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a single use only, cord blood sampling, transfer device.
The Umbilicup is suitable for vaginal delivery and caesarean delivery.
The Umbilicup reduces blood exposure and aids in blood gas collection and transport.

A blood collection/transfer device with a drinking glass shaped body, divided in half. The top half is used to collect umbilical cord blood for analysis and has a lid. The bottom half has a needle enclosed in rubber used to puncture the rubber caps of vacuum tubes and transfer the collected blood from the top chamber. It is 4 inches in length and 2.5 inches in width.

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a device called "DeRoyal Surgical, Umbilicup." This document primarily addresses the substantial equivalence of the device to a predicate device and regulatory compliance.

It does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria in the context of device performance metrics such as sensitivity, specificity, accuracy, or any clinical study results.

The document states the "Indications for Use Statement" and a brief description of the device: "a single use only, cord blood sampling, transfer device... reduces blood exposure and aids in blood gas collection and transport." However, it does not provide any data or study details to support these claims beyond the device's design and intended function.

Therefore, I cannot extract the requested information (acceptance criteria table, sample size, ground truth details, MRMC study, etc.) from the provided text.

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The Cell Saver 5 Autologous Blood Recovery System is intended for use as an autotransfusion apparatus in conjunction with the Cell Salvage and Sequestration Protocols and single use sterile disposable sets. The Cell Saver 5 Autologous Blood Recovery System is intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and pumping this processed red cell product to either a bag for gravity reinfusion into the patient or to the arterial line of an extracorporeal circuit for reinfusion into the patient. The intended use of the Sequestration Protocol is to collect an autologous preoperative platelet rich plasma product.

LN291A Haemonetics Basic Mini Volume (70mL) Cell Saver 5 Bowl Set is a functionally closed systems intended to be used to perform cell salvage using the CS5 Autologous Blood Recovery Svstem.

LN242 10L Waste Bag is intended to be used as an alternate waste bag with the CS5 Autologous Blood Recovery System.

This Special 510(k) premarket notification describes a modification to Haemonetics' currently legally marketed CELL SAVER 5 SYSTEM and the Cell Saver 5 Protocols and associated disposable sets. The proposed modifications involve the addition of a new smaller volume, blow molded bowl disposable set, the LN291A Basic Mini Volume (70mL) Cell Saver 5 Bowl Set and the associated software and hardware changes required to accommodate the smaller volume set. It also includes the addition of an alternate 10L waste bag, LN242. The intended use of the modified device is the same as for the predicate device and has not changed as result of the changes in software for the Cell Salvage and Sequestration Protocols.

Additionally, the design configuration, material composition, manufacturing methods and operational principles for the changed device are equivalent to those of the predicate device.

This document is a 510(k) premarket notification for a modification to an existing medical device, the Haemonetics Cell Saver 5 Autologous Blood Recovery System. The modification involves adding a new, smaller volume bowl disposable set (LN291A) and an alternate waste bag (LN242), along with associated software and hardware changes.

Therefore, the submission is focused on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and reported performance metrics in the way a novel device might. The document explicitly states: "These changes do not affect the intended use or alter the fundamental scientific technology of the device."

Given this context, many of the requested sections (e.g., sample size for test set, number of experts for ground truth, MRMC study, how ground truth for training set was established) are not applicable because the submission is about demonstrating equivalence of a modified, existing device, not a de novo clearance requiring extensive clinical performance studies.

Here's an attempt to answer the questions based on the provided text, while acknowledging the limitations of the document's purpose:

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

The document does not explicitly state quantitative acceptance criteria or detailed reported device performance metrics in a table format. The basis for acceptance is a demonstration of substantial equivalence to the predicate device. The "performance" assessment is qualitative, focusing on whether the modifications adversely affect performance.

The key claim relating to performance is:

• "Verification testing has been performed and demonstrated that the performance of the modified device is not adversely affected by the software changes." (Section: DESIGN CONTROL ACTIVITIES)
• "The Cell Saver 5 Autologous Blood Recovery System, the Cell Saver 5 Protocols, software revision K, and its associated disposable set LN291A are substantially equivalent to legally marketed devices." (Section: CONCLUSION)

There are no specified numerical targets (e.g., specific recovery rates, wash efficiencies, or platelet counts) or measurements presented for the modified device to compare against. The "acceptance criteria" can be inferred as maintaining the established performance characteristics of the predicate device, which is considered satisfied by the "substantial equivalence" determination.

