(127 days)
Not Found
No
The summary describes a central nursing station software that displays and stores data from bedside monitors. There is no mention of AI or ML capabilities for data analysis, interpretation, or prediction. The system primarily acts as a data aggregator and display tool.
No.
Explanation: The device is software for a central nursing system that displays and stores patient vital sign information collected from bedside monitors. It is clearly stated that it is "NOT a patient monitoring device" and serves as a secondary display, with clinicians instructed to always reference the primary bedside monitor before patient care decisions. It does not provide any therapy or direct medical treatment.
No
The device is described as Central Nursing System Software that provides centralized monitoring of vital signs and patient information from bedside monitors. It consolidates data for healthcare providers but is explicitly stated as "NOT a patient monitoring device" and is used to "provide a secondary display/announcement." It does not make a diagnosis or provide diagnostic output; instead, it aggregates and displays data for interpretation by a healthcare professional.
No
The device description explicitly states that the operation requires a "specific hardware environment such as a PC loaded with an Operating System and a software application" and that the system set-up includes a "FCC approved highperformance PC hardware system". While the submission focuses on the software, the device as a whole includes necessary hardware components.
Based on the provided text, the Skyline55 Ver 1 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Skyline55 Ver 1 Function: The Skyline55 Ver 1 is a Central Nursing System Software that collects and displays real-time physiological data (vital signs like ECG, NIBP, SpO2, etc.) directly from patient monitors. It does not analyze or process biological specimens.
- Intended Use: The intended use is for centralized monitoring of patient vital signs in a hospital setting, providing a secondary display and alarm notification based on data from bedside monitors.
- Device Description: The description clearly states it's a medical information system that collects and displays monitoring information from bedside monitors.
Therefore, the Skyline55 Ver 1 falls under the category of patient monitoring systems, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Skyline55 Ver 1 is Central Nursing System Software that is loaded in a PC, which in turn is connected to a listed patient monitor via an Ethernet communication (wired or wireless). The system software will enable a user to simultaneously monitor 8/16 beds. The system software will make available to the user, patient information in the form of continuous monitoring along with extended features in which 72-hour trend data can be stored for each patient and displayed in the form of Waveform recall, Graphical and Tabular Trends. Alarm records for 72-hours too are recorded and stored for each patient connected to the system software.
Skyline 55 Ver1 is intended to conduct centralized monitoring for adult, pediatric and neonatal patients' vital sign information from multiple monitors in a hospital, the monitoring parameters include ECG, NIBP, SPO2, RESP, IBP, TEMP, CO2 and Anesthesia agents.
The user, responsible to interpret the monitored data made available, will be a professional health care provider. The system software permits patient monitoring with adjustable visible and audible alarm signals. The system software is not intended for home use.
Product codes (comma separated list FDA assigned to the subject device)
MWI
Device Description
Central Nursing Station is a kind of medical information system widely applied in clinical monitoring, whose operation requires specific hardware environment such as a PC loaded with an Operating System and a software application. The loaded PC system is connected with multiple individual bedside monitors through a communication channel (In Skyline55 case wired Ethernet 802.3 and wireless 802.11bg). It can collect the monitoring information of the patient transferred via interface from the bedside monitor. It can also display and export the integrated information from bedside monitors so as to free-up doctors from clinical monitoring work and create centralized monitoring management.
The Skyline55 Ver1 is such Central Nursing Station software which is loaded in a PC of recommended specifications. The system set-up includes a FCC approved highperformance PC hardware system, the application software and Windows operation system (Windows XP). Through applying Larsen & Toubro specified protocol, the Central Monitoring System receives physiological information from cleared bedside monitors manufactured by Larsen & Toubro, includes: Planet 50, Star 50, Galaxy, Planet 55, Star 55 and Galaxy 55.
Skyline 55 Verl can maximally support the simultaneous interfacing of 16 bedside monitors. TCP/IP protocol is applied to ensure reliable transmission of data between the bedside monitors and the Central Nursing Station using Cat5e cable.
