(100 days)
No
The document describes a standard pulse oximeter and respiration rate monitor. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is a monitoring system that measures physiological parameters (SpO2, pulse rate, respiration rate) but does not provide therapy.
No
The device measures physiological parameters like SpO2, pulse rate, and respiration rate, but the described features do not include making diagnoses. The SPD Alert feature is for detecting patterns indicative of desaturation, which can inform a diagnosis, but the device itself does not provide a diagnosis.
No
The device description clearly outlines hardware components such as a portable pulse oximeter, internal power supply, and rechargeable battery, in addition to the software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the compatibility with potential recipients, or to monitor therapeutic measures.
- Device Function: The Covidien Nellcor Bedside Respiratory Patient Monitoring System is a non-invasive monitor. It measures physiological parameters (oxygen saturation, pulse rate, respiration rate) directly from the patient's body using sensors applied externally. It does not analyze samples taken from the body.
Therefore, based on the provided information, this device falls under the category of a non-invasive patient monitoring device, not an In Vitro Diagnostic.
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 and for patients who are well or poorly perfused. The monitoring system is intended for use in hospitals, hospital-type facilities, and during intra-hospital transport. 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 to be used for the continuous non-invasive monitoring of respiration rate in adult patients in hospitals and hospital-type facilities.
Product codes
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 of compatible Nellcor OxiMax oxygen 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 bar" presentation or plethysmographic waveform. The Bedside Respiratory Patient Monitoring System can be powered by an internal power supply 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. The Nellcor OxiMax Bedside Respiratory Patient Monitoring System is intended for prescription use with adult, pediatric and neonatal patients in hospitals, hospital-type facilities, and intra-hospital transport.
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 neonatal patients
Intended User / Care Setting
prescription use only; hospitals, hospital-type facilities, and during intra-hospital transport.
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
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Summary of Performance Studies
Bench Testing: Design verification and validation testing was performed to confirm the system mechanical and software features met specified requirements. Performance testing included verification of the stated operating range and validation of accuracy claims through 20-point COPs and Low Perfusion Pulse Rate and Saturation Accuracy tests. All verification and validation activities met product requirements.
Animal Testing: Animal testing was not required to demonstrate that the proposed device met its design requirements and therefore there are no animal data associated with this device.
Usability / Human Factors: Usability was evaluated with users in simulated operating environments. These studies consisted of formative and Summative studies, which demonstrate the device provides adequate assurance of safety and performance (in regards to human factors/usability aspects) for the patient and operator.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/0 description: The image shows the word COVIDIEN next to a black square with a white cross in the middle. The word COVIDIEN is in all caps and is in a bold, sans-serif font. The black square is to the left of the word COVIDIEN. The white cross is in the center of the black square.
K 121806 510(k) Summary
Date summary prepared: 31-Aug-2012
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
| Trade Name: | Bedside Respiratory Patient Monitoring System |
|---|---|
| Catalog Numbers: | GR101704, GR101704-RR |
| Common Name: | Pulse oximeter |
| Classification Name: | oximeter (21 CFR § 870.2700, class II, DQA) |
| monitor, breathing frequency (21 CFR § 868.2375, class II, BZQ) |
Purpose of Submission
The purpose of this submission is to introduce the Covidien Nellcor Bedside Respiratory Patient Monitoring System which effectively integrates Respiration Rate software parameter into a pulse oximetry monitor whose design is fundamentally similar to the proposed predicate. The intended use of the Bedside Respiratory Patient Monitoring System is the same as that of the predicate with the addition of the continuous noninvasive monitoring of respiration rate in adult patients.
This submission followed the "Guidance for Industry and FDA Staff: Format for Traditional and Abbreviated 510(k)s, 2005," the "Guidance for Industry on General / Specific Intended Use, 1998," and the "Draft Guidance for Industry and FDA Staff: Factors to Consider when Making Benefit-Risk Determinations in Medical Device Premarket Review, 2011."