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

The document does not specify a "test set" in the context of a clinical study or data-driven performance evaluation. The "verification testing" mentioned is likely internal engineering and quality assurance testing related to the software and hardware changes, rather than a clinical trial. Therefore, sample size, data provenance (country of origin), and retrospective/prospective nature are not described.

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)

Not Applicable. The submission does not detail a study involving expert-established ground truth. The assessment is based on design control activities and verification testing to ensure the modified device functions as intended and is equivalent to the predicate.

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

Not Applicable. There is no "test set" or adjudication process described for clinical performance.

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

Not Applicable. This device is an autotransfusion apparatus, not an AI-driven diagnostic or imaging device used with human readers.

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

Not Applicable. This is a hardware and software modification to a medical device, not an algorithm being evaluated in isolation. The "software changes" are integrated into the device's operation.

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

Not Applicable. The submission focuses on substantial equivalence based on engineering and performance characteristics relative to a predicate device, not on specific clinical endpoints validated by ground truth methods like pathology or expert consensus. The "ground truth" (if one could even apply the term loosely) would be the established performance and safety profile of the predicate device.

8. The sample size for the training set

Not Applicable. This document describes a modification to an existing device, not the development of a machine learning model that requires a training set.

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

Not Applicable. As per point 8, there is no training set mentioned or implied in this 510(k) submission.

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To be used with the Haemonetics Cell Saver HaemoLite 2 family of autologous blood recovery systems to collect, concentrate, and wash red blood cells from diluted intraoperative and post-operative shed blood for autotransfusion.

This Special 510(k) premarket notification describes a modification to Haemonetics' currently legally marketed autotransfusion disposable set LN163. The modifications are dimensional changes to 1) the centrifugal processing bowl, and the Final Product Bag and Waste Bag incorporated in the LN163 disposable set, and 2) the disposable thermoformed tub used for packaging of the LN163 disposable set. The intended use of the modified disposable set (the "LN193") is the same as for the LN163 disposable set and has not changed as result of the change in centrifugal blood processing bowl. Additionally, the design configuration, material composition, manufacturing methods and operational principles for the LN193 disposable set are equivalent to those of the LN163 disposable set.

Device Acceptance Criteria and Performance Study

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific quantitative acceptance criteria or detailed performance metrics for the LN193 disposable set. Instead, the primary acceptance criterion is described as "substantial equivalence" to the predicate device (LN163).

However, the summary indicates that "Verification testing has been performed and demonstrated that the performance of the modified LN163 Disposable Set is not adversely affected by the listed changes." This implies that the device successfully met the intended performance standards, which are assumed to be consistent with the predicate device.

Given the information, the table is structured to reflect this focus on substantial equivalence rather than explicit numerical acceptance criteria.

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

The document does not specify a sample size for any test set. The term "verification testing" is used, but details on the number of units tested, the types of tests performed, or the data collected are not provided.

The data provenance is not explicitly stated. However, given it's a 510(k) submission from Haemonetics Corporation (Braintree, MA, USA), the testing would likely have been conducted in the United States or at facilities overseen by the company. It is a retrospective analysis in the sense that the data being submitted is from testing already completed, though the specific nature of the data (e.g., patient data, lab testing) is not detailed.

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

This information is not applicable and not provided for this type of device submission. The device is a disposable set for blood processing, not a diagnostic or screening tool requiring expert interpretation of results. The "ground truth" would be established by objective measurements and functional performance tests rather than expert consensus on diagnostic images or clinical findings.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods are typically used in studies where human interpretation or consensus is required, such as when establishing ground truth for medical imaging analysis. For a manufacturing change to a disposable blood processing set, verification testing would involve objective measurements and comparisons against specifications, not an adjudication process.

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 information is not applicable and not provided. The device is a disposable set for autotransfusion, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant to this submission.

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

This information is not applicable and not provided. The device is a physical disposable medical product, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The document does not explicitly define "ground truth" in a way that aligns with typical diagnostic or AI performance studies. For this device, "ground truth" would implicitly refer to the established performance specifications and functional requirements of the predicate device (LN163). The verification testing would have aimed to demonstrate that the modified LN193 met these same objective performance criteria related to:

• Red blood cell collection, concentration, and washing efficacy.
• Sterility and biocompatibility.
• Integrity and function of the physical components (bowl, bags, tubing).
• Compatibility with the HaemoLite 2 system.

These would be verified through engineering tests, material compliance, and functional performance assessments, not through expert consensus, pathology, or outcomes data in the typical sense.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The device is a physical product, not a machine learning model, so there is no concept of a "training set" in the context of this 510(k) submission.

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

This information is not applicable and not provided for the same reasons as #8.

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