WELCH ALLYN CONNEX VITAL SOLUTIONS SOFTWARE

K053381 · Welch Allyn, Inc. · DQA · Jun 15, 2006 · Cardiovascular

Device Facts

• Record ID: K053381
• Device Name: WELCH ALLYN CONNEX VITAL SOLUTIONS SOFTWARE
• Applicant: Welch Allyn, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Jun 15, 2006
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Welch Allyn Connex™ (Vital Solutions Software) is intended for the collection and review of patient data, and also the communication of the data to information systems. It provides notifications when data deviates from ranges, allows manual entry of data, provides a means to identify and manage patients, and provides tools for enhancing productivity. Health care providers and trained personnel are the intended users of the system.

Device Story

Connex™ (Vital Solutions Software) acts as a software interface between Welch Allyn diagnostic vitals devices and facility information systems. It collects patient data from connected devices (via USB, TCP/IP, or RS-232) or manual entry; allows healthcare providers to review data; manages patient identification; and communicates data to hospital information systems via HL7. Used in clinical settings by healthcare providers and trained personnel. The software provides notifications when vitals deviate from set ranges to assist in clinical decision-making and productivity. It does not perform measurements itself, but facilitates data flow and management.

Clinical Evidence

No clinical data. Bench testing only. Risk management conducted per ISO 14971 and IEC 60601-1-4.

Technological Characteristics

Software-based instrument interface. Operates on PCs running Microsoft Windows. Connectivity via USB, TCP/IP, and RS-232. Web-based interface using HTML, JavaScript, and Cascading Style Sheets. Software Level of Concern: Moderate.

Indications for Use

Indicated for use by healthcare providers and trained personnel for the collection, review, and communication of patient vital signs data to information systems, including manual data entry and deviation notifications.

Regulatory Classification

Identification

An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.

Predicate Devices

• Welch Allyn Instrument Interface Module (K001265)

Submission Summary (Full Text)

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# WelchAllym

Abbreviated 510(k) Welch Allyn Connex™ (Vital Solutions Software)

## 510(k) Summary

[As described in 21 CFR 807.92]

| Submitted by: | Welch Allyn Inc.<br>4341 State Street Road<br>Skaneateles Falls, NY 13153-0220 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Chris Klaczyk<br>Regulatory Affairs Manager<br>Phone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
| Date Prepared: | December 01, 2005 |
| Trade Name: | Welch Allyn Connex™ (Vital Solutions Software) |
| Common Name: | Software Instrument Interface |
| Classification Reference: | Class II, Non-Invasive Blood Pressure Measurement<br>System (21 CFR 870.1130, Product Code MWI) |
| Predicate Device: | Welch Allyn Instrument Interface Module<br>Welch Allyn Inc.<br>4341 State Street Road<br>Skaneateles Falls, NY 13153-0220<br>510(k) Number: K001265 |

JUN 15 2006の - -------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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# Welch Allyn

Abbreviated 510(k) Welch Allyn Connex™ (Vital Solutions Software)

### Description of the Device:

The Welch Allyn Connex™ (Vital Solutions Software) provides for the collection and review of patient data, and also the communication of the data to information systems. It provides notifications when data deviates from ranges, allows manual entry of data, provides a means to identify and manage patients, and provides tools for enhancing productivity.

In general, Connex™ (Vital Solutions Software) shall serve as an interface between Welch Allyn medical diagnostic vitals devices and user facility information systems. It can be used either with a facility's existing information system or in the absence of an information system.

The following block diagram (figure 1) indicates the high-level interactions between the healthcare provider, patient, device, information system and Vital Solutions Software.

Image /page/1/Figure/7 description: The image shows a diagram of a healthcare system. The diagram includes a healthcare provider, a patient, a Welch Allyn Vital Signs Device, Vital Solutions Software, and a Hospital/Clinical Information System. The healthcare provider and patient are connected by a two-way arrow, indicating interaction between them. The Welch Allyn Vital Signs Device is connected to both the patient and the Vital Solutions Software, which is connected to the Hospital/Clinical Information System.

Image /page/1/Figure/8 description: The image is a title for a figure. The title reads "Figure 1 - Connex™ (Vital Solutions Software) Simplified Block Diagram". The title is centered on the page. The words "Figure 1" are underlined.

