VERSATREK

K032306 · Trek Diagnostic Systems, Inc. · MDB · Aug 22, 2003 · Microbiology

Device Facts

• Record ID: K032306
• Device Name: VERSATREK
• Applicant: Trek Diagnostic Systems, Inc.
• Product Code: MDB · Microbiology
• Decision Date: Aug 22, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.2560
• Device Class: Class 1

Indications for Use

VersaTREK System is for cultivating and recovering microorganisms, especially bacteria and yeasts, from blood and other normally sterile body fluids. VersaTREK Myco, with VersaTrek Myco GS, and Either VersaTREK as or PVNA added is a selective growth medium for use with either VersaTREK or ESP II Culture system II for the culture recovery of mycobacteria from sterile body specimens and from digested-decontaminated clinical specimens. Organism identification may be determined using nucleic acid probes (AccuProbe®) . The VersaTREK Myco Susceptibility Kit is intended for qualitative in vitro susceptibility testing of isolated colonies of Mycobacterium tuberculosis with Rifampin, Ethambutol, and Isoniazid on the VersaTREK instrument. Appropriate inoculum sources are prepared from growth on solid agar, such as Middlebrook 7H10 or Lowenstein-Jensen slants, or Middlebrook 7H9 broth.

Device Story

VersaTREK is an automated microbial growth monitoring system; used in clinical laboratories for culture and recovery of microorganisms from patient samples; also supports mycobacteria susceptibility testing. System monitors growth via detection of metabolic activity in culture media; provides automated alerts for positive cultures. Healthcare providers use results to identify pathogens and guide antimicrobial therapy; facilitates timely diagnosis of infections; enables targeted treatment for mycobacterial infections.

Clinical Evidence

No clinical data provided in the summary; device relies on substantial equivalence to previously cleared systems for microbial growth monitoring and susceptibility testing.

Technological Characteristics

Automated microbial growth monitor; utilizes metabolic detection principle for culture recovery; supports nucleic acid probe identification and qualitative susceptibility testing; intended for laboratory use.

Indications for Use

Indicated for cultivation and recovery of microorganisms (bacteria, yeasts, mycobacteria) from blood, sterile body fluids, and clinical specimens; qualitative susceptibility testing of M. tuberculosis isolates to Rifampin, Ethambutol, and Isoniazid.

Regulatory Classification

Identification

A microbial growth monitor is a device intended for medical purposes that measures the concentration of bacteria suspended in a liquid medium by measuring changes in light scattering properties, optical density, electrical impedance, or by making direct bacterial counts. The device aids in the diagnosis of disease caused by pathogenic microorganisms.

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

ODE Review Memorandum

To: THE FILE

RE: DOCUMENT NUMBER K032306 "Special"

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.

This change was for :

a. substituting a magnetic stir bar for mechanical rotation for agitation of aerobic bottles
b. mechanical and electronic design changes

(1) myco algorithms moved from computer to the instrument module board
(2) allowing aerobic and anaerobic bottles to be placed anywhere in the instrument
(3) using fans and heating coils to control temperature
(4) drawers containing 3 rows of 24 tests rather than 16 in a double row; allowing for total 22 drawers (configurations of 14, 16, 18, 20, and 22) in a floor model
(5) upgraded bar code reader
(6) upgraded circuit boards
(7) upgraded PC interface
(8) WINDOWS vs DOS
(9) Upgraded data management
(10) Upgraded graphing capability
(11) Continuously monitoring QC sensor
(12) Added alerts (motor and transducer failure)
(13) Upgraded IVDD and current design controls

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and comparison data for recovery, time to detection, reproducibility, pressure curves, and equivalent M.tuberculosis susceptibility.
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
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.

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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.

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revised:3/27/98