(29 days)
DOP
Not Found
No
The description focuses on standard analytical techniques and hardware components without mentioning AI or ML.
No
The device is described as a Gas Isotope Ratio Mass Spectrometer (GIRMS) System used for the measurement of stable isotopes in gas samples, which is an analytical laboratory instrument, not a device intended for treating or diagnosing medical conditions.
No
The device measures stable isotopes in gas samples and is described as an analytical tool, not for diagnosing medical conditions.
No
The device description explicitly lists multiple hardware components (Gas Isotope Ratio Mass Spectrometer, gas sampling module, gas purification module, autosampler, and a personal computer) that are integral to the system's function. While a computer is used for control and data, the device is not solely software.
Based on the provided information, the ABCA-NT device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the measurement of stable isotopes in gas samples. While these gas samples could originate from biological sources (like breath or metabolic studies), the device itself is analyzing the gas composition, not directly diagnosing a disease or condition in a patient based on a biological sample in vitro.
- Device Description: The description focuses on the analytical components for gas analysis (mass spectrometer, gas chromatograph, autosampler). There's no mention of analyzing biological fluids or tissues.
- Lack of IVD Characteristics: Typical IVD devices are designed to analyze biological samples (blood, urine, tissue, etc.) to provide information for the diagnosis, monitoring, or treatment of diseases. The ABCA-NT's function is purely analytical for gas composition.
- Predicate Device: The predicate device is another Isotope Ratio Mass Spectrometer, which is also an analytical instrument, not typically classified as an IVD.
While the results from this device could be used in research or clinical studies that support diagnostic efforts, the device itself is a laboratory instrument for gas analysis, not an IVD.
N/A
Intended Use / Indications for Use
The ABCA-NT is a continuous flow Gas Isotope Ratio Mass Spectrometer (GIRMS) System intended for use in the measurement of stable isotopes of carbon, nitrogen, and oxygen in gas samples. For this purpose, the system is comprised of a gas sampling module, a gas purification module, and an isotope ratio mass spectrometer which are synchronously coupled by means of an external computer which also collects and archives data.
Product codes
91DOP
Device Description
The ABCA-NT is an acronym for a configuration of modules intended for use in analysis ${}^{13}$C and ${}^{18}$O in CO${}_2$ and ${}^{15}$N in N${}_2$ and N${}_2$O gas samples. The ABCA-NT System includes, as physically separate modules:
- The Europa 20-20 continuous flow IRMS
- The Europa ABCA-G gas purification module (Gas Chromatograph)
- A Gilson (or equivalent) autosampler
- An IBM (or compatible) personal computer for system control, data analysis and data storage
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
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Consolidated Nier Model 21-201 Isotope Ratio Mass Spectrometer (IRMS)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.2860 Mass spectrometer for clinical use.
(a)
Identification. A mass spectrometer for clinical use is a device intended to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens by ionizing the compound under investigation and separating the resulting ions by means of an electrical and magnetic field according to their mass.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
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510(k) Summary
The ABCA-NT Gas Isotope Ratio Mass Spectrometer
Applicant's Name, Address, Contact Person and Date of Preparation A.
Europa Scientific Limited Europa House, Electra Way Crewe. Cheshire CW1 6ZA United Kingdom
DEC 1 6 1997
Please direct any requests for information to:
Andrew Linton Director of Sales Europa Scientific Limited Europa House, Electra Way Crewe, Cheshire CW1 6ZA United Kingdom
+44-1270-589398 Phone: +44-1270-589412 Fax:
This 510(k) was prepared November 14, 1997
Device Name and Classification B.
Trade Name of the Device
ABCA-NT Gas Isotope Ratio Mass Spectrometer System
Common Name of the Device Gas Isotope Ratio Mass Spectrometer System
Classification
| Product Code: | 91DOP |
|---|---|
| Name: | Mass Spectrometer, Clinical Use |
| Reg. Number: | 21CFR 862.2860 |
| Class: | Class I |
The Predicate Device C.
