(448 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard central monitoring functionalities without mentioning any AI/ML-specific features or performance metrics.
No.
The device is described as a central monitoring system for patient data and alarms, used by clinicians to remotely monitor patient health, which is a diagnostic/monitoring function rather than a therapeutic one.
No
The device is described as a "Central Station" for "central monitoring of patient data and alarms," and it provides "a means to remotely monitor the health of several patients simultaneously." It does not mention interpretation of data or providing a diagnosis.
Yes
The device description explicitly states that both the predicate and subject devices are "software devices for a Windows-based operating system." While it monitors patient data, it does so through software and does not appear to include any hardware components of its own.
Based on the provided information, the Connex Central Station is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the central monitoring of patient data and alarms from neonatal, pediatric, and adult patients in healthcare facilities. This involves monitoring physiological parameters, not analyzing samples taken from the body (in vitro).
- Device Description: It's described as software for a Windows-based operating system that provides remote monitoring of patient health. This aligns with a patient monitoring system, not an IVD.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.), reagents, or laboratory procedures, which are hallmarks of IVD devices.
- Performance Studies: The performance studies focus on software verification and validation, and evaluation against standards related to medical electrical equipment and software, not the analytical or clinical performance typically evaluated for IVDs.
In summary, the Connex Central Station is a patient monitoring system designed to display and manage real-time physiological data from patients, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Connex Central Station is intended to be used by clinicians for the central monitoring of neonatal, pediatric and adult patients in health care facilities. In addition to the central monitoring of patient data and alarms, the Connex software can include optional modules to provide extended recording of patient data, including full disclosure.
Product codes
MWI, MHX
Device Description
Both the Welch Allyn primary predicate and subject Connex Central Station devices are software devices for a Windows-based operating system that provide clinicians with a means to remotely monitor the health of several patients simultaneously.
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
neonatal, pediatric and adult
Intended User / Care Setting
clinicians / health care facilities
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
The Connex Central Station was tested to evaluate its performance based on the following standards: IEC 62366-1:2015 Medical Devices - Part 1: Application of usability engineering to medical devices, IEC 60601-1- 8:2012 Medical electrical equipments for basic safety and essential performance – Collateral Standard: General requirements, tests and systems in medical electrical equipment and medical electrical systems, IEC 62304:2015 Medical Device Software - Software Life Cycle Processes, IEC 60601-2-27:2011 Medical electrical equipments for the Safety, Including Essential Performance of Electrocardiographic Monitoring Equipment, ISO 14971:2019 Application of Risk Management to Medical Devices, AAMI 80001-1:2010 Application of risk management for IT networks incorporating medical devices, ISO 15223-1:2016 Symbols to be used with medical device labelling and information to be supplied – Part 1: General requirements.
Software Verification and Validation testing were conducted, and documentation provided within this submission as recommended by FDA's Guidance for Industry and FDA Staff "Guidance for the Content of Premarket Submissions for Software in Medical Devices". Connex Central Station software was considered as a "Major" level of concern since a failure of latent flaw in the software could directly result in serious injury or death to the patient or operator. This level of concern was not changed by the ECG data feature in version 1.8.5 of the software.
Not Applicable. No clinical studies were utilized for the purpose of obtaining safety and effectiveness data.
Well-established, scientific methods are were used to evaluate the new ECG parameter features of the subject device. The methods used to add ECG parameters to the central monitoring display of the same methods used to display the already cleared parameters on the primary predicate Connex Central Station device.
The methods used to collect ECG parameters on the Welch Allyn CVSM device have been cleared under K171621. Thus, to support the addition of the ECG parameters and associated FDA product code MHX to the Connex Vital Signs Monitor (K17621), is being used as a secondary predicate device in this submission.
The performance of the subject Connex Central Station device was evaluated to the same methods utilized for the primary predicate and/or the secondary predicate. The evaluation methods include IEC 62366-1:2015, IEC 62304:2015, ISO 14971:2019, AAMI 8001-1:2010 Section 3.5, ISO 15223-1:2016 and IEC 60601-2-27:2011 Section 201.12.1.101.6 and FDA Special Controls Guidance Arrhythmia Detector and Alarm - Class II Special Controls Guidance Document for Industry and FDA Staff (October 28, 2003). The software met the design requirements and performance, functionality characteristics. The differences in the technological characteristics with the addition of the EG parameter into the Connex Central Station do not impact the safety and effectiveness of the subject device. Therefore, it can be concluded the evidence presented in this submission confirms that the Connex Central Station v1.8.5 is substantially equivalent to the primary predicate Connex Central Station v1.5 cleared in K132807.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
October 28, 2022
Welch Allyn, Inc. Megan Pellenz Regulatory Affairs Manager 4341 State Street Road Skaneateles Falls, New York 13153
Re: K212473
Trade/Device Name: Welch Allyn Connex Central Station (v.1.8.5) Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MWI, MHX Dated: August 5, 2021 Received: August 6, 2021
Dear Megan Pellenz:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
Device Name
Welch Allyn® Connex® Central Station ( v.1.8.5)
Indications for Use (Describe)
The Connex Central Station is intended to be used by clinicians for the central monitoring of neonatal, pediatric and adult patients in health care facilities. In addition to the central monitoring of patient data and alarms, the Connex software can include optional modules to provide extended recording of patient data, including full disclosure.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary- K212473
Contact Details
21 CFR 807.92(a)(1)
| Applicant Name | Welch Allyn, Inc. |
|---|---|
| Applicant Address | 4341 State Street Road Skaneateles Falls NY 13153 United States |
| Applicant Contact Telephone | 315-569-4257 |
| Applicant Contact | Mrs. Megan Pellenz |
| Applicant Contact Email | megan.pellenz@hillrom.com |
Device Name 21 CFR 807.92(a)(2)
| Device Trade Name | Welch Allyn® Connex® Central Station ( v. 1.8 .5) |
|---|---|
| Common Name | Patient Monitoring Central Station |
| Classification Name | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) |
| Regulation Number | 870.2300 |
| Product Code | MWI |
Legally Marketed Predicate Devices 21 CFR 807.92(a)(3)
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K132807 | Welch Allyn® Connex® Central Station (v. 1.5) | MWI |
| K171621 | Welch Allyn® Connex® Vital Signs Monitor/CIWS | MHX |
Device Description Summary 21 CFR 807.92(a)(4)
Both the Welch Allyn primary predicate and subject Connex Central Station devices are software devices for a Windows-based operating system that provide clinicians with a means to remotely monitor the health of several patients simultaneously.
