(27 days)
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.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (LN163) | Demonstrated through verification testing; modifications (dimensional changes) do not affect intended use or alter fundamental scientific technology. Device is deemed "substantially equivalent to legally marketed devices." |
| Performance not adversely affected by dimensional changes | "Verification testing has been performed and demonstrated that the performance of the modified LN163 Disposable Set is not adversely affected by the listed changes." |
| Intended Use Maintained | The intended use of 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." |
| Equivalent design configuration, material composition, manufacturing methods, and operational principles | "the design configuration, material composition, manufacturing methods and operational principles for the LN193 disposable set are equivalent to those of the LN163 disposable set." |
| Conformity to Quality System Regulations | Haemonetics operates under a quality system based on FDA's Quality System Regulation, ISO 9001, EN 46001, and Medical Device Directive 93/42/EEC. |
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.
§ 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).