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
Urology

Device Description

XTRA Autotransfusion System consists of hardware and disposables. It is the next generation of the Sorin autotransfusion device family. The main elements of the hardware include the centrifuge, blood pump, automatic clamps, control and monitoring sensors, and an user interface (display panel and keyboard). The main modifications to the disposables are the elimination of the bowl snap on bayonet fitting system to fix the device into the centrifuge, the elimination of the silcone bayon inting bystem to and the newly designed system that allows the set up of the disposable set to simplify the installation of disposable.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the XTRA Autotransfusion System, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state quantitative acceptance criteria for performance metrics. Instead, the basis for equivalence is primarily a comparison to a predicate device (Dideco ELECTA) and compliance with general safety standards.

Criterion Type	Acceptance Criteria (Not explicitly quantitative in this document)	Reported Device Performance
Biocompatibility	Compliance with ISO 10993-1 and FDA May 1, 1995 Memorandum for raw materials. Testing for Hemolysis, Hemocompatibility, Cytotoxicity, Intracutaneous Reactivity, Sensitization, Acute Systemic Toxicity, Mutagenicity, Sterility, Pyrogenicity, ETO residuals, and package integrity. Established specifications in each category met.	"The results of the testing met established specifications." (Implies individual tests passed their respective criteria, although specific values/limits are not provided).
In Vitro Performance	Compliance with performance specifications for electrical testing, electromagnetic compatibility testing, and general performance testing. Substantial equivalence to the predicate device (Dideco ELECTA).	"Testing supplied... includes electrical testing, electromagnetic compatibility testing, and performance testing that demonstrate compliance with performance specifications. The results of the study showed the device characteristics between XTRA Autotransfusion System and Dideco ELECTA were comparable."
Safety & Effectiveness	Substantial equivalence to the predicate device (Dideco ELECTA) in terms of safety and effectiveness.	"The results of in vitro studies demonstrate that the XTRA Autotransfusion System is substantially equivalent to the predicate device in terms of safety and effectiveness."

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

Test Set Sample Size: The document does not specify the sample size for the "in vitro test results." It generally refers to "testing" and "the study."
Data Provenance: The studies were in vitro (laboratory-based testing). The country of origin for the data is not explicitly stated, but the submitter is Sorin Group Italia S.r.l., suggesting the tests were likely conducted in Italy or a contracted facility. The studies appear to be prospective in nature, as they were conducted to support the 510(k) submission.

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

This information is not applicable to the provided document. The studies described are in vitro performance tests and biocompatibility tests, not studies that would require human expert interpretation of device output to establish ground truth in the way a diagnostic imaging device might. Ground truth was established through validated laboratory testing procedures against established specifications and comparison to the predicate device's known characteristics.

4. Adjudication Method for the Test Set

This is not applicable. Since the device is an autotransfusion system and the testing described is primarily in vitro performance and biocompatibility, there is no "adjudication method" in the context of human interpretation of results (e.g., as in a clinical trial or image reading study). The results were likely assessed against pre-defined engineering and safety specifications by qualified testing personnel.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not mentioned or performed. This type of study is typically relevant for diagnostic devices where human readers interpret output (e.g., images), and the AI's impact on reader performance is evaluated. The XTRA Autotransfusion System is a therapeutic/surgical support device.

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

Yes, the "in vitro test results" and biocompatibility tests can be considered standalone performance assessments. These tests evaluate the device's inherent characteristics and functionality (electrical, electromagnetic, performance specifications, and material interactions) without specific "human-in-the-loop" interaction directly influencing the measured outcomes for these particular tests. The device is a piece of medical equipment, and its performance is assessed based on engineering specifications and biological safety.

7. The Type of Ground Truth Used

The ground truth used for these studies consisted of:

Established Specifications: For biocompatibility (e.g., limits for hemolysis, cytotoxicity) and engineering performance (electrical, electromagnetic, mechanical parameters).
Predicate Device Characteristics: For the in vitro performance study, the Dideco ELECTA's characteristics served as the comparative "ground truth" or benchmark for demonstrating substantial equivalence.

8. The Sample Size for the Training Set

This information is not applicable. The XTRA Autotransfusion System is a physical medical device, not an AI/machine learning algorithm that requires a "training set" in the computational sense. The device's design, engineering, and manufacturing would be based on established principles and prior experience, but not a data-driven training set.

