(190 days)
The Fukuda Denshi DS-5000 series Telemetry Monitoring System is indicated in those situations where centrally located hemodynamic monitoring (central station monitoring) of one or more patients cardiovascular condition is desired and those patients are currently monitored by a Fukuda Denshi bedside monitor, or is wearing a Fukuda Denshi telemetry transmitter. Use of this device is indicated only in a medically supervised healthcare environment (e.g. ER, ICU or clinic). It is not intended for home use. This device is intended for Prescription Use Only
The Fukuda Denshi model DS-5000 series Telemetry Monitoring System consists of a series of interface devices which include a central transmitter receiver, an HLX-501 Multi-parameter transmitter, LX-5120 patient worn ECG/Respiration transmitters, and a Fukuda Denshi DS-5000 series Central Patient Monitor (K970585, K000746, K020084). The unit's are processor based software control devices. The receiver module can receive data for 4 or 8 patients and can be connected either directly or by local area network (LAN) to the DS-5000 series Central Patient Monitor. Each patient data when received at the central transmitter receiver is considered as a separate network node. Input signals are provided from the patient worn LX series transmitters or from the HLX-501 Multi-parameter transmitter when connected to a Fukuda Denshi DS-5000 series patient monitor.
Patient physiological data displays, controls, recordings and alarms are controlled from the Central Patient Monitor. Recordings can also be initiated from the bedside monitor or from the patient worn transmitters. System functions such as trending, arrhythmia and ST monitoring and data access are available to the user from the central monitor.
The HLX-501 multi-parameter transmitter may provide up to six waveforms and numeric data from the bedside monitor. Parameter monitored may include ECG, SpO2, Resp, BP, NIBP and Temp.
The patient worn LX-5120 transmitter provides monitoring of ECG and Respiration parameters.
The modified transmitter subject to this submission, the patient worn LX-5630 provides ECG and Respiration monitoring identically as the LX-5120 and adds SpO2 transmission through the integration of an Pulse Oximetry OEM module designed and manufactured by Konica Minolta Sensing Inc and cleared as the Minolta Pulseox-3 LI (K010413).
Acceptance Criteria and Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Electrical Safety | Passed (Compliance with relevant standards confirmed via testing) |
| EMC Testing | Passed (Compliance with relevant standards confirmed via testing) |
| Radio Telemetry Testing | Passed (Compliance with relevant standards confirmed via testing) |
| Pulse Oximetry Accuracy | Verified compliance to clinical testing results submitted with the OEM produced predicate oximetry device (Minolta PULSOX-3Li). |
| Overall Safety & Efficacy | Deemed safe, effective, and performing as well as or better than the legally marketed predicate device(s). |
Study Information:
1. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state a specific sample size (number of patients or data points) for the "Verification and validation testing." The testing involved safety testing (electrical safety, EMC, radio telemetry) and pulse oximetry laboratory accuracy testing. The data provenance is not explicitly mentioned in terms of country of origin or whether it was retrospective or prospective. The testing aimed to confirm compliance with existing standards and predicate device performance.
2. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The document does not mention the use of experts to establish a "ground truth" for the test set in the context of diagnostic interpretation. The testing focuses on technical performance and compliance with specifications and predicate device performance.
3. Adjudication Method for the Test Set:
Not applicable. The description does not involve a diagnostic interpretation or a need for adjudication among multiple reviewers.
4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No multi-reader multi-case (MRMC) comparative effectiveness study was mentioned. The study focused on technical validation and comparison to a predicate device's established performance.
5. Standalone Performance (Algorithm Only without Human-in-the-Loop):
Yes, the testing described appears to be for standalone performance. The "Verification and validation testing" assessed the device's technical specifications, safety, and accuracy in transmitting and monitoring physiological data, and the accuracy of the integrated pulse oximeter module. This falls under the realm of evaluating the algorithm's and hardware's inherent performance.
6. Type of Ground Truth Used:
The ground truth for the technical and safety testing appears to be based on:
* Established specifications: Compliance with electrical safety, EMC, and radio telemetry standards.
* Predicate device performance data: Specifically, for pulse oximetry accuracy, the reference was the clinical testing results submitted with the Minolta PULSOX-3Li oximeter (K010413), which was a legally marketed and cleared OEM module.
