(21 days)
The SmartPReP2 Centrifuge System is intended 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 and for preparation of a cell concentrate from bone marrow.
The 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.
Not Found
Unfortunately, the provided document is a 510(k) clearance letter from the FDA for a medical device (SmartPReP2 Centrifuge System and SmartPReP Centrifuge System).
This type of document primarily confirms that the device is substantially equivalent to a legally marketed predicate device and outlines regulatory compliance.
It does NOT contain the detailed information required to answer your specific questions regarding acceptance criteria, study design, expert involvement, and ground truth establishment.
The document focuses on:
- Device name and intended use.
- Regulatory classification.
- Reference to the predicate device.
- General regulatory requirements for the manufacturer.
To answer your questions, you would typically need to refer to a detailed study report, a scientific publication, or the actual 510(k) submission document itself (which often includes more detailed performance data and study summaries, though not always in the exact format you're looking for).
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure in profile, with three faces overlapping to represent the department's focus on people and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 13, 2016
Harvest Technologies Corp. Mr. John D. Bonasera Director, Regulatory Affairs 40 Grissom Road Suite 100 Plymouth, MA 02360
Re: K103340
Trade/Device Name: SmartPReP2 Centrifuge System with ACD-A (30ml) and SmartPReP Centrifuge System with ACD-A (30ml) Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: Class II Product Code: FMF, JQC Dated: November 9, 2010 Received: November 15, 2010
Dear Mr. Bonasera:
This letter corrects our substantially equivalent letter of December 6, 2010.
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. 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.
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.
{1}------------------------------------------------
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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Leonthena R. Carrington -S
Leonthena R. Carrington, MS, MBA, MT(ASCP) Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
INDICATIONS FOR USE FORM
510k Number (if known)
Device Name: SmartPReP®2 Centrifuge System with ACD-A (30ml)
Indications for Use: The SmartPReP2 Centrifuge System is intended 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 and for preparation of a cell concentrate from bone marrow.
Prescription Use Part 21 CFR 801 Subpart D
and
Over-The-Counter Use 21 CFR 810 Subpart C
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
· · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · ----------------------------------------------------------------------------------
Division Sign-Off
Office of In Vitro Diagnostic Office of in Millo Blagher Device Evaluation and Safety
510(k) K103340
{3}------------------------------------------------
INDICATIONS FOR USE FORM
510k Number (if known)
Device Name: SmartPRePTM Centrifuge System with ACD-A (30ml)
Indications for Use: The 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.
Prescription Use ﺮ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ Part 21 CFR 801 Subpart D
and
Over-The-Counter Use 21 CFR 810 Subpart C
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) ******************************************************************************************************************************************************************************
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K103340
§ 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.