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

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. 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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SPECIAL 510(k): Device Modification

Review Memorandum

To: THE FILE

RE: DOCUMENT NUMBER k103340

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II devices requiring 510(k). The following items are present and acceptable:

1. Previously cleared devices:
- SmartPReP2 Centrifuge System (k052925)
- SmartPReP Centrifuge System (k991430)

2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).

3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed. This change was for the supply of the ADC-A anticoagulant bottle. A 30 mL bottle of ADC-A anticoagulant is included as a component in each accessory procedure pack.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics. Original devices: Customer supplied the ADC-A bottle. Modified devices: ACD-A 30 mL bottle is included in the processing kit.

5. A Design Control Activities Summary which includes:
a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis. (Section 11)
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied. (Section 11)
c) A declaration of conformity with design controls. The declaration of conformity should include:
i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, (Section 11) and
ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review. (Section 11)

6. A Truthful and Accurate Statement, a 510(k) Statement and the Indications for Use Enclosure

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared device.