(33 days)
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 include the following surgical specialties: Cardiovascular, Orthopedics, Thoracic, Transplant Surgery, Emergency (Trauma), Neurosurgery, Obstetrics and gynecology, Urology
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: centrifuge, blood pump, automatic clamps, control and monitoring sensors, and an user interface (display panel and kevboard). The modified device is a software upgraded version (SW 1.0.2.0) of the unmodified device. Besides fixing the software bugs, the main differences introduced with the new SW upgrade consist of: change of the parameters of the Pstd intraoperative factory protocol (when a 225 mL bowl size is used for blood processing); change of the table related to hematocrit measurement. when Heparin is used as anticoagulant; addition of Sorin Group Deutschland GmbH as supplementary manufacturing site for the device. Labeling has been also generally updated.
Here's an analysis of the provided text regarding the XTRA Autotransfusion System, addressing your specific questions:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific numerical acceptance criteria for the device's performance. Instead, it focuses on demonstrating substantial equivalence to the unmodified device and compliance with "safety and effectiveness requirements" through "established performance specifications."
The performance reported is generally qualitative:
- The results of in vitro tests "met established performance specifications."
- The device is "substantially equivalent to the unmodified device in terms of safety and effectiveness."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document only mentions "in vitro testing" without detailing the number of samples or runs.
- Data Provenance: The tests were "in vitro," implying laboratory-based testing. While the submitter is Sorin Group Italia S.r.l., the location of the actual testing is not explicitly stated, although it can be inferred to be internal to the manufacturer. The data is retrospective in the sense that it was conducted on the modified device after its creation to demonstrate its performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable. The "ground truth" for this device, an autotransfusion system, would typically relate to its mechanical performance, blood processing efficiency, and safety parameters (e.g., cell viability, contaminant removal). These are objective measurements determined through laboratory testing and engineering specifications rather than expert consensus on diagnostic images or clinical assessments.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. As mentioned above, the "ground truth" is based on objective in vitro measurements and engineering specifications, not on subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- MRMC Study: No. This device is an autotransfusion system, a medical device for blood processing, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant and was not performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Yes, in the sense that the device's performance was evaluated based on its own operational parameters and outputs (e.g., processed blood quality) through "in vitro testing." Since it's an autotransfusion system, its primary function is automated blood processing, not providing diagnostic information that would then be interpreted by a human. The "algorithm" here refers to the software controlling the machine. The "in vitro studies" directly assess the algorithmic and mechanical performance of the device without a human in the diagnostic loop.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for this device is based on objective laboratory measurements and established performance specifications for autotransfusion systems. These specifications would relate to parameters like:
- Blood processing efficiency (e.g., red blood cell recovery).
- Removal of contaminants (e.g., plasma, anticoagulant, cellular debris).
- Hemolysis levels.
- System accuracy and consistency.
- Biocompatibility, as evidenced by cross-referencing to the unmodified device and ISO standards.
8. The Sample Size for the Training Set
- Sample Size: Not applicable/Not specified. This document describes a software upgrade (SW 1.0.2.0) to an existing autotransfusion system. Such systems are traditionally developed and validated through engineering design, rigorous testing, and verification/validation activities against specifications. They are not typically "trained" in the machine learning sense with a "training set" of data to learn patterns. The software upgrade focused on fixing bugs and changing parameters, which would be part of a traditional software development lifecycle, not an AI/machine learning training process.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth Was Established: Not applicable. As explained above, there isn't a "training set" in the context of an AI-driven learning algorithm for this device. The software's "ground truth" or correct behavior is defined by its engineering specifications and the functional requirements of the autotransfusion process. Any "training" would have been in the traditional engineering sense of testing and refining the software against known correct outputs based on physical principles and established medical standards for blood processing.
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510(k) SUMMARY
Sorin Group Italia S.r.I. 86. Via Statale 12 Nord 41037 Mirandola (MO) Italy
CONTACT PERSON: Luigi Vecchi Phone: 39 0535 29811 Fax: 39 0535 25229 DATE PREPARED: August 4, 2011 DEVICE TRADE NAME: XTRA
COMMON NAME: Autotransfusion System
CLASSIFICATION NAME: Apparatus, Autotransfusion
UNMODIFIED DEVICE: XTRA Autotransfusion System (#K101586)
Classification Product Code CAC
Regulation Number 868.5830
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: centrifuge, blood pump, automatic clamps, control and monitoring sensors, and an user interface (display panel and kevboard).
The modified device is a software upgraded version (SW 1.0.2.0) of the unmodified device.
Besides fixing the software bugs, the main differences introduced with the new SW upgrade consist of: change of the parameters of the Pstd intraoperative factory protocol (when a 225 mL bowl size is used for blood processing); change of the table related to hematocrit measurement. when Heparin is used as anticoagulant; addition of Sorin Group Deutschland GmbH as supplementary manufacturing site for the device. Labeling has been also generally updated.
SUBMITTER:
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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, Thoracic, Transplant Surgery, Emergency (Trauma), Neurosurgery, Obstetrics and Gynecology, and Urology.
TECHNOLOGICAL CHARACTERISTICS:
The modified device XTRA with software 1.02.0 has the same materials, fundamental scientific technology, operating principles and control mechanisms of the unmodified device.
Compared to the unmodified device, XTRA with software 1.02.0 is manufactured with the same manufacturing steps 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 Italia S.r.l. believes that the XTRA with software 1.02.0 is substantially equivalent to the unmodified device and to other currently marketed 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 1.02.0 is identical to the disposable provided with the unmodified device (#K101586) and is characterized by the same materials in blood contact.
As no new materials are used, this 510(k) cross references biocompatibility data for the unmodified device, the XTRA Autotransfusion System (#K101586).
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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.
Comparative tests were performed according to internal methods developed by the manufacturer.
The results of these tests met established performance specifications.
CONCLUSIONS:
The results of in vitro studies demonstrate that the XTRA with software 1.02.0 is substantially equivalent to the unmodified device in terms of safety and effectiveness.
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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 image of an eagle or bird with three curved lines representing its wings or feathers. The bird is positioned above a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
Food and Drug Administration 10903 New Flampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Sorin Group Italia S.r.I. c/o Mr. Barry Sall 195 West Street Waltham. MA 02451
SFP - 6 2011
Re: K112245
Trade/Device Name: XTRA Autotransfusion System Regulation Number: 21 CFR 868.5830 -Regulation Name: Autotransfusion apparatus Regulatory Class: II Product Code: CAC Dated: August 4, 2011 Received: August 4, 2011
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. Iisting 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
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Page 2 - Mr. Barry Sall
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.
ff 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.hum.
Sincerely yours.
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.
510(k) Number (if known): K112245
Device Name: XTRA Autotransfusion System Indication for Use:
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 include the following surgical specialties:
- Cardiovascular .
- Orthopedics ●
- Thoracic ●
- Transplant Surgery .
- Emergency (Trauma) .
- Neurosurgery
- Obstetrics and gynecology
- Urology
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)
(Division Sign-Of (Division Sign-Off), Office of Device of Device Evaluation (ODE)
Division of Cardiovascular Devices
ל 12245 510(k) Number
દર્ભ
§ 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).