(146 days)
No
The summary mentions "VERITAS™ resting ECG algorithm" for analysis, but does not provide any details suggesting it utilizes AI or ML. The description focuses on standard signal processing and comparison against norms for Spirometry. There are no mentions of AI, ML, training data, or performance metrics typically associated with AI/ML devices.
No.
The device is intended for diagnostic purposes (acquiring, analyzing, displaying physiological signals) and not for treating a condition or lesion in the body.
Yes
The device is described as aiding in the "diagnosis of pulmonary function" and providing "measurements and advisory statements for review and interpretation by the physician" for ECGs, explicitly indicating its role in diagnosis.
No
The device description explicitly states that the Welch Allyn Diagnostic Cardiology Suite is a "PC-based software device" but also details "hardware accessories" for both ECG and Spirometry, including electrodes and a pneumotach air flow sensor, which are essential for acquiring the physiological signals. While the software processes the data, the system relies on specific hardware components to function as intended.
Based on the provided text, the Welch Allyn® Diagnostic Cardiology Suite™ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Definition of IVD: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside the body (in vitro).
- Device Function: The Welch Allyn Diagnostic Cardiology Suite acquires physiological signals directly from the patient's body (electrical activity of the heart for ECG and airflow during breathing for Spirometry). It does not analyze samples taken from the body.
- Intended Use: The intended use describes the device as acquiring, analyzing, displaying, transmitting, and printing physiological signals and providing data for physician consideration. This aligns with in vivo diagnostic procedures, not in vitro testing.
Therefore, the Welch Allyn Diagnostic Cardiology Suite is a medical device used for in vivo diagnostic procedures (ECG and Spirometry), not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Welch Allyn® Diagnostic Cardiology Suite™ is a prescription device intended for use by physicians, other licensed health care practitioners, and trained personnel who are acting on the orders of a physician. Welch Allyn Diagnostic Cardiology Suite is intended for use in medical clinics, physician offices and hospital settings to acquire, analyze, display, transmit and print certain physiological signals identified below and provide the data for consideration by a physician.
Welch Allyn Diagnostic Cardiology Suite utilizes a software platform to support 12-lead diagnostic Resting ECG and diagnostic Spirometry applications and is designed to operate within the inherent capabilities of an off-the-shelf laptop or PC Windows operating system. Welch Allyn Diagnostic Cardiology Suite also provides functions related to patient data management including communication with electronic medical records systems. Welch Allyn Diagnostic Cardiology Suite Resting ECG's are intended to be taken with the patient in the supine position and offer VERITAS™ resting ECG algorithm to generate measurements and advisory statements for review and interpretation by the physician.
Welch Allyn Diagnostic Cardiology Suite is not intended to be used as a physiological vital signs monitor, not intended to be used in a mobile medical environment (e.g. ambulance, helicopter), in magnetic resonance (MR) environments, in operating theaters, nor in conjunction with high frequency surgical equipment.
Indications for Welch Allyn Diagnostic Cardiology Suite ECG range from routine screening of cardiac health in the physician office environment to directed diagnostic differentiation in a hospital cardiology department. Welch Allyn Diagnostic Cardiology Suite ECG is indicated for patients of all ages. There are no known contraindications for resting ECG.
Welch Allyn Diagnostic Cardiology Suite Spirometry is indicated for pulmonary function testing, providing forced expiratory flow-volume and time measurements. The device is intended to be a general assessment tool assisting the clinician in the diagnosis of pulmonary function. These devices are commonly used on patients with occupational exposure to dust or chemicals; presenting with symptoms such as chronic cough, shortness of breath and wheezing; disorders such as interstitial lung disease, bronchitis, asthma, and COPD; or other patients where the clinician determines these pulmonary function measurements are needed. Welch Allyn Diagnostic Cardiology Suite with Spirometry is indicated for adult and pediatric patients age 6 years and older and should only be used with patients able to understand the instructions for performing the test.
