(30 days)
This device is capable of displaying physiological parameters received from INFINITY Modular monitors and visually displaying alarm data for those parameters. The device is capable of displaying DICOM images received over a hospital information system.
The device is intended to be used in an environment where patient care is provided by Healthcare Professionals, i.e. physicians, nurses, and technicians, trained on the use of the device, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition.
The device is intended for use with the adult, pediatric and neonatal populations.
The INFINITY EXPLORER is a software-driven application that allows the user to extend the viewing capability of the Infinity modular monitors and integrate additional patient information on a single display. INFINITY EXPLORER is capable of displaying real-time patient data, providing control back to the bedside and integrating other applications with patient data on the PC. The VF4 modifications include:
- New MDSII Hardware
- New user interface with enhanced monitor applications
The provided text is a 510(k) summary for the INFINITY Explorer with VF4 and MDS II. It describes a software-driven application that extends the viewing capability of physiological monitors. However, it does not contain any information about acceptance criteria or a study proving that the device meets those criteria, a common component of performance testing for AI/ML-enabled devices. The submission is for a device modification of an existing product, and focuses on general device functionality, safety, and regulatory compliance rather than performance metrics of the device as related to a specific diagnostic or prognostic task.
Therefore, the following information cannot be extracted from the provided text:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method for the test set
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size
- If a standalone performance (algorithm only) study was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
What is present in the document is a statement regarding non-clinical performance data:
"Assessment of non-clinical performance data for equivalence: Testing in accordance with internal design control procedures indicates no new issues relative to safety and efficacy for INFINITY EXPLORER with software version VF4 and the new MDS II."
This statement indicates that internal testing was conducted, but it does not provide specific acceptance criteria, study details, or performance metrics. It also explicitly states "Assessment of clinical performance data for equivalence: Not applicable," implying that no standalone clinical performance study was deemed necessary for this specific device modification under the 510(k) pathway.
This type of submission is common for minor modifications to existing medical devices where the primary focus is to ensure that the changes do not introduce new safety or efficacy concerns, rather than to establish or re-establish performance against specific clinical endpoints.
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510(k) SUMMARY
as required per 807.92(c)
Submitters Name, Address:
Draeger Medical Systems, Inc. Danvers, MA 01923 Tel: (978) 907-7500 Fax: (978) 750-6879 Official Correspondent: Connie Hertel, Director, QA/RA Contact person for this submission: Penelope H. Greco Date submission was prepared: April 5, 2004
Trade Name, Common Name and Classification Name:
- A. Trade Name:
INFINITY Explorer
Common Name, Classification Name, Class and Regulation Number:
| Common Name | Product Code | Class | Regulation Number |
|---|---|---|---|
| System, Network and Communication,Physiological Monitors | MSX | II | 870.2300 |
Legally Marketed Device Identification:
Infinity Explorer with MDSII, 510(k) K030615 Infinity Explorer, 510(k) K013515
Description of Modification:
- . The INFINITY EXPLORER is a software-driven application that allows the user to extend the viewing capability of the Infinity modular monitors and integrate additional patient information on a single display. INFINITY EXPLORER is capable of displaying real-time patient data, providing control back to the bedside and integrating other applications with patient data on the PC. The VF4 modifications include:
- u New MDSII Hardware
- D New user interface with enhanced monitor applications
Intended Use:
The INFINITY EXPLORER is a critical care workstation intended to display physiological parameters received from INFINITY Modular Monitors and to visually display alarm data for those parameters. The device is capable of displaying DICOM images received over a hospital information system.
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COMPANY CONFIDENTIAL
Draeger Medical Systems, Inc. 16 Electronics Avenue Danvers, MA 01923 USA Tel: (978) 907-7500 Fax: (978) 750-6879
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Special 510(k): Device Modification INFINITY Explorer VF4
Assessment of non-clinical performance data for equivalence: Testing in accordance with internal design control procedures indicates no new issues relative to safety and efficacy for INFINITY EXPLORER with software version VF4 and the new MDS II.
Assessment of clinical performance data for equivalence: Not applicable
Biocompatability: Not applicable
Sterilization: Not applicable
Standards and Guidances: IEC 60601-1-1 FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices FDA Guidance for Off-the-Shelf Software use in Medical Devices
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COMPANY CONFIDENTIAL
Draeger Medical Systems, Inc. 16 Electronics Avenue Danvers, MA 01923 USA Tel: (978) 907-7500 Fax: (978) 750-6879
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Image /page/2/Picture/2 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 top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AY 1 2 2004
Draeger Medical Systems, Inc. c/o Ms. Penelope Greco Regulatory Submissions Manager 16 Electronics Avenue Danvers, MA 01923
Re: K040945
Trade Name: INFINITY Explorer with VF4 and MDS II Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac monitor (including cardiotachometer and rate alarm) Regulatory Class: II (two) Product Code: MSX Dated: April 5, 2004 Received: April 12, 2004
Dear Ms.Greco :
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.
Please be advised that FDA's issuance of a substantial equivalence determination docs not mean that FDA has made a determination that your device complies with other requirements of the Act
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Page 2 - Ms. Penelope Greco
or any Federal statutes and regulations administered by other Federal agencies. You must or any I ecolul studies and registered to the registration and limited to: registration and listing (21 Comply with an the Fee 8 requirements)01); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in alle quality of sell provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product ladiation control pro horoms (eveting your device as described in your Section 510(k) This letter with anow you to begin mains of substantial equivalence of your device to a legally prematicated 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 If you desire specific acrioliance at (301) 594-4648. 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 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.
Dana R. Vochner
( 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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Indications for Use
510(k) Number (if known): Ko40945
Device Name: INFINITY Explorer
Indications for Use:
This device is capable of displaying physiological parameters received from INFINITY Modular monitors and visually displaying alarm data for those parameters. The device is capable of displaying DICOM images received over a hospital information system.
The device is intended to be used in an environment where patient care is provided by Healthcare Professionals, i.e. physicians, nurses, and technicians, trained on the use of the device, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition.
The device is intended for use with the adult, pediatric and neonatal populations.
MRI Compatibility Statement:
The INFINITY EXPLORER is not compatible for use in a MRI magnetic field.
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)
Duna R. Lochner
(Division Sign-Off) Division of Cardiovascular Devices
510(K) Number_K040945
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§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).