(147 days)
Not Found
No
The summary describes a standard spirometer using ultrasound technology to measure airflow and volume, with data processed and stored on a PC. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.
No
The device is described as conducting "diagnostic spirometry testing" and is used for "pulmonary function evaluation," not for treating a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for prescriptions use only to conduct diagnostic spirometry testing." The "Device Description" also refers to it as a "PC based diagnostic spirometer."
No
The device description explicitly states that the Easy on-PC system consists of both PC software and the Easy on-PC sensor (Spiroson-AS), which is a hardware component (ultrasound flow sensor).
Based on the provided information, the ndd Medical Technologies Easy on-PC Spirometer is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring, or compatibility purposes. This typically involves analyzing biological samples like blood, urine, or tissue.
- Device Function: The Easy on-PC Spirometer measures pulmonary function by analyzing the flow and volume of air exhaled by a patient. It does this by using an ultrasound sensor to measure the transit time of air. This is a direct measurement of a physiological process within the body, not an analysis of a specimen taken from the body.
- Intended Use: The intended use is to "conduct diagnostic spirometry testing." This is a functional test of the respiratory system, not a test of a biological sample.
Therefore, the Easy on-PC Spirometer falls under the category of a medical device used for physiological measurement and diagnosis, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Easy on-PC Spirometer is intended for prescriptions use only to conduct diagnostic spirometry testing of adults and pediatric patients over 4 years old, in general practice and specialty physician, industrial and hospital settings.
Product codes (comma separated list FDA assigned to the subject device)
BZG
Device Description
Easy on-PC is a PC based diagnostic spirometer and consists of a PC software and the Easy on-PC sensor (Spiroson-AS). The Easy on-PC software is installed on a Windows based PC or laptop computer to which the Easy on-PC sensor is connected.
In order to conduct simple diagnostic spirometry testing, the Easy on-PC sensor is used in combination with a commercially available disposable breathing tube with integrated mouthpiece (spirette).
The sensor is an ultrasound flow sensor that measures the transit-time to determine flow velocity, volume and molar mass of the gas. The collected data is transferred to the PC for pulmonary function evaluation and data management. The results of the testing are stored in a database and reports can be displayed or printed.
Mentions image processing
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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 4 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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Dynamic wave form testing confirmed that the Easy on-PC Spirometer meets recommendations published by the American Thoracic Society (ATS) for accuracy and precision for the intended diagnostic spirometry tests.
The device was tested to demonstrate conformance with IEC 60601-1 and IEC 60601-1-2 requirements for electrical safety.
The materials used meet the requirements for biocompatibility in accordance with ISO 10993.
Software verification and validation revealed that the Easy on-PC software meets the specified criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
510(k) Summary 5
JUN - 2 2009
In accordance with 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.
Submitter Information:
| Submitter name: | ndd Medizintechnik AG
Technoparkstrasse 1
8005 Zurich, Switzerland |
|----------------------------------|---------------------------------------------------------------------------|
| United states
contact person: | Mr. Jerry Masiello
Operations Manager
ndd Medical Technologies, Inc |
| Phone: | (877) 904.0090 x11 |
| Fax: | (978) 824.3853 |
| Mailto: | jmasiello@nddmed.com |
| Date prepared: | December 05, 2008 |
Device name:
| Proprietary name: | Easy on-PC Spirometer |
|---|---|
| Common name: | Spirometer |
| Classification name: | Diagnostic spirometer |
| Product code: | BZG |
Predicate device:
Substantial equivalence is claimed to the Brentwood/Midmark Diagnostics IQmark Digital Spirometer, cleared for commercial distribution per K002499.
Device Description:
Easy on-PC is a PC based diagnostic spirometer and consists of a PC software and the Easy on-PC sensor (Spiroson-AS). The Easy on-PC software is installed on a Windows based PC or laptop computer to which the Easy on-PC sensor is connected.
In order to conduct simple diagnostic spirometry testing, the Easy on-PC sensor is used in combination with a commercially available disposable breathing tube with integrated mouthpiece (spirette).
The sensor is an ultrasound flow sensor that measures the transit-time to determine flow velocity, volume and molar mass of the gas. The collected data is transferred to the PC for pulmonary function evaluation and data management. The results of the testing are stored in a database and reports can be displayed or printed.
1
Intended Use:
The Easy on-PC Spirometer is intended for prescriptions use only to conduct diagnostic spirometry testing of adults and pediatric patients over 4 years old, in general practice and specialty physician, industrial and hospital settings.
Comparison of technological characteristics:
The device has the same technological characteristics as the predicate devices except for the use of ultrasonic technology for flow measurement. Testing was conducted that demonstrates this method of flow measurement is as accurate as the methods used in predicate devices and therefore substantially equivalent to the predicate device.
Summary of testing:
Dynamic wave form testing confirmed that the Easy on-PC Spirometer meets recommendations published by the American Thoracic Society (ATS) for accuracy and precision for the intended diagnostic spirometry tests.
The device was tested to demonstrate conformance with IEC 60601-1 and IEC 60601-1-2 requirements for electrical safety.
The materials used meet the requirements for biocompatibility in accordance with ISO 10993.
Software verification and validation revealed that the Easy on-PC software meets the specified criteria.
Conclusion:
Based on the above, ndd Medical Technologies concluded that the Easy on-PC Spirometer is substantially equivalent to the legally marketed predicate device and is safe and effective for its intended use.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus-like symbol in the center, consisting of three abstract shapes resembling human figures. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the symbol. The text is in all caps and is evenly spaced around the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ndd Medizintechnik AG C/O Mr. Jerry Masiello Operations Manager ndd Medical Technologies, Incorporated Two Dundee Park Andover, Massachusetts 01810
JUN - 28 2009
Re: K090034
Trade/Device Name: Easy on-PC Spirometer Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: II Product Code: BZG Dated: May 27, 2009 Received: May 28, 2009
Dear Mr. Masiello:
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.
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.
3
Page 2 - Mr. Masiello
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 device-related 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/cdrh/comp/ for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/cdrh/mdr/ 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Susan Russer
Susan Runner, D.D.S., MA Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known):
Device Name: Easy on-PC Spirometer
Indications for Use:
The ndd Medical Technologies Easy on-PC Spirometer is intended for prescriptions use only to conduct diagnostic spirometry testing of adults and pediatric patients over 4 years old, in general practice and specialty physician, industrial and hospital settings.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L. Schulten
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K090034