(361 days)
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No
The document does not mention AI, ML, or related terms like deep learning or neural networks. The description focuses on standard pulse oximetry technology and signal processing for respiration rate.
No.
The device is described as a monitoring system that non-invasively measures physiological parameters (SpO2, pulse rate, respiration rate) but does not provide any therapy or treatment.
Yes
This device is a patient monitoring system that measures SpO2, pulse rate, and respiration rate, which are physiological parameters used to assess a patient's health status and aid in diagnosing conditions such as desaturation indicative of repetitive reductions in airflow.
No
The device description explicitly states it is a "portable pulse oximeter" and a "Bedside Respiratory Patient Monitoring System" that operates on AC power or an integral battery, and uses "transducers (sensors)". This indicates the device includes significant 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 clearly states that the device is a continuous non-invasive monitor of physiological parameters (arterial oxygen saturation, pulse rate, and respiration rate). It measures these parameters directly from the patient's body using sensors.
- Device Description: The description reinforces this by explaining that it monitors these parameters "by use of a range of non-invasive transducers (sensors)."
- Lack of In Vitro Testing: There is no mention of the device being used to test samples (like blood, urine, or tissue) outside of the body. IVD devices are specifically designed for testing biological samples in vitro (in glass or in a lab setting).
The device is a non-invasive physiological monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
The Nellcor™ Bedside Respiratory Patient Monitoring System is a portable pulse oximeter intended for prescription use only as a continuous non-invasive monitor of arterial oxygen saturation (SpO2) and pulse rate of adult, pediatric, and neonatal patients during both no motion conditions, and for patients who are well or poorly perfused. The monitoring system is intended for use in hospital-type facilities, and during intrahospital transport. The OxiMax SPD™ Alert (SPD) feature is intended only for facility-use care of adults to detect natterns of desaturation indicative of repettive reductions in airflow through the upper airway and into the lungs.
The Respiration Rate parameter, when used in conjunction with the Nellcor™ Bedside Respiratory Patient Monitoring System and Nellcor™ Respiratory Sensor, is intended for the continuous, non-invasive monitoring of respiration rate in adult patients who are well perfused during no motion conditions, in hospital-type facilities.
Product codes (comma separated list FDA assigned to the subject device)
DQA, BZQ
Device Description
The Covidien Nellcor Bedside Respiratory Patient Monitoring System is designed for continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate by use of a range monioning of functional onlygon transducers (sensors). The Bedside Respiratory Patient Monitoring System displays digital values of SpO2 and pulse and respiratory rate. Pulse amplitude is displayed by means of a "blip ber" presentation or plethysmographic waveform. The Bedside Respiratory Patient Monitoring System can be bur "proomation" on plannyamosphy operating on AC from a standard electrical utility receptacle (from 80VAC to 264VAC) or alternatively by an integral sealed 7.2V, 83W/hr rechargeable lithium-ion battery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
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Indicated Patient Age Range
adult, pediatric, and neonatal patients
Intended User / Care Setting
prescription use only; hospital-type facilities, and during intrahospital transport.
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
Non-clinical Summary:
Respiration rate accuracy was tested to demonstrate accuracy from 4-40 breaths per minute (BrPM) in the range of 40 -170 beats per minute (BPM) at a fixed O2 saturation of 97%.
Clinical Summary:
Clinical testing has been performed on healthy, well perfused adults ranging in skin pigmentation from light to dark, and has demonstrated that the Bedside Respiratory Patient Monitoring System meets the Accuracy Root Mean Square (ARMS), in the 70%-100% SpO2 range acceptance criteria for both SpO2 and Pulse Rate in comparison to reference-standard measurements of blood SaO2 by a CO-Oximeter during motion and non-motion conditions.
Clinical validation studies on healthy adult volunteers were conducted to assess the accuracy of the Respiration Rate Software residing on the oximeter.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical and non-clinical tests were performed to support the determination of substantial equivalence. Clinical studies were conducted following regulations under Title 21 of the Code of Federal Regulations (21 CFR), Part 812 - Investigational Device Exemptions, Part 50 - Protection of Human Subjects and Part 56 Institutional Review Boards.
