(458 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on standard signal processing and data transmission.
No
The device is intended for monitoring FEV1 and PEF, which are diagnostic measurements, not therapeutic actions.
Yes
The device is intended for monitoring FEV1 and PEF, which are diagnostic indicators for respiratory health. It is used in both home and clinical settings for monitoring, implying its role in assessing a medical condition.
No
The device description explicitly states that Aluna 2 consists of a "small hand-held peak flow meter" which is a hardware component.
Based on the provided information, the Aluna 2 device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The description of Aluna 2 clearly states it measures FEV1 and PEF by capturing differential pressure from exhaled air. This is a measurement of a physiological function (lung capacity and airflow), not an analysis of a biological specimen like blood, urine, or tissue.
- The intended use is for monitoring lung function. The intended use is focused on monitoring respiratory parameters (FEV1 and PEF) for home and clinical use. This aligns with the function of a spirometer or peak flow meter, which are generally considered medical devices, but not IVDs.
Therefore, based on the provided text, Aluna 2 falls under the category of a medical device that measures physiological parameters, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
BZH
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.
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
pediatric to adult users. Aluna is not recommended for children under 5 years of age.
Intended User / Care Setting
home use. Additionally, the device may be used by 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
Non-clinical testing was performed including:
- Electrical Safety (IEC 60601-1, IEC 60601-1-6, IEC 60601-1-11)
- Electromagnetic Compatibility (IEC 60601-1-2)
- Battery (IEC 62133-2)
- 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 ISO 26782:2009 and ISO 23747:2015
- Software Verification (IEC 62304)
- Biocompatibility (leveraged from predicate device)
- Cybersecurity
Key results:
- FEV1 accuracy: ±2.5% or 0.05 L whichever is greater
- FEV1 linearity:
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and 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 square are the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" below it.
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.
1
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
2
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
3
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) |
|---|
| 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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4
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 | Primary
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.
5
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 | |||
| 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. | 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. | Similar; Replacing age | ||
| range of intended users | |||
| with more concise | |||
| language with the same | |||
| meaning | |||
| Product Code | |||
| / Regulation | |||
| 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 | |||
| operation | Aluna 2 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. | 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. | Identical | ||
| Dimensions | 90.3 mm x 43 mm x 115.5 | ||
| mm | 90.3 mm x 43 mm x 115.5 | ||
| 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 |
| by 2019 ATS Update v. | |||
| 2005 ATS Guidelines | |||
| FEV1 | |||
| linearity |