(222 days)
No
The device description mentions "biostatistical analysis" and comparison to a "reference spectra library (database)" to generate a "probability ranking". While this involves data analysis and pattern matching, there is no explicit mention of AI or ML techniques like neural networks, deep learning, or adaptive algorithms that are characteristic of AI/ML in medical devices. The term "biostatistical analysis" is a broader term that doesn't necessarily imply AI/ML.
No.
This device is an in vitro diagnostic device used to identify microorganisms to aid in diagnosing infections, rather than to treat or prevent disease directly.
Yes
The "Intended Use / Indications for Use" section explicitly states, "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 yeast infections."
No
The device description explicitly states it is a "mass spectrometer system" and details various hardware components and procedures (MALDI-TOF, laser, target plates, sample preparation techniques) that are integral to its function. While software is used for analysis and comparison, the device is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "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 yeast infections."
This statement directly identifies the device as an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MALDI Biotyper CA System is a mass spectrometer systems using matrix-assisted laser desorption/ionization - time of flight (MALDI-TOF) for the identification 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 yeast infections.
Product codes
PEX
Device Description
The MBT-CA System uses a different methodology for organism identification based on unique protein patterns of the microorganisms obtained from mass spectrometry. The test organism's spectrum (a pattern of mass peaks) is compared with a reference spectra library (database). Using biostatistical analysis, a probability ranking of the organism identification is generated. The probability ranking is represented as a log(score) between 0.00 and 3.00. Organism identification is reported with high confidence if the log(score) is ≥2.00. An organism identification is reported with low confidence if the log(score) is between 1.70 and
§ 866.3361 Mass spectrometer system for clinical use for the identification of microorganisms.
(a)
Identification. A mass spectrometer system for clinical use for the identification of microorganisms is a qualitative in vitro diagnostic device intended for the identification of microorganisms cultured from human specimens. The device is comprised of an ionization source, a mass analyzer, and a spectral database. The device is indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial and fungal infections.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Premarket notification submissions must include detailed documentation for device software, including, but not limited to, standalone software applications and hardware-based devices that incorporate software.
(2) Premarket notification submissions must include database implementation methodology, construction parameters, and quality assurance protocols.
(3) A detailed explanation of the interpretation of results and acceptance criteria must be included in the device's 21 CFR 809.10(b)(9) compliant labeling.
(4) As part of the risk management activities performed as part of your 21 CFR 820.30 design controls, you must document an appropriate end user device training program that will be offered as part of your efforts to mitigate the risk of failure to correctly operate the instrument.
(5) Premarket notification submissions must include details on the appropriate end user device training program that will be offered while marketing the device.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird symbol, composed of three overlapping profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 26, 2017
Bruker Daltonik GmbH Mr. David Cromwick Director of Quality 40 Manning Rd Billerica. MA 01821 US
Re: K163536
Trade/Device Name: MALDI Biotyper CA (MBT-CA) System, MBT smart CA System Regulation Number: 21 CFR 866.3361 Regulation Name: Mass spectrometer system for clinical use for the identification of microorganisms Regulatory Class: II Product Code: PEX Dated: December 16, 2016 Received: December 16, 2016
Dear Mr. Cromwick:
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. 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 Parts 801 and 809); medical device reporting (reporting of
1
medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809). please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Kristian M. Roth-S
For: Uwe Scherf, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K163536
Device Name MALDI Biotyper CA System
Indications for Use (Describe)
The MALDI Biotyper CA System is a mass spectrometer systems using matrix-assisted laser desorption/ionization - time of flight (MALDI-TOF) for the identification 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 yeast infections.
