(187 days)
The SmartLink Wireless system's primary function is to transfer 12 lead 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 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.
Not Found
This document [K033642] is a 510(k) clearance letter from the FDA for the Welch Allyn Medical Research Laboratories (MRL) Inc. SmartLink Wireless Monitoring System, dated May 25, 2004. It
determines that the device is substantially equivalent to legally marketed predicate devices.
However, the provided text does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or comparative effectiveness studies.
The document only states the device's indications for use:
- 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.
- To display this data on the computer's monitor for Emergency Room staff to use for patient assessment prior to arrival, aiming to reduce treatment delays.
- To provide users of Welch Allyn PIC 50 products the capability of transmitting patient vitals wirelessly to a remote location for diagnostic purposes by trained medical personnel. Vitals may include 12-lead data, IBP, NIBP, ETCO2, Respiratory rate, Heart rate, Temperature, SPO2, and optional single lead ECG snapshot.
- To send automatic pager notifications when new patient records are received.
- To forward patient data to multiple email addresses at remote computers or PDAs.
It also explicitly states that the system is not intended to be used as a primary alarm source and received patient information should not be examined for the purpose of generating alarms.
Therefore, based solely on the provided text, I cannot answer any of the specific questions about acceptance criteria or study details. This information would typically be found in the 510(k) submission itself or in supporting clinical or performance data not included in this FDA clearance letter.
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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 (301) 594-4646. 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 (800) 638-2041 or (301) 443-6597 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
B07
Page 1 of
510(k) number K033642
§ 870.5310 Automated external defibrillator system.
(a)
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.(b)
Classification. Class III (premarket approval)(c)
Date PMA or notice of completion of PDP is required. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED that was in commercial distribution before May 28, 1976. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976. Any other AED and AED accessory described in paragraph (a), shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.