(97 days)
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No
The description focuses on Doppler radar technology and signal analysis without mentioning AI or ML algorithms for processing or interpretation.
No.
The "Intended Use" section states that the device is for "one-time measurement of respiratory rate, as part of a vital signs assessment" and "is not intended to monitor vital signs." It does not mention any therapeutic function.
No
The device is intended for a one-time measurement of respiratory rate as part of a vital signs assessment, not for diagnosing conditions.
No
The device description explicitly details hardware components including a 2.4 GHz Doppler radar, data acquisition circuitry, processing, user interface, touch-screen display, and a physical enclosure with mounting capabilities.
Based on the provided text, the Kai Medical Non-Contact Respiratory Rate Spot Check Model KMS 200 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.
- Device function: The description clearly states that the device uses Doppler radar to detect respiratory effort and calculate respiratory rate. This is a non-invasive measurement taken externally from the body.
- No mention of samples: There is no mention of the device analyzing any biological samples.
Therefore, the device falls under the category of a vital signs monitor or a medical device for physiological measurement, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Kai Medical Non-Contact Respiratory Rate Spot Check Model KMS 200 is intended for a one-time measurement of respiratory rate, as part of a vital signs assessment. The device is indicated for hospital or clinical use in adult patients. The device is intended to be operated by clinicians and medically qualified personnel. It is available for sale only upon the order of a physician or licensed health care provider.
The Kai Medical Non-Contact Respiratory Rate Spot Check Model KMS 200 is not intended to monitor vital signs. This device is not an apnea monitor
Product codes
CCK
Device Description
The sensor includes a 2.4 GHz Doppler radar, data acquisition circuitry, processing, user interface, and touch-screen display. The touch-screen display provides the display and user interface. The device is powered over the USB connection, either by a PC, with a wall-power adapter, or with an external battery. If desired, the Kai Spot KMS 200 has the capability to communicate via its USB interface with a personal computer (PC) using select Kai Spot data management software applications. The sensor uses Doppler radar to detect respiratory effort, and the respiratory effort signal is analyzed to provide a respiratory rate. A radio wave in the 2.4 GHz ISM band is emitted from the antenna included in the hardware module. The Kai Spot KMS 200 sensor enclosure includes screw holes in a VESA mounting pattern (VESA is a standard mounting configuration), which can be used to connect to any VESA mount, including stands, carts, wall-mounts, or adapters to other stands or carts. A stand is not included with the device; the customer’s Biomedical Engineering Department or maintenance service should install the device on a medical-grade stand used for vital signs measurement equipment. Screws to be used for mounting are provided with the device.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
adult patients
Intended User / Care Setting
hospital or clinical use in adult patients. The device is intended to be operated by clinicians and medically qualified personnel.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The bench performance data demonstrates that the Kai Spot KMS 200 is as safe and effective as the Kai RSpot 100. Bench performance data further demonstrates that the Kai Spot KMS 200 operates within its specifications, including accuracy over the range of measured respiratory rates.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Detectable Respiratory rate range: 8 to 48 breaths/minute
Accuracy: ±2 breaths/minute
Resolution: 0.5 breath/minute
Range between sensor and subject: 0.2 to 1 meter
Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 868.2375 Breathing frequency monitor.
(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).
0
K60773
JUN 2 3 2010
・・
510(k) SUMMARY
Kai Medical Non-Contact Respiratory Rate Spot Check Model KMS 200
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Kai Medical, Inc. 3465 Waialae Aveñue, Suite 370 Honolulu, Hawaii 96816 USA
Phone: +1.808.687.2900 Facsimile: +1.808.356.0367
Contact Person: Robert Nakata
Date Prepared: March 2, 2010
Name of Device
The Kai Medical Non-Contact Respiratory Rate Spot Check Model KMS 200 ("Kai Spot KMS 200")
Common or Usual Name
Respiratory Rate Spot Check
Classification Name
Breathing Frequency Monitor
Predicate Devices
The Kai Medical Non-Contact Respiratory Rate Spot Check Model KMS 200 ("Kai Spot KMS 200") is substantially equivalent to the Kai Medical Non-Contact Respiratory Rate Spot Check Model 100 ("Kai RSpot 100", 510(k) Number: K090273).
Device Description
The sensor includes a 2.4 GHz Doppler radar, data acquisition circuitry, processing, user interface, and touch-screen display. The touch-screen display provides the display and user interface. The device is powered over the USB connection, either by a PC, with a wall-power adapter, or with an external battery. If desired, the Kai Spot KMS 200 has the capability to communicate via its USB interface with a personal computer (PC) using select Kai Spot data
KAI MEDICAL INC, HONOLULU, HI 96816
1
management software applications. The sensor uses Doppler radar to detect respiratory effort, and the respiratory effort signal is analyzed to provide a respiratory rate. A radio wave in the 2.4 GHz ISM band is emitted from the antenna included in the hardware module. The Kai Spot KMS 200 sensor enclosure includes screw holes in a VESA mounting pattern (VESA is a standard mounting configuration), which can be used to connect to any VESA mount, including stands, carts, wall-mounts, or adapters to other stands or carts. A stand is not included with the device; the customer's Biomedical Engineering Department or maintenance service should install the device on a medical-grade stand used for vital signs measurement equipment. Screws to be used for mounting are provided with the device.
Physical Characteristics
Dimensions of the Kai Spot KMS 200 Sensor Unit: 7.5" X 7.5" X 2" Weight of the Kai Spot KMS 200 Sensor Unit: 1.2 lb
Performance
Detectable Respiratory rate range: 8 to 48 breaths/minute Accuracy: ±2 breaths/minute Resolution: 0.5 breath/minute Range between sensor and subject: 0.2 to 1 meter
Operational Modes
Measurement Duration: 30, 60, 120(3b) sec 3b mode: calculates rate for 3 consecutive breaths within 2 minute period
Power
Power Input: USB type B Power Reguirements: USB powered (5V,