(110 days)
K08073, K093268
Not Found
No
The summary describes a standard multi-parameter patient monitor and does not mention any AI or ML capabilities in the intended use, device description, or performance studies.
No.
The device is described as a patient monitoring system which measures and displays vital signs, but does not provide any therapy.
No
This device is a patient monitoring system, which measures and displays vital signs. While monitoring provides data for diagnosis, the device itself does not perform diagnostic interpretations or provide a diagnosis. The text explicitly states that the "user, responsible to interpret the monitored data made available, will be a professional health care provider."
No
The device description explicitly details hardware components, including a physical monitor with slots for parameter modules (ECG, SpO2, NIBP, CO2, IBP, AGM), and mentions inbuilt modules on an interface card. This indicates it is a hardware-based medical device with integrated software, not a software-only device.
Based on the provided text, the STAR 90 multi-parameter Patient Monitoring system is not an IVD (In Vitro Diagnostic) device.
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.
- STAR 90 Function: The STAR 90 monitors vital signs directly from the patient's body (ECG, SpO2, Respiration, Temperature, Capnography, IBP, NIBP, AGM). It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states monitoring a patient's vital signs at the bedside or during transport. This is direct patient monitoring, not laboratory testing of samples.
- Device Description: The description details modules for measuring physiological parameters directly from the patient.
Therefore, the STAR 90 is a patient monitoring system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The STAR 90 multi-parameter Patient Monitoring system is intended to monitor a single adult, pediatire or neonatal patient's vital signs at the bedside or during intra-hospital transport along with the appropriate accessories mentioned / supplied with the unit. Vital signs parameters include ECG (3 lead / 12 Lead), SpO2, Respiration, Temperature and Capnography (CO2) , IBP. It can also display the digital values of HR/PR, SpO2, RR, Non-Invasive Blood Pressure (Systolic and Mean), Temperature , IBP , EtCO2 and FiCO2 readings.
The user, responsible to interpret the monitored data made available, will be a professional health care provider. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals. The monitor is not intended for home use.
Product codes
MWI
Device Description
The STAR 90 Multi-Parameter Patient Monitoring System is a Semi Modular Patient monitor with a wide range of communication options, touch screen and capacitive sensing buttons.
Modularity in this monitor is achied by providing 3 slots wherein the parameter modules that fit into these modules are hot swappable i.e. they can be connected or disconnected from the unit without switching off the unit. The module is detected at run time. Patient monitoring modules include:
- . ECG+RESPIRATION+TEMPERATURE MODULE: This module is divided in area and functionality between the interface card and the ECG child card. The Temperature section and the DC-DC section of the ER2T lie in the interface card.
- SpO2: This module is inbuilt inside the monitor on the interface card, but there is ● an option to jack an external SpO2 module in one of the jackable slots. It is used to measure the partial pressure of oxygen in the human body.
- NIBP: This module is inbuilt inside the monitor on the interface card. It is used to non-invasively measure the systolic and diastolic blood pressure.
- CO2: This module can be jacked into one of the jackable slots. It is used to measure the level of CO2 in the blood (EtCO2 & FiCO2). When AGM is used this module will not be available
- . IBP: STAR 90 can support 2 IBP modules. For ease of understanding we shall name the 1st IBP as IBP ½ and the 2nd IBP as IBP ¾. IBP ½ module is inbuilt in the interface card, whereas the IBP ¾ can be jacked in one of the slots. It is used to invasively measure the systolic and diastolic blood pressure
- . AGM: The connectivity for this module is inbuilt inside the interface card of the system, but the AGM module has to be connected through the connector provided. It is used to measure anesthesia gas concentration, CO2 and O2.This is optional module in place of CO2 module.
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
adult, pediatire or neonatal
Intended User / Care Setting
professional health care provider / bedside or during intra-hospital transport
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)
Non Clinical Testing
Electrical and EMC Testing for the Star 90 included the following: IEC 60601-1-2, IEC 60601-1, IEC 60601-1-6, IEC 60601-1-8, IEC 60601-2-27, IEC 80601-2-30, IEC 60601-2-34, IEC 60601-2-49, ISO 80601-2-55, ISO 80601-2-56, ISO 80601-2-61.
