(187 days)
Not Found
No
The summary describes a standard spirometer and its components, focusing on hardware, software requirements, and performance testing against established standards. There is no mention of AI, ML, image processing, or any data analysis techniques that would suggest the use of such technologies.
No
The device is described for "simple diagnostic spirometry testing," which means it is used to diagnose conditions, not to treat them.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended "to conduct simple diagnostic spirometry testing".
No
The device description explicitly lists hardware components such as the spirometer itself, a cal coupler, cradle, and batteries. The performance studies also mention testing for hardware requirements and electrical safety.
Based on the provided information, the ndd Medical Technologies EasyOne™ Spirometer is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use describes the device as conducting "simple diagnostic spirometry testing." Spirometry measures lung function by assessing the volume and speed of air that can be inhaled and exhaled. This is a physiological measurement taken directly from the patient, not a test performed on a sample of biological material in vitro (outside the body).
- Device Description: The components listed are related to the spirometer itself, a mouthpiece (Spirette), calibration tools, and user instructions. There is no mention of reagents, test strips, or other components typically associated with IVD testing.
- Lack of IVD Characteristics: The description does not mention analyzing biological samples like blood, urine, tissue, or other bodily fluids.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The EasyOne™ Spirometer directly measures a physiological function of the patient.
N/A
Intended Use / 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.
Product codes
BZG
Device Description
The ndd EasyOne™ Spirometer system consists of the following: EasyOne™ Spirometer (either the Frontline Model 2000 or the Diagnostic Model 2001) Disposable Spirette Cal coupler (used to connect the spirometer to the calibration syringe) EasyStart User Instructions EasyGuide Technical Information EasyOne™ Cradle (optional) Printer cable (optional) Two AA alkaline batteries
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 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
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was conducted to demonstrate compliance with the hardware and software requirements defined in the EasyOne™ Spirometer Requirements Specification, including requirements for accuracy defined by the American Thoracic Society. The device was tested to demonstrate conformance to the applicable requirements contained in Section (h) (1) - (7) and Section (i) of Appendix A of the November 1993 Draft document "Reviewer Guidance for Premarket Notification Submissions". The device was tested to demonstrate conformance with IEC601-1 requirements for electrical safety. Biocompatibility testing was conducted in accordance with Office of Device Evaluation General Program Memorandum #G95-1, Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing '
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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510(k) SUMMARY
ndd Medical Technologies
ndd Medical Technologies EasyOne™ Spirometer
November 17, 1999
Submitter Information:
| Submitter's Name: | ndd Medical Technologies
17 Progress Avenue
Chelmsford, MA 01824 |
|-------------------|------------------------------------------------------------------------|
| Telephone: | (978) 244-0620 |
| Device Name: | |
| Proprietary name: | ndd Medical Technologies EasyOne™ Spirometer |
Spirometer Common Name:
Diagnostic spirometer Classification Name:
Predicate Device Equivalence:
Substantial equivalence is claimed to the Puritan-Bennett Renaissance Spirometer, cleared for commercial distribution per K944672, and other legally marketed devices.
Device Description:
The ndd EasyOne™ Spirometer system consists of the following: EasyOne™ Spirometer (either the Frontline Model 2000 or the Diagnostic Model 2001) Disposable Spirette Cal coupler (used to connect the spirometer to the calibration syringe) EasyStart User Instructions EasyGuide Technical Information EasyOne™ Cradle (optional) Printer cable (optional) Two AA alkaline batteries
1
Intended 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.
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 devices.
Summary of Testing:
Performance testing was conducted to demonstrate compliance with the hardware and software requirements defined in the EasyOne™ Spirometer Requirements Specification, including requirements for accuracy defined by the American Thoracic Society.
The device was tested to demonstrate conformance to the applicable requirements contained in Section (h) (1) - (7) and Section (i) of Appendix A of the November 1993 Draft document "Reviewer Guidance for Premarket Notification Submissions".
The device was tested to demonstrate conformance with IEC601-1 requirements for electrical safety.
Biocompatibility testing was conducted in accordance with Office of Device Evaluation General Program Memorandum #G95-1, Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing '
Conclusions:
Based on the above, we concluded that the ndd Medical Technologies EasyOne™ Spirometer is substantially equivalent to legally marketed predicate devices and is safe and effective for its intended use.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle, represented by three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 3 2000
Mr. Oscar Kaelin CEO ndd Medical Technologies 17 Progress Avenue Chelmsford, MA 01824
K993921 Re: EasyOne™ Spirometer Regulatory Class: II (two) 73 BZG Product Code: Dated: March 10, 2000 March 14, 2000 Received:
Dear Mr. Kaelin:
We have reviewed your Section 510(k) notification of intent to market we nave reviewed your beceiver on we have determined the device is the device referenced above and wo have tions for use stated in the s Substantially equivalence (10) one caredicate devices marketed in enclosure) to regally marketed productions the enactment date of the interstate Commerce provices that have been reclassified Medical Device Imendales, I , i In accordance with the provision of therefore, market the device, subject to The general controls the general controls provisions of the Act. the general controls provisions of the entirements for annual registration, provisions of the nee on manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special II your device ID Stablemarket Approval), it may be subject to such Controls) of Class III (Frediality of regulations affecting your device auditionar concreas. In of Federal Regulations, Title 21, Parts 800 can be round in the ood equivalent determination assumes compliance co oss. If babbeanedad as a manufacturing Practice requirements, as set with the Ourlows Sty System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS ocherar regaracter od and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in assumptions. Fraine of Stipen, FDA may publish further announcements concerning your device in the Federal Register. Please note: this concerning your action in motification submission does not affect any response to your premainedunder sections 531 through 542 of the Act obrigation you might well the electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Oscar Kaelin
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial in your of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its be obtainsd from (300) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Mark N. Milken
James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Device Name:
ndd Medical Technologies EasyOne™ Spirometer
Indications for Use:
The ndd Medical Technologies EasyOne™ Spirometer is intended for prescription use The ndd Medical Technologies Lasyone - Oplike and nediatric patients over
only to conduct simple diagnostic spirometry testing of adults and nospital settings only to conduct simple diagnostic spiromotive to addite the propositial settings.
4 years old, in general practice and specialty physician, industrial and hospital settings.
Muda A. Muhan
Division Sign Off
(Division Sign-Off Division of Cardiovascular, Respiratory, and Neurological Device 510(k) Number .