(29 days)
No
The document describes a multi-parameter patient monitor with standard physiological monitoring capabilities and software/hardware enhancements. There is no mention of AI or ML in the intended use, device description, or performance studies summary.
No
The device is described as a "multi-parameter patient monitor intended for use at the patient bedside for the collection of physiological data." Its intended use is to monitor various physiological parameters, not to provide therapy or treatment.
No
This device is described as a "multi-parameter patient monitor intended for use at the patient bedside for the collection of physiological data." It monitors various vital signs and physiological parameters, but its intended use is for data collection and monitoring, not for providing a diagnosis itself. Healthcare professionals use the data collected by the monitor to make their professional assessment of the patient's medical condition.
No
The device description explicitly states it includes both software and hardware modifications to existing patient monitors.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Infinity Delta Series Monitor is a patient monitor that measures physiological parameters directly from the patient's body (e.g., heart rate, blood pressure, oxygen saturation, temperature, etc.). While it can analyze breathing gases (which are external to the body), this is still a measurement of a physiological process (respiration) and not a diagnostic test performed on a biological sample.
- Intended Use: The intended use describes monitoring various physiological parameters to assist healthcare professionals in assessing a patient's medical condition. This is distinct from performing a diagnostic test on a sample.
- Device Description: The description reinforces that it's a multi-parameter patient monitor for collecting physiological data at the bedside.
The device is a patient monitoring device, which is a different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
The Infinity Delta Series Monitor (Delta/Delta XL/Kappa) 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
- etCO2
- · Respiratory mechanics
- · Anesthetic agents
- · Neuromuscular transmission
The devices are intended to be used in the 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.
The Infinity Delta Series (Delta XL/Kappa) monitors are intended to be used on adult, pediatric, and neonatal populations, with the exception of the parameter Cardiac Output, ST Segment Analysis, and arthythmia which are intended for use in the adult and pediations only; and tcp02, which for the neonatal population, is to only be used when the patient is not under gas anesthesia.
For combination with Scio gas module:
Scio gas module samples breathing gases from adults and pediatrics. The gas module continuously measure the content of CO2, N2O, O2 and one of the anesthetic agents, Halothane, Enflurane, Sevoflurane and Desflurane in any mixture and communicates real time and derived gas information to the Infinity monitors.
Product codes (comma separated list FDA assigned to the subject device)
MHX, DSI, MLD, DRT, DRW, DPS, BZQ, FLS, BSZ, IPF, DXN, DSK, DRQ, DQA, CCK, CBQ, CBS, CBR, CCL, FLL, LKD, KLK, LPP, GMS, MSX, BZK, DRG, DXG, KOI
Device Description
Infinity Delta and Kappa Series Monitors (Delta XL/ Kappa) are multi-parameter patient monitors intended for use at the patient bedside for the collection of physiological data. The intent of this 510(k) is to describe the proposed software and hardware modifications to the Infinity Delta and Kappa Series Monitors version VF9.1 which includes the integration of an alternative etCO2 solution for the Delta and Delta XL patient monitors as well as software enhancements for the Delta, Delta XL and Kappa patient monitors.
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
adult, pediatric, and neonatal populations
Intended User / Care Setting
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.
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)
The substantial equivalence was assessed via internal verification tests, validation evaluations and external tests to FDA recognized consensus standards. Performance data related to each proposed modification has been tested and evaluated. High level summary reports are included in this special 510k demonstrate the changes to the monitors are substantially equivalent to the predicate devices.
The modified Infinity Delta and Kappa Series Monitors have been tested in accordance with applicable standards and internal design control procedures and were determined to be as safe and effective as the predicate device for its intended use.
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.
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/11 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized emblem with three abstract human profiles facing to the right. The emblem is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Draeger Medical Sytems, Inc. Ms. Beth Zis Regulatory Affairs Director 6 Tech Drive Andover, Massachusetts 01810
Re: K152407
Trade/Device Name: Infinity Delta, Infinity Delta XL, Infinity Kappa Regulation Number: 21 CFR 870.1025 Regulation Name: Patient Physiological Monitor (with arrhythmia detection or alarms) Regulatory Class: Class II Product Code: MHX Dated: August 20, 2015 Received: August 25, 2015
Dear Ms. Beth Zis.
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR
1
Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
M.A. Hillebrand
for _ Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K152407
Device Name
Infinity Delta, Infinity Delta XL, Infinity Kappa
Indications for Use (Describe)
The Infinity Delta Series Monitor (Delta/Delta XL/Kappa) 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
- etCO2
- · Respiratory mechanics
- · Anesthetic agents
- · Neuromuscular transmission
The devices are intended to be used in the 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.
The Infinity Delta Series (Delta XL/Kappa) monitors are intended to be used on adult, pediatric, and neonatal populations, with the exception of the parameter Cardiac Output, ST Segment Analysis, and arthythmia which are intended for use in the adult and pediations only; and tcp02, which for the neonatal population, is to only be used when the patient is not under gas anesthesia.
For combination with Scio gas module:
Scio gas module samples breathing gases from adults and pediatrics. The gas module continuously measure the content of CO2, N2O, O2 and one of the anesthetic agents, Halothane, Enflurane, Sevoflurane and Desflurane in any mixture and communicates real time and derived gas information to the Infinity monitors.
3
X Prescription Use (Part 21 CFR 801 Subpart D)
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4
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K152407 Page 1 of 5
510(k) Summary of Safety and Effectiveness
Submitter / Manufacturer Name and Address:
Draeger Medical System, Inc. 6 Tech Drive, Andover, MA 01810 U.S.A.
Establishment Registration Number : 3005783425
Contact Person:
Beth Zis Director Regulatory Affairs Email: beth.zis@draeger.com Tel. No.: +1 (978) 379 8265 Fax: +1 (978) 379-8335
Date submission was prepared: 08/20/2015
Device Name / Common Names / Classification Names:
| Trade Name: | Infinity Delta; Infinity Delta XL; Infinity Kappa |
|---|---|
| Common Name: | monitor, physiological, patient(with arrhythmia detection or alarms) |
| Classification Name: | monitor, physiological, patient(with arrhythmia detection or alarms) |
| Product Code: | MHX |
| Class: | II |
| Regulation Number: | 870.1025 |
List of Product codes and classification regulations for clarification of multiple indications:
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| Common Name | Product
code | Class | Reg.
Number
21 CFR |
|---------------------------------------------------------------------------------------------------|-----------------|-------|--------------------------|
| Proposed device | | | |
| monitor, physiological, patient(with arrhythmia | MHX | II | 870.1025 |
| detection or alarms) | | | |
| Subsequent Product Codes | | | |
| detector and alarm, arrhythmia | DSI | II | 870.1025 |
| monitor, st segment with alarm | MLD | II | 870.1025 |
| monitor, cardiac (incl. cardio tachometer & rate | DRT | II | 870.2300 |
| alarm) | | | |
| adaptor, lead switching, electrocardiograph | DRW | II | 870.2350 |
| electrocardiograph (partly) | DPS | II | 870.2340 |
| monitor, breathing frequency | BZQ | II | 868.2375 |
| monitor, apnea, facility use | FLS | II | 868.2377 |
| gas-machine, anesthesia | BSZ | II | 868.5160 |
| stimulator, Muscle, Powered (NMT) | IPF | II | 890.5850 |
| system, measurement, blood-pressure, non-invasive
(NBP) | DXN | II | 870.1130 |
| computer, Blood-Pressure (iBP) | DSK | II | 870.1110 |
| amplifier And Signal Conditioner, Transducer Signal
(iBP) | DRQ | II | 870.2060 |
| oximeter | DQA | II | 870.2700 |
| analyzer, gas, carbon-dioxide, gaseous-phase | CCK | II | 868.1400 |
| analyzer, gas, enflurane, gaseous-phase (anesthetic
concentration) | CBQ | II | 868.1500 |
| analyzer, gas, halothane, gaseous-phase (anesthetic
conc.) | CBS | II | 868.1620 |
| analyzer, gas, nitrous-oxide, gaseous phase
(anesthetic conc.) | CBR | II | 868.1700 |
| analyzer, gas, oxygen, gaseous-phase | CCL | II | 868.1720 |
| thermometer, Electronic, Clinical | FLL | II | 880.2910 |
| monitor, carbon-dioxide, cutaneous (tpO2/CO2) | LKD | II | 868.2480 |
| monitor, oxygen, cutaneous, for infant not under gas
anesthesia (tpO2/CO2) | KLK | II | 868.2500 |
| monitor, oxygen, cutaneous, for uses other than for
infant not under gas anesthesia (tpO2/CO2) | LPP | II | 868.2500 |
| analyzer, spectrum, electroencephalogram signal | GMS | I | 882.1420 |
| system, network and communication, physiological
monitors | MSX | II | 870.2300 |
| spirometer, monitoring (w/wo alarm) | BZK | II | 868.1850 |
| transmitters and receivers, physiological signal, | DRG | II | 870.2910 |
