For XTRA Collection sets:
"The XTRA Autotransufion System (including the XTRA Collection sets) 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"

For XTRA Sequestration set X:
"The XTRA Autotransufion System (including the XTRA Sequestration set X) 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 Sequestration set X: The XTRA Sequestration set X is a single use sterile device made of plastic materials (mainly PVC) and it should be used in combination with a Bowl set and the XTRA autologous blood separation equipment unit (XTRA Equipment) for preoperative sequestration, aimed at autotransfusion. The XTRA Sequestration set consists of a system of tubing lines and bags, the autologous blood is recovered from the patient through routine hemodilution techniques and it's mixing with an anticoagulant in a blood bag, when blood is sufficient to fill the bowl set blood processing starts in order to separate blood into red blood cells (RBC), platelet poor plasma (PPP) and concentrated platelets or platelet rich plasma (PRP). In the bowl, because of centrifuqal force the blood components are separated and the RBC. PPP and PRP are collected into collection bags while the undesired elements (lysed cells, residuals, water, etc.) are discarded into a waste bag. The blood processed and collected in the bags is then reinfused to the patient through gravity. The system does not provide any mechanical means of reinfusing the product. The XTRA Sequestration set is a modified version of the disposable currently marketed in the XTRA autotransfusion system (K101586).

XTRA Collection sets: The XTRA Collection sets are single use sterile devices made of plastic materials (mainly PVC) and they should be used in combination with the XTRA autologous blood separation equipment unit (XTRA Equipment) for intraoperative cell salvage and/or postoperative cell salvage, aimed at autotransfusion. The XTRA Collection sets consist of a blood collection reservoir, an aspiration and anticoagulation line, a vacuum extension line and a system of tubing lines, the autologous blood is collected from the field by mean of a vacuum source (vacuum pump provided into the equipment) into a blood collection reservoir and filtered to remove large clots, debris and microaggregate and blood defoaming. From the reservoir, the blood may be immediately used for direct administration to the patient in case of emergency, otherwise, the collected blood is processed with a Bowl set (wash set) and then reinfused to the patient through gravity. The system does not provide any mechanical means of reinfusing the product. The XTRA Collection sets are a modified version of the disposables currently marketed in the XTRA autotransfusion system (K101586) and in the XRES/XRES 120um Blood Collection Reservoirs (K131103).

AI/ML Overview

This document describes a 510(k) premarket notification for the XTRA Collection sets and XTRA Sequestration set X, which are autotransfusion apparatus. The submission primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a novel AI/software-driven medical device. Therefore, a significant portion of the requested information regarding AI acceptance criteria and performance studies (e.g., MRMC studies, standalone AI performance, training/test set details, expert involvement in ground truth establishment) is not applicable to this filing as it does not describe an AI medical device.

The provided text indicates that the changes to the device are primarily related to material changes (removal of DEHP from PVC components) and a minor design change in an Aspiration and Anticoagulation line, along with a change in supplier for a drip chamber component. No clinical testing was conducted because the device's indications for use and technical characteristics are considered equivalent to the predicate devices with proven safety and efficacy.

However, I can extract information related to the non-clinical performance data and the basis for the substantial equivalence claim.

Here's the breakdown of the information that can be gleaned from the document, along with explanations for the parts that are not applicable:

1. A table of acceptance criteria and the reported device performance

Since this is not an AI/software device, there isn't a table of AI-specific acceptance criteria like accuracy, sensitivity, specificity, etc. The acceptance criteria are implicitly met by demonstrating substantial equivalence through non-clinical performance testing validated against applicable voluntary standards.

The document states:

"The XTRA Sequestration set X and XTRA Collection sets comply with all the applicable voluntary standards related to Autotransfusion systems. The devices passed all the testing in accordance with national and international standards."

This implies that the acceptance criteria are adherence to these standards, which encompass various performance aspects such as material compatibility, sterility, pyrogenicity, and mechanical integrity of the components required for safe and effective autotransfusion.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable as this is not an AI/software device submission requiring a test set for performance evaluation in the context of machine learning. The "testing" referred to is non-clinical verification and validation (e.g., bench testing, material testing, mechanical testing). No patient data is involved in this type of submission for demonstrating substantial equivalence based on material and minor design changes.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable. Ground truth establishment by experts is relevant for AI/software submissions that rely on human-labeled data for training and evaluation. For this device, "ground truth" would relate to the functional specifications and safety/performance standards for autotransfusion apparatus, which are established through engineering design, material science, and regulatory compliance, not expert image/data labeling.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. Adjudication methods are typically used to resolve discrepancies in expert labeling for AI ground truth or in reader studies. This type of review is not relevant for non-clinical device testing in a 510(k) for material changes.

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. MRMC studies are used to evaluate the impact of AI assistance on human performance in diagnostic tasks. This device is an autotransfusion apparatus, not a diagnostic AI system, and therefore, no MRMC study was conducted.