Product codes
BZG, DPS
Device Description
The Welch Allyn® Diagnostic Cardiology Suite™ is a software platform that operates on an off-the-shelf laptop or PC Windows operating system. It supports 12-lead diagnostic resting ECG and diagnostic Spirometry applications. The device is designed to acquire, analyze, display, transmit, and print physiological signals. It also provides functions for patient data management, including communication with electronic medical records systems. For ECG, it utilizes the VERITAS™ resting ECG algorithm to generate measurements and advisory statements. For Spirometry, it uses a pneumotach air flow sensor to obtain signals of forced expiratory breathing maneuvers, which are then analyzed against norms. The device is not intended for use as a vital signs monitor, in mobile medical environments, MR environments, operating theaters, or with high frequency surgical equipment.
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
Welch Allyn Diagnostic Cardiology Suite ECG is indicated for patients of all ages.
Welch Allyn Diagnostic Cardiology Suite with Spirometry is indicated for adult and pediatric patients age 6 years and older.
Intended User / Care Setting
Physicians, other licensed health care practitioners, and trained personnel who are acting on the orders of a physician. Intended for use in medical clinics, physician offices and hospital settings.
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)
No clinical studies were utilized for the purpose of showing substantial equivalence. Non-clinical performance tests were conducted to demonstrate that the Welch Allyn Diagnostic Cardiology Suite performs similarly to the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.1840 Diagnostic spirometer.
(a)
Identification. A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.(b)
Classification. Class II (performance standards).
0
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September 10, 2019
Welch Allyn, Inc. Megan Pellenz Regulatory Engineer 7865 North 86th St. Milwaukee, Wisconsin 53224
Re: K191013
Trade/Device Name: Welch Allyn® Diagnostic Cardiology Suite™ 2.X.X with Spirometry option 901128 CARDIOPULMONARY ECG SYSTEM Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic spirometer Regulatory Class: Class II Product Code: BZG, DPS Dated: August 22, 2019 Received: August 23, 2019
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
1
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 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 (QS) 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 medical devices and radiation-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,
Rachana Visaria, Ph.D. Assistant Director (Acting) DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K191013
Device Name
Welch Allyn® Diagnostic Cardiology Suite™ 2.X.X with Spirometry option 901128 CARDIOPULMONARY ECG SYSTEM
Indications for Use (Describe)
The Welch Allyn® Diagnostic Cardiology Suite™ is a prescription device intended for use by physicians, other licensed health care practitioners, and trained personnel who are acting on the orders of a physician. Welch Allyn Diagnostic Cardiology Suite is intended for use in medical clinics, physician offices and hospital settings to acquire, analyze, display, transmit and print certain physiological signals identified below and provide the data for consideration by a physician.
Welch Allyn Diagnostic Cardiology Suite utilizes a software platform to support 12-lead diagnostic Spirometry applications and is designed to operate within the inherent capabilities of an off-the-shelf laptop or PC Windows operating system. Welch Allyn Diagnostic Cardiology Suite also provides functions related to patient data management including communication with electronic medical records systems. Welch Allyn Diagnostic Cardiology Suite Resting ECG's are intended to be taken with the patient in the supine position and offer VERTAS™ resting ECG algorithm to generate measurements and advisory statements for review and interpretation by the physician.
Welch Allyn Diagnostic Cardiology Suite is not intended to be used as a physiological vital signs monitor, not intended to be used in a mobile medical environment (e.g. ambulance, helicopter), in magnetic resonance (MR) environments, in operating theaters, nor in conjunction with high frequency surgical equipment.
Indications for Welch Allyn Diagnostic Cardiology Suite ECG range from routine screening of cardiac health in the physician office environment to directed diagnostic differentiation in a hospital cardiology department. Welch Allyn Diagnostic Cardiology Suite ECG is indicated for patients of all ages.
Welch Allyn Diagnostic Cardiology Suite Spirometry is inction testing, providing forced expiratory flowvolume and time measurements. The device is intended to be a general assessment tool assisting the diagnosis of pulmonary function. These devices are commonly used on patients with occupational exposure to dust or chemicals; presenting with symptoms such as chronic cough, shorthess of breath and wheezing; disorders such as interstitial lung disease, bronchitis, ashma, and COPD; or other patients where the clinician determines these pulmonary function measurements are needed. Welch Allyn Diagnostic Cardiology Suite with Spirometry is indicated for adult and pediatric patients age 6 years and older and should only be used with patients able to understand the instructions for performing the test.
