(262 days)
No
The summary describes a standard spirometry device using ultrasound technology and PC-based software for data processing and display. There is no mention of AI or ML in the device description, intended use, or performance studies.
No.
The device is intended for diagnostic spirometry testing and measurement of lung function parameters, not for treating any condition.
Yes
The device is intended to conduct "simple diagnostic spirometry testing" and is used for "measurement of lung function" to determine parameters such as FEV1, which are used to assess respiratory health.
No
The device description explicitly states it is an "electronic measurement device" and lists hardware components such as the "hand-held ScoutSensor," "Base station," and "Spirette." While it uses a PC-based software program, it is not solely software.
Based on the provided information, the Ganshorn SpiroScout is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Definition of IVD: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- SpiroScout's Function: The SpiroScout measures lung function parameters by analyzing the air a patient breathes in and out. It does not analyze biological specimens from the body.
- Intended Use: The intended use clearly states it's for "simple diagnostic spirometry testing," which involves measuring respiratory flows and volumes directly from the patient's breathing.
Therefore, the SpiroScout falls under the category of a medical device used for physiological measurement, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Ganshorn SpiroScout is intended for prescription use only to conduct simple diagnostic spirometry testing of adults and pediatric patients over 5 years old, in general practice and specialty physician, industrial and hospital settings.
Product codes
BZG
Device Description
The SpiroScout is an electronic measurement device intended to be used for measurement of lung function (determination of the respiratory flows and volume) parameters. It enables the determination of the following parameters.
Spirometry
Inspiratory and expiratory vital capacity (VC) Inspiratory and expiratory subdivisions
Flow/Volume
The measurement of the flow/volume curve enables the determination of the dynamic lung volumes. FEV1 value (forced expiratory volume within the first second of exhalation).
Maximum Voluntary Ventilation MVV
The respiratory limit value indicates the respired volume per minute during maximally forced respiration. The respiratory limit value is also referred to as "Maximum Voluntary Ventilation".
The SpiroScout sensor operates using two diagonally opposing ultrasound transducers that alternately send and receive ultrasonic waves. The ultrasound technology simultaneously measures the flow, temperature and humidity.
The SpiroScout is a PC-based system running the Ganshorn LFX software program. The system comprises:
- the hand-held ScoutSensor
- Base station where the sensor is stored. ●
- Spirette, a single use, disposable mouthpiece and flow tube ●
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
adults and pediatric patients over 5 years old
Intended User / Care Setting
general practice and specialty physician, industrial and hospital settings.
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
Non-clinical
- Compliance with AAMI ANS ES 60601-1
- Compliance with IEC 60601-1-11
- Compliance with IEC 60601-1-2.
- . ATS (2005)
Biocompatibility: No Biocompatibility testing was done. The only patient contacting part is the Spirette that was purchased in the final finished form from the manufacturer of the Spirette of the predicate device ndd EasyOne 510(k) K993921.
Per G95-1 and ISO 10993-1:2009, this component is considered as:
- External Communicating (Indirect gas pathway) ●
- . Tissue / Bone / Dentin communicating
- Duration of Use limited (
§ 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
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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized symbol that resembles three human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 7, 2016
Ganshorn Medizin Electronic GmbH c/o Paul Dryden Consultant Industriestr 6-8 Niederlaauer, 97618 DE
Re: K160116
Trade/Device Name: SpiroScout Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: Class II Product Code: BZG Dated: September 7, 2016 Received: September 8, 2016
Dear Paul Dryden:
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 the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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 yours,
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
2
Indications for Use
510(k) Number (if known)
K160116
Device Name SpiroScout
Indications for Use (Describe)
The Ganshorn SpiroScout is intended for prescription use only to conduct simple diagnostic spirometry testing of adults and pediatric patients over 5 years old, in general practice and specialty physician, industrial and hospital settings.
