(90 days)
No
The document describes a microprocessor-based, software-controlled device for vital signs monitoring with no mention of AI or ML technologies. The performance studies focus on design verification and safety standards, not AI/ML model performance.
No
The device is described as a "monitoring system" that "detects and alarms" for various physiological parameters, rather than providing or assisting in a form of treatment.
No
The device is described as a "vital signs monitoring system" that "detects and alarms for periods of high or low heart rate, high or low breath rate, and high or low saturation" and "monitors and alarms for central apneas." While it monitors physiological parameters, its stated purpose is continuous monitoring and alarming for deviations, not to diagnose a medical condition.
No
The device description explicitly states it is a "microprocessor-based, software-controlled device" and mentions "electromechanical design" and "sensor accessories," indicating it includes hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The SmartMonitor 2PS and 2PSL are described as devices for the continuous monitoring of physiological parameters (respiration, heart rate, SpO2) of patients. This is in vivo monitoring, meaning it's done on the living body, not on samples taken from the body.
- Intended Use: The intended use clearly states monitoring of patients, not testing of biological samples.
- Device Description: The description focuses on the hardware and software for monitoring vital signs.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, reagents, or laboratory procedures, which are characteristic of IVDs.
Therefore, the SmartMonitor 2PS and 2PSL fall under the category of patient monitoring devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The SmartMonitor 2PS is intended for use in the continuous monitoring of respiration, heart rate and SpO2 levels of infant, pediatric, and adult patients. It detects and alarms for periods of high or low heart rate, high or low breath rate, and high or low saturation. When used as an infant monitor it is intended for use in a home or hospital environment. For infants only, it monitors and alarms for central apneas. When used as a pediatric or adult monitor, it is intended for use in a hospital environment.
The SmartMonitor 2PSL is intended for use in the continuous monitoring of respiration, and heart rate of infant, pediatric, and adult patients. It detects and alarms for periods of high or low heart rate, and high or low breath rate. When used as an infant monitor it is intended for use in a home or hospital environment. For infants only, it monitors and alarms for central apneas. When used as a pediatric or adult monitor, it is intended for use in a hospital environment.
Product codes
NPF, BZQ, DQA
Device Description
The SmartMonitor 2PS is a microprocessor-based, software-controlled device intended for use as an infant apnea monitoring system or as an adult or pediatric vital signs monitoring system. The electromechanical design of the SmartMonitor 2PS is unchanged from the SmartMonitor 2PS (K032403) except that cleared ECG and oximetry sensor accessories have been selected for adult and pediatric use of the monitor.
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, pediatric, and adult
Intended User / Care Setting
Home or hospital 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 was assured by the completion of IEC 60601-1 and IEC 60601-1-2 testing. The Risk Traceability Matrix provided in the Risk Analysis assures that all hazards identified by the risk analysis are successfully mitigated.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Respironics, Inc. SmartMonitor 2PS (K032403), CAS Medical Systems, Inc. 9303 Neonatal / Adult Vital Signs Monitor (K982776)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 5 – 510(k) summary
TAB 5
SmartMonitor 2PS
AUG 0 2 2006
510(K) SUMMARY
| Date of Submission | 01 May 2006 |
|---|---|
| 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 Zita.Yurko@Respironics.com |
| Proprietary Name | SmartMonitor 2PS |
| Common/Usual Name | Apnea Monitor / Vital Signs Monitor |
| Device Classification Name | Monitor, Apnea, Home Use / Monitor, Breathing Frequency / |
| Oximeter | |
| Classification Reference | 21 CFR 868.2377, 21 CFR 868.2375, and 21 CFR 870.2700 |
| Classification | Class II |
| Appropriate Classification Panel | Anesthesiology |
| Product Code | NPF, BZQ, and DQA |
| Predicate Devices | Respironics, Inc. SmartMonitor 2PS (K032403) CAS Medical Systems, Inc. 9303 Neonatal / Adult Vital Signs Monitor (K982776) |
| Reason for submission | Modified Indications for use and design |
.. .. ........ .. ...
1
Substantial Equivalence
This premarket notification submission demonstrates that the SmartMonitor 2PS with expanded claims is substantially equivalent to the Respironics SmartMonitor 2PS (K032403) cleared for the infant patient population and CAS Medical Systems 9303 Neonatal / Adult Vital Signs Monitor (K982776) cleared for the adult, pediatric, and neonatal patient population.
The functionality of the design of the monitor was verified through the use of design verification testing. The safety of the design was assured by the completion of IEC 60601-1 and IEC 60601-1-2 testing. The Risk Traceability Matrix provided in the Risk Analysis assures that all hazards identified by the risk analysis are successfully mitigated.
This submission is seeking to extend the existing claims of the SmartMonitor 2PS to include adult and pediatric use.