| 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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Traditional 510(k) Welch Allyn® Diagnostic Cardiology Suite™
510(k) SUMMARY [As described in 21 CFR 807.92]
Submitted by Manufacturer: Welch Allyn, Inc. 4341 State Street Road Skaneateles Falls, NY 13153 USA
Establishment Reqistration: 2183461
Primary Contact Person: Megan Pellenz, Regulatory Affairs Engineer
Secondary Contact Person: Mark Elliott, Quality Assurance Director, QMR
Date Updated: September 9th, 2019
Device Trade Name: Welch Allyn® Diagnostic Cardiology Suite™ 2.X.X with Spirometry option 901128 CARDIOPULMONARY ECG SYSTEM Common Name: Diagnostic Spirometer
Regulation Number: 868.1840
Device Class: Il
Product Code: BZG
Secondary Product code, and Regulation: DPS, 870.2340
Predicate Device: Welch Allyn CardioPerfect®Workstation Software™ (CPWS) 901047 CARDIOPULMONAY ECG SYSTEM (K082478)
Reference Device: Welch Allyn® RScribe™ (K120865) 901127 ELECTROCARDIOGRAPH
Background
The Welch Allyn® Diagnostic Cardiology Suite™ is a modification to Welch Allyn's current legally marketed RScribe cleared by FDA under K120865 and since branded "Connex Cardio". Welch Allyn's interpretation of when to submit a 510(k) for a change to an existing device and our planned device modification, the addition of indications for diagnostic spirometry, led us to the determination that the
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RScribe/Connex Cardio is being significantly modified and therefore this 510(k) submission is appropriate.
Indications for Use
The Welch Allyn® Diagnostic Cardiology Suite™ is a prescription device intended for use by physicians, other licensed health care practitioners, and trained personnel who are acting on the orders of a physician. Welch Allyn Diagnostic Cardiology Suite is intended for use in medical clinics, physician offices and hospital settings to acquire, analyze, display, transmit and print certain physiological signals identified below and provide the data for consideration by a physician.
Welch Allyn Diagnostic Cardiology Suite utilizes a software platform to support 12-lead diagnostic resting ECG and diagnostic Spirometry applications and is designed to operate within the inherent capabilities of an off-the-shelf laptop or PC Windows operating system. Welch Allyn Diagnostic Cardiology Suite also provides functions related to patient data management including communication with electronic medical records systems. Welch Allyn Diagnostic Cardiology Suite Resting ECG's are intended to be taken with the patient in the supine position and offer VERITAS™ resting ECG algorithm to generate measurements and advisory statements for review and interpretation by the physician.
Welch Allyn Diagnostic Cardiology Suite is not intended to be used as a physiological vital signs monitor, not intended to be used in a mobile medical environment (e.g. ambulance, helicopter), in magnetic resonance (MR) environments, in operating theaters, nor in conjunction with high frequency surgical equipment.
Indications for Welch Allyn Diagnostic Cardiology Suite ECG range from routine screening of cardiac health in the physician office environment to directed diagnostic differentiation in a hospital cardiology department. Welch Allyn Diagnostic Cardiology Suite ECG is indicated for patients of all ages. There are no known contraindications for resting ECG.
Welch Allyn Diagnostic Cardiology Suite Spirometry is indicated for pulmonary function testing, providing forced expiratory flow-volume and time measurements. The device is intended to be a general assessment tool assisting the clinician in the diagnosis of pulmonary function. These devices are commonly used on patients with occupational exposure to dust or chemicals; presenting with symptoms such as chronic cough, shortness of breath and wheezing; disorders such as interstitial lung disease, bronchitis, asthma, and
5
COPD; or other patients where the clinician determines these pulmonary function measurements are needed. Welch Allyn Diagnostic Cardiology Suite with Spirometry is indicated for adult and pediatric patients age 6 years and older and should only be used with patients able to understand the instructions for performing the test.
Contraindications for diagnostic spirometry:
- hemoptysis of unknown origin (forced expiratory maneuver may ● aggravate the underlying condition)
- pneumothorax ●
- unstable cardiovascular status (forced expiratory maneuver may worsen ● angina or cause changes in blood pressure) or recent myocardial infarction or pulmonary embolus
- . thoracic, abdominal, or cerebral aneurysms (danger of rupture due to increased thoracic pressure)
- Recent eye surgery (e.g., cataract);
- presence of an acute disease process that might interfere with test ● performance (e.g., nausea, vomiting) Recent surgery of thorax or abdomen.