The following organisms are claimed:
Bacteria: Abiotrophia defectiva Achromobacter xylosoxidans Acinetobacter baumannii / nosocomialis group Acinetobacter calcoaceticus Acinetobacter haemolyticus Acinetobacter johnsonii Acinetobacter junii Acinetobacter lwoffii Acinetobacter pittii Acinetobacter radioresistens Acinetobacter ursingii Actinomyces europaeus Actinomyces funkei Actinomyces graevenitzii Actinomyces hyovaginalis Actinomyces meyeri Actinomyces neuii Actinomyces odontolyticus Actinomyces oris Actinomyces radingae Actinomyces turicensis Actinomyces urogenitalis Actinotignum schaalii group Aerococcus sanguinicola Aerococcus urinae Aerococcus viridans Aeromonas salmonicida Aeromonas sp[7] Aggregatibacter actinomycetemcomitans Aggregatibacter aphrophilus Aggregatibacter segnis Alcaligenes faecalis Alloiococcus otitis Alloscardovia omnicolens
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Anaerococcus murdochii Anaerococcus vaginalis Arthrobacter cumminsii Bacteroides caccae Bacteroides fragilis Bacteroides nordii Bacteroides ovatus group Bacteroides pyogenes Bacteroides salyersiae Bacteroides stercoris group Bacteroides thetaiotaomicron group Bacteroides uniformis Bacteroides vulgatus group Bifidobacterium breve Bordetella group[3] Bordetella hinzii Brevibacterium casei Brevundimonas diminuta group Burkholderia cepacia complex [13] Burkholderia gladioli Burkholderia multivorans Campylobacter coli Campylobacter jejuni Campylobacter ureolyticus Capnocytophaga ochracea Capnocytophaga sputigena Chryseobacterium gleum Chryseobacterium indologenes Citrobacter amalonaticus complex Citrobacter freundii complex Citrobacter koseri Clostridium beijerinckii Clostridium bifermentans Clostridium butyricum Clostridium clostridioforme group Clostridium difficile Clostridium innocuum Clostridium paraputrificum Clostridium perfringens Clostridium ramosum Clostridium septicum Clostridium sordellii Clostridium sporogenes / Clostridium botulinum (group I) Clostridium tertium Corynebacterium accolens Corynebacterium afermentans group Corynebacterium amycolatum Corynebacterium aurimucosum group Corynebacterium bovis Corynebacterium coyleae Corynebacterium diphtheriae Corynebacterium freneyi Corynebacterium glucuronolyticum Corynebacterium glutamicum
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Corynebacterium jeikeium Corynebacterium kroppenstedtii Corynebacterium macginleyi Corynebacterium minutissimum Corynebacterium mucifaciens / ureicelerivorans group Corynebacterium propinquum Corynebacterium pseudodiphtheriticum Corynebacterium pseudotuberculosis Corynebacterium resistens Corynebacterium riegelii Corynebacterium striatum group Corynebacterium tuberculostearicum Corynebacterium ulcerans Corynebacterium urealyticum Corynebacterium xerosis Cronobacter sakazakii group Cupriavidus pauculus group Delftia acidovorans group Dermabacter hominis Dermacoccus nishinomiyaensis Edwardsiella tarda Eikenella corrodens Elizabethkingia meningoseptica group Enterobacter aerogenes Enterobacter amnigenus Enterobacter cloacae complex Enterococcus avium Enterococcus casseliflavus Enterococcus durans Enterococcus faecalis Enterococcus faecium Enterococcus gallinarum Enterococcus hirae Enterococcus mundtii Enterococcus raffinosus Escherichia coli Escherichia hermannii Escherichia vulneris Ewingella americana Facklamia hominis Finegoldia magna Fluoribacter bozemanae Fusobacterium canifelinum Fusobacterium necrophorum Fusobacterium nucleatum Gardnerella vaginalis Gemella haemolysans Gemella morbillorum Gemella sanguinis Granulicatella adiacens Haemophilus haemolyticus Haemophilus influenzae Haemophilus parahaemolyticus group Haemophilus parainfluenzae
