(775 days)
VITEK MS (K181412)
MALDI Biotyper CA System (DEN170081)
No
The description focuses on the automation of manual laboratory steps using a vision system and robotic pipetting. There is no mention of AI or ML algorithms being used for image analysis, colony selection, or any other part of the process. The operator designates the colonies to be picked.
No
The device is an in vitro diagnostic device used for the identification of bacterial species, which aids in diagnosis. It does not directly provide therapy or treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "The Colibrí System is an in vitro diagnostic device." It also mentions its use "to aid in the diagnosis of bacterial infections."
No
The device description explicitly states that the Colibrí System comprises the "Colibrí Vision System and Colibrí Preparation Station and pipette tips as consumables," indicating the presence of physical hardware components beyond just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states, "The Colibrí System is an in vitro diagnostic device..." and describes its use for "qualitative identification of isolated colonies of Gram-negative bacterial species grown on solid culture media" to "aid in the diagnosis of bacterial infections." This directly aligns with the definition of an IVD, which is used to examine specimens from the human body to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description: The description further clarifies its role as an "accessory of the downstream MALDI-TOF analyzers automating various manual steps in the workflow for the preparation of samples for the identification of isolated colonies of microorganisms cultured from the human body." This confirms its use in the diagnostic process.
- Performance Studies: The document details various analytical and performance studies (Colony Picking, Positional Effect, Inclusivity, Specificity, Reproducibility, Cross-Contamination, Colony Stability, Spot Stability) conducted to validate its performance in a clinical laboratory setting for diagnostic purposes.
- Intended User/Care Setting: It is intended for use by "trained healthcare professionals in clinical laboratories," which is a typical setting for IVD use.
- Predicate Device(s): The mention of a predicate device (K181412; VITEK MS) which is also an IVD, further supports the classification of the Colibrí System as an IVD.
All these points collectively indicate that the Colibrí System is designed and intended for use in the in vitro diagnostic process.
N/A
Intended Use / Indications for Use
The Colibrí System is an in vitro diagnostic device comprised of the Colibrí Vision System and Collbrí Preparation Station for use with the bioMérieux VITEK MS or Bruker MALDI Biotyper CA mass spectrometry systems for qualitative identification of isolated colonies of Gram-negative bacterial species grown on solid culture media. The Collbri System is a semi-automated pre-analytical processor that picks isolated by the operator and uses a pipetting system to prepare MALDI-TOF MS (Matrix-Assisted Laser Desorption/Ionization-Time Of Flight Mass Spectrometry) target slides. The Colibri software records the identity of each sample and its position on the target slide and communicates this information electronically to the MALDI-TOF MS analyzer.
The Colibrí System is intended for use by trained healthcare professionals in clinical laboratories in conjunction with other clinical and laboratory finding Gram staining, to aid in the diagnosis of bacterial infections.
The Colibrí System has not been validated for use in identification of yeast species.
Product codes
QQV, QBN
Device Description
The Copan Colibrí System is designed to be used as an accessory of the downstream MALDI-TOF analyzers automating various manual steps in the workflow for the preparation of samples for the identification of isolated colonies of microorganisms cultured from the human body.
The Colibrí System automates the preparation of MALDI target slides for the bioMérieux VITEK MS or the Bruker MALDI Biotyper CA System that are used in clinical laboratories for identification and differentiation of organisms grown on plated media by Matrix-Assisted Laser Desorption/Ionization Time-of Flight Mass Spectrometry (MALDI-TOF MS). The system comprises the Colibrí Vision System and Colibrí Preparation Station and pipette tips as consumables. After appropriate plate incubation, the operator using the graphical User Interface (Image Reading Interface) chooses the plates exhibiting adequate growth and selects the isolated colonies to be processed assigning the automatic ID tasks. By using the Collbrí Vision System, specific colonies to be picked are designated by the operator on a digital plate. The Operator manually loads the plates in the Colibri Preparation Station where colonies are automatically picked, spotted on the target slide and overlayed with the matrix.
When used in conjunction with the bioMérieux VITEK MS, the Colibrí System can prepare the 48spot target slides by performing the direct spotting of colonies. The calibrator used for quality control is manually applied by the operator at the end of the automated colony spotting. When used in conjunction with the Bruker MALDI Biotyper CA System, the Colibrí System can prepare either reusable 48-spot or disposable 96-spot targets by performing the Direct Transfer Sample Procedure. The BTS used for quality control is manually applied by the operator at the and of the automated colony spotting.
The Colibrí software records the identity of each sample and its position on the target slide and communicates this information electronically to the MALDI-TOF MS analyzers.