#### Intended Use:

Welch Allyn Connex™ (Vital Solutions Software) is intended for the collection and review of patient data, and also the communication of the data to information systems. It provides notifications when data deviates from ranges, allows manual entry of data, provides a means to identify and manage patients, and provides tools for enhancing productivity.

Health care providers and trained personnel are the intended users of the system.

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# WelchAllyn

Abbreviated 510(k) Welch Allyn Connex™ (Vital Solutions Software)

### Technological Characteristics:

The Welch Allyn Connex™ (Vital Solutions Software) is a software product. The user is the healthcare provider or administrator that gestures through a Web Browser and uses a barcode scanner and Welch Allyn medical device with the system. The Browser runs on the user's personal computer running version of Microsoft Windows operating system compatible with the Browser software and interface hardware being used.

The following table summarizes the similarities between the subject Welch Allyn Connex™ (Vital Solutions Software) and the predicate Welch Allyn Instrument Interface Module (IIM) software.

| Designation | Welch Allyn Instrument Interface<br>Module (IIM) Software<br>510(k) No.: K001265 | Welch Allyn Connex™<br>(Vital Solutions Software) |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Operating Principle | Software Instrument Interface | Software Instrument Interface |
| Operating Systems | Microsoft Windows programming<br>language and development<br>environment such as Visual Basic or<br>Visual C++ | Microsoft Windows operating system.<br>• Web browser - HTML pages that<br>also use JavaScript and<br>Cascading Style Sheets |
| Intended Use | The IIM is designed to communicate<br>with and collect data from diagnostic<br>instruments. The data collected is<br>then displayed for the user to verify<br>before being sent to a computerized<br>patient records (CPR) database where<br>it is saved for later retrieval and review<br>by a trained nurse or physician. | Connex™ (Vital Solutions Software) is<br>intended for the collection and review<br>of patient data, and also the<br>communication of the data to<br>information systems. It provides<br>notifications when data deviates from<br>ranges, allows manual entry of data,<br>provides a means to identify and<br>manage patients, and provides tools<br>for enhancing productivity.<br>Health care providers and trained<br>personnel are the intended users of<br>the system. |
| 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 |
| Operating Principle | Converts subset of device information<br>parameters through device specific<br>drivers into HL7 or DICOM format and<br>transmits that data to any<br>computerized patient record system. | Collects patient data from vitals<br>devices and/or manually from user.<br>Allows for user review of patient data<br>and communication of patient data,<br>via HL7, to existing information<br>systems. |

The technological differences do not affect the safety or effectiveness of the Welch Allyn Connex™ (Vital Solutions Software) device.

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## WelchAllyn

Abbreviated 510(k) Welch Allyn Connex™ (Vital Solutions Software)

### Summary of Effectiveness:

The Welch Allyn Connex™ (Vital Solutions Software) team has determined that the software "Level of Concern" is Moderate. (See section 10 for Connex™ software Level of Concern)

Typical concerns related to device safety are not applicable (c.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 ISO 14971 Medical Devices - Application of risk management to medical devices and will comply with IEC 60601-1-4 Medical Electrical Equipment Part 1: General Requirements for Safety, Part 4: Programmable Electrical Medical Systems.

The Welch Allyn Connex™ (Vital Solutions Software) reads data from Welch Allyn (WA) medical diagnostic vital signs devices and does not set any ranges, tolerances, or accuracy of measurements; therefore, there are no limits and tolerances.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 15 2006

Welch Allyn, Inc. c/o Mr. Christopher A. Klaczyk Regulatory Affairs Manager 4341 State Street Road P.O. Box 220 Skaneateles Falls, NY 13153-0220

Re: K053381

Trade/ Name: CONNEX™ Vital Solutions Software (VSS) Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II (two) Product Code: DQA Dated: June 1, 2006 Received: June 2, 2006

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 mav. 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 Tound 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. Christopher A. 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 (OS) 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 (see bottom for #s). 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/cdrh/industry/support/index.html.

Sincerely yours,

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

KOS 338 ( 510(k) Number (if known):

Device Name: Welch Allyn Connex™ (Vital Solutions Software)

Indications For Use:

Weich Allyn Connex™ (Vital Solutions Software) is intended for the collection and review of patient data, and also the communication of the data to information systems. It provides notifications when data deviates from ranges, allows manual entry of data, provides a means to identify and manage patients, and provides tools for enhancing productivity.

Health care providers and trained personnel are the intended users of the system.

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)

2

Division Sign-Of

510(k) Number

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