(371 days)
Not Found
No
The description focuses on standard spirometry measurements based on differential pressure and digital signal processing, with no mention of AI or ML techniques.
No
The device is described as a "diagnostic tool to measure the maximal volume and flow of air that can be moved in and out of a patient's lungs," indicating its purpose is to diagnose conditions rather than treat or alleviate them.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The spirometer (LA104, LA105) is a diagnostic tool."
No
The device description explicitly states that the spirometer "consists of the main body, handle, power adapter and a single-use flow sensor," indicating it includes hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The spirometer described measures the volume and flow of air moved in and out of a patient's lungs. This is a direct measurement of a physiological function (lung mechanics) performed on the patient, not on a sample taken from the patient.
- Intended Use: The intended use clearly states it's a "diagnostic tool to measure the maximal volume and flow of air that can be moved in and out of a patient's lungs." This aligns with in-vivo diagnostic testing, not in-vitro.
- Device Description: The description details how the device measures airflow through a sensor while the patient breathes, further confirming it's an in-vivo measurement.
Therefore, the spirometer is a diagnostic device, but it is not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The spirometer (LA104, LA105) is a diagnostic tool to measure the maximal volume and flow of air that can be moved in and out of a patient's lungs. The system is intended for use with pediatric (5 to 21 years) and adult (22 years and older) patients in hospitals, physician's offices, laboratories, and occupational health environments.
Product codes
BZG
Device Description
The spirometer is used to detect the ventilatory conditions of patients using a flow sensor. Basic test items include: Forced Vital Capacity (FVC), Slow Vital Capacity (SVC), Maximum Ventilator Volume (MVV), and Minute ventilation (MV). The device also provides bronchial diastolic and bronchial provocation tests comparison before and after medication along with time-volume and time-flow curves of the above tests.
The device comes in two models: LA104 and LA105. There are no differences between the two models apart from a minor software function. LA104 includes software incentive animations to encourage children to follow breathing instructions. The spirometer (model: LA104, LA105) consists of the main body, handle, power adapter and a single-use flow sensor. In order to conduct simple spirometry testing, the spirometer is used with a commercially available single-use disposable filter with integrated mouthpiece. This device is compatible with 30mm diameter filters.
The fundamental technology to measure flow is differential pressure. While the patient breathes, the air flows through both ends of the flow probe and produces different pressures. Then the sensor detects the pressure gap between both ends and converts it to electrical signals. The electrical signals are converted into digital signals of the pressure gap. Then digital signals are input into the computer system, which outputs values of pulmonary function related parameters after digital signal processing and data analysis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lungs
Indicated Patient Age Range
pediatric (5 to 21 years) and adult (22 years and older) patients
Intended User / Care Setting
hospitals, physician's offices, laboratories, and occupational health environments.
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)
Performance testing: The Spirometer meets the spirometry recommendations for accuracy and precision published by the American Thoracic Society (ATS). Testing demonstrated equivalence to the predicate device with regards to performance of forced vital capacity (FVC), slow vital capacity (SVC), maximum ventilator volume (MVV) and minute ventilation (MV) spirometry tests. Spirometer performance was tested according to:
- ATS/ERS 2005: ATS/ERS Task Force: Standardization of Lung Function Testing
- ISO 26782:2009: Anaesthetic and respiratory equipment — Spirometers intended for the measurement of time forced expired volumes in humans
Biocompatibility testing: The biocompatibility evaluation for the Spirometer was conducted in accordance with the FDA guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", June 16, 2016, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The biocompatibility of testing included the following tests:
- Cytotoxicity
- Sensitization
- Irritation
Also, the gas pathway testing has been conducted in accordance with ISO 18562-2 and ISO 18562-3. - Particulate Matter
- Volatile Organic Compounds
Additionally, condensate testing was performed to show that no condensate is formed in the single-use flow sensor and mouthpiece.
Electrical safety and electromagnetic compatibility (EMC): Electrical safety and EMC testing were conducted on the Spirometer. The device complies with the ANSI AAMI ES60601-1:2005/(R) 2012 and A1:2012, C1:2009/(R) 2012 and A2:2010/(R) 2012 (Consolidated Text) for safety and the IEC 60601-1-2:2014 standard for EMC.
Software Verification and Validation Testing: Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since a failure of latent design flaw could directly result in minor injury to the patient or operator.
Clinical Testing: Based on the similarities of the device specifications, intended use, indications for use between the Spirometer and its predicate devices, no clinical studies were needed to support this 510(k) Premarket Notification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 868.1840 Diagnostic spirometer.
(a)
Identification. A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.(b)
Classification. Class II (performance standards).
0
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June 10, 2021
MeHow Innovative Ltd % Olivia Meng Regulatory Affairs Manager Guangzhou Osmunda Medical Device Technical Service Co., Ltd 8-9th Floor, R&D Building, No.26 Qinglan Street, Panyu District Guangzhou, Guangdong 510006 China
Re: K201493
Trade/Device Name: Spirometer Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: Class II Product Code: BZG Dated: June 3, 2021 Received: June 7, 2021
Dear Olivia Meng:
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.
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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 (QS) 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 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-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.
Rachana Visaria, Ph.D. Assistant 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
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Indications for Use
510(k) Number (if known) K201493
Device Name Spirometer
Indications for Use (Describe)
The spirometer (LA104, LA105) is a diagnostic tool to measure the maximal volume and flow of air that can be moved in and out of a patient's lungs. The system is intended for use with pediatric (5 to 21 years and older) patients in hospitals, physician's offices, laboratories, and occupational health environments.
| 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) |
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510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
l. SUBMITTER
MeHow Innovative Ltd
Block A&B&C, NCBC Industrial Park, 6th Baolong Road, Longgang District, Shenzhen
518116, RP China
Phone: 086-0755-83051518
Fax: 086-0755-83051789
| Primary Contact Person: | Olivia Meng |
|---|---|
| Regulatory Affairs Manager | |
| Guangzhou Osmunda Medical Device Technical Service | |
| Co., Ltd | |
| Tel: (+86) 20-6231 6262 | |
| Fax: (+86) 20-8633 0253 | |
| Secondary Contact Person: | Gloria Sun |
| Regulatory registration supervisor | |
| MeHow Innovative Ltd | |
| Tel: 86-0755-83051518 | |
| Fax: 086-0755-83051789 | |
| Date Prepared: | 06/2/2021 |
II. DEVICE
| Name of Device: | Spirometer |
|---|---|
| Common or Usual Name: | Diagnostic Spirometer |
| Classification Names: | Spirometer, Diagnostic (21 CFR 868.1840) |
| Regulation Class: | II |
| Product Code: | BZG |
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III. PREDICATE DEVICE
Predicate device
GT-105: CardioTech Spirometry Model System, K090646
DEVICE DESCRIPTION IV.
The spirometer is used to detect the ventilatory conditions of patients using a flow sensor. Basic test items include: Forced Vital Capacity (FVC), Slow Vital Capacity (SVC), Maximum Ventilator Volume (MVV), and Minute ventilation (MV). The device also provides bronchial diastolic and bronchial provocation tests comparison before and after medication along with time-volume and time-flow curves of the above tests.
The device comes in two models: LA104 and LA105. There are no differences between the two models apart from a minor software function. LA104 includes software incentive animations to encourage children to follow breathing instructions. The spirometer (model: LA104, LA105) consists of the main body, handle, power adapter and a single-use flow sensor. In order to conduct simple spirometry testing, the spirometer is used with a commercially available single-use disposable filter with integrated mouthpiece. This device is compatible with 30mm diameter filters.
The fundamental technology to measure flow is differential pressure. While the patient breathes, the air flows through both ends of the flow probe and produces different pressures. Then the sensor detects the pressure gap between both ends and converts it to electrical signals. The electrical signals are converted into digital signals of the pressure gap. Then digital signals are input into the computer system, which outputs values of pulmonary function related parameters after digital signal processing and data analysis.
V. INDICATION FOR USE
The spirometer (LA104, LA105) is a diagnostic tool to measure the maximal volume and flow of air that can be moved in and out of a patient's lungs. The system is intended for use with pediatric (5 to 21 years) and adult (22 years and older) patients in hospitals, physician's offices, laboratories, and occupational health environments.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The spirometer (LA104, LA105) is substantially equivalent to the cleared predicate device (K090646). The spirometer (LA104, LA105) has same indications for use,
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patient population and technological characteristics with the predicate.
Differential pressure is the principle of spirometry testing for both the subject and predicate devices, in particular the same sensor technology is used for spirometry testing. Both the proposed device and predicated device comply with the ATS (American Thoracic Society) standards for measuring FVC, SVC, MVV, and MV (accuracy and repeatability).
| Specification | Proposed Device | Predicate Device | Comparison |
|---|---|---|---|
| Device name | Spirometer (Model: LA 104, LA 105) | CardioTech Spirometry System, Model GT-105 | |
| K number | K201493 | K090646 | |
| Indications for Use | The spirometer (LA104, LA105) is a diagnostic tool to measure the maximal volume and flow of air that can be moved in and out of a patient's lungs. The system is intended for use with pediatric (5 to 21 years) and adult (22 years and older) patients in hospitals, physician's offices, laboratories, and occupational health environments. | The CardioTech Spirometry System, Model GT-105 is a diagnostic tool to measure the maximal volume and flow of air that can be moved in and out of a patient's lungs. The system is intended for use with pediatric (4 to 17 years) and adult patients in hospitals, physician's offices, laboratories, and occupational health environments. | Same |
| Product code | BZG | BZG | Same |
| Classification regulation | 21 CFR 868.1840 | 21 CFR 868.1840 | Same |
| Patient population | Pediatric (5 to 21 years) and adult (22 years and older) patients | Pediatric (4 to 17 years) and adult patients | Same |
| Environment of use | hospitals, physician's offices, laboratories, and occupational health environments | hospitals, physician's offices, laboratories, and occupational health environments | Same |
| Prescription use or not | Prescription use | Prescription use | Same |
| Technology for measure flow and volume | Differential pressure | Differential pressure | Same |
| Device type | Portable | Portable | Same |
| Flow range | ±16 L/s | ±14 L/s | Similar |
| Flow accuracy | Comply with ATS/ERS 2005: ATS/ERS Task Force | Comply with ATS/ERS 2005: ATS/ERS Task Force | Same |
| Flow resistance |