(98 days)
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 during 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, weight, and BMI input.
This product is available for sale only upon the order of a physician or licensed health care professional.
The Welch Allyn Connex® Vital Signs Monitor 6000 Series is designed to provide a scalable, modular system of components that can be configured to address the needs for vital signs spot check and continuous monitoring.
The CVSM 6000 Series is intended to be used by clinicians and medically qualified personnel for monitoring of noninvasive blood pressure, pulse rate, noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), Total Hemoglobin (SpHb and SpHbv), and body temperature in normal and axillary modes of neonatal, pediatric, and adult patients. The CVSM can also display and transfer patient data that is electronically or manually entered from external and accessory devices, e.g., weight and height data, barcode, IR temperature, and other patient or facility information. Data can be transferred electronically via USB, wired Ethernet, or wireless communications.
The monitor has an enclosure constructed of engineering plastics with internal steel members for strengthening. A silicone light bar is prominent in a carry handle on the top of the device and illuminates for different alarm conditions. A power button is located on the side of the device. A touch screen display is prominent on the front of the device and provides the primary interface for the user to interact with the device. Internal and external communications are primarily by USB. External host USB connections for accessories are tool accessible. A USB connection for data transfer is on the side of the device, as is a connection to an internal relay for use with nurse call systems. The device contains an internal AC power supply for operating the device and charging the internal Lithium Ion battery.
The monitor can be configured for use in different workflows including desktop, affixed to a mobile stand, or on a wall mount.
The Welch Allyn Connex® Vital Signs Monitor 6000 Series is a physiological monitor. The provided text indicates that no clinical studies were performed, but rather verification and validation were conducted to ensure expected performance based on relevant international standards. Therefore, some of the requested information regarding clinical studies and ground truth cannot be extracted.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Safety and Effectiveness | Compliance with various international standards for medical electrical equipment | Verified and validated to ensure expected performance |
| IEC 60601-1:Ed. 2: 1988 | Basic safety and essential performance | Complies |
| IEC 60601-1-2: Ed. 3: 2007 | Electromagnetic compatibility | Complies |
| IEC 60601-1-4: Consolidated Ed. 1.1: 2000 | Programmable Electrical Medical Systems | Complies |
| IEC 60601-1-8: Ed. 1: 2003 | Alarm Systems | Complies |
| IEC 60601-2-30: Ed. 2: 1999 | Manual, electronic or automated sphygmomanometers | Complies |
| ISO 9919: Ed. 2: 2005 | Pulse oximeter equipment | Complies |
| ISO 14971: Ed. 2: 2007 | Application of risk management to medical devices | Complies |
| Functionality | Acquisition and/or display of total hemoglobin utilizing Masimo Rainbow SET® module | Verified and validated |
| Transfer and display of weight, height, and BMI from OEM devices (e.g., Health o meter®) | Verified and validated |
2. Sample size used for the test set and the data provenance
The document explicitly states that "No clinical studies were utilized for the purpose of obtaining safety or effectiveness data." Therefore, there is no information on a 'test set' in the context of clinical data, its sample size, or data provenance. The testing appears to have been focused on engineering verification and validation against standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical studies with human expert ground truth were conducted.
4. Adjudication method for the test set
Not applicable, as no clinical studies with human expert adjudication were conducted.
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
Not applicable. The device is a vital signs monitor and does not involve AI or human readers interpreting data in a comparative effectiveness study as described.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The entire submission focuses on the standalone performance of the device itself (the "algorithm only" in the sense of the device's inherent functionality). The device's performance was evaluated by confirming its compliance with various international standards through "Verification and validation," rather than through a clinical study where its output would be compared to a human interpretation.
7. The type of ground truth used
The "ground truth" used for this device's evaluation was primarily based on compliance with established international engineering and medical device standards. For example, the device was tested to ensure it met the requirements for basic safety, essential performance, electromagnetic compatibility, alarm systems, sphygmomanometers, and pulse oximeters as defined by the listed IEC and ISO standards.
8. The sample size for the training set
Not applicable, as the document does not describe an AI/ML model that would require a training set. The device is a physiological monitor whose performance was validated against established engineering and medical device standards.
9. How the ground truth for the training set was established
Not applicable, as there was no training set for an AI/ML model.