7. Sample Size for the Training Set:
The document does not mention a "training set" in the context of machine learning or AI. This device is described as a telemetry monitoring system with integrated hardware modules, not a machine learning-based diagnostic tool that would require a separate training dataset.
8. How Ground Truth for the Training Set Was Established:
Not applicable, as no training set for a machine learning model is mentioned or implied for this device.
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JUN - 3 2004
Fukuda Denshi Model DS-5000 Telemetry Monitoring System Special 510(k) Device Modification
Exhibit B
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR part 870.92
The assigned 510(k) number is (k) 033711
- Submitter: Fukuda Denshi U.S.A. Inc. 17725 NE 65th St. Building C Redmond, WA 98052 Tel: 425-881-7737 Fax: 425-869-2018
| Contact Person: | Larry WalkerRegulatory Affairs ManagerRedmond, WA 98052Tel: 425-881-7737Fax: 425-869-2018 |
|---|---|
| ----------------- | ----------------------------------------------------------------------------------------------------------- |
- Date Prepared: May 3, 2004
Device Name:
| Proprietary Name: Fukuda Denshi DynaScopeModel DS-5000 Central Telemetry System | |
|---|---|
| Common Name: | Central Telemetry System |
| Classification: | Arrhythmia Detector and Alarm (§870.1025)Class III |
| Legally Marketed Device: | Fukuda Denshi DS-5000 Telemetry MonitoringSystem (K 980728)Minolta PULSOX-3Li Oximeter (K010413) |
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Exhibit B 510(k) Summary
Device Description:
The Fukuda Denshi model DS-5000 series Telemetry Monitoring System consists of a series of interface devices which include a central transmitter receiver, an HLX-501 Multi-parameter transmitter, LX-5120 patient worn ECG/Respiration transmitters, and a Fukuda Denshi DS-5000 series Central Patient Monitor (K970585, K000746, K020084). The unit's are processor based software control devices. The receiver module can receive data for 4 or 8 patients and can be connected either directly or by local area network (LAN) to the DS-5000 series Central Patient Monitor. Each patient data when received at the central transmitter receiver is considered as a separate network node. Input signals are provided from the patient worn LX series transmitters or from the HLX-501 Multi-parameter transmitter when connected to a Fukuda Denshi DS-5000 series patient monitor.
Patient physiological data displays, controls, recordings and alarms are controlled from the Central Patient Monitor. Recordings can also be initiated from the bedside monitor or from the patient worn transmitters. System functions such as trending, arrhythmia and ST monitoring and data access are available to the user from the central monitor.
The HLX-501 multi-parameter transmitter may provide up to six waveforms and numeric data from the bedside monitor. Parameter monitored may include ECG, SpO2, Resp, BP, NIBP and Temp.
The patient worn LX-5120 transmitter provides monitoring of ECG and Respiration parameters.
The modified transmitter subject to this submission, the patient worn LX-5630 provides ECG and Respiration monitoring identically as the LX-5120 and adds SpO2 transmission through the integration of an Pulse Oximetry OEM module designed and manufactured by Konica Minolta Sensing Inc and cleared as the Minolta Pulseox-3 LI (K010413).
{2}------------------------------------------------
Exhibit B 510(k) Summary
Statement of Intended Use:
The DS-5000 Series Telemetry Monitoring System is intended to be uses as a central station monitoring system for the evaluation of the cardiovascular system. It is intended to be used by or on the order of a physician or similarly qualified health care professional. The DS-5000 Series Telemetry Monitoring System is intended to be used in hospital environments; ER, ICU, a clinic or similar settings. The DS-5000 Series Telemetry Monitoring System is intended to be used in those situations where the patient is being monitored by a Fukuda Denshi DS-5000 -7000 Series bedside monitor, or patient worn telemetry transmitter where remote, central station monitoring is desired. This system is not intended for home use.
Technological Characteristics:
The addition of the model LX-5630 patient worn transmitter, to the DS-5000 series Telemetry Monitoring System does not change the fundamental technology of the unmodified system. Data is transmitted from a telemetry transmitter to a Fukuda Denshi Central Patient Monitor utilizing the same central transmitter receiver. The modification allows the addition of SpO2 monitoring from a patient worn transmitter. The monitoring of SpO2 has been available as part of the DS-5000 series Telemetry Monitoring System, through the use of the multi-parameter transmitter (model HLX-501) when connected to a DS-5000 series bedside monitor. The LX-5630 adds SpO2 monitoring, through the integration of the OEM supplied SpO2 module designed and manufactured by Konica Minolta Sensing Inc as cleared as the Minolta PULSOX - 3Li Pulse Oximetery module (K010413), to the ECG and Respiration monitoring capabilities found in the model LX-5120 patient worn transmitter which was cleared in the original submission.
The technology characteristics of the modified transmitter, Model LX-5360, do not affect the safety or efficacy of the DS-5000 series Telemetry Monitoring System. Any safety issues that may be raised by a software control medical device are either the same issues already addressed during the submission of the unmodified devices or are addressed in the hazard analysis and verification/validation process.
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Exhibit B 510(k) Summary
Testing:
Verification and validation testing were conducted to establish the performance and reliability characteristics of the modified device. Testing involved safety testing from the risk analysis including electrical safety testing, EMC testing and radio telemetry testing. Additionally pulse oximetry laboratory accuracy testing was conducted to verify compliance to clinical testing results submitted with the OEM produced predicate oximetry device. Acceptance criteria were based on the specifications cleared for the predicate devices and test results showed substantial equivalence
Conclusion:
The conclusion drawn from the verification and validation testing . of the modified DS-5000 Series Telemetry Monitoring System demonstrates that the device is safe and effective and performs as well or better than the legally marketed predicate device(s).
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 3 2004
Fukuda Denshi USA, Inc. c/o Mr. Larry D. Walker Regulatory Affairs Manager 17725 N.E. 65th St., Building C Redmond, WA 98052
Re: K033711
KU33711
Trade Name: Fukuda Denshi DS-5000 Telemetry Monitoring System and LX-5630 Transmitter Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: II (two) Product Code: MHX Dated: May 3, 2004 Received: May 5, 2004
Dear Mr. Walker:
We have reviewed your Section 510(k) premarket notification of intent to market the indication we nave reviewed your Security (the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for the stated in the encrosule) to regally management date of the Medical Device American Canada Frank Frank Frank commerce prior to May 20, 1976, the exaccidance with the provisions of the Federal Food, Drug, devices that have been recadsined in accessful of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket a Act . The You may, therefore, market the device, subject to the general controls provisions of the Act. The You may, therefore, market the as received, of the Act include requirements for annual registration, listing of general controls provisions of alle ties 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 II your device is classified (see aberty) me existing major regulations affecting your device can inay be subject to suen additional controllations, Title 21, Parts 800 to 898. In addition, FDA may be found in the extrements concerning your device in the Federal Register.
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Page 2 - Mr. Larry D. Walker
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I loase be actised that I termination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I oderal 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 form in the quand of our of troll provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product in allow you to begin marketing your device as described in your Section 510(k) I the letter withing of substantial equivalence of your device of your device to a legally marketed prodicate 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 responsibilities 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.P. Oden
Bram D. Zuckerman, M.D. (
Bram D. Zuckerman, Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{6}------------------------------------------------
Exhibit E Indication for Use
| 510(k) Number ifKnown | K033711 |
|---|---|
| Device Name | Fukuda Denshi DS-5000 Telemetry MonitoringSystem |
| Indication for Use | The Fukuda Denshi DS-5000 series TelemetryMonitoring System is indicated in those situationswhere centrally located hemodynamic monitoring(central station monitoring) of one or more patientscardiovascular condition is desired and thosepatients are currently monitored by a FukudaDenshi bedside monitor, or is wearing a FukudaDenshi telemetry transmitter. Use of this device isindicated only in a medically supervised healthcareenvironment (e.g. ER, ICU or clinic). It is notintended for home use. This device is intended forPrescription Use Only |
× Prescription Use (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 CDHR, Office of Device Evaluation (ODE)
for BD2
(Division Sign-Off)
Division of Cardiovascular Devices
| 510(k) Number | K053711 |
|---|---|
| --------------- | --------- |
Page 1 of
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
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.(b)
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.