The Colibri™ is an automated in vitro diagnostic specimen preparation system for use with WASPLab® to prepare MALDI-TOF targets for the bioMérieux VITEK® MS or Bruker MALDI Biotyper® CA mass spectrometry systems for qualitative identification and microbial suspension for the bioMérieux VITEK® 2 Antimicrobial Susceptibility Testing (AST) system for qualitative testing of isolated colonies of gram-negative and gram-positive bacterial species grown on solid culture media.

The Colibri™ is an automated pre-analytical processor that nicks isolated colonies designated by the operator and uses a pipetting system to prepare MALDI-TOF MS (Matrix-Assisted Laser Desorption/lonization-Time of Flight Mass Spectrometry) target slides for bacterial identification and microbial suspension at known concentration for Antimicrobial Susceptibility Testing and purity assessment.

The Collori™ 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.

Bacterial suspensions for AST and purity plates are identified by barcode label.

The Colibri™ 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 Colibri™ has not been validated for use in the identification or processing of yeast species, or mycobacteria.

Device Description

The Colibrí is an instrument which automates the picking of selected colonies from plated media and prepares 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/Tonization Time-of Flight Mass Spectrometry (MALDI-TOF MS). The Colibrí automates the preparation of microbial suspensions at known concentration for bioMérieux VITEK 2 System that is used in clinical laboratories for AST analyses. Moreover, the Colibrí is used for Purity Plates preparation for purity assessments.

The Colibrí includes the following components:

. Colibrí instrument and software with on-board pipetting system and nephelometer
Colibrí Primary Tubes ●
. Colibrí Spreader
Colibrí Daily Verification kit. ●

Colibri is designed to be used in conjunction with the WASPLab device for culture plate incubation and image analysis. After appropriate plate incubation, the operator selects the colonies from a digital image of culture media plate streaked with microbiological human specimen, available through WebApp software, the WASPLab User Interface.

The operator assigns the automatic ID or AST tasks to the isolated colonies to be processed. Then, the operator loads the plates in the Colibri where colonies are automatically picked, spotted on the target slide and overlayed with the matrix or suspended into the dedicated solution for the preparation of the microbial suspension for AST purposes (Secondary Tube).

When used in conjunction with the bioMérieux VITEK MS, the Colibrí can prepare the 48-spot 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 Colibri 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 end of the automated colony spotting.

When used in conjunction with the bioMérieux VITEK 2, the Colibrí can prepare the microbial suspension at the proper concentration by direct colony suspension method. The onboard nephelometer allows the preparation of Secondary Tubes (AST suspensions) at the correct concentration and the Colibrí Spreader is used for Purity Plates preparation.

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.

The traceability of prepared Secondary Tube and Purity Plates is maintained by dedicated labels applications.

Colibrí requires four different calibrations, one on the nephelometer, three on the cameras. 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. The Set-up calibration of nephelometer and camera units are performed during the device initial setup. Autocalibration is performed at the end of the initial set-up and periodically during the preventive maintenance to check that 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.

Colibrí requires a daily nephelometer verification to check the proper reading of suspensions at different turbidity values.

AI/ML Overview

Acceptance Criteria and Device Performance for Colibrí

The Colibrí is an automated in vitro diagnostic specimen preparation system for use with WASPLab to prepare MALDI-TOF targets for microbial identification and microbial suspensions for Antimicrobial Susceptibility Testing (AST).

1. Table of Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria	Reported Device Performance
Colony Picking Accuracy	100% correct picking of designated colonies.	100% of designated colonies were correctly picked without any event of picking a wrong colony.
VITEK MS Identification Agreement (Gram-Negative)	High agreement with expected strain identity.	Gram-Negative Species: All species (Citrobacter koseri, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa) showed 100% agreement with good confidence for VITEK MS identification. Across 92 picked colonies, there was a 100% agreement on species/group identification.
VITEK MS Identification Agreement (Gram-Positive)	High agreement with expected strain identity.	Gram-Positive Species: Overall, 98.0% agreement with good confidence across 200 picked colonies. Individual species agreement ranged from 95.0% (Enterococcus faecium) to 100% (Staphylococcus aureus, Staphylococcus saprophyticus).
AST Essential Agreement (EA)	>98% agreement between Colibrí prepared samples and manually prepared samples.	For all species and antimicrobial agents combined, 100% (1315/1315) of on-scale MIC results were in Essential Agreement (EA).
AST Category Agreement (CA)	>98% agreement between Colibrí prepared samples and manually prepared samples.	For all species and antimicrobial agents combined, 99.4% (2703/2720) of results were in Category Agreement (CA).
AST Very Major Category Error	0%	0%
AST Major Category Error	0%	0%
AST Minor Category Error	Acceptable level (calculated based on the differences in CA from 100%).	17 minor errors occurred out of 2720 tested, resulting in a minor error rate of 0.6%. This is considered acceptable given the high overall CA.