Colibri System requires three different calibrations. None of these calibration activities require user intervention if not in terms of periodical cleaning of the mechanical component as described in the dedicated section of the User Manual. Set-up calibration is performed during the device initial setup for the camera units positioned on the Colibrí Vision System and on the Colibrí Preparation Station. Auto-calibration is performed at the end of the initial set-up and periodically during the preventive maintenance to check that, in the Colibri Preparation Station, all the mechanical references can be found inside the positioning tolerances, that the I/Os are responsive. Run-time calibration is performed during the normal usage to automatically check the proper functioning of the Colibrí Vision System and the Colibri Preparation Station.
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
Trained healthcare professionals in clinical laboratories.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Analytical Studies: Verified and validated the use of the Colibrí System with bioMérieux VITEK MS or Bruker MALDI Biotyper CA mass spectrometry systems. Demonstrated automated preparation of target slides by spotting colonies and matrix from Gram-negative and Gram-positive bacterial colonies grown on solid culture media.
Colony Picking for Microbial Identification Study:
- Purpose: Assess accuracy of Colibrí System in picking designated colonies.
- Methodology: Prepared bioMérieux VITEK MS-DS and Bruker MALDI Biotyper CA System target slides using various microbial species from different culture media (whole and bi-plated from mixed cultures) on 3 different Colibrí Systems, compared to manual preparation.
- Results (bioMérieux VITEK MS):
- Total picked colonies: 1390 spots.
- Correctly picked colonies: 100%. No wrong colony picked, no wrong identifications.
- Overall agreement with expected strain identity (≥60% confidence): 98.4%.
- Gram-positive agreement: 96.5% (600/622).
- Gram-negative agreement: 100.0% (768/768).
- Results (Bruker MALDI Biotyper CA System):
- Total picked colonies: 1690 spots.
- Correctly picked colonies: 100%. No wrong colony picked, no wrong identifications.
- Overall agreement with expected strain identity (High Confidence Log (Score) ≥ 2): 90.8% (1534/1690).
- Gram-positive agreement: 81.4% (661/812).
- Gram-negative agreement: 99.4% (873/878).
- Lower proportion of concordant results for Gram-positive species, but no incorrect identification. Package Insert to recommend repeat testing for low-confidence/no ID results.
Positional Effect Study:
- Purpose: Demonstrate ability to prepare target spots at each location on the target slide.
- Methodology: Used media plates with "on-panel" strains for bioMérieux VITEK MS and Bruker MALDI Biotyper CA System. Bruker study used US IVD 48 Spot target and MBT Biotarget 96 US IVD.
- Results (bioMérieux VITEK MS):
- Escherichia coli: 99.8% (431/432) agreement.
- Staphylococcus aureus: 99.8% (431/432) agreement.
- No positional effect detected, no wrong identifications.
- Results (Bruker MALDI Biotyper CA System - US IVD 48 Spot target):
- Escherichia coli: 99.8% (431/432) agreement.
- Staphylococcus aureus: 96.8% (418/432) agreement.
- No positional effect detected, no wrong identifications.
- Results (Bruker MALDI Biotyper CA System - MBT Biotarget 96 US IVD):
- Escherichia coli: 99.9% (845/846) agreement.
- Staphylococcus aureus: 95.7% (810/846) agreement.
- No positional effect detected, no wrong identifications.
Inclusivity Study:
- Purpose: Demonstrate ability to prepare targets with "on-panel" species providing the same microbial identification as manual preparation without false identifications.
- Methodology: Analyzed 123 bacterial strains (29 species) for VITEK MS, and 124 bacterial strains (30 species) for Bruker MALDI Biotyper CA System (on two systems with different targets). Compared to manual preparation.
- Results (bioMérieux VITEK MS):
- Overall agreement: 97.2% (334/392) with Confidence Value ≥ 60%.
- No wrong identifications.
- Gram-positive Colibrí agreement: 90.5% (76/84). Manual agreement: 92.9% (78/84).
- Gram-negative Colibrí agreement: 99.0% (258/308). Manual agreement: 91.2% (238/308).
- Results (Bruker MALDI Biotyper CA System - US IVD 48 Spot Target):
- Overall agreement: 93.2% (436/468) with High confidence ID Log (Score) ≥ 2.
- Gram-positive Colibrí agreement: 82.1% (128/156). Manual agreement: 94.9% (148/156).
- Gram-negative Colibrí agreement: 98.7% (308/312). Manual agreement: 98.4% (307/312).
- Results (Bruker MALDI Biotyper CA System - MBT Biotarget 96 US IVD):
- Overall agreement: 85.7% (401/468) with High confidence ID Log (Score) ≥ 2.
- Performance for Gram-positive target organisms was lower compared to manual preparation, but no wrong identification. Package Insert to recommend repeat testing for low-confidence/no ID results.
- Gram-positive Colibrí agreement: 67.3% (105/156). Manual agreement: 78.8% (123/156).
- Gram-negative Colibrí agreement: 94.9% (296/312). Manual agreement: 92.6% (289/312).
