SpiroScout

K160116 · Ganshorn Medizin Electronic GmbH · BZG · Oct 7, 2016 · Anesthesiology

Device Facts

• Record ID: K160116
• Device Name: SpiroScout
• Applicant: Ganshorn Medizin Electronic GmbH
• Product Code: BZG · Anesthesiology
• Decision Date: Oct 7, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1840
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Device Story

SpiroScout is a PC-based diagnostic spirometer measuring lung function parameters including vital capacity, flow/volume curves, and maximum voluntary ventilation (MVV). Input consists of patient respiratory airflow through a single-use disposable 'Spirette' mouthpiece. Device utilizes two diagonally opposing ultrasound transducers to measure flow, temperature, and humidity via ultrasound transit-time technology. System includes a handheld ScoutSensor and a base station. Operated by clinicians in general practice, specialty, industrial, or hospital settings. Output is processed by Ganshorn LFX software on a connected PC, providing clinicians with quantitative lung function data to support respiratory diagnosis and clinical decision-making.

Clinical Evidence

No clinical data or animal testing performed. Bench testing only, including compliance with AAMI ANSI ES 60601-1, IEC 60601-1-11, IEC 60601-1-2, and ATS (2005) standards.

Technological Characteristics

Ultrasound transit-time measurement; PC-based system with handheld ScoutSensor and base station; disposable Spirette mouthpiece. Flow range ± 18 l/s; volume range ± 10 liters. Power 100-240 V, 50/60 Hz. Patient contact parts (Spirette) are externally communicating, limited duration (<24 hours).

Indications for Use

Indicated for diagnostic spirometry testing in adults and pediatric patients aged 5 years and older in general practice, specialty physician, industrial, and hospital 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

• ndd Medical Technology - EasyOne (K993921)

Submission Summary (Full Text)

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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.

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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 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

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# 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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# 510(k) Summary

October 6, 2016 Page 1 of 5

| Official Contact: | Stefan Ponto<br>Ganshorn Medizin Electronic GmbH<br>Industriestr 6-8<br>97618 Niederlauer Germany<br>Tel: [phone]<br>Fax: [phone] |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary or Trade Name: | SpiroScout |
| Common/Usual Name: | Diagnostic Spirometer |
| Classification Name: | Diagnostic Spirometer<br>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.

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#### 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<br>feature/specification | ndd EasyOne<br>K993921 | Proposed<br>Ganshorn SpiroScout |
|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The ndd Medical Technologies EasyOne<br>Spirometer is intended for prescription use<br>only to conduct simple diagnostic spirometry<br>testing of adults and pediatric patients over 4<br>years old, in general practice and specialty<br>physician, industrial and hospital settings. | The Ganshorn SpiroScout is intended for<br>prescription use only to conduct simple<br>diagnostic spirometry testing of adults and<br>pediatric patients over 5 years old, in general<br>practice and specialty physician, industrial and<br>hospital settings |
| Technology | Ultrasound transit-time measurement | Ultrasound transit-time measurement |
| Environment of use | General practice and specialty physician,<br>industrial and hospital settings.as is the<br>predicate. | General practice and specialty physician,<br>industrial and hospital settings |
| Patient Population | EasyOne can be used for adults and pediatric<br>patients over 4 years old | SpiroScout can be used for adults and pediatric<br>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<br>and Surface Contact, Mucosa, limited exposure | Externally communicating (Indirect), Tissue and<br>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)<br>PEF: $\pm$ 5% or 0.200 l/s<br>MVV: $\pm$ 5% or 5 l/s | Flow: < $\pm$ 2 % or 0.03 1/s<br>PEF: < $\pm$ 3 % or 0.15 1/s<br>MVV: < $\pm$ 5 % or 5 1/s |
| Flow Resistance | approx. 0.02 cm H2O/l/s | approx. 0.02 cmH2O/l/s |
| Parameters Volume | | |
| Volume Range | $\pm$ 12 liters | $\pm$ 10 liters |
| Technical<br>feature/specification | ndd EasyOne<br>K993921 | Proposed<br>Ganshorn SpiroScout |
| Volume accuracy | $\pm$ 2% or 0.05 liters | +/- 2% or 0.05 liters |
| Parameters- Calculated | | |
| Measurement programs<br>(see legend below) | FVC, FVL, SVL, MVV, post testing | Slow Spirometry, Forced Spirometry, MVV |
| Forced Spirometry | FVC - Forced Vital Capacity (expiratory) | FVC - Forced Vital Capacity (expiratory) |
| Forced Spirometry | FIVC - Forced Vital Capacity (inspiratory) | FIVC - Forced Vital Capacity (inspiratory) |
| Forced Spirometry | FEV1 - Forced Expiratory Volume<br>(1 s) | FEV1 - Forced Expiratory Volume<br>(1 s) |
| Forced Spirometry | FEV6 - Forced Expiratory Volume | FEV6 - Forced Expiratory Volume |
| | (6 s) | (6 s) |
| | FEV1/FVC - ratio of FEV1 to FVC | FEV1/FVC - ratio of FEV1 to FVC |
| | FEV1/VCmax - ratio of FEV1 to Vcmax | FEV1/VCmax - ratio of FEV1 to Vcmax |
| | FEV1/FEV6 - ratio of FEV1 to FEV6 | FEV1/FEV6 - ratio of FEV1 to FEV6 |
| | FEF 25 (MEF 75) | FEF 25 (MEF 75) |
| | FEF 50 (MEF 50) | FEF 50 (MEF 50) |
| | FEF 75 (MEF 25) | FEF 75 (MEF 25) |
| | FEF 25-75 | FEF 25-75 |
| | PEF - Peak Expiratory Flow | PEF - Peak Expiratory Flow |
| | PIF - Peak Inspiratory Flow | PIF - Peak Inspiratory Flow |
| Slow Spirometry | VT - Tidal Volume Tidal volume at rest | VT - Tidal Volume Tidal volume at rest |
| | ERV - Expiratory Reserve Volume | ERV - Expiratory Reserve Volume |
| | IRV - Inspiratory Reserve Volume | IRV - Inspiratory Reserve Volume |
| Slow Spirometry or<br>Forced Spirometry | VCmax - Maximum Vital Capacity<br>of an SVC, FVC, FVL | VCmax - Maximum Vital Capacity<br>of an Slow or Forced Spirometry |
| Slow Spirometry | VC ex - Expiratory Vital Capacity<br>of a slow spirometric test | VC ex - Expiratory Vital Capacity<br>of a slow spirometric test |
| | VC in - Inspiratory Vital Capacity<br>of a slow spirometric test | VC in - Inspiratory Vital Capacity<br>of a slow spirometric test |
| | VC - Vital Capacity<br>of a slow spirometric test | VC - Vital Capacity<br>of a slow spirometric test |
| | IC - Inspiratory Capacity | IC - Inspiratory Capacity |
| MVV | MVV - Maximum Voluntary Ventilation | MVV - Maximum Voluntary Ventilation |

