(113 days)
Not Found
No
The summary describes the software as a "decision management tool" that analyzes and reports data based on "customized, user-selected parameters." It does not mention AI, ML, or any related terms, nor does it describe a training or test set, which are typical for ML-based devices. The analysis appears to be based on predefined rules or algorithms rather than learned patterns.
No.
The device is described as a software tool for collecting, analyzing, and reporting oximetry trend data to assist in the diagnosis of pediatric obstructive sleep apnea. It is explicitly stated that "NPOSES in itself is not a diagnosis tool" and it does not directly treat or prevent a disease or condition.
No
The document explicitly states, "NPOSES in itself is not a diagnosis tool. It is a decision management tool which allows medical personnel to upload and view data related to a sleep study and provide output reports as feedback which may be used by an MD to form a diagnosis."
Yes
The device description and intended use clearly state that NPOSES is an "application" and "software" that processes data from a pulse oximeter (which is a separate device not included in this submission) and generates reports. There is no mention of any hardware component being part of the NPOSES device itself.
Based on the provided information, the NPOSES software is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples: IVDs are designed to examine specimens taken from the human body, such as blood, urine, tissue, etc., to provide information about a person's health.
- NPOSES analyzes physiological data: NPOSES collects and analyzes data from a pulse oximeter, which measures physiological parameters (pulse rate and oxygen saturation) non-invasively from the body. It does not process biological samples.
- Intended Use: The intended use clearly states that NPOSES collects, analyzes, reports, and archives oximetry trend data. This data is derived from a medical device (pulse oximeter) applied to the patient, not from a biological sample.
Therefore, NPOSES falls under the category of a medical device software that processes physiological data, rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of NPOSES (Nocturnal Pulse Oximetry Study Expert System) software is to provide information to a Medical Doctor specializing in sleep medicine to assist in the timely diagnosis of pediatric obstructive sleep apnea (OSA). NPOSES in itself is not a diagnosis tool. It is a management tool which allows medical personal to input and view data relating to a study and give feedback which may be used by an MD to form a diagnosis.
The intended use of NPOSES (Nocturnal Pulse Oximetry Study Expert System) software is to collect, analyze, report and archive oximetry trend data to provide information to a Medical Doctor specializing in sleep medicine, as a supplemental tool to assist in the timely diagnosis of pediatric obstructive sleep apnea (OSA).
NPOSES is intended for use by an MD/Respiratory Specialist through the following process steps (1) recording and transferring data from a pulse oximeter to a computer in order to maintain unique records per patient of pulse oximetry data, (2) analyzing. reviewing and validating patient data and summary statistics according to customized. user-selected parameters, and (3) generating and archiving reports.
NPOSES in itself is not a diagnosis tool. It is a decision management tool which allows medical personnel to upload and view data related to a sleep study and provide output reports as feedback which may be used by an MD to form a diagnosis.
Product codes
DQA
Device Description
The PHD Medical NPOSES (Nocturnal Pulse Oximetry Study Expert System) application scores data in the patient history, physician comments and test results to automatically produce an analysis report as input to the identification of pediatric obstructive sleep apnea which is presented to Respiratory Specialists and Medical Doctors. The suggested diagnosis is used to assist the Medical Director in the diagnosis of the severity of obstructive sleep apnea. The application enables the efficient processing of patient sleep evaluation studies while allowing the medical staff to concentrate on critical cases.
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
pediatric
Intended User / Care Setting
Medical Doctor specializing in sleep medicine, MD/Respiratory Specialist
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)
Testing was performed to confirm that NPOSES software is capable of meeting all of its intended functional requirements. NPOSES passed all tests.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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).
