Aluna 2 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.

Device Description

Aluna 2 consists of three main components:

A small hand-held peak flow meter that captures differential pressure, converts it to digital data points, and transmits the data to a mobile device via Bluetooth.
A mobile application that collects and transmits the differential pressure readings from the spirometry device and processes it to estimate the exhaled air flow rate and volume.
An Application Programming Interface (API) to facilitate communication with a cloud server used for data storage.

AI/ML Overview

The provided text is a 510(k) summary for the medical device Aluna 2, a peak flow meter for spirometry. It compares the Aluna 2 to its predicate device, the original Aluna, and details the non-clinical testing performed to establish substantial equivalence.

However, the document explicitly states: "Clinical testing was not required." This means there was no clinical study conducted involving human subjects to directly prove the device meets acceptance criteria for improved human reader performance with AI assistance, or standalone performance against clinical ground truth.

Therefore, many of the requested points regarding acceptance criteria and study design for clinical or AI-driven performance cannot be answered from the provided text, as this type of study was not performed. The device's substantial equivalence was demonstrated through non-clinical bench testing and adherence to standards for accuracy, safety, and software.

Here's an analysis of what can be extracted from the document regarding acceptance criteria and performance, focusing on the technical specifications and non-clinical testing:

Acceptance Criteria and Reported Device Performance (Non-Clinical)

The acceptance criteria are derived from the specified accuracy, linearity, repeatability, and impedance/resistance limits required by the "2019 ATS Update v. 2005 ATS Guidelines" and ISO standards. The reported device performance is implicitly demonstrated by the statement: "The results of these tests indicate that Aluna 2 is substantially equivalent to the predicate device." and the fact that it tightened some specifications compared to the predicate.

Acceptance Criteria Category	Subject Device (Aluna 2) Acceptance Criteria / Performance	Predicate Device (Aluna) Performance	Comparison to Predicate / Notes
FEV1 Accuracy	±2.5% or 0.05 L whichever is greater	±3% or 0.05 L whichever is greater	Tightened: Required by 2019 ATS Update v. 2005 ATS Guidelines. This indicates improved or more stringent accuracy.
FEV1 Linearity	<2.5%	Unspecified	New Parameter / Similar: Stating new parameter and limit required by 2019 ATS Update that was not required in 2005 ATS Guidelines. The "Similar" classification here means similar in that it meets modern standards, not that it's numerically similar to a predicate value (since none existed).
FEV1 Repeatability	±2.5% or 0.05 L whichever is greater	Unspecified	New Parameter / Similar: Stating new parameter and limit required by 2019 ATS Update that was not required in 2005 ATS Guidelines.
FEV1 Impedance	≤0.15 kPa/(l/s)	Unspecified	New Parameter / Similar: Stating new parameter and limit required by 2019 ATS Update that was not required in 2005 ATS Guidelines.
PEF Accuracy	±10% or 0.17 L/s whichever is greater	±10% or 0.3 L/s whichever is greater	Tightened: Required by 2019 ATS Guidelines v. 2005 ATS Guidelines. This indicates improved or more stringent accuracy.
PEF Linearity	≤5%	Unspecified	New Parameter / Similar: Stating new parameter and limit required by 2019 ATS Update that was not required in 2005 ATS Guidelines.
PEF Resistance to Flow	≤0.36 kPa/l/s	Unspecified	New Parameter / Similar: Stating new parameter and limit required by 2019 ATS Update that was not required in 2005 ATS Guidelines.
PEF Frequency Response	≤0.25 l/s), or 12 %, whichever is greater	Unspecified	New Parameter / Similar: Stating new parameter and limit required by 2019 ATS Update that was not required in 2005 ATS Guidelines.
Electrical Safety	Meets IEC 60601-1, IEC 60601-1-6, IEC 60601-1-11	Implied by predicate clearance	Compliance demonstrated via testing.
EMC	Meets IEC 60601-1-2	Implied by predicate clearance	Compliance demonstrated via testing.
Battery	Meets IEC 62133-2	Implied by predicate clearance	Compliance demonstrated via testing.
Software Verification	Meets IEC 62304	Implied by predicate clearance	Compliance demonstrated via testing.
Biocompatibility	Leveraged from predicate device (identical materials)	Meets ISO 10993-1	Demonstrated by leveraging predicate data; implies continued compliance.
Cybersecurity	Meets FDA Guidance (Sept 27, 2023)	Implicit, but perhaps not as strict as new guidance	Compliance demonstrated via testing to contemporary guidance.

