(68 days)
Not Found
No
The document explicitly states that AI/ML terms were "Not Found" and the description focuses on standard vital signs monitoring and a general-purpose software framework without mentioning AI/ML capabilities.
No
The device is described as a monitor intended for monitoring vital signs (noninvasive blood pressure, pulse rate, SpO2, body temperature, and total hemoglobin concentration). Its function is to provide information, not to administer therapy or treat a condition.
Yes
The device is intended for monitoring vital signs and other physiological parameters (e.g., noninvasive blood pressure, pulse rate, SpO2, body temperature, total hemoglobin concentration), which are measurements used to assess a patient's health status and aid in diagnosis.
No
The device description clearly states it is a modified version of a previously cleared vital signs monitor (K110516), which is a hardware device. While it includes a software framework, the core device is a physical monitor with vital signs measuring capabilities.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device monitors vital signs like noninvasive blood pressure, pulse rate, SpO2, and body temperature. It also mentions optional monitoring of total hemoglobin concentration (which is a blood parameter, but the monitoring is described as "continuous noninvasive monitoring").
- Lack of Sample Analysis: There is no mention of the device analyzing samples taken from the patient. All the measurements described are taken on the patient's body.
- Framework Function: The Framework is described as general-purpose software for running applications, not for analyzing biological samples.
While the optional Masimo Rainbow SET® monitors total hemoglobin, the description emphasizes "continuous noninvasive monitoring," which is different from analyzing a blood sample in a lab setting, which is characteristic of an IVD.
Therefore, the primary function and description of the device align with a vital signs monitor, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The VSM 6000 Series of monitors is intended to be used by clinicians and medically qualified personnel for monitoring of neonatal, pediatric, and adult patients for:
- noninvasive blood pressure,
- pulse rate. -
- noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), and
- । body temperature in normal and axillary modes.
The most likely locations for patients to be monitored are general medical and surgical floors, general hospital, and alternate care environments.
The Welch Allyn Connex® Vital Signs Monitor (CVSM) 6000 Series also contains the Welch Allyn Applications Framework, general purpose software that allows medical device and non-medical device software applications to be run on the CVSM independently of, and isolated from, the CVSM's vital signs monitoring functionality. All such applications are intended to be used on the CVSM by trained professionals in a health care setting.
This product is available for sale only upon the order of a physician or licensed health care professional.
Product codes (comma separated list FDA assigned to the subject device)
MWI
Device Description
The proposed modified Connex Vital Signs Monitor 6000 Series (CVSM) is the same device that was cleared under K110516; in particular, the indications for use for vital signs measuring/monitoring subsystem of the proposed device are the same as those cleared under K110516. In the modified device, the Welch Allyn Application Framework (Framework) - has been included as a separate subsystem. The Framework is general purpose software that allows medical device and non-medical device software applications to run on the Framework independently of, and isolated from, the CVSM's vital signs monitoring functionality.
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 patients
Intended User / Care Setting
clinicians and medically qualified personnel for monitoring of neonatal, pediatric, and adult patients.
The most likely locations for patients to be monitored are general medical and surgical floors, general hospital, and alternate care environments.
All such applications are intended to be used on the CVSM by trained professionals in a health care setting.
This product is available for sale only upon the order of a physician or licensed health care professional.
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)
Verification and validation were conducted to ensure expected performance of the CVSM 6000 and to demonstrate the addition of the Framework does not affect the functionality or performance of the CVSM and that applications run on the Framework are isolated from and independent of CVSM vital signs monitoring functionality and do not control or otherwise affect the performance of the CVSM.
No clinical studies were utilized for the purpose of obtaining safety or effectiveness data.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Welch Allyn
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: | Kevin Crossen, Director Regulatory Affairs
Phone: (315) 685-2609
Fax: (315) 685-2532
E-mail: Kevin.Crossen@welchallyn.com |
| Date Prepared: | September 2, 2011 |
| Trade Name: | Welch Allyn Connex® Vital Signs Monitor 6000 Series |
| Common Name: | Monitor,physiological,patient(without arrhythmia
detection or alarms) |
| Device Classification: | Class II |
| Classification Reference: | 870.2300, Cardiac Monitor (including Cardiotachometer
and Rate Alarm) |
| Classification Product Code: | MWI |
| Predicate Devices: | Welch Allyn Vital Signs Monitor - CVSM 6000 Series
Vital Signs Monitor, CVSM 6000 Series, CVSM
Welch Allyn, Inc.
510(k) Number K110516 |
Description of Device:
The proposed modified Connex Vital Signs Monitor 6000 Series (CVSM) is the same device that was cleared under K110516; in particular, the indications for use for vital signs measuring/monitoring subsystem of the proposed device are the same as those cleared under K110516. In the modified device, the Welch Allyn Application Framework (Framework) - has been included as a separate subsystem. The Framework is general purpose software that allows medical device and non-medical device software applications to run on the Framework independently of, and isolated from, the CVSM's vital signs monitoring functionality.
1
WelchAllyn
Indications for Use:
The VSM 6000 Series of monitors is intended to be used by clinicians and medically qualified personnel for monitoring of neonatal, pediatric, and adult patients for:
- noninvasive blood pressure,
- pulse rate. -
- noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), and
- । body temperature in normal and axillary modes.
The most likely locations for patients to be monitored are general medical and surgical floors, general hospital, and alternate care environments.
