(50 days)
Not Found
No
The description focuses solely on data communication and integration capabilities, with no mention of AI or ML algorithms for data analysis or interpretation.
No
The device is a software development kit (SDK) used to communicate with and collect data from medical devices; it is not an end product and does not directly provide therapy.
No
The document states that the Device Connectivity SDK collects data from "electronic diagnostic devices" but is an "enabling data communication tool" itself, not a diagnostic device. It facilitates data transfer from diagnostic devices to other applications.
Yes
The device is explicitly described as "strictly a software product" and its function is to enable communication and data collection from medical devices, not to perform any physical action or directly interact with the patient.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to communicate with and collect data from electronic diagnostic devices (which are likely medical devices used on patients, not for testing samples in vitro) and integrate this data into software applications like CPR systems. This is focused on data management and communication, not on analyzing biological samples.
- Device Description: The description explicitly states it's a "strictly a software product" designed to work with operating systems and development environments to communicate with "select Welch Allyn medical devices" via standard communication protocols (USB, TCP/IP, RS232). It facilitates the transfer of "physiological data, device information, patient information," etc. This aligns with a data connectivity tool for medical devices, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any of the typical components or processes associated with in vitro diagnostics.
The purpose of this software is to enable other software applications (like CPRs) to access data from medical devices that are used on patients, not to perform diagnostic tests outside the body on biological samples.
N/A
Intended Use / Indications for Use
The Welch Allyn Device Connectivity Software Developer's Kit (SDK) is an Original Equipment Manufacturer (OEM) software product that will be integrated into software applications, such as Computerized Patient Record (CPR) systems. The Device Connectivity SDK is designed to as communicate with and collect data from electronic diagnostic devices to enable an application to request, retrieve and review device data.
The Device Connectivity SDK is an enabling data communication tool and is not intended to be an end, finished product.
Product codes
DXN
Device Description
The Welch Allyn Device Connectivity Software Developers Kit (SDK) is strictly a software product.
It is designed to work with the following operating systems (Microsoft Windows 2000, XP Professional and Server 2003) and software development environments (Microsoft Visual C++ 6.0, Visual Basic 6.0, Visual Basic .NET 2003, C# .NET 2003 and Borland Delphi 8.0).
It communicates with select Welch Allyn medical devices via USB, TCP/IP and RS232 (see figure 1).
Once integrated with a third-party Computerized Patient Record (CPR), the Device Connectivity SDK will provide the CPR the ability to request and receive physiological data, device information, patient information, healthcare provider information, configuration information and error information from select Welch Allyn medical devices.
The Device Connectivity SDK will also provide an Application Programming Interface (API), communication, device errors in a human readable form, electronic help and user support information (overall description, explanation of input and outputs, online support locations and phone number).
Welch Allyn will provide a Device Connectivity Software Developer's Kit (SDK) as an OEM product licensed to 3td party software developers, such as CPRS vendors that will enable the software developer to automate communication with and data collection from Welch Allyn's electronic medical diagnostic devices and save and store the data within the CPR's database. This Device Connectivity SDK will provide the software developers the ability to connect and capture the data through an Application Programming Interface (API).
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).
0
K052784
p1/5
NOV 2 2 2005
Welch Allyn
510(k) Summary [As described in 21 CFR 807.92]
Submitted by:
Welch Allyn Inc. 4341 State Street Road Skaneateles Falls, NY 13153-0220
Contact Person: Chris Klaczyk Regulatory Affairs Manager
Date Prepared: September 23, 2005
Device Connectivity Software Developers Kit (SDK) Trade Name:
Common Name: Software Instrument Interface
Classification Name: Non-Invasive Blood Pressure Measurement System (21 CFR 870.1130, Product Code DXN) . '
Predicate Device:
Welch Allyn Vitals Software Developers Kit (SDK) Welch Allyn Inc. 4341 State Street Road Skaneateles Falls, NY 13153-0220 510(k) Number: K023495
510(k) Summary
1
Welch Allyn
Description of the Device:
The Welch Allyn Device Connectivity Software Developers Kit (SDK) is strictly a software product.
It is designed to work with the following operating systems (Microsoft Windows 2000, XP Professional and Server 2003) and software development environments (Microsoft Visual C++ 6.0, Visual Basic 6.0, Visual Basic .NET 2003, C# .NET 2003 and Borland Delphi 8.0).
It communicates with select Welch Allyn medical devices via USB, TCP/IP and RS232 (see figure 1).
Once integrated with a third-party Computerized Patient Record (CPR), the Device Connectivity SDK will provide the CPR the ability to request and receive physiological data, device information, patient information, healthcare provider information, configuration information and error information from select Welch Allyn medical devices.
The Device Connectivity SDK will also provide an Application Programming Interface (API), communication, device errors in a human readable form, electronic help and user support information (overall description, explanation of input and outputs, online support locations and phone number).
Welch Allyn will provide a Device Connectivity Software Developer's Kit (SDK) as an OEM product licensed to 3td party software developers, such as CPRS vendors that will enable the software developer to automate communication with and data collection from Welch Allyn's electronic medical diagnostic devices and save and store the data within the CPR's database. This Device Connectivity SDK will provide the software developers the ability to connect and capture the data through an Application Programming Interface (API).