The predicate device is the Consolidated Nier Model 21-201 Isotope Ratio Mass Spectrometer (IRMS) manufactured by Consolidated Electrodynamics Corporation, Inc., (CEC) of Pasadena, California. The instrument is a preamendment device in that it was legally marketed in the United States by CEC before May 28, 1976.
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D. Description of the Device
The ABCA-NT is an acronym for a configuration of modules intended for use in analysis ${}^{13}$C and ${}^{18}$O in CO${}_2$ and ${}^{15}$N in N${}_2$ and N${}_2$O gas samples. The ABCA-NT System includes, as physically separate modules:
- The Europa 20-20 continuous flow IRMS �
- The Europa ABCA-G gas purification module (Gas Chromatograph) �
- A Gilson (or equivalent) autosampler �
- � An IBM (or compatible) personal computer for system control, data analysis and data storage
1. Principle of Operation
Gas samples for analysis are contained in tubes which may be either pre-evacuated or flushed with air or helium. Most commonly, pre-evacuated tubes such as Exetainers® or Vacutainers® are used and are placed in the holding rack of the autosampler of the Europa Scientific ABCA-NT System. During operation, the sampler moves over each tube in turn and injects a 'double needle' probe consisting of two concentric cylinders. Purified helium carrier gas blows out of a hole in the tip of the inner cylinder of the probe and flushes all of the sample gas from the sample tube through an aperture in the side of the outer cylinder of the probe to the gas purification module. Prior to injection, the probe is purged with helium to rid it of any air. This is especially important if nitrogen is to be analyzed or with very low levels of carbon dioxide.
The helium carrier gas plus sample gases pass through a solid desiccant to remove water vapor, then into a gas chromatographic (GC) column which separates sample gas components. When carbon dioxide is the species of interest (which is frequently the case), it is undesirable for nitrogen and oxygen to enter the Isotope Ratio Mass Spectrometer. To prevent this, a secondary helium flow moves into the IRMS module while oxygen and nitrogen are directed to waste by a Diverter Valve. As the CO2 emerges from the column, the valves switch to direct the pure CO2 into the IRMS with the secondary helium flow directed to waste. For nitrogen analysis, no such 'dumping' to waste is necessary and all column effluent is allowed to pass into the IRMS.
Once in the IRMS, the neutral molecules, e.g., ${}^{12}$CO${}_2$ and ${}^{13}$CO${}_2$, are ionized in the molecules are then given a precise amount of energy by an electric field and directed into a magnetic field where they follow curved paths dependent on the mass to charge The separated 'beams' of molecules are focused on three different Faraday ratio. 'bucket' collectors, thus generating independent electrical currents corresponding to masses 44, 45, and 46 amu. The ratio of currents generated at the 45 and 44 amu 'Source' producing positively charged ions, e.g., ${}^{13}$CO${}_2^+$ and ${}^{12}$CO${}_2^+$. The charged collectors corresponds to the ratio of ${}^{13}$CO${}_2$ to ${}^{12}$CO${}_2$ in the original gas sample. The current generated at the 46 amu collector corresponds to the ${}^{12}$C${}^{16}$O${}^{18}$O${}^+$ ion and is used to correct for contributions of ${}^{12}$C${}^{16}$O${}^{17}$O${}^+$ to the 45 amu current using the Craig
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2. Calibration
Calibration of the system is achieved by placing sample tubes containing reference gas of known isotopic composition (from NIST, for example) at the beginning and at the end of a sample run. Reference gas tubes may also be interspersed at different intermediate positions throughout a run when there is a large number of samples. This procedure also monitors any instrumental drift and corrects for it at the end of the run.
Calculation of Results 3.
correction since the ${}^{17}$O/${}^{18}$O ratio is constant. For a given gas specimen, the ratio of the electrical current signals from the ${}^{13}$CO${}_2^+$ and isotopic abundance is introduced into the GIRMS system under identical conditions. The result of this differential measurement is expressed as the "delta per mil" difference ${}^{12}$CO${}_2^+$ ions is compared to that obtained when a reference CO${}_2$ sample of known
between the (${}^{13}$CO${}_2$/${}^{12}$CO${}_2$) ratio of the sample (R${}_R$) and the reference (R${}_S$):
$$\text{So } ^{13}\text{C} = \frac{R_{\text{B}} - R_{\text{S}}}{R_{\text{S}}} \text{ * 1000, \text{\textdegreezo}$$
The symbol for the "delta per mil" unit is %00.