Non-clinical Summary:
Appropriate safety, environmental, performance and functional tests were conducted to ensure that the specifications of the Bedside Respiratory Patient Monitoring System were met. Verification testing of the performance of the Respiration Rate parameter, when used in conjunction with the Nellcor™ Bedside Respiratory Patient Monitoring System and Nellcor™ Respiratory Sensor has been performed. Noneor - Docent data has been applied to closely mimic clinical free breathing studies on healthy volunteer subjects. Respiration rate accuracy was tested to demonstrate accuracy from 4-40 breaths per minute (BrPM) in the range of 40 -170 beats per minute (BPM) at a fixed O2 saturation of 97%.
Clinical Summary:
Clinical testing has been performed on healthy, well perfused adults ranging in skin pigmentation from light to dark, and has demonstrated that the Bedside Respiratory Patient Monitoring System meets the Accuracy Root Mean Square (ARMS), in the 70%-100% SpO2 range acceptance criteria for both SpO2 and Pulse Rate in comparison to reference-standard measurements of blood SaO2 by a CO-Oximeter during motion and non-motion conditions. Testing has also demonstrated accuracy of SpO2 and Pulse Rate in low saturation conditions and equivalent performance of the Respiration Rate V 1.0 software to that of the cleared predicate.
Clinical validation studies on healthy adult volunteers were conducted to assess the accuracy of the Respiration Rate Software residing on the oximeter. The studies have demonstrated that the accuracy of the Respiration Rate Software algorithm is equivalent to that of the predicate. The studies demonstrated the Respiration Rate Software algorithm calculates respiration rate within a stated accuracy of ±1 breath per minute, and is shown to be substantially equivalent to the predicate device with respect to Respiration Rate (for adults). No device related adverse event were observed during the clinical studies.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Respiration Rate Software algorithm calculates respiration rate within a stated accuracy of ±1 breath per minute.
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.
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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).
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Image /page/0/Picture/1 description: The image shows the word "COVIDIEN" in bold, black letters. To the left of the word is a black square with a white cross in the center. The cross is made up of four smaller squares, and there are also some other white shapes in the black square.
510(k) Summary
Date: 24-Jan-2014
510(k) Submitter/Holder
Covidien IIc 6135 Gunbarrel Avenue Boulder, CO 80301
Contact
Elizabeth Malo Sr. Regulatory Affairs Specialist Office 303.305.2763 Mobile 720.539.9634 Fax: 303-305-2212 Email: elizabeth malo@covidien.com
Name of Device
| Device Name: | Bedside Respiratory Patient Monitoring System |
|---|---|
| Catalog Numbers: | GR101704, GR101704-RR, 10099029 |
| Common Name: | Pulse oximeter |
| Classification: | Class II |
| Regulation: | 21 CFR § 870.2700 Oximeter |
| Primary Product Code: | DQA |
| Secondary Product Code: | BZQ |
Purpose of Submission
Bedside Respiratory Patient Monitoring System has undergone an engineering design change associated with the replacement of the printed circuit board assembly that performs oximetry functions for the device. Futhermore, the indications for use have been expanded to specifically claim oximetry accuracy for "both no motion and motion conditions". The purpose of this submission is to demonstrate substantial equivalence of the Covidien Mellor Bedride Respiratory Patient Monitoring System to the predicate devices as related to these specific changes.
Summaries of clinical and non-clinical testing were provided to support 1) accuracy of oximetry performance, and 2) the expansion in the indications for use to include accuracy in the presence of motion.
Predicate Devices
Bedside Respiratory Patient Monitoring System was compared and found to be substantially equivalent to the following products of comparable type in commercial distribution:
| Trade Name: | Bedside Respiratory Patient Monitoring System |
|---|---|
| Device Common Name: | Oximeter, monitor, breathing frequency |
| 510(k) Number: | K121806 (cleared 9/2012) |
| Manufacturer: | Covidien, formerly Nellcor, a division of Tvco Healthcare |
| Trade Name: | Nellcor Puritan Bennett OxiMAX N-595 Pulse Oximeter |
| Device Common Name: | Monitor, breathing frequency |
| 510(k) Number: | K012891 (cleared 3/2002) |
| Manufacturer: | Covidien, formerly Nellcor, a division of Tyco Healthcare |
1
Device Description
The Covidien Nellcor Bedside Respiratory Patient Monitoring System is designed for continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate by use of a range monioning of functional onlygon transducers (sensors). The Bedside Respiratory Patient Monitoring System displays digital values of SpO2 and pulse and respiratory rate. Pulse amplitude is displayed by means of a "blip ber" presentation or plethysmographic waveform. The Bedside Respiratory Patient Monitoring System can be bur "proomation" on plannyamosphy operating on AC from a standard electrical utility receptacle (from 80VAC to 264VAC) or alternatively by an integral sealed 7.2V, 83W/hr rechargeable lithium-ion battery.
