(70 days)
No
The document describes a vital signs monitor with various modules for standard physiological measurements. While it calculates an "Integrated Pulmonary Index" based on multiple parameters, this is described as a calculation and not indicative of AI/ML. There are no mentions of AI, ML, deep learning, or any related terms in the provided text.
No
The device is described as a monitor intended for measuring and monitoring vital signs and does not perform any therapeutic functions.
No
Explanation: While the device monitors vital signs and indicates changes in a patient's status (such as through the IPI), its primary purpose as described is monitoring, not diagnosing a specific disease or condition. The IPI is explicitly stated as an "adjunct to, and is not intended to replace, vital sign monitoring."
No
The device description clearly outlines a physical vital signs monitor with various hardware modules (NIBP, SpO2, Temperature, Capnography, EarlySense) that measure physiological parameters. While it includes software components (like the Framework and IPI calculation), it is fundamentally a hardware device with integrated software, not a software-only medical device.
Based on the provided text, the Welch Allyn Connex® Vital Signs Monitor 6000 Series is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for monitoring physiological parameters (blood pressure, pulse rate, SpO2, temperature, CO2, respiration rate, heart rate, movement). These are measurements taken directly from the patient's body, not from samples of bodily fluids or tissues.
- Device Description: The description details the modules and sensors that measure these vital signs directly from the patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples to diagnose or monitor a condition.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device focuses on non-invasive, direct physiological measurements.
N/A
Intended Use / Indications for Use
The Connex® Vital Signs Monitor 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® Pulse CO-Oximeter and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, total hemoglobin concentration (SpHb), and/or respiration rate (RRa). The Masimo Rainbow SET® Radical 7R Pulse CO-Oximeter and accessories are indicated for use with adult, pediatric, and neonatal patients during both motion conditions, and for patients who are well or poorly perfused in hospitals and hospital-type facilities.
The optional Oridion module and accessories are intended for the continuous non invasive measurement and monitoring of carbon dioxide concentration of the expired and respiration rate. It is intended for use with neonatal, pediatic and adult patients in hospitals and hospital type facilities.
The optional Oridion module also provides the clinician with an integrated pulmonary index (IPI). The IPI is based on four parameters provided by the monitor: end tidal carbon dioxide, respiration and pulse rate. The IPI is a single index of an adult or pediatric patient's ventilatory status displayed on a scale of 1 - 10, where 10 indicates optimal pulmonary status. IPI monitoring displays a single value that represents the patient's pulmonary parameters and alerts clinicians to changes in the patient's pulmonary status.
The IPI is an adjunct to, and is not intended to replace, vital sign monitoring.
Optional compatible weight scales (e.g., Health o meter") can be used for height, weight, and BMI input.
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 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.
The EarlySense (Everon) module is intended for continuous measurement of respiration rate, heart rate and movement, in an automatic contact-less manner, in a hospital or clinic setting. The system is indicated for use in children, adolescents and adults. The operation of the EarlySense has been studied in children (weight
§ 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
K132808 P 1/16
510(k) Summary
[As described in 21 CFR 807.92]
Submitted by: Welch Allyn Inc. 4341 State Street Road Skaneateles Falls, NY 13153-0220
Kevin Crossen
Contact Person:
Director Regulatory Affairs Phone: (315) 685-2609 Fax: (315) 685-2532 E-mail: Kevin.Crossen@welchallyn.com
NOV 2 0 2013
Date Prepared:
Trade Name:
Connex® Vital Signs Monitor 6000 Series
901060 Vital Signs Monitor
September 9, 2013
Common Name:
Classification Reference:
Predicate Device:
Connex® Vital Signs Monitor 6000 Series 510(k) Number: K121013 Electrocardiograph, 21 CFR 870.2300 Class II, MWI
(21 CFR 870.2300, Product Code MWI)
Monitor, physiological, patient (without arrhythmia detection or alarms)
Class II, monitor, physiological, patient (without arrhythmia detection or alarms)
Section 11 510(k) Summary (per 21 CFR 807.92)
1
Image /page/1/Picture/0 description: The image shows the logo for Welch Allyn. The text is in a bold, sans-serif font. The logo is black and the background is white.
