(198 days)
No
The device description focuses on standard physiological measurements (EtCO2, SpO2, BR, PR) and explicitly states the use of commercially available, unaltered modules (Nellcor MP-204/MP-203) for these measurements. There is no mention of AI, ML, or any advanced processing beyond standard signal analysis for these parameters.
No
The device measures and displays physiological parameters (EtCO2, SpO2, breath rate, pulse rate) to aid in determining a patient's ventilatory status and oxygenation, which are diagnostic functions, not therapeutic.
Yes
Explanation: The device measures and displays physiological parameters such as end-tidal CO2, saturated arterial oxygen, breath rate, and pulse rate, which are used to determine a patient's ventilatory status and oxygenation. These measurements provide information that aids in diagnosis.
No
The device description explicitly states that the device is an "integrated instrument" that measures EtCO2 and SpO2, and it incorporates hardware components like a capnograph section and a pulse oximeter module (specifically mentioning Nellcor modules). This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Description: The description clearly states that the device measures end tidal CO2 (EtCO2) and saturated arterial oxygen (SpO2) directly from the patient. These are measurements taken in vivo (within the living body), not in vitro (outside the living body).
- No mention of samples: There is no mention of the device analyzing samples taken from the patient.
Therefore, the device described is a patient monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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Product codes
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Device Description
The Spegas MicroCap/NPB-75 and the comparison device Gemini+ (K950387) are integrated instruments that measure end tidal CO2 (EtCO2) and saturated arterial oxygen (SpO2). As a derivative of the EtCO2 measurement the devices measure and display the breath rate (BR) and as a derivative of the saturated arterial oxygen measurement the devices measure and display the pulse rate (PR). The capnograph section of both devices function as a carbon dioxide gas analyzer that measures in mmHg, Vol %, or kPa the concentration of CO2 in a gas mixture to aid in determining the patient's ventilatory status. The pulse oximeter module in both devices measures the oxygenated hemoglobin (HbO2) and displays the results as a percent of oxygen and as a plethysmographic waveform. The Spegas MicroCap/NPB-75 pulse oximeter module is essentially identical to the Spegas Gemini+ (K950387) pulse oximeter module. The Gemini+ uses the Nellcor M-203 Spon module and the MicroCap/NPB-75 utilizes the Nellcor MP-204 module. The MP-204 SpO2 module is very similar, essentially equivalent, to the MP-203 module. Spegas integrates the Nellcor MP-204, without alteration, into the MicroCap/NPB-75 and Gemini (MP203).
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
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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
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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).
0
Image /page/0/Picture/0 description: The image shows the word "SPEGAS" in a bold, outlined font. Each letter is outlined with multiple lines, creating a layered effect. The letters are evenly spaced and appear to be in a sans-serif typeface.
K964239
MAY 9, 1997
Date prepared 10 October 1996
Section 2.1
510(k) Summary of Safety and Effectiveness Information in This Submission
The following is a summary of the safety and effectiveness statements and data contained in this pre market notification for the Spegas MicroCap/NPB-75 capnograph/pulse oximeter.
PRODUCT NAME
Proprietary: MicroCap/NPB-75
Combination Oximeter/Carbon Dioxide Gas Analyzer Common:
ESTABLISHMENT REGISTRATION NUMBER Establishment Registration Number: 8044004
ESTABLISHMENT ADDRESS:
Contact Person: Sanford Brown, Manager of Regulatory Affairs Spegas Industries Ltd. Har Hotzvim Science Based Industrial Park POB 45025 91450 Jerusalem, Israel Telephone: +972-2-582-8867 FAX: +972-2-582-8873
ESTABLISHMENT USA Designated Representative:
Contact person: Yacov Bubis Spegas Industries Ltd. 70 Walnut Street Welleslev, MA 02181 617-239-8030
DEVICE LISTING FDA FORM 2892: A 733250
DOC: 2.1 MICROCAP/NPB-75
Sectiion 2.1.1
1
DEVICE DESCRIPTION
The Spegas MicroCap/NPB-75 and the comparison device Gemini+ (K950387) are integrated instruments that measure end tidal CO2 (EtCO2) and saturated arterial oxygen (SpO2). As a derivative of the EtCO2 measurement the devices measure and display the breath rate (BR) and as a derivative of the saturated arterial oxygen measurement the devices measure and display the pulse rate (PR). The capnograph section of both devices function as a carbon dioxide gas analyzer that measures in mmHg, Vol %, or kPa the concentration of CO2 in a gas mixture to aid in determining the patient's ventilatory status. The pulse oximeter module in both devices measures the oxygenated hemoglobin (HbO2) and displays the results as a percent of oxygen and as a plethysmographic waveform. The Spegas MicroCap/NPB-75 pulse oximeter module is essentially identical to the Spegas Gemini+ (K950387) pulse oximeter module. The Gemini+ uses the Nellcor M-203 Spon module and the MicroCap/NPB-75 utilizes the Nellcor MP-204 module. The MP-204 SpO2 module is very similar, essentially equivalent, to the MP-203 module. Spegas integrates the Nellcor MP-204, without alteration, into the MicroCap/NPB-75 and Gemini (MP203).
SUBSTANTIAL EQUIVALENCE INFORMATION
The new device, the MicroCap/NPB-75, is a two parameter monitor incorporating the functions of currently marketed two parameter monitors. It is substantially equivalent, in terms of indications for use and technological characteristics to the two parameter Spegas Gemini+ capnograph/ pulse oximeter (K950387),