(66 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on software updates for existing monitoring functionalities and connections to external modules, not on new analytical capabilities driven by AI/ML.
No
The device is described as a monitor that displays various physiological parameters, which is used for diagnostic purposes rather than providing direct therapy.
No
The device is a monitor that tracks various physiological parameters, which are measurements of the body's functions. While these measurements can be used by healthcare professionals to diagnose conditions, the device itself is not described as performing the diagnostic process (e.g., analyzing data to determine a disease). It provides data for diagnosis, rather than being a diagnostic device itself.
No
The device description explicitly states "Infinity Modular Monitors" and mentions "variants of the SC 7000 and Delta monitors," which are hardware devices. The software version VF5 is described as a release of these monitors, indicating it's software running on hardware, not a standalone software device.
Based on the provided information, the INFINITY Modular monitors are not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use/Indications for Use: The listed parameters (Heart rate, Respiration rate, Invasive pressure, etc.) are all physiological measurements taken directly from the patient's body. IVD devices, by definition, are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description focuses on software updates and connections to modules that measure physiological parameters (gas, BisX, NMT). There is no mention of analyzing biological specimens.
- Lack of IVD-related information: The document does not mention any analysis of biological samples, reagents, or laboratory procedures, which are characteristic of IVD devices.
Therefore, the INFINITY Modular monitors are patient monitoring devices, not IVD devices.
N/A
Intended Use / Indications for Use
The INFINITY Modular monitors are capable of monitoring:
- Heart rate
- Respiration rate
- Invasive pressure
- Non-invasive pressure
- Arrhythmia
- Temperature
- Cardiac output
- Arterial oxygen saturation
- Pulse rate
- Apnea
- ST Segment Analysis
- 12-Lead ST Segment Analysis
- tcp02/tcpC02
- EEG signals
- FiO2
Product codes (comma separated list FDA assigned to the subject device)
MHX, DSI, MSX
Device Description
Software version VF5 is the latest release of the Infinity Modular Monitors, including the Infinity Vista XL and Gamma X XL (variants of the SC 7000 and Delta monitors) that supports direct connection to the Scio gas module, display of data received from the Infinity BisX and Infinity Trident NMT pods, as well as other minor software modifications. In addition, new devices have been tested for use with the Infinity MIB Protocol converter. Testing in accordance with internal design control procedures has verified that the Infinity Modular Monitors and the Infinity MIB Protocol Converter with VF5 modifications are as safe and effective as submitted in 510(k) K033807 and K033694.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Assessment of non-clinical performance data for equivalence: Verification and validation testing performed indicates that the modifications implemented with software version VF5 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
510(k) SUMMARY
as required per 807.92(c)
Submitters Name, Address:
Draeger Medical Systems, Inc. 16 Electronics Avenue Danvers, MA 01923 Tel: (978) 907-7500 Fax: (978) 750-6879 Contact person for this submission: Penelope H. Greco Regulatory Submissions Manager Date submission was prepared: December 6, 2004
Trade Name, Common Name and Classification Name:
INFINITY Modular Monitors with VF5 Modifications Trade Name: (Delta/Kappa/Delta XL/Vista XL/Gamma X XL and SC 7000/8000/9000XL)
Common Name, Classification Name, Class and Regulation Number:
| Common Name | Product Code | Class | Regulation Number |
|---|---|---|---|
| Monitor, Physiological, Patient (with Arrhythmia | |||
| Detection or Alarms) | MHX | II | 8*0.1025 |
| Arrhythmia Detector & Alarm | 74DSI | II | 8*0.1025 |
| System, Network and Communication, | |||
| Physiological Monitors | MSX | II | 8*0.2300 |
Legally Marketed Device
| Infinity Modular Monitors | K033694 |
|---|---|
| Infinity MIB | K033807 |
Description of Device Modifications:
Software version VF5 is the latest release of the Infinity Modular Monitors, including the Infinity Vista XL and Gamma X XL (variants of the SC 7000 and Delta monitors) that supports direct connection to the Scio gas module, display of data received from the Infinity BisX and Infinity Trident NMT pods, as well as other minor software modifications. In addition, new devices have been tested for use with the Infinity MIB Protocol converter. Testing in accordance with internal design control procedures has verified that the Infinity Modular Monitors and the Infinity MIB Protocol Converter with VF5 modifications are as safe and effective as submitted in 510(k) K033807 and K033694.