The Welch Allyn Connex® Vital Signs Monitor (CVSM) 6000 Series also contains the Welch Allyn Applications Framework, general purpose software that allows medical device and non-medical device software applications to be run on the CVSM independently of, and isolated from, the CVSM's vital signs monitoring functionality. All such applications are intended to be used on the CVSM by trained professionals in a health care setting.
This product is available for sale only upon the order of a physician or licensed health care professional.
Technological Characteristics:
The subject device has the same technological characteristics and indications for use as the predicate CVSM 6000 device. This version of the CVSM also includes the Welch Allyn Applications Framework) for running software applications developed by Welch Allyn or third-party providers. The Framework is general purpose software that allows medical device and non-medical device software applications to run on the Framework independently of, and isolated from, the CVSM's vital signs monitoring functionality. Welch Allyn or third-party software applications will incorporate program interfaces, data structures, and communications protocols prescribed by Welch Allyn in its Application Developer Toolkit (ADK). These ADK specifications conform to the architectural control points used in the Framework. Available software applications may. at the end user's option, be included as part of the purchase of the CVSM, pre-loaded on the Application Framework, or uploaded after purchase of the CVSM by utilization of an embedded service tool for installation.
Non-Clinical Tests:
Verification and validation were conducted to ensure expected performance of the CVSM 6000 and to demonstrate the addition of the Framework does not affect the functionality or performance of the CVSM and that applications run on the
2
Welch Allyn
Framework are isolated from and independent of CVSM vital signs monitoring functionality and do not control or otherwise affect the performance of the CVSM.
The following standards were applied to the modified device.
- . IEC 60601-1:Ed. 2: 1988 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (with A 1: 1991+A2:1995)
- . IEC 60601-1-2: Ed. 3: 2007 - Medical Electrical Equipment -- Part 1-2: General requirements for safety - collateral standard: Electromagnetic compatibility -Requirements and Test
- . IEC 60601-1-4: Consolidated Ed. 1.1: 2000 - General Requirement for Safety: Collateral Standard: Programmable Electrical Medical Systems
- IEC 60601-1-8: Ed. 1: 2003 General requirements for safety Collateral Standard: . Alarm Systems - Requirements, tests and guidances - General requirements and guidelines for alarm systems in medical equipment (with A 1:2006)
- IEC 60601-2-30: Ed. 2: 1999 Manual, electronic or automated sphygmomanometers ● (with A1:2003, A2:2006)
- . ISO 9919: Ed. 2: 2005 - Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use
- . ISO 14971: Ed. 2: 2007 - Medical devices - Application of risk management to medical devices
Clinical Performance Data:
No clinical studies were utilized for the purpose of obtaining safety or effectiveness data.
Conclusion:
Based on the information presented in this 510(k) premarket notification, Welch Allyn's Connex® Vital Signs Monitor 6000 Series as modified is considered substantially equivalent (as safe, as effective and performs as well as) the currently marketed predicate device.
2011-09-07
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular arrangement of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a symbol that resembles a stylized caduceus or a representation of human figures. The symbol is composed of three curved lines that converge at the bottom.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
NOV 22222011
Welch Allyn, Inc. c/o Mr. Kevin Crossen Director Regulatory Affairs 4341 State Street Road P.O. Box 220 Skaneateles Falls, NY 13153-0220
Re: K112687
Trade/Device Name: Connex® Vital Signs Monitor 6000 Series Regulatory Number: 21 CFR 870.2300 Regulation Name: Physiological Patient Monitor (without arrhythmia detection or alarms) Regulatory Class: II (two) Product Code: 74 MWI Dated: October 24, 2011 Received: October 25, 2011
Dear Mr. Crossen:
We have reviewed your Section 510(k) premarket notification of intent to market the device for use at the 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 (Act 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. 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 he subject to 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.
4
Page 2 - Mr. Kevin Crossen
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K
Device Name: Welch Allyn Connex® Vital Signs Monitor 6000 Series
Indications for Use:
The VSM 6000 Series of monitors is intended to be used by clinicians and medically qualified
personnel for monitoring of neonatal, pediatric, and adult patients for:
- noninvasive blood pressure.
- pulse rate,
- noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), and
- body temperature in normal and axillary modes.
The most likely locations for patients to be monitored are general medical and surgical floors, general hospital, and alternate care environments.
The optional Masimo Rainbow SET® and accessories are indicated for the continuous noninvasive monitoring of total hemoglobin concentration of adult, pediatric, and neonatal patients turing both motion and no motion conditions, and for patients who are well or poorly perfused in hospitals and hospital-type facilities.
Optional compatible weight scales (e.g., Health o meter®) can be used for height, and BMI input.
Prescription Use AND/OR X (Part 21 CFR 801 Subpart D)
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)
sion Sign iovascular Devices
Cardiovascular Devices
510(k) Number K112682
Page 1 of 2
: 乐
P1/2
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Indications for Use (continued)
The Welch Allyn Connex® Vital Signs Monitor (CVSM) 6000 Series also contains the Welch Allyn Applications Framework ("Framework"). The Framework is general purpose software that allows medical device and non-medical device software applications to be run on the CVSM independently of, and isolated from the CVSM's vital signs monitoring functionality. All such applications are intended to be used on the CVSM by trained professionals in a health care setting.
This product is available for sale only upon the order of a physician or licensed health care professional.