Intended Use
The SmartMonitor 2PS is intended for use in the continuous monitoring of respiration, heart rate and SpO2 levels of infant, pediatric, and adult patients. It detects and alarms for periods of high or low heart rate, high or low breath rate, and high or low saturation. When used as an infant monitor it is intended for use in a home or hospital environment. For infants only, it monitors and alarms for central apneas. When used as a pediatric or adult monitor, it is intended for use in a hospital environment.
The SmartMonitor 2PSL is intended for use in the continuous monitoring of respiration, and heart rate of infant, pediatric, and adult patients. It detects and alarms for periods of high or low heart rate, and high or low breath rate. When used as an infant monitor it is intended for use in a home or hospital environment. For infants only, it monitors and alarms for central apneas. When used as a pediatric or adult monitor, it is intended for use in a hospital environment.
2
Device Description
The SmartMonitor 2PS is a microprocessor-based, software-controlled device intended for use as an infant apnea monitoring system or as an adult or pediatric vital signs monitoring system. The electromechanical design of the SmartMonitor 2PS is unchanged from the SmartMonitor 2PS (K032403) except that cleared ECG and oximetry sensor accessories have been selected for adult and pediatric use of the monitor.
Patient Usage:
The SmartMonitor 2PS is designed to analyze and record physiologic signals (ECG, respiration, SpO2, and pulse rate) acquired from 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 (for infants), low breath rate (for adults and pediatrics), bradycardia, and high or low SpOx. The portable design of the device facilitates its use in a home environment. The primary functions are unchanged from the existing design of the SmartMonitor 2PS (K032403). The only difference is that the implementation of these functions has been expanded to include the adult and pediatric patient populations.
System Description:
ECG and respiration signals are acquired via a single transducer set that is 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 are acquired via an oximeter finger or foot sensor. The acquired physiologic signals are classified and stored for use at a later time. These system inputs are unchanged from the SmartMonitor 2PS (K032403), except that these features now include the adult and pediatric populations. No modifications to the SmartMonitor 2PS predicate firmware or hardware were needed to support the expanded intended use.
All of the following features are unchanged from the SmartMonitor 2PS (K032403):
- 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.
3
- The SmartMonitor 2PS is approximately 7.4 inches wide, 10 inches deep and 2.5 inches high. It u weighs approximately 2 pounds.
- The enclosure for the monitor is constructed of plastic injection molded materials, which are unchanged from K032403. Components and assemblies are securely mounted inside. The enclosure design is resistant to the entrance of liquids and other foreign materials.
- Locations for serial number plate and necessary user notes are provided at the bottom of the . monitor.
- Accessories for the SmartMonitor 2PS include a patient cable, lead wires, ECG electrodes, a l sensor belt to secure the sensors, and an oximeter sensor.
- Respironics Synergy-E Host PC Software is used to download or direct serial connect with the l SmartMonitor 2PS for the purpose of downloading the monitor's previously stored data or retrieving the monitor's real time data.
- The functionality of the design of the monitor was verified through the use of design verification . testing.
- . The safety of the design was assured by IEC 60601-1 and IEC 60601-1-2 testing.
- . The Risk Traceability Matrix provided the Risk Analysis assures that all hazards identified by the risk analysis are successfully mitigated.
(End of Tab.)
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread. The eagle is composed of four curved lines that represent the four major goals of the department.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG # 2 2006
Respironics, Incorporated C/O Ms. Zita A. Yurko Manager, Regulatory Affairs Sleep & Home Respiratory Group 1001 Murry Ridge Lane Murrysville, Pennsylvania 15668
Re: K061256
Trade/Device Name: Respironics SmartMonitor 2PS and 2PSL Regulation Number: 21 CFR 868.2377 Regulation Name: Apnea Monitor Regulatory Class: II Product Code: NPF Dated: July 5, 2006 Received: July 7, 2006
Dear Mr. 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 ffor 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 vour 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.
5
Page 2 - Ms. 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 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,
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
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Page 1 of 1
510(k) Number (if known): K061256_________________________________________________________________________________________________________________________________________
Device Name(s): Respironics SmartMonitor 2PS and 2PSL
The SmartMonitor 2PS is intended for use in the continuous monitoring of respiration, heart rate and SpO2 levels of infant, pediatric, and adult patients. It detects and alarms for periods of high or low heart rate, high or low breath rate, and high or low saturation. When used as an infant monitor it is intended for use in a home or hospital environment. For infants only, it monitors and alarms for central apneas. When used as a pediatric or adult monitor, it is intended for use in a hospital environment.
The SmartMonitor 2PSL is intended for use in the continuous monitoring of respiration, and heart rate of infant, pediatic, and adult patients. It detects and alarms for periods of high or low heart rate, and high or low breath rate. When used as an infant monitor it is intended for use in a home or hospital environment. For infants only, it monitors and alarms for central apneas. When used as a pediatric or adult monitor, it is intended for use in a hospital environment.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use XXXXXX (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ (Optional Format 1-2-96)
lille Salim
Thesiology, Gene
ber: K041254