NELLCOR OXIMAX N-600X PULSE OXIMETER, NELLCOR BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, NELLCOR BEDSIDE SPO2 PATIEN
Device Facts
| Record ID | K123581 |
|---|---|
| Device Name | NELLCOR OXIMAX N-600X PULSE OXIMETER, NELLCOR BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, NELLCOR BEDSIDE SPO2 PATIEN |
| Applicant | Covidien, Formerly Nellcor Puritan Bennett, Inc. |
| Product Code | DQA · Cardiovascular |
| Decision Date | May 9, 2013 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.2700 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
The Nellcor OxiMAX N-600X Pulse Oximetry System with N-600X Pulse Oximeter and OxiMAX Sensors and Cables is indicated for prescription use only for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The N-600X Pulse Oximeter is intended for use with neonatal, pediatric, and adult patients during both no motion conditions and for patients who are either well or poorly perfused, in hospital-type facilities, intra hospital transport, and home environments. The N-600X with SPD feature is intended for use on adults to detect patterns of desaturation that are indicative of repetitive reductions in airflow through the upper airway and into the lungs.
Device Story
OxiMAX family (N-600X, Bedside Respiratory, Bedside SpO2) provides continuous non-invasive monitoring of arterial oxygen saturation (SpO2) and pulse rate. System utilizes OxiMAX sensors and DOC-10 cables to capture optical signals; processes data to derive SpO2 and pulse rate; includes SPD feature for adult desaturation detection and respiration rate monitoring (on specific models). Used in hospitals, transport, and home settings by clinicians. Output displayed on bedside monitor; assists clinicians in patient assessment and respiratory monitoring. Benefits include accurate monitoring during motion and screening support for critical congenital heart disease (CCHD).
Clinical Evidence
Invasive hypoxia study conducted on healthy, well-perfused adult volunteers per ISO 80601-2-61. Data collected at targeted oxygen saturation plateaus (70-100% SpO2) during motion and no-motion conditions. SpO2 compared against CO-oximeter; pulse rate compared against ECG. Results validated accuracy in the presence of motion. No adverse events reported.
Technological Characteristics
Oximetry PCBA and software; OxiMAX sensors and DOC-10 cables. Continuous non-invasive optical sensing. Dimensions/form factor: portable bedside monitor. Connectivity: standalone. Sterilization: N/A (sensors are patient-applied). Software: Nell-1 family firmware.
Indications for Use
Indicated for continuous non-invasive monitoring of SpO2 and pulse rate in neonatal, pediatric, and adult patients, including well or poorly perfused patients, during motion and no-motion conditions. Used in hospitals, hospital-type facilities, intra-hospital transport, and home environments. SPD feature indicated for adults to detect desaturation patterns indicative of repetitive airflow reductions.
Regulatory Classification
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.
Predicate Devices
- Nellcor Puritan Bennett Model N-595 Pulse Oximeter (K012891)
Reference Devices
Submission Summary (Full Text)
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9 2013 MAY
K123581
## 3. 510(K) SUMMARY
| Applicant Name and Address: | Covidien llc.<br>6135 Gunbarrel Ave<br>Boulder, CO 80301<br>Phone: (303) 305-2750<br>Fax: (303) 305-2212 |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration Number: | 2936999 |
| Device Name(s): | OxiMax N-600X Pulse Oximeter with OxiMax Sensors and Cables (aka "Accessories")<br>Covidien Nellcor Bedside SpO2 Patient Monitoring System<br>Covidien Nellcor Bedside Respiratory Patient Monitoring System |
| Classification: | Class II |
| Classification Name: | Oximeter (74DQA) (per 21 CFR §870.2700) |
| Product Code: | DQA |
| Date Prepared: | 11/27/2012 |
| 510(k) Contact Person and Phone Number: | Mia M. Ware<br>Sr. Regulatory Affairs Specialist<br>Covidien - Respiratory and Monitoring Solutions<br>6135 Gunbarrel Ave.<br>Boulder, CO 80301<br>Phone: (303)305-2750<br>Fax: (303) 305-2212 |
| Name and Address of Manufacturing Site(s) | |
| Establishment Registration Number: | 8020893 |
| Registered Establishment Name: | Covidien (formerly: Nellcor Puritan Bennett Ireland, Ltd) |
| Address: | Michael Collins Road, Mervue, Galway, IRELAND |
| Establishment Registration Number: | 30003591740 |
| Registered Establishment Name: | Mediana Co. LTD |
| Address: | Wonju Medical Industry Park,<br>1650-1, Donghwa-ri, Munmak-<br>eup, Wonju-si, Gangwon-do, Korea |
## Predicate Devices:
The Nellcor OxiMax N-600X Pulse Oximeter, Nellcor Bedside SpO2 Patient Monitoring System, and Nellcor rine Releor Unitial N 00011 marketed predicate device:
1. Nellcor Puritan Bennett Model N-595 Pulse Oximeter, cleared under 510(k) # K012891 on 03/07/2002.
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### Purpose of this 510(k):
This submission is to expand the indications for use for the OxiMAX pulse oximeters using the Nell-1 oximetry board (including the N-600X, Nellcor Bedside Respiratory Patient Monitoring System, and Nellcor Bedside SpO2 Patient Monitoring System) to include SpO2 and Pulse Rate accuracy during motion and no motion conditions.
Summaries of clinical and non-clinical testing were provided to support 1) the expansion in the indications for use to include accuracy in the presence of motion, and 2) modifications to the device(s) labeling to incorporate the results of clinical trials described in peer-reviewed publications regarding the use of Nellcor pulse oximeters and sensors intended to screen newborn patients for critical congenital heart disease (CCHD). FDA Guidance for Industry and FDA Staff - Bundling Multiple Indications in a Single Submission was used in the preparation of this Traditional 510(k) submission.
### General Description:
The OxiMAX family of pulse oximeters (including the N-600X, Nellcor Bedside Respiratory Patient Monitoring System, and Nellcor Bedside SpO2 Patient Monitoring System) provides continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate.
The N-600X, Nellcor Bedside Respiratory Patient Monitoring System, and Nellcor Bedside Sp02 Patient Monitoring System are designed for continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate using OxiMAX pulse oximetry sensors and the DOC-10 cable.
### Current N-600X Indications for Use (cleared via K083325 on 03/09/2009):
The N600x Pulse Oximeter is indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate.
The N-600X Pulse Oximeter is intended for use with neonatal, pediatric, and adult patients, and for patients who are well or poorly perfused, in hospital-type facilities, intra-hospital transport, and home environments.
The N-600X with SPD feature is intended for use on adults to detect patterns of desaturation that are indicative of repetitive reductions in airflow through the upper airway and in to the lungs.
## Current Nellcor Bedside Respiratory Patient Monitoring System Indications for Use (cleared via K121806 on 09/28/2012) :
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 who are well or poorly perfused. The monitoring system is intended for use in 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.
## Current Nellcor Bedside Sp02 Patient Monitoring System Indications for Use (cleared via K120773 on 06/10/2012):
The Nellcor Bedside SpO2 Patient Monitoring System is indicated for the continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpOz) and pulse rate. The Nellcor Bedside SpO2 Patient Monitoring System is intended for prescription use only with neonatal, pediatric, and adult patients, and for patients who are well or poorly perfused, in hospital-type facilities, and intra-hospital transport.
#### Proposed N-600X Indications for Use:
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The Nellcor OxiMAX N-600X Pulse Oximetry System with N-600X Pulse Oximeter and OxiMAX Sensors and Cables is indicated for prescription use only for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate. The N-600X Pulse Oximeter is intended for use with neonatal, pediatric, and adult patients during both no motion conditions and for patients who are either well or poorly perfused, in hospital-type facilities, intra hospital transport, and home environments.