Skyline 55 Ver1 offers centralized display of physiological information of many patients who are monitored simultaneously. The software can support one display with display information from up to 16 bedside monitors. If any of the bedside monitors gives off a patient vital sign parameter alarm (also referred as Red Alam), prompt information will be immediately displayed by means of audible and visual alarm for medical personnel attention.
The physiological waveforms displayed on Skyline 55 Ver1 include: ECG, RESP, CO2, SPO2, IBP and Anesthesia agents. The physiological parameters displayed on the central monitoring system include: HR, RR, SPO2, SysDia/Mean NIBP and IBP, TEMP and CO2, Archythmia, ST indications and Anesthesia agents. The software also performs notification directly for Red alarms from the bedside monitor. Moreover database technology is applied to store these from the bedside monitor.
Skyline 55 Ver1 is used to provide a secondary display/announcement for the physiological parameters based on the bedside monitor and is NOT a patient monitoring device. The clinician is instructed to always reference the primary bedside monitor before making any patient care decisions.
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, pediatric and neonatal
Intended User / Care Setting
professional health care provider / hospital. Not intended for home use.
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 conclusions drawn from testing and validation of Skyline 55 Ver1 demonstrates that the device is as safe, as effective, and performs as well as the legally marketed predicate devices Skyline55 Ver0 (K081552) and the Hypervisor VI Central Monitoring System (K062194, by Shenzen Mindray Bio-Medical Electronics Co., Ltd, China)
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
§ 870.2300 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/0 description: The image shows a logo with a circle surrounding two mirrored and stylized "L" shapes. The "L" shapes are positioned horizontally, facing each other within the circle. The logo is black and white and appears to be a simple, geometric design.
Image /page/0/Picture/1 description: The image shows the text "K092153 pg 1 of 5" in black ink on a white background. The text appears to be handwritten. The top line contains the alphanumeric code "K092153", and the bottom line indicates the page number as "pg 1 of 5".
LARSEÑ & TOUBRO LIMITED
ELECTRICAL & ELECTRONICS DIVISION - ELECTRONIC PRODUCTS -
Mysore Campus, KIADB Industrial Area, Hebbal - Hootagalli, Mysore - 570 018 • Tel: +91 (821) 2405000 • Fax : +91 (821) 2402468
E - Mail :
Rel :
12
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NOV 2 0 2009.
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『 『 』『 』『 』『 』『 』『 』『 』『 』『 』『 』『 』『 』『 』『 』『 』『 』『 』『 』『 』『 』『 』『 』『 』『 』『 』『 』『 』『 』『 』『 』『 』『 』『 』『 』『 』『 』『 』『 』『 』『 』『 』『 』『 』『 』『 』『 』『 』『 』『 』『 』『 』『 』『 』『 』『 『 』『
Date: 24.09.2009 Page: 01 of 05
510(K) SUMMARY
(Per section 807.92 ©)
| CONTACT DATA | |||
|---|---|---|---|
| Submitter's Name | Larsen & Toubro Limited | ||
| Address | KIADB Industrial Area, Hebbal Hootagalli, | ||
| Mysore – 570018, Karnataka, INDIA | |||
| Telephone | 91-821-2405439 | Fax | 91-821-2402468 |
| Contact Person | A.B.Deshpande | Title | Head – Quality Assurance & |
| Management Representative | |||
| E-Mail address | DeshpandeAB@myw.ltindia.com | ||
| Date the summary was prepared | 24th September 2009 |
| DEVICE | |||
|---|---|---|---|
| Trade name | Skyline 55 Ver 1 | ||
| Common name | Central Nursing Station or Central | ||
| Monitoring System | |||
| Classification name | Monitor, Physiological, Patient Monitor | ||
| CFR21 Section | 870.2300 | Product code | MWI |
| PREDICATE DEVICE IDENTIFICATION | |||
|---|---|---|---|
| CFR21 Section | 870.2300 | Product code | MWI |
| Classification panel | Cardiovascular | ||
| Device Class | Class II | ||
| Legally marketed Comparison Device / | |||
| K# | • SKYLINE 55 Ver 0 / K081552 | ||
| • Mindray HYPERVISOR VI / K062194 |
Regd. Off : L & T House, Ballard Estate, P.O.Box 278, Mumbai 400 001 ● Phone:+91(22)67525658 Website : www.LNTEBG.com
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1
Image /page/1/Picture/0 description: The image shows a logo consisting of two stylized letters, 'L' and 'T', enclosed within a circle. The 'L' and 'T' are designed with sharp, angular lines, giving them a modern and geometric appearance. The logo is presented in black against a white background, creating a high contrast and making it easily visible. The overall design is simple yet distinctive, suggesting a corporate or brand identity.