2. Sample Size Used for the Test Set and Data Provenance

The study utilized a test set consisting of various bacterial strains to evaluate the Colibrí's performance in preparing samples for MALDI-TOF identification and AST.

Sample Size for Identification:
- Gram-Negative Species: 5 species (4 Enterobacterales, 1 Non-fermenter) with 92 colonies picked and analyzed.
- Gram-Positive Species: 5 species (2 Enterococcus, 2 Staphylococcus, 1 Streptococcus) with 200 colonies picked and analyzed.
- Total for Identification: 292 colonies.
Sample Size for AST:
- Total AST Tested: 2720 tests (sum of "Total tested" column from AST summary tables).
- This included: 1400 Enterobacterales, 200 Non-fermenters, 520 Staphylococci, 380 Enterococci, and 220 Streptococci.
Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. However, given that it is a submission to the U.S. Food & Drug Administration (FDA) by an Italian company (Copan WASP Srl, Brescia, Italy), the study was likely conducted to meet international regulatory standards, potentially with data from one or more clinical laboratories. The nature of the "Full workflow validation" study described suggests a prospective experimental design to assess the device's performance under controlled conditions.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not explicitly state the number of experts used or their specific qualifications for establishing ground truth. However, the study focuses on the accuracy of identification results against "expected strain identity" and comparison of MICs and SIR categories against "MICs obtained by bioMérieux VITEK 2 using manual sample preparation" and "FDA-Recognized Antimicrobial Susceptibility Test Interpretive Criteria."

This implies that:

For identification, the "expected strain identity" would have been established using a gold standard method, likely by skilled microbiologists or reference laboratories with established credentials in microbial identification.
For AST, the "manual sample preparation" by bioMérieux VITEK 2 would serve as the comparator, and the interpretation of results would follow "FDA-Recognized Antimicrobial Susceptibility Test Interpretive Criteria," likely applied by qualified laboratory personnel.

4. Adjudication Method

The document does not describe a formal adjudication method (e.g., 2+1, 3+1) for the test set.

For identification, performance was calculated as "percentage of spotted colonies matching the expected identity," suggesting a direct comparison to a single reference (ground truth).
For AST, the "MICs obtained by bioMérieux VITEK 2 using Colibrí were compared to the MICs obtained by bioMérieux VITEK 2 using manual sample preparation," indicating a direct method-to-method comparison. Discrepant SIR results were categorized, implying a systematic evaluation rather than a consensus-based adjudication in the traditional sense.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or any effect size of how much human readers improve with AI vs. without AI assistance. The Colibrí device is a pre-analytical automated system for sample preparation, not an AI-assisted diagnostic interpretation tool for human readers. Its function is to automate the preparation steps for subsequent analysis by other IVD systems (MALDI-TOF MS and VITEK 2 AST).

6. Standalone Performance Study

Yes, a standalone performance study was done for the algorithm/system. The "Full workflow validation" study directly assesses the Colibrí device's ability to accurately pick colonies and prepare samples for downstream analysis without human intervention in the picking and preparation steps themselves. The results presented for "VITEK MS Identification Result" and "AST summary of results" directly reflect the performance of the Colibrí-prepared samples when analyzed by the respective analytical instruments.

7. Type of Ground Truth Used

For microbial identification: The ground truth was based on "expected strain identity," which implies confirmed identification results likely obtained through established, highly accurate microbiological methods serving as a reference.
For AST: The ground truth for comparative purposes was "MICs obtained by bioMérieux VITEK 2 using manual sample preparation," interpreted according to "FDA-Recognized Antimicrobial Susceptibility Test Interpretive Criteria."