Additional Performance Testing included: ANSI/AAMI EC 13 (Cardiac Monitors, Heart rate Meter and Alarms), ANSI/SSMI SP10 (Manual, Electronic or Automated Sphygmomanometers), IEC 62304 (Medical device software – software life cycle processes), ISO 14971 (Application of risk management to medical devices).
The inclusion of the advanced features have been validated and verified to ensure that the new features do not impact performance and the safety and efficacy of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K08073, K093268
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features an abstract eagle design, with three stylized profiles facing right, representing the department's focus on people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 17, 2015
Skanray Technologies Pvt Ltd. c/o Ms. Yolanda Smith Regulatory Consultant Smith Associates 1468 Harwell Avenue Crofton. Marvland 21114
Re: K150512
Trade/Device Name: Star 90 Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including Cardiotachometer and Rate Alarm) Regulatory Class: Class II Product Code: MWI Dated: May 12, 2015 Received: May 14, 2015
Dear Ms. Yolanda Smith,
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.
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
1
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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Mitchell Stein
forBram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31. 2017 See PRA Statement below.
Device Name STAR90
Indications for Use (Describe)
The STAR 90 multi-parameter Patient Monitoring system is intended to monitor a single adult, pediatire or neonatal patient's vital signs at the bedside or during intra-hospital transport along with the appropriate accessories mentioned / supplied with the unit. Vital signs parameters include ECG (3 lead / 12 Lead), SpO2, Respiration, Temperature and Capnography (CO2) , IBP. It can also display the digital values of HR/PR, SpO2, RR, Non-Invasive Blood Pressure (Systolic and Mean), Temperature , IBP , EtCO2 and FiCO2 readings.
The user, responsible to interpret the monitored data made available, will be a professional health care provider. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals. The monitor is not intended for home use.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperw ork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EWAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions. search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwoork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
K150512 Page 1 of 4
510(k) Summary
(As Per 21 CFR 807.92)
| SPONSOR | ||
|---|---|---|
| Company Name: | Skanray Technologies PVt Ltd | |
| Healthcare Division | ||
| Company Address: | Skanray Technologies PVT Ltd. No. 15-17, | |
| Hebbal Industrial Area, Mysore, KA 570016 | ||
| India | ||
| Telephone: | 91-821-2407200 | |
| Fax: | 92-821-2407001 | |
| Contact Person: | Hema Singh | |
| Summary Prepared | September 5, 2014 | |
| Trade Name: | Star 90 | |
| Common/Usual Name: | Patient Monitoring System | |
| Classification Name: | Physiological Patient Monitor (without arrhythmia | |
| detection or alarms) | ||
| Product Code: | MWI | |
| Device Class: | Class II | |
| Regulation Number: | 21 CFR 870.2300 | |
| Predicate Device | ||
| Company | Product | 510(k) # |
| Larsen & Toubro Ltd | Star 55 | K08073 |
| Philips medizin Systeme Boeblingen | Philips Intellivue patient Monitor | K093268 |
Device Description
The STAR 90 Multi-Parameter Patient Monitoring System is a Semi Modular Patient monitor with a wide range of communication options, touch screen and capacitive sensing buttons.
Modularity in this monitor is achied by providing 3 slots wherein the parameter modules that fit into these modules are hot swappable i.e. they can be connected or disconnected from the unit without switching off the unit. The module is detected at run time. Patient monitoring modules include:
- . ECG+RESPIRATION+TEMPERATURE MODULE: This module is divided in area and functionality between the interface card and the ECG child card. The Temperature section and the DC-DC section of the ER2T lie in the interface card.
4
- SpO2: This module is inbuilt inside the monitor on the interface card, but there is ● an option to jack an external SpO2 module in one of the jackable slots. It is used to measure the partial pressure of oxygen in the human body.
- NIBP: This module is inbuilt inside the monitor on the interface card. It is used to non-invasively measure the systolic and diastolic blood pressure.
