K Number

Device Name

Aluna

Manufacturer

Knox Medical Diagnostics, Inc.

Date Cleared

2020-03-25

(117 days)

Product Code

BZH

Regulation Number

868.1860

Intended Use

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K181666, K152276

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard peak flow meter that measures FEV1 and PEF and transmits data to a mobile app. There is no mention of AI, ML, or any related technologies in the device description, intended use, or performance studies. The performance studies focus on standard medical device testing and accuracy metrics for lung function measurements.

Therapeutic

No
The device is described as a monitor for FEV1 and PEF, indicating it measures and displays lung function, rather than providing treatment.

Diagnostic

Yes

The device is intended for "monitoring FEV1 (Forced exhalation in the first second) and PEF (Peak Expired Flow Rate)", which are measurements used to assess lung function and can help diagnose and track respiratory conditions.

SaMD (Software as a Medical Device)

The device description explicitly states "Aluna is a small hand-held peak flow meter," indicating it includes a physical hardware component for capturing lung health information. The software component is used to make this information available, but it is not the sole component of the medical device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
Aluna's Function: Aluna measures lung function parameters (FEV1 and PEF) directly from the patient's breath. It does not analyze specimens taken from the body.
Intended Use: The intended use describes monitoring lung health through direct measurement of exhaled air, not through the analysis of biological samples.

Therefore, Aluna falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

BZH

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

children 5 years of age or older, adolescent and adult subjects.

Intended User / Care Setting

Home use, Clinicians for in-office monitoring.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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, and Ambient temperature and ambient pressure testing.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

FEV1 accuracy: +/- 3% or 0.05 L whichever is greater
PEF accuracy: +/- 10% or 0.3 L/s whichever is greater

Predicate Device(s)

K181666, K152276

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

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

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 and
Anesthesia 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

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.

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 and
Peak Flow Meter
(K152276)
Indications
for Use	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 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.	Smart One is intended
for home use by
patients to monitor PEF
(Peak Expiratory Flow)
and FEV1 (Forced
Expiratory Volume in
one second). The
device is designed for
children greater than
five years of age,
adolescent and adult
subjects.	Wing 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 pediatric to adult
users. Wing is not
recommended for
children under 5 years
of age.
Product
Code /
Regulation
Number	BZH / 21 CFR 868.1860	BZH / 21 CFR 868.1860	BZH / 21 CFR 868.1860
Regulation
Description	Peak-flow meter for
spirometry	Peak-flow meter for
spirometry	Peak-flow meter for
spirometry
Rx/OTC	OTC	OTC	OTC
Mode of
operation	Aluna is a Lilly type
pneumotachometer that
uses a differential
pressure sensor to
measure the pressure
difference across the
stainless-steel mesh. The
resulting pressure drop is
used to calculate FEV1
and PEF.	The device is equipped
with a plastic
mouthpiece connected
to a turbine flow meter
based on the infrared
interruption principle.
The device detects the
signals generated by
the turbine and
measures the
exhalation flow. At the
end of the expiration,
the device calculates
the PEF and FEV1.	The Wing uses an
acoustic transducer to
measure frequency of
oscillation caused by
the airstream to
calculate FEV1 and PEF
Dimensions	90.3 mm x 43 mm x
115.5 mm	49 mm x 109 mm x 21
mm	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 and
Peak Flow Meter
(K152276)
FEV1
accuracy	$\pm$ 3% or 0.05 L whichever
is greater	$\pm$ 3% or 0.1 L whichever
is greater	$\pm$ 5% or 0.1 L whichever
is greater
PEF max	14 L/s	16 L/s	15 L/s
PEF accuracy	$\pm$ 10% or 0.3 L/s
whichever is greater	$\pm$ 10% or 0.4 L/s
whichever is greater	$\pm$ 12% or 0.417 L/s
whichever is greater
Materials	Polymers, stainless steel	Plastic body	Plastic body
Transmission
Method	Bluetooth 4.0 LE	Bluetooth 4.0 LE	Audio cable
Power
Source	Rechargeable battery	2x1.5V AAA batteries	Smartphone battery
Smartphone
compatibility	iPhone (iOS 11 or later)	iPhone, Android
devices	iPhone and iPad (iOS 9
or later)
Sterilization	Non-sterile	Non-sterile	Non-sterile
App
functions	• Primary user interface
• Data acquisition and
processing
• Data display
• Data transmission to
server	• Primary user
interface
• Data acquisition and
processing
• Data display and
storage	• Primary user
interface
• Data acquisition and
processing
• Data display
• Data transmission to
server
Game
function	Yes	No	Yes
Data Storage	Cloud server	Phone	Cloud server
Data sharing	Yes, via email	Yes, via email	Yes, via email

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

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.