The Kai Sensors Non-Contact Respiratory Rate Spot Check Model 100 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 Sensors Non-Contact Respiratory Rate Spot Check Model 100 is not intended to monitor vital signs. This device is not an apnea monitor.

Device Description

The Kai Sensors Non-Contact Respiratory Rate Spot Check Model 100 ("Kai RSpot 100") is a reusable sensor for measuring respiratory rate during vital sign spot checks. The Kai RSpot 100 uses a low-power radar to sense chest displacement in order to obtain a respiratory rate. When the hardware module 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 sent to the computer portable computer via USB. The portable computer runs the Kai RSpot 100 software, which determines a respiratory rate from the chest motion (respiratory effort) signal and provides the display, user interface, and power source for the device. The portable computer can operate on battery power or on wall power through outlets when used with the supplied power cord.

AI/ML Overview

The provided 510(k) summary for the Kai Sensors Non-Contact Respiratory Rate Spot Check Model 100 (K090273) states that bench and clinical performance data demonstrate the device is as safe and effective as its predicate devices and operates within its specifications, including accuracy over the range of measured respiratory rates. However, the document does not include specific acceptance criteria values (e.g., minimum accuracy percentages or statistical thresholds) or detailed results from the supporting study to populate a table of acceptance criteria and reported device performance.

Therefore, many of the requested details cannot be extracted directly from the provided text.

Here's a summary of what can be inferred and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Accuracy over the range of measured respiratory rates (Specific threshold for accuracy is not provided in the document)	"Clinical testing of the device demonstrated its ability to generate respiratory rate information of sufficient accuracy for its intended use." (Specific quantitative performance metrics are not provided.)
Safety and Effectiveness compared to predicate devices	"The bench and clinical performance data demonstrates that the Kai RSpot 100 is as safe and effective as its predicate devices."
Operates within specifications (Specific technical specifications are not provided)	"The bench testing of this device demonstrates that the Kai RSpot 100 operates within its specifications."

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not specified in the provided text.
Data Provenance (e.g., country of origin, retrospective or prospective): Not specified in the provided text. The study is referred to as "clinical testing," implying a prospective study, but details are lacking.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not provided in the document.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No mention of an MRMC study or comparative effectiveness study involving human readers with and without AI assistance is present. The device is a standalone spot-check respiratory rate monitor, not an AI-assisted diagnostic tool for interpretation by human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, a standalone performance assessment was conducted for the device. The document explicitly states: "The Kai RSpot 100 software... determines a respiratory rate from the chest motion (respiratory effort) signal" and "Clinical testing of the device demonstrated its ability to generate respiratory rate information." This indicates the algorithm's performance in generating the respiratory rate independently.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The document implies that the ground truth for respiratory rate was established against which the Kai RSpot 100's measurements were compared. However, the method for establishing this ground truth (e.g., manual counting by experts, comparison to another gold-standard device) is not specified. It can be inferred that it would be another established method for measuring respiratory rate.

8. The sample size for the training set

This information is not provided in the document. The document primarily discusses performance testing, not details of model training.

9. How the ground truth for the training set was established

This information is not provided, as details about a training set are not mentioned.

In summary, while the submission states that testing was performed to demonstrate "sufficient accuracy" and substantial equivalence to predicate devices, the specific quantitative details regarding acceptance criteria, sample sizes, ground truth methods, and expert involvement are not included in the provided 510(k) summary. This is common for older 510(k) summaries which often contained less granular data than more recent submissions.

Summary

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K090273

510(k) SUMMARY

JUN - 5 2009

Kai Sensors Non-Contact Respiratory Rate Spot Check Model 100

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Kai Sensors, Inc.

3465 Waialae Avenue, Suite 370

Honolulu, Hawaii 96816 USA

Phone: +1.808.447.2525

Facsimile: +1.808.356.0367

Contact Person: Amy Droitcour Date Prepared: May 8, 2009

Name of Device and Name/Address of Sponsor

Kai Sensors Non-Contact Respiratory Rate Spot Check Model 100 ("Kai RSpot 100") (K090273)

Common or Usual Name

Breathing Frequency Monitor (868.2375)

Classification Name

Class II, Product Code BZQ

Breathing Frequency Monitor (868.2375)

Predicate Devices

The Kai Sensors Non-Contact Respiratory Rate Spot Check Model 100 (K090273) is substantially equivalent to the Welch Allyn Propaq Encore Model 242 (K012451), the Welch Allyn Propaq CS (K012451), the Medcare Flaga Universal XactTrace (K043132), the Embla Embletta Gold (K073682), and the Ferguson Medical Somnologica software (as part of the Embla System, K971813).

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Intended Use / Indications for Use

The Kai Sensors Non-Contact Respiratory Rate Spot Check Model 100 is not intended to monitor vital signs. This device is not an apnea monitor

Technological Characteristics

Performance Data

The bench and clinical performance data demonstrates that the Kai RSpot 100 is as safe and effective as its predicate devices. The bench testing of this device demonstrates that the Kai RSpot 100 operates within its specifications, including accuracy over the range of measured respiratory rates. Clinical testing of the device demonstrated its ability to generate respiratory rate information of sufficient accuracy for its intended use.

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Because the Kai RSpot 100 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 RSpot100 are at a power well below that emitted by many consumer wireless devices and many medical devices.

Substantial Equivalence

The Kai RSpot100 and its predicate devices, which include the Welch Allyn Propaq 200series monitors (K012451) and the Embletta Gold system with Universal XactTrace belts and Somnologica software (K043132, K073682, and K971813), have the same intended use and similar indications, technological characteristics and principles of operation.

The Kai RSpot 100, the Welch Allyn Propaq 200-series (K012451), and the Embla Embletta system with XactTrace belts and Somnologica software (K043132, K073682, and K971813) all provide a respiratory rate based on a respiratory effort measurement. The minor technological differences between the Kai RSpot 100 and its predicate devices raise no new issues of safety or effectiveness. The bench and clinical performance data demonstrate that the Kai RSpot 100 is as safe and effective as the Welch Allyn Propag 200-series monitors (K012451) and the Embla Embletta Gold system with Medcare Flaga Universal XactTrace belts and Ferguson Medical Somnologica software (as part of Embla system) (K043132, K073682, and K971813). Thus, the Kai RSpot 100 is substantially equivalent to its predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three stripes forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Amy Droitcour Technology Director Kai Sensors, Incorporated 3465 Waialae Avenue, Suite 370 Honolulu, Hawaii 96816

Re: K090273

Trade/Device Name: Kai Sensors Non-Contact Respiratory Rate Spot Check Model 100 ("Kai RSpot 100") Regulation Number: 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: II Product Code: BZQ Dated: May 8, 2009 Received: May11, 2009

JUN - 5 2009

Dear Ms. Droitcour:

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 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.

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Page 2- Ms. Droitcour

Enclosure

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/Centers Offices/CDRH/CDRHOffices /ucm 115809.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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Susen Rumo

Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use Statement

510(k) Number (if known):

K09 0273

Device Name: Kai Sensors Non-Contact Respiratory Rate Spot Check Model 100 ("Kai RSpot 100")

Indications for Use:

The Kai Sensors Non-Contact Respiratory Rate Spot Check Model 100 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 Sensors Non-Contact Respiratory Rate Spot Check Model 100 is not intended to monitor vital signs. This device is not an apnea monitor.

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)

Susan Chase

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

V - 2

ና 10(k) Number:

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).