(136 days)
Not Found
No
The summary describes a standard physiological monitoring device and does not mention any AI or ML capabilities.
No
The device is described as a monitor that measures and displays physiological parameters, rather than providing treatment or altering bodily function.
No
The device is described as a monitor that measures and displays physiological parameters (SpO2, ETCO2, respiration, and pulse rate). While these measurements are crucial for patient assessment and can inform diagnostic decisions, the text does not state that the device itself makes a diagnosis or provides diagnostic interpretations. It continuously monitors parameters for healthcare professionals.
No
The device description explicitly mentions a "lightweight, portable Capnography/Pulse Oximeter monitor" with a "liquid crystal display (LCD) monitor" and a "touch panel display," indicating it is a physical hardware device, not software only.
Based on the provided information, the LifeSense® Model LS1-9R Capnography/Pulse Oximeter monitor is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The LifeSense® Model LS1-9R directly measures physiological parameters (SpO2, ETCO2, respiration, pulse rate) from the patient's body through non-invasive means (pulse oximetry sensor, sample line for breath). It does not analyze blood, urine, tissue, or other bodily fluids or substances in a laboratory setting.
- The intended use and device description clearly state that it is for continuous, non-invasive monitoring of patients. This is a characteristic of in vivo diagnostic or monitoring devices, not in vitro diagnostics.
Therefore, the LifeSense® Model LS1-9R falls under the category of a patient monitoring device rather than an IVD.
N/A
Intended Use / Indications for Use
The LifeSense® Model LS1-9R Capnography/Pulse Oximeter monitor indicated for use in simultaneously measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2), end tidal carbon dioxide (ETCO2), respiration and pulse rate of well or poorly perfused adult, pediatric and infant patients. It is intended for use in environments where patients require continuous, non-invasive monitoring of these parameters by a healthcare professional, e.g. hospitals, medical facilities, post-operative care, patient transport, home-use, or any emergency medical services and environments.
Product codes (comma separated list FDA assigned to the subject device)
DQA, CCK
Device Description
The LifeSense® Model LS1-9R is a lightweight, portable Capnography/Pulse Oximeter monitor indicated for use in simultaneously measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2), end tidal carbon dioxide (ETC02), respiration and pulse rate of adult, pediatric, and infant patients. It is intended for use in any environment where patients require continuous, non-invasive monitoring of intubated or spontaneous breathing patients.
When measuring ETCO2 the patient is attached to the monitor by a simple sample line that can be either an airway adapter for an endotracheal tube, a nasal cannula, or a nasal cannula with oxygen input.
The liquid crystal display (LCD) monitor of the Model LS1-9R displays factory default or operator defined parameters and alarm settings, ETCO2 and respiration graphs, battery status and fault messages. Operator defined settings can be made on the touch panel display.
LifeSense Model LS1-9R monitor is intended for prescription use with adult, pediatric, and infant patients.
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
adult, pediatric, and infant patients.
Intended User / Care Setting
environments where patients require continuous, non-invasive monitoring of these parameters by a healthcare professional, e.g. hospitals, medical facilities, post-operative care, patient transport, home-use, or any emergency medical services and environments.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonin's Model LS1-9R Capnography/Pulse Oximeter monitor has undergone both bench and clinical testing in order to demonstrate that it has appropriate functional features and is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).
0
SECTION 2. SUMMARY AND CERTIFICATION
510(k) Summary A.
MAY - 4 2007
| Submitter: | Nonin Medical, Inc. |
|---|---|
| Contact Person: | Lori M. Roth |
| Clinical/Regulatory Specialist | |
| Nonin Medical, Inc. | |
| 13700 1st Ave. North | |
| Plymouth, MN 55441-5443 | |
| Date Prepared: | December 15, 2006 |
| Trade Name: | LifeSense® Model LS1-9R Capnography/Pulse Oximeter |
| Monitor | |
| Classification Name: | |
| and Number: | Class II, 21 CFR 868.1400 |
| Product Code: | DQA, CCK |
| Predicate Device(s): | Nonin's LifeSense® Model LS1-9R is substantially equivalent to the MicroCap Plus/NPB-75 Capnograph/Pulse Oximeter manufactured by Oridion Medical, LTD cleared by the FDA under K024300 on 4/03/03 and the Capnocheck® Plus manufactured by BCI International, Inc. cleared under K970209 on 4/18/97. |
| Device Description: | The LifeSense® Model LS1-9R is a lightweight, portable Capnography/Pulse Oximeter monitor indicated for use in simultaneously measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2), end tidal carbon dioxide (ETC02), respiration and pulse rate of adult, pediatric, and infant patients. It is intended for use in any environment where patients require continuous, non-invasive monitoring of intubated or spontaneous breathing patients. |
| When measuring ETCO2 the patient is attached to the monitor by a simple sample line that can be either an airway adapter for an endotracheal tube, a nasal cannula, or a nasal cannula with oxygen input. | |
| The liquid crystal display (LCD) monitor of the Model LS1-9R displays factory default or operator defined |
1
parameters and alarm settings, ETCO2 and respiration graphs, battery status and fault messages. Operator defined settings can be made on the touch panel display.
LifeSense Model LS1-9R monitor is intended for prescription use with adult, pediatric, and infant patients.
Intended Use: The LifeSense® Model LS1-9R Capnography/Pulse Oximeter monitor indicated for use in simultaneously measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2), end tidal carbon dioxide (ETC02), respiration and pulse rate of well or poorly perfused adult, pediatric and infant patients. It is intended for use in environments where patients require continuous, non-invasive monitoring of these parameters by a healthcare professional, e.g. hospitals, medical facilities, post-operative care, patient transport, home-use, or any emergency medical services and environments.
Safety Testing: Nonin's Model LS1-9R Capnography/Pulse Oximeter monitor has undergone both bench and clinical testing in order to demonstrate that it has appropriate functional features and is substantially equivalent to the predicate devices.
Conclusion: Nonin's LifeSense Model LS1-9R is substantially equivalent to the MicroCap Plus/NPB-75 Capnograph/Pulse Oximeter manufactured by Oridion Medical, LTD cleared by the FDA under K024300 and the Capnocheck® Plus manufactured by BCI International, Inc. under K970209.
Functional and
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its wings. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Lori M. Roth Clinical/Regulatory Specialist Nonin Medical, Incorporated 13700 1st Avenue North Plymouth, Minnesota 55441-5443
MAY - 4 2007
Re: K063752
Trade/Device Name: Nonin LifeSense® Model LS1-9R Capnography/ Pulse Oximeter Monitor Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DOA, CCK Dated: April 25, 2007 Received: April 27, 2007
Dear Ms. Roth:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 – Ms. Roth
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 Part 801); 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.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Susan Runne
Chiu Lin, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(K) Number: K063752
Device Name:
Nonin LifeSense® Model LS1-9R Capnography/Pulse Oximeter Monitor _____________________________________________________________________________________________________________
Indications for Use:
The LifeSense® Model LS1-9R Capnography/Pulse Oximeter monitor indicated for use in simultaneously measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2), end tidal carbon dioxide (ETCO2), respiration and pulse rate of well or poorly perfused adult, pediatric and infant patients. It is intended for use in environments where patients require continuous, non-invasive monitoring of these parameters by a healthcare professional, e.g. hospitals, medical facilities, post-operative care, patient transport, home-use, or any emergency medical services and environments.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Cheffto | |
| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital, | |
| Infection Control, Dental Devices | |
| 510(k) Number: | K063752 |
Nonin Medical, Inc.
LifeSense® Model LS1-9R Traditional 510(K): Premarket Notification Confidential