8. Sample Size for the Training Set

The document explicitly states that the "Colibrí uses equally designed and developed hardware and software modules as the Colibrí System. Therefore, the performance of the predicate device represents the performance of the new device." It also mentions that "The results of the analytical studies were submitted to support the 510(k) Premarket Notifications K193138 and K220546." This indicates that the current submission (K223245) relies on the performance data of the predicate device (Colibrí System, K220546). The document does not provide details on the training set sample size for the Colibrí System's development.

9. How the Ground Truth for the Training Set Was Established

As the current submission relies on the predicate device's performance, the ground truth for any training set related to the predicate Colibrí System would have been established during its development and prior FDA submission (K220546). The current document does not provide details of how the ground truth for the predicate device's training set was established. However, based on the performance parameters listed (e.g., accuracy of colony picking, reproducibility of identification, accuracy of nephelometer), it likely involved:

Microbial cultures: Using well-characterized microbial strains with confirmed identities.
Manual reference methods: Comparing automated colony picking against visual confirmation by trained personnel.
Reference AST methods: Comparing automated suspension preparation and subsequent AST results against established manual AST methods and interpretive criteria to assess agreement in MICs and categorical susceptibility (Susceptible, Intermediate, Resistant).

Summary

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Image /page/0/Picture/0 description: The image shows 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 letters "FDA" in a blue square. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 20, 2023

Copan WASP Srl Chiara Congiu Regulatory Affairs Via A. Grandi, 32 Brescia, Brescia 25125 Italy

Re: K223245

Trade/Device Name: Colibrí Regulation Number: 21 CFR 866.3378 Regulation Name: Clinical Mass Spectrometry Microorganism Identification And Differentiation System Regulatory Class: Class II Product Code: QQV, QBN, LON Dated: December 21, 2022 Received: December 21, 2022

Dear Chiara Congiu:

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

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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 -S

Ribhi Shawar, Ph.D. (ABMM) Branch Chief, General Bacteriology and Antimicrobial Susceptibility Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K223245

Device Name Colibrí

Indications for Use (Describe)

The Collori™ 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.

Bacterial suspensions for AST and purity plates are identified by barcode label.

The Colibri™ has not been validated for use in the identification or processing of yeast species, or mycobacteria.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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I. Submitter

Applicant Name:	Copan WASP SrlVia A. Grandi 3225125 Brescia, Italy+39 030 2687211copan.regulatory@copangroup.com
Contact Person	Chiara CongiuCopan WASP SrlVia A. Grandi 3225125 Brescia, Italy+39 338 6904942copan.regulatory@copangroup.com
Establishment Registration Number:	3009288740

Date Prepared:

February 18, 2022

II. Device Name

Proprietary Name	Colibrí
Common/Usual Name	Colibrí
Classification Name	Clinical mass spectrometry microorganismidentification and differentiation system (21 CFR 866.3378)Fully automated short-term incubation cycleantimicrobial susceptibility system (21 CFR 866.1645)
Device Class	II
Product Code	QQV, QBN, LON
Panel	Microbiology

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III. Legally Marketed Predicate Device

Device Name	Colibrí System
510(K) Number	K220546

No reference Devices were used in this submission.

Device Description IV.

The Colibrí includes the following components:

. Colibrí instrument and software with on-board pipetting system and nephelometer
Colibrí Primary Tubes ●
. Colibrí Spreader
Colibrí Daily Verification kit. ●

When used in conjunction with the bioMérieux VITEK MS, the Colibrí can prepare the 48-spot target slides by performing the direct spotting of colonies. The calibrator used for quality control

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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 Colibri 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 end 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.

The traceability of prepared Secondary Tube and Purity Plates is maintained by dedicated labels applications.

Colibrí requires a daily nephelometer verification to check the proper reading of suspensions at different turbidity values.

V. Intended Use / Indications For Use

The Colibri is an automated in vitro diagnostic specimen preparation system for use with WASPLab to prepare MALDI-TOF targets for the bioMérieux VITEK MS or Bruker MALDI Biotyper CA mass spectrometry systems for qualitative identification and microbial suspension for the bioMérieux VITEK 2 Antimicrobial Susceptibility Testing (AST) system for qualitative testing of isolated colonies of gram-negative and gram-positive bacterial species grown on solid culture media.

The Colibrí is an 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/lonization-Time of Flight Mass Spectrometry) target slides for bacterial identification and microbial suspension at known concentration for Antimicrobial Susceptibility Testing and purity assessment.

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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.

