(192 days)
The PureBMC SupraPhysiologic Concentrating System is intended to be used in a clinical laboratory or intraoperatively at the point of care for the safe and rapid preparation of platelet concentrate from a small sample of bone marrow aspirate. The safety and effectiveness of this device for in vivo indications for use has not been established.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called the "PureBMC SupraPhysiologic Concentrating System." It does not contain information about acceptance criteria or a study that proves the device meets those criteria, as it is a clearance letter, not a study report.
The letter states that the device is "substantially equivalent" to legally marketed predicate devices. This means that the FDA reviewed information provided by the manufacturer (EmCyte Corporation) and determined that the new device is as safe and effective as existing devices on the market for its stated "Indications for Use."
The "Indications for Use" section (page 3) specifies:
"The PureBMC SupraPhysiologic Concentrating System is intended to be used in a clinical laboratory or intraoperatively at the point of care for the safe and rapid preparation of platelet concentrate from a small sample of bone marrow aspirate. The safety and effectiveness of this device for in vivo indications for use has not been established."
Key points from the document regarding the device and its clearance:
- Device Name: PureBMC SupraPhysiologic Concentrating System (available in 30 mL, 60 mL, and 120 mL systems).
- Intended Use: Preparation of platelet concentrate from bone marrow aspirate in a clinical laboratory or intraoperatively.
- Regulatory Status: Cleared via 510(k) as substantially equivalent to predicate devices.
- Regulatory Class: Class I.
- Limitations: The FDA explicitly states that "The safety and effectiveness of this device for in vivo indications for use has not been established." This is a crucial labeling limitation.
Therefore, I cannot provide the requested information because the provided document is an FDA clearance letter and not a study report containing acceptance criteria and performance data from a specific study.
The information requested in your prompt (Tables of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, training set size) is typically found in pre-market submission documents (like the 510(k) summary or detailed study reports) that would have been reviewed by the FDA, rather than the clearance letter itself.
§ 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.