ACUITY CENTRAL STATION, MODEL 020XXXXX (NOTE: XXXXX = VARIOUS CONFIG.)
Device Facts
| Record ID | K052160 |
|---|---|
| Device Name | ACUITY CENTRAL STATION, MODEL 020XXXXX (NOTE: XXXXX = VARIOUS CONFIG.) |
| Applicant | Welch Allyn, Inc. |
| Product Code | DSI · Cardiovascular |
| Decision Date | Dec 16, 2005 |
| Decision | SESE |
| Submission Type | Abbreviated |
| Regulation | 21 CFR 870.1025 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
The Acuity® Central Monitoring Station is intended to be used by clinicians for the central monitoring of neonatal, pediatric, and adult patients in health care facilities. In addition to the central monitoring of patient data, waveforms, alarms and alerts, the Acuity software can include optional modules to provide extended recording of patient data (Full Disclosure), arrhythmia monitoring and ST analysis. - Full Disclosure stores patient data for up to 96 hours. - Arrhythmia monitoring module provides real-time monitoring and alarms for specific changes in cardiac rhythms. The clinician is responsible for determining the clinical significance of each detected arrhythmia event or alarm. The arrhythmia module is not intended for use with neonatal patients. - ST analysis module provides real-time monitoring and alarms for ST segment deviations, from a reference beat, for patients with suspected heart disease and anomalies. The clinician is responsible for determining the clinical significance of each selected ST segment deviation or alarm. The ST analysis module is not intended for use with neonatal patients.
Device Story
Acuity Central Monitoring Station is a digital system for central monitoring of patient data, waveforms, and alarms; connects to bedside monitors via network (hard-wired or wireless 802.11). System collects ECG data; performs arrhythmia detection and ST segment analysis; provides 96-hour full disclosure storage. Used in clinical settings by physicians, nurses, or healthcare providers. Output displayed on station monitor; alerts clinicians to cardiac rhythm changes or ST deviations. Clinician responsible for interpreting significance of alarms. Benefits include centralized patient oversight and extended data recording for clinical decision-making.
Clinical Evidence
Bench testing only. Performance evaluated using AHA and MIT-BIH databases. QRS detection sensitivity reported as 99.86% (AHA) and 99.95% (MIT); QRS positive predictivity 99.89% (AHA) and 99.88% (MIT); Ventricular sensitivity 93.26% (AHA) and 95.52% (MIT); Ventricular positive predictivity 98.21% (AHA) and 97.07% (MIT).
Technological Characteristics
Digital central monitoring station; supports 3 or 5 wire ECG (7 vector display). Connectivity via hard-wired or wireless 802.11 network. Data sampling: 180 samples/sec for display, 500 samples/sec for arrhythmia analysis. Includes arrhythmia noise detection. Software-based analysis for heart rate, arrhythmia, and ST segment deviation. Prescription use only.
Indications for Use
Indicated for central monitoring of neonatal, pediatric, and adult patients in healthcare facilities. Arrhythmia and ST analysis modules are indicated for pediatric and adult patients only; not indicated for neonatal patients.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- Acuity® Central Monitoring System (K022453)
- Acuity Central Station (K972121)
- Model Acuity Central Station (K935846)
Submission Summary (Full Text)
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DEC 16 2005
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## 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with This summaly of STO(K) sailety and enocifical mornation supporting claims of substantial the requirements of OMDA 1000 and E. R. R. S. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . effectiveness is outlined below.