Bacterial suspensions for AST and purity plates are identified by barcode label.

The Colibrí 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 has not been validated for use in the identification or processing of yeast species, molds, Nocardia, or mycobacteria.

VI. Comparison to Predicate

According to its intended use, Colibrí supports the performance of the connected IVD Analyzers by facilitating sample preparation for Gram-Negative and Gram-Positive bacteria ID or AST according to their intended use.

The conjunction of Colibrí device with WASPLab device does not change, expand or limit the intended use of the Predicate Device and does not affect the safety and effectiveness of the predicate.

Both the Colibrí in conjunction with WASPLab device and the Predicate Device are intended for the preparation of target ID and AST microbial suspensions of colonies grown on culture media plates streaked with human specimens indicated as an aid in the diagnosis and treatment definition for the bacterial infections.

Similarities
Item	New Device	Predicate Device
Device Name(K number)	Colibrí	Colibrí System (K220546)
Device Classification	Class II (special controls)	Class II (special controls)
Regulation Number	21 CFR 866.3378 and 21 CFR 866.1645	21 CFR 866.3378 and 21 CFR 866.1645
Product Code	QQV, Automated System For SamplePreparation And Identification OfMicroorganisms From Cultured Isolates ByMass SpectrometryQBN, Mass Spectrometry, Maldi Tof,Microorganism Identification, Cultured IsolatesLON, System, Test, Automated, AntimicrobialSusceptibility, Short Incubation	QQV, Automated System For SamplePreparation And Identification OfMicroorganisms From Cultured Isolates ByMass SpectrometryQBN, Mass Spectrometry, Maldi Tof,Microorganism Identification, Cultured IsolatesLON, System, Test, Automated, AntimicrobialSusceptibility, Short Incubation
Indications for Use	The Colibrí is an automated in vitro diagnosticspecimen preparation system for use withWASPLab to prepare MALDI-TOF targets forthe bioMérieux VITEK MS or Bruker MALDIBiotyper CA mass spectrometry systems forqualitative identification and microbialsuspensions for the bioMérieux VITEK 2	The Colibrí System is an in vitro diagnosticdevice comprised of the Colibrí Vision Systemand Colibrí Preparation Station for use with thebioMérieux VITEK® MS or Bruker MALDIBiotyper® CA mass spectrometry systems forqualitative identification and with thebioMérieux VITEK® 2 Antimicrobial
Similarities
Item	New Device	Predicate Device
Device Name(K number)	Colibrí	Colibrí System (K220546)
	Antimicrobial Susceptibility Testing (AST) system for qualitative testing of isolated colonies of gram-negative and gram-positive bacterial species grown on solid culture media.The Colibrí is an 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 for bacterial identification and microbial suspension at known concentration for Antimicrobial Susceptibility Testing and purity assessment.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.Bacterial suspensions for AST and purity plates are identified by barcode label.The Colibrí 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 has not been validated for use in the identification or processing of yeast species, molds, Nocardia, or mycobacteria.	Susceptibility Testing (AST) system for qualitative testing 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 for bacterial identification and microbial suspension at known concentration for Antimicrobial Susceptibility Testing and purity assessment.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.Bacterial suspensions for AST and purity plates are identified by barcode label.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 the identification or processing of yeast species, molds, Nocardia, or mycobacteria.
Method of testing	Direct testing from isolated colonies for ID purposes in conjunction with bioMérieux VITEK MS or Bruker MALDI Biotyper CA System.Direct testing from isolated colonies for AST purposes in conjunction with bioMérieux VITEK 2.	Same
Sample/Media Type	Isolated bacterial colonies from any patient source grown on plates included in K193138 and K220546.	Same
Plate management	Automatic image capturing management and manual loading into instrument for picking activities.	Same
Colonies selection	The colony to be picked is selected by an operator on a digital plate using a Graphical User Interface on a dedicated workstation.	Same
Method of Colony Picking	Automatic picking of colonies using pipette tips.	Same
ID Target preparation	When connected with VITEK MS, a portion of microbial colony from an agar plate is automatically spotted on a Vitek MS-DS target slide (VITEK MS DS Target Slides, 48 positions disposable plastic targets) by using the pipetting system. 1µL of matrix is automatically applied to the spot using the pipetting system. The dried target slide is then manually loaded into the VITEK MS.	Same
Similarities
Item	New Device	Predicate Device
Device Name(K number)	Colibrí	Colibrí System (K220546)
AST SuspensionPreparation	Using a pipetting system, a predefined number of morphologically similar colonies are transferred into Primary Tube containing saline solution (0.45% NaCl Saline Solution pH 4.5 to 7.0). A homogenous heavy suspension of organisms is prepared and checked by using on-board Colibrí nephelometer. In the Secondary Tube containing 3.0mL of the same saline solution, a variable aliquot of the heavy suspension is automatically transferred to obtain the final microbial concentration according to IVD package insert indications. The suspensions prepared by Colibrí must be tested in MANUAL MODE on the VITEK 2.	Same
Calibration	Colibrí requires four different calibrations, one on the nephelometer, three on the cameras. None of these calibration activities require user intervention.	Same
Preparatory activities	Nephelometer verification by check using Daily verification Kit.	Same
Quality control	Completely dependent on next-step IVD analyzers.	Same

