Aluna

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K193311 Device Name Aluna Indications for Use (Describe) 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. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------------------------------------------------------| | <div> <span> ☑ Demonstration Use (§1.377-3(c), Subject to Exceptions) </span> </div> | | <div> <span> ☑ On-The-Spot Testing (§1.377-3(d), Subject to Exceptions) </span> </div> | > Prescription Use (Part 21 CFR 801 Subpart D) |X Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ 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<br>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 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. {4}------------------------------------------------ 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 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. #### 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. {5}------------------------------------------------ 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<br>(K181666) | Wing Smart FEV1 and<br>Peak Flow Meter<br>(K152276) | | Indications<br>for Use | 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 pediatric to<br>adult users. Aluna is not<br>recommended for<br>children under 5 years of<br>age. Additionally, the<br>device may be used by<br>clinicians for in-office<br>monitoring. | Smart One is intended<br>for home use by<br>patients to monitor PEF<br>(Peak Expiratory Flow)<br>and FEV1 (Forced<br>Expiratory Volume in<br>one second). The<br>device is designed for<br>children greater than<br>five years of age,<br>adolescent and adult<br>subjects. | Wing is intended for<br>monitoring FEV1<br>(Forced exhalation in<br>the first second) and<br>PEF (Peak Expired Flow<br>Rate) for home use.<br>The device is designed<br>for pediatric to adult<br>users. Wing is not<br>recommended for<br>children under 5 years<br>of age. | | Product<br>Code /<br>Regulation<br>Number | BZH / 21 CFR 868.1860 | BZH / 21 CFR 868.1860 | BZH / 21 CFR 868.1860 | | Regulation<br>Description | Peak-flow meter for<br>spirometry | Peak-flow meter for<br>spirometry | Peak-flow meter for<br>spirometry | | Rx/OTC | OTC | OTC | OTC | | Mode of<br>operation | Aluna is a Lilly type<br>pneumotachometer that<br>uses a differential<br>pressure sensor to<br>measure the pressure<br>difference across the<br>stainless-steel mesh. The<br>resulting pressure drop is<br>used to calculate FEV1<br>and PEF. | The device is equipped<br>with a plastic<br>mouthpiece connected<br>to a turbine flow meter<br>based on the infrared<br>interruption principle.<br>The device detects the<br>signals generated by<br>the turbine and<br>measures the<br>exhalation flow. At the<br>end of the expiration,<br>the device calculates<br>the PEF and FEV1. | The Wing uses an<br>acoustic transducer to<br>measure frequency of<br>oscillation caused by<br>the airstream to<br>calculate FEV1 and PEF | | Dimensions | 90.3 mm x 43 mm x<br>115.5 mm | 49 mm x 109 mm x 21<br>mm | 3.2 x 2.4 x 1.5 inches<br>(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<br>(K181666) | Wing Smart FEV1 and<br>Peak Flow Meter<br>(K152276) | | FEV1<br>accuracy | $\pm$ 3% or 0.05 L whichever<br>is greater | $\pm$ 3% or 0.1 L whichever<br>is greater | $\pm$ 5% or 0.1 L whichever<br>is greater | | PEF max | 14 L/s | 16 L/s | 15 L/s | | PEF accuracy | $\pm$ 10% or 0.3 L/s<br>whichever is greater | $\pm$ 10% or 0.4 L/s<br>whichever is greater | $\pm$ 12% or 0.417 L/s<br>whichever is greater | | Materials | Polymers, stainless steel | Plastic body | Plastic body | | Transmission<br>Method | Bluetooth 4.0 LE | Bluetooth 4.0 LE | Audio cable | | Power<br>Source | Rechargeable battery | 2x1.5V AAA batteries | Smartphone battery | | Smartphone<br>compatibility | iPhone (iOS 11 or later) | iPhone, Android<br>devices | iPhone and iPad (iOS 9<br>or later) | | Sterilization | Non-sterile | Non-sterile | Non-sterile | | App<br>functions | • Primary user interface<br>• Data acquisition and<br>processing<br>• Data display<br>• Data transmission to<br>server | • Primary user<br>interface<br>• Data acquisition and<br>processing<br>• Data display and<br>storage | • Primary user<br>interface<br>• Data acquisition and<br>processing<br>• Data display<br>• Data transmission to<br>server | | Game<br>function | Yes | No | Yes | | Data Storage | Cloud server | Phone | Cloud server | | Data sharing | Yes, via email | Yes, via email | Yes, via email | {6}------------------------------------------------ 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 {7}------------------------------------------------ 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.