(84 days)
Not Found
No
The description focuses on standard signal processing and analysis of physiological data using a microprocessor and software, without mentioning AI or ML techniques.
No
The device is a monitor that detects and alarms for physiological events, but it does not provide treatment or intervene therapeutically.
No
This device is for continuous monitoring and alarming for physiological events, not for diagnosing a condition. While it detects events like apnea and abnormal heart rates, this detection leads to an alarm, not a diagnosis of a specific disease or condition. It monitors current physiological states rather than performing an assessment leading to a diagnostic conclusion.
No
The device description explicitly states it is a "microprocessor-based, software-controlled device" but also details physical components like an enclosure, connectors, and the acquisition of signals via transducers and sensors directly connected to the monitor. It describes a physical unit with dimensions and weight. This indicates it is a hardware device with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The SmartMonitor 2 Professional Series Infant Apnea Monitor directly monitors physiological signals (respiration, heart rate, and SpO2) from the infant patient using external sensors attached to the body. It does not analyze samples taken from the body.
- Intended Use: The intended use is for continuous monitoring of vital signs and alarming for specific physiological events, not for analyzing biological samples.
Therefore, the SmartMonitor 2 Professional Series Infant Apnea Monitor falls under the category of a patient monitoring device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SmartMonitor® 2 Professional Series Infant Apnea Monitor is intended for use in the continuous monitoring of respiration, heart rate, and SpO2 of infant patients in a hospital or home environment. The monitor detects and alarms for periods of central apnea, high or low heart rate, and high or low saturation.
Product codes (comma separated list FDA assigned to the subject device)
NPF, DQA
Device Description
The SmartMonitor 2PS is a microprocessor-based, software-controlled device intended for use as an infant apnea monitoring system.
The SmartMonitor 2PS is designed to analyze and record physiologic signals (ECG, respiration, SpO2 and pulse rate) acquired from infant patients during sleep. Its primary function is to analyze the physiologic signals and generate visual and audible alarm indications upon detection of physiologic events such as central apnea, bradycardia, and high or low SpO2. The portable design of the device facilitates its use in a hospital or in a home environment.
ECG and respiration signals are acquired via a single transducer set attached to the patient and directly connected to the monitor. The measurement method used to derive the respiration signal is Transthoracic Impedance. SpO2 and plethysmographic pulse rate acquired via an oximeter finger sensor. The acquired physiologic signals are classified and stored for use at a later time.
A Host PC may interface to the SmartMonitor 2PS via a direct serial connection for the purpose of downloading the monitor's previously stored data and/or retrieving the monitor's real time data.
The SmartMonitor 2PS is a compact, lightweight unit. Two front panel connectors are provided for the patient sensor input. The sensor connectors and associated sensor plugs are individually keyed to prevent improper insertion.
The SmartMonitor 2 is approximately 7.4 inches wide, 10 inches deep and 2.5 inches high. It weighs approximately 2 pounds.
The enclosure for the monitor is constructed of plastic injection molded materials. Components and assemblies are securely mounted inside. The enclosure design is resistant to the entrance of liquids and other foreign materials.
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
Infant patients
Intended User / Care Setting
Hospital or home environment
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)
The functionality of the design of the monitor was verified through the use of design verification testing. The safety of the design will be assured by the completion of the IEC 60601-1 and 60601-2 testing.
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.
Respironics SmartMonitor 2 (K011597), Masimo SET Oximeter (K990966)
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
§ 868.2377 Apnea monitor.
(a)
Identification. An apnea monitor is a complete system intended to alarm primarily upon the cessation of breathing timed from the last detected breath. The apnea monitor also includes indirect methods of apnea detection such as monitoring of heart rate and other physiological parameters linked to the presence or absence of adequate respiration.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Apnea Monitors; Guidance for Industry and FDA.”
0
Abbreviated 510(k) Tab 10 - 510(K) Summary
TAB 10
510(K) SUMMARY
| Official Contact / Address
of Manufacturing facility | Zita A. Yurko
Manager, Regulatory Affairs
Respironics Inc.
