(117 days)
Not Found
No
The description of the SPD feature explicitly states it is analogous to existing alarm features and does not mention AI/ML terminology or methodologies.
No.
The device is indicated for continuous non-invasive monitoring of functional oxygen saturation and pulse rate, and to detect patterns of desaturation. It provides information and alerts but does not directly treat or prevent a disease or condition.
Yes
The device diagnoses patterns of desaturation indicative of repetitive reductions in airflow through the upper airway, which is a diagnostic function.
No
The device description explicitly states that the N-600x Pulse Oximeter with SPD is comprised of the software and a variety of OxiMax Adult Sensors and cables, which are hardware components. While the SPD feature itself is software, the overall medical device includes hardware.
Based on the provided text, the N600x Pulse Oximeter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The N600x Pulse Oximeter is a non-invasive device that measures oxygen saturation and pulse rate directly from the patient's body using a sensor.
- The intended use and device description clearly state that it monitors physiological parameters directly from the patient. It does not analyze samples taken from the patient.
Therefore, the N600x Pulse Oximeter falls under the category of a non-invasive physiological monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
The OxiMax N-600x pulse oximeter is intended for prescription use only with neonatal, pediatric, and adult patients who are well or poorly perfused in hospitals, hospital-type facilities, intra-hospital transport, and home environments. The saturation pattern detection with OXIMAX™ SPD™ technology (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 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 who are 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 in to the lungs.
Product codes (comma separated list FDA assigned to the subject device)
DQA
Device Description
This section describes the N-600x Pulse Oximeter with SPD. The N-600x with SPD is comprised of the N-600x Pulse Oximeter with SPD software and a variety of OxiMax Adult Sensors and cables that have been previously cleared.
The Saturation Pattern Detection (SPD) is a software option which is compatible with the N-600x. The software option is intended to add an advanced SpO2 trend analysis feature. SPD will detect patterns in the saturation trend that are associated with a reduction in airflow and provide annunciation. The SPD feature mines information that is present in the SpO2 trend history stored in the monitor and alerts the caregiver to patterns in that trend. The SPD feature is a means of evaluating the SpO2 information being collected by the oximeter, analogous to the threshold or SatSeconds™ alarm features currently available on the predicate device. The addition of the SPD feature to the predicate device does not affect the device hardware.
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
Neonatal, pediatric, and adult patients
Intended User / Care Setting
Hospitals, hospital-type facilities, intra-hospital transport, and home environments.
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
Not Found
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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).
0
510(k) Summary
KO8335
Submitted by:
Covidien, (formerly Nellcor Puritan Bennett Inc.) 6135 Gunbarrel Avenue Boulder, CO 80301
Company Contact:
Scott Dickerhoff Director. Requlatory Affairs Phone: (303) 305-2382 Fax: (303) 305-2212
MAR - 9 2009
November 3, 2008 Date Summary Prepared:
Trade Name: -
OxiMax N-600x Pulse Oximeter with SPD
Pulse Oximeter, Sensors and Cables
Common/Usual Name:
Classification Name:
Oximeter (74DQA) (per 21 CFR §870.2700) Patient Transducer and Electrode Cable (including connector) (74DSA) (per 21 CFR §870.2900)
Substantially Equivalent Devices:
I. Device Description
This section describes the N-600x Pulse Oximeter with SPD. The N-600x with SPD is comprised of the N-600x Pulse Oximeter with SPD software and a variety of OxiMax Adult Sensors and cables that have been previously cleared.
The Saturation Pattern Detection (SPD) is a software option which is compatible with the N-600x. The software option is intended to add an advanced SpO2 trend analysis feature. SPD will detect patterns in the saturation trend that are associated with a reduction in airflow and provide annunciation. The SPD feature mines information that is present in the SpO2 trend history stored in the monitor and alerts the caregiver to patterns in that trend. The SPD feature is a means of evaluating the SpO2 information being collected by the oximeter, analogous to the threshold or SatSeconds™ alarm features currently available on the predicate device. The addition of the SPD feature to the predicate device does not affect the device hardware.
1
II. Intended Use
The OxiMax N-600x pulse oximeter is intended for prescription use only with neonatal, pediatric, and adult patients who are well or poorly perfused in hospitals, hospital-type facilities, intra-hospital transport, and home environments. The saturation pattern detection with OXIMAX™ SPD™ technology (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.
III. Technological Characteristics
The OxiMax Pulse Oximetry System measures functional oxygen saturation noninvasively via a light signal interacting with tissue, by utilizing the time-varying changes in tissue optical properties that occur with pulsatile blood flow. Red and infrared lightemitting diodes (LEDs) are utilized as light sources. A photodiode acting as a photodetector senses the signal strengths of the two wavelengths of light, which vary with the amount of light transmitted through the tissue. The N-600x Pulse Oximeter receives this electrical information from the sensor and processes the information by use of an algorithm to provide real time values of SpO2, pulse rate and pulse amplitude.
IV. Tests Performed to Support Determination of Substantial Equivalence
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.
V. Conclusions
The technological characteristics of the OxiMax N-600x Pulse Oximetry System with SPD and the results of non-clinical and clinical tests do not raise new questions of safety or effectiveness when compared to the legally marketed predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 human figure with three arms reaching upwards, representing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the figure.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Scott D. Dickerhoff Director, Regulatory Affairs Covidien 6135 Gunbarrel Avenue Boulder, Colorado 80301
- 9 2009 MAR
Re: K083325
Trade/Device Name: N-600x Pulse Oximeter with Oximax SPD™ Alert Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: February 20, 2009 Received: February 23, 2009
Dear Mr. Dickerhoff:
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.
3
Page 2 - Mr. Dickerhoff
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 (OS) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 yours,
Judite y. Michan Ond.
Ginette Y. Michaud, M.D. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number:
Device Name: N-600x Pulse Oximeter with Oximax SPD™ Alert
Indications for Use:
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 who THE N-000X Fullse Damecer of Interiod for acilities, 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.
AND/OR Over-The-Counter Use _________________(Part 21 CFR 801 Subpart D) (21 CFR 801 Prescription Use × Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
. Concurrence of CDRH, Office of Device Evaluation (ODE)
Suon uane
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: 1083365
Page 26 of 1650
Confidential & Proprietary Information
Covidien