The N-600X with SPD feature is intended for use on adults to detect patterns of desaturation that are indicative of repetitive reductions in airflow through the upper airway and into the lungs.
## Proposed Nellcor Bedside Respiratory Patient Monitoring System 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 (SpOz) 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 hospitals, hospital-type 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 to be used for the continuous non-invasive monitoring of respiration rate in adult patients in hospitals and hospital-type facilities.
## Proposed Nellcor Bedside SpO2 Patient Monitoring System Indications for Use:
The Nellcor Bedside SpO2 Patient Monitoring System is indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The Nellcor Bedside SpO2 Patient Monitoring System is intended for prescription use only with neonatal, pediatric, and adult patients, during both no motion and motion conditions and for patients who are well or poorly perfused, in hospitals, hospital-type facilities, and intra-hospital transport.
#### Summary of Technical Characteristics
The Nellcor Bedside Respiratory Patient Monitoring System, Bedside SpO₂ Patient Monitoring System and the OxiMAX N-600X Pulse Oximetry System, the Nell-1 family of pulse oximeters, are technologically identical. They have the same oximetry PCBA and software. This submission includes clinical reports to expand the indications for use and labeling claims for the Nell-1 pulse oximeters. The N-600X Pulse Oximetry System, the representative model of the Nell-1 family of pulse oximeters, is substantially equivalent to the N-595 Pulse Oximeter, the predicate device in this submission, as evidenced in 510(k) K060576. The test method used to demonstrate performance during motion as described in the motion testing Clinical Trial Protocol uses the same definition of standard motion as was used in the invasive hypoxia clinical study which validated the accuracy in the presence of motion of the N-595 Pulse Oximeter, the predicate device. Based on the results of the studies, Covidien has established that the Nell-1 family of pulse oximeters including N-600X, Nellcor Bedside Respiratory Patient Monitoring System, and Nellcor Bedside SpO2 Patient Monitoring Systems, are substantially equivalent to the predicate device.
### Tests Performed to Support Determination of Substantial Equivalence
## Non-clinical/bench-testing data
The performance testing section of this submission references the previous Non-clinical data submitted in previously cleared 510(k)s K060576, K120773, and K121806. Additional testing incorporating simulated motion performed to validate the pulse rate accuracy of N-600X in the range of 25 -250 beats per minute during motion using a functional tester, is provided for review.
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## Discussion of clinical data
#### Device Description:
In order to support this claims expansion, Covidien performed an invasive hypoxia study on healthy, well perfused adults using the N-600X as the representative for the Nell-1 family of pulse oximeters including N-600X, Nellcor Bedside Respiratory Patient Monitoring System, and Nellcor Bedside SpO2 Patient Monitoring Systems. In accordance to ISO 80601-2-61, an invasive hypoxia study was carried on healthy, well-perfused adults. Data was collected at targeted oxygen saturation plateaus during periods of motion. The SpO2 data was compared against SaO2 values from a CO-Oximeter. Pulse rate data was compared against ECG values.
#### Sensors Tested:
Performance claims during motion was demonstrated on the OxiMAX sensors, the same sensors as submitted and cleared in the 510(k) for the N-595 pulse oximeter,
#### Study Results and Adverse Events:
The Nell-1 family of pulse oximeters, including N-600X, Nellcor Bedside Respiratory Patient Monitoring System, and Nellcor Bedside SpO2 Patient Monitoring Systems has been validated for accuracy in the presence of motion in human blood studies on healthy adult volunteers in induced hypoxia studies in the range of 70-100% Sp02 against a laboratory CO-oximeter and ECG monitor. There were no adverse events or complications observed in the invasive hypoxia studies.
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Image /page/4/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is in a bold, sans-serif font. The words are arranged on a single line and are centered horizontally.