Specificity Study:
- Purpose: Demonstrate ability to prepare targets with "off-panel" species yielding expected organism identity (no identification) without false identifications.
- Methodology: Used "off-panel" Gram-positive and Gram-negative strains (20 spots for each IVD analyzer).
- Results (bioMérieux VITEK MS):
- "Off-panel" organisms resulted in 100% No ID (20/20).
- 100% agreement with expected (no ID). No false positive results for "on-panel" species.
- Results (Bruker MALDI Biotyper CA System):
- "Off-panel" organisms resulted in 100% No ID (20/20).
- 100% agreement with expected (no ID). No false positive results for "on-panel" species.
Reproducibility Study:
- Purpose: Assess repeatability of results from automatically processed samples.
- Methodology: Used three Colibrí Systems, blinded panel of 10 common "on-panel" strains (Gram-negative and Gram-positive). Repeated for 5 days, 3 replications per strain, performed by two operators in rotation. Total 1800 spots for both IVD Analyzers.
- Results (bioMérieux VITEK MS):
- 99.9% (1799/1800) agreement between reported Good Confidence identification and expected identity.
- Gram-positive: 99.9% (899/900).
- Gram-negative: 100.0% (720/900 for Good Confidence or 900/900 including low discrimination for Enterobacter cloacae). The 180 low discrimination results for Enterobacter cloacae were included in agreement calculations as per VITEK MS labeling.
- Results (Bruker MALDI Biotyper CA System):
- 88.1% (1585/1800) agreement between reported High Confidence identification (Log (Score) ≥ 2.00) and expected identity.
- Gram-positive: 76.7% (690/900). 19.9% (179/900) were low confidence, 3.4% (31/900) no ID.
- Gram-negative: 99.4% (895/900). 0.1% (1/900) low confidence, 0.4% (4/900) no ID.
- Lower proportion for Gram-positive, consistent with MALDI Biotyper CA labeling. Package Insert to recommend manual retesting for low confidence/no ID.
Cross-Contamination Studies:
- Purpose: Demonstrate no false-positive results due to contamination of adjacent spots.
- Methodology: Alternating "on-panel" and "off-panel" strains on target slides for VITEK MS and Bruker MALDI Biotyper CA System.
- Results (bioMérieux VITEK MS):
- Total spots: 572.
- "On-panel" species: 99.3% (284/286) agreement for expected result. No false identifications.
- "Off-panel" species: 100% no identification (286/286).
- No cross-contamination observed.
- Results (Bruker MALDI Biotyper CA System - US IVD 48 Spot target):
- "On-panel" species: 95.0% (190/200) agreement.
- "Off-panel" species: 100% no identification (200/200).
- No cross-contamination observed.
- Results (Bruker MALDI Biotyper CA System - MBT Biotarget 96 US IVD):
- "On-panel" species: 85.3% (122/143 identified with High Confidence, 133/143 including low confidence) agreement. Lower agreement due to limited ability for Gram-positive, not cross-contamination.
- "Off-panel" species: 100% no identification (143/143).
- No cross-contamination observed. Device labeling to note the need for additional testing.
Colony Stability Study:
- Purpose: Demonstrate ability to prepare target slides from cultures of different ages.
- Methodology: Used "on-panel" strains grown on different culture plates at various incubation times (min/max specified in labeling). Bruker study included additional 12h post-incubation at RT.
- Results (bioMérieux VITEK MS):
- Total spots: 576.
- 99.8% agreement for expected identification at each time point and agar media. No false identification.
- Results (Bruker MALDI Biotyper CA System):
- Total spots: 1440.
- Good agreement for Gram-negative species regardless of culture medium or incubation duration.
- Lower agreement observed with Gram-positive species.
- No incorrect identification results reported. Colony age did not affect accuracy.
- Bordetella pertussis on Bordet Gengou Agar showed decreased High Confidence Log(scores) after 7 days incubation + 12h @RT; noted in labeling.
Spot Stability Prior To and After Matrix Deposition:
- Purpose: Evaluate stability of spots before and after matrix application, and target stability before MALDI-TOF MS analysis.
- Methodology: Compared Standard Deposition Mode (matrix applied immediately) vs. Delayed Deposition Mode (matrix after 60 mins). Tested stability for 24, 48, 72 hours after matrix deposition. Held targets at RT (ambient air or on deck). Evaluated for both MBT Biotarget 96 US IVD and US IVD 48 Spot target for Bruker.
- Results (bioMérieux VITEK MS):
- Colonies stable up to 60 minutes without matrix.
- Targets stable for 48h (on Colibrí deck) and 72h (in original box) after matrix application, with no difference in performance.
- Results (MALDI Biotyper CA System):
- Colonies stable up to 60 minutes without matrix.
- Targets stable for 24h at room temperature after matrix addition (on Colibrí deck and lab bench).