E. Intended Use
The ABCA-NT is a continuous flow Gas Isotope Ratio Mass Spectrometer (GIRMS) System intended for use in the measurement of stable isotopes of carbon, nitrogen, and oxygen in gas samples. For this purpose, the system is comprised of a gas sampling module, a gas purification module, and an isotope ratio mass spectrometer which are synchronously coupled by means of an external personal computer which also collects and archives data.
F. Comparison of Technological Characteristics
-
- Technological Similarities of the ABCA-NT and Predicate Device
- a) The principles of operation and basic design of the two systems are equivalent.
- b) Calibrations of the two systems are based on the same principles.
- c) Calculations of results are identical.
- d) The Craig correction for the 45 amu current is based on the same experimental and theoretical principles.
- e) The technical specifications of the systems are essentially equivalent.
-
- Technological Differences Between the ABCA-NT and the Predicate Device
- a) Continuous Flow vs. Dual Inlet
The methods of introducing sample and reference gases are different for the two systems. The Europa ABCA-NT is a continuous flow system in which the gas
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component for analysis, e.g., CO2, separated from other gas components by molecular sieve gas chromatography, is automatically and continuously presented to the IRMS module for consecutive samples and references. Only the purified gas component and helium carrier gas enter the IRMS source for ionization. Helium gas is ionized but because of the low helium mass to charge ratio, the helium ion beam causes no interference in the measurement of the CO2 molecular ion beams at the Faraday cup collectors.
The predicate device is a dual-inlet system in which purified sample gas and reference gas are alternately introduced into the IRMS source chamber for ionization, acceleration, separation and detection.
Since the helium ion beam causes no interference in measurement of the desired isotope ratios, no systematic bias between systems is introduced due to the different modes of sample introduction.
b) Triple-collector vs. dual-collector detection systems
The Europa System uses three Faraday cup collectors while the Consolidated system uses two collectors. In the case of CO2 studies for example, the 44 and 45 amu collectors serve the same function in both systems. The third collector in the Europa System, at 46 amu, is used to make the Craig correction to the 45 amu current. The same compensation is made in the predicate device, but not automatically. In the Consolidated unit, a separate step is required to focus and measure the 46 amu beam current on a collector previously used for another beam.
Thus, the same interference corrections are applied, but the Europa ABCA-NT System is faster and more convenient.
G. Conclusion
The ABCA-NT is Substantially Equivalent to the cited Predicate Device.
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Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around it. Inside the circle is a stylized graphic of three human profiles facing to the right, with flowing lines suggesting movement or progress.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 16 1997
Robert F. Martin, Ph.D. . Europa Scientific, Inc. C/O Marchem Associates, Inc. 325 College Road Concord, Massachusetts 01742
Re : K974322 ABCA-NT Gas Isotope Ratio Mass Spectrometer System Requlatory Class: I Product Code: DOP November 14, 1997 Dated: Received: November 17, 1997
Dear Dr. Martin:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
sincerely yours,
Steven Litman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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VIII. Indications for Use Statement
Device Name:
ABCA-NT Gas Isotope Ratio Mass Spectrometer System
Indications for Use:
The ABCA-NT is a continuous flow Gas Isotope Ratio Mass Spectrometer (GIRMS) System intended for use in the measurement of stable isotopes of carbon, nitrogen, and oxygen in gas samples. For this purpose, the system is comprised of a gas sampling module, a gas purification module, and an isotope ratio mass spectrometer which are synchronously coupled by means of an external computer which also collects and archives data.
Prescription Use: No
Image /page/6/Picture/6 description: The image shows a form with the title "Division Sign-Off Division of Clinical Laboratory devices". The form also has a section labeled "510(k) Number" which is filled in with the number 74322. There is also a signature on the form.