SMARTLANK WIRELESS, MODEL 001970

K033642 · Mrl, A Welch Allyn Company · MKJ · May 25, 2004 · Cardiovascular

Device Facts

• Record ID: K033642
• Device Name: SMARTLANK WIRELESS, MODEL 001970
• Applicant: Mrl, A Welch Allyn Company
• Product Code: MKJ · Cardiovascular
• Decision Date: May 25, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5310
• Device Class: Class 3

Indications for Use

The SmartLink Wireless system's primary function is to transfer 12 lead ECG and other vital signs data from a Welch Allyn PIC50 Defibrillator/Monitor at a remote location to a personal computer station, and to display the data on the computer's monitor. The data is intended to be used by Emergency Room staff for the patient assessment prior to arrival of the patient at the Emergency Room, in order to reduce the delay in treating the patient upon arrival. The SmartLink Wireless system can be used to: Provide users of Welch Allyn PIC 50 products in the field the capability of transmitting patient vitals using wireless technology to a remote location. At the remote location the information will be used for diagnostic purposes by trained medical personnel. Patient's vitals may include 12 lead data, IBP, NIBP, ETCO2, Respiratory rate, Heart rate, Temperature, SPO2, and optional single lead ECG snapshot. Send automatic pager notification when a new patient record is received at the personal computer station. Forward the patient data to any number of e-mail address at remote computers or personal digital assistants. The SmartLink Wireless system is not intended to be used as a primary alarm source. Patient information received by the SmartLink Wireless system should not be examined for the purpose of generating alarms.

Device Story

SmartLink Wireless system facilitates wireless transmission of patient vital signs from field-deployed Welch Allyn PIC50 Defibrillator/Monitors to a remote personal computer station. Inputs include 12-lead ECG, IBP, NIBP, ETCO2, respiratory rate, heart rate, temperature, SPO2, and single-lead ECG snapshots. System transmits data via wireless technology to a receiving PC, which displays information for ER staff assessment. Features include automatic pager notifications upon record receipt and data forwarding capabilities to email addresses or PDAs. Device serves as a secondary monitoring tool to expedite clinical decision-making and patient treatment upon arrival at the hospital. Not intended for primary alarm generation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Wireless data transmission system; interfaces with Welch Allyn PIC50 Defibrillator/Monitor; outputs to PC/PDA; utilizes wireless communication protocols for remote data relay.

Indications for Use

Indicated for transmission and display of patient vital signs (12-lead ECG, IBP, NIBP, ETCO2, Resp rate, HR, Temp, SPO2) from field-based Welch Allyn PIC50 monitors to remote ER staff for pre-arrival assessment. Not for use as a primary alarm source.

Regulatory Classification

Identification

An automated external defibrillator (AED) system consists of an AED and those accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., battery, pad electrode, adapter, and hardware key for pediatric use). An AED system analyzes the patient's electrocardiogram, interprets the cardiac rhythm, and automatically delivers an electrical shock (fully automated AED), or advises the user to deliver the shock (semi-automated or shock advisory AED) to treat ventricular fibrillation or pulseless ventricular tachycardia.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES-USA

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 5 2004

Welch Allyn, Inc. c/o Mr. David Klementowski Sr. Manager, Regulatory Affairs 4341 State Street Road Skaneateles Falls, NY 13153

Re: K033642

Trade Name: Welch Allyn Medical Rescarch Laboratories (MRL) Inc. SmartLink Wireless Monitoring System Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: Class III (three) Product Code: MKJ Dated: February 25, 2004 Received: May 04, 2004

Dear Mr. Klementowski:

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 cither 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. David Klementowski

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r fease or acreased 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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 contact the 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 responsibilitics under the Act may be obtained from the Division of Small Manufacturers, International 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,

Neil R. Ogle

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Hcalth

Enclosure

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510(k) Number (if known):

## Device Name:_SmartLink Wireless

Indications For Use: The SmartLink Wireless system's primary function is to transfer 12 Inaleations nd other vital signs data from a Welch Allyn PIC50 Defibrillator/Monitor at a remote location to a personal computer station, and to display the data on the computer's monitor. The data is intended to be used by Emergency Room staff for the bempater & matient assessment prior to arrival of the patient at the Emergency Room, in order to reduce the delay in treating the patient upon arrival.

The SmartLink Wireless system can be used to:

- Provide users of Welch Allyn PIC 50 products in the field the capability of . transmitting patient vitals using wireless technology to a remote location. At the remote location the information will be used for diagnostic purposes by trained medical personnel. Patient's vitals may include 12 lead data, IBP, NIBP, ETCO2, Respiratory rate, Heart rate, Temperature, SPO2, and optional single lead ECG snapshot.
- Send automatic pager notification when a new patient record is received at the . personal computer station.
- Forward the patient data to any number of e-mail address at remote computers . or personal digital assistants.

The SmartLink Wireless system is not intended to be used as a primary alarm source. Patient information received by the SmartLink Wireless system should not be examined for the purpose of generating alarms.

Prescription Use x (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (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)

Neil RP Order for
(Division Sign-Off)
Divisi vascular Devices
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510(k) number K033642