(125 days)
Not Found
No
The description focuses on standard spirometry technology (Fleisch principle, pressure measurement) and software for data acquisition, calculation, display, and storage. There is no mention of AI or ML algorithms for data analysis, interpretation, or prediction.
No.
The device is for diagnostic purposes, measuring respiratory function, rather than providing therapy. It helps practitioners explore respiratory function, not treat a condition.
Yes.
The device is intended to perform spirometry, which measures lung function parameters (flow and volume) to help in the exploration and diagnosis of respiratory conditions. The output data is used by health professionals to interpret the patient's respiratory function.
No
The device description explicitly states that the device is composed of a physical spirometer (SPIROLYSER® Q13) with a sensor and handle, in addition to the software (SPIROWIN® EXPERT). It is not solely 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 SPIROLYSER® Q13 is a spirometer. It measures lung function by assessing the volume and flow of air during breathing. This is a direct measurement of a physiological process within the body, not an analysis of a sample taken from the body.
- Intended Use: The intended use is to "perform spirometry in hospital and clinical environments, for adult patients and pediatric patients aged 6 years and above." This describes a diagnostic procedure performed directly on the patient.
Therefore, the SPIROLYSER® Q13 falls under the category of a medical device used for physiological measurement and diagnosis, but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Intended to perform spirometry in hospital and clinical environments, for adult patients and pediatric patients aged 6 years and above.
Product codes
BZG
Device Description
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.
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
adult patients and pediatric patients aged 6 years and above.
Intended User / Care Setting
hospital and clinical environments, health professionals (doctor, lung specialist, allergist ...)
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
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.
Key Metrics
Accuracy:
§ 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).
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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
1
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
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- 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
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- Equivalent legally marketed device: K010761, SPIROLYSER SPL-50, FIM Medical
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- Indications for Use: Intended to perform spirometry in hospital and clinical environments, for adult patients and pediatric patients aged 6 years and above.
-
- 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.
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- Safety and Effectiveness, comparison to predicate device. This device has the same indications for use and very similar technological characteristics as the predicate device.
-
- Substantial Equivalence Chart: Please see the next page.
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Substantial Equivalence Chart 7.
| | Spirolyser SPL-50 K010761
(Predicate) | Q13° Spirolyser | Assessment of
Differences and why
device is as safe and
effective as the
predicate and does
not raise different
questions of safety
and effectiveness |
|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Type | Portable | Portable | Same |
| Indications for
Use | Intended to perform spirometry
and may be used in hospitals and
medical offices or at other
locations including homes. | Intended to perform spirometry in
hospital and clinical environments, for
adult patients and pediatric patients
aged 6 years and above. | Slightly revised
wording, no real
difference.
Patient
population now
specified. |
| Weight | Out of case 1 Kg with case 2.5 Kg | 250g without PC | Not relevant to
safety/
effectiveness |
| Power Supply | 110/220 VAC ~ output 12 volts DC | 5V DC via USB | DC, same. |
| Sensor | Fleisch type sensor
pneumotachograph
Multiple Use with filter accessory
Ergofilter™ SP1 Accessory
(K050424) | Fleisch type sensor
pneumotachograph
Single USE | Single use is
safer, lowers the
possibility of
cross-
contamination |
| Measurement
Range | - 9 l/s to + 14 l/s | -14 L/s to +14 L/s | New device is
better |
| Volumes | 0 to 10 liters | 0 to 10 liters | Same |
| Accuracy | +/- 3% |