Technoloqical Characteristics
The Welch Allyn Diagnostic Cardiology Suite is a PC-based software device. Section 16 details the software technology including its requirements, architecture, detailed design, development environment, verification and validation and lifecycle management plan. Medical device software development and management is characterized in IEC 62304 Medical device software – Software life cycle processes.
The technology of the hardware accessories are:
cited herein as a reference device.
- . For diagnostic ECG, the technology involves applying surface electrodes to the patient's skin to obtain signals of the heart's electrical activity. The electrical signals are then amplified, analyzed (VERITAS algorithms) and displayed on Welch Allyn Diagnostic Cardiology Suite ECG module user interface. Clinical Users can evaluate these ECGs, store them, save them or send them via the technological characteristics provided by the Welch Allyn Diagnostic Cardiology Suite. The diagnostic ECG technology is characterized in IEC 60601-2-25 Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs. The Welch Allyn RScribe K120865 utilizes the same VERITAS algorithms as Welch Allyn Diagnostic Cardiology Suite ECG and therefore is being
- For diagnostic Spirometry, a pneumotach air flow sensor obtains signals ● of a patient's forced expiratory breathing maneuvers, called "efforts", that are then analyzed against norms contained within Welch Allyn Diagnostic Cardiology Suite Spirometry module. Patient breathing efforts are
6
displayed on the Welch Allyn Diagnostic Cardiology Suite Spirometry user interface. Clinical Users can evaluate these Spirometry efforts, store them, save them or send them via the technological characteristics provided by the Welch Allyn Diagnostic Cardiology Suite. The diagnostic Spirometry technology is characterized in ISO 26782 Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans and follows ATS 2005 Standardization of Spirometry quidelines.
Device Comparison
It is of the opinion of Welch Allyn, Inc. that Welch Allyn Diagnostic Cardiology Suite is substantially equivalent to the predicate device. Welch Allyn CardioPerfect Workstation Software (K082478) as they share similar fundamental technical characteristics, intended use including indications for use, target population and use environment, detailed in the device comparison table below. The Welch Allyn® RScribe™ K120865 utilizes the same VERITAS algorithms as Welch Allyn Diagnostic Cardiology Suite ECG and therefore is presented as a Reference device.
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| Characteristic | Reference Device | Subject Device | Predicate Device |
|---|---|---|---|
| Trade Name | Welch Allyn® RScribe™ | ||
| K120865 | Welch Allyn® Diagnostic | ||
| Cardiology Suite™ | Welch Allyn® CardioPerfect | ||
| Workstation Software™ (CPWS) | |||
| V1.6.2 K082478 | |||
| Model Identifier | 901127 | ||
| ELECTROCARDIOGRAPH | 901128 | ||
| CARDIOPULMONARY ECG SYSTEM | 901047 | ||
| CARDIOPULMONARY ECG SYSTEM | |||
| Manufacturer | Welch Allyn, Inc. | Welch Allyn, Inc. | Welch Allyn, Inc. |
| 510(k) Number | K120865 | K082478 | K082478 |
| Product Code | DPS | BZG | BZG |
| Classification | |||
| Name | Electrocardiograph, Class II | Diagnostic Spirometer, Class II | Diagnostic Spirometer, Class II |
| Regulation | |||
| Number | 21 CFR 870.2340 | 21 CFR 868.1840 | 21 CFR 868.1840 |
| Indications for Use | The RScribe Electrocardiograph is a | ||
| multi-channel electrocardiograph | |||
| product used for acquiring, analyzing, | |||
| displaying and printing resting ECG's. | |||
| The RScribe is a 12-channel | |||
| diagnostic electrocardiograph intended | |||
| for recording and printing ECG's of | |||
| adult and pediatric patients. The | |||
| acquired ECG will be displayed for | |||
| quality check purpose, analyzed using | |||
| the Mortara VERITAS resting | |||
| interpretation, optionally printed, stored | |||
| and/or transmitted to a ECG | |||
| Management System or Hospital | |||
| Information System. The device is not | |||
| intended to be used as a vital signs | |||
| physiological monitor. | |||
| It is a system comprised of a Mortara | |||
| ECG amplifier (Wireless Acquisition | |||
| Module [WAM] or AM12 Patient | |||
| Cable) and an off-the-shelf personal | |||
| computer with Mortara software | |||
| application that allows clinicians to | |||
| collect ECGs on patients during | The Welch Allyn® Diagnostic Cardiology | ||
| Suite™ is a prescription device intended | |||
| for use by physicians, other licensed | |||
