DEVICE CONNECTIVITY SOFTWARE DEVELOPERS KIT (SDK), MODEL 4500-900

K052784 · Welch Allyn, Inc. · DXN · Nov 22, 2005 · Cardiovascular

Device Facts

• Record ID: K052784
• Device Name: DEVICE CONNECTIVITY SOFTWARE DEVELOPERS KIT (SDK), MODEL 4500-900
• Applicant: Welch Allyn, Inc.
• Product Code: DXN · Cardiovascular
• Decision Date: Nov 22, 2005
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.1130
• Device Class: Class 2
• Attributes: Software as a Medical Device

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 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.

Device Story

Software-only OEM product; integrates into third-party Computerized Patient Record (CPR) systems. Communicates with Welch Allyn electronic diagnostic devices via USB, TCP/IP, or RS232. Provides API for CPR software to request/receive physiological data, device/patient/provider info, configuration, and error logs. Used by software developers to automate data collection from diagnostic devices into CPR databases. Does not perform measurements or set clinical ranges; acts as communication bridge. Facilitates electronic health record integration; improves data management efficiency for healthcare providers.

Clinical Evidence

Bench testing only. No clinical data provided. Device is a software-only communication tool that does not perform measurements or clinical analysis.

Technological Characteristics

Software-only product. Operates on Microsoft Windows (2000, XP, Server 2003). Uses Microsoft COM development technology. Interfaces: USB, TCP/IP, RS232. Complies with IEC 60601-1-4 for programmable electrical medical systems.

Indications for Use

Indicated for integration into Computerized Patient Record (CPR) systems to enable the request, retrieval, and review of physiological and diagnostic data from Welch Allyn electronic diagnostic devices. Not intended as a finished end-user product.

Regulatory Classification

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.

Predicate Devices

• Welch Allyn Vitals Software Developers Kit (SDK) (K023495)

Submission Summary (Full Text)

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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 SDK<br>510(k) No.: K023495 | Welch Allyn Device Connectivity<br>SDK |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Operating Principle | Software Instrument Interface | Software Instrument Interface |
| Operating Systems | Microsoft Windows 98, NT, 2000 and<br>XP | Microsoft Windows 2000, XP<br>Professional, Server 2003 |
| Intended Use | OEM software product that will be<br>licensed to CPR manufacturers who<br>will integrate it with and sell it as part<br>of their CPR system. The Vitals SDK<br>is designed to communicate with and<br>collect data from diagnostic<br>instruments using an instrument<br>specific interface that is compatible<br>with the instrument's existing<br>communication capability. Existing<br>instruments will not have to be<br>changed. The data that is collected<br>will be displayed for the user to verify<br>before it is sent to the CPR where it is<br>saved as part of the CPR's database. | OEM software product that will be<br>integrated into software applications,<br>such as CPR systems. The Device<br>Connectivity SDK is designed to<br>communicate with and collect data<br>from electronic diagnostic devices to<br>enable an application to request,<br>retrieve and review device data. The<br>Device Connectivity SDK is an<br>enabling data communication tool and<br>is not intended to be an end, finished<br>product.<br>The Device Connectivity SDK is<br>intended to be used by qualified<br>software developers. |
| Supported Devices | Welch Allyn Electronic Diagnostic<br>Devices | Welch Allyn Electronic Diagnostic<br>Devices |
| Patient Connection | No | No |
| Input/Output Port | RS-232 | USB, TCP/IP, RS-232 |
| Communication | Parse alphanumeric observational<br>data, error messages | Physiologic data, device information,<br>patient information, healthcare<br>provider information, configuration<br>information, 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 [phone]. 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 [phone] or [phone] 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

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