Intended Use/Indications for Use 21 CFR 807.92(a)(5)
The Connex Central Station is intended to be used by clinicians for the central monitoring of neonatal, pediatric and adult patients in health care facilities. In addition to the central monitoring of patient data and alarms, the Connex software can include optional modules to provide extended recording of patient data, including full disclosure.
Indications for Use Comparison 21 CFR 807.92(a)(5)
The subject device Connex Central Station and the primary predicate Connex Central Station (K132807) have the same Indications for Use: The Connex Central Station is intended to be used by clinicians for the central monitoring of neonatal, pediatric, and adult patients in health care facilities. In addition to the central monitoring of patient data and alarms, the Connex software can include optional modules to provide extended recording of patient data, including full disclosure.
Technological Comparison 21 CFR 807.92(a)(6)
4
The subject device Connex Central Station and the primary predicate device Connex Central Station (K132807) have the same fundamental technology characteristics. A feat the subject Connex Central Station device displays EG physiological parameters received from the Connex Vital Signs Monitor (K171621) while the primary predicate device does not. The addition of the new feature (i.e., ECG parameters) on the subject device does not alter the subject device compared to the primary predicate nor does it raise new questions of safety and effectiveness. Specifically, the methods used to add ECG parameters to the central monitoring display of the subject device are the same methods used to display the already cleared paramaty predicate Connex Central Station device. Additionally, the methods used to collect ECG parameters on the CVSM have been cleared under K171621. Thus, to support the addition of the ECG parameters and associated FDA product code MHX to the subject device, the Connex Vital Signs Monitor (K171621), is being used as a secondary predicate device in this submission.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The Connex Central Station was tested to evaluate its performance based on the following standards: IEC 62366-1:2015 Medical Devices - Part 1: Application of usability engineering to medical devices
IEC 60601-1- 8:2012 Medical electrical equipments for basic safety and essential performance – Collateral Standard: General requirements, tests and systems in medical electrical equipment and medical electrical systems
IEC 62304:2015 Medical Device Software - Software Life Cycle Processes
IEC 60601-2-27:2011 Medical electrical equipments for the Safety, Including Essential Performance of Electrocardiographic Monitoring Equipment
ISO 14971:2019 Application of Risk Management to Medical Devices
AAMI 80001-1:2010 Application of risk management for IT networks incorporating medical devices
ISO 15223-1:2016 Symbols to be used with medical device labelling and information to be supplied – Part 1: General requirements.
Software Verification and Validation testing were conducted, and documentation provided within this submission as recommended by FDA's Guidance for Industry and FDA Staff "Guidance for the Content of Premarket Submissions for Software in Medical Devices". Connex Central Station software was considered as a "Major" level of concern since a failure of latent flaw in the software could directly result in serious injury or death to the patient or operator. This level of concern was not changed by the ECG data feature in version 1.8.5 of the software.
Not Applicable. No clinical studies were utilized for the purpose of obtaining safety and effectiveness data.
Well-established, scientific methods are were used to evaluate the new ECG parameter features of the subject device. The methods used to add ECG parameters to the central monitoring display of the same methods used to display the already cleared parameters on the primary predicate Connex Central Station device.
The methods used to collect ECG parameters on the Welch Allyn CVSM device have been cleared under K171621. Thus, to support the addition of the ECG parameters and associated FDA product code MHX to the Connex Vital Signs Monitor (K17621), is being used as a secondary predicate device in this submission.
The performance of the subject Connex Central Station device was evaluated to the same methods utilized for the primary predicate and/or the secondary predicate. The evaluation methods include IEC 62366-1:2015, IEC 62304:2015, ISO 14971:2019, AAMI 8001-1:2010 Section 3.5, ISO 15223-1:2016 and IEC 60601-2-27:2011 Section 201.12.1.101.6 and FDA Special Controls Guidance Arrhythmia Detector and Alarm - Class II Special Controls Guidance Document for Industry and FDA Staff (October 28, 2003). The software met the design requirements and performance, functionality characteristics. The differences in the technological characteristics with the addition of the EG parameter into the Connex Central Station do not impact the safety and effectiveness of the subject device. Therefore, it can be concluded the evidence presented in this submission confirms that the Connex Central Station v1.8.5 is substantially equivalent to the primary predicate Connex Central Station v1.5 cleared in K132807.