(190 days)
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No
The document describes a standard medical device for monitoring CO2 and respiration using infrared measurement. There is no mention of AI, ML, or any related concepts in the intended use, device description, or performance studies.
No
The device is a monitoring device that measures CO2 and respiration, it does not provide any treatment.
Yes
The device is intended for monitoring CO2 and respiration, which involves collecting physiological data from a patient to assess their medical condition. This process of data collection for health assessment falls under the definition of a diagnostic device.
No
The device description explicitly states that the M-miniC module consists of a "miniCO2 infrared measuring sensor" and is assembled in a physical module that plugs into a monitor frame. This indicates the presence of hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to monitor CO2 and respiration from the patient's airway. This involves measuring gases directly from the patient's breath, not from a sample of bodily fluid or tissue that is tested in vitro (outside the body).
- Device Description: The description details how the device connects to the patient's airway via sampling lines and adapters. It measures infrared absorption of gases in the breath. This is a direct physiological measurement, not an in vitro test.
- Lack of IVD Characteristics: The description does not mention any reagents, test strips, or analysis of biological samples (blood, urine, tissue, etc.) which are characteristic of IVD devices.
The device is a physiological monitoring device used to assess a patient's respiratory status in real-time.
N/A
Intended Use / Indications for Use
The Datex-Ohmeda S/5 Single-width airway module, M-miniC is intended to be used with Datex-Ohmeda S/5 modular monitors; S/5 Anesthesia Monitor, S/5 Compact Anesthesia Monitor, S/5 Critical Care Monitor and S/5 Compact Critical Care Monitor for monitoring CO2 and respiration.
The Datex-Ohmeda S/5 Single-width airway module, M-miniC and accessories is indicated for monitoring CO2 and respiration rate of all hospital patients. M-miniC is indicated for monitoring patients weighing more than 5kg (11 lbs.). The device is indicated for use by qualified medical personnel only.
Product codes
CCK
Device Description
The M-miniC is used in the Datex-Ohmeda S/5 modular family which consists of four different types of monitors: Anesthesia Monitor, Compact Anesthesia Monitor, Critical Care Monitor and Compact Critical Care Monitor. An monitor consists of four basic elements: display, keyboard, Central unit and modules. The display shows up to eight waveforms, real-time data and trends. With keyboard you can control the monitor. The keyboard consists of membrane keys and a comwheel. By pushing a key you can open a menu in which you can move by turning the comwheel.
The M-miniC module consists of miniCO2 infrared measuring sensor for measuring CO2. It is assembled in a Single-width module, which occupies one slot in a Datex-Ohmeda S/5 modular monitor frame. The main accessories include airway gas sampling lines, mini D-fend water traps and airway adapters The module is first plugged into the frame of the monitor. The sampling line is attached to the module connector. The monitor is switched on and the gas sampling line is attached to the airway adapter. The airway adapter is attached between ventilator Y-piece and Heat and moisture exchanger (HME) of the patient's intubation tube. The monitor displays measurements from the M-miniC module in the form of numeric values, curve and trends. The monitor also generates audible and visual alarms for this module and indicates the priorities and sources of alarms.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
qualified medical personnel only / hospital patients
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
The device has been thoroughly tested including electrical safety, electromagnetic compatibility, mechanical and environmental tolerance, software validation and verification of specifications. Verification of compliance with the following mandatory and voluntary standards has been made:
- IEC 60601-1:1988+Amdt 1:1991+Amdt 2:1995
- EN 60601-1: 1990+A1:1993+A2:1995+A13:1996
- CAN/CSA-C22.2 No. 601.1-M90 +S1:1994+Amdt2:1998
- IEC 60601-1-2:1993
- EN 60601-1-2:1993
- IEC 60601-1-4:1996+Amdt 1:1999
- EN 60601-1-4:1996+Amdt A1:1999
- ISO 9918:1993 / EN 864:1996
- ASTM F-1456 (1992)
- UL 2601:1997
Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 868.1400 Carbon dioxide gas analyzer.
(a)
Identification. A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image shows a logo with the letter 'D' inside a circle. There is a small square in the upper right corner of the circle. The text 'KZ3454' is written diagonally above the logo. The text appears to be handwritten.
Premarket Notification 510(k) Summary As required by section 807.92 Datex-Ohmeda S/5™ Single-width Airway Module M-miniC and accessories
GENERAL COMPANY INFORMATION as required by 807.92(a)(1)
COMPANY NAME/ADDRESS/PHONE/FAX:
Datex-Ohmeda 86 Pilgrim Road Needham, MA 02492 USA Tel: 781-449-8685 Fax: 781-433-1344
NAME OF CONTACT:
Mr. Joel Kent
DATE:
October 8, 2002
DEVICE NAME as required by 807.92(a)(2)
TRADE NAME:
Datex-Ohmeda S/5TM Single-width Airway Module M-miniC and accessories
COMMON NAME:
Carbon dioxide gas monitor
CLASSIFICATION NAME:
The following Class II classification appears applicable:
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-phase 868.1400
NAME OF LEGALLY MARKETED DEVICE FOR WHICH A CLAIM OF SUBSTANTIAL EQUIVALENCE IS MADE as required by 807.92(a)(3)
The Datex-Ohmeda S/5TM Single-width Airway Module M-miniC and accessories is substantially equivalent in safety and effectiveness to the legally marketed predicate M-CAIOVX module (K001814).
