(129 days)
No
The summary describes a system using a UWB motion sensor and proprietary software to measure vital signs and patient presence. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies. The focus is on sensor technology and signal processing.
No.
The system is explicitly described as a monitoring device to measure heart rate, respiration rate, and bed occupancy, not to provide therapy or treatment.
No
The device is intended to measure heart rate and respiration rate, monitor patient presence/absence in bed, and time length of patient motion. These are monitoring functions, not diagnostic functions that identify a disease or condition. While the data collected might be used by a clinician for diagnostic purposes, the device itself does not provide a diagnosis.
No
The device description clearly outlines multiple hardware components: a Bed Sensor Panel (BSP), Repeater Base Stations (RBS), and a Central Computer Station (CCS) with a Central Base Station (CBS). While it includes proprietary GUI software, it is part of a larger system that relies on these physical components for data acquisition and transmission.
Based on the provided information, the PAM™3000 system is not an IVD (In Vitro Diagnostic).
Here's why:
- 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.
- PAM™3000 function: The PAM™3000 system is described as a contact-less and wireless monitoring system that measures heart rate, respiration rate, bed occupancy, and patient motion. It does this by detecting the motion of the heart and thorax using a UWB-based motion sensor placed under the mattress.
- No sample analysis: The system does not involve the collection or analysis of any biological samples from the patient. It directly monitors physiological signals from the body.
Therefore, the PAM™3000 system falls under the category of patient monitoring devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The PAM™3000 system is intended to measure heart rate and respiration rate ın adult patients, in a general care hospital environment including, nursing homes The system monitors presence or absence of a patient in bed (bed exit) The system also times the length of continuous patient motion or absence of patient motion
Product codes
DRT/BZQ
Device Description
The PAM™3000 System is intended for contact-less and wreless monitoring of bed occupancy, motion and heart and respiration rates of adult patients 11 healthcare facilities The system utilizes a hıghly sensitive UWB-based motion sensor to detect the motion of heart and thorax The system consists of a Bed Sensor Panel (BSP), placed under the patient's mattress, Repeater Base Stations (RBS) that are typically mounted around the hallways in facility, and the Central Computer Station (CCS) with plugged-in Central Base Station (CBS) The signal containing the patient's heart rate and respiration rate data, bed occupancy data, patient motion, and the alerts generated by system are displayed on a PC monitor using Wireless 2000's proprietary Graphic User Interface (GUI) software The Central Computer Station (CCS) is typically located at the nursing station
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 patients
Intended User / Care Setting
General care hospital environment including, nursing homes
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 PAMTM3000 System underwent bench validation testing and clinical validation testing. The results of the testing indicate that the PAM™3000 performs according to its specifications and accurately detects respiration rate and heart rate of patients and patient presence in bed.
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
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/17 description: The image shows the logo for Wireless2000 RF & UWB Technologies Ltd. The logo features a stylized wireless signal icon above the word "WIRELESS2000" in a bold, sans-serif font. Below "WIRELESS2000" is the text "RF & UWB Technologies Ltd" in a smaller font.
K082626 Page 123
510(k) Summary
(per 21 CFR 807 92)
JAN 1 6 2009
I. Applicant Wireless 2000 RF & UWB Technologies Ltd 2421 Alpha Ave Burnaby, BC, V5C5L2
Efraim Gavrilovich, President and CEO Contact Person Tel (604) 298-8471 Fax (604) 298-8470 Email egav@wireless2000 com
August 27, 2008 Date Prepared
II. Device Name
| Proprietary Name | PAM™ 3000 |
|---|---|
| Common/ Usual Name | Heart Rate and Respiration Rate Monitor |
| Classification Name | monitor, cardiac (incl cardiotachometer & rate |
| alarm) monitor, breathing frequency | |
| Regulation Number | 870 2300/868 2375 |
| Product Codes | DRT/BZQ |
| Classification | II |
| Classification Panel | Cardiovascular/Anesthesiology |
III. Predicate Device
The Wireless 2000 PAM™ 3000 is substantially equivalent to the EarlySense ES-16 System from EarlySense Ltd (K070375) and LG1TM Intelligent Medical Vigilance System from Hoana Medical Inc (K052446)
IV. Intended Use of the Device
The PAM™3000 system is intended to measure heart rate and respiration rate ın adult patients, in a general care hospital environment including, nursing homes The system monitors presence or absence of a patient in bed (bed exit) The system also times the length of continuous patient motion or absence of patient motion
V. Description of the Device
The PAM™3000 System is intended for contact-less and wreless monitoring of bed occupancy, motion and heart and respiration rates of adult patients 11 healthcare facilities The system utilizes a hıghly sensitive UWB-based motion sensor to detect the motion of heart and thorax The system consists of
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Image /page/1/Picture/1 description: The image shows the logo for Wireless2000 RF & UWB Technologies Ltd. The logo features a stylized wireless signal icon above the word "WIRELESS2000" in a bold, sans-serif font. Below "WIRELESS2000" is the text "RF & UWB Technologies Ltd" in a smaller font size.
