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.

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.

AI/ML Overview

The provided document is a 510(k) summary for a Spirometer (models LA104, LA105). It outlines the device's technical specifications, comparison to a predicate device, and performance data to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance:

The document primarily focuses on demonstrating equivalence to the predicate device (CardioTech Spirometry Model System, K090646) and compliance with recognized standards. The acceptance criteria are implicit in these standards and the predicate comparison.

Acceptance Criteria / Specification	Device Performance (Spirometer LA104, LA105)
Spirometry Performance:
Flow range	±16 L/s
Flow accuracy	Comply with ATS/ERS 2005
Flow resistance	<0.15 kPa/l/s
Volume range	0-16 L
Volume accuracy	± 3% or ±50 ml, whichever is greater
Performance of FVC, SVC, MVV, MV	Equivalence to predicate
Biocompatibility:
Cytotoxicity	Compliant
Sensitization	Compliant
Irritation	Compliant
Particulate Matter (gas pathway)	Compliant (ISO 18562-2)
Volatile Organic Compounds (gas pathway)	Compliant (ISO 18562-3)
Condensate formation	No condensate formed in flow sensor/mouthpiece
Electrical Safety & EMC:
Electrical Safety	Compliant (ANSI AAMI ES60601-1:2005/(R) 2012 and A1:2012, C1:2009/(R) 2012 and A2:2010/(R) 2012)
Electromagnetic Compatibility (EMC)	Compliant (IEC 60601-1-2:2014)
Software:
Software Verification & Validation	Conducted; documentation provided

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

The document does not specify exact "sample sizes" in terms of number of patient cases for the performance testing. Instead, it refers to compliance with standards (ATS/ERS 2005, ISO 26782:2009) for spirometry performance. These standards themselves define the test methodologies, which typically involve simulating various flow and volume patterns using calibrated equipment.

Spirometry Performance: "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." This implies a non-clinical test set using simulated conditions or calibration checks rather than human patient data.
Biocompatibility Testing: Tests like Cytotoxicity, Sensitization, Irritation, Particulate Matter, and Volatile Organic Compounds are conducted on material samples according to ISO standards, not on patient data.
Electrical Safety and EMC Testing: Conducted on the device itself to ensure compliance with relevant safety and electromagnetic compatibility standards.
Software Verification and Validation: Performed on the software system of the device.

The document does not explicitly state the country of origin for the performance data or whether it was retrospective or prospective, but given it's a 510(k) submission from "MeHow Innovative Ltd" in China, the testing likely occurred in China or at certified testing labs globally.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not applicable or not provided for this device and evaluation. The performance testing relies on engineering and laboratory measurements against established international standards (ATS/ERS, ISO) for lung function testing, biocompatibility, electrical safety, and EMC, rather than human expert interpretation of clinical cases. The "ground truth" for these tests is defined by the parameters and limits set by these standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This is not applicable or not provided. Since the primary performance evaluations are based on objective measurements against engineering standards and a predicate device (rather than clinical interpretation or diagnosis), an adjudication method for a test set (like those for image-based AI studies) is not relevant to this submission.

5. 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:

This is not applicable. The device is a diagnostic spirometer, which directly measures lung function parameters. It is a standalone measurement device, not an AI-powered assistive tool for human readers or clinicians that would necessitate an MRMC study to evaluate improved diagnostic performance.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Yes, the performance testing described (spirometry performance against ATS/ERS standards, biocompatibility, electrical safety, EMC, software V&V) constitutes standalone testing of the device. The spirometer itself, as a piece of medical equipment, is evaluated for its inherent accuracy, safety, and functionality without human intervention being part of the core measurement process. The device's output (measurements of flow and volume) is the primary performance endpoint, which is generated by the algorithm/hardware of the device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The ground truth for the performance evaluations is based on:

Reference Standards: For spirometry performance, the ground truth is defined by the requirements and test methods outlined in the ATS/ERS 2005 guidelines and ISO 26782:2009. These standards specify the acceptable accuracy and precision for flow and volume measurements.
Predicate Device Equivalence: Another aspect of "ground truth" is demonstrating that the proposed device performs comparably to the legally marketed predicate device (K090646) in terms of key technical specifications and measured parameters.
Material Science/Biological Standards: For biocompatibility, the ground truth refers to established safety thresholds and methodologies outlined in ISO 10993-1 and ISO 18562 for material safety and gas pathway purity.
Engineering Standards: For electrical safety and EMC, the ground truth is defined by the compliance requirements of ANSI AAMI ES60601-1 and IEC 60601-1-2.

8. The sample size for the training set:

This is not applicable or not provided. The spirometer is a traditional medical device that involves hardware measurements and signal processing, not a machine learning or AI-driven system requiring a "training set" in the conventional sense. The "software" aspect mentioned refers to control logic, user interface, and data processing, which undergo verification and validation, but not statistical training with a data set.

9. How the ground truth for the training set was established:

This is not applicable. As stated above, the device does not employ a machine learning model that requires a training set and associated ground truth labeled data.

Summary

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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)

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.

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	<0.15 kPa/l/s	<0.15 kPa/l/s	Same
Volume range	0-16 L	0 -10 L	Similar
Volume accuracy	± 3% or ±50 ml, whichever is greater	± 3% or ±50 ml, whichever is greater	Same
Data Storagecapacity	≥ 3000 patients data	More than 300 patient's data (HD)	Same
Communication	USB	USB and RS-232C	Same
Coaching	Display of volume-time andflow-volume curves	Display of volume-time andflow-volume curves	Same
Measurementparameters	SVC, FVC, MVV, MV + BD + Challenge	SVC, FVC, MVV, MV	Similar
Power source	Power adapter, battery	Power adapter, battery	Same
Display	8.4 inchtouch(resolutionscreen800x600)	8 inch TFT color LCD (640x480dots)	Similar
Printer	104 mm width, thermo-sensitive printer	112mm width, Thermal dot printer	Similar
Patient contact	Indirect contact with tissue less than 24h	Indirect contact with tissue less than 24h	Same
Biocompatibilitycontact duration	Less than 24 hours	Less than 24 hours	Same

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VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

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 device is an external communicating, non-sterile, with single use patient contacting

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components (Flow sensor/Flow sensor head). 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. The flow sensor is considered to be tissue indirect contacting type for duration of less than 24 hours.

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.

VIII. CONCLUSION

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The Spirometer and its application comply with standards as detailed the premarket notification. The non-clinical tests conducted on the device determined the Spirometer to be substantially equivalent to its predicate in terms of safety, effectiveness and performance.

Regulation Number and Section

§ 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).