The SPIROLYSER® Q13 is an electronic spirometer operating on a PC, for the exploration of respiratory function. The spirometer is composed of a single-use sensor that propels the air (FLEISCH principle) and obtains a difference in pressure. Definition of Fleisch type pneumotachograph: A pneumotachograph that measures flow in terms of the proportional pressure drop across a resistance consisting of numerous capillary tubes in parallel. The SPIROWIN® EXPERT software acquires samples sent by the spirometer and determines a flow and a volume so as to display the curves and deduce results. The SPIROLYSER® 013 spirometer is a portable device. In normal use, the patient holds it by the handle, placing the single-use sensor in the mouth. The SPIROLYSER® Q13 is directly powered by the computer USB port via its USB lead. The SPIROWIN® EXPERT software (on the attached PC) calculates, displays and stores data to help the practitioner in the exploration of a patient's respiratory function.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Q13 SPIROLYSER® based on the provided FDA 510(k) summary:

Acceptance Criteria and Device Performance Study for Q13 SPIROLYSER®

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Q13 SPIROLYSER® are largely aligned with the performance characteristics of its predicate device, the SPIROLYSER SPL-50 (K010761), and additionally demonstrate compliance with the ATS 2005 Spirometry Testing Recommendations.

Metric	Acceptance Criteria (Predicate)	Reported Device Performance (Q13 SPIROLYSER®)	Notes
Measurement Range	-9 l/s to +14 l/s	-14 L/s to +14 L/s	New device is better, exceeding predicate's range.
Volumes	0 to 10 liters	0 to 10 liters	Same as predicate.
Accuracy	+/- 3%	< +/- 3%	Same as predicate, indicating it meets or exceeds the accuracy.
Resolution	12 bits	15 bits	New device is better, offering higher resolution.
Compliance with ATS 2005 Spirometry Testing Recommendations	Not explicitly stated for predicate but implied by general spirometer standards for predicate.	Fully Compliant	Enhancement: Q13 explicitly demonstrates compliance, which improves effectiveness.
Repeatability	Not explicitly quantified for predicate, but expected.	Satisfactory (measurements performed several times)	Verified through bench testing.
Maximum Errors (FT and PW curves)	Tolerated maximum errors (established by ATS 2005)	All results obtained are below tolerated maximum errors	Device meets or exceeds the industry-standard error limits.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document does not specify a distinct "test set" in terms of patient data. The performance evaluation was primarily conducted via bench testing using a "flow/volume Pulmonary Waveform Generator."
Data Provenance: Not applicable in the context of patient data. The testing was conducted by FIM MEDICAL, the manufacturer. The document does not specify the country of origin of patient data, as human subjects were not used for performance validation.
Retrospective or Prospective: Not applicable as the study was bench testing, not clinical.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Number of Experts: Not applicable. The "ground truth" for the bench testing was established by the specifications of the "flow/volume Pulmonary Waveform Generator" and the ATS 2005 Spirometry Testing Recommendations.
Qualifications of Experts: N/A.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable, as there was no human adjudication of diagnostic findings from a patient test set. The validation was against established technical specifications and standards (ATS 2005).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No, an MRMC comparative effectiveness study was not reported. The device is a diagnostic spirometer, and its performance was evaluated in terms of its technical measurement accuracy against established standards, not its ability to improve human reader interpretation of results in a clinical setting.
Effect Size of Human Readers with/without AI: Not applicable, as no MRMC study was conducted, and the device's function does not involve AI-assisted interpretation by human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Standalone Study: Yes, a standalone performance evaluation was conducted. The "bench testing" described in the summary represents the algorithm's (and hardware's) standalone performance. The device independently acquires, calculates, displays, and stores spirometry data. The document states:

"Bench testing also included Compliance with ATS 2005 Spirometry Testing Recommendations. Using its flow/volume Pulmonary Waveform Generator the FIM MEDICAL has carried out all essential requirements recommended by the American Thoracic Society (ATS 2005). The measurements were performed several times in order to check repeatability, as well as the performance of the Spirolyser® Q13 spirometer. All the results obtained are below the tolerated maximum errors on all the FT and PW curves tested, in both positive and negative flows. All test results were satisfactory."

7. Type of Ground Truth Used

Ground Truth Type:
- Technical Specifications: The primary ground truth for accuracy, range, and resolution was based on the design specifications derived to meet or exceed those of the predicate device.
- ATS 2005 Spirometry Testing Recommendations: This serves as a widely accepted industry standard for spirometry device performance, and the device was tested against its requirements for flow/volume and pulmonary waveform generation.
- Flow/volume Pulmonary Waveform Generator: This physical instrument provided the controlled and known inputs against which the device's measurements were compared.

