The XTRA Autotransfusion System is indicated for intraoperative recovery of blood, washing of blood collected in the postoperative period, and preoperative sequestration (with indirect patient connection). Typical clinical applications of autotransfusion include the following surgical specialties: Cardiovascular, Orthopedics, Thoracic, Transplant Surgery, Emergency (Trauma), Neurosurgery, Obstetrics and gynecology, and Urology.

Device Description

XTRA is an Autotransfusion System designed to recover shed blood during intraoperative and postoperative procedures and for collection of platelet poor plasma (PPP) and platelet rich plasma (PRP) in preoperative procedures.

It is a software-controlled device provided with disposable and hardware elements that include the following major components: master, driving actuators (pump, centrifuge, clamps, pump loop ejector, cover lock), control and monitoring sensors, and an user interface (display panel and keyboard).

The modified device is a software upgraded version (SW 1.05.0) of the unmodified device (SW 1.02.0).

The current SW release 1.05.0 has been implemented to improve device's performances and to respond to feedback/indications coming from the users in the field. Other minor changes have been also implemented for user convenience and some bugs have been fixed. The main performances improvement implemented with the new SW upgrade consists of the introduction of a new factory protocol (Pfat) that has been optimized to eliminate non emulsified fat from the processed blood. The labeling and the instructions for use have been generally updated to include Pfat features as well as to reflect the modifications, where applicable.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the XTRA Autotransfusion System based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Test Classification	Test Title	Acceptance Criteria	Reported Device Performance
1	Functional/Performance	Processing performances for intraoperative use (fat removal performance)	Successfully met all acceptance criteria	Successfully met all acceptance criteria
2	Functional/Performance	Processing performances for intraoperative use (washing performance)	Successfully met all acceptance criteria	Successfully met all acceptance criteria

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

The document does not specify the exact sample size used for the in vitro test set. It only states that "Comparative tests were performed according to internal methods developed by the manufacturer."

The data provenance is internal to the manufacturer (Sorin Group Deutschland GmbH) as the tests were performed "in vitro" and according to their "internal methods." The country of origin of the data is implicitly Germany, where the submitter is located. The tests were prospective in vitro experiments.

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

Not applicable. This device is an autotransfusion system, and the reported tests are in vitro performance evaluations of its processing capabilities (fat removal and washing performance), not diagnostic interpretations requiring expert human review. The "ground truth" for these tests would be objective measurements of the device's output (e.g., amount of fat removed, effectiveness of washing).

4. Adjudication Method for the Test Set

Not applicable. As noted above, the tests are in vitro performance evaluations, not diagnostic image interpretations that would require adjudication among experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The study performed was an in vitro performance test of the device itself, comparing its performance to an unmodified version of the device, rather than assessing human reader performance with or without AI assistance.

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

Yes, the studies described are standalone in vitro performance tests of the device (which includes software) without human intervention in the performance evaluation itself. The device is a software-controlled system, and its "algorithm" (the software upgrade to version 1.05.0) was tested for its impact on fat removal and washing performance.

7. The Type of Ground Truth Used

The ground truth used for these in vitro performance tests would be objective measurements and laboratory results related to the device's functional outputs, specifically:

For "fat removal performance": objective measurements of the presence or absence of non-emulsified fat in processed blood.
For "washing performance": objective measurements of the effectiveness of the washing process (e.g., removal of plasma, waste products).

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of device performance testing. The device is a "software upgraded version" of an existing system, and the reported tests are in vitro performance validations of this upgrade. There's no indication that machine learning or AI models requiring a training set were developed or validated in this submission. The software upgrade focused on "improving device's performances and to respond to feedback/indications coming from the users in the field."

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

Not applicable, as no training set for a machine learning model is mentioned in the provided text.