t092153
pg 2 of 5
ARSEÑ & TOUBRO LIMITED
ELECTRICAL & ELECTRONICS DIVISION - ELECTRONIC PRODUCTS
Mysore Campus, KIADB Industrial Area, Hebbal - Hootagalli, Mysore - 570 018 · Tel. +91 (821) 240500 · Fax : +91 (821) 2402468
E - Mail :
Ref .
な . कुछ Date: 24.09.2009 Page: 02 of 05
DEVICE DESCRIPTION
Central Nursing Station is a kind of medical information system widely applied in clinical monitoring, whose operation requires specific hardware environment such as a PC loaded with an Operating System and a software application. The loaded PC system is connected with multiple individual bedside monitors through a communication channel (In Skyline55 case wired Ethernet 802.3 and wireless 802.11bg). It can collect the monitoring information of the patient transferred via interface from the bedside monitor. It can also display and export the integrated information from bedside monitors so as to free-up doctors from clinical monitoring work and create centralized monitoring management.
The Skyline55 Ver1 is such Central Nursing Station software which is loaded in a PC of recommended specifications. The system set-up includes a FCC approved highperformance PC hardware system, the application software and Windows operation system (Windows XP). Through applying Larsen & Toubro specified protocol, the Central Monitoring System receives physiological information from cleared bedside monitors manufactured by Larsen & Toubro, includes: Planet 50, Star 50, Galaxy, Planet 55, Star 55 and Galaxy 55.
Skyline 55 Verl can maximally support the simultaneous interfacing of 16 bedside monitors. TCP/IP protocol is applied to ensure reliable transmission of data between the bedside monitors and the Central Nursing Station using Cat5e cable.
Skyline 55 Ver1 offers centralized display of physiological information of many patients who are monitored simultaneously. The software can support one display with display information from up to 16 bedside monitors. If any of the bedside monitors gives off a patient vital sign parameter alarm (also referred as Red Alam), prompt information will be immediately displayed by means of audible and visual alarm for medical personnel attention.
Regd. Off : L & T House, Ballard Estate, P.O.Box 278, Mumbai 400 001 · Phone : +91(22)67525656 Website : www.LNTEBG.com
2
Image /page/2/Picture/0 description: The image shows a logo consisting of two stylized letters, 'L' and 'T', enclosed within a circle. The 'L' is on the left side of the circle, and the 'T' is on the right side. The letters are designed with a bold, geometric style, and they appear to be interconnected or overlapping slightly. The logo is presented in black and white, with the letters and the circle outline in black against a white background.
Image /page/2/Picture/1 description: The image shows the text "K092153 pg 3 of 5". The text appears to be handwritten in black ink on a white background. The text is likely a page number or document identifier.
& TOUBRO LIMITED
ECTRONICS DIVISION - ELECTRONIC PRODUCTS
Mysore Campus, KIADB Industrial Area, Hebbal - Hootagalli, Mysore - 570 018 • Tel: +91 (821) 2405000 • Fax : +91 (821) 2402468
E - Mail :
Rel .
1 - 4
Date: 24.09.2009 Page: 03 of 05
The physiological waveforms displayed on Skyline 55 Ver1 include: ECG, RESP, CO2, SPO2, IBP and Anesthesia agents. The physiological parameters displayed on the central monitoring system include: HR, RR, SPO2, SysDia/Mean NIBP and IBP, TEMP and CO2, Archythmia, ST indications and Anesthesia agents. The software also performs notification directly for Red alarms from the bedside monitor. Moreover database technology is applied to store these from the bedside monitor.