8. Sample Size for the Training Set

Sample Size for Training Set: The document does not mention a "training set" in the context of machine learning or AI. The Q13 SPIROLYSER® is a traditional spirometer and does not appear to utilize machine learning for its core measurement functions, and therefore, a training set for an algorithm is not applicable.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set Establishment: Not applicable, as no training set for a machine learning algorithm was used or described.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 20, 2016

Fim Medical % Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct Naples, Florida 34114

Re: K161676

Trade/Device Name: Q13 SPIROLYSER® Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: Class II Product Code: BZG Dated: September 14, 2016 Received: September 19, 2016

Dear Daniel Kamm:

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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K161676

Device Name Q13 SPIROLYSER®

Indications for Use (Describe)

Intended to perform spirometry in hospital and clinical environments, for adult patients and pediative patients aged 6 years and above.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) Summary, 510(k) K161676 Submitter: FIM MEDICAL 51 rue Antoine Primat Villeurbanne - FRANCE Tel: +33 04 72 34 89 89 - Fax: +33 04 72 33 43 51 Email: contact@fim-medical.com Contact: Marie-Ange Derei, President Date Prepared: October 20, 2016

1. Identification of the Device: Proprietary-Trade Name: Q13 SPIROLYSER® Classification Name: Spirometer Common/Usual Name: Spirometer Device Class: II per regulation 868.1840 Product Code BZG
1. Equivalent legally marketed device: K010761, SPIROLYSER SPL-50, FIM Medical
1. Indications for Use: Intended to perform spirometry in hospital and clinical environments, for adult patients and pediatric patients aged 6 years and above.
1. Description of the Device: The SPIROLYSER® Q13 is an electronic spirometer operating on a PC, for the exploration of respiratory function. The spirometer is composed of a single-use sensor that propels the air (FLEISCH principle) and obtains a difference in pressure. Definition of Fleisch type pneumotachograph: A pneumotachograph that measures flow in terms of the proportional pressure drop across a resistance consisting of numerous capillary tubes in parallel. The SPIROWIN® EXPERT software acquires samples sent by the spirometer and determines a flow and a volume so as to display the curves and deduce results. The SPIROLYSER® 013 spirometer is a portable device. In normal use, the patient holds it by the handle, placing the single-use sensor in the mouth. The SPIROLYSER® Q13 is directly powered by the computer USB port via its USB lead. The SPIROWIN® EXPERT software (on the attached PC) calculates, displays and stores data to help the practitioner in the exploration of a patient's respiratory function. The SPIROLYSER® Q13 should only be used by health professionals (doctor, lung specialist, allergist ...). Results should only be interpreted by health professionals having undergone pneumology training.
1. Safety and Effectiveness, comparison to predicate device. This device has the same indications for use and very similar technological characteristics as the predicate device.
1. Substantial Equivalence Chart: Please see the next page.

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Substantial Equivalence Chart 7.