Intended Use:
The Infinity Modular Monitors are intended for multi-parameter patient monitoring. The devices will produce visual and audible alarms if any of the physiological parameters monitored vary beyond preset limits and timed or alarm recordings will be produced. These devices will connect to an R50 Bedside recorder, either directly or via the Infinity Network.
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COMPANY CONFIDENTIAL
Draeger Medical Systems, Inc.
16 Electronics Avenue Danvers, MA 01923 Tel: (978) 907-7500 Fax: (978) 750-6879
1
Assessment of non-clinical performance data for equivalence: Verification and validation testing performed indicates that the modifications implemented with software version VF5 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
and the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the commen
Standards: IEC 60601-1
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COMPANY CONFIDENTIAL
Draeger Medical Systems, Inc.
16 Electronics Avenue Danvers, MA 01923 Tel: (978) 907-7500 Fax: (978) 750-6879
2
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 and Human Services. The logo is circular and contains the department's name around the perimeter. In the center of the logo is an abstract symbol that resembles an eagle or a stylized human figure. The logo is black and white.
FEB 1 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Draeger Medical Systems, Inc. c/o Ms. Penelope H. Greco Regulatory Submissions Manager 16 Electronics Ave. Danvers, MA 01923
Re: K043439
KU43439
Trade Name: Infinity Delta / Kappa / Delta XL / Gamma X XL / Vista XL with VF5 Software Regulation Number: 21 CFR 870.1025 Regulation Name: 21 CFR 876.1025
Regulation Name: Arrhythmia Detector and Alarm (including ST-segment measurement and alarm) Regulatory Class: Class II (two) Product Code: MHX Dated: December 10, 2004 Received: December 14, 2004
Dear Ms. Greco:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your bection 910(s) pe device 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 encrosule for legally while in the Medical Device Amendments, or to commerce prior to May 20, 1776, the encordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). and Costlience Act (Act) that to not require the general controls provisions of the Act. The r ou may, mercere, manel the device, equirements for annual registration, listing of general controls provisions of tactice, 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 crassified (see aboro) the existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations and may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Coursements concerning your device in the Federal Register.
3
Page 2 -- Ms. Penelope H. Greco
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I loase oc advised that I Dris brounders a your device complies with other requirements of the Act that I DA has made a and regulations administered by other Federal agencies. You must of any it call 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 CI It Far 6077, laceming (21 CFR Part 820); and if applicable, the electronic forul in the quarty bystems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (1) (1) = 1) = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = I his letter will anow you to ough finding of substantial equivalence of your device to a legally premaired 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 advice for your as (240) 276-0120. Also, please note the regulation entitled, Contact the Ories of Company of Set notification" (21CFR Part 807.97) you may obtain. IMISolanding of reference to premation on your responsibilities under the Act may be obtained from the Oiler general information on Jour respectional 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,
Bhimmafor
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
KD4343939 510(k) Number (if known):__
Device Name: Infinity Delta / Kappa / Delta XL / Gamma X XL / Vista XL
Indications for Use:
The INFINITY Modular monitors are capable of monitoring:
- . Heart rate
- Respiration rate .
- . Invasive pressure
- . Non-invasive pressure
- . Arrhythmia
- . Temperature
- Cardiac output .
- Arterial oxygen saturation .
- Pulse rate .
- Apnea .
- . ST Segment Analysis
- 12-Lead ST Segment Analysis .
- tcp02/tcpC02 .
- EEG signals .
- FiO2 .
Prescription Use_ く (Per 21 CFR 801.109)
.
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(PI.EASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bhimmer
(Division/Sign-Off) Division of Cardiovascular Dev 510(k) Number
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