Aluna is intended for monitoring FEV1 (Forced exhalation in the first second) and PEF (Peak Expired Flow Rate) for home use. The device is designed for children 5 years of age or older, adolescent and adult subjects. Additionally, the device may be used by clinicians for in-office monitoring.

Device Description

Aluna is a small hand-held peak flow meter that captures lung health information and makes it available through a mobile application. Aluna is intended for monitoring FEV1 (Forced Expiratory Volume in one second) and PEF (Peak Expiratory Flow) for over-the-counter use. Aluna is designed for use by pediatric to adult users. Aluna is not recommended for children under 5 years of age. Additionally, the device may be used by clinicians for in-office monitoring.

AI/ML Overview

Here's an analysis of the provided text to extract the acceptance criteria and study information for the Aluna device:

1. Table of Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (Aluna)	Reported Device Performance (Aluna)
FEV1 Accuracy	± 3% or 0.05 L, whichever is greater	Meets criteria
PEF Accuracy	± 10% or 0.3 L/s, whichever is greater	Meets criteria

Note: The document states that the technological differences (rechargeable battery, cloud data storage, game function) "have undergone testing to ensure the device is as safe and effective as the predicate" and that "non-clinical performance bench testing including FEV1/PEF measurement accuracy and repeatability per 2005 American Thoracic Society document ATS/ERS Task Force: Standardization of Lung Function Testing" was performed. While the specific numerical performance results are not explicitly listed in a separate "reported performance" column, the conclusion section states that "performance characteristics for the proposed Aluna are assessed to be substantially equivalent to the predicate device," implying that the device met these stated accuracy criteria.

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

The provided FDA 510(k) summary does not specify the sample sizes used for the FEV1/PEF measurement accuracy and repeatability testing. It only mentions that these tests were performed as "non-clinical performance bench testing."

Regarding data provenance, the document does not explicitly state the country of origin or if the data was retrospective or prospective. Given it's a bench test, the data would be generated in a controlled laboratory environment.

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

The document does not mention the use of experts to establish ground truth for the test set. For FEV1/PEF accuracy testing, the "ground truth" is typically established by comparing the device's readings against a highly accurate standard spirometer calibrated to known volumes and flows, or established physical simulators that produce precise airflow patterns. This is a technical measurement, not an expert interpretive judgment.

4. Adjudication Method for the Test Set

Not applicable. The accuracy testing described is a technical comparison against a standard, not an interpretive task requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The Aluna device is a peak-flow meter, which measures physiological parameters. Its effectiveness is assessed through accuracy and repeatability against established standards, not through human reader interpretation of images or data. Therefore, a study comparing human readers with and without AI assistance is not relevant to this type of device.

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

Yes, a standalone performance assessment was done. The FEV1/PEF measurement accuracy and repeatability testing assesses the algorithm's ability to accurately measure lung function parameters by itself, without human intervention in the measurement process (though a human operates the device).

7. The Type of Ground Truth Used

For the FEV1/PEV measurement accuracy and repeatability testing, the ground truth would be established by:

Highly accurate standard spirometry equipment or flow/volume simulators: These devices are precisely calibrated and serve as the reference standard against which the Aluna device's measurements are compared. The "2005 American Thoracic Society document ATS/ERS Task Force: Standardization of Lung Function Testing" explicitly details the methods and standards for this type of testing, which involves comparing the device's output to known, accurate flow and volume signals.

8. The Sample Size for the Training Set

The document does not provide information on a "training set" sample size. The Aluna is a medical device for measuring physical parameters, not an AI model that learns from a dataset in the traditional sense (e.g., machine learning for image classification). While there might be internal algorithms for signal processing or data analysis within the device, the summary does not detail the development or validation of such algorithms using a distinct training set. The emphasis is on the device's performance against established physical measurement standards.

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

Not applicable, as a traditional "training set" and associated ground truth establishment (as seen in AI/ML contexts) are not described for this device in the provided document. The device's performance is validated through specific bench testing against established physical and physiological measurement standards.