- Lower agreement for Gram-positive species using the 96-spot disposable format; noted in labeling.
- Device Labeling Recommendation: Prepared targets should be tested within 24 hours for Bruker MALDI Biotyper CA and within 48 hours for bioMérieux VITEK MS.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Key metrics provided are primarily "Agreement" or "% agreement" which represents the percentage of correct identifications (or no identification for off-panel species) out of the total number of picked colonies. Confidence values (e.g., ≥60% for VITEK MS, Log (Score) ≥2 or 1.7-1.99 for Bruker) are used to categorize identification results.
Examples:
- Colony Picking Study (bioMérieux VITEK MS): Overall % agreement 98.4%. Gram-positive 96.5%, Gram-negative 100.0%.
- Colony Picking Study (Bruker MALDI Biotyper CA System): Overall % agreement 90.8%. Gram-positive 81.4%, Gram-negative 99.4%.
- Specificity Study: 100% agreement for "off-panel" organisms (meaning 100% no identification).
- Reproducibility Study (bioMérieux VITEK MS): Overall % agreement 99.9%.
- Reproducibility Study (Bruker MALDI Biotyper CA System): Overall % agreement 88.1%.
- Cross-Contamination Study (bioMérieux VITEK MS "on-panel"): 99.3% agreement.
- Cross-Contamination Study (Bruker MALDI Biotyper CA "on-panel" US IVD 48 Spot): 95.0% agreement.
- Cross-Contamination Study (Bruker MALDI Biotyper CA "on-panel" MBT Biotarget 96 US IVD): 85.3% agreement.
Predicate Device(s)
VITEK MS (K181412)
Reference Device(s)
MALDI Biotyper CA System (DEN170081)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.3378 Clinical mass spectrometry microorganism identification and differentiation system.
(a)
Identification. A clinical mass spectrometry microorganism identification and differentiation system is a qualitative in vitro diagnostic device intended for the identification and differentiation of microorganisms from processed human specimens. The system acquires, processes, and analyzes spectra to generate data specific to a microorganism(s). The device is indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial and fungal infection.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The intended use statement must include a detailed description of what the device detects, the type of results provided to the user, the clinical indications appropriate for test use, and the specific population(s) for which the device is intended, when applicable.
(2) Any sample collection device used must be FDA-cleared, -approved, or -classified as 510(k) exempt with an indication for in vitro diagnostic use.
(3) The labeling required under § 809.10(b) of this chapter must include:
(i) A detailed device description, including all device components, control elements incorporated into the test procedure, instrument requirements, ancillary reagents required but not provided, and a detailed explanation of the methodology and all pre-analytical methods for processing of specimens, and algorithm used to generate a final result. This must include a description of validated inactivation procedure(s) that are confirmed through a viability testing protocol, as applicable.
(ii) Performance characteristics for all claimed sample types from clinical studies with clinical specimens that include prospective samples and/or, if appropriate, characterized samples.
(iii) Performance characteristics of the device for all claimed sample types based on analytical studies, including limit of detection, inclusivity, reproducibility, interference, cross-reactivity, interfering substances, carryover/cross-contamination, sample stability, and additional studies regarding processed specimen type and intended use claims, as applicable.
(iv) A detailed explanation of the interpretation of test results for clinical specimens and acceptance criteria for any quality control testing.
(4) The device's labeling must include a prominent hyperlink to the manufacturer's website where the manufacturer must make available their most recent version of the device's labeling required under § 809.10(b) of this chapter, which must reflect any changes in the performance characteristics of the device. FDA must have unrestricted access to this website, or manufacturers must provide this information to FDA through an alternative method that is considered and determined by FDA to be acceptable and appropriate.
(5) Design verification and validation must include:
(i) Any clinical studies must be performed with samples representative of the intended use population and compare the device performance to results obtained from an FDA-accepted reference method and/or FDA-accepted comparator method, as appropriate. Documentation from the clinical studies must include the clinical study protocol (including predefined statistical analysis plan, if applicable), clinical study report, and results of all statistical analyses.
(ii) Performance characteristics for analytical and clinical studies for specific identification processes for the following, as appropriate:
(A) Bacteria,
(B) Yeasts,
(C) Molds,
(D) Mycobacteria,
(E) Nocardia,
(F) Direct sample testing (
e.g., blood culture),(G) Antibiotic resistance markers, and
(H) Select agents (
e.g., pathogens of high consequence).(iii) Documentation that the manufacturer's risk mitigation strategy ensures that their device does not prevent any device(s) with which it is indicated for use, including incorporated device(s), from achieving their intended use (
e.g., safety and effectiveness of the functions of the indicated device(s) remain unaffected).(iv) A detailed device description, including the following:
(A) Overall device design, including all device components and all control elements incorporated into the testing procedure.
