(196 days)
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Not Found
No
The provided text does not contain any keywords or descriptions related to AI or ML technology.
No.
The spirotel spirometer is used to test lung function, which is a diagnostic purpose, not a therapeutic one.
Yes
The device is described as testing lung function, which is a diagnostic purpose.
No
The device is described as a "spirometer," which is a hardware device used to measure lung function. The summary does not provide a device description, but the intended use clearly indicates a physical spirometer is involved.
Based on the provided information, the spirotel spirometer is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use of the spirotel spirometer is to test lung function by having the patient breathe into the device. This is a direct measurement of a physiological function, not the analysis of a biological sample (like blood, urine, or tissue).
- The description focuses on lung function testing. The intended use and anatomical site clearly indicate the device is used for respiratory measurements.
Therefore, the spirotel spirometer falls under the category of a medical device used for physiological measurement, not an IVD.
N/A
Intended Use / Indications for Use
The spirotel spirometer is intended to be used by a patient under indications For 500. The opirator epiratory therapist to test lung function in people of all the matraction of a priyation of a single-patient device only and can be used in any setting - home, factory, hospital or physician's office.
Product codes
BZG
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
lung
Indicated Patient Age Range
all ages
Intended User / Care Setting
patient, operator, respiratory therapist / home, factory, hospital or physician's office
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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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).
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 9 2003
Mr. Michael J. Boyle President SDI Diagnostics, Incorporated 10 Hampden Drive South Easton, MA 02375
Re: K031643
Trade/Device Name: Spirotel, Model 29-1020 Regulation Number: 21 CFR 868.1840 Regulation Name: Spirometer, Diagnostic Regulatory Class: II Product Code: BZG Dated: not dated Received: October 28, 2003
Dear Mr. Boyle:
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. Michael J. Boyle
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 (301) 594-4646. 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/dsma/dsmamain.html
Sincerely vours,
Susan Ruar
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 (if known): K031643
Device Name: Spirotel
Indications For Use: The spirotel spirometer is intended to be used by a patient under indications For 500. The opirator epiratory therapist to test lung function in people of all the matraction of a priyation of a single-patient device only and can be used in any setting - home, factory, hospital or physician's office.
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hineh Pinto
· General Hospital, Infection Control, Dental Devices
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510(k) Number: K031643