0
510(k) SUMMARY
Manufacturer's Name, Contact Person, Address, Phone, Fax, Email, Date Prepared
| Mfr Name: | PHD Medical |
|---|---|
| Contact Name: | Tanima Ghosh |
| Postal Address. | 500 Chemin Morgan, Suite 100 |
| Baie D'Urfé | |
| Québec H9X 3V1 | |
| Canada | |
| Phone: | 514-694-0367 |
| Fax: | 514-694-4280 |
| Email: | tanima.ghosh@phdmedical.com |
| Date Prepared: | January 6, 2006 |
Device Name, Common/Generic Name and Classification Name
| Proprietary Name: | NPOSES |
|---|---|
| Common/Usual Name: | Pulse Oximeter Data Management Software |
| Classification Name: | Oximeter |
Predicate DevicesnVISION Data Management Software (K033307), manufactured by Nonin Medical, Inc.
Description of the Device
The PHD Medical NPOSES (Nocturnal Pulse Oximetry Study Expert System) application scores data in the patient history, physician comments and test results to automatically produce an analysis report as input to the identification of pediatric obstructive sleep apnea which is presented to Respiratory Specialists and Medical Doctors. The suggested diagnosis is used to assist the Medical Director in the diagnosis of the severity of obstructive sleep apnea. The application enables the efficient processing of patient sleep evaluation studies while allowing the medical staff to concentrate on critical cases.
Intended Use of the Device
The intended use of NPOSES (Nocturnal Pulse Oximetry Study Expert System) software is to provide information to a Medical Doctor specializing in sleep medicine to assist in the timely diagnosis of pediatric obstructive sleep apnea (OSA). NPOSES in itself is not a diagnosis tool. It is a management tool which allows medical personal to input and view data relating to a study and give feedback which may be used by an MD to form a diagnosis.
1
Technological Characteristics
The software will operate under Windows 98, Windows ME, Windows NT 4.0 with Service Pack 6 (SP6), Windows 2000, or Windows XP or later. Also under Linux: Debian, LinuxOS, Pack of (Sr o), Windows 2000, er in the predicate device can be used on a personal computer.
Performance Data
Testing was performed to confirm that NPOSES software is capable of meeting all of its intended functional requirements. NPOSES passed all tests.
Substantial Equivalence
NPOSES does not have a significant descriptive difference in comparison to the selected rs oble does marketed software device. There are no technological characteristics which impact prodicate maincouse betw. Based on our review of the candidate predicate device's description, surery and of one of enebel of performance specifications vs. NPOSES, it is concluded that NPOSES is substantially equivalent to the predicated device.
Conclusion
The cumulative test results demonstrated the functionality, safety and effectiveness of NPOSES, as well as its substantial equivalence to the predicate device.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, a staff with two snakes entwined around it, representing medicine and health. The seal is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 9 2006
PHD Medical C/O Ms. Nancy Ruth Associate Director, Regulatory Services CanReg, Incorporated 4 Innovation Drive Dundas, ON CANADA L9H 7P3
Re: K060616
Trade/Device Name: NPOSES Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: June 2, 2006 Received: June 5, 2006
Dear Ms. Ruth:
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 - Ms. Ruth
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 (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.
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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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.
Chih-Lin, Ph.D.
Chiu Lin, Ph.D. 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
510(k) Number (if known):
Device Name: NPOSES
Indications For Use:
The intended use of NPOSES (Nocturnal Pulse Oximetry Study Expert System) software is to collect, analyze, report and archive oximetry trend data to provide information to a Medical Doctor specializing in sleep medicine, as a supplemental tool to assist in the timely diagnosis of pediatric obstructive sleep apnea (OSA).
NPOSES is intended for use by an MD/Respiratory Specialist through the following process steps (1) recording and transferring data from a pulse oximeter to a computer in order to maintain unique records per patient of pulse oximetry data, (2) analyzing. reviewing and validating patient data and summary statistics according to customized. user-selected parameters, and (3) generating and archiving reports.
NPOSES in itself is not a diagnosis tool. It is a decision management tool which allows medical personnel to upload and view data related to a sleep study and provide output reports as feedback which may be used by an MD to form a diagnosis.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| gn Offl | |
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