2
WelchAllyn
Image /page/2/Figure/2 description: The image shows a diagram of the Welch Allyn Electronic Devices and their connectivity. The diagram includes devices such as VSM 300, VSM 5200, Spot Ultra, and Spot, which are connected through various interfaces like USB, TCP/IP, and RS232. The diagram also illustrates the software interface, including the Device Connectivity SDK and CPR Software Implementation, which are part of the Development Workstation used by the Software Developer.
Figure 1 Device Connectivity SDK Use and Interactions Diagram
3
WelchAllyn
Intended Use:
The Welch Allyn Device Connectivity Software Developers Kit (SDK) is an Original Equipment Manufacture (OEM) software product that will be integrated into software applications, such as Computerized Patient Record (CPR) systems. The Device apprioutions, such as e signed to communicate with and collect data from electronic diagnostic devices to enable an application to request, retrieve and review device data.
The Device Connectivity SDK is an enabling data communication tool and is not intended to be an end, finished product.
Technological Characteristics:
The Welch Allyn Device Connectivity Software Developers Kit (SDK) is strictly a software product. It is designed to work with Microsoft Windows operating systems using a Microsoft-based development technology (COM) similar to the Welch Allyn Vitals Software Developer's Kit (SDK).
The following table summarizes the similarities between the Welch Allyn Vitals Software SDK and the new Welch Allyn Device Connectivity SDK.
| Designation | Welch Allyn Vitals Software SDK
510(k) No.: K023495 | Welch Allyn Device Connectivity
SDK |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Operating Principle | Software Instrument Interface | Software Instrument Interface |
| Operating Systems | Microsoft Windows 98, NT, 2000 and
XP | Microsoft Windows 2000, XP
Professional, Server 2003 |
| Intended Use | OEM software product that will be
licensed to CPR manufacturers who
will integrate it with and sell it as part
of their CPR system. The Vitals SDK
is designed to communicate with and
collect data from diagnostic
instruments using an instrument
specific interface that is compatible
with the instrument's existing
communication capability. Existing
instruments will not have to be
changed. The data that is collected
will be displayed for the user to verify
before it is sent to the CPR where it is
saved as part of the CPR's database. | OEM software product that will be
integrated into software applications,
such as CPR systems. The Device
Connectivity SDK is designed to
communicate with and collect data
from electronic diagnostic devices to
enable an application to request,
retrieve and review device data. The
Device Connectivity SDK is an
enabling data communication tool and
is not intended to be an end, finished
product.
The Device Connectivity SDK is
intended to be used by qualified
software developers. |
| Supported Devices | Welch Allyn Electronic Diagnostic
Devices | Welch Allyn Electronic Diagnostic
Devices |
| Patient Connection | No | No |
| Input/Output Port | RS-232 | USB, TCP/IP, RS-232 |
| Communication | Parse alphanumeric observational
data, error messages | Physiologic data, device information,
patient information, healthcare
provider information, configuration
information, error information |
The technological differences do not affect the safety or effectiveness of the SDK device.
510(k) Summary
4
K052784
P5/5
WelchAllyn
Summary of Effectiveness:
The Device Connectivity Software Developers Kit (SDK) is a software only product and not an end product; therefore, patient safety shall not be directly compromised (minor risk). The Device Connectivity SDK is non-contact and designed to communicate with and collect data from electronic diagnostic devices to enable an application to request, retrieve and review device data.
The Device Connectivity SDK reads data from Welch Allyn (WA) electronic diagnostic devices and does not set any ranges, tolerances, or accuracy of measurements; therefore, there are no limits and tolerances.
Therefore, typical safety areas are not applicable (e.g., electrical, and mechanical, biocompatibility, toxicity, corrosion, explosion, temperature, and fire hazard, EMC). However, risk management (risk, SFMEA and safety analysis) activities will be conducted in accordance with Risk Management (MPD SOP-9067) & Risk Management Policy (MPD SOP-20095, using ISO 14971) and will comply with IEC 60601-1-4 Medical Electrical Equipment Part 1: General Requirements for Safety, Part 4: Programmable Electrical Medical Systems.
5
Image /page/5/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure, composed of several curved lines that suggest feathers or wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the bird-like figure.
NOV 2 2 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Welch Allyn, Inc. c/o Mr. Chris Klaczyk Regulatory Affairs Manager 4341 State Street Road Skaneateles Falls, NY 13153-0220
Re: K052784
Trade Name: Device Connectivity Software Developers Kit (SDK) Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: September 30, 2005 Received: October 03, 2005
Dear Mr. Klaczyk:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
6
Page 2 - Mr. Chris Klaczyk
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 (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. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.
Sincerely yours,
Bhumma for
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):
Device Name: Device Connectivity Software Developers Kit (SDK)
Indications For Use:
.
The Welch Allyn Device Connectivity Software Developer's Kit (SDK) is an Original Equipment Manufacturer (OEM) software product that will be integrated into software applications, such as Computerized Patient Record (CPR) systems. The Device Connectivity SDK is designed to as communicate with and collect data from electronic diagnostic devices to enable an application to request, retrieve and review device data.
The Device Connectivity SDK is an enabling data communication tool and is not intended to be an end, finished product.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Blummen
Sign Off
510(k) Number
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