Q13 SPIROLYSER®

K161676 · Fim Medical · BZG · Oct 20, 2016 · Anesthesiology

Device Facts

• Record ID: K161676
• Device Name: Q13 SPIROLYSER®
• Applicant: Fim Medical
• Product Code: BZG · Anesthesiology
• Decision Date: Oct 20, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1840
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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

Device Story

Q13 SPIROLYSER is a portable electronic spirometer for respiratory function assessment. Device uses single-use Fleisch-type pneumotachograph sensor to measure airflow via pressure drop across capillary tubes. Patient holds ABS plastic handle, breathes through sensor; device connects via USB to PC running SPIROWIN EXPERT software. Software acquires pressure samples, calculates flow/volume, displays curves, and stores results. Used by healthcare professionals (doctors, lung specialists, allergists) to interpret respiratory function. Output aids clinical decision-making by providing diagnostic data (e.g., FVC, SVC, MVV). Single-use sensor design reduces cross-contamination risk compared to multi-use predicate.

Clinical Evidence

No clinical data. Bench testing only. Performance validated using a pulmonary waveform generator to verify compliance with ATS 2005 standards. Testing confirmed repeatability and accuracy within tolerated maximum errors for all flow/volume curves. Biocompatibility testing (ISO 10993-5, 10993-10) and electrical/EMC safety (IEC 60601-1, 60601-1-2) were successfully completed.

Technological Characteristics

Fleisch-type pneumotachograph sensor (polypropylene); ABS plastic handle; foam nose clip. Powered by 5V DC via USB. Dimensions: 250g (excluding PC). Connectivity: USB to PC. Software: SPIROWIN EXPERT. Standards: ISO 10993 (biocompatibility), IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), ATS 2005 (spirometry performance).

Indications for Use

Indicated for adult and pediatric patients aged 6 years and older requiring spirometry testing in hospital or clinical settings.

Regulatory Classification

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.

Predicate Devices

• SPIROLYSER SPL-50 (K010761)

Reference Devices

• Ergofilter™ SP1 Accessory (K050424)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized caduceus, which is a symbol often associated with healthcare and medicine.

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 [phone] or [phone] 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 [phone] or [phone] 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: [phone] - Fax: [phone] Email: [e-mail] 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
- 2. Equivalent legally marketed device: K010761, SPIROLYSER SPL-50, FIM Medical
- 3. Indications for Use: Intended to perform spirometry in hospital and clinical environments, for adult patients and pediatric patients aged 6 years and above.
- 4. 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.
- 5. Safety and Effectiveness, comparison to predicate device. This device has the same indications for use and very similar technological characteristics as the predicate device.
- 6. Substantial Equivalence Chart: Please see the next page.

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#### Substantial Equivalence Chart 7.