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

This is not applicable. Standalone performance is evaluated for AI algorithms. This device does not contain an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

As explained previously, "ground truth" in the AI context is not applicable here. The "truth" or "basis" for device performance is demonstrated through:

Compliance with applicable voluntary standards: This includes national and international standards for autotransfusion systems.
Non-clinical verification and validation testing: This covers aspects like material properties, functional performance (e.g., blood collection, washing, concentrating), sterility, and pyrogenicity.
Substantial equivalence to predicate devices: The predicate devices have a proven track record of safety and efficacy.

8. The sample size for the training set

This is not applicable. There is no training set mentioned or implied as this is not an AI/machine learning device.

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

This is not applicable. As no training set exists, no ground truth needed to be established for it.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

August 16, 2024

Sorin Group Italia S.r.1. Martina Carlini RA Specialist Via Statale 12 Nord, 86 Mirandola (Modena). 41037 Italy

Re: K241236

Trade/Device Name: XTRA Collection sets; XTRA Sequestration set X Regulation Number: 21 CFR 868.5830 Regulation Name: Autotransfusion Apparatus Regulatory Class: Class II Product Code: CAC Dated: May 2, 2024 Received: July 18, 2024

Dear Martina Carlini:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely, Digitally signed Kathleen ( by Kathleen M. M. M. / Grunder -S Date: 2024.08.16 Grunder -S 15:28:30 -04:00 for Nicole Gillette Assistant Director DHT2B: Division of Circulatory Support, Structural, and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K241236

Device Name

XTRA Collection sets:

XTRA Sequestration set X

Indications for Use (Describe)

For XTRA Collection sets:
"The XTRA Autotransufion System (including the XTRA Collection sets) 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"

For XTRA Sequestration set X:

"The XTRA Autotransufion System (including the XTRA Sequestration set X) 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"

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/4/Picture/0 description: The image shows the logo for LivaNova, a medical technology company. The logo consists of the company name in a stylized purple font. Below the name is the tagline "Health innovation that matters" in a smaller, orange font. The logo is simple and modern, and it conveys the company's focus on health and innovation.

510(k) Summary

(in accordance with 21 CFR 807.92)

510(k) Number: K241236

Applicant:	SORIN GROUP ITALIA S.R.L. Via Statale 12 Nord, 86 Mirandola, MO 41037 Italy
Contact Person:	Martina Carlini Regulatory Affairs Specialist Tel: +39 0535 29811 e-mail: martina.carlini@livanova.com
Application Correspondent:	SORIN GROUP ITALIA S.R.L. Via Statale 12 Nord, 86 Mirandola, MO 41047 Italy
Contact Person:	Martina Carlini Regulatory Affairs Specialist Tel: +39 0535 29811 e-mail: martina.carlini@livanova.com

August 16th 2024 Date Prepared:

II. Subject Device Identification

Device Trade Name:	XTRA Sequestration set XandXTRA Collection sets
Classification Name:	Apparatus, Autotransfusion
Regulation Number:	21 CFR 868.5830
Product Code:	CAC
Classification:	Class II
Classification Panel:	Anesthesiology

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lll. Predicate Device

The XTRA Sequestration set X is substantially equivalent to the following cleared predicate device. Both models have the same fundamental scientific technology and intended use:

510(k) Number:	K101586
Device Trade Name:	XTRA autotransfusion system
Classification Name:	Apparatus, Autotransfusion
Regulation Number:	21 CFR 868.5830
Product Code:	CAC
Classification:	Class II
Classification Panel:	Anesthesiology

The XTRA Collection set is substantially equivalent to the following cleared predicate devices. Both models have the same fundamental scientific technology and intended use:

510(k) Number:	K101586	K131103
Device Trade Name:	XTRA autotransfusionsystem	XRES/XRES 120µm BloodCollection Reservoirs
Classification Name:	Apparatus,Autotransfusion	Reservoir, blood,cardiopulmonary bypass
Regulation Number:	21 CFR 868.5830	21 CFR 870.4400
Product Code:	CAC	DTN
Classification:	Class II	Class II
Classification Panel:	Anesthesiology	Cardiovascular

IV. Device Description

XTRA Sequestration set X

The XTRA Sequestration set X is a single use sterile device made of plastic materials (mainly PVC) and it should be used in combination with a Bowl set and the XTRA autologous blood separation equipment unit (XTRA Equipment) for preoperative sequestration, aimed at autotransfusion.

