XRES BLOOD COLLECTION RESERVOIR XRES 120MICROMETER BLOOD COLLECTION RESERVOIR

K131103 · Sorin Group Italia S.R.L. · DTN · Jun 6, 2013 · Cardiovascular

Device Facts

• Record ID: K131103
• Device Name: XRES BLOOD COLLECTION RESERVOIR XRES 120MICROMETER BLOOD COLLECTION RESERVOIR
• Applicant: Sorin Group Italia S.R.L.
• Product Code: DTN · Cardiovascular
• Decision Date: Jun 6, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4400
• Device Class: Class 2

Intended Use

The XRES Blood Collection Reservoir is an accessory to an autotransfusion device and is intended for the sterile collection and filtration of recovered blood for subsequent processing for autotransfusion. The XRES 120pm Blood Collection Reservoir is an accessory to an autotransfusion device and is intended for the sterile collection and filtration of recovered blood for subsequent processing for autotransfusion.

Device Story

XRES and XRES 120µm Blood Collection Reservoirs are sterile, single-use devices for collecting and filtering blood salvaged during surgery. Devices connect to external vacuum source to suction blood from operating field; blood passes through internal filtering system and defoamer to remove aggregates and entrained air. Output is filtered blood ready for processing by autotransfusion device. Used in clinical surgical settings; operated by medical professionals. Modifications include removal of 40µm filter layer (XRES 120µm version), updated blood conveyor shape, addition of o-ring, and optional 1/4" outlet tube. Benefits include improved blood recovery and filtration consistency for autotransfusion.

Clinical Evidence

Bench testing only. In vitro performance testing conducted per FDA guidance for extracorporeal blood circuit defoamers. Evaluated break-through time/volume, defoaming efficiency, filtration efficiency, graduated scale accuracy/residual volume, and hemolysis. Modified devices met all acceptance criteria and demonstrated performance equivalent to the predicate.

Technological Characteristics

Sterile, non-pyrogenic, single-use cardiopulmonary bypass blood reservoir. Materials: polyester filter fabric, ABS plastic outlet port. Sensing/Actuation: passive filtration and vacuum-assisted suction. Configuration: BOTTOM or TOP (modified XRES/XRES 120µm). Connectivity: None. Sterilization: Ethylene oxide. No software or electronic components.

Indications for Use

Indicated for sterile collection and filtration of recovered blood during surgical procedures for subsequent autotransfusion processing. Used as an accessory to autotransfusion devices.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• XRES Blood Collection Reservoir (K100507)

Submission Summary (Full Text)

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#### 510(k) SUMMARY

#### JUN 6 2013

| SUBMITTER: | Sorin Group Italia<br>86. Via Statale 12 Nord<br>41037 Mirandola (MO) Italy |
|----------------------|-----------------------------------------------------------------------------|
| CONTACT PERSON: | Luigi Vecchi<br>Phone: [phone]<br>Fax: [phone] |
| DATE PREPARED: | April 18, 2013 |
| DEVICE TRADE NAMES: | XRES Blood Collection Reservoir<br>XRES 120um Blood Collection Reservoir |
| COMMON NAME: | Blood Collection Reservoir |
| CLASSIFICATION NAME: | Cardiopulmonary Bypass Blood Reservoir |
| UNMODIFIED DEVICE: | XRES Blood Collection Reservoir (K100507) |

#### DEVICE DESCRIPTION:

The XRES and XRES 120µm Blood Collection Reservoirs are modified versions of the currently marketed XRES reservoir. The XRES contains both a 40um and a 120µm filtering material whereas the XRES 120um only contains a 120um filtering material.

The XRES and XRES 120µm reservoirs are sterile, non-pyrogenic device used to collect and filter blood salvaged during surgical procedures. Both reservoirs have an intering system designed to filter and remove aggregates from the recovered blood.

During surgical procedures the devices operate by means of an external vacuum source to suction and filter blood from the operating field prior to subsequent processing by an autotransfusion device. Entrained air is removed from blood by the defoamer.

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#### INDICATIONS FOR USE:

The XRES Blood Collection Reservoir is an accessory to an autotransfusion device and is intended for the sterile collection and filtration of recovered blood for subsequent processing for autotransfusion

The XRES 120pm Blood Collection Reservoir is an accessory to an autotransfusion device and is intended for the sterile collection and filtration of recovered blood for subsequent processing for autotransfusion

#### TECHNOLOGICAL CHARACTERISTICS:

The modified devices have the same principles of operation and control mechanisms as the unmodified devices.

The unmodified XRES contains two layers of filtering material; a 40μm non woven polyester filter covered by a 120pm polyester filter.