As for the specific questions regarding a study that proves the device meets acceptance criteria, based on clinical performance or AI-driven insights, the document explicitly states:

Sample sizes used for the test set and the data provenance: Not applicable. No clinical test set involving human data was used for a clinical study comparing AI performance or human reader improvement. The "test set" for non-clinical performance would be the calibrated flow and volume generators used in the lab. Data provenance is not specified beyond "non-clinical performance bench testing."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No human experts were involved in establishing ground truth for a clinical or AI performance test, as there was no clinical study. The ground truth for bench testing would be from calibrated reference standards.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No clinical test set requiring adjudication.
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. The device is a direct measurement spirometer, not an AI-assisted diagnostic imaging or classification tool for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is largely standalone in its primary operation (measuring FEV1 and PEF). The "algorithm only" performance is evaluated by the non-clinical bench testing for accuracy, linearity, and repeatability against calibrated flows and volumes. The table above details these performance metrics.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the performance (accuracy, linearity, repeatability) of the device, the ground truth was established by calibrated reference standards/simulators as per ISO and ATS guidelines during bench testing. No biological or clinical ground truth (like pathology or outcomes) was used for device functional performance evaluation for this 510(k).
The sample size for the training set: Not applicable. This refers to an AI/machine learning training set. The Aluna 2 is a measurement device that calculates FEV1 and PEF based on differential pressure readings, not a device that uses machine learning models trained on large datasets.
How the ground truth for the training set was established: Not applicable, for the same reason as above.

Summary

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November 25, 2024

Knox Medical Diagnostics % Carol Vierling Senior Principal Ram+ 2790 Mosside Blvd. Suite 800 Monroeville, Pennsylvania 15146

Re: K232588

Trade/Device Name: Aluna 2 Regulation Number: 21 CFR 868.1860 Regulation Name: Peak-Flow Meter For Spirometry Regulatory Class: Class II Product Code: BZH Dated: October 25, 2024 Received: October 25, 2024

Dear Carol Vierling:

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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-regulatory

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assistance/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,

Rachana Visaria -S

Rachana Visaria, Ph.D. Assistant Director DHT1C: Division of Anesthesia, Respiratory, and Sleep 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) K232588

Device Name Aluna 2

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

escription 303 (Part 21 CFR 1301, Subpart B)

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

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510(k) Summary

DATE PREPARED

November 25, 2024

MANUFACTURER

Knox Medical Diagnostics 650 California Street, FL 7 San Francisco, CA 94108 Telephone: (415) 637-9852 Official contact: Michael Raftery, VP Operations and Quality

REPRESENTATIVE/CONSULTANT

Allison Komiyama, Ph.D., RAC Pierre Bounaud, Ph.D. ROM+ 2790 Mosside Blvd., Suite 800 Monroeville, PA 15146 Telephone: (412) 816-8253 Email: akomiyama@rqmplus.com, pbounaud(@rqmplus.com

DEVICE INFORMATION

Device trade name, or proprietary name: Aluna 2 ●
Device common name: Peak flow meter for spirometry ●
Classification: II
21 CFR 868.1860: Meter, peak flow, spirometry ●
Product Code(s): BZH
Panel: Anesthesiology ●
Basis for submission: Device modifications ●

PREDICATE DEVICE IDENTIFICATION

Aluna 2 is substantially equivalent to the following predicate:

510(k) Number	Predicate Device Name / Manufacturer	PrimaryPredicate
K193311	Aluna manufactured by Knox Medical Diagnostics	✓

DEVICE DESCRIPTION

Aluna 2 consists of three main components:

A small hand-held peak flow meter that captures differential pressure, converts it to ● digital data points, and transmits the data to a mobile device via Bluetooth.
A mobile application that collects and transmits the differential pressure readings from ● the spirometry device and processes it to estimate the exhaled air flow rate and volume.
An Application Programming Interface (API) to facilitate communication with a cloud ● server used for data storage.

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INDICATIONS FOR USE

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

Modifications are proposed to Aluna, the first generation device cleared under K193311. Modifications include minor cosmetic changes to hardware, additional capabilities to the software and changes to non-patient contacting materials.

The subject device has the same design and dimensions and uses similar materials as the first generation Aluna. The subject device has the same intended use and similar technological characteristics to the device cleared in K193311. Any difference in technological characteristics have undergone testing to ensure the device is as safe and effective as the predicate.

Substantial equivalence comparison between the subject device and the device cleared in K193311 is summarized in the table below.

