(120 days)
Not Found
No
The summary describes a standard patient monitoring system that measures physiological parameters and triggers alarms based on preset limits. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is described as a patient monitoring system that measures and displays various physiological parameters, indicating a diagnostic rather than therapeutic function.
Yes
The device is capable of measuring a wide range of physiological parameters and producing alarms when these parameters vary beyond preset limits. This function supports healthcare professionals in monitoring a patient's condition and identifying potential medical issues, which is a core aspect of diagnosis. The device's ability to measure heart rate, respiration rate, blood pressure, temperature, cardiac output, oxygen saturation, and analyze ECG signals, including arrhythmia and ST Segment Analysis, are all considered diagnostic measurements.
No
The device description explicitly states that the system consists of three basic hardware components: the Vital Signs Engine, the Display, and the Power Supply. It also mentions connecting to various hardware pods and modules for signal acquisition and measurement.
Based on the provided information, the Infinity Kappa XLT is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, to provide information for diagnostic, monitoring, or compatibility purposes.
- Infinity Kappa XLT Function: The description clearly states that the Infinity Kappa XLT is a patient monitoring system that measures various physiological parameters directly from the patient (heart rate, respiration rate, blood pressure, temperature, etc.). It also receives signals from connected pods and modules that interact with the patient or their breathing gases.
- No Specimen Examination: There is no mention of the device examining specimens derived from the human body in vitro.
Therefore, the Infinity Kappa XLT falls under the category of a patient monitoring device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Infinity Kappa XLT is capable of measuring heart rate, respiration rate, invasive pressure, non-invasive pressure, arrhythmia, temperature, cardiac output, arterial oxygen saturation, pulse rate, apnea, ST Segment Analysis, and 12-Lead ST Segment Analysis.
The device produces visual and audible alarms if any of the physiological parameters monitored vary beyond preset limits and timed or alarm recordings will be produced. The device will connect to an R50 recorder via the Infinity Network and is capable of displaying clinical data received over a hospital information system.
Kappa XLT receives EEG signals when connected to an Infinity EEG pod.
The Infinity Trident NMT pod measures the muscle response to electrical stimulation of a peripheral nerve and when connected to a Kappa XLT transmits that information to the device.
The SCIO module sample breathing gases from adults and pediatrics. The gas module continuously measures 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 Kappa XLT.
With etCO2 the Kappa XLT can measure end tidal carbon dioxide, inspired carbon dioxide, and respiration rate in either mainstream or side-stream measurement mode; and with etCO2+Respiratory Mechanics, spirometry and carbon dioxide can be monitored. The device can interface with specific third party devices via an RS 232 connection.
The device is 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 devices 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.
Product codes
MHX, MSX, LNX
Device Description
The Infinity Kappa XLT is an addition to Draeger's INFINITY patient monitoring system that combines on one platform the patient monitoring features of the Infinity Delta/DeltaXL/Kappa and the Infinity Explorer, Draeger's software-driven critical care workstation.
The Kappa XLT System consists of three basic components:
- The Kappa XLT Vital Signs Engine that acquires all signals ●
- The Kappa XLT Display, a medical grade display unit .
- . The Kappa XLT Power Supply.
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, with the exception of the parameter Cardiac Output, ST Segment Analysis, and arrhythmia which are intended for use in the adult and pediatric 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 Infinity Kappa XLT was tested in accordance with applicable standards and internal design control procedures and was determined to be as safe and effective for its intended use as the predicate devices.
Clinical performance evaluation indicates that the Infinity Kappa XLT is substantially equivalent to the Infinity Delta series monitors and the Infinity Explorer.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Infinity Explorer (K040945), Infinity Delta / DeltaXL / Kappa (K033957), Infinity SC 8000 (K012016)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 FEB | 8 2005
as required per 807.92(c)
Submitters Name, Address:
Draeger Medical Systems, Inc. Danvers, MA 01923 Tel: (978) 907-7500 Fax: (978) 750-6879 Contact person for this submission: Penelope H. Greco October 20, 2004 Date submission was prepared:
Trade Name, Common Name and Classification Name:
A. Trade Name: Infinity Kappa XLT
B. Common Name, Classification Name, Class and Regulation Number:
| Common Name | Classification Number | Class | Regulation Number |
|---|---|---|---|
| Monitor, physiological, patient (with arrhythmia detection or alarms | MHX | 2 | 870.1025 |
| System, Network and Communication, Physiological Monitors | MSX | 2 | 870.2300 |
| Computers and Software, Medical | LNX |
Predicate Device Identification:
Infinity Explorer (K040945) Infinity Delta / DeltaXL / Kappa (K033957) Infinity SC 8000 (K012016)
Device Description:
The Infinity Kappa XLT is an addition to Draeger's INFINITY patient monitoring system that combines on one platform the patient monitoring features of the Infinity Delta/DeltaXL/Kappa and the Infinity Explorer, Draeger's software-driven critical care workstation.
The Kappa XLT System consists of three basic components:
- The Kappa XLT Vital Signs Engine that acquires all signals ●
- The Kappa XLT Display, a medical grade display unit .
- . The Kappa XLT Power Supply.
Page 1 of 2
Draeger Medical Systems, Inc.
16 Electronics Avenue Danvers, MA 01923 Tel: (978) 907-7500 Fax: (978) 750-6879
1
Intended Use:
The Infinity Kappa XLT is capable of measuring heart rate, respiration rate, invasive pressure, I he inimity trapper HD rovingia, temperature, cardiac output, arterial oxygen saturation, pulse non invasite prossure, and 12-Lead ST Segment Analysis. The device produces rate, apped, of beginent if any of the physiological parameters monitored vary beyond preset Imits and timed or alarm recordings will be produced. The device will connect to an R50 millis and thised or thank rocereings with the evice is capable of displaying clinical data received over a hospital information system.
Assessment of non-clinical performance data for equivalence:
The Infinity Kappa XLT was tested in accordance with applicable standards and internal design control procedures and was determined to be as safe and effective for its intended use as the predicate devices.
Assessment of clinical performance data for equivalence:
Clinical performance evaluation indicates that the Infinity Kappa XLT is substantially equivalent to the Infinity Delta series monitors and the Infinity Explorer.
Biocompatability:
Not applicable
Sterilization:
Not applicable
Standards and Guidance: IEC 60601-1
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 & Human Services. The logo features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
FEB 1 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Draeger Medical Systems c/o Ms. Penelope H. Greco Regulatory Submissions Manager 16 Electronics Avenue Danvers, MA 01923
K042904 Re: Trade Name: Infinity Kappa XLT Regulation Number: 21 CFR 870.1025 Regulation Name: Arrythmia Detector and Alarm Regulatory Class: Class II (two) Product Code: 74 MHX Dated: January 20, 2005 Received: January 21, 2005
Dear Ms. Greco:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becement on the 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 encreativent of the enactment date of the Medical Device Amendments, or 10 eonimered prior to may 2017 11:11 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.
3
Page 2 - Ms. Penelope H. Greco
Please be advised that FDA's issuance of a substantial equivalence determination does not mean i touse oc northou that I Dr bristian that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I oderated and 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 forth in the quality systems (21 CFR Part 820); and if applicable, the electronic for at many a morely by so wisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) rms letter will anow yours ough finding of substantial equivalence of your device to a legally prestiated 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 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 may be obtained from the Division of Small Manufacturers, 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/dsma/dsmamain.html
Sincerely yours,
Bhimma for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use K042904
510(k) Number (if known):_
Device Name: Infinity Kappa XLT
The Infinity Kappa XLT is capable of measuring heart rate, respiration rate, invasive pressure, non-invasive pressure, arthythmia, temperature, cardiac output, arterial oxygen saturation, pulse rate, apnea, ST Segment Analysis, and 12-Lead ST Segment Analysis.
The device produces visual and audible alarms if any of the physiological parameters monitored vary beyond preset limits and timed or alarm recordings will be produced. The device will connect to an R50 recorder via the Infinity Network and is capable of displaying clinical data received over a hospital information system.
Kappa XLT receives EEG signals when connected to an Infinity EEG pod.
The Infinity Trident NMT pod measures the muscle response to electrical stimulation of a peripheral nerve and when connected to a Kappa XLT transmits that information to the device.
The SCIO module sample breathing gases from adults and pediatrics. The gas module continuously measures 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 Kappa XLT.
With etCO2 the Kappa XLT can measure end tidal carbon dioxide, inspired carbon dioxide, and respiration rate in either mainstream or side-stream measurement mode; and with etCO2+Respiratory Mechanics, spirometry and carbon dioxide can be monitored. The device can interface with specific third party devices via an RS 232 connection.
The device is 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 devices 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.
MRI Compatibility Statement:
The Infinity Kappa XLT is not compatible for use in a MRI magnetic field.
Prescription Use - -Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ OR (Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Blumuma