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Differences
Item	New Device	Predicate Device
Device Name(K number)	Colibrí	Colibrí System (K220546)
Plate management	Automatic plate loading for image capturing that is performed according to set image protocol.	Manual loading for image capturing and selection by the operator of media plate type.
Plate incubation	Automatic and managed by the WASPLab.	Manual.

These differences do not affect substantial equivalence of Colibrí and the Predicate Device.

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VII. Performance Data

Colibrí uses equally designed and developed hardware and software modules as the Colibrí System. Therefore, the performance of the predicate device represents the performance of the new device. The results of the analytical studies were submitted to support the 510(k) Premarket Notifications K193138 and K220546 and showed that Colibrí technology allow the preparation of target slides for MALDI-TOF identifications and microbial suspension for AST with good performance regarding the:

Accuracy of colony picking from culture plates -
Reproducibility of identification results -
Inclusivity of species and genera with different colony morphologies and characteristics and at various incubation times
-Absence of positional effect on the target slides
-Stability of the spots with and without the matrix
-Accuracy of the on-board nephelometer
-Accuracy of microbial content of the suspensions for AST
Accuracy of AST results, including between-instruments and operators' reproducibility -
-On-board reagent stability
-Absence of carry-over

The following performance data were provided in support of the substantial equivalence determination.

Full workflow validation

This study aims to demonstrate the accuracy of Colibri in picking designated colonies of different microbial species, selected by the laboratory technologist using WASPLab WebApp, for the preparation of target slides for MALDI-TOF identification and of microbial suspensions for AST.

Three Colibrí interfaced with three WASPLab were used to pick isolated colonies from mixed cultures prepared with gram-positive and gram-negative strains, to prepare target slides for microbial identification and microbial suspensions for AST. Strains were selected to be representative of different species of Enterobacterales (n=4), Staphylococcus (n=2), Streptococcus (n=1), Enterococcus (n=2) and non-fermenters (n=1), including "on-panel" species for VITEK MS exhibiting a range of on-scale MIC values toward at least 4 antibiotics representative for the major classes of drugs in VITEK 2 cards.

After the automatic preparation, the target slides were analysed by the mass spectrometer and microbial suspensions were associated to the appropriate card of antibiotics to perform susceptibility testing. Furthermore, processed plates were visually inspected by the operator in comparison to the colonies designated on the plate image in WASPLab WebApp to verify that were successfully picked by the Colibri. For microbial identification, performance was calculated as percentage of spotted colonies matching the expected identity; for AST, the MICs obtained by bioMérieux VITEK 2 using Colibrí were compared to the MICs obtained by bioMérieux VITEK 2 using manual sample preparation and the SIR category was reported according to the FDA-

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Recognized Antimicrobial Susceptibility Test Interpretive Criteria. Essential Agreement (EA) of the MICs and Category Agreement (CA) were calculated. The discrepant SIR results were categorized as Very Major Category Error, Major Category Error and Minor Category Error.

Colonies designated by the operator were 100% correctly picked without any event in which a wrong colony was picked, providing evidence that the picking coordinates defined by WASPLab software are correct and are successfully interpreted by Colibri. For the VITEK MS, a total of 292 spots were prepared and 98.6% of designated colonies has been identified correctly with high confidence in comparison to the expected strain identity. Data show that no incorrect identification occurred on spots prepared by the Colibrí and that it was always able to accurately pick designated colonies.