K132808 P 2/2
Description of the Device:
The Welch Allyn Connex® Vital Signs Monitor 6000 Series (CVSM) is designed to provide a scalable, modular system of components which can be configured to address the needs for vital signs soot checking and continuous monitoring.
The Welch Allyn Connex® Vital Signs Monitor 6000 Series monitor is intended to be used by clinicians and medically qualified personnel for measuring or monitoring patient vital signs. The particular vital sign measurements available are determined by the sensor/processing modules installed into the base unit including;
- NIBP Module provides measurements of noninvasive blood pressure and pulse rate.
- SpO2 Modules from Nellcor and Masimo provide pulse rate, noninvasive functional oxygen saturation of . arteriolar hemoglobin.
- . The Masimo SpO2 Module can also provide hemoglobin measurements (SpHb, SpHbv) and acoustic respiration rate (RRa),
- . The Temperature Module measures body temperature in normal and axillary modes of neonatal, pediatric, and adult patients.
- . The Oridion Capnography Module equipped systems are also capable of carbon dioxide (CO2), respiration rate (RR) and calculation of Integrated Pulmonary Index (IPI) measurements,
- . The EarlySense Module provide users the option of continuous and contact-less monitoring of respiration rate, heart rate and patient movement. The addition of this Module is the subject of this 510(k).
The CVSM can also display and transmit patient data that is electronically or manually entered from external and accessory devices, e.g., weight and height data, barcode scanner. IR temperature, and other patient or facility information. Data can be transmitted electronically via USB, wired Ethernet, or wireless communications, including, for example, to electronic record systems and for remote display and alarming (e.g., central station).
Indications for Use:
The Connex® Vital Signs Monitor 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.
- ー pulse rate,
- noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), and
- l 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® Pulse CO-Oximeter and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, total hemoglobin concentration (SpHb), and/or respiration rate (RRa). The Masimo Rainbow SET® Radical 7R Pulse CO-Oximeter and accessories are indicated for use with adult, pediatic, and neonal patients during both motion conditions, and for patients who are well or poorly perfused in hospitals and hospital-type facilities.
The optional Oridion module and accessories are intended for the continuous non invasive measurement and monitoring of carbon dioxide concentration of the expired and respiration rate. It is intended for use with neonatal, pediatric and adult patients in hospitals and hospital type facilities.
2
Image /page/2/Picture/0 description: The image shows the logo for Welch Allyn. The text is in a bold, serif font. The logo is black and the background is white.
K132808 b3/16
The optional Oridion module also provides the clinician with an integrated pulmonary index (IPI). The IPI is based on four parameters provided by the monitor: end tidal carbon dioxide, respiration and pulse rate. The IP is a single index of an adult or pediatic patilatory status displayed on a scale of 1 - 10, where 10 indicates optimal pulmonary status. IPI monitoring displays a single value that represents the patient's pulmonary parameters and alerts clinicians to changes in the patient's pulmonary status.
The IPI is an adjunct to, and is not intended to replace, vital sign monitoring.
Optional compatible weight scales (e.g., Health o meter") can be used for height, weight, and BMI input.
The Welch Allyn Conner® Vital Signs Monitor (CVSM) 6000 Series also contains the Welch Allyn Applications Framework ("Framework"). The Framework is general purpose software that allows 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.