Summary

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MAR 2 1 2014

510(k) Premarket Notification March 04, 2014

K131553

SUBMITTER:	Sorin Group Deutschland GmbHLindberghstrasse, 25D-80939 MünchenGermany
CONTACT PERSON:	Luiqi VecchiPhone: 39 0535 29811Fax: 39 0535 25229
DATE PREPARED:	March 04, 2014
DEVICE TRADE NAME:	XTRA
COMMON NAME:	Autotransfusion System
CLASSIFICATION NAME:	Apparatus, Autotransfusion
CLASSIFICATION CODE:	CAC
REGULATION NUMBER:	868.5830
UNMODIFIED DEVICE(S):	XTRA Autotransfusion System (K112245)

510(k) SUMMARY

DEVICE DESCRIPTION:

The modified device is a software upgraded version (SW 1.05.0) of the unmodified device (SW 1.02.0).

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INDICATION FOR USE:

The XTRA Autotransfusion System is indicated for intraoperative and postoperative recovery of blood, washing of the processed blood and preoperative sequestration (with indirect patient connection). Typical clinical applications of autotransfusion include the following surgical specialties: Cardiovascular, Orthopedics, Transplant Surgery, Emergency (Trauma), Neurosurgery, Obstetrics and Gynecology, and Urology.

TECHNOLOGICAL CHARACTERISTICS:

The modified device XTRA with software 1.05.0 has the same fundamental scientific technology, operating principles and control mechanisms of the unmodified device.

Compared to the unmodified device, XTRA with software 1.05.0 is manufactured with the same fundamental manufacturing process and is provided with the same hardware components.

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

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

The disposable provided with both modified and unmodified devices is ethylene oxide sterilized and have a non-pyrogenic fluid path. It is for single use only.

Sorin Group Deutschland GmbH believes that the XTRA with software 1.05.0 is substantially equivalent to the unmodified device and to other currently marketed automated autotransfusion devices, that any differences are minor, and raise no new issues of safety and effectiveness.

NON CLINICAL TEST RESULTS:

Applicable tests were carried out 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 raw materials.

The disposable designed for the modified device, XTRA with software 1.05.0, is identical to the disposable provided with the XTRA Autotransfusion device originally cleared (K101586). The same materials are in contact with blood.

As no new materials are used, this 510(k) cross references biocompatibility data to the XTRA 1.00.0 (K101586).

The electrical safety of XTRA 1.05.0 was determined by testing the unit against the IEC 60601-1 electrical safety standard.

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IN VITROTEST 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.

Comparative tests were performed according to internal methods developed by the manufacturer.

The following table lists the performance tests conducted to demonstrate compliance to the product's performance specifications. The XTRA 1.05.0 successfully met all acceptance criteria for each test.

TEST	TEST CLASSIFICATION	TEST TITLE
1	Functional/Performance	Processing performances for intraoperative use(fat removal performance)
2	Functional/Performance	Processing performances for intraoperative use(washing performance)

CONCLUSIONS:

The results of in vitro studies demonstrate that the XTRA with software 1.05.0 is substantially equivalent to the unmodified device in terms of safety and effectiveness.

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Public Health Service

Food and Drug Administration 0903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 21, 2014

Sorin Group Deutschland GmbH % Mr. Barry Sall, PAC Principal Consultant Parexel Consulting 195 West Street Waltham, MA 02451

Re: K131553

Trade/Device Name: XTRA Autotransfusion System Regulation Number: 21 CFR 868.5830 Regulation Name: Autotransfusion System Regulatory Class: Class II Product Code: CAC Dated: March 4, 2014 Received: March 5, 2014

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 (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 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. 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 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

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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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Bram D. Zuckerman -S

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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Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: XTRA Autotransfusion System

Indications for Use:

Cardiovascular l
Orthopedics
Thoracic -
Transplant Surgery -
Emergency (Trauma) -
Neurosurgerv -
-Obstetrics and gynecology
Urology

Prescription Use _____________________________________________________________________________________________________________________________________________________________

Over-the-Counter Use_

(Part 21 CFR 801 Subpart D)

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)

Bram D. Zuckerman -S 2014.03.21 15:21:39 -04'00'

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Regulation Number and Section

§ 868.5830 Autotransfusion apparatus.

(a)
Identification. An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma.(b)
Classification. Class II (performance standards).