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K11051.6
JUN - 1 2011
510(k) Summary [As described in 21 CFR 807.92]
Submitted by:
Contact Person:
Welch Allyn Inc. 4341 State Street Road Skaneateles Falls, NY 13153-0220
Fred Schweitzer Vice President, QA/RA Phone: (315) 554-4001 Fax: (315) 685-2532 E-mail: schweitzerf@welchallyn.com
Welch Allyn Connex® Vital Signs Monitor 6000 Series
Monitor, Physiological, Patient (without Arrhythmia
Class II, 870.2300, Cardiovascular Monitoring Devices
Welch Allyn Vital Signs Monitor -- VSM 6000 Series
Masimo Rainbow SET® Radical 7 Pulse CO-Oximeter
Patient scales marketed pursuant to 21 CFR 880.2700 and 880.2720, Class I, 510(k) Exempt (e.g. Health o meter)
Vital Signs Monitor, CVSM 6000 Series, CVSM
Masimo Rainbow SET® Radical 7R Pulse CO-
Feb 18, 2011
Detection or Alarms)
Product Code - MWI
Welch Allyn, Inc.
and Accessories
Masimo Corporation 510(k) Number K080238
Masimo Corporation 510(k) Number K100428
510(k) Number K101445
Pulse Oximeter and Sensor
Oximeter and Accessories Pulse Oximeter and Sensor
Date Prepared:
Trade Name:
Common Name:
Classification Reference:
Predicate Devices:
Special 510(k) – Connex® Vital Signs Monitor 6000 Series
Page 1 of 4
{1}------------------------------------------------
Welch Allyn:
Description of the Device:
The Welch Allyn Connex® Vital Signs Monitor 6000 Series is designed to provide a scalable, modular system of components that can be configured to address the needs for vital signs spot check and continuous monitoring.
The CVSM 6000 Series is intended to be used by clinicians and medically qualified personnel for monitoring of noninvasive blood pressure, pulse rate, noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), Total Hemoglobin (SpHb and SpHbv), and body temperature in normal and axillary modes of neonatal, pediatric, and adult patients. The CVSM can also display and transfer patient data that is electronically or manually entered from external and accessory devices, e.g., weight and height data, barcode, IR temperature, and other patient or facility information. Data can be transferred electronically via USB, wired Ethernet, or wireless communications.
The monitor has an enclosure constructed of engineering plastics with internal steel members for strengthening. A silicone light bar is prominent in a carry handle on the top of the device and illuminates for different alarm conditions. A power button is located on the side of the device. A touch screen display is prominent on the front of the device and provides the primary interface for the user to interact with the device. Internal and external communications are primarily by USB. External host USB connections for accessories are tool accessible. A USB connection for data transfer is on the side of the device, as is a connection to an internal relay for use with nurse call systems. The device contains an internal AC power supply for operating the device and charging the internal Lithium Ion battery.
The monitor can be configured for use in different workflows including desktop, affixed to a mobile stand, or on a wall mount.
Indications for 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
- 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.
{2}------------------------------------------------
Welch Allyn
The optional Masimo Rainbow SET® and accessories are indicated for the continuous noninvasive monitoring of total hemoglobin concentration of 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.
Optional compatible weight scales (e.g.,Health o meter®) can be used for height, weight, and BMI input.
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 devices; minor modifications and additions to software and hardware were made to the CVSM to enable acquisition and/or display of total hemoglobin utilizing the existing Masimo Rainbow SET® module and the transfer and display of weight, height, and BMI from OEM devices (e.g., Health o meter®).
Non-Clinical Tests:
Verification and validation were conducted to ensure expected performance of the CVSM 6000 Series with enabled Masimo Rainbow SET® and data transfer from accessory patient scales.
The Connex® Vital Signs Monitor 6000 Series was tested to evaluate its safety and effectiveness based on the following standards:
- . IEC 60601-1:Ed. 2: 1988 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (with A1: 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 A1:2006)
- 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
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Welch Allyn
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 is considered substantially equivalent (as safe, as effective and performs as well as) the currently marketed devices cited in this submission.
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Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with outstretched wings.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN - 1 2011
Welch Allyn, Inc. c/o Mr. Fred Schweitzer Vice President, Regulatory Affairs 4341 State Street Road Skaneateles Falls, NY 13153-0220
Re: K110516
Trade/Device Name: Connex® Vital Signs Monitor 6000 Series, with models 6300, 6400 and 6500 Regulatory Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including Cardiotachometer and Rate Alarm) Regulatory Class: Class II (Two) Product Code: MWI Dated: May 5, 2011
Received: May 6, 2011
Dear Mr. Schweitzer:
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 10 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.
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
{5}------------------------------------------------
Page 2 - Mr. Fred Schweitzer
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 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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/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.fdai.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
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Indications for Use
510(k) Number (if known): K (( 0 د ک
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. ー
- pulse rate, l
- 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 during bath 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.
This product is available for sale only upon the order of a physician or licensed health care professional.
| Prescription Use(Part 21 CFR 801 Subpart D) | X AND/OR |
|---|---|
| ------------------------------------------------- | ----------------- |
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)
(Division Sign-Off)
(Division Sign-Off)
Division of Cardiovascular Devices
Page 1 of 1
§ 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).