(118 days)
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, 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 hospitaltype 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.
The Nelloor™ Bedside SpO2 Patient Monitoring System provides continuous, noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate.
Here's an analysis of the provided text regarding the Nellcor™ Bedside SpO2 Patient Monitoring System's acceptance criteria and studies:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document, a 510(k) Summary, acts as a submission for substantial equivalence. It does not explicitly state acceptance criteria in a quantitative format (e.g., specific accuracy thresholds for SpO2 or pulse rate) for the device under review. Instead, the primary "acceptance criterion" is qualitative: substantial equivalence to the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device (Covidien Oximeter, Model Nellcor OxiMax N-600x Pulse Oximeter with SPD - K083325) in terms of performance, technology, and intended use. | The Nellcor™ Bedside SpO2 Patient Monitoring System uses the same Oximax SpO2 technology and software algorithm as the predicate device (N-600X). It is intended to be used with the same Nellcor SpO2 sensors. The clinical performance is stated to be equivalent to the Nellcor Puritan Bennett, model OxiMax N-600X Pulse Oximeter with. The device operates with an extended pulse rate measurement range of 20 to 250 BPM, same as the predicate. |
| Compliance with general controls and relevant standards for medical devices. | The system has been tested in accordance with system V&V summary (#MDR-YW110610-01). Risk analysis has been developed and applied. Mediana's quality system conforms to 21CFR820, ISO 9001, ISO13485, and CMDCAS ISO 13485. |
2. Sample Size Used for the Test Set and Data Provenance:
The document states: "Because there are no changes to the performance, technology, and intended use of the device, the clinical data submitted as part of the premarket notifications for the predicate device (N-600X) also applies to the Nellcor Bedside SpO2 Patient Monitoring System."
Therefore, there is no new clinical test set specifically for the Nellcor™ Bedside SpO2 Patient Monitoring System described in this 510(k) summary. The "test set" and its provenance would refer to the clinical studies submitted for the predicate device (K083325). The current document does not provide details about the sample size, country of origin, or retrospective/prospective nature of the data pertaining to the predicate device's studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
As explained above, no new clinical test set for this device is detailed. Therefore, this document does not provide information on the number or qualifications of experts used to establish ground truth for a test set. This information would need to be found in the 510(k) submission for the predicate device (K083325).
4. Adjudication Method for the Test Set:
Given that no new clinical test set specific to this device is presented, the document does not describe an adjudication method. This information would refer to the studies for the predicate device.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This device is an oximeter, which provides direct physiological measurements (SpO2 and pulse rate). It is not an AI-assisted diagnostic imaging device or a system that involves human "readers" interpreting images or complex data and making decisions that could be improved by AI assistance. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed or mentioned in this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The document describes the device as a "continuous, noninvasive monitoring system" that provides "functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate." This is inherently a "standalone" performance by the algorithm/device. The device's performance is reported in terms of its equivalence to the predicate, which itself is a standalone oximetry device.
The statement, "The clinical performance of the Nellcor™ Bedside SpO2 Patient Monitoring System when used with adult, pediatric and neonatal patients is equivalent to the Nelloor Puritan Bennett, model OxiMax N-600X Pulse Oximeter with," suggests a standalone comparison was essentially accepted by virtue of its identical technology to the predicate.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):
Again, referring to the predicate device's clinical data, the ground truth for pulse oximetry accuracy is typically established through arterial blood gas (ABG) analysis, where direct measurements of arterial oxygen saturation (SaO2) are obtained and then compared to the SpO2 readings from the pulse oximeter. This is a physiological gold standard. The document does not explicitly state the type of ground truth, but for pulse oximeters, ABG is the standard.
8. The Sample Size for the Training Set:
The device utilizes the "same Oximax SpO2 technology and software algorithm as the predicate device, N-600X." This implies that any "training" (e.g., algorithm development and optimization) for this specific technology would have occurred during the development of the predicate device. The current submission does not provide details on the sample size used for training for the underlying Oximax SpO2 algorithm.
9. How the Ground Truth for the Training Set Was Established:
Similar to the above, any ground truth establishment for the training of the Oximax SpO2 algorithm would refer to the development phase of the predicate device. This document does not describe how ground truth was established for the training set.
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510(k) Summary of Safety and Effectiveness
11,120773
Submitter
Covidien LLC 6135 Gunbarrel Ave. Boulder, CO, 80301, USA Tel) (1) 303 305 2750 Fax) (1) 303 305 2212
JUL 1 0 2012
Company Contact: Mia M. Ware, Sr. Regulatory Affairs Specialist
Date Summary Prepared: January 10, 2012
Device Name
Nellcor™ Bedside SpO2 Patient Monitoring System Trade Name: Common Name: Oximeter Classification Name: Oximeter (21 CFR 870,2700) Classification: Class II Product Code: DQA
Predicate Devices (Legally Marketed Devices)
The predicate device for the Nellcor™ Bedside SpO2 Patient Monitoring System is:
- Covidien Oximeter, Model Nellcor OxiMax N-600x Pulse Oximeter with SPD cleared by FDA through 510(k) No. K083325
Device Description
The Nelloor™ Bedside SpO2 Patient Monitoring System provides continuous, noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate.
Intended 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, 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 hospitaltype 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.
Summary of Technical Characteristics of the Device Compared to the Predicate Devices (Legally Marketed Devices)
The Nellcor Bedside SpO2 Patient Monitoring System is substantially equivalent to the Covidien, Nellcor OxiMax N-600x Pulse Oximeter with SPD.
The clinical performance of the Nellcor Bedside SpO2 Patient Monitoring System when used with adult, pediatric and neonatal patients is equivalent to the Nelloor Puritan
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Bennett, model OxiMax N-600X Pulse Oximeter with. The Nellcor™ Bedside SpO Patient Monitoring System consists of the NELL 1SR PCBA (oximetry board) for its performance of Pulse Oximetry and uses the same Oximax SpO2 technology and software algorithm as the predicate device, N-600X. It is intended to be used with the same Nellcor SpO2 sensors that are commercially available and used with the predicate device. Because there are no changes to the performance, technology, and intended use of the device, the clinical data submitted as part of the premarket notifications for the predicate device (N-600X) also applies to the Nellcor Bedside SpO2 Patient Monitoring System.
The pulse rate derived from the pulse oximetry (SpO2) channel of the Covidien LLC. model Nelloor Bedsige SpO2 Patient Monitoring System has the extended measurement range of 20 to 250BPM, same as the Nellcor model OxiMax N-600X Pulse Oximeter with SPD.
Summary of Performance Testing
The Nellcor Bedside SpO2 Patient Monitoring System has been tested in accordance with the system V & V summary (#MDR-YW110610-01) included with the submission using production equivalent units prior to release to market. A summary matrix of the V&V testing is included in section 17 of this submission.
A risk analysis identifying potential hazards and documenting mitigation of the hazards has been developed and applied as part of Mediana design control procedure. Mediana's quality system confirms to 21CFR820, ISO 9001, ISO13485 and CMDCAS ISO 13485 certified by DNV (Det Norske Veritas) and QMI (Quality Measuring Instrument).
Conclusions
As stated above, the Nellcor Bedside SpO2 Patient Monitoring System is safe and effective, complies with the appropriate medical device guidance and standards and is substantially equivalent to the predicate device.
End of Section-
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Covidien LLC C/O Mr. Charlie Mack International Regulatory Consultants 77325 Joyce Way Echo. Oregon 97826
JUL 10 2012
Re: K120773
Trade/Device Name: Nellcor™ Bedside SpO2 Patient Monitoring System Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: June 8, 2012 Received: June 14, 2012
Dear Mr. Mack:
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 - Mr. Mack
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.
hn 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
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INDICATIONS FOR USE
510(k) Number:
Device Name: 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, 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 hospitaltype 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 type facility.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use_ (Part 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)
L. Schillton
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: k1200773
§ 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).