(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.
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May 30, 2019
EmCyte Corporation Patrick Pennie Chairman & CEO 4331 Veronica S. Shoemaker Blvd, Suite 4 Fort Myers, Florida 33916
Re: K183205
Trade/Device Name: PureBMC SupraPhysiologic Concentrating System 30 mL System. PureBMC SupraPhysiologic Concentrating System 60 mL System. PureBMC SupraPhysiologic Concentrating System 120 mL System Regulation Number: 21 CFR 862.2050 Regulation Name: General purpose laboratory equipment labeled or promoted for a specific medical use Regulatory Class: Class I Product Code: JQC Dated: October 29, 2018 Received: November 19, 2018
Dear Patrick Pennie:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
The OHT7: Office of In Vitro Diagnostics and Radiological Health has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that
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such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the device's labeling:
The safety and effectiveness of this device for in vivo indications for use has not been established.
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.
The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4. Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and
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Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For, Timothy Stenzel, M.D., Ph.D. Director OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K183205
Device Name
PureBMC SupraPhysiologic Concentrating System
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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§ 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.