(287 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the device using traditional sensor and monitoring technologies.
No.
A therapeutic device is used to treat or cure a disease or condition. This device is indicated for continuous monitoring of vital signs and central apnea, which is a diagnostic or monitoring function, not a therapeutic one.
No
The device is a monitor for continuous vital sign monitoring (heart rate, respiration rate, and occurrences of central apnea) and includes alarms, but it does not diagnose a condition. It provides information to alert users to specific physiological events.
No
The device description explicitly states that the system includes "sensors" and uses "radio frequencies to transmit the monitoring information from infant-placed sensors to the central unit," indicating the presence of hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The HANNAH Wireless Vital Signs Monitor directly monitors physiological parameters (heart rate, respiration rate, central apnea) of an infant. It uses sensors placed on the infant's body (ECG leads, pressure sensor) to collect this data.
- The device description and intended use clearly indicate it's a monitoring device for vital signs, not a device that analyzes biological samples.
Therefore, the HANNAH Wireless Vital Signs Monitor falls under the category of a medical device used for patient monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The HANNAH Wireless Vital Signs Monitor is indicated for the continuous monitoring of an infant's heart rate, respiration rate, and occurrences of central apnea in home, hospital and other environments.
Product codes (comma separated list FDA assigned to the subject device)
73 FLS and BZQ
Device Description
The HANNAH system is an infant apnea monitor, which is substantially equivalent to legally marketed devices. The HANNAH system includes features incorporated in legally marketed devices. Like most legally marketed infant apnea monitors, the HANNAH incorporates sensors and alarms for monitoring both breath and heart rate. Like most legally marketed infant apnea monitors, the HANNAH system monitors heart rate using a 3-lead ECG measurement.
The HANNAH system has the same technological characteristics as legally marketed devices. Because lead wires connected to the infant present a documented risk for strangulation and electrocution, and because lead wires are the source of a substantial majority of the false alarms associated with wired monitors, the decision was made to use radio frequencies to transmit the monitoring information from infant-placed sensors to the central unit. Further, since the more common method of monitoring, impedance pneumography, is highly susceptible to false readings due to interference with cardiac signals and motion artifacts, respiration is monitored using a pressure sensor instead.
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
infant
Intended User / Care Setting
home, hospital and other environments.
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)
a clinical study of the device was conducted by an independent contract research organization in order to evaluate the HANNAH monitor's clinical performance relative to a legally marketed predicate device.
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.
EdenTec 2000W (K844327, K871302, K884614, K901060), Monitron (K874148), Model AMI Infant Central Apnea/Heart Rate Monitor (K961972), Respiration Monitor Type MR-10 (K822077)
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.
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
§ 868.2377 Apnea monitor.
(a)
Identification. An apnea monitor is a complete system intended to alarm primarily upon the cessation of breathing timed from the last detected breath. The apnea monitor also includes indirect methods of apnea detection such as monitoring of heart rate and other physiological parameters linked to the presence or absence of adequate respiration.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Apnea Monitors; Guidance for Industry and FDA.”
0
K991087
JAN | 2 2000
510(k) SUMMARY HANNAH Wireless Vital Signs Monitor March 29, 1999
This summary is provided in accordance with the Safe Medical Devices Act of 1990 (SMDA). The information provided in the 510(k), premarket notification was in accordance with 21 CFR 807.87.
1. Applicant/Submitter
iLife Systems, Inc. 5910 N. Central Expressway, Suite 1775 Dallas, TX 75206
Contact person: Joshua A. Adler, Vice President, Business Development 214-365-7400 Telephone: Facsimile: 214-365-7401 E-mail: jadler@ilifesystems.com
Consultant
Joel S. Faden, Ph.D., Inc. 11605 Hitching Post Lane Rockville, MD 20852
2. Name of Device
Trade Name: HANNAH Wireless Vital Signs Monitor Common/Usual Name: Infant Apnea Monitor Classification Name: 21 CFR 868.2375 "Breathing Frequency Monitor"
3. Legally Market Predicate Devices
The HANNAH system is an infant apnea monitor, which is substantially equivalent' to legally marketed devices, including the following:
- EdenTec 2000W (applicant: EdenTec; K844327, K871302, K884614, K901060) .