Skyline 55 Ver1 is used to provide a secondary display/announcement for the physiological parameters based on the bedside monitor and is NOT a patient monitoring device. The clinician is instructed to always reference the primary bedside monitor before making any patient care decisions.
STATEMENT OF INTENDED USE
The Skyline55 Ver 1 is Central Nursing System Software that is loaded in a PC, which in turn is connected to a listed patient monitor via an Ethernet communication (wired or wireless). The system software will enable a user to simultaneously monitor 8/16 beds. The system software will make available to the user, patient information in the form of The system bening with extended features in which 72-hour trend data can be stored for each patient and displayed in the form of Waveform recall, Graphical and Tabular Trends. Alarm records for 72-hours too are recorded and stored for each patient connected to the system software.
Skyline 55 Verl is intended to conduct centralized monitoring for adult, pediatric and neonatal patients' vital sign information from multiple monitors in a hospital, the monitoring parameters include ECG, NIBP, SPO2, RESP, IBP, TEMP, CO2 and Anesthesia agents.
The user, responsible to interpret the monitored data made available, will be a The ason, responder. The system software permits patient monitoring with adjustable visible and audible alarm signals. The system software is not intended for home use
Regd. Off : L & T House, Ballard Estate, P.O.Box 278, Mumbai 400 001 · Phone : +9 1(22)67525856 Website : www.LNTEBG.com
3
Image /page/3/Picture/0 description: The image shows a logo with two stylized, mirrored 'L' shapes inside of a circle. The 'L' shapes are thick and bold, and they are positioned so that they appear to be facing each other. The logo is black and white, with the shapes and the circle being black and the background being white. The logo has a simple and modern design.
K092153
pg 4 of S
LARSEN & TOUBRO LIMITED
ELECTRICAL & ELECTRONICS DIVISION - ELECTRONIC PRODUCTS
Mysore Campus, KIADB Industrial Area, Hebbal - Hootagalli, Mysore - 570 018 · Tel: +91 (821) 2402468
E - Mail :
Hef :
Date: 24.09.2009 Page: 04 of 05
TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE
The Skyline55 Ver1 Central Nursing Station is substantially equivalent to the currently marketed predicate devices HypervisorVI and Skyline55 Ver0 Central Monitoring System. All Skyline55 Ver1 and predicate devices HypervisorVI and Skyline55 Ver0 free-up doctors from clinical monitoring work at each bedside monitor and create centralized monitoring management. All systems get connected to bedside monitors through Ethernet interface 802.3(wired) and 802.11(wireless). The requirement of Operating system in the PC for both the software is same, which is Windows XP professional.
The notable differences between the technical specifications of Skyline 55 Verl and HypervisorVI are as mentioned below:
- The PC processor (host CPU) requirement is little different; HypervisorVI requires P l . IV 2.0G, while Skyline55 Ver1 requires Core 2 duo processor 1.8 GHz.
-
- For HypervisorVI, the maximum number of simultaneously connected and displayed monitors is 32 whereas for Skyline55 Ver1, the number is 16.
-
- For HypervisorVI either 1 or 2 displays can be simultaneously connected whereas for Skyline55 Ver1, only 1 display can be connected.
-
- There is no provision to connect a recorder in SkylineS5Ver1 whereas HypervisoVI has provision to connect a Recorder. In Skyline55 Ver1, a standard computer printer can be connected with the PC by loading the appropriate Printer Driver and parameter trend, alarm recall and patient discharge summary can be printed on normal paper.