a Bed Sensor Panel (BSP), placed under the patient's mattress, Repeater Base Stations (RBS) that are typically mounted around the hallways in facility, and the Central Computer Station (CCS) with plugged-in Central Base Station (CBS) The signal containing the patient's heart rate and respiration rate data, bed occupancy data, patient motion, and the alerts generated by system are displayed on a PC monitor using Wireless 2000's proprietary Graphic User Interface (GUI) software The Central Computer Station (CCS) is typically located at the nursing station
VI. Summary of the Technical Characteristics
| Measurement Range | ||
|---|---|---|
| Heart Rate | Normal 45-115 beats per minute | Elevated 85-170 beats per minute |
| Respiration Rate | Normal 3-30 breaths per minute | Elevated 3-50 breaths per minute |
VII. Safety & Effectiveness
The PAMTM3000 System was designed and tested using the following standards
- IEC 60601-1 (2nd Edition) Medical Electrical Equipment -- Part 1 . General Requirements for Safety
- IEC 60601-1-2 (3td Edition) Medical Electrical Equipment Part 1 o General Requirements For Safety 2 Collateral Standard Electromagnetic Compatibility
- FCC Part 15 207/209/517 Conducted limits / Radiated emission limits, o general requirements / Technical requirements for indoor UWB systems
- ANSI C63 4 2003 Methods of Measurement of Rad10-No1se ● Emissions from Low-Voltage Electrical and Electronic Equipment in the Range of 9 kHz to 40 GHz
- IEC 62-2- 27 Shock Peak acceleration 100 g (980 m/s2), Duration o 6 msec. Pulse shape half sine
- IEC 68-2-6 Sinusoidal Vibration Frequency range 10 to 500 Hz, o Acceleration amplitude 1 g (9 8 m/s2), Type and duration of endurance 10 sweep cycles in each axıs
- IEC 68-2-34 Random Vibration (Wide band) Frequency range 20 Hz -. 500 Hz, Acceleration spectral density 0 02 g2/Hz, Degree of reproducibility low, Duration of conditioning 9 minutes
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Image /page/2/Picture/1 description: The image shows the logo for Wireless2000 RF & UWB Technologies Ltd. The logo features a stylized wireless signal icon above the word "WIRELESS2000" in a bold, sans-serif font. Below the main text, the words "RF & UWB Technologies Ltd" are printed in a smaller font size.
In addition, the PAM™ 3000 System underwent bench validation testing and clinical validation testing The results of the testing indicate that the PAM™3000 performs according to its specifications and accurately detects respiration rate and heart rate of patients and patient presence in bed
Overall there are no known substantial differences between the PAM™ 3000 system defined in this 510(k) submission and the predicate devices The devices have the same intended uses and any differences in technological characteristics do not raise 1ssues of safety and effectiveness
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Image /page/3/Picture/2 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans. The eagle is depicted in black and white, and the overall design is simple and clean.
Food and Drug Admınıstratıon 9200 Corporate Boulevard Rockville MD 20850
JAN 1 6 2009
Wireless 2000 RF and UWB Technologies, Ltd c/o Mr Efraim Gavrilovich President & CEO 2421 Alpha Ave Burnaby V5C5L2 Canada
Re K082626 PAM 3000 Regulation Number 21 CFR 870 2300 Regulation Name Heart rate monitor, cardiac (incl cardiotachometer and rate alarm) Regulatory Class II Product Code DRT Dated December 16, 2008 Received December 22, 2008
Dear Mr Gavrilovich
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 etther class II (Special Controls) or class III (PMA), 11 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
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
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Page 2 - Mr Efraim Gavrılovich
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807 97) For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Brometric's (OSB's) DIvision of Postmarket Surveillance at 240-276-3474 For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464 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,
Bram D Zuckerman, M D Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/5/Picture/1 description: The image shows the logo for Wireless2000 RF & UWB Technologies Ltd. The logo features a stylized wireless signal icon above the word "WIRELESS2000" in a bold, slightly distressed font. Below the company name, the text "RF & UWB Technologies Ltd" is printed in a smaller, sans-serif font. The overall design is simple and professional, conveying a sense of technological expertise.
4. Indication for Use Statement
510(k) Number (if known):
PAM™ 3000 Device Name:
Indications for Use:
The PAM™3000 system is intended to measure heart rate and respiration rate in adult patients, in a general care hospital environment including, nursing homes The system monitors presence or absence of a patient in bed (bed exit) The system also times the length of continuous patient motion or absence of patient motion
| Prescription Use ✗
(Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use
(21 CFR 801 Subpart C) |
| --------------------------------------------------- | -------- | ------------------------------------------------ |
|---|
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER
PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | Page 1 of _ |
|---|---|
| (Division Sign-Off) | |
| Division of Cardiovascular Devices | |
| 510(k) Number | K082626 |