(B) Algorithm used to generate a final result from raw data (
e.g., how raw signals are converted into a reported result).(C) A detailed description of device software, including validation activities and outcomes.
(D) Acquisition parameters (
e.g., mass range, laser power, laser profile and number of laser shots per profile, raster scan, signal-to-noise threshold) used to generate data specific to a microorganism.(E) Implementation methodology, construction parameters, and quality assurance protocols, including the standard operating protocol for generation of reference entries for the device.
(F) For each claimed microorganism characteristic, a minimum of five reference entries for each organism (including the type strain for microorganism identification), or, if there are fewer reference entries, a clinical and/or technical justification, determined by FDA to be acceptable and appropriate, for why five reference entries are not needed.
(G) DNA sequence analysis characterizing all type strains and at least 20 percent of the non-type strains of a species detected by the device, or, if there are fewer strain sequences, then a clinical and/or technical justification, determined by FDA to be acceptable and appropriate, must be provided for the reduced number of strains sequenced.
(H) As part of the risk management activities, an appropriate end user device training program, which must be offered as an effort to mitigate the risk of failure from user error.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the words "U.S. FOOD & DRUG" on one line and "ADMINISTRATION" on the line below. The FDA logo is in blue.
December 27, 2021
COPAN WASP S.r.l.
% Enrico Bisson Consultant Studio D'ingegneria Enrico Bisson Via Marzia 9 Abano Terme, 35031 Italy
Re: K193138
Trade/Device Name: Colibri System Regulation Number: 21 CFR 866.3378 Regulation Name: Clinical mass spectrometry microorganism identification and differentiation system Regulatory Class: Class II Product Code: QQV, QBN Dated: June 16, 2020 Received: June 19, 2020
Dear Enrico Bisson:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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 Part
1
801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ribhi Shawar. Ph.D. (ABMM) Chief General Bacteriology and Antimicrobial Susceptibility Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K193138
Device Name Colibrí System
Indications for Use (Describe)
The Colibrí System is an in vitro diagnostic device comprised of the Colibrí Vision System and Collbrí Preparation Station for use with the bioMérieux VITEK MS or Bruker MALDI Biotyper CA mass spectrometry systems for qualitative identification of isolated colonies of Gram-negative bacterial species grown on solid culture media. The Collbri System is a semi-automated pre-analytical processor that picks isolated by the operator and uses a pipetting system to prepare MALDI-TOF MS (Matrix-Assisted Laser Desorption/Ionization-Time Of Flight Mass Spectrometry) target slides. The Colibri software records the identity of each sample and its position on the target slide and communicates this information electronically to the MALDI-TOF MS analyzer.
The Colibrí System is intended for use by trained healthcare professionals in clinical laboratories in conjunction with other clinical and laboratory finding Gram staining, to aid in the diagnosis of bacterial infections.
The Colibrí System has not been validated for use in identification of yeast species.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CER 801 Subnart D) | Over-The-Counter I Ise (21 CER 801 Subnart C) |
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I. SUBMITTER
| Applicant Name: | Copan WASP Srl |
|---|---|
| Via A. Grandi 32 | |
| 25125 Brescia, Italy | |
| +39 030 2687211 | |
| copan.regulatory@copangroup.com | |
| Contact Person | Enrico Bisson |
| ISOPLAN CONSULTING | |
| Studio di Ingegneria Enrico Bisson | |
| Via Marzia, 9 | |
| 35031 Abano Terme (PD), Italy | |
| +39 030 2687211 +39 3286439091 | |
| copan.regulatory@copangroup.com | |
| Establishment Registration Number: | 3009288740 |
| Date Prepared: | December 23, 2021 |
II. DEVICE NAME
| Proprietary Name | Colibrí System |
|---|---|
| Common/Usual Name | Colibrí System |
| Classification Name | Clinical mass spectrometry microorganism identification and differentiation system (21 CFR 866.3378) |
| Device Class | II |
| Product Code | QQV, QBN |
| Panel | Microbiology |
4
III. LEGALLY MARKETED PREDICATE DEVICE
| Device Name | VITEK MS |
|---|---|
| 510(K) Number | K181412 |
No reference Devices were used in this submission.
IV. DEVICE DESCRIPTION
The Copan Colibrí System is designed to be used as an accessory of the downstream MALDI-TOF analyzers automating various manual steps in the workflow for the preparation of samples for the identification of isolated colonies of microorganisms cultured from the human body.
The Colibrí System automates the preparation of MALDI target slides for the bioMérieux VITEK MS or the Bruker MALDI Biotyper CA System that are used in clinical laboratories for identification and differentiation of organisms grown on plated media by Matrix-Assisted Laser Desorption/Ionization Time-of Flight Mass Spectrometry (MALDI-TOF MS). The system comprises the Colibrí Vision System and Colibrí Preparation Station and pipette tips as consumables. After appropriate plate incubation, the operator using the graphical User Interface (Image Reading Interface) chooses the plates exhibiting adequate growth and selects the isolated colonies to be processed assigning the automatic ID tasks. By using the Collbrí Vision System, specific colonies to be picked are designated by the operator on a digital plate. The Operator manually loads the plates in the Colibri Preparation Station where colonies are automatically picked, spotted on the target slide and overlayed with the matrix.