| Date Prepared: | July 27, 2005 | | |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|----------------------------|
| Name of Submitter: | John E. Sawyer<br>Director, World Wide Regulatory Affairs<br>Welch Allyn, Inc<br>4341 State Street Road<br>Skaneateles Falls, NY 13153-0220 | | |
| Device Proprietary Name: | Acuity® Central Monitoring Station | | |
| Classification Name: | Arrhythmia Detector and Alarm (Including ST Segment and<br>Alarm) | | |
| Common/Usual Names: | Arrhythmia Detector and Alarm | | |
| Predicate Device: | The subject device has the same indications for use as the<br>predicates. | | |
| | K022453 | Acuity® Central Monitoring System | Welch Allyn Protocol, Inc. |
| | K972121 | Acuity Central Station | Protocol Systems, Inc. |
| | K935846 | Model Acuity Central Station | Protocol Systems, Inc. |
### Device Description:
Acuity® Central Monitoring Station Product Code: DSI and MLD CFR Section: 870.1025
The Acuity® Central Monitoring Station is Welch Allyn's Central Monitoring solution. It consists of the I no routy® Central Monitoring Station, the Acuity software and a collection of other commercially available networking hardware products. The system connects to a network of patient monitors to record and analyze the data being acquired by those devices. This solution offers a proven record and untily to the auto and features needed to support a distributed network of connected devices while providing arrhythmia detection and alarms for adult and pediatric patients.
The Acuity system supports patient information management, patient alert and alarm management, rite noaty oyotem administration and product installation and service. It leverages various networking and connectivity options to obtain and distribute information where and when needed.
Acuity is available in multiple product configurations. Acuity systems can be ordered off-the-
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510(k) Summary - Acuity® Central Monitoring Station
shelf or custom configured to meet a customer's unique needs based on hospital policy, healthcare Shell of custom conlingured to meet a oaster. In all cases, the user must carefully review the features facility size, patient cerisus and noor rayour and the Acuity® Central Monitoring Station to ensure that clinical needs are met.
The Acuity® Central Monitoring Station is not directly connected to patients. It is designed to be used The Aculty® Octitur Monitoring Station of patient monitors supporting both continuously and as a central monkoning oyeten for a sites supported include, but are not limited to, the following interfilterity acquired duta: The mentlers supported to interface with Acuity.
Acuity systems monitor patient data supplied by a bedside monitor and do further processing of that Aculty Systems monitor pation acts eappliering Station. Acuity systems with the arrhythmia option data by Sollware at the Acally® Oontral mornethmia analysis algorithms, where the bedside calculate heart rate algorithm based on data from a single ECG lead. The overall performance monitor uses a ficult rato algontining and data management techniques consistent with industry practice and applicable standards.
It is important to note that some Acuity software options and/or devices will support adult and it is important to not other neonatal patients. Specifically, the ST Analysis and Arrhythmia Analysis software options are intended only for adult and pediatric patients.
Acuity® Central Monitoring Stations and distributed monitoring devices are prescription devices to be Aculty® Ochrail Mohitoring blancher by institutional standard procedures and good clinical practice guidelines for monitoring of specific patients. Staff trained in the operation of Acuity clinical praction monitoring devices connected to it is essential for optimal use. System users should and the patient monitoring doniose connese, physician, healthcare provider or medical specialist.
## Indications For Use
The Acuity® Central Monitoring Station is intended to be used by clinicians for the central monitoring of neonatal, pediatric, and adult patients in health care facilities.
In addition to the central monitoring of patient data, waveforms, alarms and alerts, the Acuity software can include optional modules to provide extended recording of patient data (Full Disclosure), arrhythmia monitoring and ST analysis.
- Full Disclosure stores patient data for up to 96 hours. .
- r an blood an entoring module provides real-time monitoring and alarms for specific changes in . cardiac rhythms. The clinician is responsible for determining the clinical significance of each cardido mythmia event or alarm. The arrhythmia module is not intended for use with neonatal patients.
- pations.
ST analysis module provides real-time monitoring and alarms for ST segment deviations, from a . reference beat, for patients with suspected heart disease and anomalies. The clinician is responsible for determining the clinical significance of each selected ST segment deviation or alarm. The ST analysis module is not intended for use with neonatal patients.
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Image /page/2/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.
