(448 days)
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.
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.
This document is a 510(k) summary for the Welch Allyn Connex Central Station (v.1.8.5). It primarily focuses on demonstrating substantial equivalence to a predicate device, not on presenting a detailed study proving performance against specific acceptance criteria for a new AI/ML device.
Therefore, many of the requested details regarding acceptance criteria, study design, expert qualifications, and ground truth establishment for an AI/ML model are not present in this document. The document states "No clinical studies were utilized for the purpose of obtaining safety and effectiveness data." and refers to software verification and validation, and adherence to various medical device standards.
However, based on the provided text, I can infer and extract some relevant information as best as possible, particularly regarding the non-clinical testing performed and the nature of the device.
Here's an attempt to answer your questions based on the provided text, noting where information is explicitly not available for an AI/ML context:
Acceptance Criteria and Device Performance (Inferred)
Since this is a submission for substantial equivalence based on a predicate device and not a new AI/ML algorithm requiring performance metrics like sensitivity/specificity against a ground truth, the "acceptance criteria" here are primarily met through software verification and validation testing and adherence to recognized medical device standards. The performance is not reported as specific clinical metrics but rather as meeting the functional and safety requirements for a central patient monitoring station.
The key change is the addition of ECG parameter display from another cleared device (Welch Allyn CVSM, K171621), and the acceptance is that this integration does not introduce new safety or effectiveness concerns.
| Acceptance Criteria Category (Inferred from standards) | Reported Device Performance (Summary from document) |
|---|---|
| Software Functionality & Performance: | Met design requirements and performance, functionality characteristics. The methods for displaying ECG parameters are the same as previously cleared parameters. |
| Usability Engineering (IEC 62366-1): | Tested (implies acceptance criteria met). |
| Basic Safety & Essential Performance (IEC 60601-1-8): | Tested (implies acceptance criteria met). |
| Software Life Cycle Processes (IEC 60304): | Tested (implies acceptance criteria met); classified as "Major" level of concern. |
| Electrocardiographic Monitoring Equipment Safety (IEC 60601-2-27): | Tested (implies acceptance criteria met). |
| Risk Management (ISO 14971, AAMI 80001-1): | Tested (implies acceptance criteria met). |
| Labeling and Information (ISO 15223-1): | Tested (implies acceptance criteria met). |
| Substantial Equivalence: | Concluded that the device is substantially equivalent to the primary predicate, with the added ECG feature not altering safety/effectiveness. |
2. Sample size used for the test set and the data provenance:
- Test Set: Not applicable in the context of an AI/ML test set with patient data. The "testing" here refers to software verification and validation activities and compliance with standards. There's no mention of a "test set" of patient data for performance evaluation in the way an AI/ML algorithm would use it.
- Data Provenance: Not applicable. The document refers to "well-established, scientific methods" for evaluating new ECG parameter features, but this is about the display of parameters already collected by another cleared device (CVSM, K171621), not new data analysis or inference from a patient data set by the Connex Central Station itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This submission does not involve establishing ground truth for an AI/ML algorithm's clinical performance. The ground truth for the ECG parameters themselves would have been established during the clearance of the Welch Allyn CVSM (K171621), but that's not detailed here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is not an AI/ML study involving human readers and adjudicated ground truth.
5. 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:
- No. The document explicitly states: "No clinical studies were utilized for the purpose of obtaining safety and effectiveness data."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device integrates and displays data from other cleared devices; it's a central monitoring station, not an AI/ML algorithm that operates "standalone" to produce a diagnostic or prognostic output from raw data. Its "performance" is based on its ability to accurately receive, process, and display parameters from connected devices and manage alarms, complying with relevant standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the context of an AI/ML performance study for this submission. The "ground truth" for the displayed ECG parameters originates from the cleared Welch Allyn CVSM device (K171621), which would have undergone its own validation. For the central station itself, the "ground truth" lies in its adherence to functional specifications, risk management, and the standards listed (e.g., IEC 62304 for software, IEC 60601-2-27 for ECG monitoring equipment safety aspects relevant to its display).
8. The sample size for the training set:
- Not applicable. This device is not an AI/ML algorithm that undergoes a training phase with a dataset.
9. How the ground truth for the training set was established:
- Not applicable. (See point 8).
Summary of what the document DOES tell us about the "study":
The "study" or evaluation performed was primarily:
- Software Verification and Validation (V&V): This involved testing the software against its design requirements and functional specifications. The "level of concern" for the software was "Major" (meaning a failure could result in serious injury or death).
- Compliance with Recognized Standards: The device was tested to evaluate its performance based on various international standards for medical devices, specifically:
- IEC 62366-1:2015 (Usability Engineering)
- IEC 60601-1-8:2012 (Basic Safety and Essential Performance)
- IEC 62304:2015 (Medical Device Software - Software Life Cycle Processes)
- IEC 60601-2-27:2011 (Electrocardiographic Monitoring Equipment Safety)
- ISO 14971:2019 (Risk Management)
- AAMI 80001-1:2010 (Risk Management for IT networks with medical devices)
- ISO 15223-1:2016 (Symbols for labeling)
- FDA Special Controls Guidance for Arrhythmia Detector and Alarm (October 28, 2003).
The key finding from this "study" or evaluation was that even with the new feature (displaying ECG parameters), the device continues to meet these standards and its design requirements, and therefore remains substantially equivalent to its predicate, raising no new questions of safety or effectiveness.
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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
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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
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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)
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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)
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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.
§ 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).