| health care practitioners, and trained | |||
| personnel who are acting on the orders | |||
| of a physician. Welch Allyn Diagnostic | |||
| Cardiology Suite is intended for use in | |||
| medical clinics, physician offices and | |||
| hospital settings to acquire, analyze, | |||
| display, transmit and print certain | |||
| physiological signals identified below | |||
| and provide the data for consideration | |||
| by a physician. Welch Allyn Diagnostic | |||
| Cardiology Suite utilizes a software | |||
| platform to support 12-lead diagnostic | |||
| resting ECG and diagnostic Spirometry | |||
| applications and is designed to operate | |||
| within the inherent capabilities of an off- | |||
| the-shelf laptop or PC Windows | |||
| operating system. Welch Allyn | |||
| Diagnostic Cardiology Suite also | |||
| provides functions related to patient | |||
| data management including | |||
| communication with electronic medical | The Welch Allyn® CardioPerfect | ||
| Workstation Software™ (CPWS) and | |||
| associated accessories are indicated | |||
| for the acquisition, analysis, formatting, | |||
| display, printing and storage of certain | |||
| physiologic signals, as identified | |||
| below, for the purpose of assisting the | |||
| clinician in the diagnosis and | |||
| monitoring of various diseases and/or | |||
| treatment regimens. The | |||
| CardioPerfect Workstation software | |||
| also provides non-diagnostic functions | |||
| such as patient management, data | |||
| security, search tools for patient and/or | |||
| test records and support for exporting | |||
| data to Electronic Medical Record | |||
| systems. | |||
| The CardioPerfect Workstation | |||
| Software and associated accessories | |||
| are intended for use by or on the order | |||
| of a physician in a hospital or clinic | |||
| setting. The product is designed for | |||
| use on both adult and pediatric | |||
| patients as included in the cleared | |||
| Characteristic | Reference Device | Subject Device | Predicate Device |
| routine visits. The patient populations | |||
| for which the device will be used may | |||
| be healthy or diseased of any age. | |||
| ECG's are taken with the patient in the | |||
| supine position. The RScribe is intended | |||
| to be used by a licensed health care | |||
| practitioner in a hospital, medical clinic | |||
| and offices of any size, including Clinical | |||
| Research Organizations. | records systems. Welch Allyn | ||
| Diagnostic Cardiology Suite Resting | |||
| ECG's are intended to be taken with the | |||
| patient in the supine position and offer | |||
| VERITAS™ resting ECG algorithm to | |||
| generate measurements and advisory | |||
| statements for review and interpretation | |||
| by the physician. | indications for use listed below, subject | ||
| to any specific contraindications | |||
| identified below. | |||
| The RScribe electrocardiograph is a | |||
| non-invasive prescription device. | |||
| The device is indicated for use | |||
| to acquire, analyze, display, | |||
| transmit and print | |||
| electrocardiograms. The device is indicated for use | |||
| to provide interpretation of the | |||
| data for consideration by a | |||
| physician. The device is indicated for use | |||
| in a clinical setting, by a | |||
| physician or by trained | |||
| personnel who are acting on | |||
| the orders of a licensed | |||
| physician. It is not intended as | |||
| a sole means of diagnosis. The interpretations of ECG | |||
| offered by the device are only | |||
| significant when used in | |||
| conjunction with a physician | |||
| over-read as well as | |||
| consideration of all other | |||
| relevant patient data. The device is indicated for use | |||
| on adult and pediatric | |||
| populations. The device is not intended to | |||
| be used as a vital signs | |||
| physiological monitor. The device is not designed for | |||
| out of hospital transport. | Welch Allyn Diagnostic Cardiology Suite | ||
| is not intended to be used as a | |||
| physiological vital signs monitor, not | |||
| intended to be used in a mobile medical | |||
| environment (e.g. ambulance, | |||
| helicopter), in magnetic resonance (MR) | |||
| environments, in operating theaters, nor | |||
| in conjunction with high frequency | |||
| surgical equipment. |
Indications for Welch Allyn Diagnostic
Cardiology Suite ECG range from
routine screening of cardiac health in
the physician office environment to
directed diagnostic differentiation in a
hospital cardiology department. Welch
Allyn Diagnostic Cardiology Suite ECG
is indicated for patients of all ages.