- Monitron (applicant: American Health Products, Inc .; K874148) .
- . Model AMI Infant Central Apnea/Heart Rate Monitor (applicant: Aequitron Medical, Inc .; K961972)
- . Respiration Monitor Type MR-10 (applicant: New Dimensions In Medicine, Inc .; K822077)
' Any statement made in conjunction with this submission regarding a determination of substantial equivalence to any other product is intended only to refer to whether the product can be lawfully marketed without pre-market approval or reclassification and is not intended to be interpreted as an admission or any other type of evidence in patent infringement litigation. (Establishment Registration and Premarket Notification Procedures, Final Regulation, Preamble, August 23, 1977, FR 42520 (Docket No. 76N-0355))
1
K99/087
4. Indications for Use
The HANNAH Wireless Vital Signs Monitor is indicated for the continuous monitoring of an infant's heart rate, respiration rate, and occurrences of central apnea in home, hospital and other environments.
5. Device Description and Substantial Equivalence
The HANNAH system is an infant apnea monitor, which is substantially equivalent to legally marketed devices. The HANNAH system includes features incorporated in legally marketed devices. Like most legally marketed infant apnea monitors, the HANNAH incorporates sensors and alarms for monitoring both breath and heart rate. Like most legally marketed infant apnea monitors, the HANNAH system monitors heart rate using a 3-lead ECG measurement.
The HANNAH system has the same technological characteristics as legally marketed devices. Because lead wires connected to the infant present a documented risk for strangulation and electrocution, and because lead wires are the source of a substantial majority of the false alarms associated with wired monitors, the decision was made to use radio frequencies to transmit the monitoring information from infant-placed sensors to the central unit. Further, since the more common method of monitoring, impedance pneumography, is highly susceptible to false readings due to interference with cardiac signals and motion artifacts, respiration is monitored using a pressure sensor instead.
The manufacture, design and clinical and laboratory testing of the HANNAH system, and the information provided in the 510(k) conformed, where applicable, to FDA guidelines, as well as proposed and recognized standards. In particular, the HANNAH system conforms, where applicable, to FDA's "Performance Standard for the Infant Apnea Monitor" (proposed), FR Tuesday, February 21, 1995, 9762 (vol. 60, no. 34). Further, the device was tested, where applicable, in accordance with IEC 601-1, AAMI EC-13, and other recognized standards. Lastly, a clinical study of the device was conducted by an independent contract research organization in order to evaluate the HANNAH monitor's clinical performance relative to a legally marketed predicate device. The information provided in the 510(k) demonstrates the substantial equivalence of the HANNAH system to legally marketed predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol of medicine and health. The caduceus has three lines representing the snakes entwined around a staff.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 2 2000
Mr. Joshua A. Adler iLife Systems, Inc. 5910 North Central Expressway Suite 1775 Dallas, TX 75206
K991087 Re : Hannah Wireless Vital Signs Monitor Regulatory Class: II (two) Product Code: 73 FLS and BZQ Dated: November 2, 1999 November 3, 1999 Received:
Dear Mr. Adler:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Joshua A. Adler
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Nancy C. Brogdon for
Celia M. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Premarket Notification Caring Technologies, Inc. HANNAH Wireless Vital Signs Monitor
991087
Indications For Use
Device Name: HANNAH Wireless Vital Signs Monitor
Indications For Use: The HANNAH Wireless Vital Signs Monitor is indicated for the continuous monitoring of an infant's heart rate, respiration rate, and occurrences of central apnea in home, hospital and other environments.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: (Per 21 CFR 801.109) OR
Over-The-Counter:
(Optional Format 1-2-96)
Nancy C. Brogdon
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devi
510(k) Number K 99/087