COMBINATION OXIMETER/CARBON DIOXIDE GAS ANALYZER
K964239 · Spegas Industries, Ltd. · CCK · May 9, 1997 · Anesthesiology
Device Facts
| Record ID | K964239 |
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| Device Name | COMBINATION OXIMETER/CARBON DIOXIDE GAS ANALYZER |
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| Applicant | Spegas Industries, Ltd. |
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| Product Code | CCK · Anesthesiology |
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| Decision Date | May 9, 1997 |
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| Decision | SESE |
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| Submission Type | Traditional |
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| Regulation | 21 CFR 868.1400 |
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| Device Class | Class 2 |
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Device Story
MicroCap/NPB-75 is an integrated capnograph and pulse oximeter; measures EtCO2, breath rate, SpO2, and pulse rate. Capnograph section analyzes CO2 concentration in gas mixtures (mmHg, Vol %, or kPa); pulse oximeter module measures oxygenated hemoglobin (HbO2) and displays plethysmographic waveform. Device integrates Nellcor MP-204 pulse oximeter module. Used by clinicians to monitor patient ventilatory status. Output displayed on device screen; assists healthcare providers in assessing patient respiratory and circulatory health.
Clinical Evidence
No clinical data provided; substantial equivalence based on technological characteristics and comparison to predicate device.
Technological Characteristics
Integrated capnograph/pulse oximeter. Capnograph measures CO2 concentration; pulse oximeter uses Nellcor MP-204 module for SpO2 and pulse rate. Displays plethysmographic waveform. No specific materials or software architecture details provided.
Indications for Use
Indicated for monitoring end-tidal CO2 (EtCO2), breath rate (BR), saturated arterial oxygen (SpO2), and pulse rate (PR) to assess patient ventilatory status.
Regulatory Classification
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.
Predicate Devices
Related Devices
- K024300 — MICROCAP PLUS/NPB-75 · Oridion Medical 1987 , Ltd. · Apr 3, 2003
- K160582 — WiCap · Athena Gtx · Sep 2, 2016
- K170820 — Capnograph and Oximeter · Cmi Health, Inc. · Jul 18, 2018
- K981114 — MICROCAP · Oridion Medical , Ltd. · Jun 25, 1998
- K082268 — CAPNOSTREAM20 WITH INTEGRATED PULMONARY INDEX · Oridion Capnography, Inc. · Feb 6, 2009
Submission Summary (Full Text)
{0}
K964239
MAY 9, 1997
SPEGAS
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
Common: Combination Oximeter/Carbon Dioxide Gas Analyzer
### 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
Wellesley, MA 02181
617-239-8030
DEVICE LISTING FDA FORM 2892: A 733250
DOC: 2.1 MICROCAP/NPB-75
Section 2.1.1
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# DEVICE DESCRIPTION
The Spegas MicroCap/NPB-75 and the comparison device Gemini+ (K950387) are integrated instruments that measure end tidal $\mathrm{CO}_{2}$ ($\mathrm{EtCO}_{2}$) and saturated arterial oxygen ($\mathrm{SpO}_{2}$). As a derivative of the $\mathrm{EtCO}_{2}$ 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 $\mathrm{CO}_{2}$ in a gas mixture to aid in determining the patient's ventilatory status. The pulse oximeter module in both devices measures the oxygenated hemoglobin ($\mathrm{HbO}_{2}$) 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 $\mathrm{SpO}_{2}$ module and the MicroCap/NPB-75 utilizes the Nellcor MP-204 module. The MP-204 $\mathrm{SpO}_{2}$ 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).
DOC: 2.1 MICROCAP/NPB-75
Section 2.1.2
