(50 days)
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.
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).
The provided documentation for the Welch Allyn Device Connectivity Software Developers Kit (SDK) does not contain information about specific acceptance criteria or a study demonstrating device performance against such criteria.
The document primarily focuses on describing the device, its intended use, technological characteristics, and its substantial equivalence to a predicate device for 510(k) clearance. As a "software only product and not an end product," the FDA deemed typical safety and effectiveness studies, as would be expected for a diagnostic device, unnecessary.
Here's a breakdown of what is and is not present, in relation to your requested information:
1. A table of acceptance criteria and the reported device performance
- Not found. This information is absent from the provided document. The device is described as an "enabling data communication tool" that "reads data from Welch Allyn (WA) electronic diagnostic devices and does not set any ranges, tolerances, or accuracy of measurements." Therefore, quantitative performance metrics and acceptance criteria for patient-related outcomes are not discussed.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not found. Since no performance study against specific criteria is reported, there is no mention of a test set, its sample size, or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not found. Ground truth establishment, typically relevant for diagnostic accuracy studies, is not applicable or discussed for this software SDK.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not found. Adjudication methods are relevant for studies involving human interpretation or subjective assessments, which are not described for this software.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not found. An MRMC study is not mentioned. The Device Connectivity SDK is a data communication tool, not an AI-assisted diagnostic tool that would directly improve human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not found. While the SDK is a "software only product," the performance evaluation described isn't in terms of a standalone diagnostic algorithm. Its function is to facilitate data transfer. The document states its effectiveness summary is that "patient safety shall not be directly compromised (minor risk)" because it's not an end product.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not found. As no diagnostic performance study is described, the concept of ground truth in that context is not relevant to the information provided.
8. The sample size for the training set
- Not found. This is not an AI/ML device that undergoes model training, so there is no mention of a training set or its size.
9. How the ground truth for the training set was established
- Not found. Not applicable, as there is no training set for this type of software product.
Summary of Effectiveness from the Document:
The provided document (K052784, page 5/5) explicitly states the following regarding its 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."
This indicates that the assessment of this device's "effectiveness" by the manufacturer and the FDA was focused on its role as a data communication tool with minimal direct patient risk, rather than on specific diagnostic performance metrics. Its substantial equivalence to the predicate device (Welch Allyn Vitals Software Developers Kit, K023495) was based on similar operating principles, intended use, and supported devices, with the new SDK offering expanded operating system compatibility and communication protocols. Risk management measures were deemed sufficient for this product type.
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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
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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).
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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
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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 SDK510(k) No.: K023495 | Welch Allyn Device ConnectivitySDK |
|---|---|---|
| Operating Principle | Software Instrument Interface | Software Instrument Interface |
| Operating Systems | Microsoft Windows 98, NT, 2000 andXP | Microsoft Windows 2000, XPProfessional, Server 2003 |
| Intended Use | OEM software product that will belicensed to CPR manufacturers whowill integrate it with and sell it as partof their CPR system. The Vitals SDKis designed to communicate with andcollect data from diagnosticinstruments using an instrumentspecific interface that is compatiblewith the instrument's existingcommunication capability. Existinginstruments will not have to bechanged. The data that is collectedwill be displayed for the user to verifybefore it is sent to the CPR where it issaved as part of the CPR's database. | OEM software product that will beintegrated into software applications,such as CPR systems. The DeviceConnectivity SDK is designed tocommunicate with and collect datafrom electronic diagnostic devices toenable an application to request,retrieve and review device data. TheDevice Connectivity SDK is anenabling data communication tool andis not intended to be an end, finishedproduct.The Device Connectivity SDK isintended to be used by qualifiedsoftware developers. |
| Supported Devices | Welch Allyn Electronic DiagnosticDevices | Welch Allyn Electronic DiagnosticDevices |
| Patient Connection | No | No |
| Input/Output Port | RS-232 | USB, TCP/IP, RS-232 |
| Communication | Parse alphanumeric observationaldata, error messages | Physiologic data, device information,patient information, healthcareprovider information, configurationinformation, error information |
The technological differences do not affect the safety or effectiveness of the SDK device.
510(k) Summary
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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.
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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.
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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
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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
Page 1 of __ 1________________________________________________________________________________________________________________________________________________________________
§ 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).