The results are summarized in the tables below. Due to the high degree of agreement between MICs determined from samples prepared manually and samples prepared by the Colibrí with WASPLab (with both EA and CA >98% for each antimicrobial agent/organism group tested), the AST accuracy was deemed acceptable. In addition, and since this is a method-to-method comparison, the cumulative results for all antimicrobial agents and species combined were evaluated. For all species and antimicrobial agents, 100% (1315/1315) of on-scale MIC results were in EA and 99.4% (2703/2720) were in CA with the comparator result. No very major or major errors occurred.

ExpectedOrganismIdentity	CultureMedium	StrainsTested	ColoniesPicked	VITEK MS Identification Result			% Agreement*
				GoodConfidence	LowDiscrimination	No ID	CultureMedium	Species/ Group
Citrobacterkoseri	TSA	1	10	10	--	--	100%	100%
Citrobacterkoseri	MAC	1	11	11	--	--	100%
Escherichiacoli	TSA	1	14	14	--	--	100%	100%
Escherichiacoli	MAC	1	9	9	--	--	100%
Klebsiellapneumoniae	TSA	1	7	7	--	--	100%
Klebsiellapneumoniae	MAC	1	9	9	--	--	100%	100%
Proteusmirabiliis	TSA	1	7	7	--	--	100%
Proteusmirabiliis	MAC	1	8	8	--	--	100%	100%
Pseudomonasaeruginosa	TSA	1	8	8	--	--	100%
Pseudomonasaeruginosa	MAC	1	9	9	--	--	100%	100%
TOTAL	2	5	92	92	--	--	100%	100%

Identification results of the Colibrí obtained with the bioMérieux VITEK MS stratified per gram-negative species.

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Identification results of the Colibrí obtained with the bioMérieux VITEK MS stratified per gram-positive species.

Expected OrganismIdentity	StrainsTested	ColoniesPicked	VITEK MS Identification Result		No ID	% Agreement*
			GoodConfidence	LowDiscrimination
Enterococcus faecalis	1	40	39	--	1	97.5%
Enterococcus faecium	1	40	38	--	2	95.0%
Staphylococcus aureus	1	40	40	--	0	100%
Staphylococcussaprophyticus	1	40	40	--	0	100%
Streptococcus agalactiae	1	40	39	--	1	97.5%
TOTAL	5	200	196	--	4	98.0%

*Calculated as Agreement(%) = = No. of correct results with Good Confidence value (≥60%) x100 Total number of picked colonies