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: | N-600x Pulse Oximeter with Oximax SPD Alert |
|---|---|
| Device Common Name: | Oximeter |
| 510(k) Number: | K083325 (cleared 3/2009) |
| Manufacturer: | Covidien, formerly Nellcor, a division of Tyco Healthcare |
| Trade Name: | Covidien Respiration Rate Software |
| Device Common Name: | Monitor, breathing frequency |
| 510(k) Number: | K111933 (cleared 3/2012) |
| Manufacturer: | Covidien, formerly Nellcor, a division of Tyco Healthcare |
SEP 2 8 2012
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 of compatible Nellcor OxiMax oxygen 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 bar" presentation or plethysmographic waveform. The Bedside Respiratory Patient Monitoring System can be powered by an internal power supply 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. The Nellcor OxiMax Bedside Respiratory Patient Monitoring System is intended for prescription use with adult, pediatric and neonatal patients in hospitals, hospital-type facilities, and intra-hospital transport.
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 and for patients who are well or poorly perfused. The monitoring system is intended for use in hospitals, hospital-type facilities, and during intra-hospital transport. 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 to be used for the continuous non-invasive monitoring of respiration rate in adult patients in hospitals and hospital-type facilities.
Technological and Performance Characteristics
The Bedside Respiratory Patient Monitoring System features the same performance characteristics as the predicate K083325, N-600x Pulse Oximeter with Oximax SPD Alert. There are no significant changes to the function of the device other than the addition of the respiration rate software as an optional parameter for use on the finished device.
Performance Data
The design of the Bedside Respiratory Patient Monitoring System features the same internal printed circuit board assembly as the predicate device thus performance data to demonstrate saturation and pulse rate accuracy, and SPD are unchanged and the associated information provided in K060576 and K083325 are applicable to the device subject of this submission. Integration of Covidien Respiration Rate Software has not resulted in any change to the software algorithm which calculates patient respiration rate based upon oximetry ohotoplethysmography data, therefore performance data to respiration rate are unchanged and the associated information provided in K111933 are applicable to the device subject of this submission
Bench Testing: Design verification and validation testing was performed to confirm the system mechanical and software features met specified requirements. Performance testing included verification of the stated operating range and validation of accuracy claims through 20-point COPs and Low Perfusion Pulse Rate and Saturation Accuracy tests. All verification and validation activities met product requirements.
Animal Testing: Animal testing was not required to demonstrate that the proposed device met its design requirements and therefore there are no animal data associated with this device.
Usability / Human Factors
Usability was evaluated with users in simulated operating environments. These studies consisted of formative and Summative studies, which demonstrate the device provides adequate assurance of safety and performance (in regards to human factors/usability aspects) for the patient and operator.
Substantial Equivalence
In establishing substantial equivalence of the Bedside Respiratory Patient Monitoring System to the predicate in establishing Subtainer oquindines o events, and instrument risk profiles. The use of the Bedside Respiratory Patient Monitoring System in patient events, and finstranient her promotive with a more withpes of safety and effectiveness compared with the predicate devices currently in use.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP 2 8 2012
Covidien Ms. Elizabeth Malo Senior Regulatory Affairs Specialist 6135 Gunbarrel Avenue Boulder, Colorado 80301
Re: K121806
Trade/Device Name: Covidien Nellcor™ Bedside Respiratory Patient Monitoring System and the Covidien Nellcor 114 Bedside Respiratory Patient Monitoring System with Respiration Rate Software
Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA, BZQ Dated: August 31, 2012 Received: September 4, 2012
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 1 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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 vours.
for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement 4.1
. 510(k) Number (if known): 121806
Device Name: Covidien Nelloor™ Bedside Respiratory Patient Monitoring System and the Covidien 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 The None - Butly as a continuous non-invasive monitor of arterial oxygen saturation (SpO₂) and pulse rate of adult, pediatric, and neonatal patients and for patients who are well or poorly perfused. The monitoring system is intended for use in hospitals, hospital-type facilities, and during intra-hospital transport. montoning of com is intenced 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 to be used for the continuous non-invasive monitoring of respiration rate in adult patients in hospitals and hospital-type facilities.
Use Prescription (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter (21 CFR 801 Subpart C)
Use
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L. Schulthe
Division of Anestheslology, General Ho Infection Control, Dental
510(k) Number: K121806