials, biocompatibility and performance of the SMA treatment, operating principles, control mechanisms, fundamental scientific technology and manufacturing process. The differences in design consist of the addition of a polyester net in the filtering section for enhanced defoaming capability and the addition of a female luer lock port and a cardiotomy luer lock port on the reservoir lid for user convenience.

The SMA treatment of the Modified VVR 4000i is identical to that used on Unmodified VVR 4000i. The materials and manufacturing process in regards to the SMA treatment are unchanged with respect to the unmodified device

NON CLINICAL TEST RESULTS:

A complete battery of Biocompatibility tests to be performed in accordance with the requirements of ISO 10993-1 and the FDA May 1, 1995 Memorandum has not been carried out since there are no new materials in blood contact with respect to the unmodified VVR4000i.

The polyester used in the net is, in fact, already used into the device. Accordingly, the complete battery of Biocompatibility testing has not been carried out on the

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basis of a concrete rationale and a cross reference has been referred to the 510(k) submission of the unmodified device (#K004046).

Similarly, the package integrity testing has not been performed since the packaging is unchanged from unmodified device. For this reason this 510(k) cross references packaging data previously submitted for the unmodified device (#K004046).

IN VITRO TEST RESULTS:

In vitro testing was performed in order to provide the data necessary to demonstrate both the substantial equivalence with the unmodified device and also to comply with safety and effectiveness requirements.

The tests were carried out in accordance with the requirements of the "Guidance for Blood Extracorporeal Blood Circuit Defoamer 510(k) Submission" Final Guidance for industry and FDA issued on November 29, 2000. The aged device was tested for in vitro pressure drop, haemolysis/cell depletion, wetting volume (breakthrough times/volumes & priming volume (static)), filter flow rate capacity and defoaming efficiency, and dynamic priming volume (hold-up volumes).

The results of these tests met established specifications. This 510(k) crossreferences performance data previously acquired for the Unmodified VVR 4000i since, as above stated, these aspects are not affected by the modification.

CONCLUSIONS:

The Modified VVR 4000i device performs in a manner substantially equivalent to the Unmodified VVR 4000i 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.

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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 stripes forming its wing and tail. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

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

AUG 1 2 2009

Re: K092315

VVR 4000i and VVR 4000i SMARxT Filtered Hardshell Venous Reservoir Regulation Number: 21 CFR 870.4400 Regulation Name: Cardiopulmonary bypass blood defoamer Regulatory Class: Class II (two) Product Code: DTN, DTP, JOD Dated: July 29, 2009 Received: July 30, 2009

Dear Mr. Sall:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent 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. However, you are responsible to determine that the medical devices you use as components in the [kit/tray] have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.

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Page 2 - Mr. Barry Sall

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours,

Ouna R. V. Luner

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

Enclosure

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VVR 4000i and VVR 4000i SMARxT Filtered Hardshell Venous Reservoirs Sorin Group Italia S.r.I.

Special 510(k) July 29, 2009

Ko92315 510(k) Number (if known):

Device Name: Sorin VVR 4000i and Sorin VVR 4000i SMARxT Filtered Hardshell Venous Reservoirs.

Indication for Use:

Sorin VVR 4000i and Sorin VVR 4000i SMARxT filtered hardshell reservoirs are intended to be used in surgical procedures requiring cardiopulmonary bypass for periods up to six hours.

Prescription Use × (Part 21CFR 801 Subpart D) Over-the- Counter Use AND/OR (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)

D. Vachner

(Division Sign-Off) (Division of Cardiovascular Devices

510(k) Number Kog 2315

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.