(262 days)
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.
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
The provided text lacks a detailed study description with acceptance criteria and reported device performance. It primarily focuses on the device's substantial equivalence to a predicate device for regulatory approval. However, certain performance specifications and adherence to standards are mentioned, which can be interpreted as acceptance criteria.
Here's an attempt to extract and present the information based on the available text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are derived from the technical specifications provided for the proposed device (Ganshorn SpiroScout) and are implicitly considered acceptable due to its substantial equivalence claim to the predicate device.
| Acceptance Criteria Category | Specific Metric | Acceptance Criteria (from predicate/general expectation) | Reported Device Performance (Ganshorn SpiroScout) |
|---|---|---|---|
| Flow Parameters | Flow Range | ± 16 l/s (Predicate) | ± 18 l/s |
| Flow Accuracy | ± 2% or 0.020 l/s (Predicate) | < ± 2 % or 0.03 l/s | |
| PEF Accuracy | ± 5% or 0.200 l/s (Predicate) | < ± 3 % or 0.15 l/s | |
| MVV Accuracy | ± 5% or 5 l/s (Predicate) | < ± 5 % or 5 l/s | |
| Flow Resistance | approx. 0.02 cm H2O/l/s (Predicate) | approx. 0.02 cmH2O/l/s | |
| Volume Parameters | Volume Range | ± 12 liters (Predicate) | ± 10 liters |
| Volume Accuracy | ± 2% or 0.05 liters (Predicate) | +/- 2% or 0.05 liters | |
| Safety and EMC Standards | Electrical Safety | AAMI ANS ES 60601-1 (Compliance) | Complies with AAMI ANS ES 60601-1 |
| Home Healthcare Environment | IEC 60601-1-11 (Compliance) | Complies with IEC 60601-1-11 | |
| EMC | IEC 60601-1-2 (Compliance) | Complies with IEC 60601-1-2 | |
| Spirometry Standards | ATS (2005) Standards | Compliance with ATS (2005) | Compliance with ATS (2005) |
Notes on the Table:
- Acceptance Criteria Derivation: The "Acceptance Criteria" column is largely inferred from the predicate device's specifications, as the submission claims "substantial equivalence" to the predicate. The text states: "Performance and Specifications -As above the performance and specifications are substantially equivalent to the predicate." For standards compliance, the acceptance criterion is simply compliance with the named standard.
- "Reported Device Performance": This refers to the specifications listed for the proposed device, the "Ganshorn SpiroScout."
2. Sample size used for the test set and the data provenance
The document explicitly states "No clinical testing was performed" and "No animal testing was performed." Therefore, there is no test set of patient or animal data used in a clinical study for performance evaluation that can be described. The performance data presented (e.g., flow and volume accuracy) appears to be from non-clinical, likely bench or engineering, testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical testing was performed, and therefore, no expert ground truth was established for a clinical test set. The accuracy and performance metrics are based on non-clinical engineering testing against established standards and specifications, not expert interpretation of patient data.
4. Adjudication method for the test set
Not applicable, as no clinical testing was performed requiring adjudication of results from a test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The device is a diagnostic spirometer, not an AI-assisted diagnostic tool that would involve "human readers" or AI assistance in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the performance listed in the table (flow accuracy, volume accuracy, etc.) represents the standalone performance of the device (SpiroScout) based on non-clinical testing. The text describes it as an "electronic measurement device intended to be used for measurement of lung function." The approval is based on its direct measurement capabilities, not an algorithm's interpretation of findings that would require human-in-the-loop consideration.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical performance evaluation, the "ground truth" would have been established by reference standards or calibrated instruments used to measure flow, volume, and other parameters according to the requirements of the ATS (2005) standards and the device's technical specifications. These are laboratory-based, objective measurements, not clinical ground truth like pathology or expert consensus.
8. The sample size for the training set
Not applicable. This device is a measurement device, not a machine learning or AI model that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
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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 (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
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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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FORM FDA 3881 (8/14)
Page 1 of 1
PSC Publishing Services (301) 443-6740
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510(k) Summary
October 6, 2016 Page 1 of 5
| Official Contact: | Stefan PontoGanshorn Medizin Electronic GmbHIndustriestr 6-897618 Niederlauer GermanyTel: +49 (9771) 6222-0Fax: +49 (9771) 6222-55 |
|---|---|
| Proprietary or Trade Name: | SpiroScout |
| Common/Usual Name: | Diagnostic Spirometer |
| Classification Name: | Diagnostic SpirometerBZG, 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
| Technicalfeature/specification | ndd EasyOneK993921 | ProposedGanshorn SpiroScout |
|---|---|---|
| Indications for Use | The ndd Medical Technologies EasyOneSpirometer is intended for prescription useonly to conduct simple diagnostic spirometrytesting of adults and pediatric patients over 4years old, in general practice and specialtyphysician, industrial and hospital settings. | The Ganshorn SpiroScout is intended forprescription use only to conduct simplediagnostic spirometry testing of adults andpediatric patients over 5 years old, in generalpractice and specialty physician, industrial andhospital settings |
| Technology | Ultrasound transit-time measurement | Ultrasound transit-time measurement |
| Environment of use | General practice and specialty physician,industrial and hospital settings.as is thepredicate. | General practice and specialty physician,industrial and hospital settings |
| Patient Population | EasyOne can be used for adults and pediatricpatients over 4 years old | SpiroScout can be used for adults and pediatricpatients 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), Tissueand Surface Contact, Mucosa, limited exposure | Externally communicating (Indirect), Tissue andSurface 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/sMVV: $\pm$ 5% or 5 l/s | Flow: < $\pm$ 2 % or 0.03 1/sPEF: < $\pm$ 3 % or 0.15 1/sMVV: < $\pm$ 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 |
| Technicalfeature/specification | ndd EasyOneK993921 | ProposedGanshorn SpiroScout |
| Volume accuracy | $\pm$ 2% or 0.05 liters | +/- 2% or 0.05 liters |
| Parameters- Calculated | ||
| Measurement programs(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(1 s) | FEV1 - Forced Expiratory Volume(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 orForced Spirometry | VCmax - Maximum Vital Capacityof an SVC, FVC, FVL | VCmax - Maximum Vital Capacityof an Slow or Forced Spirometry |
| Slow Spirometry | VC ex - Expiratory Vital Capacityof a slow spirometric test | VC ex - Expiratory Vital Capacityof a slow spirometric test |
| VC in - Inspiratory Vital Capacityof a slow spirometric test | VC in - Inspiratory Vital Capacityof a slow spirometric test | |
| VC - Vital Capacityof a slow spirometric test | VC - Vital Capacityof 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 ProgramLegend | FVC (Forced Vital Capacity), FVL (FlowVolume 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.
§ 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).