The FarlySense (Fiveron) module is intended for continuous measurement of respiration rate, heart rate in an automatic contact-less manner. in a hospital or clinic setting. The system is indicated for use in children, add adults. The operation of the EarlySense has been studied in children (weight 30kg) CO2 accuracy:
0 to 38 mmHg: ±2 mmHg
39 to 150 mmHg: ±2 (5% of
reading + 0.08% for every 1
mmHg above 38 mmHg)
Flow rate:
50 (42.5 ≤ flow ≤ 65) ml/min,
flow measured by volume
Initialization time:
40 seconds (typical, includes
power-up and
initialization time)
System response time:
2.9 seconds
Compensation:
BTPS (standard correction
used by Microstream
capnography during all
measurement procedures for
body temperature, pressure,
and saturation) | 4 - 70 +/- 1 breath per minute, adults (>30kg) CO2 accuracy:
0 to 38 mmHg: ±2 mmHg
39 to 150 mmHg: ±2 (5% of
reading + 0.08% for every 1
mmHg above 38 mmHg)
Flow rate:
50 (42.5 ≤ flow ≤ 65) ml/min,
flow measured by volume
Initialization time:
40 seconds (typical, includes
power-up and
initialization time)
System response time:
2.9 seconds
Compensation:
BTPS (standard correction
used by Microstream
capnography during all
measurement procedures for
body temperature, pressure,
and saturation) | Same - the
CO2 module
has not been
modified |
| EarlySense Module | No | Yes | Subject of this
submission |
| Respiration rate | Also provided by Masimo and
Oridion Modules | 6 to 45 breaths per minute
(±4% or ±1.5 breaths per
minute, whichever is greater) | Same as
cleared by
EarlySense in
K120465. |
| Heart Rate | Also provided by NIBP,
Nellcor, and Masimo Modules | 30 to 170 beats per minute
(±4% or ±5 beats per minute,
whichever is greater) | Same as
cleared by
EarlySense in
K120465. |
| Patient Movement | Not previously available. | Movement during defined
period (percent of time
moving in 1.5 minutes)
0 = 0% | Same as
cleared by
EarlySense in
K120465. |
.
14
| Subject Device and Predicate Device Comparison | |||
|---|---|---|---|
| Characteristic | Predicate Devices | Subject Device | Differences |
| L = Up to 40% | |||
| M = 40% to 60% | |||
| H = 60% to 80% | |||
| EH = 80% to 100% | |||
| (Adult: | |||
| 0 = 100%, L = 100%, M = | |||
| 81%, H = 100%, EH = 96% | |||
| Pediatric: | |||
| 0 = 100%, L = 100%, M = | |||
| 81%, H = 86%, EH = 94%) | |||
| External Device | |||
| Communication | |||
| Protocol | WACP | WACP | Same |
| Communication | |||
| with electronic | |||
| record systems for | |||
| alarming and | |||
| remote monitoring | Patient date uploaded | ||
| episodically to electronic | |||
| record systems. | Patient date uploaded | ||
| episodically to electronic | |||
| record systems. | Same except | ||
| includes | |||
| modified | |||
| interface that | |||
| allows | |||
| (e.g., central | |||
| station) | SpO2 and Pulse Rate | ||
| continuous monitoring and | |||
| interval measurements of | |||
| NIBP and Temperature | SpO2 and Pulse Rate | ||
| continuous monitoring and | |||
| interval measurements of | |||
| NIBP and Temperature. | clinicians to | ||
| manually enter | |||
| patient notes. | |||
| Interface also allows clinician | |||
| to manually enter Patient | |||
| notes. | |||
| Display type | LCD | LCD | Same |
| Touch Screen | Touch Screen | ||
| Barcode scanner | Yes | Yes | Same |
| The monitor enables the | |||
| scanning of patients' and/or | |||
| clinicians' barcodes to enter | |||
| identification information. The | |||
| barcode scanner supports | |||
| linear and 2D barcodes. | The monitor enables the | ||
| scanning of patients' and/or | |||
| clinicians' barcodes to enter | |||
| identification information. | |||
| The barcode scanner supports | |||
| linear and 2D barcodes. | |||
| Sterility | Device not supplied Sterile | Device not supplied Sterile | Same |
| Power source | 100 -240 V ac 50/60 Hz | 100 -240 V ac 50/60 Hz | Same |
| Battery Power | • Yes | ||
| • Level of Charge indicator | |||
| • Lithium ion | • Yes | ||
| • Level of Charge indicator | |||
| • Lithium ion | Same |
.
.
