(46 days)
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No
The summary provides no information about the device's internal workings, and the intended use describes a disposable flow sensor for a spirometer, which typically relies on physical principles of flow measurement rather than AI/ML. There are no mentions of AI, ML, or related concepts.
No
The device is described as a disposable pneumotach for spirometers, which are diagnostic tools, not therapeutic devices.
No
The device is described as a "disposable pneumotach for the Puritan-Bennett Renaissance II Spirometers." A pneumotach is a flow sensor used in spirometry, which measures lung function. While spirometry is used in diagnosis, the pneumotach itself is a measurement component, not a device that directly provides a diagnosis or interprets data for diagnostic purposes. Its intended use is to provide data to a spirometer.
No
The device is described as a "disposable pneumotach," which is a hardware component used in spirometry. The summary does not mention any software functionality.
Based on the provided information, the Flosense II is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use states it's a disposable pneumotach for a spirometer. Spirometers are devices used to measure lung function by assessing airflow and volume. This is a physiological measurement, not a diagnostic test performed on samples taken from the body (like blood, urine, or tissue).
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in biological samples.
- Providing information for the diagnosis, monitoring, or treatment of diseases based on analysis of biological samples.
The Flosense II is a component used in a device that measures a physiological parameter (airflow during breathing). This falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Flosense II is intended to be used as a disposable pneumotach for the Puritan-Bennett Renaissance II Spirometers which currently use the Puritan Bennett FSII Flow Sensor.
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
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Indicated Patient Age Range
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Intended User / Care Setting
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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/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three overlapping human profiles facing to the right, with three curved lines above them, possibly representing the flow of services or support.
JAN 3 0 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Michael J. Boyle President SDI Diagnostics, Incorporated 10 Hampden Drive Easton, MA 02375
Re: K033939
Trade/Device Name: FloSense II, Model 29-8040 Regulation Number: 21 CFR 868.1840 Regulation Name: Spirometer, Diagnostic (Accessory to) Regulatory Class: Il Product Code: BZG Dated: January 23, 2004 Received: January 26, 2004
Dear Mr. Boyle:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed yourse determined the device is substantially equivalent (for the referenced doore and has not osure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, or to devices that have been reclassified in accordance with the provisions of Annendinens, or to do roviets and Cosmetic Act (Act) that do not require approval of a premarket the I cucrar I vou, Drag, and Counting, therefore, market the device, subject to the general approvin uppreation (the Act. The general controls provisions of the Act include controls provinces or 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 If your device is classified (oos as a difional controls. Existing major regulations affecting (1 MA), it may of Subject to Back of Federal Regulations, Title 21, Parts 800 to 898. In your device can be fountish further announcements concerning your device in the Eederal Register.
1
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. or the Fet of any a 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 and instille (2) CF CF rett 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 procced to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), n for a contact the Office of Compliance at (301) 594-4646. Also, please note the regulation cntitled, "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 yours,
Chiu Lin, Ph.D.
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
2
January 23, 2004
SDI Diagnostics, Inc.
Statement of Intended Use
The Flosense II is intended to be used as a disposable pneumotach for the Puritan-Bennett Renaissance II Spirometers which currently use the Puritan Bennett FSII Flow Sensor.
/ Prescription use
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(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices 510(k) Number: