Aluna 2

K232588 · Knox Medical Diagnostics · BZH · Nov 25, 2024 · Anesthesiology

Device Facts

• Record ID: K232588
• Device Name: Aluna 2
• Applicant: Knox Medical Diagnostics
• Product Code: BZH · Anesthesiology
• Decision Date: Nov 25, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1860
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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 Story

Aluna 2 is a handheld Lilly-type pneumotachometer for monitoring FEV1 and PEF. Device captures differential pressure across a stainless-steel mesh during patient exhalation; transmits digital data via Bluetooth to a mobile application. Mobile app processes pressure readings to estimate exhaled air flow rate and volume; displays results to user; transmits data to cloud server via API. Used in home or clinical settings by patients or clinicians. Output allows tracking of pulmonary function over time, aiding clinical decision-making for respiratory conditions. Benefits include convenient, remote monitoring of lung function.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including FEV1/PEF measurement accuracy, repeatability, linearity, and frequency response per 2019 ATS standards, plus electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), battery safety (IEC 62133-2), and software verification (IEC 62304).

Technological Characteristics

Lilly-type pneumotachometer; stainless-steel mesh; differential pressure sensor. Dimensions: 90.3mm x 43mm x 115.5mm; Weight: 95g. Power: rechargeable battery. Connectivity: Bluetooth 4.0 LE. Materials: polymers, stainless steel. Non-sterile. Software: mobile app (iOS/Android) and cloud-based API.

Indications for Use

Indicated for monitoring FEV1 and PEF in pediatric (5+ years) to adult patients for home or in-office use. Not for children under 5 years.

Regulatory Classification

Identification

A peak-flow meter for spirometry is a device used to measure a patient's maximum ventilatory flow rate.

Predicate Devices

• Aluna manufactured by Knox Medical Diagnostics (K193311)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

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

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: [phone] 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: [phone] Email: [e-mail], 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 | Primary<br>Predicate |
|---------------|------------------------------------------------|----------------------|
| 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

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.

## 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) | |
| Indications<br>for Use | Aluna 2 is intended for<br>monitoring FEV1 (Forced<br>exhalation in the first<br>second) and PEF (Peak<br>Expired Flow Rate) for<br>home use. The device is<br>designed for pediatric to<br>adult users. Aluna is not<br>recommended for children<br>under 5 years of age.<br>Additionally, the device<br>may be used by clinicians<br>for in-office monitoring. | Aluna is intended for<br>monitoring FEV1 (Forced<br>exhalation in the first<br>second) and PEF (Peak<br>Expired Flow Rate) for<br>home use. The device is<br>designed for children 5<br>years of age or older,<br>adolescent and adult<br>subjects. Additionally, the<br>device may be used by<br>clinicians for in-office<br>monitoring. | Similar; Replacing age<br>range of intended users<br>with more concise<br>language with the same<br>meaning |
| Product Code<br>/ Regulation<br>Number | 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 of<br>operation | Aluna 2 is a Lilly type<br>pneumotachometer that<br>uses a differential pressure<br>sensor to measure the<br>pressure difference across<br>the stainless-steel mesh.<br>The resulting pressure<br>drop is used to calculate<br>FEV1 and PEF. | Aluna is a Lilly type<br>pneumotachometer that<br>uses a differential pressure<br>sensor to measure the<br>pressure difference across<br>the stainless-steel mesh.<br>The resulting pressure<br>drop is used to calculate<br>FEV1 and PEF. | Identical |
| Dimensions | 90.3 mm x 43 mm x 115.5<br>mm | 90.3 mm x 43 mm x 115.5<br>mm | 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 required<br>by 2019 ATS Update v.<br>2005 ATS Guidelines |
| FEV1<br>linearity | <2.5% | Unspecified | Similar; Stating new<br>parameter and limit<br>required by 2019 ATS<br>Update that was not<br>required in 2005 ATS<br>Guidelines |
| | Subject Device | Predicate Device | Comparison |
| | Aluna 2<br>(K232588) | Aluna<br>(K193311) | |
| FEV1<br>repeatability | ±2.5% or 0.05 L<br>whichever is greater | Unspecified | Similar; Stating new<br>parameter and limit<br>required by 2019 ATS<br>Update that was not<br>required in 2005 ATS<br>Guidelines |
| FEV1<br>impedance | ≤0.15 kPa/(l/s) | Unspecified | Similar; Stating new<br>parameter and limit<br>required by 2019 ATS<br>Update that was not<br>required in 2005 ATS<br>Guidelines |
| PEF max | 14 L/s | 14 L/s | Identical |
| PEF<br>accuracy | ±10% or 0.17 L/s<br>whichever is greater | ±10% or 0.3 L/s<br>whichever is greater | Similar; Tightened<br>accuracy limits as required<br>by 2019 ATS Guidelines<br>v. 2005 ATS Guidelines |
| PEF<br>linearity | ≤5% | Unspecified | Similar; Stating new<br>parameter and limit<br>required by 2019 ATS<br>Update that was not<br>required in 2005 ATS<br>Guidelines |
| PEF<br>resistance to<br>flow | ≤0.36 kPa/l/s | Unspecified | Similar; Stating new<br>parameter and limit<br>required by 2019 ATS<br>Update that was not<br>required in 2005 ATS<br>Guidelines |
| PEF<br>frequency<br>response | ≤0.25 l/s), or 12 %,<br>whichever is greater | Unspecified | Similar; Stating new<br>parameter and limit<br>required by 2019 ATS<br>Update that was not<br>required in 2005 ATS<br>Guidelines |
| Materials | Polymers, stainless steel | Polymers, stainless steel | Identical |
| Transmission<br>Method | Bluetooth 4.0 LE | Bluetooth 4.0 LE | Identical |
| Power Source | Rechargeable battery | Rechargeable battery | Identical |
| Smartphone<br>compatibility | iPhone (iOS 15 or later)<br>Android (8 or later) | iPhone (iOS 11 or later) | Similar; Updated to<br>include Android<br>application and to include<br>newer versions of iOS |
| Sterilization | Non-sterile | Non-sterile | Identical |
| | Subject Device | Predicate Device | Comparison |
| | Aluna 2<br>(K232588) | Aluna<br>(K193311) | |
| App<br>functions | • Primary user interface<br>• Data acquisition and<br>processing<br>• Data display<br>• Data transmission to<br>server | • Primary user interface<br>• Data acquisition and<br>processing<br>• Data display<br>• Data transmission to<br>server | Identical |
| Game<br>function | Yes or No depending on<br>user preference | Yes | Similar; Updated to allow<br>the game function to be<br>switched off depending on<br>user 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.