WELCH ALLYN CARDIOPERFECT WORKSTATION VERSION 1.5.0 SOFTWARE

K052158 · Welch Allyn, Inc. · BZG · Sep 8, 2005 · Anesthesiology

Device Facts

• Record ID: K052158
• Device Name: WELCH ALLYN CARDIOPERFECT WORKSTATION VERSION 1.5.0 SOFTWARE
• Applicant: Welch Allyn, Inc.
• Product Code: BZG · Anesthesiology
• Decision Date: Sep 8, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.1840
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

Intended Use

The CardioPerfect Workstation software 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 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, subject to any specific contraindications identified below.

Device Story

CardioPerfect Workstation software operates on off-the-shelf Windows/DOS PCs; integrates ECG, ABP, and spirometry modules. Inputs: physiologic signals from connected hardware modules. Processing: software acquires, formats, displays, stores, and prints data; optional MEANS algorithm provides advisory interpretive statements for resting ECG. Output: waveforms, measurements, and interpretive reports for clinician review. Used in hospitals/clinics by physicians or under physician order. Facilitates diagnosis and monitoring of cardiac and pulmonary conditions; supports EMR data export and patient management. Benefits: centralized diagnostic data access and standardized reporting for clinical decision-making.

Clinical Evidence

No clinical data provided. Device relies on established performance of predicate modules and algorithms (MEANS). Bench testing only.

Technological Characteristics

Software-based workstation for ECG, ABP, and spirometry. Operates on standard Windows/DOS desktop or laptop PCs. Includes optional MEANS algorithm for resting ECG interpretation. Connectivity includes EMR data export. No specific hardware materials or sterilization methods applicable to the software component.

Indications for Use

Indicated for adult and pediatric patients in hospital or clinic settings for ECG (stress/resting), ambulatory blood pressure (ABP) monitoring, and spirometry. Resting ECG with optional MEANS algorithm indicated for patients 16+ years. Spirometry normal values not calculated for children under 6. Specific indications include cardiac screening, hypertension management (white coat, nocturnal, resistant, pregnancy-related, masked), hypotension evaluation, autonomic failure, diabetes, and pulmonary conditions (shortness of breath, cough, bronchitis, asthma, wheezing).

Regulatory Classification

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.

Predicate Devices

• ECG-resting, CardioPerfect with Means (K962854)
• ECG-stress, CardioPerfect ST (K935732)
• Caird Technology Spirometer (K971336)

Submission Summary (Full Text)

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K052158

p/13

Image /page/0/Picture/1 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.

SEP = 8 2005

Special 510(k) Premarket Notification CardioPerfect Workstation Software Version 1.5.0 and Accessory Product

### 11. Premarket Notification [510(k)] Summary

- Welch Allyn, Inc. Submitted By: 4341 State Street Road P.O. Box 220 Skaneateles Falls, NY 13153-0220
315 685 3694 Phone: [phone] Fax:

Contact: Christopher Klaczyk, Regulatory Affairs Manager

- Medical Device Software for interpretive and stress testing Common Name: electrocardiographs, and diagnostic spirometry
Welch Allyn CardioPerfect Workstation software (with) Trade Name:

> CardioPerfect Workstation Resting ECG Module CardioPerfect Workstation ST ECG Module CardioPerfect Workstation SpiroPerfect Module CardioPerfect Workstation ABP Module

| Classification: | |
|-----------------|-----------------|
| LOS: | None |
| DSI: | 21 CFR 870.1025 |
| DXN: | 21 CFR 870.1130 |
| BZG: | 21 CFR 868.1840 |

- ECG-resting, CardioPerfect with Means, K962854 Predicate Device: ECG-stress, CardioPerfect ST, K935732 Caird Technology Spirometer, K971336
- CardioPerfect Workstation software is used to create a computer Description: platform on which ECG, ABP, & Spirometry applications can operate within inherent capabilities of an off-the-shelf desktop or laptop personal computer utilizing a Windows or DOS based operating system.

Indications for use:

### CardioPerfect Workstation Software Version 1.5.0 and Accessories Product

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K052159
p2/3

# WelchAllyn

Special 510(k) Premarket Notification CardioPerfect Workstation Software Version 1.5.0 and Accessory Product

The CardioPerfect Workstation software and associated accessories are indicated for the The Cardion, 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 various diseases and of weatherns such as patient management, data security, search tools for provides non thaghebels rand support for exporting data to Electronic Medical Record systems.

The CardioPerfect Workstation and associated accessories are intended for use by or on the order I ho Cardio' in in a hospital or clinic setting. The product is designed for use on both adult and pediatric patients, subject to any specific contraindications identified below.

### Electrocardiograph - Stress

Using the optional ECG module and associated accessories the user can acquire, view, store and obing are specificans for electrocardiography range from routine screening of cardiac health in the physician office environment to directed diagnostic differentiation in a hospital cardiology department.

### Electrocardiograph - Resting

The same as defined for stress ECG plus the ability to use optional algorithms (MEANS) to generate measurements, data presentations, graphical presentations and interpretive statements on an advisory basis for patients sixteen (16) years of age and above. These are presented for review and interpretation by the clinician.

### Ambulatory Blood Pressure

Using the optional ABP module and associated accessories the user can acquire, retrieve, view, store and print patient ambulatory blood pressure history. Indications for ambulatory blood pressure measurement (as listed in Journal of Hypertension 2003, 21:821-848, E. O'Brien et. al.) include, but are not limited to, the following:

- suspected "white coat" hypertension .
- Suspected nocturnal hypertension .
- To establish dipper status .
- Resistant hypertension .
- . Elderly patient
- To monitor antihypertensive drug treatment .
- Type 1 diabetes .
- Hypertension of pregnancy .
- Evaluations of hypotension .
- Autonomic failure .
- Masked hypertension .

### Spirometry

Using the optional spirometry module and associated accessories to acquire, view, store and print measures and waveforms of pulmonary function. Normal values and comparative results are not calculated for children under the age of six. Indications for spirometry include, but are not limited to, the following:

- Shortness of breath .

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# WelchAllyn

Special 510(k) Premarket Notification CardioPerfect Workstation Software Version 1.5.0 and Accessory Product

- 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 .

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" written around the perimeter of the circle.

SEP - 8 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Welch Allyn, Inc c/ o Mr. Christopher Klaczyk Regulatory Affairs Manager 4341 State Street Road P.O. Box 220 Skaneateles Falls, NY 13153-0220

Re: K052158

Trade Name: CardioPerfect Workstation Software Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: Class II (two) Product Code: BZG Dated: August 5, 2005 Received: August 9, 2005

Dear Mr. Klaczyk:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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Page 2 - Mr. Christopher Klaczyk

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); 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. product radially w you to begin marketing your device as described in your Section 510(k) I mo letter wrification. The FDA finding of substantial equivalence of your device to a legally premated predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please it you attent office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Other general mironmational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Brimmer for

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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### WelchAllyn

Special 510(k) Premarket Notification CardioPerfect Workstation Software Version 1.5.0 and Accessory Product

10. Statement of Indications For Use

K052158 510(k) Number:

Device Name:

CardioPerfect Workstation, Software Version 1.5.0 and Accessories Product.

### CardioPerfect Workstation Software Version 1.5.0 and Accessories Product

The CardioPerfect Workstation software 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 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, subject to any specific contraindications identified below.

### Electrocardiograph - Stress

Using the optional ECG module and associated accessories the user can acquire, view, store and print ECG waveforms. Indications for electrocardiography range from routine screening of cardiac health in the physician office environment to directed diagnostic differentiation in a hospital cardiology department.

### Electrocardiograph - Resting

The same as defined for stress ECG plus the ability to use optional algorithms (MEANS) to generate measurements, data presentations, graphical presentations and interpretive statements on an advisory basis for patients sixteen (16) years of age and above. These are presented for review and interpretation by the clinician.

### Ambulatory Blood Pressure

Using the optional ABP module and associated accessories the user can acquire, retrieve, view, store and print patient ambulatory blood pressure history. Indications for ambulatory blood pressurement (as listed in Journal of Hypertension 2003, 21:821-848, E. O'Brien et. al.) include, but are not limited to, the following:

- Suspected "white coat" hypertension .
- . Suspected nocturnal hypertension
- To establish dipper status .
- Resistant hypertension �
- . Elderly patient
- To monitor antihypertensive drug treatment .
- Type 1 diabetes �
- Hypertension of pregnancy �
- Evaluations of hypotension .

- Autonomic failure .
Masked hypertension *

Page 48 of 52 This document contains information considered to be CONFIDENTIAL to Welch Allyn, Inc.

MPD FCD-0026, Rev. 2

page 1 of 2

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## Welch Allyn

Special 510(k) Premarket Notification CardioPerfect Workstation Software Version 1.5.0 and Accessory Product

#### Spirometry

Using the optional spirometry module and associated accessories to acquire, view, store and print measures and waveforms of pulmonary function. Normal values and comparative results are not calculated for children under the age of six. Indications for spirometty 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 ◆

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

B. Rymmmer

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K052158

MPD FCD-0026, Rev. 2

Page 49 of 52 This document contains information considered to be CONFIDENTIAL to Welch Allyn, Inc.