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#### Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 09, 2013
Ms. Mia M. Ware Senior Regulatory Affairs Specialist Covidien Limited Liability Company 6135 Gunbarrel Avenue BOULDER CO 80301
Re: K123581
Trade/Device Name: Nellcor OxiMAX N-600X Pulse Oximetry System Nellcor Bedside SpO2 Patient Monitoring System Covidien Nellcor Bedside Respiratory Patient Monitoring System and The Covidien Nellcor Bedside Respiratory Patient Monitoring System Respiration Rate Software
Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: April 10, 2013 Received: April 11, 2013
Dear Ms. Ware:
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. Ware
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 devicerelated 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/ResourcesforYou/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,
Kwame O. Ulmer -
S FDA
for
Anthony D. Watson, B.S., M.S., M.B.A. 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
510(k) Number: KIZ 3581
Device Name: Nellcor OxiMAX N-600X Pulse Oximetry System
Indications for Use:
The Nellcor OxiMAX N-600X Pulse Oximetry System with N-600X Pulse Oximeter and OxiMAX The News and Cables is indicated for prescription use only for the continuous non-invasive monitoring School oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The N-600X Pulse or functional oxygen suchratin of arratal, pediatric, and adult patients during both no motion and onalieter is intents and for patients who are either well or poorly perfused, in hospitals, hospital-type facilities, intra hospital transport, and home environments.
The N-600X with SPD feature is intended for use on adults to detect patterns of desaturation that are indicative of repetitive reductions in airflow through the upper airway and into the lungs.
AND/OR Prescription Use (Part 21 CFR 801 Subpart D)
Over-the Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Lester W. Schultheis Jr 2013.04.22 15:32:16-04'00
(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital Division of Alton Control, Dental Devices
Page 1 of __ 1_
510(k) Number: K123581
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## Indications for Use
# 510(k) Number: |〈インスS8 |
Device Name: Covidien Nellcor 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: For Coviden Respiratory Patient Monitoring System is a portable pulse oximeter intended for I he Nellcor bedslue Respiratory Tradent Monitor of arterial oxygen saturation (SpO-) and pulse prescription use only as a continuous non-unative of the motion and motion conditions and for patients rate of adult, peniatic, and neonating system is intended for use in hospitals, hospital-type in hospital-type who are well of pourly perfused. The momenting System is intert (SPD) feature is intended only for facility-use care of adults to detect patterns of desauration indicative of repetitive reductions in aifflow through the upper airway and into the lungs.
The Respiration Rate parameter, when used in conjunction with the Nellor Bedside Respiration Patient I he Respiration Rate parameter, with ased in conjunted to be used for the continuous non-invasive Monitoring System and Weller Reoph accir School of School of Scilities. I
AND/OR ਮ Prescription Use (Part 21 CFR 801 Subpart D)
Over-the Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|---------------|
| Lester W. Schultheis Jr | |
| 2013.04.22-15:33:36 -04'00' | |
| (Division Sign-Off) | Page 1 of _1_ |
| Division of Anestheslology, General Hospital | |
| Infection Control, Dental Devices | |
| 510(k) Number: | K123581 |
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## Indications for Use
510(k) Number: |< |2 3 S 8 |
Device Name: Nellcor Bedside SpO2 Patient Monitoring System
Indications for Use:
The Nellcor Bedside SpOz Patient Monitoring System is indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The Nellcor Bedside SpO2 Patient Monitoring System is intended for prescription use only with neonatal, pediatric, and adult patients, during both no motion and motion conditions and for patients who are well or poorly perfused, in hospitals, hospital-type facilities, and intra-hospital transport.
Note:
- Hospital use typically covers such areas as general care floors (GCFs), operating rooms, . ● special procedure areas, intensive and critical care areas within the hospital, and in hospital type facilities.
- Hospital-type facilities include physician office-based facilities, sleep labs, skilled nursing . facilities, surgicenters, and sub-acute centers.
- Intra-hospital transport includes transport of a patient within the hospital or hospital-type . facility.
Prescription Use_ AND/OR x (Part 21 CFR 801 Subpart D)
Over-the Counter Use . (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Lester W. Schultheis Jr
2013.04.22 15:32:50-04'00'
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
| 510(k) Number: | K123581 |
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