(29 days)
The Infinity MultiView WorkStation, Infinity Network and Remote Display are intended for use as a central monitoring device, communications network, and remote display for Draeger patient monitoring systems and recorders.
The Infinity Gateway Suite software applications are intended to provide clinicians with the capability of viewing patient data remotely via the Infinity Network and for the data exchange of select clinical and administrative information between the Infinity Network and the hospital network.
The Infinity Gateway Suite (K014213/K030657) is a server-based software application that provides a connection to the Infinity Network and the hospital network infrastructure for the data exchange of select clinical and administrative information. The Infinity Gateway complies with healthcare information protocols to support data sets of many different sources, including medical devices, hospital information systems, clinical information systems, and laboratory systems.
Infinity Gateway includes a suite of software products to support the unique needs of hospitals, and provide a complete range of options for information connectivity:
- . Server Software
- . Interface Software Options
- Developers Tools .
- Remote View Applications 해
- . Pager Interface
The primary modification included in the VF4 software release of the Infinity Gateway Suite is the visual display of alarms on WinView and WebViewer.
I am sorry, but the provided text does not contain information regarding acceptance criteria, device performance, or any studies conducted on the Infinity Gateway Suite. The document is a 510(k) summary and FDA clearance letter, which describes the device, its intended use, and indicates that verification and validation testing was performed to establish equivalence to previous versions, but does not provide details of such testing or specific performance metrics.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.
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JAN 2 1 2005
1. 510(k) SUMMARY
as required per 807.92(c)
Submitters Name, Address:
Draeger Medical Systems, Inc. Danvers, MA 01923 Contact person for this submission: Penelope H. Greco Date submission was prepared: December 20, 2004
Trade Name, Common Name and Classification Name:
-
A. Trade Name:
INFINITY Gateway Suite -
B. Common Name, Classification Name, Class and Regulation Number:
| Common Name | ProductCode | Class | Regulation Number |
|---|---|---|---|
| System, Network and Communication,Physiological Monitors | MHX | III | 21 CFR 870.1025 |
| Computers and Software, Medical | LNX |
Legally Marketed Device Identification:
K030657 INFINITY Gateway Suite
Device Description:
The Infinity Gateway Suite (K014213/K030657) is a server-based software application that provides a connection to the Infinity Network and the hospital network infrastructure for the data exchange of select clinical and administrative information. The Infinity Gateway complies with healthcare information protocols to support data sets of many different sources, including medical devices, hospital information systems, clinical information systems, and laboratory systems.
Infinity Gateway includes a suite of software products to support the unique needs of hospitals, and provide a complete range of options for information connectivity:
- . Server Software
- . Interface Software Options
- Developers Tools .
- Remote View Applications 해
- . Pager Interface
Page 1 of 2
COMPANY CONFIDENTIAL
Draeger Medical Systems, Inc. 16 Electronics Avenue Danvers, MA 01923 Tel: (978) 907-7500 Fax: (978) 750-6879
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The primary modification included in the VF4 software release of the Infinity Gateway Suite is the visual display of alarms on WinView and WebViewer.
Intended Use:
The Infinity MultiView WorkStation,Infinity Network and remote display are intended to act as a central monitoring device, communications network, and remote display for Infinity Patient Monitoring Systems and recorders.
The INFINITY Gateway Suite software applications are intended to provide clinicians with the capability of viewing patient data remotely via the Infinity Network and the hospital network infrastructure and for the data exchange of select clinical and administrative information. The Infinity Gateway is not patient connected.
Assessment of non-clinical performance data for equivalence: Verification and validation testing performed indicates that the modifications implemented with software version VF4 are as safe and effective as previous versions and have not altered the fundamental technology of the device.
Assessment of clinical performance data for equivalence: Not applicable
Biocompatability: Not applicable
Sterilization: Not applicable
Standards and Guidances: FDA Guidance, The New 510(k) Paradigm
Page 2 of 2
COMPANY CONFIDENTIAL
Draeger Medical Systems, Inc. 16 Electronics Avenue Danvers, MA 01923 Tel: (978) 907-7500 Fax: (978) 750-6879
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol. The logo is black and white.
JAN 2 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Draeger Medical Systems, Inc. C/O Penelope H. Greco Regulatory Submissions Manager 16 Electronics Ave. Danvers, MA 01923
Re: K043549
Trade Name: Infinity Gateway Suite, VF4 Regulation Number: 21 CFR 870.1025 Regulation Number. 21 CFR 870.1023
Regulation Name: Patient Physiology Monitor (with Arrhythmia Detection or Alarms) Regulatory Class: Class II (two) Product Code: MHX Dated: December 20, 2004 Received: December 23, 2004
Dear Ms. Greco:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 310(x) premained is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the cherosure for regars manat date of the Medical Device Amendments, or to
r commerce prior to May 28, 1976, the enactment date of the local Food Drug commerce provide to May 20, 1978, the encordance with the provisions of the Federal Food. Drug. devices that have been reclassified in accerdance will of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval and Cosment Act (Act) that do not require appent of the general controls provisions of the Act. The You may, inerelore, mance the act include requirements for annual registration, listing of general controls provisions of the tice, 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 (500 a0070) also Existing major regulations affecting your device can
ce and high be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Code of Poucharing your device in the Federal Register.
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Page 2 – Ms. Penelope H. Greco
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease oc advised that FDF of issualites over device complies with other requirements of the Act that IDA has made a decormination an administered by other Federal agencies. You must of any Federal statutes and regulations annuality, but not limited to: registration and listing (21 comply with an the 71ct 31equirements) 11. sood manufacturing practice requirements as set CFK Part 807), labeling (21 CFR Part 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (evens (ever as described in your Section 510(k) This Icticle witi anow you to begin mailing of substantial equivalence of your device to a legally premarket hollication: "The PDF Price of Sification 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 If you desire specific advice 101 your as 1) 594-4646. Also, please note the regulation entitled, Contact the Office of Collier of Colline (21CFR Part 807.97) you may obtain. . Other general information on your responsibilities under the Act may be obtained from the Other general informational 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,
Donna R. Vachner
Image /page/3/Picture/5 description: The image contains a signature on the left and the words "Bran" and "Dire" on the right. The signature appears to be a stylized set of initials. The text is in a simple, sans-serif font and is vertically aligned.
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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510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: Infinity Gateway Suite
Indications for Use:
The Infinity MultiView WorkStation, Infinity Network and Remote Display are I he infinity for use as a central monitoring device, communications network, and mencated for ass as a braeger patient monitoring systems and recorders.
The Infinity Gateway Suite software applications are intended to provide clinicians i he minnity Oateway batte between data remotely via the Infinity Network and for with the capability of trowing paint grative information between the Infinity Network and the hospital network.
) 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)
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_k043549
Page 1 of 1
§ 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.