(96 days)
Not Found
No
The document describes standard patient monitoring functionalities and software modifications without mentioning AI or ML.
No.
The document states that the devices are intended for "multiparameter patient monitoring" and that they "will produce visual and audible alarms if any of the physiological parameters monitored vary beyond preset limits." This indicates a diagnostic or monitoring function, not a therapeutic one. The primary purpose is to observe and alert, not to treat or directly intervene.
Yes
Explanation: The device is described as a "multiparameter patient monitoring" system that measures various physiological parameters (e.g., heart rate, respiration rate, blood pressure, temperature, arterial oxygen saturation, EEG signals, CO2, O2, anesthetic gases). It also produces visual and audible alarms if parameters vary beyond preset limits and can generate recordings. This comprehensive monitoring and the capability to detect deviations from normal physiological parameters clearly indicate its diagnostic function.
No
The device description explicitly states that the 510(k) is for "software modifications for the Infinity Delta and Kappa series modular monitors". The intended use and device description clearly refer to physical monitoring devices (modular monitors) that measure various physiological parameters using hardware components. The software modifications are applied to these existing hardware devices.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "multiparameter patient monitoring." It measures physiological parameters directly from the patient (heart rate, respiration, pressure, temperature, etc.).
- 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. This device does not perform such tests on samples.
- Device Description: The description focuses on software modifications for patient monitors.
- Lack of IVD-related terms: The text does not mention any terms typically associated with IVD devices, such as "sample," "reagent," "assay," "laboratory," or "diagnostic test."
The device is a patient monitor that measures physiological parameters in vivo (within the living body).
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 .
- t FiO2
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.
With etCO2 the monitors 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 monitors can interface with specific third party devices via an MIB protocol converter.
Product codes
MHX
Device Description
The intent of this 510(k) is to describe software modifications for the Infinity Delta and Kappa series modular monitors (Delta, Delta XL, Kappa, Vista XL, Gamma X XL, SC7000, SC8000, SC9000XL), including MIB modifications.
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 only; and tcpO2 which is to be used in the neonatal population only when the patient is not under gas anesthesia.
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)
Verification and validation testing performed indicates that the software modifications described in this submission are as safe and effective as previous versions and have not altered the fundamental technology of the device(s).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
Special 510(k) Infinity Delta and Kappa Series Monitors Modifications
Image /page/0/Picture/1 description: The image shows the logo for Dräger medical, with the words "Dräger medical" in bold, black letters. Below the logo, it says "A Dräger and Siemens Company" in a smaller font. In the upper right corner of the image, there is a handwritten number, K070566.
JUN - 4 2007
as required per 807.92(c)
| Submitter's Name and Address: | Draeger Medical Systems, Inc.
6 Tech Drive
Andover, MA 01810 |
|-------------------------------|---------------------------------------------------------------------------------------------|
| Contact Person: | Mark Kieras
Sr. Regulatory Affairs Manager
Tel: (978) 379-8219
Fax: (978) 379-8330 |
Date submission was prepared: February 16, 2007
Device Name:
Common Name: Monitor, Physiological, Patient (with arrhythmia detection or alarms) Classification Name: MHX Regulation Number: 21 CFR 870.1025 Class: 2 Legally Marketed Device Identification: Infinity Delta and Kappa Series Monitors
Device Description:
The intent of this 510(k) is to describe software modifications for the Infinity Delta and Kappa series modular monitors (Delta, Delta XL, Kappa, Vista XL, Gamma X XL, SC7000, SC8000, SC9000XL), including MIB modifications.
Intended Use:
The Infinity Delta and Kappa series modular monitors are intended for multiparameter 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.
Predicate Devices:
| Infinity Delta and Kappa Series Monitors with VF6 Modifications | K060039 |
|---|---|
| Infinity Modular Monitors with SCIO Modifications | K051628 |
| Infinity Delta and Kappa Series Monitors with VF5 Modifications | K043439 |
Substantial Equivalence:
Verification and validation testing performed indicates that the software modifications described in this submission are as safe and effective as previous versions and have not altered the fundamental technology of the device(s).
Page 1 of 1
DRAEGER MEDICAL SYSTEMS, INC. 6 Tech Drive Andover, MA 01810 Tel: 978-379-8219 Fax:978-379-8330
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 4 2007
Draeger Medical Systems, Inc. c/o Mr. Mark Kieras Sr. Regulatory Affairs Manager 6 Tech Drive Andover, MA 01810
Re: K070566
Trade/Device Name: Infinity Delta and Kappa Series Modular Monitors (Infinity Delta/Delta XL/Kappa/Vista XL/Gamma X XL, SC7000, SC8000, SC9000XL) Regulation Number: 21 CFR 870.1025 Regulation Name: Physiological Patient Monitor (with arrhythmia detection or alarms) Regulatory Class: Class II Product Code: MHX Dated: May 1, 2007 Received: May 7, 2007
Dear Mr. Kieras:
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.
2
Page 2 - Mr. Mark Kieras
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 Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (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) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
H
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): K070566
Device Name: Infinity Delta / Delta XL / Kappa / Gamma X XL / Vista XL / SC7000 / SC8000 / SC9000XL
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 .
- t FiO2
Prescription Use_ ~ (Per 21 CFR 801.109) OR
Over-The-Counter Use
Continued on page 2
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Division | |
|---|---|
| Division | Odor Devic |
| 510(k) Number | K070566 |
Page 1 of 2
4
Indications for Use
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.
With etCO2 the monitors 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 monitors can interface with specific third party devices via an MIB protocol converter.
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 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 only; and tcpO2 which is to be used in the neonatal population only when the patient is not under gas anesthesia.
MRI Compatibilitv Statement:
The INFINITY Modular Monitors are not compatible for use in a MRI magnetic field.
Concurrence of CDRH, Office of Device Evaluation (ODE)