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 Description

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.

AI/ML Overview

The provided text is a 510(k) Summary for the Welch Allyn Connex™ (Vital Solutions Software), a device that serves as an interface between Welch Allyn medical diagnostic vital signs devices and user facility information systems.

Based on the provided document, there is no study or specific acceptance criteria reported for the Welch Allyn Connex™ (Vital Solutions Software) regarding its performance in medical diagnosis or patient monitoring accuracy.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Welch Allyn Instrument Interface Module) based on technological characteristics and intended use, rather than clinical performance metrics. It's important to note that this is a 510(k) submission, which often relies on demonstrating equivalence rather than extensive clinical efficacy studies, especially for devices like software interfaces that don't directly make medical diagnoses or provide treatment.

Here's a breakdown of why the requested information cannot be fully provided from the text:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated for performance metrics. The document instead emphasizes that the software "does not set any ranges, tolerances, or accuracy of measurements."
- Reported Device Performance: Not provided. The submission focuses on functional equivalence and risk management.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not mentioned in the document. No "test set" in the context of clinical performance is described.
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 applicable. There is no clinical test set described that would require expert ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No clinical test set described.
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 applicable. This device is an interface software, not an AI diagnostic tool that would assist human readers in a diagnostic task.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The device's function is to interface and manage data, not to perform standalone diagnostic calculations.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. There is no clinical data or diagnostic ground truth mentioned in relation to the device's performance.
The sample size for the training set: Not applicable. The document does not describe a machine learning algorithm that would require a training set.
How the ground truth for the training set was established: Not applicable. As there's no mention of a training set, the establishment of its ground truth is not discussed.

Summary of Effectiveness (as described in the document):

The document states that the software's "Level of Concern" is Moderate. It also indicates that typical safety concerns (electrical, mechanical, biocompatibility, etc.) are "not applicable." Risk management activities were conducted in accordance with ISO 14971 and would comply with IEC 60601-1-4. Crucially, the 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." This implies the software's effectiveness is tied to its ability to correctly collect, review, and communicate data from existing, approved vital signs devices, rather than establishing its own diagnostic accuracy.

Summary

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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.4341 State Street RoadSkaneateles Falls, NY 13153-0220
Contact Person:	Chris KlaczykRegulatory Affairs ManagerPhone: (315) 685-3694Fax: (315) 685-2532E-mail: klaczykc@welchallyn.com
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 MeasurementSystem (21 CFR 870.1130, Product Code MWI)
Predicate Device:	Welch Allyn Instrument Interface ModuleWelch Allyn Inc.4341 State Street RoadSkaneateles Falls, NY 13153-0220510(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 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:

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 InterfaceModule (IIM) Software510(k) No.: K001265	Welch Allyn Connex™(Vital Solutions Software)
Operating Principle	Software Instrument Interface	Software Instrument Interface
Operating Systems	Microsoft Windows programminglanguage and developmentenvironment such as Visual Basic orVisual C++	Microsoft Windows operating system.• Web browser - HTML pages thatalso use JavaScript andCascading Style Sheets
Intended Use	The IIM is designed to communicatewith and collect data from diagnosticinstruments. The data collected isthen displayed for the user to verifybefore being sent to a computerizedpatient records (CPR) database whereit is saved for later retrieval and reviewby a trained nurse or physician.	Connex™ (Vital Solutions Software) isintended for the collection and reviewof patient data, and also thecommunication of the data toinformation systems. It providesnotifications when data deviates fromranges, allows manual entry of data,provides a means to identify andmanage patients, and provides toolsfor enhancing productivity.Health care providers and trainedpersonnel are the intended users ofthe system.
Supported Devices	Welch Allyn Electronic DiagnosticDevices	Welch Allyn Electronic DiagnosticDevices
Patient Connection	No	No
Input/Output Port	RS-232	USB, TCP/IP, RS-232
Operating Principle	Converts subset of device informationparameters through device specificdrivers into HL7 or DICOM format andtransmits that data to anycomputerized patient record system.	Collects patient data from vitalsdevices and/or manually from user.Allows for user review of patient dataand communication of patient data,via HL7, to existing informationsystems.

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 (800) 638-2041 or (240) 276-3150 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)

Division Sign-Of

510(k) Number

Page 1 of 1

Regulation Number and Section

§ 870.2700 Oximeter.

(a)
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.(b)
Classification. Class II (performance standards).