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Hafnia alvei Helcococcus kunzii Kingella denitrificans Kingella kingae Klebsiella oxytoca / Raoultella ornithinolytica Klebsiella pneumoniae Klebsiella variicola Kocuria kristinae Kytococcus sedentarius Lactobacillus gasseri Lactobacillus jensenii Lactobacillus rhamnosus Lactococcus garvieae Lactococcus lactis Leclercia adecarboxylata Legionella longbeachae Legionella pneumophila Leuconostoc citreum Leuconostoc mesenteroides Leuconostoc pseudomesenteroides Listeria monocytogenes Macrococcus caseolyticus Mannheimia haemolytica group Micrococcus luteus Micrococcus lylae Mobiluncus curtisii Moraxella sg Branhamella catarrhalis* Moraxella sg Moraxella nonliquefaciens* Moraxella sg Moraxella osloensis* Morganella morganii Myroides odoratimimus Myroides odoratus Neisseria bacilliformis Neisseria cinerea Neisseria elongata Neisseria flavescens / subflava group Neisseria gonorrhoeae Neisseria lactamica Neisseria meningitidis Neisseria sicca group Neisseria weaveri Nocardia brasiliensis Nocardia cyriacigeorgica Nocardia farcinica group Nocardia nova Nocardia otitidiscaviarum Ochrobactrum anthropi Oligella ureolytica Oligella urethralis Pantoea agglomerans Parabacteroides distasonis Parabacteroides goldsteinii Parabacteroides johnsonii / merdae group Parvimonas micra
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Pasteurella multocida Pediococcus acidilactici Pediococcus pentosaceus Peptoniphilus harei group Peptostreptococcus anaerobius Plesiomonas shigelloides Pluralibacter gergoviae Porphyromonas gingivalis Porphyromonas somerae Prevotella bivia Prevotella buccae Prevotella denticola Prevotella intermedia Prevotella melaninogenica Propionibacterium acnes Proteus mirabilis Proteus vulgaris group Providencia rettgeri Providencia stuartii Pseudomonas aeruginosa Pseudomonas fluorescens group Pseudomonas oryzihabitans Pseudomonas putida group Pseudomonas stutzeri Ralstonia pickettii Rhizobium radiobacter Rothia aeria Rothia dentocariosa Rothia mucilaginosa Salmonella sp** Serratia fonticola Serratia liquefaciens Serratia marcescens Serratia odorifera Serratia plymuthica Serratia rubidaea Sphingobacterium multivorum Sphingobacterium spiritivorum Sphingomonas paucimobilis group Staphylococcus aureus Staphylococcus auricularis Staphylococcus capitis Staphylococcus caprae Staphylococcus carnosus Staphylococcus cohnii Staphylococcus delphini Staphylococcus epidermidis Staphylococcus equorum Staphylococcus felis Staphylococcus haemolyticus Staphylococcus hominis Staphylococcus intermedius Staphylococcus lentus Staphylococcus lugdunensis
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Staphylococcus pasteuri Staphylococcus pettenkoferi Staphylococcus pseudintermedius Staphylococcus saccharolyticus Staphylococcus saprophyticus Staphylococcus schleiferi Staphylococcus sciuri Staphylococcus simulans Staphylococcus vitulinus Staphylococcus warneri Staphylococcus xylosus Stenotrophomonas maltophilia Streptococcus agalactiae Streptococcus anginosus Streptococcus canis Streptococcus constellatus Streptococcus dysgalactiae Streptococcus equi Streptococcus gallolyticus Streptococcus gordonii Streptococcus intermedius Streptococcus lutetiensis Streptococcus mitis / oralis group Streptococcus mutans Streptococcus parasanguinis Streptococcus pneumoniae Streptococcus pyogenes Streptococcus salivarius / vestibularis group Streptococcus sanguinis Streptococcus sobrinus Streptococcus thermophilus Sutterella wadsworthensis Trueperella bernardiae Turicella otitidis Vagococcus fluvialis Veillonella parvula group Vibrio parahaemolyticus Vibrio vulnificus Weeksella virosa Yersinia enterocolitica Yersinia frederiksenii Yersinia intermedia Yersinia kristensenii Yersinia pseudotuberculosis
