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 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for two medical devices, the XRES Blood Collection Reservoir and the XRES 120µm Blood Collection Reservoir. This submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving that an AI-driven device meets specific acceptance criteria through a clinical study.

Therefore, many of the requested elements (e.g., sample sizes for test sets, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, training set details) are not applicable to this document, as it concerns a physical medical device and its performance, not an AI or digital health product.

Here's a breakdown of the information that is available based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria. Instead, it refers to "performance specifications" and concludes that the modified devices "successfully met all acceptance criteria for each test" and "perform in a manner substantially equivalent to the unmodified device with respect to the relevant functional parameters." The performance is reported in a qualitative manner, affirming compliance.

Test Title	Test Classification	Acceptance Criteria	Reported Device Performance
Break-through time and volume	Functional/Performance	Not explicitly stated, implicitly met performance specifications and substantial equivalence	Successfully met all acceptance criteria, substantially equivalent to unmodified device.
Defoaming efficiency	Functional/Performance	Not explicitly stated, implicitly met performance specifications and substantial equivalence	Successfully met all acceptance criteria, substantially equivalent to unmodified device.
Filtration efficiency	Functional/Performance	Not explicitly stated, implicitly met performance specifications and substantial equivalence	Successfully met all acceptance criteria, substantially equivalent to unmodified device.
Graduated scale accuracy/residual volume	Functional/Performance	Not explicitly stated, implicitly met performance specifications and substantial equivalence	Successfully met all acceptance criteria, substantially equivalent to unmodified device.
Hemolysis	Functional/Performance	Not explicitly stated, implicitly met performance specifications and substantial equivalence	Successfully met all acceptance criteria, substantially equivalent to unmodified device.

Note: The acceptance criteria are implied to be "meeting the product's performance specifications" and demonstrating "substantial equivalency" to the predicate device.

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

The document indicates "In vitro testing was conducted," comparing the XRES 120µm (which included all modifications) to the unmodified XRES device. However, it does not specify the sample size for this in vitro testing (e.g., number of devices tested, number of runs).

Sample Size: Not specified for test set.
Data Provenance: The tests are in vitro, meaning they were conducted in a laboratory setting. No country of origin is explicitly stated for the testing data, but the submitter is "Sorin Group Italia" and the contact person is from Italy. The context suggests the testing was likely conducted or overseen by the manufacturer. It is a prospective evaluation of the new device designs against established performance metrics.

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

This is not applicable as the document describes performance testing of a physical medical device (blood collection reservoir), not an AI or digital health product that requires expert-established ground truth for a test set. The "ground truth" for this device would be objective measurements of its physical and functional performance characteristics.

4. Adjudication method for the test set

This is not applicable for the same reasons as #3.

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

This is not applicable as the document describes a physical medical device, not an AI-assisted diagnostic or therapeutic tool involving human readers.

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

This is not applicable as the document describes a physical medical device, not an algorithm.

7. The type of ground truth used

The ground truth used for this device would be based on objective measurements and laboratory analyses of the device's functional performance, such as:

Fluid dynamics measurements (e.g., break-through time and volume)
Microscopic analysis of filtered contents for filtration efficiency
Precision measurements for graduated scale accuracy
Biochemical analysis for hemolysis levels

8. The sample size for the training set

This is not applicable as the document describes a physical medical device. There is no concept of a "training set" in the context of this 510(k) submission.

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

This is not applicable as there is no training set for this type of device submission.

Summary

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510(k) SUMMARY

JUN 6 2013

SUBMITTER:	Sorin Group Italia86. Via Statale 12 Nord41037 Mirandola (MO) Italy
CONTACT PERSON:	Luigi VecchiPhone: 39 0535 29811Fax: 39 0535 25229
DATE PREPARED:	April 18, 2013
DEVICE TRADE NAMES:	XRES Blood Collection ReservoirXRES 120um Blood Collection Reservoir
COMMON NAME:	Blood Collection Reservoir
CLASSIFICATION NAME:	Cardiopulmonary Bypass Blood Reservoir
UNMODIFIED DEVICE:	XRES Blood Collection Reservoir (K100507)

DEVICE DESCRIPTION:

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INDICATIONS FOR USE:

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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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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.