(239 days)
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.
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.
The provided text lacks specific details about acceptance criteria, a detailed study design, and the performance characteristics of the SDI ASTRA 300 Diagnostic Spirometer that would allow for a comprehensive answer to your request. The document is a 510(k) summary and an FDA clearance letter, which primarily focuses on establishing substantial equivalence to predicate devices rather than providing detailed performance study results.
However, based on the information available, here's what can be extracted and what is missing:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Explicitly Stated in Document | Not Explicitly Stated in Document |
| (Typically, spirometer acceptance criteria would involve parameters like accuracy, precision, linearity, and repeatability for flow and volume measurements against recognized standards (e.g., ATS/ERS guidelines).) | (While the device measures flow and volume, specific performance numbers are not provided in this 510(k) summary.) |
Study Details (Based on available information and assumptions about typical 510(k) submissions for such devices)
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided document.
- Data Provenance: Not specified. For 510(k) substantial equivalence, data might come from internal testing, comparisons to predicate devices, or adherence to recognized standards. It's likely involved a combination of bench testing and potentially clinical data, but the specifics are absent.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. This type of information is typically not included in a 510(k) summary for a diagnostic spirometer, as the "ground truth" for spirometry measurements is usually established by highly calibrated reference devices and standardized test gases/flows rather than expert interpretation of patient data in the same way it would be for imaging diagnostics.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified. Given the nature of a spirometer, adjudication methods like 2+1 or 3+1 are generally not applicable. Performance is assessed against objective flow and volume measurements.
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:
- No, an MRMC comparative effectiveness study was likely not performed. This device is a diagnostic spirometer, which directly measures physiological parameters (flow and volume). It does not involve "readers" in the context of interpreting complex images or data that require AI assistance for improved human performance. The device provides raw and calculated spirometric values.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The device inherently operates as a standalone diagnostic tool. The algorithms determine values based on flow measurement. Its performance would be evaluated in a standalone manner against a gold standard for spirometry. The 510(k) process typically requires demonstrating that the device alone performs comparably to its predicate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for spirometers is typically established using highly accurate and calibrated reference spirometers, flow meters, or syringes that deliver known volumes and flows. Performance is then compared against these physical standards according to international guidelines (e.g., ATS/ERS).
- For the pulse oximetry function, ground truth would involve co-oximetry readings from arterial blood samples.
8. The sample size for the training set:
- Not applicable/Not specified. This device primarily uses algorithms based on physics principles (flow measurement via turbine transducer and infrared interruption) and established spirometric calculations, rather than machine learning models that require large training datasets in the traditional sense. Therefore, a "training set" as understood in AI/ML is unlikely to have been used or reported.
- If any modeling or calibration was done, it would be based on engineering principles and calibration data, not a "training set" of patient data.
9. How the ground truth for the training set was established:
- Not applicable (see point 8).
Summary of Limitations:
The provided document, being a 510(k) summary, focuses on establishing "substantial equivalence" to predicate devices (SDI Spirolab II Spirometer and Motion Media Technology CareStation 126S). It does not contain the detailed performance study results, specific acceptance criteria with numerical targets, or comprehensive methodologies that would be found in a full technical report or peer-reviewed publication. Its purpose is to demonstrate that the new device is as safe and effective as a legally marketed device, not to present a detailed scientific validation study in the way you might find for a novel AI diagnostic.
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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 - President10 Hampden DriveEaston, MA 02375 |
|---|---|
| Tel: (508)238-7033, fax (508)230-8497 | |
| e-mail: mjboyle@sdidiagnostics.com | |
| Establishment Registration No.: | 1221256 |
| Contact: | Cosimo Carioloe-mail: ccariolo@sdidiagnostics.com |
| Trade Name: | SDI ASTRA 300 Diagnostic Spirometer With or Without PulseOximetry 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 Spirometer510(k) #K031863 Motion Media Technology CareStation 126S |
| Device Description: | The ASTRA 300 Diagnostic Spirometer is a hand-held portablediagnostic spirometer for the measurement of patient breath flowand volume. The device uses a turbine transducer that measuresflow via infrared interruption. Algorithms are used to determinevalues based on this flow measurement. Tabular and graphicaldata are displayed on the spirometer LCD display. |
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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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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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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§ 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).