(84 days)
Not Found
No
The description focuses on data collection, storage, display, and transmission from ventilators. There is no mention of algorithms that learn or make predictions based on the data. The "advanced device-management functionality" and "evolving connectivity technology" do not inherently imply AI/ML.
No
The VentLink system is for data display, storage, and processing from ventilator devices, not for direct patient interaction or therapeutic intervention. It explicitly states it is "not connected directly to any patient nor does the VentLink device remotely control any connected ventilator device."
No
The VentLink system is described as a device that collects, displays, stores, and processes ventilator data from other devices. It explicitly states it "does not alter or change any patient data" and is not connected to a patient. Its purpose is to provide a "secondary display of data" and move data to other hospital systems, rather than to make a diagnosis.
No
The device description explicitly states that the VentLink system is "composed of MediServe Information Systems' proprietary software and various off-the-shelf hardware, operating system software and third-party proprietary software". This indicates the system includes hardware components in addition to software.
Based on the provided information, the VentLink system 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. They are used to provide information for diagnosis, monitoring, or screening.
- VentLink's Function: The VentLink system's intended use and description clearly state that it is a system for collecting, displaying, storing, and processing data from ventilator devices. It does not perform any tests on patient samples. It is a data management and display system for information already generated by a medical device (the ventilator).
- No Direct Patient Connection: The description explicitly states that VentLink is "not connected directly to any patient." IVDs, by their nature, interact with patient samples.
- Data Source: The data processed by VentLink comes from the ventilator, not from a biological sample.
Therefore, the VentLink system falls outside the scope of an In Vitro Diagnostic device. It is a medical device that supports the use of another medical device (the ventilator) by managing its data.
N/A
Intended Use / Indications for Use
The VentLink sVstem is intended for use with specified or validated ventilator devices to obtain ventilator data and provide the user with the ability to display, store, print and otherwise process that data to other interfaced systems.
VentLink is not connected directly to any patient nor does the VentLink device remotely control any connected ventilator device.
The VentLink system is intended for use in any clinical setting while interfaced to any specified or validated ventilator device. The VentLink system is intended to provide a secondary display of data received from an interfaced ventilator device to appropriately configured workstations and wireless laptop computers and to be made available to any interfaced hospital information system (HIS).
Product codes (comma separated list FDA assigned to the subject device)
MOD
Device Description
The VentLink system is a device composed of MediServe Information Systems' proprietary software and various off-the-shelf hardware, operating system software and third-party proprietary software intended to be interfaced with specified or validated ventilator devices to allow authorized users to move ventilator patient data to wireless laptops and workstations configured with MediServe Information Systems' MediLinks data storage software'. Additionally, the VentLink system allows users to move ventilator data to the user's hospital information system (HIS). It is intended to be used in an environmentally controlled hospital and hospital type environment.
The VentLink system software allows users to:
- Enable or disable automatic device data collection.
- Set a default data collection time interval.
- Specify how long unauthenticated data will be retained.
- Alert the user when data collection is paused.
After user review and validation of results received via the Ethernet the results are stored short-term on the VentLink system and transmitted to MediLinks for acceptance and storage.
Specified or validated ventilator devices are interfaced and added to the VentLink system through VentLink's devices' dictionary.
The VentLink system does not alter or change any patient data, but does allow the user to display the received patient data.
VentLink will function within a wide array of connectivity modules which allow VentLink to adapt to the evolving connectivity technology.
VentLink also has advanced device-management functionality.
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
Not Found
Intended User / Care Setting
Not Found
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 performance data testing and review: Since the submitter uses only off-the-shelf hardware components, only certifications provided by the manufacturers of those components were obtained to document that EMI compatibility and susceptibility meets acceptable industry levels. Those certifications are attached in Exhibit 10 Component/Accessory Validation.
The submitted device has undergone significant verification and validation testing. Alpha validation testing included testing of all functionality and confirmation that all identified hazards have been adequately addressed by software functionality, the user interface or documentation.
Alpha validation activities included specified system software and operating software performance and environmental testing within the specified environment.
Additionally, each specified ventilator system has been or will be fully validated by users in beta testing environments PRIOR to implementation to ensure that each specified or validated ventilator operating environment meets all appropriate specifications.
The submitter requires that any user of an un-validated specified or unspecified ventilator device perform a documented, successful, ventilator/VentLink validation prior to authorizing the user operate their system in a live environment. See Section IV, for a description of the User's Validation Protocol and Exhibit 12 Users' Manual, Implementation Manual and Users' Validation Protocol for a User's Validation Protocol provided to users of un-validated specified or unspecified ventilator devices.
The submitter's validation testing fully documents that specified ventilator device's data is transmitted from the ventilator through the VentLink system into the submitter's MediLinks device2 with user control of data review and acceptance. No changes were made to transmitted ventilator data.
In these regards, the VentLink system is similar to and substantially equivalent to the capabilities of the predicate device, the Ventnet system.
The predicate device, Ventnet system, did not provide or reference any clinical tests submitted in compliance with 807.92(b)(2), therefore the submitter believes such clinical testing is not appropriate or required by FDA and has not made or provided any summary of such 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.
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
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).
0
K05275/
DEC 2 3 2005
PREMARKET NOTIFICATION 510(k) SUMMARY As required by §807.92
Device Name - as required by 807,92(a)(2):
| Trade Name: | VentLink™ System VentLink is a Trade Mark of
MediServe Information Systems, Tempe, AZ |
|-----------------------------|------------------------------------------------------------------------------------------|
| Common/Classification Name: | Ventilator Data Management System/ Accessory To
Continuous Ventilator (respirator) |
| Classification Regulation: | 868.5895 |
| Device Class: | Class II (accessory to) |
| Product Code: | MOD |
| Panel: | Anesthesiology |
Premarket Notification submitter: MediServe Information Systems, 3225 South Hardy Drive, Ste. 101, Tempe, AZ 85282
Contact: Mark Ofori-Kyei, Director of Quality Assurance and Change Management
Preparation Date: 9/28/2005
A. LEGALLY MARKETED PREDICATE DEVICE – as required by 807.92(a)(3)
The VentLink device is substantially equivalent to the Ventnet system, K963633, submitted by Puritan Bennett Corporation, Tustin, CA.
B. DEVICE DESCRIPTION - as required by 807.92(a)(4)
The VentLink system is a device composed of MediServe Information Systems' proprietary software and various off-the-shelf hardware, operating system software and third-party proprietary software intended to be interfaced with specified or validated ventilator devices to allow authorized users to move ventilator patient data to wireless laptops and workstations configured with MediServe Information Systems' MediLinks data storage software'. Additionally, the VentLink system allows users to move ventilator data to the
1 MediLinks data storage software is a Class I proprietary standalone software application of MediServe Information Systems, the submitter.
1
user's hospital information system (HIS). It is intended to be used in an environmentally controlled hospital and hospital type environment.
The VentLink system software allows users to:
- Enable or disable automatic device data collection. .
- Set a default data collection time interval. .
- Specify how long unauthenticated data will be retained. .
- Alert the user when data collection is paused. .
After user review and validation of results received via the Ethernet the results are stored short-term on the VentLink system and transmitted to MediLinks for acceptance and storage.
Specified or validated ventilator devices are interfaced and added to the VentLink system through VentLink's devices' dictionary.
The VentLink system does not alter or change any patient data, but does allow the user to display the received patient data.
VentLink will function within a wide array of connectivity modules which allow VentLink to adapt to the evolving connectivity technology.
VentLink also has advanced device-management functionality.
C. DEVICE CLAIMS - as required by 807.92(a)(4)
The VentLink™ system is an interface application for ventilator devices that runs as a service on a server. VentLink works in concert with MediLinks®, an integrated point-of-care application suite intended for managing clinical departmental information activities and tasks.
The VentLink service communicates via Ethernet with the ventilator devices that have been configured within MediLinks. The purpose of the VentLink service is to collect data from the designated ventilators at specific time intervals and store the data in a database utilized by MediLinks.
The VentLink service cannot be used without MediLinks. MediLinks provides the user interface to the VentLink service. A MediLinks user can enter new ventilators, set data collection intervals, create Patient - Ventilator associations, and review and authenticate ventilator data collected by the VentLink service. MediLinks allows the user to generate reports of monitored ventilator information and also provides means for archiving data.
MediLinks will be used as a Central Monitoring Station that will allow users to remotely review summary information from many different ventilators at a
2
glance. The system will also be configurable to page an appropriate user when certain events (e.g. alarms) occur.
PRODUCT AND TECHNICAL SPECIFICATIONS - as required by D. 807.92(a)(4)
The purpose of this section is to show recommended minimum specifications for the VentLink system. MediServe Information Systems does not supply any hardware. While specific requirements may vary from one customer to another, the specifications listed below provide general guidance in determining hardware and system software needed for VentLink.
Client/Server Workstations
| Recommended | |
|---|---|
| Workstations | |
| • Pentium4 2.8 GHz or higher | |
| • 80 GB Hard Disk or greater | |
| • 512 MB RAM or greater | |
| • Windows 2000 Professional SP4 or | |
| • Windows XP Pro SP2 | |
| • 32-bit SVGA Graphics Card, 32 MB RAM | |
| • 1024x768 Display Resolution | |
| • SVGA Monitor (17") or greater |
- 100BaseT 32-bit PCI Network Card .
Thin Client Workstations
| Recommended Recommended | |
|---|---|
| Workstations | |
| • Pentium4 2 GHz or higher | |
| 40 GB Hard Disk or greater | |
| 512 MB RAM or greater | |
| Windows 2000 Professional SP4 or | |
| Windows XP Pro SP1 | |
| Internet Explorer 6.0 or greater (with 128-bit | |
| encryption) | |
| 32-bit SVGA Graphics Card, 32 MB RAM | |
| 1024x768 Display Resolution | |
| SVGA Monitor (17") or greater | |
| 100BaseT 32-bit PC1 Network Card | |
| Career Station Company Control Concession Company Controller Company Controller Company Controller Company Company Company Company Company Comments of Children | 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 |
| t the country of the county of the county of the first of the first of the first of the first of the first of the first of the first of the first of the first for the finishe |
Note: Thin client devices can be used for thin client computing via Citrix MetaFrame and must include Internet Explorer 5.5 or greater and support Citrix ICA and NFuse clients.
3
Database Server (up to 1200-1500 procedures/day or up to 50 concurrent users)
| Recommended | |
|---|---|
| Database Server | |
| • | Dual (2) Pentium4 2 GHz or greater |
| • | 3 GB RAM or greater |
| • | 4(+) x 36 GB Ultra 3/4 SCSI Hard Drives |
| (RAID-5) | |
| • | 32-bit Caching Array Controller 64 MB RAM or |
| greater | |
| • | 2 x 100BaseT 32-bit Network Card |
| • | Windows 2000 Server SP4 or Windows Server |
| 2003 |
- Microsoft SQL Server 2000 Enterprise Ed. SP3 ●
- . Monitor, CD-ROM
Database Server (up to 2500+ procedures/day or up to 100 concurrent users)
1 Recommended Recommended
Database Server
- Dual (2) Intel Xeon 3 GHz or greater. 4 . processors for larger volume sites
- . 4 GB RAM or greater
- . 6(+) x 36 GB or 72 GB Ultra 3/4 SCSI Hard Drives (RAID-5 or RAID 10)
- . 32-bit Multi-Channel Caching Array Controller 128 MB RAM or greater (the array should be constructed using multiple I/O channels) with additional embedded 64MB controller for system drive
- 2 x 100BaseT 32-bit Network Card .
- Windows 2000 Advanced Server SP4 or . Windows Advanced Server 2003
- Microsoft SQL Server 2000 Enterprise Edition . SP3
- Monitor, CD-ROM .
4
Thin Client Server(s)
| Recommended |
|---|
| Citrix MetaFrame Server (up to 30 users) |
| • Dual (2) Xeon 2.8 GHz or greater |
| • 3 GB RAM or greater (64 MB per concurrent user) |
| • 3 x 36 GB Ultra 3/4 SCSI Hard Drives (RAID-5) or |
| • 2 x 72 GB Ultra 3/4 SCSI Hard Drives (RAID-1) |
| • 32-bit Caching Array Controller 64 MB RAM or greater |
| • 2 x 100BaseT 32-bit Network Card |
| • Windows 2000 Server SP4 or Windows Server 2003 |
| • Citrix MetaFrame v1.8 or XP (XPs, XPa, XPe) |
| • Citirx Load Balancing is required for multiple servers |
- Monitor, CD-ROM .
