(136 days)
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.
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.
This 510(k) summary (K063752) describes a Capnography/Pulse Oximeter monitor, which is a device for measuring physiological parameters. For this type of device, a "study" in the traditional sense of a clinical trial for diagnostic performance (e.g., sensitivity, specificity) is not typically performed or reported in the same way as for an AI/ML-based diagnostic algorithm. Instead, the "study" demonstrating the device meets acceptance criteria refers to bench and clinical testing to verify the accuracy and functionality of the measurements against established standards or reference methods.
Here's a breakdown of the requested information based on the provided text, with acknowledgments for what is generally applicable to such device submissions vs. what specifically is not mentioned in this document:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided 510(k) summary does not explicitly list specific numerical acceptance criteria (e.g., +/- x% accuracy) or detailed reported device performance for SpO2, ETCO2, respiration, and pulse rate. It generally states the device has "appropriate functional features" and is "substantially equivalent" to predicate devices. For these types of devices, the acceptance criteria are typically alignment with international standards for pulse oximetry (e.g., ISO 80601-2-61) and capnography (e.g., ISO 80601-2-55), which define accuracy ranges under various conditions. The "reported device performance" would consist of the results of testing against these standards, demonstrating the device operates within those defined accuracy limits. However, these specific numerical results are not detailed in this summary.
2. Sample Size Used for the Test Set and Data Provenance:
The summary states that the device "has undergone both bench and clinical testing." However, it does not specify the sample size for the clinical test set (number of patients, number of measurements) or the data provenance (e.g., country of origin, retrospective or prospective nature of the clinical test).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
For a device like a Capnography/Pulse Oximeter, "experts" in the context of establishing ground truth for individual readings are typically not involved in the same way as for image-based diagnostic AI. Instead, the ground truth for parameters like SpO2 and ETCO2 during clinical testing is established using reference devices or methods that are considered highly accurate and reliable (e.g., co-oximetry for SpO2, calibrated gas analyzers for ETCO2). The document does not specify the number or qualifications of any human "experts" involved in establishing ground truth.
4. Adjudication Method for the Test Set:
Given the nature of the device and the typical ground truth establishment methods (reference devices), an adjudication method (like 2+1, 3+1) used for human expert disagreement in image interpretation is not applicable and therefore not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A MRMC comparative effectiveness study is designed to assess the impact of an AI system on human reader performance for diagnostic tasks. This is not applicable to a device that measures physiological parameters like a Capnography/Pulse Oximeter. The device is not an AI-assisted diagnostic tool for human readers, but rather a measurement device. Therefore, no such study was performed or reported.
6. Standalone Performance Study:
Yes, a form of "standalone" performance was effectively done by subjecting the device to "bench and clinical testing." This testing evaluates the device's ability to accurately measure and display the physiological parameters (SpO2, ETCO2, respiration, pulse rate) on its own, without a human in the loop adjusting its measurements or interpretations. The details of these tests (e.g., specific protocols, results) are not included in this summary but are submitted to the FDA during the review process.
7. Type of Ground Truth Used:
The ground truth for devices like this typically comes from:
- Reference Devices/Methods: For SpO2, this would involve arterial blood gas analysis with a co-oximeter. For ETCO2, this would involve a highly accurate and calibrated gas analyzer.
- Physiological Stimuli: For pulse oximetry, controlled hypoxia studies are often performed. For capnography, controlled ventilation or gas mixture studies are used.
The summary does not explicitly state the types of ground truth used but implies standard clinical testing procedures.
8. Sample Size for the Training Set:
This device is not an AI/ML algorithm that requires a "training set" in the conventional sense. It's a hardware device with embedded algorithms for signal processing and measurement. Therefore, the concept of a "training set" for an AI model does not apply to this submission.
9. How the Ground Truth for the Training Set Was Established:
As mentioned above, the concept of a "training set" for AI/ML does not apply. The device's internal algorithms are developed and refined through engineering, calibration, and extensive testing against known physiological signals and reference standards, rather than "training" on a labeled dataset in the AI sense.
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SECTION 2. SUMMARY AND CERTIFICATION
510(k) Summary A.
MAY - 4 2007
| Submitter: | Nonin Medical, Inc. |
|---|---|
| Contact Person: | Lori M. RothClinical/Regulatory SpecialistNonin Medical, Inc.13700 1st Ave. NorthPlymouth, MN 55441-5443 |
| Date Prepared: | December 15, 2006 |
| Trade Name: | LifeSense® Model LS1-9R Capnography/Pulse OximeterMonitor |
| 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 |
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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
§ 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).