(78 days)
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No
The summary describes a centrifuge system for preparing blood and bone marrow samples, with no mention of AI, ML, image processing, or data-driven decision-making.
No
The device is used to prepare blood components, such as platelet poor plasma, platelet concentrate, and cell concentrate, from blood or bone marrow samples. While these prepared components might be used in therapeutic applications, the device itself is a centrifuge for preparation, not a direct therapeutic intervention.
No
The device is described as a centrifuge system used for preparing blood components (platelet poor plasma, platelet concentrate) and cell concentrate from bone marrow. Its intended use is for "preparation," not for diagnosing diseases or conditions.
No
The device description explicitly states it includes a "table-top, self-decanting swinging bucket centrifuge," which is a hardware component.
Based on the provided information, the SmartPReP2 Centrifuge System is likely an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states it's 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." These are procedures performed on biological samples (blood and bone marrow) outside of the body to obtain components for further analysis or use. This aligns with the definition of an in vitro diagnostic device.
- Care Setting: It's intended for use in a "clinical laboratory or intraoperatively at point-of-care." Clinical laboratories are a primary setting for IVD testing.
- Device Description: While it's a centrifuge, the description mentions a "Process Disposable" and accessories for separating cells from bone marrow aspirate. This suggests it's part of a system designed for processing biological samples.
While the document doesn't explicitly state "IVD," the intended use and the nature of the procedures performed strongly indicate that it falls under the category of an In Vitro Diagnostic device. It's used to prepare components from biological samples for diagnostic or therapeutic purposes, which is a core function of many IVDs.
N/A
Intended Use / 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.
Product codes
FMF, JQC
Device Description
The Harvest Technologies SmartPReP2 System includes a table-top, self-decanting swinging bucket centrifuge. The SmartPReP2 Bone Marrow Procedure Pack includes a Process Disposable and other accessories to allow for separation of cells from bone marrow aspirate.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
clinical laboratory or intraoperatively at point-of-care
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Results of biocompatibility and performance testing have established that the SmartPReP2 System is suitable for the intended use indicated.
Key Metrics
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Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized image of three human profiles facing to the right, stacked one behind the other.
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 of Regulatory Affairs 40 Grissom Road Suite 100 Plymouth, MA 02360
Re: K052925
Trade/Device Name: SmartPReP2 Centrifuge System Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: Class II Product Code: FMF, JQC Dated: October 14, 2005 Received: October 18, 2005
Dear Mr. Bonasera:
This letter corrects our substantially equivalent letter of January 4, 2006.
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.
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
1
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
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INDICATIONS FOR USE STATEMENT
510(k) Number if Known: K052925
Device Name:
SmartPReP2 Centrifuge System
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/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert M. Becker
Division Sign-Off
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Office of In Vitro Diagnostic Device
Evaluation and Safety
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JAN 4 2006
510(k) Summary for the SmartPReP2 Centrifuge System for Bone Marrow Processing
Page 1 of 1 Submitter's Name and Address: Harvest Technologies Corp. 40 Grissom Road, Suite 100 Plymouth, MA Phone Number: 508-732-7530 Telefax Number: 503-732-0400 Contact Person: John D. Bonasera, Director, Regulatory Affairs Date Summary Prepared: September 20, 2005 Device Trade Name: SmartPReP2 Centrifuge System Common Name: Centrifuge for Clinical Use Classification Name: General Purpose Laboratory Centrifuge Labeled or Promoted for a Specific Medical Use Regulation Number: 21 CFR 862.2050 Substantial Equivalence: The proposed device is substantially equivalent to SmartPReP Centrifuge System described in K991430 and other table-top centrifuges previously cleared by the FDA via the 510(k) Notification process. Device Description: The Harvest Technologies SmartPReP2 System includes a table-top, self-decanting swinging bucket centrifuge. The SmartPReP2 Bone Marrow Procedure Pack includes a Process Disposable and other accessories to allow for separation of cells from bone marrow aspirate. Intended Use: The SmartPReP2 Centrifuge System is intended to be used in the clinical laboratory or intraoperatively at pointof-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. Technological Characteristics: The proposed device has the same technological characteristics and is similar in design and configuration compared with the predicate devices.
Performance Testing: Results of biocompatibility and performance testing have established that the SmartPReP2 System is suitable for the intended use indicated.