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DEVICE DESCRIPTION as required by 807.92(a)(4)
The M-miniC is used in the Datex-Ohmeda S/5 modular family which consists of four different types of monitors: Anesthesia Monitor, Compact Anesthesia Monitor, Critical Care Monitor and Compact Critical Care Monitor. An monitor consists of four basic elements: display, keyboard, Central unit and modules. The display shows up to eight waveforms, real-time data and trends. With keyboard you can control the monitor. The keyboard consists of membrane keys and a comwheel. By pushing a key you can open a menu in which you can move by turning the comwheel.
The M-miniC module consists of miniCO2 infrared measuring sensor for measuring CO2. It is assembled in a Single-width module, which occupies one slot in a Datex-Ohmeda S/5 modular monitor frame. The main accessories include airway gas sampling lines, mini D-fend water traps and airway adapters The module is first plugged into the frame of the monitor. The sampling line is attached to the module connector. The monitor is switched on and the gas sampling line is attached to the airway adapter. The airway adapter is attached between ventilator Y-piece and Heat and moisture exchanger (HME) of the patient's intubation tube. The monitor displays measurements from the M-miniC module in the form of numeric values, curve and trends. The monitor also generates audible and visual alarms for this module and indicates the priorities and sources of alarms.
INTENDED USE as required by 807.92(a)(5)
Intended use:
The Datex-Ohmeda S/5 Single-width airway module, M-miniC is intended to be used with Datex-Ohmeda S/5 modular monitors; S/5 Anesthesia Monitor, S/5 Compact Anesthesia Monitor, S/5 Critical Care Monitor and S/5 Compact Critical Care Monitor for monitoring CO2 and respiration.
Indications for use:
The Datex-Ohmeda S/5 Single-width airway module, M-miniC and accessories is indicated for monitoring CO2 and respiration rate of all hospital patients. M-miniC is indicated for monitoring patients weighing more than 5kg (11 lbs.). The device is indicated for use by qualified medical personnel only.
SUMMARY OF TECHNOLOGICAL CHARACTERITICS OF DEVICE COMPARED TO THE PREDICATE DEVICE as required by 807,92(a)(6)
The M-miniC module is substantially equivalent in safety and effectiveness to the predicate M-CAIOVX module (K001814). Both the M-miniC and predicate can be used with the same Datex-Ohmeda modular monitors, S/5 Anesthesia Monitor, S/5 Critical Care Monitor, S/5 Compact Anesthesia monitor and S/5 Compact Critical Care Monitor. The M-miniC is compatible with monitor main software L-ANE02(A), L-CANE02(A), L-ICU02(A) and L-CICU02(A) and newer while the predicate (because it was released previously) is compatible with S-ANE97, S-ARK97 and S-ICU97 monitor main software and newer. The measurement principle of CO2 is the same for both the M-miniC and predicate M-CAIOVX modules. They are side stream gas analyzers. measuring real time concentrations of CO2. They measure absorbtion of CO2 at 4.2-4.3um using narrow band IR filters. The detectors of both sensors are thermopiles. The principal structure of the CO2 sensors is the same; there is an IR source, a thermal insulator, a sample chamber and a detector. The sample chamber and detector are inside an aluminium frame and that frame has a thermal insulator around it. The IR source is constant current controlled.
The main difference is that the M-miniC measures only CO2 while the predicate M-CAIOVX measures additionally N2O and anesthetic agents and therefore the CO2 sensor of the M-miniC is smaller and consumes less power. The predicate M-CAIOVX also has a separate paramagnetic
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sensor which measures Oxygen and a separate spirometry unit which monitors patient ventilation and a gas exchange measurement. Both the M-miniC and predicate M-CAIOVX fulfill the same electrical safety standard IEC 601-1. Software in the M-miniC module is based on the same principles as the software of the predicate M-CAIOVX. It is simpler because it has only one gas measurement channel. Its basic functions such as CO2 concentration calculation, pump and IR source control are the same. Its communication protocol with the monitor is also the same. The M-miniC uses the same type of CO2 accessories as the predicate M-CAIOVX. The M-CAIOVX also has many accessories that are not used with the M-miniC because the M-miniC only uses accessories associated with CO2 monitoring. The M-miniC and predicate M-CAIOVX CO2 monitoring accessories are identical except for a new 6 m sampling line and the new mini Dfend water trap. The 6 m sampling line is just a longer version of the 2 m/3 m sampling lines of the predicate and is made from identical materials. The new mini D-fend is a smaller version of the predicate D-fend. The operation principle is the same. The M-miniC module is a single width module while the predicate M-CAIOVX is a double width module. This means the MminiC module only takes up one slot in the monitor frame. The CO2 measurement range of the M-miniC is from 0 to 20 vol% while the CO2 measurement range of the predicate M-CAIOVX is from 0 to 15 yol%. The warm-up time of the M-miniC is 1 min while the warm-up time of the predicate M-CAIOVX is 2 min. The sample flow of the M-miniC is 150 ml/min while the sample flow of the predicate M-CAIOVX is 200 ml/min. The CO2 rise time of the M-miniC is