SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM

K103340 · Harvest Technologies, Corp. · JQC · Dec 6, 2010 · Clinical Chemistry

Device Facts

• Record ID: K103340
• Device Name: SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM
• Applicant: Harvest Technologies, Corp.
• Product Code: JQC · Clinical Chemistry
• Decision Date: Dec 6, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.2050
• Device Class: Class 1
• Attributes: Therapeutic

Intended 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. 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.

Device Story

SmartPReP2 and SmartPReP Centrifuge Systems process small blood or bone marrow samples; centrifuge-based separation; produces platelet poor plasma, platelet concentrate, or bone marrow cell concentrate; used in clinical labs or intraoperatively at point-of-care; operated by clinicians; provides concentrated autologous components for clinical use; facilitates rapid preparation of biological concentrates.

Clinical Evidence

Bench testing only; design control activities and risk analysis performed to validate modification impact.

Technological Characteristics

Centrifuge-based separation system; utilizes ACD-A anticoagulant; 30ml capacity; point-of-care form factor.

Indications for Use

Indicated for clinical laboratory or intraoperative point-of-care preparation of platelet poor plasma, platelet concentrate from blood, and cell concentrate from bone marrow.

Regulatory Classification

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.

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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 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)

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Division Sign-Off

Office of In Vitro Diagnostic Office of in Millo Blagher Device Evaluation and Safety

510(k) K103340

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## 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