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	Subject Device	Predicate Device	Comparison
	Aluna 2	Aluna
	(K232588)	(K193311)
Indicationsfor Use	Aluna 2 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 for childrenunder 5 years of age.Additionally, the devicemay be used by cliniciansfor in-office monitoring.	Aluna is intended formonitoring FEV1 (Forcedexhalation in the firstsecond) and PEF (PeakExpired Flow Rate) forhome use. The device isdesigned for children 5years of age or older,adolescent and adultsubjects. Additionally, thedevice may be used byclinicians for in-officemonitoring.	Similar; Replacing agerange of intended userswith more conciselanguage with the samemeaning
Product Code/ RegulationNumber	BZH / 21 CFR 868.1860	BZH / 21 CFR 868.1860	Identical
Regulation	Peak-flow meter for	Peak-flow meter for	Identical
Description	spirometry	spirometry
Rx / OTC	Rx or OTC	Rx or OTC	Identical
Mode ofoperation	Aluna 2 is a Lilly typepneumotachometer thatuses a differential pressuresensor to measure thepressure difference acrossthe stainless-steel mesh.The resulting pressuredrop is used to calculateFEV1 and PEF.	Aluna is a Lilly typepneumotachometer thatuses a differential pressuresensor to measure thepressure difference acrossthe stainless-steel mesh.The resulting pressuredrop is used to calculateFEV1 and PEF.	Identical
Dimensions	90.3 mm x 43 mm x 115.5mm	90.3 mm x 43 mm x 115.5mm	Identical
Weight	95 g	95 g	Identical
FEV1 Max	8 L	8 L	Identical
FEV1	±2.5% or 0.05 L	±3% or 0.05 L whichever	Similar; Tightened
accuracy	whichever is greater	is greater	accuracy limits as requiredby 2019 ATS Update v.2005 ATS Guidelines
FEV1linearity	<2.5%	Unspecified	Similar; Stating newparameter and limitrequired by 2019 ATSUpdate that was notrequired in 2005 ATSGuidelines
	Subject Device	Predicate Device	Comparison
	Aluna 2(K232588)	Aluna(K193311)
FEV1repeatability	±2.5% or 0.05 Lwhichever is greater	Unspecified	Similar; Stating newparameter and limitrequired by 2019 ATSUpdate that was notrequired in 2005 ATSGuidelines
FEV1impedance	≤0.15 kPa/(l/s)	Unspecified	Similar; Stating newparameter and limitrequired by 2019 ATSUpdate that was notrequired in 2005 ATSGuidelines
PEF max	14 L/s	14 L/s	Identical
PEFaccuracy	±10% or 0.17 L/swhichever is greater	±10% or 0.3 L/swhichever is greater	Similar; Tightenedaccuracy limits as requiredby 2019 ATS Guidelinesv. 2005 ATS Guidelines
PEFlinearity	≤5%	Unspecified	Similar; Stating newparameter and limitrequired by 2019 ATSUpdate that was notrequired in 2005 ATSGuidelines
PEFresistance toflow	≤0.36 kPa/l/s	Unspecified	Similar; Stating newparameter and limitrequired by 2019 ATSUpdate that was notrequired in 2005 ATSGuidelines
PEFfrequencyresponse	≤0.25 l/s), or 12 %,whichever is greater	Unspecified	Similar; Stating newparameter and limitrequired by 2019 ATSUpdate that was notrequired in 2005 ATSGuidelines
Materials	Polymers, stainless steel	Polymers, stainless steel	Identical
TransmissionMethod	Bluetooth 4.0 LE	Bluetooth 4.0 LE	Identical
Power Source	Rechargeable battery	Rechargeable battery	Identical
Smartphonecompatibility	iPhone (iOS 15 or later)Android (8 or later)	iPhone (iOS 11 or later)	Similar; Updated toinclude Androidapplication and to includenewer versions of iOS
Sterilization	Non-sterile	Non-sterile	Identical
	Subject Device	Predicate Device	Comparison
	Aluna 2(K232588)	Aluna(K193311)
Appfunctions	• Primary user interface• Data acquisition andprocessing• Data display• Data transmission toserver	• Primary user interface• Data acquisition andprocessing• Data display• Data transmission toserver	Identical
Gamefunction	Yes or No depending onuser preference	Yes	Similar; Updated to allowthe game function to beswitched off depending onuser preference.
Data Storage	Cloud server	Cloud server	Identical
Data sharing	Yes, via email	Yes, via email	Identical

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SUMMARY OF NON-CLINICAL TESTING

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

. Electrical Safety
- IEC 60601-1 Medical electrical equipment Part 1: General requirements for O basic safety and essential performance
- IEC 60601-1-6 Medical electrical equipment Part 1-6: General requirements for o basic safety and essential performance - Collateral standard: Usability
- IEC 60601-1-11 General requirements for basic safety and essential performance о — Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
Electromagnetic Compatibility .
- 0 IEC 60601-1-2 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
Battery
- IEC 62133-2 Secondary cells and batteries containing alkaline or other non-acid O electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems

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. FEV1/PEF measurement accuracy, repeatability, linearity, and Frequency Response per the American Thoracic Society Technical Statement on "Standardization of Spirometry 2019 Update" to meet the requirements of:
- o ISO 26782:2009 Anaesthetic and respiratory equipment Spirometers intended for the measurement of time forced expired volumes in humans
- ISO 23747:2015 Anaesthetic and respiratorv equipment Peak expiratory flow O meters for the assessment of pulmonary function in spontaneously breathing humans
. Software Verification
- o IEC 62304 Medical device software Software life cycle processes
Biocompatibility
- o FDA Guidance: Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (issued September 8, 2023) Note: The patient contacting materials are identical to the predicate device. Biocompatibility testing was leveraged from the predicate device to support substantial equivalence.
. Cybersecurity
- o FDA Guidance: Cybersecurity in Medical Devices: Oualitv System Considerations and Content of Premarket Submissions (issued September 27, 2023)

The results of these tests indicate that Aluna 2 is substantially equivalent to the predicate device.

SUMMARY OF CLINICAL TESTING

Clinical testing was not required.

CONCLUSION

Based on the testing performed, including software testing, electrical safety and EMC testing, battery 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. Aluna 2 has the same design and dimensions and uses similar materials as the first generation Aluna. The subject device has the same intended use and similar technological characteristics as the predicate device. Aluna 2 is 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).