When used in conjunction with the bioMérieux VITEK MS, the Colibrí System can prepare the 48spot target slides by performing the direct spotting of colonies. The calibrator used for quality control is manually applied by the operator at the end of the automated colony spotting. When used in conjunction with the Bruker MALDI Biotyper CA System, the Colibrí System can prepare either reusable 48-spot or disposable 96-spot targets by performing the Direct Transfer Sample Procedure. The BTS used for quality control is manually applied by the operator at the and of the automated colony spotting.
The Colibrí software records the identity of each sample and its position on the target slide and communicates this information electronically to the MALDI-TOF MS analyzers.
Colibri System requires three different calibrations. None of these calibration activities require user intervention if not in terms of periodical cleaning of the mechanical component as described in the dedicated section of the User Manual. Set-up calibration is performed during the device initial setup for the camera units positioned on the Colibrí Vision System and on the Colibrí Preparation Station. Auto-calibration is performed at the end of the initial set-up and periodically during the preventive maintenance to check that, in the Colibri Preparation Station, all the mechanical references can be found inside the positioning tolerances, that the I/Os are responsive. Run-time calibration is
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performed during the normal usage to automatically check the proper functioning of the Colibrí Vision System and the Colibri Preparation Station.
V. INTENDED USE/INDICATIONS FOR USE
The Colibrí System is an in vitro diagnostic device comprised of the Colibrí Vision System and Colibri Preparation Station for use with the bioMérieux VITEK MS or Bruker MALDI Biotyper CA mass spectrometry systems for qualitative identification of isolated colonies of Gram-negative and Gram-positive bacterial species grown on solid culture media. The Colibrí System is a semiautomated pre-analytical processor that picks isolated colonies designated by the operator and uses a pipetting system to prepare MALDI-TOF MS (Matrix-Assisted Laser Desorption/Ionization-Time Of Flight Mass Spectrometry) target slides. The Colibrí software records the identity of each sample and its position on the target slide and communicates this information electronically to the MALDI-TOF MS analyzer.
The Colibrí System is intended for use by trained healthcare professionals in clinical laboratories in conjunction with other clinical and laboratory findings, including Gram staining, to aid in the diagnosis of bacterial infections.
The Colibrí System has not been validated for use in identification of yeast species.
VI. COMPARISON TO PREDICATE DEVICE
The Colibrí System is designed to automatize the standard manual workflow for the preparation of targets for MALDI-TOF MS identification via Direct Colony Transfer decreasing the risk of crosscontamination among colonies grown on the culture plate and scratching from the media plate surface. Specifically, the Vision System aids the operator in selecting a single, well-isolated colony. The Preparation Station allows the automatic picking of the preselected colony, its spotting in the available position and the addition of the manufacturer recommended matrix.
With reference to the sample preparation flow, comparison with the predicate is provided in the following tables:
| Similarities | |||
|---|---|---|---|
| Item | New Device | Primary Predicate Device | Other |
| Device Name | |||
| (K number) | Colibrí System | ||
| (K193138) | VITEK MS | ||
| (K181412) | MALDI Biotyper CA System | ||
| (DEN170081) | |||
| Device | |||
| Classification | Class II (special controls) | Class II (special controls) | Class II (special controls) |
| Regulation | |||
| Number | 21 CFR 866.3378 Clinical Mass | ||
| Spectrometry Microorganism | |||
| Identification and Differentiation | |||
| System | 21 CFR 866.3378 Clinical Mass | ||
| Spectrometry Microorganism | |||
| Identification and Differentiation | |||
| System | 21 CFR 866.3378 Clinical Mass | ||
| Spectrometry Microorganism | |||
| Identification and Differentiation | |||
| System | |||
| Product Code | QQV: Automated System for | ||
| Sample Preparation And | QBN: Mass Spectrometry, Maldi | ||
| Tof, Microorganism Identification, | QBN: Mass Spectrometry, Maldi | ||
| Tof, Microorganism Identification. | |||
| Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry | Cultured Isolates | Cultured Isolates | |