Summary

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March 25, 2020

Knox Medical Diagnostics, Inc. % Pierre Bounaud Senior Regulatory Specialist Acknowledge Regulatory Strategies 2251 San Diego Ave, Suite B-257 San Diego, California 92110

Re: K193311

Trade/Device Name: Aluna Regulation Number: 21 CFR 868.1860 Regulation Name: Peak-Flow Meter For Spirometry Regulatory Class: Class II Product Code: BZH Dated: February 26, 2020 Received: February 27, 2020

Dear Pierre Bounaud:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Michael Ryan Division Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K193311

Device Name Aluna

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Demonstration Use (§1.377-3(c), Subject to Exceptions)
☑ On-The-Spot Testing (§1.377-3(d), Subject to Exceptions)

Prescription Use (Part 21 CFR 801 Subpart D)

|X Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image shows the logo for Aluna. The logo consists of a circle that is divided into two halves. The left half of the circle is a solid color, while the right half of the circle has two curved lines inside of it. Below the circle is the word "aluna" in lowercase letters.

510(k) Summary

DATE PREPARED

March 25, 2020

MANUFACTURER AND 510(k) OWNER

Aluna 345 California Street, Suite 600, San Francisco, CA 94104, USA Telephone: Official Contact: Charvi Shetty, CEO

REPRESENTATIVE/CONSULTANT

Pierre Bounaud, Ph.D.
Allison C. Komiyama, Ph.D., R.A.C.
Acknowledge Regulatory Strategies, LLC
Telephone: +1 (619) 458-9547
Email: pbounaud@acknowledge-rs.com
akomiyama@acknowledge-rs.com
Website : www.Acknowledge-RS.com

DEVICE CLASSIFICATION

Proprietary Name/Trade Name:	Aluna
Common Name:	Peak-flow meter
Regulation Number:	21 CFR 868.1860
Class:	II
Product Code:	BZH
Premarket Review:	OHT1/ENT, Sleep Disordered Breathing, Respiratory andAnesthesia Devices (DHT1C)
Review Panel:	Anesthesiology

PREDICATE DEVICE IDENTIFICATION

Aluna is substantially equivalent to the following predicates:

510(k) Number	Predicate Device Name / Manufacturer	Primary Predicate
K181666	Smart One / MIR Medical International Research	✓
K152276	Wing Smart FEV1 and Peak Flow Meter / Sparo Inc.

DEVICE DESCRIPTION

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Image /page/4/Picture/1 description: The image shows a logo for a company called "aluna". The logo consists of the word "aluna" in lowercase letters, with a stylized circle above it. The circle is divided into three sections by two curved lines, creating a crescent moon shape on the right side. The logo is simple and modern, with a clean font and a light blue color scheme.

INDICATIONS FOR USE

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

Aluna is substantially equivalent to the predicate device based on the information summarized here:

The subject device has a similar design, dimensions and uses similar materials as the devices cleared in K181666 and in K152276. The subject device has the same intended use and similar technological characteristics to the devices cleared in K181666 and in K152276.

Technological differences of the subject device compared to the predicate device cleared in K181666 include:

. rechargeable lithium ion battery
. data storage on a cloud server
. game function

These technological differences have undergone testing to ensure the device is as safe and effective as the predicate.

The game function in the subject device is similar to the game function in the predicate device cleared in K152276. The role of the game function is to encourage users to take readings and to perform correct spirometry measurements with the use of game rewards as incentives.

Substantial equivalence comparison between subject devices cleared in K181666 and in K152276 is summarized in the table below.

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Image /page/5/Picture/1 description: The image shows the logo for Aluna. The logo consists of a circle with a vertical line through the center and two curved lines on the right side, resembling a crescent moon. Below the circle is the word "aluna" in lowercase letters and a light blue color.