Interface Computers
| Recommended | |
|---|---|
| Interface Computer | |
| • Dual (2) Intel Xeon 2.4 GHz or greater | |
| • 3 GB RAM or greater | |
| • 2 x 72 GB Ultra 3/4 SCSI Hard Drives (RAID-1) | |
| • 32-bit Caching Array Controller 16 MB RAM or greater | |
| • 100BaseT 32-bit Network Card | |
| • Windows 2000 Server SP4 or Windows Server 2003 | |
| • Microsoft SQL Server 2000 Personal Edition SP3 |
- Monitor, CD-ROM .
5
Network Environment
科技术学院 - Recommended - Commended - Commended
Report Writing
- . Crystal Reports v11 Pro
Backup and Printing
- Laser Quality Printer .
- . Uninterruptible Power Supply w/Monitoring Software (all servers)
- . Tape Backup Unit (DAT, DLT, etc.) w/Backup Software (e.g. ArcServe)
Cabling and Connectivity
- 100BaseT (100Mbps) Ethernet Multiport Hub . or Switch
- . Category 5e Patch cabling (CAT5e)
- Category 5e Facility cabling (CAT5e) .
Remote Support
- Terminal Services or Symantec pcAnywhere to . Database Server and Interface Computers
- VPN Client connection via the Internet. .
LAN/WAN Bandwidth Requirements
- . 128Kbps per concurrent user (for Citrix: 32Kbps per concurrent user)
Wireless Requirements
- MediLinks must connect using Citrix . MetalFrame.
ASP Requirements
- TCP/IP protocol support required ●
- . Host-to-Host or Client-Host VPN connections between MediServe ASP and facility are supported. Contact MediServe for details.
6
INTENDED USE - as required by 807.92(a)(5) E.
Intended use:
The VentLink system is intended for use with specified or validated ventilator devices to obtain ventilator data and provide the user with the ability to display, store, print and otherwise process that data to other interfaced systems.
VentLink is not connected directly to any patient nor does the VentLink device remotely control any connected ventilator device.
Indications For Use
The VentLink system is intended for use in any clinical setting while interfaced to any specified or validated ventilator device. The VentLink system is intended to provide a secondary display of data received from an interfaced ventilator device to appropriately configured workstations and wireless laptop computers and to be made available to any interfaced hospital information system (HIS).
TECHNOLOGICAL CHARACTERISTICS SUMMARY - as required by 下. 807.92(a)(6)
The VentLink system has the same indications for use as the Ventnet system, K963633. The VentLink system has the same technological characteristics as the Ventnet system. Section III Substantial Equivalence of this submission provides a detailed COMPARISON MATRIX of the VentLink system to the predicate Ventnet system.
The submitter claims that the VentLink system is substantially equivalent to the predicate device, the Ventnet system.
The technological characteristics of the VentLink system are very similar to those of the Ventnet system. The differences include:
| Characteristic | VentLink system | Ventnet system |
|---|---|---|
| Hardware | No hardware provided. | Solution includes hardware. |
| Computer hardware | Specified but not provided by | |
| user. | Solution includes computer | |
| hardware. | ||
| Computer Operating System | Specified but not provided by | |
| user. | Solution includes computer | |
| operating system. | ||
| Color Monitor | Specified but not provided by | |
| user. | Solution includes color monitor. |
TABLE OF DIFFERENCES BETWEEN THE VENTLINK SYSTEM AND THE VENTNET SYSTEM
7
| Radio Transmitter Interface
(wireless) | Specified but not provided by
user. | Solution includes radio
transmitter interface. |
|-------------------------------------------|----------------------------------------|---------------------------------------------------|
| Remote Transceiver | Not specified. | Solution includes remote
transceiver. |
| Central Transceiver | Not specified. | Solution includes central
transceiver. |
The submitter concludes that the VentLink system employs the same type of technological characteristics including computer hardware, operating system(s), cabling, networking and similar functionality to the Ventnet system. The majority of differences relate to evolutionary changes in technology that has occurred since the release of the Ventnet system.
NON-CLINICAL PERFORMANCE DATA TESTING AND REVIEW - as G. required by 807.92(b)(1)
Since the submitter uses only off-the-shelf hardware components, only certifications provided by the manufacturers of those components were obtained to document that EMI compatibility and susceptibility meets acceptable industry levels. Those certifications are attached in Exhibit 10 Component/Accessory Validation.
