(192 days)
Not Found
No
The summary describes a data collection, review, and communication system with basic notification features based on predefined ranges. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices. The functionality described is consistent with standard data management software.
No
The device is described as software for vital data collection, review, and communication, not for treating or preventing disease.
No
The device is described as an interface for collecting, reviewing, and communicating patient data, and providing notifications when data deviates from ranges. It explicitly states it "shall serve as an interface between Welch Allyn medical diagnostic vitals devices and user facility information systems," implying it processes data from diagnostic devices, rather than performing a diagnosis itself.
Yes
The device description explicitly states "Welch Allyn Connex™ (Vital Solutions Software)" and describes its function as an interface and data management tool, without mentioning any accompanying hardware components that are part of the device itself. It acts as an interface between existing medical devices and information systems.
Based on the provided information, the Welch Allyn Connex™ (Vital Solutions Software) is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is focused on the collection, review, and communication of patient data, providing notifications based on data deviation, and managing patients. It does not describe any testing of samples taken from the human body (like blood, urine, tissue, etc.) to provide information about a physiological state, health, or disease.
- Device Description: The description reinforces its function as an interface and data management system for vital signs devices. It doesn't mention any analytical or diagnostic procedures performed on biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples.
- Reagents or assays.
- Diagnostic interpretation of test results.
The device's function is primarily to manage and communicate data from other medical devices (Welch Allyn medical diagnostic vitals devices), which are likely the devices performing the actual diagnostic measurements (e.g., blood pressure, temperature, pulse oximetry).
Therefore, the Welch Allyn Connex™ (Vital Solutions Software) falls under the category of a medical device but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
MWI, DQA
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.
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
Health care providers and trained personnel are the intended users of the system.
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)
Welch Allyn Instrument Interface Module K001265
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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 Road
Skaneateles Falls, NY 13153-0220 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Chris Klaczyk
Regulatory Affairs Manager
Phone: (315) 685-3694
Fax: (315) 685-2532
E-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 Measurement
System (21 CFR 870.1130, Product Code MWI) |
| Predicate Device: | Welch Allyn Instrument Interface Module
Welch Allyn Inc.
4341 State Street Road
Skaneateles Falls, NY 13153-0220
510(k) Number: K001265 |
JUN 15 2006の - -------------------------------------------------------------------------------------------------------------------------------------------------------------------------
:
1
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.
2
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
Module (IIM) Software
510(k) No.: K001265 | Welch Allyn Connex™
(Vital Solutions Software) |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Operating Principle | Software Instrument Interface | Software Instrument Interface |
| Operating Systems | Microsoft Windows programming
language and development
environment such as Visual Basic or
Visual C++ | Microsoft Windows operating system.
• Web browser - HTML pages that
also use JavaScript and
Cascading Style Sheets |
| Intended Use | The IIM is designed to communicate
with and collect data from diagnostic
instruments. The data collected is
then displayed for the user to verify
before being sent to a computerized
patient records (CPR) database where
it is saved for later retrieval and review
by a trained nurse or physician. | 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. |
| 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 |
| Operating Principle | Converts subset of device information
parameters through device specific
drivers into HL7 or DICOM format and
transmits that data to any
computerized patient record system. | Collects patient data from vitals
devices and/or manually from user.
Allows for user review of patient data
and communication of patient data,
via HL7, to existing information
systems. |
The technological differences do not affect the safety or effectiveness of the Welch Allyn Connex™ (Vital Solutions Software) device.
3
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.
4
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.
5
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
6
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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