	Spirolyser SPL-50 K010761(Predicate)	Q13° Spirolyser	Assessment ofDifferences and whydevice is as safe andeffective as thepredicate and doesnot raise differentquestions of safetyand effectiveness
Device Type	Portable	Portable	Same
Indications forUse	Intended to perform spirometryand may be used in hospitals andmedical offices or at otherlocations including homes.	Intended to perform spirometry inhospital and clinical environments, foradult patients and pediatric patientsaged 6 years and above.	Slightly revisedwording, no realdifference.Patientpopulation nowspecified.
Weight	Out of case 1 Kg with case 2.5 Kg	250g without PC	Not relevant tosafety/effectiveness
Power Supply	110/220 VAC ~ output 12 volts DC	5V DC via USB	DC, same.
Sensor	Fleisch type sensorpneumotachographMultiple Use with filter accessoryErgofilter™ SP1 Accessory(K050424)	Fleisch type sensorpneumotachographSingle USE	Single use issafer, lowers thepossibility ofcross-contamination
MeasurementRange	- 9 l/s to + 14 l/s	-14 L/s to +14 L/s	New device isbetter
Volumes	0 to 10 liters	0 to 10 liters	Same
Accuracy	+/- 3%	< +/- 3%	Same
Resolution	12 bits	15 bits	New device isbetter
Display	Graphic LCD128 x 64 pixels	No, 1024x768 min on PC	New device isbetter
Printer	58 mm thermal	PC Connected, User's choice	New device isbetter
Tests	Slow Vital Capacity, Forced VitalCapacity, Maximum VoluntaryVentilation, Pre/Post-Medication	Slow Vital Capacity, Forced VitalCapacity, Maximum VoluntaryVentilation, Pre/Post-Medication	SAME
Curves	Flow/volume loop, volume/time,pre/post-medication, predictivecurves	Flow/volume loop, volume/time,pre/post-medication, predictive curves	SAME
Correction	BTPS, temperature, Hygrometry,Atmos. pressure.	BTPS, temperature, Hygrometry,Atmos. pressure.	SAME.
Predictivenorms	Knudson, Eccs (SECCA), ITS(Crapo), Polgar	Knudson, Eccs (SECCA), ITS (Crapo),Polgar, NHANES III	NHANES III addedfor Canada
	Spirolyser SPL-50 K010761(Predicate)	Q13® Spirolyser®	Assessment ofDifferences and whydevice is as safe andeffective as thepredicate and doesnot raise differentquestions of safetyand effectiveness
Interpretation	Perdrix - CHU Grenoble	Perdrix - CHU Grenoble	SAME
Other	Auto date, 150 tests memorized,transfer to PC, calibration,management of calibrations	Auto date, essentially unlimited testsmemorized, calibration, managementof calibrations	Use of theattached laptopallows forunlimited tests tobe memorizedwhich we see asadvantageous.
Referencestandards:	IEC 60601-1, IEC 6060601-1-2	IEC 60601-1, IEC 60601-1-2, ATS 2005(American Thoracic Society)	ATS complianceenhanceseffectiveness.
Photo	Image: Spirolyser SPL-50 K010761	Image: Q13® Spirolyser®	The larger displayscreen is easierto read. The useof a laptoppermits the userto use their localprinter instead ofthe small formatthermal paperprinter. Betterfor archiving.
PATIENTCONTACTMATERIALSBiocompatibility	ABS plastic handle (shown above)and "Ergofilter" (K050424)(contacts patient'smouth/mucosa) Moplen HP648N(6331NW) Antistatic andNucleated PolypropyleneHomopolymer Resin (safe for foodcontact) Nose clip	Patient Contact items:Single use Qflow® sensor made ofpolypropylene contacts patient'smouth/mucosa. Patient holds theABS plastic handle (shown above). Afoam nose clip is worn by the patient.ISO 10993 testing conducted on theQflow® sensor, the handle, and theNose clip	Single use mouthcontact piecereduces thepossibility ofcrosscontamination.
OperatingTemperature	17°C - 37°C	17°C - 37°C	SAME
StorageTemperature	0°C - 50°C	0°C - 50°C	SAME
Hygrometry	75% max.	75% max.	SAME
	Spirolyser SPL-50 K010761(Predicate)	Q13® Spirolyser®	Assessment ofDifferences and whydevice is as safe andeffective as thepredicate and doesnot raise differentquestions of safetyand effectiveness
OperatingAltitude	< 2000m	< 2000m	SAME
SuppliedAccessories	Transport caseMains supply and battery1 nose-clip2 rolls of paper1 filter	1 computer software (Spirowin®Expert)1 calibration certificate1 software license2 single use Qflow® sensorsOptional, recommended: Single UseNose Clip	No substantialdifference inSafety/Effectiveness butsingle use sensorreduces cross-contamination risk
Option	Transfer to Computer	Transfer to Computer is standard,required.	No materialdifference inSafety/Effectiveness

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The technological characteristics, including design, materials, composition, and energy source, are substantially the same, so there are no issues impacting safety and effectiveness, as detailed in the right hand column in the table above.

1. Summary of non-clinical testing: Biocompatibility of the mouthpiece, handle, and the nose clip wasevaluated according to FDA recommendations and ISO 10993 standards for cytoxicity, irritation, andsensitization (ISO 10993-5 (2009) and ISO 10993-10 (2010). Software validation and risk analysis wasperformed. Electrical safety (IEC 60601-1:2005) and EMC compatibility (IEC 60601-1-2:2007) testing wassuccessfully performed. Bench testing also included Compliance with ATS 2005 Spirometry TestingRecommendations. Using its flow/volume Pulmonary Waveform Generator the FIM MEDICAL has carriedout all essential requirements recommended by the American Thoracic Society (ATS 2005). Themeasurements were performed several times in order to check repeatability, as well as the performance of theSpirolyser® Q13 spirometer. All the results obtained are below the tolerated maximum errors on all the FTand PW curves tested, in both positive and negative flows. All test results were satisfactory.
1. Summary of clinical testing: Not required. Bench testing was sufficient to establish the performance characteristics as being safe and effective.
1. Conclusion: The 013® Spirolyser® is as safe and as effective as the predicate device. It has insignificant technological differences, and has essentially identical indications for use, thus rendering it substantially equivalent to the predicate device. The small differences do not impact safety of effectiveness..

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).