| Indications for Use | The Colibrí System is an in vitro diagnostic device comprised of the Colibrí Vision System and Colibrí Preparation Station for use with the bioMérieux VITEK MS or Bruker MALDI Biotyper CA mass spectrometry systems for qualitative identification of isolated colonies of Gram-negative and Gram-positive bacterial species grown on solid culture media. The Colibrí System is a semi-automated pre-analytical processor that picks isolated colonies designated by the operator and uses a pipetting system to prepare MALDI-TOF MS (Matrix-Assisted Laser Desorption/Ionization-Time Of Flight Mass Spectrometry) target slides. The Colibrí software records the identity of each sample and its position on the target slide and communicates this information electronically to the MALDI-TOFMS analyzer. The Colibrí System is intended for use by trained healthcare professionals in clinical laboratories in conjunction with other clinical and laboratory findings, including Gram staining, to aid in the diagnosis of bacterial infections. The Colibrí System has not been validated for use in identification of yeast species. | VITEK MS is a mass spectrometry system using matrix-assisted laser desorption/ionization time of flight mass spectrometry (MALDI-TOF MS) for the identification of microorganisms cultured from human specimens. The VITEK MS system is a qualitative in vitro diagnostic device indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial, yeast and mould infections. (list of claimed organisms omitted for brevity; refer to K181412) | The MALDI Biotyper CA System is a mass spectrometer system using matrix-assisted laser desorption/ionization - time of flight (MALDI-TOF) for the identification and differentiation of microorganisms cultured from human specimens. The MALDI Biotyper CA System is a qualitative in vitro diagnostic device indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial and fungal infections. (list of validated organisms omitted for brevity; refer to DEN1 70081) |
| Sample/Media Type | Isolated bacterial colonies from any patient source on plated culture media. |
Acceptable media when Colibrí System is used in connection with VITEK MS:
• Columbia blood agar with 5% sheep blood
• Trypticase soy agar with 5% sheep blood
• Chocolate agar
• MacConkey Agar
Acceptable media when Colibrí System is used in connection with MALDI Biotyper CA: | Isolated bacterial colonies from any patient source on plated culture media.
Acceptable media:
• Columbia blood agar with 5% sheep blood
• Trypticase soy agar with 5% sheep blood
• Chocolate polyvitex agar
• MacConkey agar | Isolated bacterial colonies from any patient source on plated culture media.
Acceptable media:
• Columbia blood agar with 5% sheep blood (Gram-negative bacteria)
• Trypticase soy agar with 5% sheep blood (Gram-negative bacteria)
• Chocolate agar (Gram-negative bacteria, Gram-positive bacteria)
• MacConkey Agar (Gram-negative bacteria)
• Columbia CNA agar with 5% sheep blood (Gram-positive bacteria) |
| | • sheep blood
• Trypticase soy agar with 5%
sheep Blood
• Chocolate agar
• MacConkey Agar
• Columbia CNA agar with 5%
sheep blood
• Bordet Gengou Agar with 15%
sheep blood
Note: media are selected among
those recommended forthe
Legally marketed Predicate
Devices and suitable for Gram-
negative and Gram-positive
bacteria.
Strains used to evaluate Colibrí
System performance
characteristics have been selected | | • Bordet Gengou Agar with 15%
sheep blood ( Bordetella species |
| | among those claimed from the
Legally marketed Predicate
devices. | | |
| Method of
Sample
Preparation | Direct spotting to target/slide of
Gram-negative and Gram-positive
bacteria. | Direct spotting to slide of Gram-
negative and Gram-positive
bacteria. | Bacteria: Direct spotting to target
of Gram-negative and Gram-
positive bacteria. |
| | A portion of microbial colony
from an agar plate is automatically
spotted on a VITEK MS-DS target
slide or MALDI Biotyper target by
using the pipetting system. | A portion of microbial colony from
an agar plate is manually applied to
a spot of VITEK MS-DS target
slide using a 1uL loop. | An isolated colony of bacteria is
smeared as a thin film using a
sterile colony transfer device,
directly onto a sample position on a
cleaned US IVD 48 Spot Target or
an unused sample position of a
MBT Biotarget 96 US IVD plate. |
| Target Slide | When connected with VITEK MS,
VITEK MS-DS Target Slides, 48
positions disposable plastic targets
When connected with Bruker
MALDI Biotyper CA, following
targets may be processed:
Bruker US IVD 48 Spot target
Bruker MBT Biotarget 96 US IVD
plate. | following target may be processed positions disposable plastic targets | IVD 48 Spot Target
MBT Biotarget 96 US IVD plate. |
| Matrix | 1 µL VITEK MS-CHCA matrix is
automatically applied to the spot
using the pipetting system.
The dried target slide is then
manually loaded into the VITEK
MS instrument.
1 µL US IVD HCCA portioned is
automatically applied to the spot
using the pipetting system.
The dried target slide is then
manually loaded into the MALDI
Biotyper CA instrument. | 1 µL VITEK MS-CHCA is applied
to the spot using a pipette.
The dried target slide is then
manually loaded into the VITEK
MS instrument. | 1 µL US IVD HCCA portioned is
applied to the spot using a pipette.