Intended Use
The Nellcor™ Bedside Respiratory Patient Monitoring System is a portable pulse oximeter intended for prescription use only as a continuous non-invasive monitor of arterial oxygen saturation (SpO2) and pulse rate of adult, pediatric, and neonatal patients during both no motion conditions, and for patients who are well or poorly perfused. The monitoring system is intended for use in hospital-type facilities, and during intrahospital transport. The OxiMax SPD™ Alert (SPD) feature is intended only for facility-use care of adults to detect natterns of desaturation indicative of repettive reductions in airflow through the upper airway and into the lungs.
The Respiration Rate parameter, when used in conjunction with the Nellcor™ Bedside Respiratory Patient Monitoring System and Nellcor™ Respiratory Sensor, is intended for the continuous, non-invasive monitoring of respiration rate in adult patients who are well perfused during no motion conditions, in hospital-type facilities.
Technological and Performance Characteristics
The Bedside Respiratory Patient Monitoring System features the same performance characteristics and design, chemical composition, and energy source as the predicate K121806 (9/2012).
The external appearance and hardware of the subject device is exactly the same as that of the primary predicate, utilizing a similar molded plastic exterior case, display, and interface cables.
Design Change
The only significant difference between the subject and primary predicate device is the internal printed circuit board assembly (PCBA). The key element of the design change to the subject device is the difference in the analog hardware that was introduced through integration of the new PCBA. These hardware changes are specifically related to the Sample Rate/Interval and T-Mux frequency which were the main drivers for clinical validation of the design change to demonstrate that these differences produced equivalent results in the clinical setting. Results of performance testing has demonstrated that the performance of the Bedside Respiratory Patient Monitoring System has not changed due to the integration of the new PCBA and that the performance of the oximeter is equivalent to that of the primary predicate device.
There are no significant changes to the function or performance of the device other than the expansion in the indications for use to include accuracy in the presence of motion as based upon test methods cleared through K012891 (3/2002).
Usability / Human Factors
Usability of the Bedside Respiratory Patient Monitoring System was evaluated with users in simulated operating environments during original design and testing. These studies consisted of formative studies, which demonstrate the device provides adequate assurance of safety and performance (in regards to human factors/usability aspects) for the patient and operator. No features associated with device usability have changed through design change to the subject device and thus no additional usability testing was performed.
Performance Data
Clinical and non-clinical tests were performed to support the determination of substantial equivalence. Clinical studies were conducted following regulations under Title 21 of the Code of Federal Regulations (21 CFR), Part 812 - Investigational Device Exemptions, Part 50 - Protection of Human Subjects and Part 56 Institutional Review Boards.
2
Non-clinical Summary
Appropriate safety, environmental, performance and functional tests were conducted to ensure that the specifications of the Bedside Respiratory Patient Monitoring System were met.
Verification testing of the performance of the Respiration Rate parameter, when used in conjunction with the Nellcor™ Bedside Respiratory Patient Monitoring System and Nellcor™ Respiratory Sensor has been performed. Noneor - Docent data has been applied to closely mimic clinical free breathing studies on healthy volunteer subjects. Respiration rate accuracy was tested to demonstrate accuracy from 4-40 breaths per minute (BrPM) in the range of 40 -170 beats per minute (BPM) at a fixed O2 saturation of 97%.
Testing was conducted according to the FDA Guidance documents and consensus standards shown below:
- "Pulse Oximeters Premarket Notification Submissions [510(k)s]: Guidance for Industry and Food and Drug . Administration Staff" - July 19, 2007
- "Use of Standards in Substantial Equivalence Determinations" March 12, 2000 .
- "General principles of Software Validation, Final Guidance for Industry and FDA Staff" January 11, 2002 .
- International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human . Use: ICH Harmonized Tripartite Guideline: Guideline for Good Clinical Practice E6(R1)10 - June 1996
- EN 60601-1:2006- Medical Electrical Equipment Part 1: General Requirements for Safety and Essential Performance -.
