(72 days)
The Infinity MultiView WorkStation, Infinity Network and Remote Display are indicated for use as a central monitoring device, communications network, and remote display for Draeger Patient Monitoring Systems and recorders.
Use of the Infinity MultiView WorkStation Telemetry System is indicated for adult and pediatric patient populations in an environment where patient care is provided by Healthcare Professionals (Physicians, Nurses, Technicians) when the professional determines that a device is required to measure and produce visual and audible alarms for any one or more of the following parameters:
- Heart rate .
- ECG Arrhythmia Analysis .
- Arterial oxygen saturation .
- Pulse rate .
- ST segment analysis .
Infinity Telemetry Pacer Fusion
Infinity MultiView Telemetry with VF6 software supports the new pacer detection mode, Fusion. The Pacer Fusion mode has increased sensitivity to psuedofusion paced beats, sometimes known as fused beats.
Infinity Symphony
The MultiView WorkStation with VF6 supports the new web-based browser application, Infinity Symphony, for enhanced full disclosure review. Infinity Symphony provides users with retrospective reviews of stored continuous and episodic patient information -- continuous physiologic waveforms and other stored data over an extended period of time -- to provide review, analysis, and documentation of the patient's condition.
The provided text is related to a 510(k) summary for a medical device called "Infinity MultiView Workstation and Telemetry" manufactured by Draeger Medical Systems, Inc. However, it does not contain any information about acceptance criteria, device performance, sample sizes used for testing, expert qualifications, adjudication methods, details of comparative effectiveness studies, standalone performance, type of ground truth used, or details about the training set.
The document primarily describes:
- The device name and classification.
- The submitter's information.
- A brief description of the device's features (Pacer Fusion mode, Infinity Symphony web-based browser application).
- The intended use of the device as a central monitoring device, communications network, and remote display for Draeger Patient Monitoring Systems, measuring vital signs like heart rate, ECG arrhythmia analysis, arterial oxygen saturation, pulse rate, and ST segment analysis.
- A statement regarding substantial equivalence, noting that "Verification and validation testing performed indicates that the modifications implemented are as safe and effective as previous versions and have not altered the fundamental technology of the device(s)." It explicitly states "Assessment of clinical performance data for equivalence: Not applicable".
- The FDA's letter of clearance stating that the device is substantially equivalent to legally marketed predicate devices.
Therefore, I cannot provide the requested table and study details as that information is not present in the provided text.
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K060223
P1/2
APR 1 2 2006
510(k) SUMMARY
as required per 807.92(c)
Submitter's Name and Address: Draeger Medical Systems, Inc. 16 Electionics Avenue Danvers, MA 01923
Contact Person:
Karen Iorio, Director OA/RA Ph: (978) 564-8364 Fax: (978) 750-6879
Date submission was prepared:
January 25, 2006
Device Name:
Detector and Alarm, Arrhythmia
Classification Name: MHX
Regulation Number: 21 CFR 870.1025
2
Class:
Common Name:
Legally Marketed Device Identification:
Infinity MultiView Workstation and Telemetry
Device Description:
Infinity Telemetry Pacer Fusion
Infinity MultiView Telemetry with VF6 software supports the new pacer detection mode, Fusion. The Pacer Fusion mode has increased sensitivity to psuedofusion paced beats, sometimes known as fused beats.
Infinity Symphony
The MultiView WorkStation with VF6 supports the new web-based browser application, Infinity Symphony, for enhanced full disclosure review. Infinity Symphony provides users with retrospective reviews of stored continuous and episodic patient information -- continuous physiologic waveforms and other stored data over an extended period of time -- to provide review, analysis, and documentation of the patient's condition.
1 of 2
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Intended Use:
The Infinity MultiView WorkStation, Infinity Network and Remote Display are indicated for use as a central monitoring device, communications network, and remote display for Draeger Patient Monitoring Systems and recorders.
060223 , 2/2
The Infinity MultiView WorkStation (MVWS) Telemetry System is intended to measure and produce visual and audible alarms for one or more physiological parameters
This device is intended for use in an environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition.
Substantial Equivalence:
Assessment of non-clinical performance data for equivalence:
Verification and validation testing performed indicates that the modifications implemented are as safe and effective as previous versions and have not altered the fundamental technology of the device(s).
Assessment of clinical performance data for equivalence: Not applicable
Biocompatability: Not applicable
Sterilization: Not applicable
Standards and Guidance: IEC 60601-1
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized lines forming its body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 2 2006
Draeger Medical Systems, Inc. c/o Mr. Thomas M. McIntosh Regulatory Submission Manager 16 Electronics Avenue Danvers, MA 01923
Re: K060223
Trade Name: Infinity MultiView WorkStation and Telemetry Regulation Number: 21 CFR 870.1025 Regulation Name: Patient Physiological Monitor (with arrhythmia detection or alarms) Regulatory Class: Class II (two) Product Code: MHX Dated: March 21, 2006 Received: March 22, 2006
Dear Mr. McIntosh:
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. Thomas M. McIntosh
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 that I Dr lass Intactions and regulations administered by other Federal agencies. You must or any I 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 Of It Far 007); its eller (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 taxilation some 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 premance notification "ceresults 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 (240) 276-0120. 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 from the Division of Small other general 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/industry/support/index.html.
Sincerely yours,
Bhimmar 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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060223
510(k) Number (if known):_
Device Name: Infinity MultiView WorkStation and Telemetry
Indications for Use
The Infinity MultiView WorkStation, Infinity Network and Remote Display are indicated for use as a central monitoring device, communications network, and remote display for Draeger Patient Monitoring Systems and recorders.
Use of the Infinity MultiView WorkStation Telemetry System is indicated for adult and pediatric patient populations in an environment where patient care is provided by Healthcare Professionals (Physicians, Nurses, Technicians) when the professional determines that a device is required to measure and produce visual and audible alarms for any one or more of the following parameters:
- Heart rate .
- ECG Arrhythmia Analysis .
- Arterial oxygen saturation .
- Pulse rate .
- ST segment analysis .
Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Blummana
510(k) Number
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§ 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.