The notable differences between the Skyline55 Verl and Skyline55 Ver0 are as mentioned below: ·
-
- ECG + 2 user selectable waveform storage for 72 hours added in Skyline55 Verl which is not there in Skyline55 Ver0
-
- Tabular tread, graphical trend and alarm recall storage is extended up to 72 hours from 24 hours in Skyline55 Ver0
-
- Monitor to CNS bi-directional patient admission is added in Skyline55 Verl which is not there in Skyline55 Ver0
-
- ECG strip for 36 seconds for each alarm in last 72 hours is added in Skyline55 Verl which is not there in Skyline55 Ver0
Regd. Off:L & T House, Ballard Estate, P.O.Box 278, Mumbai 400 001 ● Phone:+91(22)67525656 Website : www.liNTEBG.com
ー: )
4
Image /page/4/Picture/0 description: The image shows a logo consisting of the letters 'L' and 'T' inside of a circle. The 'L' is on the top left, and the 'T' is on the bottom right. The letters are stylized and connected to each other.
Image /page/4/Picture/1 description: The image shows handwritten text. The top line reads '2092153'. The bottom line reads 'pg 5 of 5'.
LARSEN & TOUBRO LIMITED
ELECTRICAL & ELECTRONICS DIVISION - ELECTRONIC PRODUCTS
Mysore Campus, KIADB Industrial Area, Hebbal - Hootagaili, Mysore - 570 018 • Tel: +91 (821) 2405000 • Fax : +91 (821) 2402468
E - Mail :
Ref :
్యాల
文
Date: 24.09.2009 Page: 05 of 05
The detailed feature-by-feature comparison of Skyline55 Ver1 with predicate device HypervisorVI and Skyline55 Ver0 has been given in the document titled as `Predicate Device Comparison Document'.
Conclusion:
The conclusions drawn from testing and validation of Skyline 55 Ver1 demonstrates that the device is as safe, as effective, and performs as well as the legally marketed predicate devices Skyline55 Ver0 (K081552) and the Hypervisor VI Central Monitoring System (K062194, by Shenzen Mindray Bio-Medical Electronics Co., Ltd, China)
(N. Ravindran) Head - Design & Development
Regd. Off : L & T House, Ballard Estate, P.O.Box 278, Mumbai 400 001 · Phone : +91(22)67525858 Website : www.LNTEBG.com
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling an emblem. The emblem is a stylized depiction of an eagle, with its wings forming a symbolic representation of protection and care. The text is arranged in a circular pattern around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Larsen & Toubro Limited c/o Mr. E.J. Smith Smith Associates 1468 Harwell Ave. Crofton, MD 21114
NOV 2 0 2009
Re: K092153
Skyline 55 Version 1 Regulation Number: 21 CFR 870.2300 Regulation Name: Physiological Patient Monitor (without arrhythmia detection or alarms) Regulatory Class: Class II (two) Product Code: MWI Dated: October 6, 2009 Received: October 6, 2009
Dear Mr. 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.
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.
6
Page 2 - Mr. E.J. Smith
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-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,
W. M. D.
Co. Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Indications for Use
510(k) Number (if known) K092153
Device name: Skyline55 Ver 1
Indication for use:
The Skyline55 Ver 1 is Central Nursing System Software that is loaded in a PC, which in turn is connected to a listed patient monitor via an Ethernet communication (wired or wireless). The system software will enable a user to simultaneously monitor 8/16 beds. The system software will make available to the user, patient information in the form of continuous monitoring along with extended features in which 72-hour trend data can be stored for each patient and displayed in the form of Waveform recall, Graphical and Tabular Trends. Alarm records for 72-hours too are recorded and stored for each patient connected to the system software.
Skyline 55 Ver1 is intended to conduct centralized monitoring for adult, pediatric and neonatal patients' vital sign information from multiple monitors in a hospital, the monitoring parameters include ECG, NIBP, SPO2, RESP, IBP, TEMP, CO2 and Anesthesia agents.
The user, responsible to interpret the monitored data made available, will be a professional health care provider. The system software permits patient monitoring with adjustable visible and audible alarm signals. The system software is not intended for home use.
Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The -Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH. Office of Devies Evaluation (ODE)
ence of CDRH, Office of Device Evaluati
Page 1 of 1
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number