Due to customer preference, the device will be also offered without the 40µm polyester filter material. Devices without the 40µm will be referred to as the XRES 120µm.

The XRES 120µm will be provided with the 120um polvester fabric only. which acts as a holder sock for the entire filter assembly. In order to accommodate the modified filtering system the shape of the blood conveyor has been changed and an o-ring has been placed at the bottom of the filtering assembly.

The XRES 120pm will be available with the BOTTOM configuration only (i.e. the reservoir outlet is on the bottom). The TOP configuration will not be available.

The modifications to the XRES consist of: the introduction of the same newly shaped blood conveyor for both BOTTOM and TOP configurations. The change is being implemented in order to provide consistency with the XRES 120um product.

Also, the BOTTOM versions of modified XRES / XRES 120um will be offered with and without a short piece of tube that ends in a 1/4" outlet port.

The short piece might be used as an alternative to the existing rigid ABS 1/4" outlet port. The outlet port size continues to be 1/4".

In addition, the 120um polyester sock will be provided by a different supplier for the entire family of XRES devices. The raw material remains the same (polyester) and pore size is within the existing specification.

No change to the intended use has been made as a result of the modifications.

The modified and unmodified devices share fundamental technological characteristics except for some modifications that do not affect the basic device function. These differences do not raise any new issues of safety and effectiveness.

The modified devices are substantially equivalent to the unmodified devices on the basis of operating principles and basic function.

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There are no differences in packaging type and material between unmodified and modified device.

The modified devices are ethylene oxide sterilized and have a non-pyrogenic fluid path. The devices are for single use only.

#### NON CLINICAL TEST RESULTS:

Applicable tests were conducted in accordance with the requirements of ISO 10993-1 and the FDA May 1st, 1995 Memorandum on the use of the ISO 10993 standard for biocompatibility testing of materials.

#### IN VITRO TEST RESULTS:

In vitro testing was conducted in accordance with the relevant requirements of "Guidance for Extracorporeal Blood Circuit Defoamer 510(k) Submissions; Final Guidance for Industry and FDA" issued on November 29, 2000.

In vitro testing was conducted to demonstrate unmodified reservoir substantial equivalency and compliance to safety and effectiveness requirements. Since the XRES 120um includes all the modifications introduced, the impact of the overall changes was evaluated by comparing XRES 120pm performances data to the XRES unmodified device.

The following table lists the performance and tests conducted to demonstrate compliance to the product's performance specifications. The XRES 120pm blood collection reservoir successfully met all acceptance criteria for each test.

| TEST | TEST CLASSIFICATION | TEST TITLE |
|------|------------------------|------------------------------------------|
| 1 | Functional/Performance | Break-through time and volume |
| 2 | Functional/Performance | Defoaming efficiency |
| 3 | Functional/Performance | Filtration efficiency |
| 4 | Functional/Performance | Graduated scale accuracy/residual volume |
| 5 | Functional/Performance | Hemolysis |

### CONCLUSIONS:

The results of in vitro studies demonstrate that the modified devices perform in a manner substantially equivalent to the unmodified device with respect to the relevant functional parameters. Test results of this study demonstrate that the modified devices are equivalent to unmodified device with respect to device function.

Additional testing has also demonstrated the effectiveness of production techniques to assure that the devices are sterile and non-pyrogenic.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an abstract human figure with three flowing lines emanating from it, enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle.

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

June 6, 2013

Sorin Group Italia S.r.l. ' Scott Light Sorin Group USA, Inc. 14401 W 65th Way Arvada, CO 80004

Re: K131103

Trade/Device Names: XRES Blood Collection Reservoir XRES 120um Blood Collection Reservoir

Regulation Number: 21 CFR 870.4400 Regulation Name: Cardiopulmonary Bypass Blood Reservoir Regulatory Class: Class II Product Code: DTN Dated: May 6, 2013 Received: May 7, 2013

Dear Scott Light:

We have reviewed your Section 510(k) premarket notification of intent to market the devices referenced above and have determined the devices are substantially equivalent (for the indications for use stated in the enclosure) 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the devices, 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your devices are 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 devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your devices 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 devices comply 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

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#### Page 2 - Scott Light

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 devices on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

## Matthew GMMillebrenner

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

Enclosure

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#### Indication for Use:

510(k) Number (if known): K131103

Device Name: XRES Blood Collection Reservoir

Indication for Use: The device is an accessory to an autotransfusion device and is intended for the sterile collection and filtration of recovered blood for subsequent processing for autotransfusion

Device Name: XRES 120pm Blood Collection Reservoir

Indication for Use: The device is an accessory to an autotransfusion device and is intended for the sterile collection and filtration of recovered blood for subsequent processing for autotransfusion

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)

# Matthew G퀘咖lebrenner

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