(55 days)
The 3i "CelSep" Centrifuge System, is designed for use in the clinical laboratory or intraoperatively at point-of care, for the safe and effective preparation of platelet poor plasma and platelet concentrate from a small sample (50-60ml) of whole blood.
The plasma and concentrated platelets produced can be used for diagnostic tests.
"CelSep" Centrifuge System consists of a table-top, non self-decanting, swinging bucket centrifuge and single-use processing disposable, designed to permit rapid and completely self-contained and safe separation of plasma and platelets from a small volume of whole blood. The centrifuge spins at a maximum speed of 3400 rpms at a maximum force of approximately 2050g.
The provided text is a 510(k) summary for the 3i CelSep Centrifuge System. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics in the way a medical device seeking de novo authorization or a clinical trial report would.
Therefore, many of the requested sections (2-9) cannot be fully answered as the provided document does not contain that level of detail regarding a formal study to prove performance against acceptance criteria. The submission is a comparison of technological characteristics to a legally marketed predicate device.
Here's an attempt to extract and interpret the information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the traditional sense of performance thresholds for a new device. Instead, the submission focuses on demonstrating substantial equivalence to an existing predicate device based on technological characteristics. The "performance" is implied by demonstrating that its characteristics are similar enough to the predicate to perform the intended function safely and effectively.
| Feature / Characteristic | Predicate Centrifuge (Reference) | 3i "CelSep" (Proposed Device) | Substantial Equivalence Justification / Performance |
|---|---|---|---|
| Principle of operation | Separation based on density processing speed and equipment | Separation based on density processing speed and equipment | Equivalent |
| Table-Top Design | Yes | Yes | Equivalent |
| Refrigerated | No | No | Equivalent |
| Swinging Bucket | Yes | Yes | Equivalent |
| Automatic Decanting | Yes | No (1) | Difference noted: Justified as not required by "CelSep" design (manual, pneumatic decanting with self-contained disposable). |
| Micro-Processor Controlled | Yes | Yes | Equivalent |
| User Programmable | No | Yes | Difference noted: This is an added feature, not a detraction from equivalence. |
| Speed Control | Preset | Selectable | Difference noted: Selectable speed control offers more flexibility. |
| Maximum RPM | 6000g (likely a typo, should be RPM) | 3400 RPM | Difference noted: Lower max RPM, but "CelSep" requires lower speeds. |
| Maximum RCF | 3550g | 2050 RPM (likely a typo, should be g) | Difference noted: Lower max RCF, but "CelSep" requires lower speeds. |
| Processing capacity | 2 disposables 50ml/disposable | 1 disposable 60ml/disposable | Difference noted: Different capacity, but both capable of processing small blood samples. |
| Lid Locking/Holding | Yes | Yes | Equivalent |
| Imbalance Detector | Yes | No (2) | Difference noted: Justified as not required due to lower speeds. |
| Construction | Anti-rotational, metal housing and rotor | Anti-rotational, metal housing and rotor | Equivalent |
Note: The performance of the device in terms of preparing platelet poor plasma and platelet concentrate from a small sample of blood is stated as its intended use. The 510(k) process typically relies on demonstrating that the device performs as well as or in a similar manner to the predicate device for its intended use, rather than requiring new, specific performance metrics studies like accuracy, sensitivity, or specificity. The "acceptance criteria" here are essentially the shared technological characteristics with the predicate device, implying that if the characteristics are substantially equivalent, the performance for the intended use will also be equivalent.
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not describe a formal test set, sample size, or data provenance from a prospective or retrospective study to evaluate the device's performance against specific metrics. The submission focuses on comparing the device's technological characteristics to a predicate device.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not available in the provided 510(k) summary. The submission does not detail a study where ground truth was independently established by experts for a test set.
4. Adjudication Method
This information is not available in the provided 510(k) summary. There is no mention of an adjudication process for a test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not reported in this 510(k) summary. This type of study is typically associated with AI/CAD devices that assist human readers in interpretation, which is not the function of a centrifuge.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
This question is not applicable. The 3i CelSep Centrifuge System is a physical device, not an algorithm, and therefore doesn't have "standalone" algorithm performance in the context of AI/CAD devices. Its operation is independent of human interpretation of algorithmic output.
7. The Type of Ground Truth Used
This information is not available in the provided 510(k) summary. The summary does not describe a study that required establishing 'ground truth' in the context of clinical outcomes, pathology, or expert consensus. The equivalence is based on device characteristics and intended use.
8. The Sample Size for the Training Set
This information is not available in the provided 510(k) summary. The device is a centrifuge, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not available in the provided 510(k) summary. The device is a centrifuge, not an AI model requiring a training set and associated ground truth establishment.
§ 862.2050 General purpose laboratory equipment labeled or promoted for a specific medical use.
(a)
Identification. General purpose laboratory equipment labeled or promoted for a specific medical use is a device that is intended to prepare or examine specimens from the human body and that is labeled or promoted for a specific medical use.(b)
Classification. Class I (general controls). The device is identified in paragraph (a) of this section and is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.