- EN 60601-1-4:1999- Medical electrical equipment Part 1-4 : general requirements for safety Collateral standard : . programmable electrical medical systems
- EN 60601-1-6:2010- Medical electrical equipment Part 1-6: General requirements for safety Collateral standard. . Usability
- EN 60601-1-8:2006- Medical electrical equipment Part 1-8: General requirements for basic safety and essential . EN 0000 F 7 0.2000 Thoursel equirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems -
- EN 60601-1-9- Medical electrical equipment Part 1-9: General requirements for basic safety and essential performance . - Collateral Standard: requirements for environmentally conscious design
- EN 80601-2-61:2011- Medical electrical equipment Part 2-61: Particular requirements for basic safety and essential . performance of pulse oximeter equipment
- IEC 60601-1-2: 2007- Medical electrical equipment Part 1-2: General requirements for basic safety and essential . performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
Clinical Summary
Clinical testing has been performed on healthy, well perfused adults ranging in skin pigmentation from light to dark, and has demonstrated that the Bedside Respiratory Patient Monitoring System meets the Accuracy Root Mean Square (ARMS), in the 70%-100% SpO2 range acceptance criteria for both SpO2 and Pulse Rate in comparison to reference-standard measurements of blood SaO2 by a CO-Oximeter during motion and non-motion conditions. Testing has also demonstrated accuracy of SpO2 and Pulse Rate in low saturation conditions and equivalent performance of the Respiration Rate V 1.0 software to that of the cleared predicate.
Clinical validation studies on healthy adult volunteers were conducted to assess the accuracy of the Respiration Rate Software residing on the oximeter. The studies have demonstrated that the accuracy of the Respiration Rate Software algorithm is equivalent to that of the predicate. The studies demonstrated the Respiration Rate Software algorithm calculates respiration rate within a stated accuracy of ±1 breath per minute, and is shown to be substantially equivalent to the predicate device with respect to Respiration Rate (for adults).
No device related adverse event were observed during the clinical studies.
Substantial Equivalence
In establishing substantial equivalence of the Bedside Respiratory Patient Monitoring System to the predicate devices, Covidien has evaluated the intended use, indications for use, technological characteristics, and elements of risk analysis and risk management. The use of the Bedside Respiratory Patient Monitoring System in patient monitoring environments does not raise any new questions of safety and effectiveness when compared with the predicate devices currently in use.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing wings or feathers. The symbol is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the border of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 04, 2014
Covidien, LLC Ms. Elizabeth Malo Senior Regulatory Affairs Specialist 6135 Gunbarrel Avenue Boulder, CO 80301
Re: K130320
Trade/Device Name: Bedside Respiratory Patient Monitoring System Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA, BZQ Dated: November 6, 2013 Received: November 7, 2013
Dear Ms. Malo:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Malo
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Image /page/4/Picture/8 description: The image shows a logo or seal with text and graphic elements. The text includes "Tejashri Purohit-Sheth, M.D." and "Clinical Deputy Director", indicating a medical professional's name and title. The acronym "DAGRID" is also present, possibly representing an organization or department. The word "FOR" is visible at the bottom right, suggesting the purpose or recipient of the document or seal.
Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, 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 (if known): KI30320
Covidien Nellcor™ Bedside Respiratory Patient Monitoring System and the Covidien Device Name: Nellcor™ Bedside Respiratory Patient Monitoring System Respiration Rate Software
Indications for Use:
For Covidien Nellcor Bedside Respiratory Patient Monitoring System with Respiration Rate Software:
The Nellcor™ Bedside Respiratory Patient Monitoring System is a portable pulse oximeter intended for prescription use only as a continuous non-invasive monitor of arterial oxygen saturation (SpO2) and pulse rate of adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused. The monitoring system is intended for use in hospitals, hospitaltype facilities, and during intra-hosport. The OxiMax SPD™ Alert (SPD) feature is intended only for facility-use care of adults to detect patterns of desaturation indicative of repetitive reductions in airflow through the upper airway and into the lungs.
The Respiration Rate parameter, when used in conjunction with the Nellcor™ Bedside Respiratory Patient Monitoring System and Nellcor™ Respiratory Sensor, is intended for the continuous, non-invasive monitoring of respiration rate in adult patients who are well perfused during no motion conditions, in hospitals and hospital-type facilities.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Navan J