*sg = subgenus **sp = species
Yeasts: Candida albicans Candida boidinii Candida dubliniensis Candida duobushaemulonii
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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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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10. 510(k) SUMMARY
| Date of Summary: | June 21, 2017 |
|---|---|
| Product Name | MBT-CA System |
| Sponsor | Bruker Daltonik GmbH |
| Fahrenheitstrasse 4 | |
| 28359 Bremen, Germany | |
| Correspondent | Bruker Daltonik GmbH |
| Markus Kostrzewa, Vice President Clinical Mass Spectrometry R&D | |
| Fahrenheitstrasse 4 | |
| 28359 Bremen, Germany | |
| Phone: +49 (0)421-2205 1258 | |
| Fax: +49 (0)421-2205 1400 | |
| Email: Markus.Kostrzewa@bruker.com | |
| Device Identification | |
| Trade or Proprietary Name: | MALDI Biotyper CA System |
| Common or Usual Name: | System, mass spectrometry, maldi tof, microorganism identification, |
| cultured isolates | |
| Product Code: | PEX |
| Regulation Section: | 21 CFR 866.3361 Instrumentation for clinical multiplex test systems |
| Device Class: | Class II |
| Panel: | Microbiology |
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Substantial Equivalency
The MBT-CA System (K163536) is substantially equivalent to the MBT-CA System (K142677). Table 1 compares the characteristics of the MBT-CA System (New Device) and the MBT-CA System (Predicate Device).
| Similarities | ||
|---|---|---|
| NEW DEVICE | PRIMARY PREDICATE DEVICE | |
| Characteristic | MBT-CA System (K163536) | MBT-CA System (K142677) |
| Product Codes | PEX | PEX |
| Intended use | The MALDI Biotyper CA System is a mass | |
| spectrometer systems using matrix-assisted | ||
| laser desorption/ionization - time of flight | ||
| (MALDI-TOF) for the identification of | ||
| microorganisms cultured from human | ||
| specimens. |
The MALDI Biotyper CA System is a
qualitative in vitro diagnostic devices
indicated for use in conjunction with other
clinical and laboratory findings to aid in the
diagnosis of bacterial and yeast infections. | The MALDI Biotyper CA System is a mass
spectrometer system using matrix-assisted
laser desorption/ionization - time of flight
(MALDI-TOF) for the identification 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 yeast infections. |
| Sample type | Isolated colony from any patient sample
source.
Acceptable media:
• Columbia blood agar with 5% sheep
blood (Gram-negative bacteria)
• Trypticase soy agar with 5% sheep blood
(Gram-negative bacteria, Gram-positive
bacteria, yeasts)
• Chocolate agar (Gram-negative bacteria,
Gram-positive bacteria)
• MacConkey Agar (Gram-negative
bacteria)
• Columbia CNA agar with 5% sheep blood
(Gram-positive bacteria)
• Brucella Agar with 5% horse blood (Gram-
negative anaerobic bacteria, Gram-
positive anaerobic bacteria)
• CDC anaerobe Agar with 5% sheep blood
(Gram-negative anaerobic bacteria,
Gram-positive anaerobic bacteria)
• CDC anaerobe 5% sheep blood Agar with
phenylethyl alcohol (Gram-negative
anaerobic bacteria, Gram-positive
anaerobic bacteria)
• CDC anaerobe laked sheep blood Agar
with kanamycin and vancomycin (Gram-
negative anaerobic bacteria)
• Bacteroides bile esculin Agar with
amikacin ( Bacteroides species) | Isolated colony from any patient sample
source.
