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

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.

AI/ML Overview

The Kai Medical Non-Contact Respiratory Rate Spot Check Model KMS 200 is intended for a one-time measurement of respiratory rate in adult patients in a hospital or clinical setting.

1. Table of Acceptance Criteria and Reported Device Performance:

Feature	Acceptance Criteria (Specification)	Reported Device Performance
Detectable Respiratory Rate Range	8 to 48 breaths/minute	8 to 48 breaths/minute
Accuracy	±2 breaths/minute	±2 breaths/minute
Resolution	0.5 breath/minute	0.5 breath/minute
Range between sensor and subject	0.2 to 1 meter	0.2 to 1 meter

2. Sample Size Used for the Test Set and Data Provenance:

The provided document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It generally refers to "bench performance data."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

The document does not provide details on the number of experts used to establish ground truth or their qualifications. The study described focuses on bench performance and comparison to a predicate device, not a human reader study.

4. Adjudication Method for the Test Set:

No information is provided regarding an adjudication method. The performance assessment appears to be a direct comparison of the device's measurements against specified technical criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. The document describes a bench performance study demonstrating the device's adherence to its specifications and substantial equivalence to a predicate device, not a study involving human readers with and without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Yes, a standalone study was done. The "bench performance data" and the reported "device performance" (accuracy, range, resolution) are indicative of the algorithm's performance without human intervention. The device itself is designed for standalone measurement of respiratory rate.

7. The Type of Ground Truth Used:

The ground truth used appears to be the defined technical specifications for respiratory rate measurement (e.g., a "true" respiratory rate within certain parameters) against which the device's performance was evaluated. This would likely involve a validated method for generating known respiratory rates in a bench setting.

8. The Sample Size for the Training Set:

The document does not specify a training set or its sample size. This is likely because the device's underlying technology (Doppler radar detecting chest displacement) and signal processing are based on established physical principles rather than a machine learning model that typically requires a large training dataset.

9. How the Ground Truth for the Training Set Was Established:

As no training set is indicated, there is no information on how its ground truth would have been established. The device's performance is gauged against its technical specifications.

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is referred to as "bench performance data."

Study Description: The submission states, "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."
Methodology (Inferred): While the detailed methodology is not provided, "bench performance data" typically involves testing the device in a controlled laboratory environment against known or simulated conditions. For respiratory rate measurement, this would likely include:
- Using a呼吸模拟器 (respiratory simulator) or controlled mechanical setup that can generate precise respiratory rates within the specified range (8 to 48 breaths/minute).
- Measuring the output of the Kai Spot KMS 200 at various simulated respiratory rates.
- Comparing the device's reported respiratory rate to the "true" simulated rate.
- Verifying that the measured values fall within the specified accuracy (±2 breaths/minute) and resolution (0.5 breath/minute) across the operational range and at different sensor-to-subject distances (0.2 to 1 meter).
Result: The bench performance data confirmed that the Kai Spot KMS 200 operates "within its specifications." This directly correlates to meeting the acceptance criteria outlined in the table.

Summary

{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

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, < 500mA) Power Consumption: Less than 500 mA at 5V

Communications

USB 2.0

Start/Stop measurement .
Aiming light on/off .
Respiration rate in breaths/minute .
Retry/Error with code for type of Retry/Error .
Sensor status feedback .

Radio Specifications

Radio frequencies: 2.435 to 2.465 GHz Radio power (EIRP): Less than 18dBm Signal Bandwidth: Less than 2MHz Modulation: Psuedo Random Phase modulation Antenna gain: 13 dBi

KAI MEDICAL INC, HONOLULU, HI 96816

{2}------------------------------------------------

Features

Aiming Light: 8° viewing angle illuminating area of measurement

OLED Touch Screen Displav

Diagonal Size; 2.83" Resolution: 240 x RGB x 320 Pixel Pitch: 0.060 × 0.180 mm Active Area; 43.2 x 57.6 mm Outline Area; 49.1 x 67.3 mm Thickness; 1.75 (Typ) ; 1.95 (Max) mm

Speaker

Impedance: 8Ω±15% Rated power: 0.75 W Maximum power: 1.10 W Resonant frequency: 620 ±20% Hz Frequency range: 240 Hz - 20KHz

Intended Use / Indications for Use

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

Technological Characteristics

The The Kai Spot KMS 200 is a reusable sensor for measuring respiratory rate during vital sign assessments. The Kai Spot KMS 200 uses a low-power radar to sense chest displacement in order to obtain a respiratory rate. When the Kai Spot KMS 200 is operating and facing a patient, the Doppler radar transmits a low-power radio-frequency signal and receives the signal after it has reflected off the patient's torso. The receiver detects a phase shift on the signal due to chest displacement and converts this phase shift into a voltage that is digitized and processed with software, which determines a respiratory rate from the chest motion (respiratory effort) signal. A touch-screen provides the display and user interface for the device. The Kai Spot KMS 200 may communicate over USB with a personal computer (PC) using select Kai Spot data management software applications. The Kai Spot KMS 200 may operate on wall power, USB power from a PC, or power from an external battery.

KAI MEDICAL INC, HONOLULU, HI 96816

{3}------------------------------------------------

Performance Data

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.

Because the Kai Spot KMS 200 does not contact the patient, there is no risk of inadvertent exposure to electric current, and there are no patient-contacting materials that could cause allergic reactions or skin sensitivity. The radio signals emitted by the Kai Spot KMS 200 are at a power well below that emitted by many consumer wireless devices and many medical devices.

Substantial Equivalence

The Kai Spot KMS 200 has the same intended use, indications, and principles of operation as its predicate device, the Kai RSpot 100, and similar technological characteristics. The minor technological differences between the Kai Spot KMS 200 and its predicate device raise no new issues of safety or effectiveness. Performance data demonstrates that the Kai Spot KMS 200 is as safe and effective as the Kai RSpot 100. Thus, the Kai Spot KMS 200 is substantially equivalent.

KAI MEDICAL INC, HONOLULU, HI 96816

{4}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Robert Nakata Chief Technology Officer Kai Sensors, Incorporated 3465 Waialae Avenue, Suite 370 Honolulu, Hawaii 96816

JUN 2 8 2010

Re: K100773

Trade/Device Name: The Kai Sensors Non-Contact Respiratory Rate Spot Check Model 200 Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: II Product Code: CCK Dated: May 20, 2010 Received: May 24, 2010

Dear Mr. Nakata:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

{5}------------------------------------------------

Page 2- Mr. Nakata

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours

Susan Tunnes

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

Indications for Use Statement

510(k) Number (if known): K090273

Device Name: The Kai Sensors Non-Contact Respiratory Rate Spot Check Model 200

Indications for Use:

The Kai Sensors Non-Contact Respiratory Rate Spot Check Model 200 is intended for a onetime 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 Sensors Non-Contact Respiratory Rate Spot Check Model 200 is not intended to monitor vital signs. This device is not an apnea monitor

enter

L. Schultheis

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: k/00773

Prescription Use X (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Regulation Number and Section

§ 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).