15
K132808 P 16/16
Conclusion
Based on the information presented in this 510(k) premarket notification the Connex® Vital Signs Monitor 6000 Series(CVSM) is considered substantially equivalent (as safe, as effective and performs as well as) the currently marketed devices (K121013) citied in this submission. The differences noted between the CVSM and the predicate devices do not impact safety or effectiveness based on the successfully conducted testing of the modified device. The hardware, software, and mechanical aspects of the CVSM itself remain the same as the cleared device (Vital Signs Monitor - VSM 6000 Series, K 121013, S.E. date July 26, 2012) except as described below. The modification is to make the EarlySense module available on the CVSM to provide continuous and contact-less monitoring of respiration rate, heart rate, and movement. The software of the CVSM has been modified to enable display of the Early Sense measurements, which are received by CVSM via the same USB communications used to receive data from the currently available module is the same form factor as the current modules. EarlySense has incorporated sensor processing system into this format of a Connex Vital Signs Monitor 6000 Series module. EarlySense changed the case of their components to fit the Connex® Vital Signs Monitor 6000 Series platform. It follows the same software communication format as our currently available modules. The fidelity of these data transfers were tested in our design control process. Like the predicate CVSM device, this version of the CVSM can transfer acquired data electronically via USB, wired Ethernet, or wireless communications to other locations. Like the CVSM cleared in K121013, this version of the CVSM can transmit data continuously for secondary remote viewing and alarming (e.g., central station). Also included in this version of CVSM are minor software and connectivity enhancements to improve performance and customer experience.
16
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
November 20, 2013
Welch Allyn, Inc. Mr. Kevin Crossen Director of Regulatory Affairs 4341 State St. Rd. P.O. Box 220 Skaneateles Falls, NY 13153-0220 US
Re: K132808
Trade/Device Name: Connex Vital Signs Monitor Regulation Number: 21 CFR 870.2300 Regulation Name: Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) Regulatory Class: II (two) Product Code: MWI Dated: October 24, 2013 Received: October 25, 2013
Dear Mr. Kevin Crossen:
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. 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.
17
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 http://www.fda.goy/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Owen P. Faris -S
for Bram D. Zuckerman, Ph.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
18
Indications for Use
510(k) Number (if known): K 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, l
- pulse rate, l
- noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), and l
- 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® Pulse CO-Oximeter and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpOZ), pulse rate, total hemoglobin concentration (SpHb), and/or respiration rate (RRa). The Masimo Rainbow SET® Radical 7R Pulse CO-Oximeter and accessories are indicated for use with adult, pediatric, and neonatal patients during both motion and no motion conditions, and for patients who are well or poorly perfused in hospitals and hospital-type facilities.
The optional Oridion module and accessories are intended for the continuous non invasive measurement and monitoring of carbon dioxide concentration of the expired breath and respiration rate. It is intended for use with neonatal, pediatic and adult patients in hospitals and hospital type facilities.
AND/OR
| Prescription Use
| (Part 21 CFR 801 Subpart D) | x |
|---|---|
| ------------------------------------------------- | --- |
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)
Digitally signed by Owen P.
Faris -5
Date: 2013.11.20 10:37:53
-05'00'
Page 6-2
19
K132808 P 2/2
Indications for Use (Continued)
The optional Oridion module also provides the clinician with an integrated pulmonary index (IPI). The IPI is based on four parameters provided by the monitor: end tidal carbon dioxide, respiration rate, oxygen saturation and pulse rate. The IPI is a single index of an adult or pediatric patient's ventilatory status displayed on a scale of i - 10, where 10 indicates optimal pulmonary status. IPI monitoring displays a single value that represents the patient's pulmonary parameters and alerts clinicians to changes in the patient's pulmonary status.
The IPI is an adjunct to, and is not intended to replace, vital sign monitoring.
Optional compatible weight scales (e.g., Health o meter") can be used for height, and BMI input.
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.
The EarlySense (Everon) module is intended for continuous measurement of respiration rate, heart rate and movement, in an automatic contact-less manner, in a hospital or clinic setting. The system is indicated for use in children, adolescents and adults. The operation of the EarlySense has been studied in children (weight ≥ 10 Kg) and adults (weight