(28 days)
Not Found
No
The document describes a vital signs monitor with various modules for measuring standard physiological parameters (NIBP, SpO2, temperature, CO2, ECG, respiration rate, heart rate, movement). While it calculates an "Integrated Pulmonary Index" based on multiple parameters, this is described as a simple index calculation, not an AI/ML algorithm. There is no mention of AI, ML, or related terms in the text.
No
The device is described as a monitor intended for measuring or monitoring patient vital signs, such as blood pressure, pulse rate, oxygen saturation, and temperature. Its function is to provide data and alert clinicians to changes, not to directly treat or provide therapy to patients.
Yes
The device is described as a "Vital Signs Monitor" that measures and monitors various physiological parameters such as blood pressure, heart rate, oxygen saturation, temperature, CO2, and ECG. While it primarily monitors, the collection of this physiological data is fundamental to diagnosing medical conditions. The "Integrated Pulmonary Index (IPI)" also provides a single index of ventilatory status to alert clinicians to changes in pulmonary status, and the ECG module detects conditions like ventricular tachycardia and ventricular fibrillation, all of which are diagnostic in nature.
No
The device description clearly outlines a physical vital signs monitor (CVSM 6000 Series) that incorporates various hardware modules (NIBP, SpO2, Temperature, Capnography, EarlySense, ECG/Impedance Respiration) to acquire physiological data. While it includes software (the Framework and module-specific software), it is fundamentally a hardware device with integrated software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The VSM 6000 series monitors vital signs directly from the patient's body (non-invasively) through sensors applied to the skin or placed near the patient. It measures parameters like blood pressure, pulse rate, oxygen saturation, temperature, CO2 concentration in breath, respiration rate, heart rate, and ECG signals.
- Lack of Specimen Analysis: The device does not analyze any biological specimens removed from the patient's body.
The device is a patient monitoring device used for directly measuring physiological parameters in living patients.
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 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 inspired breath and respiration rate. It is intended for use with neonatal, pediatric 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 rate, oxygen saturation and pulse rate. The IPI is a single index of an adult or pentilatory 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 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 = 10 Kg) and adults (weight
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.
0
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 30, 2017
Welch Allyn, Inc. Mark Alsberge Lead Engineer, Regulatory Affairs 4341 State Street Road Skaneateles Falls, New York 13153
Re: K171621
Trade/Device Name: Welch Allyn Connex Vital Signs Monitor 6000 Series, Welch Allyn Connex Integrated Wall System 80000 Series, 901060 Vital Signs Monitor Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MHX, MWI Dated: May 31, 2017 Received: June 2, 2017
Dear Mark Alsberge:
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.
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
1
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 devicerelated 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 Industry and Consumer Education 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. 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.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 Industry and Consumer Education 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,
M.A. Hillebrand
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K171621
Device Name
Welch Allyn Connex® Vital Signs Monitor 6000 Series Welch Allyn Connex® Integrated Wall System 80000 Series 901060 Vital Signs Monitor
Indications for Use (Describe)
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 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 inspired breath and respiration rate. It is intended for use with neonatal, pediatric 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 rate, oxygen saturation and pulse rate. The IPI is a single index of an adult or pentilatory 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 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 ☑ |
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ |
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K171621 Page 1 of 19
Special 510(k) Premarket Notification Connex® Vital Signs Monitor 6000 Series
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: | Mark Alsberge |
Lead Regulatory Affairs Engineer | |
Phone: (315) 685-4471 | |
Fax: (315) 685-2532 | |
E-mail: Mark.Alsberge@welchallyn.com | |
Date Prepared: | May 19, 2017 |
Trade Name: | Connex® Vital Signs Monitor 6000 Series |
Connex® Integrated Wall System 80000 Series | |
901060 Vital Signs Monitor | |
Common Name: | monitor, physiological, patient(with arrhythmia detection or alarms) |
Classification Reference: | Class II, monitor, physiological, patient(with arrhythmia detection or alarms) |
(21 CFR 870.1025, Product Code MHX) | |
Predicate Device: | Connex® Vital Signs Monitor 6000 Series |
510(k) Number: K132808 | |
monitor,physiological,patient(without arrhythmia detection or alarms), 21 CFR | |
870.2300 | |
Class II, MWI | |
Matrix Mini ECG Monitor | |
510(k) Number: K152701 | |
Arrhythmia Detector and Alarm (Including ST-Segment Measurement | |
and Alarm), 21 CFR 870.1025 | |
Class II, DSL, DRT, BZO |
4341 State Street Road, P.O. Box 220, Skaneateles Falls, NY 13153-0220 www.welchallyn.com
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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 spot 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 SureTemp Temperature Module measures body temperature in normal and axillary modes of neonatal, pediatric, and adult patients. Temperature can also be measured IR ear thermometer.
- . 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 Global Instruments module provides 3 -5 lead ECG/Impedance Respiration. The ECG modules is for continuous measurement of respiration rate, heart rate and detection of cardiac standstill (asystole), ventricular tachycardia and ventricular fibrillation of this Global Instruments 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, -
- 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.
4341 State Street Road, P.O. Box 220, Skaneateles Falls, NY 13153-0220 www.welchallyn.com
Enhancing outcomes for patients and their caregivers.