Welch Allyn Diagnostic Cardiology Suite
Spirometry is indicated for pulmonary
function testing, providing forced
expiratory flow-volume and time
measurements. The device is intended
to be a general assessment tool
assisting the clinician in the diagnosis of
pulmonary function. These devices are
commonly used on patients with
occupational exposure to dust or
chemicals; presenting with symptoms
such as chronic cough, shortness of
breath and wheezing; disorders such as
interstitial lung disease, bronchitis,
asthma, and COPD; or other patients | Electrocardiograph - Indications for
Use
Indications for electrocardiography
range from routine screening of
cardiac health in the physician office
environment to directed diagnostic
differentiation in a hospital cardiology
department.
Spirometry - Indications for Use
Indications for Spirometry include, but
are not limited to, the following:
Shortness of breath Chronic cough Occupational exposure to dust
or chemicals Assist in the diagnosis of
Bronchitis Assist in the diagnosis of
Asthma Wheezing Assist in the monitoring of
bronchodilator
Ambulatory Blood Pressure -
Indications for Use
Indications for ambulatory blood
pressure measurement (as listed in
Journal of Hypertension 2003, 21:821-
848, E. O'Brien et. at.) include, but are
not limited to, the following:
Suspected "white coat"
hypertension Suspected nocturnal
hypertension To establish dipper status Resistant hypertension Elderly patient |
| Characteristic | Reference Device | Subject Device | Predicate Device |
| | use in highly invasive environments, such as an operating theatre. | where the clinician determines these pulmonary function measurements are needed. Welch Allyn Diagnostic Cardiology Suite with Spirometry is indicated for adult and pediatric patients age 6 years and older and should only be used with patients able to understand the instructions for performing the test. | To monitor antihypertensive drug treatment Type 1 diabetes Hypertension of pregnancy Evaluations of hypotension Autonomic failure Masked hypertension |
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Non-clinical Performance Data
Non-clinical data was utilized in this submission. The non-clinical standards and tests that were submitted. referenced or relied upon to support a determination of substantial equivalence are:
ISO 14971 Medical devices - Application of risk management to medical devices (2007)
ANSI/AAMI ES 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (2005+A1:2012)
IEC 60601-1:2005+A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
ANSI/AAMI IEC 62304 Medical device software - Software life cycle processes (2006)
IEC 62366-1 Medical devices - Part 1: Application of usability engineering to medical devices (2015)
AAMI/ANSI HE75 Human Factors Engineering – Design of Medical Devices (2009 R2013)
IEC 60601-1-6 General requirements for basic safety and essential performance -Collateral standard: Usability (2010+A1:2013)
IEC 60601-2-25 Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs (2011)
ISO 26782 Anaesthetic and respiratory equipment -- Spirometers intended for the measurement of time forced expired volumes in humans (2009)
ATS 2005 Standardization of Spirometry
ISO 10993-1 (2009+Cor.1:2010) Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process. The spirometry patientcontacting materials are identical or equivalent to the materials cleared in K133428. The ECG patient-contacting materials are identical to the materials cleared in K120865.
Clinical Performance Data
No clinical studies were utilized for the purpose of showing substantial equivalence.
Conclusion
The Welch Allyn Diagnostic Cardiology Suite subject device and its predicate, the Welch Allyn CardioPerfect Workstation Software (CPWS) K082478 share the same intended use, the same modular software design, the same installation environment, the same general operating principles, the same basic technology and share similar performance claims and labeling. The Welch Allyn RScribe K120865 utilizes the same VERITAS algorithms as the subject device and has been in clinical use since 2012. Minor differences between the devices do not raise concerns of differences in safety. efficacy or intended use. Non-clinical performance tests were conducted and submitted to demonstrate that the Welch Allyn Diagnostic Cardiology Suite performs similarly to the predicate. It is Welch Allyn's opinion that the Welch Allyn Diagnostic Cardiology
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Suite subject device is substantially equivalent to its predicate, the Welch Allyn CardioPerfect Workstation Software (CPWS) cleared through K082478.