(32 days)
Not Found
Not Found
No
The summary describes a centrifuge system for blood separation and does not mention any AI or ML components or functionalities.
No.
The device is used for the "preparation of platelet poor plasma and platelet concentrate" for "diagnostic tests", not for therapeutic purposes.
No
Explanation: The device is used for the "preparation of platelet poor plasma and platelet concentrate from a small sample of blood." The output of this device, "plasma and concentrated platelets," can then be "used for diagnostic tests," but the device itself does not perform diagnostics.
No
The device description explicitly states it includes a "table-top, self-decanting, swinging bucket centrifuge," which is a physical hardware component.
Based on the provided information, the Harvest SmartPReP™ CENTRIFUGE SYSTEM is not an IVD (In Vitro Diagnostic) device itself, but it is a device used to prepare samples for diagnostic tests.
Here's why:
- Intended Use: The intended use states that the plasma and concentrated platelets produced by the system "can be used for diagnostic tests." This indicates that the system is a tool for sample preparation, not a diagnostic test itself.
- Device Description: The description details a centrifuge and processing disposable designed for separating blood components. This is a physical process, not a diagnostic assay or test.
- Lack of Diagnostic Function: There is no mention of the device performing any analysis, measurement, or interpretation of biological samples to diagnose a condition or disease.
In summary, the Harvest SmartPReP™ CENTRIFUGE SYSTEM is a sample preparation device that facilitates the use of blood components in subsequent diagnostic tests.
N/A
Intended Use / Indications for Use
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.
Product codes
JQC
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinical laboratory or intraoperatively at point-of-care
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
MAY 2 8 1999
510(k) Summary for the Harvest Technologies SmartPReP Centrifuge System
| Submitter's Name and Address: | Harvest Technologies Corp.
77 Accord Park Drive, D-7 |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Phone Number: | 781-982-1900 |
| Telefax Number: | 781-982-7288 |
| Contact Person: | Richard Lariviere, Operations Manager |
| Date Summary Prepared: | April 22, 1999 |
| Device Trade Name: | SmartPRePTM Centrifuge System |
| Common name: | General Purpose Centrifuge for Clinical Use |
| Classification Name: | General purpose laboratory equipment labeled or
promoted for a specific medical use (21 CFR
862.2050) |
| Substantial Equivalence: | The proposed device is substantially equivalent
to other table-top centrifuges previously cleared
by the FDA via the 510(k) Notification process |
| Device Description: | 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. |
| Intended Use: | 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. |
| Technological Characteristics: | The proposed device has the same technological
characteristics and is similar in design and
configurations compared with the predicate
device (See Table 6-1). |
1
TABLE 6-1
COMPARISON OF THE HARVEST SMARTPReP AND PREDICATE CENTRIFUGES
| Features | SmartPReP
(This Submission) | Predicate Centrifuge |
|----------------------------|----------------------------------------------------|----------------------------------------------------|
| 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 | Yes | No |
| Micro-processor Controlled | Yes | Yes |
| User Programmable | No, program set by manufacturer | Yes |
| Speed Control | Preset | Selectable |
| Acceleration and Braking | Current-controlled | Current-controlled |
| Maximum RPM | 6000 RPM | 4000 RPM |
| Maximum RCF | 3550 g | 3077 g |
| Tube Capacity | Two Processing Disposables
(50 mL/disposable) | Variety of sizes and volumes
up to 250mL |
| 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 |
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 28 1999
Richard Lariviere Operations Manager HARVEST TECHNOLOGIES CORPORATION 77 Accord Park Drive, D-7 Norwell, MA 02061
Re: K991430 Trade Name: SmartPREP Centrifuge System Requlatory Class: I Product Code: JQC April 23, 1999 Dated: Received: April 26, 1999
Dear Mr. Lariviere:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general controls The general controls provisions of the provisions of the Act. Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. this response to your premarket notification Please note: submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
Image /page/2/Picture/8 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" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
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Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Putman
Steven I. Gutman, M.D. M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT
Page 1 of 1
510(k) Number (if known):
Harvest Technologies SmartPRePTM Centrifuge System Device Name:
The Harvest SmartPReP™ CENTRIFUGE SYSTEM is designed to be Indications for Use: 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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jiter E. Malin
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
t