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Agent	Organism group	Totaltested	#EA	% EA	TotalEvaluable	# EA ofEvaluable	% EA ofEvaluable	Totalcat.	# CA	% CA	# S	# R	#vmj	#maj	#min
Amikacin	Enterobacterales	80	80	100.0%	80	80	100.0%	80	80	100.0%	80	0	0	0	0
Amikacin	Non-fermenters	20	20	100.0%	20	20	100.0%	20	20	100.0%	20	0	0	0	0
Ampicillin	Enterococcus	40	40	100.0%	20	20	100.0%	40	40	100.0%	20	20	0	0	0
Ampicillin	Streptococcus	20	20	100.0%	0	0	N/A	20	20	100.0%	20	0	0	0	0
Ampicillin /Sulbactam	Enterobacterales	60	60	100.0%	20	20	100.0%	60	59	98.3%	20	40	0	0	1
Aztreonam	Enterobacterales	80	80	100.0%	40	40	100.0%	80	80	100.0%	20	60	0	0	0
Cefazolin	Enterobacterales	60	60	100.0%	0	0	N/A	60	60	100.0%	0	60	0	0	0
Cefepime	Enterobacterales	80	80	100.0%	80	80	100.0%	80	76	95.0%	40	0	0	0	4
Cefepime	Non-fermenters	20	20	100.0%	20	20	100.0%	20	20	100.0%	20	0	0	0	0
Cefotaxime	Streptococcus	20	20	100.0%	0	0	N/A	20	20	100.0%	20	0	0	0	0
Cefoxitin	Enterobacterales	80	80	100.0%	38	38	100.0%	80	80	100.0%	20	60	0	0	0
Ceftazidime	Enterobacterales	80	80	100.0%	80	80	100.0%	80	76	95.0%	0	40	0	0	4
Ceftazidime	Non-fermenters	20	20	100.0%	20	20	100.0%	20	20	100.0%	20	0	0	0	0
Ceftriaxone	Enterobacterales	80	80	100.0%	20	20	100.0%	80	80	100.0%	0	80	0	0	0
Ceftriaxone	Streptococcus	20	20	100.0%	0	0	N/A	20	20	100.0%	20	0	0	0	0
Ciprofloxacin	Non-fermenters	20	20	100.0%	0	0	N/A	20	20	100.0%	20	0	0	0	0
Ciprofloxacin	Staphylococcus	40	40	100.0%	20	20	100.0%	40	40	100.0%	20	0	0	0	0
Clindamycin	Enterococcus	40	40	100.0%	40	40	100.0%	40	40	100.0%	20	0	0	0	0
Clindamycin	Staphylococcus	40	40	100.0%	0	0	N/A	40	40	100.0%	20	20	0	0	0
Clindamycin	Streptococcus	20	20	100.0%	0	0	N/A	20	20	100.0%	20	0	0	0	0
Ertapenem	Enterobacterales	80	80	100.0%	0	0	N/A	80	80	100.0%	60	20	0	0	0
Erythromycin	Staphylococcus	40	40	100.0%	0	0	N/A	40	40	100.0%	20	20	0	0	0
Erythromycin	Enterococcus	40	40	100.0%	20	20	100.0%	40	40	100.0%	0	20	0	0	0
Erythromycin	Streptococcus	20	20	100.0%	19	19	100.0%	20	20	100.0%	0	20	0	0	0
Agent	Organism group	Totaltested	#EA	% EA	TotalEvaluable	# EA ofEvaluable	% EA ofEvaluable	Totalcat.	# CA	% CA	# S	# R	#vmj	#maj	#min
Gentamicin	Enterobacterales	80	80	100.0%	20	20	100.0%	80	80	100.0%	60	20	0	0	0
Gentamicin	Non-fermenters	20	20	100.0%	20	20	100.0%	20	20	100.0%	20	0	0	0	0
Imipenem	Staphylococcus	40	40	100.0%	0	0	N/A	40	40	100.0%	20	20	0	0	0
Imipenem	Non-fermenters	20	20	100.0%	20	20	100.0%	20	20	100.0%	20	0	0	0	0
Levofloxacin	Enterobacterales	80	80	100.0%	20	20	100.0%	80	80	100.0%	0	60	0	0	0
Levofloxacin	Non-fermenters	20	20	100.0%	20	20	100.0%	20	19	95.0%	20	0	0	0	1
Levofloxacin	Staphylococcus	20	20	100.0%	20	20	100.0%	20	20	100.0%	20	0	0	0	0
Linezolid	Enterococcus	40	40	100.0%	40	40	100.0%	40	40	100.0%	20	0	0	0	0
Linezolid	Streptococcus	20	20	100.0%	20	20	100.0%	20	20	100.0%	20	0	0	0	0
Linezolid	Staphylococcus	40	40	100.0%	40	40	100.0%	40	40	100.0%	40	0	0	0	0
Linezolid	Enterococcus	40	40	100.0%	40	40	100.0%	40	40	100.0%	40	0	0	0	0
Meropenem	Streptococcus	20	20	100.0%	0	0	N/A	20	20	100.0%	20	0	0	0	0
Meropenem	Enterobacterales	80	80	100.0%	20	20	100.0%	80	80	100.0%	60	20	0	0	0
Meropenem	Non-fermenters	20	20	100.0%	20	20	100.0%	20	20	100.0%	20	0	0	0	0
Moxifloxacin	Staphylococcus	40	40	100.0%	0	0	N/A	40	40	100.0%	40	0	0	0	0
Nitrofurantoin	Enterobacterales	80	80	100.0%	80	80	100.0%	80	77	96.3%	0	40	0	0	3
Nitrofurantoin	Staphylococcus	40	40	100.0%	0	0	N/A	40	40	100.0%	40	0	0	0	0
Oxacillin	Enterococcus	40	40	100.0%	20	20	100.0%	40	40	100.0%	20	20	0	0	0
Oxacillin	Staphylococcus	40	40	100.0%	20	20	100.0%	40	40	100.0%	0	40	0	0	0
Penicillin (Benzyl-penicillin)	Enterococcus	40	40	100.0%	39	39	100.0%	40	40	100.0%	20	20	0	0	0
Penicillin (Benzyl-penicillin)	Streptococcus	20	20	100.0%	20	20	100.0%	20	20	100.0%	20	0	0	0	0
Penicillin (Benzyl-penicillin)	Staphylococcus	40	40	100.0%	19	19	100.0%	40	40	100.0%	0	40	0	0	0
Piperacillin /Tazobactam	Enterobacterales	80	80	100.0%	40	40	100.0%	80	76	95.0%	60	20	0	0	4
Piperacillin /Tazobactam	Non-fermenters	20	20	100.0%	20	20	100.0%	20	20	100.0%	20	0	0	0	0
Quinupristin /Dalfopristin	Staphylococcus	40	40	100.0%	40	40	100.0%	40	40	100.0%	40	0	0	0	0
Tetracycline	Enterobacterales	80	80	100.0%	40	40	100.0%	80	80	100.0%	40	40	0	0	0
Agent	Organism group	Totaltested	#EA	% EA	TotalEvaluable	# EA ofEvaluable	% EA ofEvaluable	Totalcat.	# CA	% CA	# S	# R	#vmj	#maj	#min
	Staphylococcus	40	40	100.0%	0	0	N/A	40	40	100.0%	20	20	0	0	0
	Enterococcus	40	40	100.0%	0	0	N/A	40	40	100.0%	0	40	0	0	0
	Streptococcus	20	20	100.0%	0	0	N/A	20	20	100.0%	0	20	0	0	0
Tigecycline	Enterobacterales	80	80	100.0%	40	40	100.0%	80	80	100.0%	60	20	0	0	0
	Staphylococcus	20	20	100.0%	0	0	N/A	20	20	100.0%	20	0	0	0	0
	Enterococcus	20	20	100.0%	0	0	N/A	20	20	100.0%	20	0	0	0	0
	Streptococcus	20	20	100.0%	0	0	N/A	20	20	100.0%	20	0	0	0	0
Tobramycin	Enterobacterales	80	80	100.0%	20	20	100.0%	80	80	100.0%	0	60	0	0	0
	Non-fermenters	20	20	100.0%	0	0	N/A	20	20	100.0%	20	0	0	0	0
Trimethoprim /Sulfamethoxazole	Enterobacterales	80	80	100.0%	0	0	N/A	80	80	100.0%	0	80	0	0	0
Vancomycin	Staphylococcus	40	40	100.0%	20	20	100.0%	40	40	100.0%	40	0	0	0	0
	Enterococcus	40	40	100.0%	40	40	100.0%	40	40	100.0%	40	0	0	0	0
	Streptococcus	20	20	100.0%	20	20	100.0%	20	20	100.0%	20	0	0	0	0