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The optional Oridion module and accessories are intended for the continuous non invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate. It is intended for use with neonatal, pediatric 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 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 30kg) | Masimo hardware provided
and software enabled
• 4 – 70 +/- 1 breath per
minute, adults (>30kg) | Same |
| Capnography for
carbon dioxide
(CO2), respiration
rate (RR)
measurements and
calculation of
Integrated
Pulmonary Index
(IPI). | CO2 accuracy: | CO2 accuracy: | Same – the
CO2 module
has not been
modified |
| | 0 to 38 mmHg: ±2 mmHg
39 to 150 mmHg: ±2 ( 5% of
reading + 0.08% for every 1
mmHg above 38 mmHg) | 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: | Flow rate: | |
| | 50 (42.5 ≤ flow ≤ 65) ml/min,
flow measured by volume | 50 (42.5 ≤ flow ≤ 65) ml/min,
flow measured by volume | |
| | Initialization time: | Initialization time: | |
| | 40 seconds (typical, includes
power-up and
initialization time) | 40 seconds (typical, includes
power-up and
initialization time) | |
| | System response time: | System response time: | |
| | 2.9 seconds | 2.9 seconds | |
| | Compensation: | Compensation: | |
| | BTPS (standard correction
used by Microstream
capnography during all
measurement procedures for | BTPS (standard correction
used by Microstream
capnography during all
measurement procedures for | |
| Subject Device and Predicate Device Comparison | | | |
| Characteristic | Predicate Devices | Subject Device | Differences |
| | body temperature, pressure, and saturation) | body temperature, pressure, and saturation) | |
| EarlySense Module | Yes | Yes | Same |
| Respiration rate | Also provided by Early Sense, Masimo and Oridion Modules | 6 to 45 breaths per minute
(±4% or ±1.5 breaths per minute, whichever is greater) | Same as
cleared by
Global
Instruments
Impedance
Respiration in
K152701. |
| Heart Rate | Also provided by Early Sense, Masimo and Oridion Modules | 30 to 170 beats per minute
(±4% or ±5 beats per minute, whichever is greater) | Same as
cleared by
Global
Instruments
Impedance
Respiration in
K152701. |
| Display of ECG | N/A | 3 - 5 Lead ECG added by
Global Instruments Module | Same as
cleared by
Global
Instruments in
K152701. |
| Detect abnormal
ECG's | N/A | detection of cardiac
standstill (asystole),
ventricular tachycardia and
ventricular fibrillation. | Same as
cleared by
Global
Instruments in
K152701 |
| Patient Movement | Movement during defined
period (percent of time
moving in1.5 minutes)
0 = 0% | Movement during defined
period (percent of time
moving in1.5 minutes)
0 = 0% | Same. |
| | L = Up to 40% | L = Up to 40% | |
| | M = 40% to 60%
H = 60% to 80%
EH = 80% to 100%
(Adult: | M = 40% to 60%
H = 60% to 80%
EH = 80% to 100%
(Adult: | |
| | 0 = 100%, L = 100%, M =
81%, H = 100%, EH = 96% | 0 = 100%, L = 100%, M =
81%, H = 100%, EH = 96% | |
| Subject Device and Predicate Device Comparison | | | |
| Characteristic | Predicate Devices | Subject Device | Differences |
| | Pediatric:
0 = 100%, L = 100%, M =
81%, H = 86%, EH = 94%). | 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
(e.g., central
station) | Patient date uploaded
episodically to electronic
record systems.
SpO2 and Pulse Rate
continuous monitoring and
interval measurements of
NIBP and Temperature | Patient date uploaded
episodically to electronic
record systems.
SpO2 and Pulse Rate
continuous monitoring and
interval measurements of
NIBP and Temperature.
Interface also allows clinician
to manually enter Patient
notes. | Same. |
| Display type | LCD
Touch Screen | LCD
Touch Screen | Same |
| Barcode scanner | Yes
The monitor enables the
scanning of patients' and/or
clinicians' barcodes to enter
identification information. The
barcode scanner supports
linear and 2D barcodes. | Yes
The monitor enables the
scanning of patients' and/or
clinicians' barcodes to enter
identification information.
The barcode scanner supports
linear and 2D barcodes. | Same |
| 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 |
4341 State Street Road, P.O. Box 220, Skaneateles Falls, NY 13153-0220 www.welchallyn.com
Enhancing outcomes for patients and their caregivers?
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Section 11 510(k) Summary (per 21 CFR 807.92)
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Image /page/20/Picture/6 description: The image shows the Hill-Rom logo. The logo is white text on a blue background. The background is a rounded rectangle shape.
Section 11 510(k) Summary (per 21 CFR 807.92)
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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 (K132808 and K152701) 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
4341 State Street Road, P.O. Box 220, Skaneateles Falls, NY 13153-0220 www.welchallyn.com
Section 11 510(k) Summary (per 21 CFR 807.92)
This document contains information considered to be CONFIDENTIAL to Welch Allyn, Inc.
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Enhancing outcomes for patients and their caregivers?
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Connex® Vital Signs Monitor 6000 Series
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, K132808, S.E. date November 30, 2012) except as described below. The modification is to make the Global Instruments ECG module (K152701) available on the CVSM to provide ECG monitoring. The software of the CVSM has been modified to enable display of the Global Instruments ECG measurements, which are received by CVSM via the same USB communications used to receive data from the currently available modules. 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 K132808, this version of the CVSM can transmit data continuously for secondary remote viewing and alarming (e.g., central station, NCE).
4341 State Street Road, P.O. Box 220, Skaneateles Falls, NY 13153-0220 www.welchallyn.com
Enhancing outcomes for patients and their caregivers?
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