| Common Name | Product code | Class | Reg. Number 21 CFR |
| radiofrequency | | | |
| computer, diagnostic, pre-programmed, single-function | DXG | II | 870.1435 |
| stimulator, nerve, peripheral, electric | KOI | II | 870.2775 |
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Identification of Legally Marketed Devices to which the equivalence is claimed:
| 510(k)
| number | Trade name | |
|---|---|---|
| K070566 | INFINITY DELTA/DELTA XL/ KAPPA/ | |
| GAMMA X XL/ VISTA XL/ | ||
| SC7000/SC8000/ SC9000XL | Predicate Device |
Device Description:
Infinity Delta and Kappa Series Monitors (Delta XL/ Kappa) are multi-parameter patient monitors intended for use at the patient bedside for the collection of physiological data. The intent of this 510(k) is to describe the proposed software and hardware modifications to the Infinity Delta and Kappa Series Monitors version VF9.1 which includes the integration of an alternative etCO2 solution for the Delta and Delta XL patient monitors as well as software enhancements for the Delta, Delta XL and Kappa patient monitors.
Intended Use:
The Infinity Delta and Kappa series 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.
Indications for Use:
The Infinity Delta Series Monitor (Delta/Delta XL/Kappa) are capable of monitoring:
- Heart rate
- . Respiration rate
- Invasive pressure
- . Non-invasive pressure
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- Arrhythmia ●
- Temperature
- Cardiac output
- Arterial oxygen saturation
- Pulse rate
- Apnea ●
- ST Segment Analysis
- 12-Lead ST Segment Analysis
- tcp02/tcpC02 ●
- EEG signals
- . FiO2
- etCO2
- Respiratory mechanics
- . Anesthetic agents
- . Neuromuscular transmission
The devices are intended to be used in the 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.
The Infinity Delta Series (Delta/Delta XL/Kappa) monitors are intended to be used on adult, pediatric, and neonatal populations, with the exception of the parameter Cardiac Output. ST Segment Analysis, and arrhythmia which are intended for use in the adult and pediatric populations only; and tcpO2, which for the neonatal population, is to only be used when the patient is not under gas anesthesia.
For combination with Scio gas module:
Scio gas module samples breathing gases from adults and pediatrics. The gas module continuously measure the content of CO2, N2O, O2 and one of the anesthetic agents, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane in any mixture and communicates real time and derived gas information to the Infinity monitors.
8
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Summary of Technological Characteristics:
The major change to the Infinity Delta and Kappa Series Monitors (Delta/Delta XL/ Kappa) is the integration of the Draeger Infinity Mcable Mainstream CO2 sensor (K100941) which measures end-tidal CO2, inspired CO2 and Respiration Rate from the patient and displays it on the Infinity Delta and Delta XL patient monitors. Other software modifications were made for the enhancement of usability in field to all three monitors.
Summary of non-clinical data:
The substantial equivalence was assessed via internal verification tests, validation evaluations and external tests to FDA recognized consensus standards. Performance data
related to each proposed modification has been tested and evaluated. High level summary reports are included in this special 510k demonstrate the changes to the monitors are substantially equivalent to the predicate devices.
Substantial Equivalence:
The modified Infinity Delta and Kappa Series Monitors have been tested in accordance with applicable standards and internal design control procedures and were determined to be as safe and effective as the predicate device for its intended use.
Biocompatibility
Not applicable for this change to Infinity Delta and Kappa Series Monitors. The integrated Infinity Mcable - Mainstream CO2 Sensor was already cleared under K100941 with the reusable/ disposable cuvettes.
Shelf Life
Not applicable. No components have been added that require shelf life data.
Sterilization
Not applicable for this change to Infinity Delta and Kappa Series Monitors. The integrated Infinity Mcable - Mainstream CO2 Sensor was already cleared under K100941 with the reusable/ disposable cuvettes, and monitors are provided non-sterile.
Conclusion:
The intended use and general construction of the patient monitors have not been changed. The comparison with predicate device and testing of the described VF9.1 modifications demonstrate the Infinity Delta and Kappa Series Monitors are as safe and effective as the previous cleared in K070566.