(239 days)
Not Found
No
The summary mentions "Algorithms are used to determine values based on this flow measurement," but there is no mention of AI, ML, or deep learning, nor is there any description of training or test sets which are typical for AI/ML devices.
No.
The device is a diagnostic spirometer intended for performing basic lung function tests and oximetry, which are diagnostic measurements, not therapeutic interventions.
Yes
The device description clearly states "The ASTRA 300 Diagnostic Spirometer". Additionally, it performs "basic lung function tests and oximetry" and measures "patient breath flow and volume" to "determine values," which are all diagnostic activities.
No
The device description explicitly states it is a "hand-held portable diagnostic spirometer" that uses a "turbine transducer" and has an "LCD display," indicating it is a physical hardware device, not software only.
Based on the provided information, the SDI Astra 300 Spirometer is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The intended use and device description clearly state that the spirometer measures breath flow and volume directly from the patient's lungs. It also measures oxygen saturation and pulse rate, which are physiological parameters measured directly from the patient.
- The device description focuses on measuring physiological parameters. It describes a turbine transducer measuring airflow and algorithms determining values based on this measurement. The optional pulse oximeter measures SpO2 and pulse rate. These are all direct measurements from the living patient, not analysis of a biological sample taken from the patient.
Therefore, the SDI Astra 300 Spirometer falls under the category of a diagnostic device used for physiological measurements, not an IVD device used for analyzing biological specimens.
N/A
Intended Use / Indications for Use
The SDI Astra 300 Spirometer is a freestanding laboratory instrument for performing basic lung function tests and oximetry in people of all ages. It is intended to be used by physicians or professional medical personnel for testing in any setting.
Product codes
BZG, DQA
Device Description
The ASTRA 300 Diagnostic Spirometer is a hand-held portable diagnostic spirometer for the measurement of patient breath flow and volume. The device uses a turbine transducer that measures flow via infrared interruption. Algorithms are used to determine values based on this flow measurement. Tabular and graphical data are displayed on the spirometer LCD display. With the optional Pulse Oximeter module, the specific patient parameters oxygen saturation in the blood (SpO2) and pulse rate, both relating to the patient's pulmonary condition, may be measured and displayed.
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
all ages
Intended User / Care Setting
physicians or professional medical personnel for testing in any setting.
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
Not Found
Key Metrics
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
Image /page/0/Picture/1 description: The image shows the logo for SDI Diagnostics. The logo consists of the letters "sdi" in a bold, sans-serif font, stacked above the word "DIAGNOSTICS" in a smaller, sans-serif font. A horizontal line separates the letters "sdi" from the word "DIAGNOSTICS".
JAN 3 1 2007
510(k) Summary
[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 |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Tel: (508)238-7033, fax (508)230-8497 |
| | e-mail: mjboyle@sdidiagnostics.com |
| Establishment Registration No.: | 1221256 |
| Contact: | Cosimo Cariolo
e-mail: ccariolo@sdidiagnostics.com |
| Trade Name: | SDI ASTRA 300 Diagnostic Spirometer With or Without Pulse
Oximetry Function |
| Common Name: | Spirometer |
| Classification Name: | Spirometer, Diagnostic |
| Regulation Number | 868.1840 |
| Classification Panel: | Anesthesiology |
| Regulatory Class: | II |
| Product Code: | BZG, DQA |
| Predicate Devices | 510(k) #K013812 SDI Spirolab II Spirometer
510(k) #K031863 Motion Media Technology CareStation 126S |
| Device Description: | The ASTRA 300 Diagnostic Spirometer is a hand-held portable
diagnostic spirometer for the measurement of patient breath flow
and volume. The device uses a turbine transducer that measures
flow via infrared interruption. Algorithms are used to determine
values based on this flow measurement. Tabular and graphical
data are displayed on the spirometer LCD display. |
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HAMPDEN :
ELEPHONE
,
1
Device Description (cont'd):
With the optional Pulse Oximeter module, the specific patient parameters oxygen saturation in the blood (SpO2) and pulse rate, both relating to the patient's pulmonary condition, may be measured and displayed.
The state and the commend of the comments of the first to the first to the first to the first
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Cosimo Cariolo Director of Marketing SDI Diagnostics, Incorporated 10 Hampden Drive Easton, Massachusetts 02375
Re: K061571
JAN 3 1 2007
Trade/Device Name: Astra 300 Regulation Number: 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: II Product Code: BZG Dated: January 29, 2007 Received: January 30, 2007
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, 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: K061571
Device Name: Astra 300
Indications For Use: The SDI Astra 300 Spirometer is a freestanding laboratory instrument for performing basic lung function tests and oximetry in people of all ages. It is intended to be used by physicians or professional medical personnel for testing in any setting.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Whet Whal
(Division Sign-Off) Division of Anastin Cities Cisneral Hospital, Infection Control, Dental Devices
510(k) Number: K061571
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