- CO2: This module can be jacked into one of the jackable slots. It is used to measure the level of CO2 in the blood (EtCO2 & FiCO2). When AGM is used this module will not be available
- . IBP: STAR 90 can support 2 IBP modules. For ease of understanding we shall name the 1st IBP as IBP ½ and the 2nd IBP as IBP ¾. IBP ½ module is inbuilt in the interface card, whereas the IBP ¾ can be jacked in one of the slots. It is used to invasively measure the systolic and diastolic blood pressure
- . AGM: The connectivity for this module is inbuilt inside the interface card of the system, but the AGM module has to be connected through the connector provided. It is used to measure anesthesia gas concentration, CO2 and O2.This is optional module in place of CO2 module.
Indications for Use
The STAR 90 Multi-Parameter Patient Monitoring System is intended to monitor a single adult, pediatric or neonatal patient's vital signs at the bedside or during intra-hospital transport along with the appropriate accessories mentioned / supplied with the unit. Vital signs parameters include ECG (3 lead / 12 lead), Spo2, Respiration, Temperature and Capnography (CO2), IBP. It can also display the numeric values of HR/PR, SpO2, RR, Non-Invasive Blood Pressure (Systolic, Diastolic and Mean). Temperature, IBP, EtCO2 and FiCO2 readings.
The user, responsible to interpret the monitored data made available, will be a professional health care provider. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals. The monitor is not intended for home use.
Summary of Technological Characteristics
Star 90 is designed and developed with reference to our previous 510K cleared product Star55 with same product code as Star90 – MWI. These 2 products are same in terms of:
- ECG,
- Respiration, ●
- Temperature, ●
- IBP,
- NIBP,
5
- SpO2 and ●
- CO2
- Display type ●
- Alarm systems
- Thermal recorder / printer ●
- Equipment classification, applicable standards
Star90 is compared with MP70 for advanced features that are included in the Star 90 and include:
- . Communication with external equipment including analog and system outputs
- Display size and resolution. ●
Differences between Star 90 and Star 55
The differences between the two devices includes advanced features that include:
- Number of waveform traces displayed .
- Waveform display options / selections
The inclusion of the advanced features have been validated and verified to ensure that the new features do not impact performance and the safety and efficacy of the device.
Non Clinical Testing
Electrical and EMC Testing for the Star 90 included the following
| IEC 60601-1-2 | EMC Test Report |
|---|---|
| IEC 60601-1 | Medical electrical equipment - Part 1: General |
| requirements for basic safety and essential performance | |
| IEC 60601-1-6 | Medical electrical equipment - Part 1-6: General |
| requirements for basic safety and essential performance - | |
| Collateral standard: Usability | |
| IEC 60601-1-8 | Medical electrical equipment -- Part 1-8: General |
| requirements for basic safety and essential performance -- | |
| Collateral standard: General requirements, tests and | |
| guidance for alarm systems in medical electrical | |
| equipment and medical electrical systems | |
| IEC 60601-2-27 | Medical electrical equipment - Part 2-27: Particular |
| requirements for the basic safety and essential | |
| performance of electrocardiographic monitoring | |
| equipment | |
| IEC 80601-2-30 | Medical electrical equipment -- Part 2-30: Particular |
| requirements for the basic safety and essential | |
| performance of automatic cycling non-invasive blood | |
| pressure monitoring equipment. |
6
- IEC 60601-2-34 Medical electrical equipment -- Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment.
- IEC 60601-2-49 Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment
- ISO 80601-2-55 Medical electrical equipment -- Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
- Medical electrical equipment -- Part 2-56: Particular ISO 80601-2-56 requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
- Medical electrical equipment -- Part 2-61: Particular ISO 80601-2-61 requirements for basic safety and essential performance of pulse Oximeter equipment
Additional Performance Testing:
| ANSI/AAMI EC 13 | Cardiac Monitors, Heart rate Meter and Alarms |
|---|---|
| ANSI/SSMI SP10 | Manual, Electronic or Automated Sphygmomanometers |
| IEC 62304 | Medical device software – software life cycle processes |
| (Software/Informatics) | |
| ISO 14971 | Application of risk management to medical devices |
Substantial Equivalence
The Star 90 is substantially equivalent to the predicate device in Indications for Use, Materials and Design. Safety and performance testing was performed and Skanray Technologies has concluded that the device does not introduce any significant questions of safety and efficacy and is substantially equivalent to the predicate devices.