# Technological Comparison to Predicate Devices:
| | Subject | Predicate | |
|---------------------------------------------|----------------------------------------------------------------------------------|----------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| | | Welch Allyn Protocol | Protocol Systems |
| Manufacturer | Welch Allyn Protocol | | K935846 / K972121 |
| 510(k) Number | Pending | K022453 | |
| Device Name | Acuity® Central Monitoring<br>Station | Modification to<br>Acuity Central Monitoring<br>System | Acuity Central Station |
| Classification<br>Code | Pending | DSI | MLD |
| Patient Population | Neonate, Pediatric, Adult<br>No arrhythmia support or<br>ST analysis for neonate | Neonate, Pediatric, Adult<br>No arrhythmia support or<br>ST analysis for neonate | Neonate, Pediatric, Adult<br>No arrhythmia support or<br>ST analysis for neonate |
| Use Environment | Medical/Clinical | Medical/Clinical | Medical/Clinical |
| Analog or Digital | Digital | Digital | Digital |
| Electrode<br>Configuration | 3 or 5 wire: 7 vector<br>display | 3 or 5 wire: 7 vector<br>display | 3 or 5 wire: 7 vector<br>display |
| Frequency<br>Response | Not Used | Not Used | Not Used |
| Input Impedance | Not Used | Not Used | Not Used |
| Dynamic Range | Not Used | Not Used | Not Used |
| Common Mode<br>Rejection Rate<br>(CMMR) | Not Used | Not Used | Not Used |
| QRS Detection<br>Sensitivity | AHA 99.87 MIT 99.95 | AHA 99.88 MIT 99.93 | AHA 99.18 MIT 99.51 |
| Pacemaker Pulse<br>Rejection | Not Used | Not Used | Not Used |
| System Noise | Arrhythmia Noise<br>Detection | Arrhythmia Noise<br>Detection | Arrhythmia Noise<br>Detection |
| Hard-wired and/or<br>Wireless | Both | Both | Both |
| Radio Frequency<br>Telemetry | Wireless 802.11 support | Wireless 802.11 support | 455 to 465 MHz |
| Transtelephonic<br>and/or Fax<br>Capability | Technical Support Remote<br>Dial Up | Technical Support<br>Remote Dial Up | Technical Support<br>Remote Dial Up |
| Alarm<br>Levels/Mgmt.<br>Standalone | Vital Signs, Arrhythmia,<br>and ST Analysis | Vital Signs, Arrhythmia,<br>and ST Analysis | Vital Signs, Arrhythmia,<br>and ST Analysis |
| Alarm<br>Levels/Mgmt.<br>Connected/Linked | Vital Signs, Arrhythmia,<br>and ST Analysis | Vital Signs, Arrhythmia,<br>and ST Analysis | Vital Signs, Arrhythmia,<br>and ST Analysis |
| Data Storage | 96 hour Full Disclosure | 96 hour Full Disclosure | 96 hour Full Disclosure |
| Samples per<br>second - Bit<br>Resolution | 180 samples/sec for<br>display<br>500 samples/sec for | 180 samples/sec for<br>display<br>500 samples/sec for<br>arrhythmia | 180 samples/sec for<br>display<br>500 samples/sec for<br>arrhythmia |
| | arrhythmia | | |
| | AHA | MIT | |
| QRS Sensitivity | 99.86 | 99.95 | |
| QRS Positive Predictivity | 99.89 | 99.88 | |
| Ventricular Sensitivity | 93.26 | 95.52 | |
| Ventricular Positive Predictivity | 98.21 | 97.07 | |
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510(k) Summary - Acuity® Central Monitoring Station
# Performance Data:
# Conclusions:
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
The Acuity® Central Monitoring Station is as safe, as effective and performs as well as the legally marketed devices predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
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DEC 1 6 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Welch Allyn, Inc. c/o Mr. John E. Sawyer C/0 MIT John E. BanJa
Vice President, World Wide Regulatory Affairs 4341 State Street Road Skaneateles Falls, NY 13153-0220
Re: K052160
Trade Name: Acuity® Central Monitoring Station Regulation Number: 21 CFR 870.1025 Regulation Number: 21 CFR 8 70.1025
Regulation Name: Arrhythmia Detector and Alarm (including ST-segment measurement
Programmand Arrhythmia Detector and Alarm (including ST and alarm) Regulatory Class: Class II (two) Product Code: DSI Dated: November 08, 2005 Received: November 15, 2005
Dear Mr. Sawyer:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 3 IQ(x) prematics is substantially equivalent (for the indications
referenced above and have determined the device marketed in interstate referenced above and have determined the devices marketed in interstate for use stated in the enclosure) to regally manced producal Device Amendments, or to
commerce prior to May 28, 1976, the enactment of the Federal Food. Drue commerce prior to May 28, 1976, the enactinent and of the Federal Food, Drug, devices that have been reclassified in accordance with as proval application (PMA).
