(96 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes modifications that do not inherently suggest AI/ML capabilities (Pacer Fusion mode, Age-Based MAC, support for specific pods and FiO2). The performance studies also state the modifications "have not altered the fundamental technology of the device(s)".
No
The device is strictly for monitoring and measuring breathing gases and related physiological parameters; it does not provide any treatment or therapy.
Yes.
The device continuously measures and communicates real-time and derived gas information, including CO2, N2O, O2, and anesthetic agents, for monitoring patient condition which is indicative of a diagnostic function.
No
The device description explicitly states that the 510(k) is for modifications to "Infinity Delta and Kappa series monitors," which are hardware devices. The modifications described are to the functionality of these physical monitors, not a standalone software application.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device samples and measures gases directly from the patient's breathing (in vivo). IVD devices are intended for use on specimens derived from the human body (in vitro), such as blood, urine, or tissue.
- Device Description: The description focuses on monitoring physiological parameters and anesthetic gases in real-time from the patient.
- No mention of specimens: There is no mention of collecting or analyzing biological specimens.
The device is a patient monitoring system that measures physiological parameters and respiratory gases directly from the patient.
N/A
Intended Use / Indications for 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 R50 recorders, either directly or via the Infinity Network.
The Scio and MultiGas/MultiGas+ modules sample breathing gases from adults and pediatrics. The gas modules continuously measure the content of CO2, N2O, O2 and one of the anesthetic agents, Halothane, Isoflurane, 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.
Product codes
MHX
Device Description
The intent of this 510(k) is to describe modifications for the Infinity Delta and Kappa series monitors (Delta, Delta XL, Kappa,, Vista XL, Gamma X XL, and Kappa XLT), including Pacer Fusion mode and Age-Based MAC. Kappa XLT now supports the BisX and tpO2 pods, and FiO2.
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
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 VF6 modifications described 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)
K043439, K042904, K050974, K053484
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
Image /page/0/Picture/1 description: The image shows the words "Dräger medical" in a stylized font. The word "Dräger" is in a bold, sans-serif font, while the word "medical" is in a thinner, sans-serif font. The two words are next to each other, with "Dräger" on the left and "medical" on the right. The text is black against a white background.
Image /page/0/Picture/2 description: The image shows the text "K060039" on the top line and "P 1/1" on the second line. The text is written in a handwritten style with thick, dark strokes. The numbers are clearly visible, and the letters are easily distinguishable.
A Dräger and Siemens Company
APR 1 2 2006
510(k) SUMMARY
as required per 807.92(c)
| Submitter's Name and Address: | Draeger Medical Systems, Inc.
16 Electronics Avenue
Danvers, MA 01923 | |
|-----------------------------------------|---------------------------------------------------------------------------------------------------|----------|
| Contact Person: | Thomas M. McIntosh
Regulatory Submissons Manager
Tel: (978) 907-7500
Fax: (978) 750-6879 | |
| Date submission was prepared: | January 2, 2006 | |
| 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 modifications for the Infinity Delta and Kappa series monitors (Delta, Delta XL, Kappa,, Vista XL, Gamma X XL, and Kappa XLT), including Pacer Fusion mode and Age-Based MAC. Kappa XLT now supports the BisX and tpO2 pods, and FiO2.
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 R50 recorders, either directly or via the Infinity Network.
Predicate Devices:
Infinity Modular Monitors Infinity Kappa XLT Infinity MIB Infinity Gamma/Gamma XL
K043439 (Prior cleared submission K042904 (Prior cleared submission) K050974 (Prior cleared submission) K053484 - Predicate device
Substantial Equivalence:
Verification and validation testing performed indicates that the VF6 modifications described are as safe and effective as previous versions and have not altered the fundamental technology of the device(s).
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Draeger Medical Systems, Inc. 16 Electronics Avenue Danvers, MA 01923 Tel: (978) 907-7500 Fax: (978) 750-6879
1
Image /page/1/Picture/11 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines representing the staff and a single line representing the snake. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 2 2006
Draeger Medical Systems, Inc. c/o Mr. Thomas M. McIntosh Regulatory Submission Manager 16 Electronics Avenue Danvers, MA 01923
Re: K060039
Trade Name: Infinity Delta and Kappa Series Monitors Regulation Number: 21 CFR 870.1025 Regulation Name: Patient Physiological Monitor (with arrhythmia detection or alarms) Regulatory Class: Class II (two) Product Code: MHX Dated: March 17, 2006 Received: March 20, 2006
Dear Mr. McIntosh:
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. Iisting 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. Thomas M. McIntosh
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
B/fimmuma for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(K) Number (if known): K060039
Device Name: Infinity Delta / Kappa / Delta XL / Gamma X XL / Vista XL and Kappa XLT
Indications For Use:
The Scio and MultiGas/MultiGas+ modules sample breathing gases from adults and pediatrics. The gas modules continuously measure the content of CO2, N2O, O2 and one of the anesthetic agents, Halothane, Isoflurane, 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.
MR! Compatibility Statement:
The INFINITY Modular Monitors are not compatible for use in a MRI magnetic field.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Blumuma
Division Sign-Off
5100kl Number
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