The submitted device has undergone significant verification and validation testing. Alpha validation testing included testing of all functionality and confirmation that all identified hazards have been adequately addressed by software functionality, the user interface or documentation.
Alpha validation activities included specified system software and operating software performance and environmental testing within the specified environment.
Additionally, each specified ventilator system has been or will be fully validated by users in beta testing environments PRIOR to implementation to ensure that each specified or validated ventilator operating environment meets all appropriate specifications.
The submitter requires that any user of an un-validated specified or unspecified ventilator device perform a documented, successful, ventilator/VentLink validation prior to authorizing the user operate their system in a live environment. See Section IV, for a description of the User's Validation Protocol and Exhibit 12 Users' Manual, Implementation Manual and Users' Validation Protocol for a User's Validation Protocol provided to users of un-validated specified or unspecified ventilator devices.
The submitter's validation testing fully documents that specified ventilator device's data is transmitted from the ventilator through the VentLink system into
8
the submitter's MediLinks device2 with user control of data review and acceptance. No changes were made to transmitted ventilator data.
In these regards, the VentLink system is similar to and substantially equivalent to the capabilities of the predicate device, the Ventnet system.
The predicate device, Ventnet system, did not provide or reference any clinical tests submitted in compliance with 807.92(b)(2), therefore the submitter believes such clinical testing is not appropriate or required by FDA and has not made or provided any summary of such testing.
2 MediLinks is a Trade Mark of MediServe Information Systems, Tempe, AZ
9
CONCLUSIONS AND SUMMARY- as required by 807.92(b)(3) and (c) H.
The nonclinical testing, in the form of alpha and beta validation studies document that the VentLink system is
- . Safe, and
- As effective as the predicate device, the Ventnet system, and .
- Performs as well or better than the predicate device, the Ventnet system, . and, is therefore,
- Substantially equivalent to the identified predicate device, the Ventnet . system.
10
Image /page/10/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a bird in flight, composed of three curved lines.
DEC 2 3 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Mark Ofori-Kyei Official Correspondent Mediserve Information Systems, Incorporated 3225 Suoth Hardy Drive, Suite 101 Tempe, Arizona 85282
Re: K052751
Trade/Device Name: VentLinkTM System Regulation Number: 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: MOD Dated: September 30, 2005 Received: September 30, 2005
Dear Mr. Kyei:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becater mined the device is substantially equivalent (for the referenced above and have actoring/osure) to legally marketed predicate devices marketed in indications for use stated in the encreations of the enactment date of the Medical Device interstate commerce pror to fray 30, 20, 20, 2017 10:00 accordance with the provisions of Ameliuments, of to devices that nave o Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvin uppreation (the Act. The general controls provisions of the Act include controls provibions of the or 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 II your device is classified (500 additional controls. Existing major regulations affecting (I MA), it may oc subject to back adam f Federal Regulations, Title 21, Parts 800 to 898. In your device can be roundsh further announcements concerning your device in the Federal Register.
11
Page 2 - Mr. Kyei
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that IDA S Issualled of a substance ice complies with other requirements mean that FDA has made a decemination administered by other Federal agencies. of the Act of ally rederal statutes and regulations, but not limited to: registration You must colliply with an the Fee 3 requirement 801); good manufacturing practice and ifsing (21 CFR I art 607), laboling (21 CFR Part 820); and if (21 CFR Part 820); and if requirements as set forth in the quality bytellis (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) This letter will anow you to begin maileding your substantial equivalence of your device to a premarket notification. The PDA miams of sassification 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), If you desire specific advice for your device on our career on and the regulation in 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 may obtain other general missimations and Consumer Assistance at its toll-free Division (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Smith Y. Michael Davis
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
12
INDICATIONS FOR USE
interfaced hospital information system (HIS).
K052751 [510(k)] Number: VentLink™ system Device Name: The VentLink System is intended to be used in any Indications For Use: THC VentEining while interfaced to any specified or validated ventilator device. The VentLink system is intended to provide a secondary display of data received from an interfaced ventilator device to appropriately configured workstations and wireless laptop computers and to be made available to any
Prescription Use (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)
Cure Suleom