The dried target slide is then
manually loaded into the MALDI
Biotyper CA instrument |
| Calibration/ | For VITEK MS: Escherichia coli | Escherichia coli ATCC 8739 | US IVD Bacterial Test Standard |
| Quality
Controls | ATCC 8739 (calibrator strain) and Klebsiella aerogenes ATCC 13048 (positive control strain) are manually spotted in predetermined positions.
For MALDI Biotyper CA: US
IVD Bacterial Test Standard
(BTS) is manually spotted before loading in the instrument. | (calibrator strain) and Klebsiella aerogenes ATCC 13048 (positive
control strain) are manually spotted in predetermined positions | (BTS) is manually spotted before
loading in the instrument. |
| Culture
Stability | For Bacteria:
When connected with VITEK MS,
incubation of culture should be 18
- 72hrs (18-48hrs for Chocolate
Agar).
When connected with MALDI
Biotyper CA, incubation of culture
should be 18-48hrs (+12hrs
storage at RT). | For Bacteria:
Incubation of culture should be 18
-72hrs | For Bacteria:
Incubation of culture should be
between 18-48hrs (+12hrs
storage at RT). |
| Spot Stability | When connected with VITEK MS, after matrix addition, targets are
stable for 48h at room temperature
when held on the Colibrí deck and
for 72h when held in the original
box.
When connected with MALDI
Biotyper CA, after matrix addition
targets are stable for 24h at room
temperature. | After matrix addition, targets are
stable for 72h when held in the
original box. | After matrix addition, targets are
stable for 24h at room temperature |
| MALDI-TOF
MS Analyzer | bioMérieux VITEK MS
Bruker MALDI Biotyper CA | bioMérieux VITEK MS | Bruker MALDI Biotyper CA |
| Method of
Testing | When connected with VITEK MS,
direct testing from isolated
colonies.
When connected with Bruker
MALDI Biotyper CA, direct
testing from isolated colonies. If
after initial analysis the log(score)
is reported at 2.
Performance of the Copan Colibrí System for preparation of Gram-positive target organisms for the Bruker MALDI Biotyper CA is lower when compared to manual preparation; however, none of the colonies in the study provided a wrong identification. Instructions will be included in the Colibrí System Package Insert for the operator to repeat testing of the isolate manually using the extended Direct Transfer (eDT) or Extraction (Ext) Sample Preparation Procedure if a lowconfidence identification or no identification result is obtained. This is consistent with the Instructions for Use of the Bruker MALDI Biotyper CA System.
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Inclusivity Study identification results of the Colibri System obtained with the bioMerieux VITEK MS and stratified per species
| Test strain | Total no.
of picked
colonies | Correct Single Choice
(≥60% Confidence value) | Low discrimination
(Total Gram-positive | 84 | 76 | 78 | 0 | 0 | 8 | 6 | 0 | 0 | 90.5% | 92.9% |
| Gram Negative | | | | | | | | | | | |
| Acinobacter baumannii | 24 | 24 | 20 | 0 | 0 | 0 | 4 | 0 | 0 | 100.0% | 83.3% |
| Bacteroides fragilis | 2 | 2 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 100.0% | 100.0% |
| Citrobacter koseri | 24 | 24 | 21 | 0 | 0 | 0 | 3 | 0 | 0 | 100.0% | 87.5% |
| Eikenella corrodens | 2 | 2 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 100.0% | 100.0% |
| Enterobacter
aerogenes/Klebsiella
aerogenes | 24 | 23 | 22 | 0 | 0 | 1 | 2 | 0 | 0 | 95.8% | 91.7% |
| Enterobacter cloacae | 24 | 0 | 0 | 23a | 20a | 1 | 4 | 0 | 0 | 95.8%a | 83.3%a |
| Escherichia coli | 24 | 24 | 23 | 0 | 0 | 0 | 1 | 0 | 0 | 100.0% | 95.8% |
| Haemophilus influenzae | 4 | 4 | 3 | 0 | 0 | 0 | 1 | 0 | 0 | 100.0% | 75.0% |
| Klebsiella oxytoca | 24 | 24 | 20 | 0 | 0 | 0 | 4 | 0 | 0 | 100.0% | 83.3% |
| Klebsiella pneumoniae | 24 | 23 | 21 | 0 | 0 | 1 | 3 | 0 | 0 | 95.8% | 87.5% |
| Moraxella catarrhalis | 4 | 4 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 100.0% | 100.0% |
| Morganella morganii | 16 | 16 | 15 | 0 | 0 | 0 | 1 | 0 | 0 | 100.0% | 93.8% |
| Neisseria gonorrhoeae | 4 | 4 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 100.0% | 100.0% |
| Neisseria meningitidis | 2 | 2 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 100.0% | 50.0% |
| Test strain | Total no. of picked colonies | Correct Single Choice (≥60% Confidence value) | | Low discrimination (