1001 Murry Ridge Lane
Murrysville, PA 15668
Phone: 724-387-4120
Fax: 724-387-4216 |
|---------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary Name | SmartMonitor 2 Professional Series |
| Common/Usual Name | Apnea Monitor w/ Internal Oximeter |
| Classification Reference | 21 CFR 868.2377 and 21 CFR 870.2700. |
| Classification | Class II |
| Appropriate Classification Panel | Anesthesiology and Cardiovascular Devices |
| Product Code | NPF - Apnea Monitor |
| | DQA -Oximeter |
| Predicate Devices | Respironics SmartMonitor 2 (K011597) |
| | Masimo SET Oximeter (K990966) |
| Reason for submission | Additional or expanded indications |
Substantial Equivalence
This premarket notification submission demonstrates that the SmartMonitor 2 PS is substantially equivalent to a combination of the Respironics SmartMonitor 2 (K011597) and the Masimo SET Pulse Oximeter (K990966).
The functionality of the design of the monitor was verified through the use of design verification testing. The safety of the design will be assured by the completion of the IEC 60601-1 and 60601-2 testing. The Risk Traceability Matrix provided in Appendix B of the Risk Analysis assures that all hazards identified by the risk analysis are successfully mitigated.
1
This submission is seeking to extend the existing claims of the monitor to include an internal pulse oximeter.
Indications for Use
The SmartMonitor® 2 Professional Series Infant Apnea Monitor is intended for use in the continuous monitoring of respiration, heart rate, and SpO2 of infant patients in a hospital or home environment. The monitor detects and alarms for periods of central apnea, high or low heart rate, and high or low saturation.
Device Description
The SmartMonitor 2PS is a microprocessor-based, software-controlled device intended for use as an infant apnea monitoring system.
The SmartMonitor 2PS is designed to analyze and record physiologic signals (ECG, respiration, SpO2 and pulse rate) acquired from infant patients during sleep. Its primary function is to analyze the physiologic signals and generate visual and audible alarm indications upon detection of physiologic events such as central apnea, bradycardia, and high or low SpO2. The portable design of the device facilitates its use in a hospital or in a home environment.
ECG and respiration signals are acquired via a single transducer set attached to the patient and directly connected to the monitor. The measurement method used to derive the respiration signal is Transthoracic Impedance. SpO2 and plethysmographic pulse rate acquired via an oximeter finger sensor. The acquired physiologic signals are classified and stored for use at a later time.
A Host PC may interface to the SmartMonitor 2PS via a direct serial connection for the purpose of downloading the monitor's previously stored data and/or retrieving the monitor's real time data.
The SmartMonitor 2PS is a compact, lightweight unit. Two front panel connectors are provided for the patient sensor input. The sensor connectors and associated sensor plugs are individually keyed to prevent improper insertion.
The SmartMonitor 2 is approximately 7.4 inches wide, 10 inches deep and 2.5 inches high. It weighs approximately 2 pounds.
The enclosure for the monitor is constructed of plastic injection molded materials. Components and assemblies are securely mounted inside. The enclosure design is resistant to the entrance of liquids and other foreign materials.
©2003 Respironics Inc.
2
Locations for serial number plate, and necessary user notes are provided at the bottom of the unit. Refer to Tab 6 of this 510(k) for labels.
Accessories for the SmartMonitor 2PS include a patient cable, lead wires, and reusable ECG electrodes; a sensor belt to secure the sensors; a reusable oximeter finger sensor.
The functionality of the design of the monitor was verified through the use of design verification testing. The safety of the design will be assured by the completion of the IEC 60601-1 and 60601-2 testing. The Risk Traceability Matrix provided the Risk Analysis assures that all hazards identified by the risk analysis are successfully mitigated.
(End of Tab)
3
Image /page/3/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 lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 27 2003
Ms. Zita Yurko Manager, Regulatory Affairs Respironics, Inc. Homecare Division 1001 Murry Ridge Lane Murrysville, Pennsylvania 15668-8550
Re: K032403
Trade/Device Name: SmartMonitor 2PS Regulation Number: 868.2377 Regulation Name: Apnea Monitor Regulatory Class: II Product Code: NPF, DQA Dated: August 1, 2003 Received: August 4. 2003
Dear Ms. Yurko:
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.
4
Page 2 - Ms. Zita Yurko
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 Office of Compliance at (301) 594-4646. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
or, 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
5
Center of Devices and Radiological Health
510(k) Number (if known): KO32463
Page 1 of 1
SMARTMONITOR 2PS Device Name:
Indications for Use:
The SmartMonitor® 2 Professional Series Infant Apnea Monitor is intended for use in the continuous monitoring of respiration, heart rate, and SpO2 of infant patients in a hospital or home environment. The monitor detects and alarms for periods of central apnea, high or low heart rate, and high or low saturation.
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
prescription use √
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
033403
510(k) Number: