(88 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, deep learning, or specific algorithms typically associated with AI/ML in medical devices. The description focuses on standard spirometry measurements.
No
The device measures lung function, which is diagnostic, not therapeutic.
Yes
The device is a spirometer used to measure lung function, which is a diagnostic activity to assess a patient's respiratory health.
No
The device is described as a "Spirolab II Spirometer," which is a hardware device used to measure lung function. The description does not indicate it is solely software.
Based on the provided information, the Spirolab II Spirometer is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The Spirolab II Spirometer measures lung function directly from the patient. It's a diagnostic tool that interacts with the patient's body (measuring airflow and volume during breathing), not a device that analyzes a biological sample taken from the patient.
Therefore, it falls under the category of a diagnostic device but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Spirolab II Spirometer is intended to be used by a physician or respiratory therapist or other trained health care professional for the purpose of measuring a subject's lung function. It collects, measures, stores and records a subject's forced vital capacity (FVC), forced expiratory volume in one second (FEV1), the FEV1/FVC ratio and peak expiratory flow (PEF).
Product codes
73 BZG
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lung
Indicated Patient Age Range
all ages
Intended User / Care Setting
a physician or respiratory therapist or other trained health care professional / home, factory, hospital or physician's office
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three human profiles incorporated into its body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 1 2002
Mr. Michael J. Boyle SDI Diagnostics, Inc. 10 Hampden Drive Easton, MA 02375
Re: K013812
SDI Spirolab II Spirometer Regulation Number: 868.1840 Regulation Name: Spirometer, Diagnostic Regulatory Class: Class II (two) Product Code: 73 BZG Dated: November 9, 2001 Received: November 15, 2001
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.
1
Page 2 - Mr. Michael J. Boyle
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease oc acrisou that I Dr o resum that your device complies with other requirements of the Act that I DA has made a asid regulations administered by other Federal agencies. You must of any I coloral statutes and regainments, including, but not limited to: registration and listing (21 Comply with an the 11et 31equirements) and manufacturing practice requirements as set CFN in the quality systems (DF CFR Part 820); and if applicable, the electronic form in the quality by see in orovisions (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) I mis icher will anow you to organ maing of substantial equivalence of your device to a legally prematics notineation: The PDF interessification 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 If you desire specific ad 100 for you in vitro diagnostic devices), please contact the Office of additionally 21 OFF Far 8041. Additionally, for questions on the promotion and advertising of Compliance at (301) 694-639 Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regulation circulou, Tribonananing responsibilities under the Act may be obtained from the Oiner general information 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 yours,
Roderick Teller
Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
SDI Diagnostics, Inc.
SDI Spirolab II Spirometer . K013812
Statement of Intended Use
The Spirolab II Spirometer is intended to be used by a physician or respiratory therapist or The Spirolab if Spirometer is mendou to of all ages. It can be used in any setting, home, factory hospital or physician's office.
Prescription Use √
Division of Cardiovascular & Respiratory Devices
510(k) Number K013812