(305 days)
Not Found
No
The description mentions "algorithms" but provides no indication that these algorithms utilize AI or ML techniques. The performance study relies on standard ATS waveforms, not a training or test set typical of ML models.
No
The device is a diagnostic tool used for measuring lung function, not for treating a condition or disease.
Yes
The device is explicitly called a "hand-held portable diagnostic spirometer" in the Device Description section and is used for "performing basic lung function tests," which are diagnostic in nature.
No
The device description explicitly states it is a "hand-held portable diagnostic spirometer" that uses an "ultrasonic transducer that measures flow," indicating it is a hardware device with integrated software.
Based on the provided information, the SDI AstraSonic Spirometer is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Spirometer function: The AstraSonic Spirometer measures lung function by analyzing breath flow and volume. This is a direct measurement of a physiological process within the body, not an analysis of a sample taken from the body.
- Intended Use: The intended use describes performing "basic lung function tests," which aligns with physiological measurement rather than in vitro analysis.
Therefore, the device falls under the category of a diagnostic medical device, but not specifically an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SDI AstraSonic Spirometer is a freestanding laboratory instrument for performing basic lung function tests in adults and and children over the age of four years. It is intended to be used by physicians or professional medical personnel for testing in physicians' offices, industrial medical and hospital settings.
Product codes
BZG
Device Description
The AstraSonic Diagnostic Spirometer is a hand-held portable diagnostic spirometer for the measurement of patient breath flow and volume. The device uses an ultrasonic transducer that measures flow. Algorithms are used to determine values based on this flow measurement. Tabular and graphical data are displayed on the spirometer LCD display.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lung
Indicated Patient Age Range
adults and children over the age of four years.
Intended User / Care Setting
Physicians or professional medical personnel for testing in physicians' offices, industrial medical 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)
A direct comparison of the Astrasonic spirometer and the predicate device was made using the 26 waveforms described by the American Thoracic Society to determine substantial equivalence.
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
JUL 1 32010
510(k) Summary
March 10, 2010
[As Required by 21 CFR 807.92]
Owner / Submitter of 510(k)
SDI Diagnostics, Inc. Michael J. Boyle - President 10 Hampden Drive Easton, MA 02375 e-mail: mjboyle@sdidiagnostics.com
Establishment Registration No .: 1221256
Contact:
......
Cosimo Cariolo e-mail: ccariolo@sdidiagnostics.com
Tel: (508) 238-7033, fax (508) 230-8497
SDI AstraSonic Diagnostic Spirometer
Spirometer
868.1840
ll
BZG
Anesthesiology
Spirometer, Diagnostic
Trade Name:
Common Name:
Classification Name:
Regulation Number
Classification Panel:
Regulatory Class:
Product Code:
Predicate Device
510(k) #K993921 ndd Medical Technologies EasyOne Spirometer
Device Description:
Intended Use:
measures flow. Algorithms are used to determine values based on this flow measurement. Tabular and graphical data are displayed on the spirometer LCD display.
The AstraSonic Diagnostic Spirometer is a hand-held portable diagnostic spirometer for the measurement of patient breath flow and volume. The device uses an ultrasonic transducer that
The SDI AstraSonic Spirometer is a freestanding laboratory instrument for performing basic lung function tests in adults and children over the age of four vears. It is intended to be used by physicians or professional medical personnel for testing in physicians' offices, industrial medical and hospital settings.
1
The AstraSonic spirometer has the same technological Technological Comparison: characteristics as the predicate device, except that the predicate device has a disposable transducer mouthpiece that is an integral part of the circuit. The Astrasonic spirometer utilizes a cleanable transducer and a disposable filter mouthpiece that is inserted into the transducer. Testing was conducted to demonstrate that the measurement of flow by the device was equivalent in accuracy to the predicate device. A direct comparison of the Astrasonic spirometer and the Summary of Testing: predicate device was made using the 26 waveforms described by the American Thoracic Society to determine substantial equivalence.
Conclusion:
દ્ર કે
Based on the above, we have concluded that the SDI AstraSonic Spirometer is substantially equivalent to the predicate device and is safe and effective for its intended use.
2
Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is in a bold, sans-serif font. The text is centered horizontally in the image. The background of the image is white.
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUL 1 5 2010
Mr. Cosimo Cariolo Director of Marketing SDI Diagnostics, Incorporated 10 Hampden Drive Easton, Massachusetts 02375
Re: K092813
Trade/Device Name: SDI AstraSonic Diagnostic Spirometer Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: II Product Code: BZG Dated: July 14, 2010 Received: July 15, 2010
Dear Mr. Cariolo:
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.
3
Page 2- Mr. Cariolo
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/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm 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/MedicalDevices/Safety/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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.
Wh for
Anthony D. Watson, B.S., M.S., M.B.A. 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
510(k) Number:
Device Name: AstraSonic™ Spirometer
Indications for Use:
The SDI AstraSonic Spirometer is a freestanding laboratory instrument for performing basic lung function tests in adults and children over the age of four years. It is intended to be used by physicians or professional medical personnel for testing in physicians' offices, industrial medical and hospital settings.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-the-Counter Use (Part 21 CFR 801 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
10
rədmull (x)Orçə 212260)
Intection Control, Dental Devices latiqsoH larenee , ypoloisentsenA to noisiviO (UNISON (Single Collection)