and Cosmetic Act (Act) that do not required as assess as arrovisions of the Act. The and Cosmetic Act (Act) that do not require approval or a pell controls provisions of the Act. The
You may, therefore, market the device, subject to the emerge for emistrati You may, therefore, market the device, subject to the gents for annual registration, listing of
general controls provisions of the Act include requirements misbranding and general controls provisions of the Act merade requirement.
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 If your device is classified (see above) mio child cass if eperilations affecting your device can
may be subject to such additional controls. Existing major regulations affe may be subject to such additions. Existing may of the 21, Parts 800 to 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to Regist be found in the Code of I cacral regarates, in the Federal Register.
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Page 2 – Mr. John E. Sawyer
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s Issualice of a substance of the requirements of the Act
that FDA has made a determination that your device complies with other requires. You must that FDA has made a decemination and regulations administered by other Federal agencies. You must a or any Federal statures and regulations daministered or registration and listing (21)
comply with all the Act's requirements, including, but not limited to set comply with all the Act 3 requirements, me, and manufacturing practice requirements as setting CFR Part 807), labeling (21 CFR Part 800); god and 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and 11 app 1000, 10 forth in the quality systems (Sections 531-542 of the Act); 21 CFF 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFF 1000-1050. product radiation control provisions (Declons 507 C vice as described in your Section 510(k)
This letter will allow you to begin marketing your device as described in your de I his letter will anow you to ocgin manxomis your antial equivalence of your device to a legally premarket nothcation. The PDA midning of substance results and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Patt 801), please If you desire specific advice for your dones at (240) 276-0120. Also, please note the regulation entitled, Contact the Office of Comphalloo at (210) 276 - 11 - 11 807.97). You may obtain " Misorationing by reference to promantee nowlite as a carrest the Act from the Division of Small other general information on your responsionner at its toll-free number (800) 638-2041 or Manufacturers, International and Consumer Fissionality and corporation of the many in the support/index.html.
Sincerely yours,
B. Ammerman for
Brath 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
Abbreviated 510(k) Premarket Notification Acuity® Central Monitoring Station
#### Statement of Indications for Use 1
KO58160 510(k) Number (if known):
Acuity® Central Monitoring Station Device Name:
# Indications for Use:
:
The Acuity® Central Monitoring Station is intended to be used by clinicians for the The Acarey of neonatal, pediatric, and adult patients in health care facilities.
In addition to the central monitoring of patient data, waveforms, alarms and alerts, the Acuity software can include optional modules to provide extended recording of patient data (Full Disclosure), arrhythmia monitoring and ST analysis.
- Full Disclosure stores patient data for up to 96 hours. .
- Arrhythmia monitoring module provides real-time monitoring and alarms for specific . changes in cardiac rhythms. The clinician is responsible for determining the clinical eilance of each detected arrhythmia event or alarm. The arrhythmia module is not intended for use with neonatal patients.
- ST analysis module provides real-time monitoring and alarms for ST segment . B r unalyons from a reference beat, for patients with suspected heart disease and avomalies. The clinician is responsible for determining the clinical significance of each selected ST segment deviation or alarm. The ST analysis module is not intended for use with neonatal patients.
| (Part 21 CFR 801 Subpart D) | (Part 21 CFR 807 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 of Cardiovascular Devices | |
| 510(k) Number | K052160 |
Section 1 – Page 1 of 1
AND/OR
MPD FCD-0025, Rev. 2
Prescription Use
X
This document contains information considered to be CONFIDENTIAL to Welch Allyn, Inc.
Over-The-Counter Use
DD 007 Cubnart