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#### 510(k) Summary October 6, 2016 Page 3 of 5

Legend: The predicate ndd EasyOne and Ganshorn SpiroScout use different terms for the same programs. The equivalence of these terms is described in the table below.

| | ndd Term | Ganshorn Term |
|-------------------------------|--------------------------------------------------------|----------------------------------|
| Measurement Program<br>Legend | FVC (Forced Vital Capacity), FVL (Flow<br>Volume Loop) | Forced Spirometry |
| | SVL (Slow Volume Loop) | Slow Spirometry |
| | MVV (Maximal Volume Ventilation) | MVV (Maximal Volume Ventilation) |

# Summary of Performance Testing

#### Non-clinical

- Compliance with AAMI ANS ES 60601-1
- Compliance with IEC 60601-1-11
- Compliance with IEC 60601-1-2 .
- . ATS (2005)

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#### 510(k) Summary October 6, 2016 Page 4 of 5

## 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 (<24 hours) .

And

- Surface Contact
- Mucosal membrane
- Duration of Use limited (< 24 hours) ●

#### Animal

No animal testing was performed

Clinical: No clinical testing was performed

# Comparison to Predicate Devices:

#### Indications for Use

As in Comparison of Indications For Use above, we conclude that the indications for use for the SpiroScout and the predicate are substantially equivalent.

Prescriptive - The SpiroScout and predicate are prescription devices.

Design and Technology – As above design and technology are substantially equivalent to the predicate.

Performance and Specifications -As above the performance and specifications are substantially equivalent to the predicate.

Compliance with Standards - The SpiroScout complies with the currently recognized safety and EMC standards (AAMI ANSI ES 60601-1, IEC 60601-1-2). The predicate complied with IEC 601-1.

Patient Population - The SpiroScout and predicate are indicated for pediatric and adult patients.

Environment of Use - The SpiroScout is for use in general practice and specialty physician, industrial and hospital settings.as is the predicate.

Differences: There are some differences:

- Patient population is 5 and up vs. 4 yo and up
- This has been changed based upon FDA request O
- Difference in flow ranges where the proposed device has a high flow range which is consistent with the ● recommendations of ATS spirometer designs

The differences between the proposed device and the predicate device do not raise any new safety and efficacy concerns.

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#### 510(k) Summary October 6, 2016 Page 5 of 5

# Substantial Equivalence Conclusion

Based upon the performance testing and comparison to the legally marketed predicate devices for use, technology, and performance we believe we have demonstrated that the SpiroScout is substantially equivalent in safety and effectiveness to the predicate devices.