	Subject Device	Predicate Device	Predicate Device
	Aluna	Smart One(K181666)	Wing Smart FEV1 andPeak Flow Meter(K152276)
Indicationsfor Use	Aluna is intended formonitoring FEV1 (Forcedexhalation in the firstsecond) and PEF (PeakExpired Flow Rate) forhome use. The device isdesigned for pediatric toadult users. Aluna is notrecommended forchildren under 5 years ofage. Additionally, thedevice may be used byclinicians for in-officemonitoring.	Smart One is intendedfor home use bypatients to monitor PEF(Peak Expiratory Flow)and FEV1 (ForcedExpiratory Volume inone second). Thedevice is designed forchildren greater thanfive years of age,adolescent and adultsubjects.	Wing is intended formonitoring FEV1(Forced exhalation inthe first second) andPEF (Peak Expired FlowRate) for home use.The device is designedfor pediatric to adultusers. Wing is notrecommended forchildren under 5 yearsof age.
ProductCode /RegulationNumber	BZH / 21 CFR 868.1860	BZH / 21 CFR 868.1860	BZH / 21 CFR 868.1860
RegulationDescription	Peak-flow meter forspirometry	Peak-flow meter forspirometry	Peak-flow meter forspirometry
Rx/OTC	OTC	OTC	OTC
Mode ofoperation	Aluna is a Lilly typepneumotachometer thatuses a differentialpressure sensor tomeasure the pressuredifference across thestainless-steel mesh. Theresulting pressure drop isused to calculate FEV1and PEF.	The device is equippedwith a plasticmouthpiece connectedto a turbine flow meterbased on the infraredinterruption principle.The device detects thesignals generated bythe turbine andmeasures theexhalation flow. At theend of the expiration,the device calculatesthe PEF and FEV1.	The Wing uses anacoustic transducer tomeasure frequency ofoscillation caused bythe airstream tocalculate FEV1 and PEF
Dimensions	90.3 mm x 43 mm x115.5 mm	49 mm x 109 mm x 21mm	3.2 x 2.4 x 1.5 inches(81 x 61 x 37mm)
Weight	95 g	60.7 g	70g
FEV1 Max	8 L	10 L	0.99 L
	Subject Device	Predicate Device	Predicate Device
	Aluna	Smart One(K181666)	Wing Smart FEV1 andPeak Flow Meter(K152276)
FEV1accuracy	$\pm$ 3% or 0.05 L whicheveris greater	$\pm$ 3% or 0.1 L whicheveris greater	$\pm$ 5% or 0.1 L whicheveris greater
PEF max	14 L/s	16 L/s	15 L/s
PEF accuracy	$\pm$ 10% or 0.3 L/swhichever is greater	$\pm$ 10% or 0.4 L/swhichever is greater	$\pm$ 12% or 0.417 L/swhichever is greater
Materials	Polymers, stainless steel	Plastic body	Plastic body
TransmissionMethod	Bluetooth 4.0 LE	Bluetooth 4.0 LE	Audio cable
PowerSource	Rechargeable battery	2x1.5V AAA batteries	Smartphone battery
Smartphonecompatibility	iPhone (iOS 11 or later)	iPhone, Androiddevices	iPhone and iPad (iOS 9or later)
Sterilization	Non-sterile	Non-sterile	Non-sterile
Appfunctions	• Primary user interface• Data acquisition andprocessing• Data display• Data transmission toserver	• Primary userinterface• Data acquisition andprocessing• Data display andstorage	• Primary userinterface• Data acquisition andprocessing• Data display• Data transmission toserver
Gamefunction	Yes	No	Yes
Data Storage	Cloud server	Phone	Cloud server
Data sharing	Yes, via email	Yes, via email	Yes, via email

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Image /page/6/Picture/1 description: The image shows a logo with the word "aluna" in lowercase letters. Above the word is a circular symbol that resembles a stylized moon or a partially shaded circle. The logo has a clean and modern design, with a light and airy feel.

SUMMARY OF NON-CLINICAL TESTING

The following tests were performed to demonstrate safety based on current industry standards:

Biocompatibility testing per ISO 10993-1, ANSI/AAMI/ISO 10993-5, ISO 10993-10, ISO . 18562-1, ISO 18562-2, and ISO 18562-3
. Software testing per IEC 62304
. Electrical safety testing per IEC 60601-1, IEC 60601-1-6, and IEC 60601-1-11
EMC testing per IEC 60601-1-2
Battery testing per IEC 62133-2
Wireless coexistence testing per ANSI PC63.27
Non-clinical performance bench testing including: ●
- o FEV1/PEF measurement accuracy and repeatability per 2005 American Thoracic Society document ATS/ERS Task Force: Standardization of Lung Function Testing
- o Ambient temperature and ambient pressure testing

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Image /page/7/Picture/1 description: The image shows the logo for Aluna. The logo consists of a circle divided into three sections, with the left section being a half-circle and the other two sections being quarter-circles. Below the circle is the word "aluna" in lowercase letters.

Usability testing per IEC 62366-1
The results of these tests indicate that Aluna is substantially equivalent to the predicate device.

CONCLUSION

Based on the testing performed, including biocompatibility, software testing, electrical safety and EMC testing, battery testing, wireless coexistence testing, and non-clinical performance bench testing, it can be concluded that the subject device does not raise new issues of safety or effectiveness compared to the predicate device. The similar indications for use, technological characteristics, and performance characteristics for the proposed Aluna are assessed to be substantially equivalent to the predicate device.

Regulation Number and Section

§ 868.1860 Peak-flow meter for spirometry.

(a)
Identification. A peak-flow meter for spirometry is a device used to measure a patient's maximum ventilatory flow rate.(b)
Classification. Class II (performance standards).