(32 days)
The Harvest SmartPReP™ CENTRIFUGE SYSTEM is designed to be used in the clinical laboratory or intraoperatively at point-of-care for the safe and rapid preparation of platelet poor plasma and platelet concentrate from a small sample of blood. The plasma and concentrated platelets produced can be used for diagnostic tests.
SmartPReP Centrifuge System: Includes a table-top, self-decanting, swinging bucket centrifuge and processing disposable designed to allow for rapid automatic separation of plasma and platelets. The centrifuge spins at a maximum speed of 6000 rpms at a maximum force of approximately 3550g.
Here is an analysis of the provided text regarding the Harvest Technologies SmartPReP Centrifuge System:
1. A table of acceptance criteria and the reported device performance
Based on the provided text, the submission focuses on demonstrating substantial equivalence to a predicate device rather than defining specific acceptance criteria for performance metrics (e.g., specific platelet concentration levels or plasma purity). The "Substantial Equivalence" section states: "The proposed device is substantially equivalent to other table-top centrifuges previously cleared by the FDA via the 510(k) Notification process."
The table below summarizes the comparison of features between the SmartPReP and the predicate centrifuge, effectively acting as the "acceptance criteria" here, where "reported device performance" means demonstrating that the SmartPReP possesses these characteristics as intended.
| Feature | Acceptance Criteria (Predicate Device Characteristic) | Reported Device Performance (SmartPReP Characteristic) |
|---|---|---|
| Principle of Operation | Separation based on density of liquids | Separation based on density of liquids |
| Table-Top | Yes | Yes |
| Refrigerated | No | No |
| Swinging Bucket | Yes | Yes |
| Automatic Decanting | No | Yes |
| Micro-processor Controlled | Yes | Yes |
| User Programmable | Yes | No, program set by manufacturer |
| Speed Control | Selectable | Preset |
| Acceleration and Braking | Current-controlled | Current-controlled |
| Maximum RPM | 4000 RPM | 6000 RPM |
| Maximum RCF | 3077 g | 3550 g |
| Tube Capacity | Variety of sizes and volumes up to 250mL | Two Processing Disposables (50 mL/disposable) |
| Lid Locking, Lid Holding | Yes | Yes |
| Imbalance Detector | Yes | Yes |
| Construction | Anti-torsion construction, metal housing and rotor | Anti-torsion construction, metal housing and rotor |
Notes on Acceptance Criteria:
- The primary "acceptance criterion" for a 510(k) is demonstrating substantial equivalence to a legally marketed predicate device. This is achieved by showing similar intended use, technological characteristics, and safety and effectiveness.
- For quantitative features like 'Maximum RPM' and 'Maximum RCF', the SmartPReP exceeds the predicate, which is generally acceptable as long as it doesn't raise new questions of safety or effectiveness.
- For differences like 'Automatic Decanting', 'User Programmable', and 'Speed Control', the submission implicitly argues that these differences do not alter the fundamental mechanism of action or intended use in a way that would require new clinical data or raise significant safety concerns.
2. Sample size used for the test set and the data provenance
The provided 510(k) summary does not contain information about a test set with a specific sample size, data provenance, or a study to prove performance against specific clinical or analytical targets. The submission is a comparison of technological characteristics to a predicate device, not a performance study with a test set of samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As noted above, there is no mention of a test set or ground truth established by experts in this submission.
4. Adjudication method for the test set
Not applicable. There is no mention of a test set or adjudication.
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 a centrifuge for preparing blood components, not an AI-assisted diagnostic device that would involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a physical centrifuge, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. This submission is based on a comparison of engineering and design characteristics to a predicate device, not on clinical performance data requiring a ground truth.
8. The sample size for the training set
Not applicable. This device is a centrifuge, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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.