Acceptable media:
• Columbia blood agar with 5% sheep
blood (Gram-negative bacteria)
• Trypticase soy agar with 5% sheep blood
(Gram-negative bacteria, Gram-positive
bacteria, yeasts)
• Chocolate agar (Gram-negative bacteria,
Gram-positive bacteria)
• MacConkey Agar (Gram-negative
bacteria)
• Columbia CNA agar with 5% sheep blood
(Gram-positive bacteria)
• Brucella Agar with 5% horse blood (Gram-
negative anaerobic bacteria, Gram-
positive anaerobic bacteria)
• CDC anaerobe Agar with 5% sheep blood
(Gram-negative anaerobic bacteria,
Gram-positive anaerobic bacteria)
• CDC anaerobe 5% sheep blood Agar with
phenylethyl alcohol (Gram-negative
anaerobic bacteria, Gram-positive
anaerobic bacteria)
• CDC anaerobe laked sheep blood Agar
with kanamycin and vancomycin (Gram-
negative anaerobic bacteria)
• Bacteroides bile esculin Agar with
amikacin ( Bacteroides species) |
| Similarities | | |
| | NEW DEVICE
MBT-CA System (K163536) | PRIMARY PREDICATE DEVICE
MBT-CA System (K142677) |
| Characteristic | blood ( Clostridium difficile )
• Sabouraud-Dextrose Agar (Yeasts)
• Brain Heart Infusion Agar (Yeasts)
• Campylobacter Agar with 5 Antimicrobics
and 10% Sheep Blood ( Campylobacter
species)
• Bordet Gengou Agar with 15% sheep
blood ( Bordetella species)
• plus three (3) additionally validated
media (see differences). | blood ( Clostridium difficile )
• Sabouraud-Dextrose Agar (Yeasts)
• Brain Heart Infusion Agar (Yeasts)
• Campylobacter Agar with 5 Antimicrobics
and 10% Sheep Blood ( Campylobacter
species)
• Bordet Gengou Agar with 15% sheep
blood ( Bordetella species) |
| Type of Test | Automated Mass Spectrometry System | Automated Mass Spectrometry System |
| Matrix | α-Cyano-4-hydroxycinnamic acid | α-Cyano-4-hydroxycinnamic acid |
| Method of
Testing | Bacteria & Yeast: Direct testing
If after initial analysis the log(score) is
reported at Legionella species)
• Buffered Charcoal Yeast Extract Selective Agar with polymyxin, anisomycin and vancomycin ( Nocardia species)
• Modified Thayer-Martin Agar ( Neisseria species) | See Similarities |
| MALDI-TOF MS instruments | Bruker microflex LT/SH (benchtop)
Bruker microflex LT/SH smart (benchtop) | Bruker microflex LT/SH (benchtop) |
| MALDI Target Plates | US IVD 48 Spot Target (48 positions reusable steel targets)
MBT Biotarget 96 US IVD (96 positions disposable targets) | US IVD 48 Spot Target (48 positions reusable steel targets) |
The differences do not affect substantial equivalence of the MBT-CA System and MBT-CA System (K142677). Both systems are mass spectrometers using matrix-assisted laser desorption/ionization-time to flight (MALDI-TOF) for the identification of microorganisms cultured from human specimens. The differences noted above do not impact the intended use and do not raise questions as to the safety and effectiveness of the test (new) device.
Intended Use
The MALDI Biotyper CA System is a mass spectrometer system using matrix-assisted laser desorption/ionization - time of flight (MALDI-TOF) for the identification 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 veast infections.
Methodology
Biochemical methods are currently the most commonly used methods for the identification of microorganisms. Organisms are tested against a range of reagents and organism identification is based on a microorganism's reaction to these reagents.
The MBT-CA System uses a different methodology for organism identification based on unique protein patterns of the microorganisms obtained from mass spectrometry. The test organism's spectrum (a pattern of mass peaks) is compared with a reference spectra library (database). Using biostatistical analysis, a probability ranking of the organism identification is generated. The probability ranking is represented as a log(score) between 0.00 and 3.00. Organism identification is reported with high confidence if the log(score) is ≥2.00. An organism identification is reported with low confidence if the log(score) is between 1.70 and