(129 days)
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
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
Here's the detailed breakdown of the acceptance criteria and study information for the Wireless2000 PAM™ 3000 device based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document explicitly states that "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."
However, it does not provide specific quantitative acceptance criteria or the reported device performance in a table format. It mentions the measurement ranges for heart rate and respiration rate for the device's capabilities, but not as acceptance thresholds for the validation study.
Measurement Ranges:
| Measurement Range | Normal | Elevated |
|---|---|---|
| Heart Rate | 45-115 beats per minute | 85-170 beats per minute |
| Respiration Rate | 3-30 breaths per minute | 3-50 breaths per minute |
2. Sample Sizes and Data Provenance
The provided text does not specify the sample size used for the test set or the training set. It also does not mention the data provenance (e.g., country of origin of the data, retrospective or prospective).
3. Number of Experts and Qualifications
The provided text does not mention the number of experts used to establish ground truth or their qualifications.
4. Adjudication Method
The provided text does not mention any adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The provided text does not mention a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size of human readers improving with AI vs. without AI assistance. This device appears to be a standalone monitoring system, not one designed for human interpretation assistance.
6. Standalone (Algorithm Only) Performance
Yes, a standalone performance assessment was done. The document states: "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." This refers to the device itself (the algorithm/system) directly detecting these parameters.
7. Type of Ground Truth Used
The provided text does not explicitly state the type of ground truth used. Given the nature of the device (heart rate, respiration rate, and bed occupancy), it is highly probable that the ground truth would have been established using reference medical devices (e.g., ECG for heart rate, capnography or a reference respiration monitor for respiration rate, and direct observation for bed occupancy/motion). However, this is an inference and not directly stated in the document.
8. Sample Size for the Training Set
The provided text does not specify the sample size for the training set.
9. How Ground Truth for the Training Set was Established
The provided text does not state how the ground truth for the training set was established.
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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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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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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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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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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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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 |
§ 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).