| | Spirolyser SPL-50 K010761<br>(Predicate) | Q13° Spirolyser | Assessment of<br>Differences and why<br>device is as safe and<br>effective as the<br>predicate and does<br>not raise different<br>questions of safety<br>and effectiveness |
|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Type | Portable | Portable | Same |
| Indications for<br>Use | Intended to perform spirometry<br>and may be used in hospitals and<br>medical offices or at other<br>locations including homes. | Intended to perform spirometry in<br>hospital and clinical environments, for<br>adult patients and pediatric patients<br>aged 6 years and above. | Slightly revised<br>wording, no real<br>difference.<br>Patient<br>population now<br>specified. |
| Weight | Out of case 1 Kg with case 2.5 Kg | 250g without PC | Not relevant to<br>safety/<br>effectiveness |
| Power Supply | 110/220 VAC ~ output 12 volts DC | 5V DC via USB | DC, same. |
| Sensor | Fleisch type sensor<br>pneumotachograph<br>Multiple Use with filter accessory<br>Ergofilter™ SP1 Accessory<br>(K050424) | Fleisch type sensor<br>pneumotachograph<br>Single USE | Single use is<br>safer, lowers the<br>possibility of<br>cross-<br>contamination |
| Measurement<br>Range | - 9 l/s to + 14 l/s | -14 L/s to +14 L/s | New device is<br>better |
| Volumes | 0 to 10 liters | 0 to 10 liters | Same |
| Accuracy | +/- 3% | < +/- 3% | Same |
| Resolution | 12 bits | 15 bits | New device is<br>better |
| Display | Graphic LCD128 x 64 pixels | No, 1024x768 min on PC | New device is<br>better |
| Printer | 58 mm thermal | PC Connected, User's choice | New device is<br>better |
| Tests | Slow Vital Capacity, Forced Vital<br>Capacity, Maximum Voluntary<br>Ventilation, Pre/Post-Medication | Slow Vital Capacity, Forced Vital<br>Capacity, Maximum Voluntary<br>Ventilation, Pre/Post-Medication | SAME |
| Curves | Flow/volume loop, volume/time,<br>pre/post-medication, predictive<br>curves | Flow/volume loop, volume/time,<br>pre/post-medication, predictive curves | SAME |
| Correction | BTPS, temperature, Hygrometry,<br>Atmos. pressure. | BTPS, temperature, Hygrometry,<br>Atmos. pressure. | SAME. |
| Predictive<br>norms | Knudson, Eccs (SECCA), ITS<br>(Crapo), Polgar | Knudson, Eccs (SECCA), ITS (Crapo),<br>Polgar, NHANES III | NHANES III added<br>for Canada |
| | Spirolyser SPL-50 K010761<br>(Predicate) | Q13® Spirolyser® | Assessment of<br>Differences and why<br>device is as safe and<br>effective as the<br>predicate and does<br>not raise different<br>questions of safety<br>and effectiveness |
| Interpretation | Perdrix - CHU Grenoble | Perdrix - CHU Grenoble | SAME |
| Other | Auto date, 150 tests memorized,<br>transfer to PC, calibration,<br>management of calibrations | Auto date, essentially unlimited tests<br>memorized, calibration, management<br>of calibrations | Use of the<br>attached laptop<br>allows for<br>unlimited tests to<br>be memorized<br>which we see as<br>advantageous. |
| Reference<br>standards: | IEC 60601-1, IEC 6060601-1-2 | IEC 60601-1, IEC 60601-1-2, ATS 2005<br>(American Thoracic Society) | ATS compliance<br>enhances<br>effectiveness. |
| Photo | Image: Spirolyser SPL-50 K010761 | Image: Q13® Spirolyser® | The larger display<br>screen is easier<br>to read. The use<br>of a laptop<br>permits the user<br>to use their local<br>printer instead of<br>the small format<br>thermal paper<br>printer. Better<br>for archiving. |
| PATIENT<br>CONTACT<br>MATERIALS<br>Biocompatibility | ABS plastic handle (shown above)<br>and "Ergofilter" (K050424)<br>(contacts patient's<br>mouth/mucosa) Moplen HP648N<br>(6331NW) Antistatic and<br>Nucleated Polypropylene<br>Homopolymer Resin (safe for food<br>contact) Nose clip | Patient Contact items:<br>Single use Qflow® sensor made of<br>polypropylene contacts patient's<br>mouth/mucosa. Patient holds the<br>ABS plastic handle (shown above). A<br>foam nose clip is worn by the patient.<br>ISO 10993 testing conducted on the<br>Qflow® sensor, the handle, and the<br>Nose clip | Single use mouth<br>contact piece<br>reduces the<br>possibility of<br>cross<br>contamination. |
| Operating<br>Temperature | 17°C - 37°C | 17°C - 37°C | SAME |
| Storage<br>Temperature | 0°C - 50°C | 0°C - 50°C | SAME |
| Hygrometry | 75% max. | 75% max. | SAME |
| | Spirolyser SPL-50 K010761<br>(Predicate) | Q13® Spirolyser® | Assessment of<br>Differences and why<br>device is as safe and<br>effective as the<br>predicate and does<br>not raise different<br>questions of safety<br>and effectiveness |
| Operating<br>Altitude | < 2000m | < 2000m | SAME |
| Supplied<br>Accessories | Transport case<br>Mains supply and battery<br>1 nose-clip<br>2 rolls of paper<br>1 filter | 1 computer software (Spirowin®<br>Expert)<br>1 calibration certificate<br>1 software license<br>2 single use Qflow® sensors<br>Optional, recommended: Single Use<br>Nose Clip | No substantial<br>difference in<br>Safety/<br>Effectiveness but<br>single use sensor<br>reduces cross-<br>contamination risk |
| Option | Transfer to Computer | Transfer to Computer is standard,<br>required. | No material<br>difference in<br>Safety/<br>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.

- 8. 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.
- 9. Summary of clinical testing: Not required. Bench testing was sufficient to establish the performance characteristics as being safe and effective.
- 10. 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..