K083420 · Boule Medical AB · GKZ · Feb 3, 2009 · Hematology
Device Facts
Record ID
K083420
Device Name
MEDONIC M SERIES
Applicant
Boule Medical AB
Product Code
GKZ · Hematology
Decision Date
Feb 3, 2009
Decision
SESE
Submission Type
Special
Regulation
21 CFR 864.5220
Device Class
Class 2
Device Story
Automated hematology analyzer modification; includes sample inlet, fluidic system, hardware, and software updates. Input: blood samples via autoloader or manual inlet. Processing: fluidic system with pipettors, bi-stable valves, and capillary chambers; electrical blood detection; 32-bit CPU analysis. Output: hematology data displayed on color touch screen; serial output; barcode-identified reagent/sample tracking. Used in clinical laboratory settings by trained personnel. Benefits: improved sample handling, increased storage capacity, and enhanced connectivity.
Clinical Evidence
No clinical data provided; substantial equivalence based on design control activities, risk analysis, and verification/validation testing of hardware and software modifications.
An automated differential cell counter is a device used to identify one or more of the formed elements of the blood. The device may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow, or other body fluids. These devices may combine an electronic particle counting method, optical method, or a flow cytometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers.
Special Controls
*Classification.* Class II (special controls). The special control for this device is the FDA document entitled “Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA.”
Submission Summary (Full Text)
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SPECIAL 510(k): Device Modification
ODE Review Memorandum
To: THE FILE
RE: DOCUMENT NUMBER K083420
This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary):
1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.)
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.
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.
The modification is for sample inlet, fluidic system, hardware, software, and labeling (users manual to support changes).
4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and stability.
a) The sample inlet differences are:
- Added Autoloader component.
- Added built in sample mixer.
b) The Fluidic system differences are:
- Improved plastic bi-stable valves
- Use pipettors for sample dilutions
- Rounded capillary edges.
c) The hardware differences are:
- Electrical blood detector
- 32 bit CPU
- Smaller footprint
- Molded measuring chambers and glass tube detectors
- Added USB connectivity
- WBC hardware scale extended
- External/Internal Barcode scanner for cap piercer & autoloader modes
- Main power supply located externally.
d) The Software differences are:
- Color touch display
- Sample ID, alpha-numeric
- Added reagent barcode identification
- Increased patient and QC storage memory
- Serial sample output
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
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
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, and
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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.
6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).
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 (or their preamendment) device.
(Reviewer's Signature)
(Date)
Comments
Revised: 3/27/98
