(106 days)
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"
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).
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.
§ 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).