Type of Use (Select one or both, as applicable)
XX Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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FORM FDA 3881 (8/14)
Page 1 of 1
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510(k) Summary
October 6, 2016 Page 1 of 5
| Official Contact: | Stefan Ponto
Ganshorn Medizin Electronic GmbH
Industriestr 6-8
97618 Niederlauer Germany
Tel: +49 (9771) 6222-0
Fax: +49 (9771) 6222-55 |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary or Trade Name: | SpiroScout |
| Common/Usual Name: | Diagnostic Spirometer |
| Classification Name: | Diagnostic Spirometer
BZG, Class II, 21 CFR 868.1840 |
| Predicate Device: | ndd Medical Technology - EasyOne 510(k) K99392 |
Device Description:
The SpiroScout is an electronic measurement device intended to be used for measurement of lung function (determination of the respiratory flows and volume) parameters. It enables the determination of the following parameters.
Spirometry
Inspiratory and expiratory vital capacity (VC) Inspiratory and expiratory subdivisions
Flow/Volume
The measurement of the flow/volume curve enables the determination of the dynamic lung volumes. FEV1 value (forced expiratory volume within the first second of exhalation).
Maximum Voluntary Ventilation MVV
The respiratory limit value indicates the respired volume per minute during maximally forced respiration. The respiratory limit value is also referred to as "Maximum Voluntary Ventilation".
The SpiroScout sensor operates using two diagonally opposing ultrasound transducers that alternately send and receive ultrasonic waves. The ultrasound technology simultaneously measures the flow, temperature and humidity.
The SpiroScout is a PC-based system running the Ganshorn LFX software program. The system comprises:
- the hand-held ScoutSensor
- Base station where the sensor is stored. ●
- Spirette, a single use, disposable mouthpiece and flow tube ●
Indications for Use:
The Ganshorn SpiroScout is intended for prescription use only to conduct simple diagnostic spirometry testing of adults and pediatric patients over 5 years old, in general practice and specialty physician, industrial and hospital settings.
4
Patient Population:
Adult and pediatric patients 5 years of age and older
Environment of Use:
General practice and specialty physician, industrial and hospital settings
Contraindications:
None
Device Comparison
The following table compares the proposed device to the predicate ndd Medical Technology – EasyOne - K993921
| Technical
feature/specification | ndd EasyOne
K993921 | Proposed
Ganshorn SpiroScout |
|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The ndd Medical Technologies EasyOne
Spirometer is intended for prescription use
only to conduct simple diagnostic spirometry
testing of adults and pediatric patients over 4
years old, in general practice and specialty
physician, industrial and hospital settings. | The Ganshorn SpiroScout is intended for
prescription use only to conduct simple
diagnostic spirometry testing of adults and
pediatric patients over 5 years old, in general
practice and specialty physician, industrial and
hospital settings |
| Technology | Ultrasound transit-time measurement | Ultrasound transit-time measurement |
| Environment of use | General practice and specialty physician,
industrial and hospital settings.as is the
predicate. | General practice and specialty physician,
industrial and hospital settings |
| Patient Population | EasyOne can be used for adults and pediatric
patients over 4 years old | SpiroScout can be used for adults and pediatric
patients over 5 years old |
| Accessory | Disposable spirette respiratory tube | Single use, disposable spirette respiratory tube |
| Energy Type | 100-240 V / 50-60Hz | 100 to 240 V, 50/60 Hz |
| Materials and type of | Spirette | Spirette |
| Patient contact | Externally communicating (Indirect), Tissue
and Surface Contact, Mucosa, limited exposure | Externally communicating (Indirect), Tissue and
Surface Contact, Mucosa, limited exposure |
| Hardware components | EasyOne device | SpiroScout |
| | Spirette | Spirette |
| | USB Cradle | Base station |
| Parameters- Flow | | |
| Flow Range | $\pm$ 16 1/s | $\pm$ 18 1/s |
| Flow Accuracy | Flow: $\pm$ 2% or 0.020 l/s, (except PEF)
PEF: $\pm$ 5% or 0.200 l/s
MVV: $\pm$ 5% or 5 l/s | Flow: