(148 days)
Not Found
No
The summary describes a standard patient monitor with alarm functions based on preset limits, and there is no mention of AI, ML, or related concepts in the provided text.
No
The device is clearly indicated for monitoring physiological parameters and providing alarms, not for treating or providing therapy.
No
The device is a patient monitor that tracks vital signs and physiological parameters, which are used for monitoring and not for diagnosis. While it can detect variations and alarms, the determination of use is based on the healthcare professional's assessment of the patient's condition, emphasizing monitoring over diagnostic capabilities.
No
The device description explicitly states it is a "light-weight, handheld portable patient monitor," indicating it is a hardware device with integrated software, not a software-only device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The description of the Infinity Alpha clearly states it is a patient monitor that measures physiological parameters directly from the patient (heart rate, blood pressure, oxygen saturation, etc.). It does not mention analyzing blood, urine, tissue, or any other bodily fluid or substance.
- The intended use and device description focus on monitoring vital signs and physiological functions. This is characteristic of a patient monitoring device, not an IVD.
Therefore, the Infinity Alpha is a patient monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
The Infinity Alpha is intended for multi-parameter patient monitoring. 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.
This device is capable of monitoring heart rate, respiration rate, invasive blood pressure, non-invasive blood pressure, arrhythmia, cardiac output, temperature, arterial oxygen saturation, pulse rate, apnea, ST segment analysis.
Infinity Alpha will produce visual and audible alarms if any of these parameters vary beyond preset limits and produce timed or alarm recordings.
Product codes
MHX
Device Description
The Infinity Alpha is a light-weight, handheld portable patient monitor that displays real-time vital signs and provides continuous trending. The Infinity Alpha is capable of measuring heart rate, respiration rate, invasive blood pressure, non-invasive blood 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.
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
The devices are intended for use in the Adult, Pediatric and Neonatal populations, with the exception of Arrhythmia and ST Segment Analysis which are not intended for the neonatal population.
Intended User / Care Setting
The device is intended to be used in an environment where patient care is provided by Healthcare Professionals, i.e. physicians, nurses, and technicians, trained on the use of the device, 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)
Assessment of non-clinical performance data for equivalence:
The Infinity Alpha Patient Monitor 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 device.
Assessment of clinical performance data for equivalence:
Clinical performance evaluations indicate that the Infinity Alpha Patient Monitor is substantially equivalent to the Infinity Delta series monitors.
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
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
K 051658
NOV 1 6 2005
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: | Penelope H. Greco
Regulatory Affairs Manager
Tel: (978) 907-7503
Fax: (978) 750-6879 |
| Date submission was prepared: | June 17, 2005 |
| 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 Alpha
Device Description:
The Infinity Alpha is a light-weight, handheld portable patient monitor that displays real-time vital signs and provides continuous trending. The Infinity Alpha is capable of measuring heart rate, respiration rate, invasive blood pressure, non-invasive blood 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.
Intended Use:
The Infinity Alpha is intended for multi-parameter patient monitoring. 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.
| Predicate Devices: | |
|---|---|
| Infinity Modular Monitors | K043439 |
Page 1 of 2
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Substantial Equivalence:
Assessment of non-clinical performance data for equivalence:
The Infinity Alpha Patient Monitor 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 device.
Assessment of clinical performance data for equivalence:
Clinical performance evaluations indicate that the Infinity Alpha Patient Monitor is substantially equivalent to the Infinity Delta series monitors.
Biocompatability: Not applicable
Sterilization: Not applicable
IEC 60601-1 and applicable and collateral standards Standards and Guidance: IEC 60601-1-2 Electromagnetic Compatibility CISPR11, Class B UL60601-1, CSA 22.2 No 60601-1
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like symbol on the right side. To the left of the symbol, the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular fashion around the symbol.
NOV 1 6 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Draeger Medical Systems, Inc. c/o Ms. Penelope H. Greco Regulatory Affairs Manager 16 Electronics Avenue Danvers, MA 01923
Re: K051658
Trade Name: Infiniti Alpha Regulation Number: 21 CFR 870.1025 Regulation Name: Patient Physiological Monitor (with arrhythmia detection or alarm) Regulatory Class: Class II (two) Product Code: MHX Dated: October 14, 2005 Received: October 17, 2005
Dear Ms. Greco:
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.
3
Page 2 - Ms. Penelope H. Greco
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,
Blumman for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):
Device Name: InfinityAlpha
Indications for Use:
This device is capable of monitoring heart rate, respiration rate, invasive blood pressure, non-invasive blood pressure, arrhythmia, cardiac output, temperature, arterial oxygen saturation, pulse rate, apnea, ST segment analysis.
Infinity Alpha will produce visual and audible alarms if any of these parameters vary beyond preset limits and produce timed or alarm recordings.
The device is intended to be used in an environment where patient care is provided by Healthcare Professionals, i.e. physicians, nurses, and technicians, trained on the use of the device, 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 for use in the Adult, Pediatric and Neonatal populations, with the exception of Arrhythmia and ST Segment Analysis which are not intended for the neonatal population.
MRI Compatibility Statement: The Infinity Alpha is not compatible for use in a MRI magnetic field.
Prescription Use く (Per 21 CFR 801.109) OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Blamimina
Division Sign-Off
(División Sign-Off
Division of Cardiovascular Devices
510(k) Number Ko51458
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