AST summary of results, antimicrobial agent

Copan WASP S.r.l., Traditional 510(k)- Colibrí

CONFIDENTIAL Page 10

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Copan WASP S.r.l., Traditional 510(k)- Colibrí

CONFIDENTIAL Page 11

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AST summary of results, organism group

Group	Totaltested	# EA	% EA	TotalEvaluable	# EA ofEvaluable	% EA ofEvaluable	Totalcateg.	# CA	% CA	# S	# R	#min
Enterobacterales	1400	1400	100.0%	638	638	100.0%	1400	1384	98.9%	520	720	16
Non-fermenters	200	200	100.0%	160	160	100.0%	200	199	99.5%	200	0	1
Staphylococci	520	520	100.0%	179	179	100.0%	520	520	100.0%	340	160	0
Enterococci	380	380	100.0%	259	259	100.0%	380	380	100.0%	200	120	0

CONFIDENTIAL Page 12

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Group	Totaltested	# EA	% EA	TotalEvaluable	# EA ofEvaluable	% EA ofEvaluable	Totalcateg.	# CA	% CA	# S	# R	#vmj	#maj	#min
Streptococci	220	220	100.0%	79	79	100.0%	220	220	100.0%	180	40	0	0	0

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VIII. Non-Clinical and/or Clinical Tests Summary & Conclusions

Conclusions:

The predicate device, Colibrí System and the new device, Colibrí both utilize the same technology for the preparation of the MALDI-TOF targets and the AST microbial suspensions. The minor differences between the devices do not adversely affect safety and effectiveness. The submitted documentation demonstrates that the subject device is substantially equivalent to the predicate device.

Regulation Number and Section

§ 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.