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

This information is not applicable for the same reason as point 8.

Summary

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	510(k) SUMMARY	K101586
SUBMITTER:	Sorin Group Italia S.r.I.86, Via Statale 12 Nord41037 Mirandola (MO) Italy
CONTACT PERSON:	Luigi VecchiPhone: 011 39 0535 29811Fax: 011 39 0535 25229
DATE PREPARED:	June 3, 2010	OCT 5 2010
DEVICETRADE NAME:	XTRA
COMMON NAME:	Autotransfusion System
CLASSIFICATION NAME:	Apparatus, Autotransfusion
PREDICATE DEVICE:	Dideco ELECTAK020647

DEVICE DESCRIPTION:

The main modifications to the disposables are the elimination of the bowl snap on bayonet fitting system to fix the device into the centrifuge, the elimination of the silcone bayon inting bystem to and the newly designed system that allows the set up of the disposable set to simplify the installation of disposable.

INDICATION FOR USE:

INDIOATION CON OOL 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, Thoracic, Transplant following "Sarglour" opeolation" "Sansargery, Obstetrics and Gynecology, and Urology.

TECHNOLOGICAL CHARACTERISTICS:

Sorin makes the claim of substantial equivalence to cited predicates based on intended Oom makes the olain of echnological characteristics, and operational characteristics.

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XTRA Autotransfusion System	Traditional 510(k) ~
Sorin Group Italia S.r.l.	June 3, 2010

Sorin Group Italia Srl believes that the XTRA Autotransfusion Svstem is substantially equivalent to the Dideco ELECTA and to other currently marketed automated autotransfusion devices, that any differences are minor, and raise no new issues of safety and effectiveness.

BIOCOMPATIBILITY TEST RESULTS:

A complete battery of tests was carried out in accordance with the requirements of ISO 10993-1 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 Disposable set of XTRA Autotransfusion System (accelerated aging). The device was tested for Hemolysis, Hemocompatibility, Cytotoxicity, Intracutaneous Reactivity, Sensitization, Acute Systemic Toxicity and Mutagenicity, Sterility, Pyrogenicity, ETO residuals and package integrity testing were also conducted. The results of the testing met established specifications.

IN VITRO TEST RESULTS:

Testing supplied in the 510(k) premarket notification for the XTRA Autotransfusion System includes electrical testing, electromagnetic compatibility testing, and performance testing that demonstrate compliance with performance specifications. The results of the study showed the device characteristics between XTRA Autotransfusion System and Dideco ELECTA were comparable.

CONCLUSIONS:

The results of in vitro studies demonstrate that the XTRA Autotransfusion System is substantially equivalent to the predicate device in terms of safety and effectiveness.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three wing-like shapes. The bird is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circular border.

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 195 West Street · Waltham, MA 02451

OCT. 5 2010

Re: K101586

Trade/Device Name: XTRA Autotransfusion System Regulation Number: 21 CFR 868.5830 Regulation Name: Autotransfusion apparatus Regulatory Class: II Product Code: CAC Dated: September 3, 2010 Received: September 7, 2010

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 for abounding 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 I va mayy attrerey misions 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 adulteration: Trease noter u, 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 I least of davisou that I Drivision that your device complies with other requirements of the Act that I DX has made a devel regulations administered by other Federal agencies. You must or any Fedelal statutes and regulations and admited to: registration and listing (21

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Page 2 - Mr. Barry Sall

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

suma R. Vc. Aner

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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XTRA Autotransfusion System Sorin Group Italia S.r.I.

Traditional 510(k) June 3, 2010

Device Name: XTRA Autotransfusion System

(K101586)

Indications for Use:

Cardiovascular
Orthopedics
Thoracic
Transplant Surgery
Emergency (Trauma)
Neurosurgery
Obstetrics and gynecology
Urology

X Prescription Use _ (Part 21 CFR 801 Subpart D) C)

Over-the-Counter Use AND/OR (21 CFR 807 Subpart

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dian R. Vilmer

(Division Sign-Off) (Division Sign of Cardiovascular Devices

540(k) Number Kvolts & C

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).