The XTRA Sequestration set consists of a system of tubing lines and bags, the autologous blood is recovered from the patient through routine hemodilution techniques and it's mixing with an anticoagulant in a blood bag, when blood is sufficient to fill the bowl set blood processing starts in order to separate blood into red blood cells (RBC), platelet poor plasma (PPP) and

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Image /page/6/Picture/0 description: The image contains the logo for LivaNova. The logo is purple and has the word "LivaNova" in a stylized font. Below the logo is the text "Health innovation that matters" in a smaller, orange font. The logo is simple and modern, and the text below it conveys the company's mission.

concentrated platelets or platelet rich plasma (PRP). In the bowl, because of centrifuqal force the blood components are separated and the RBC. PPP and PRP are collected into collection bags while the undesired elements (lysed cells, residuals, water, etc.) are discarded into a waste bag. The blood processed and collected in the bags is then reinfused to the patient through gravity. The system does not provide any mechanical means of reinfusing the product.

The XTRA Sequestration set is a modified version of the disposable currently marketed in the XTRA autotransfusion system (K101586).

XTRA Collection sets

The XTRA Collection sets are single use sterile devices made of plastic materials (mainly PVC) and they should be used in combination with the XTRA autologous blood separation equipment unit (XTRA Equipment) for intraoperative cell salvage and/or postoperative cell salvage, aimed at autotransfusion.

The XTRA Collection sets consist of a blood collection reservoir, an aspiration and anticoagulation line, a vacuum extension line and a system of tubing lines, the autologous blood is collected from the field by mean of a vacuum source (vacuum pump provided into the equipment) into a blood collection reservoir and filtered to remove large clots, debris and microaggregate and blood defoaming. From the reservoir, the blood may be immediately used for direct administration to the patient in case of emergency, otherwise, the collected blood is processed with a Bowl set (wash set) and then reinfused to the patient through gravity. The system does not provide any mechanical means of reinfusing the product.

The XTRA Collection sets are a modified version of the disposables currently marketed in the XTRA autotransfusion system (K101586) and in the XRES/XRES 120um Blood Collection Reservoirs (K131103).

V. Indications for Use

The XTRA Autotransufion System (including the XTRA Sequestration set X and the XTRA Collection sets) 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.

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Image /page/7/Picture/0 description: The image shows the logo for LivaNova, a medical technology company. The logo is purple and consists of the word "LivaNova" in a bold, sans-serif font. Below the company name is the tagline "Health innovation that matters" in a smaller, orange font. The logo is simple and modern, and it conveys a sense of innovation and health.

VI. Summary of Technical Characteristics

The XTRA Sequestration set X and the XTRA Collection sets have the same fundamental technological characteristics, principles of operation and control mechanisms as the unmodified devices.

Several components made of PVC materials were changed within the modified XTRA Sequestration set X and XTRA Collection sets in order to remove the diethylhexyl phthalate (DEHP) used as plasticizer currently present in the device.

Additionally, for the XTRA Collection sets, a new Aspiration and Anticoagulation line (AAL1/4-20ft) has been created. It will be identical to the AAL1/4, the only difference is in the length of the main tube of the line, which will be longer (20ft) then the current AAL1/4.

Moreover, the supplier of the 2-way drip chamber of the AAL lines (AAL1/4, AAL1/4-20ft and AAL1/4-3/8) has been changed so, also the component itself is changed. The current 2-way drip chamber and the new one are very similar. but the new one is slightly different in the design of the pipe bonding profile, which doesn't have a double wall anymore.

No other design changes have been made to the devices.

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

VII. Non-Clinical Performance Data

Sorin Group Italia S.r.l. has conducted verification and validation testing of the XTRA Sequestration set and XTRA Collection sets, as disposable parts of an autotransfusion system capable of providing adequate blood collection from the operating field or from the extracorporeal circuit, washing and concentrating the blood products which then have to be reinfused to the patient.

The XTRA Sequestration set X and XTRA Collection sets comply with all the applicable voluntary standards related to Autotransfusion systems. The devices passed all the testing in accordance with national and international standards.

VIII. Clinical Performance Data

No clinical testing was conducted in support of the XTRA Sequestration set X and XTRA Collection sets, as the indications for use and technical characteristics are equivalent to those of the predicate devices, which have been on the market for several years with proven safety and efficacy of use. The non-clinical testing summarized in this submission supports the substantial equivalence of the subject devices with the predicate devices when used according to their intended use.

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Health innovation that matters

IX. Statement of Substantial Equivalence

Based on equivalent intended use and technological characteristics, as well as on equivalent performance testing, the XTRA Sequestration set X and the XTRA Collection sets can be deemed to be substantially equivalent to their predicate devices, for the Sequestration set the disposable of the Unmodified XTRA Autotransfusion system, cleared under K101586, while, for the Collection sets the disposables of the Unmodified XTRA Autotransfusion system, cleared under K101586, and of the Unmodified XRES/XRES 120um Blood Collection Reservoirs, cleared under K131103.

The XTRA Sequestration set X and XTRA Collection sets, as designed and manufactured, do not raise new questions regarding safety and effectiveness as compared to their predicate devices and are determined to be substantially equivalent to their predicate devices, the disposables of the Unmodified XTRA Autotransfusion system and XRES/XRES 120µm Blood Collection Reservoirs.

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).