(291 days)
Not Found
None
No
The summary describes a disposable pneumotach, a mechanical device for measuring airflow, and makes no mention of AI or ML.
No
The device is a disposable pneumotach intended for use with spirometers, which are diagnostic tools for measuring lung function, not therapeutic devices.
No
The device is described as a disposable pneumotach for spirometers, which measures airflow during respiration. This is a measurement tool, not a device that diagnoses a disease or condition. Its intended use is to replace an existing flow sensor for a spirometer.
No
The device is described as a "disposable pneumotach," which is a hardware component used in spirometry. The description does not mention any software functionality.
Based on the provided information, the Flosense device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "disposable pneumotach for Puritan-Bennett spirometers." A pneumotach is a device used to measure airflow during respiration. This is a physiological measurement taken directly from a patient, not a test performed on a sample of bodily fluid or tissue in vitro (outside the body).
- Lack of IVD Characteristics: The description doesn't mention any of the typical characteristics of an IVD, such as:
- Testing of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of analytes (substances in the body)
- Diagnosis or monitoring of diseases based on laboratory tests.
The Flosense is a component used with a spirometer, which is a device for measuring lung function. This falls under the category of medical devices used for physiological measurement, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Flosense is intended to be used as a disposable pneumotach for Puritan-Bennett spirometers which currently use the Puritan Bennett FS200 Flow Sensor.
Product codes
JAX
Device Description
Flosense, Model 29-8010
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
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.2550 Pneumotachometer.
(a)
Identification. A pneumotachometer is a device intended for medical purposes that is used to determine gas flow by measuring the pressure differential across a known resistance. The device may use a set of capillaries or a metal screen for the resistive element.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three human profiles facing to the right, resembling a family or group of people.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 7 2000
Mr. Michael J. Boyle President SDI Diagnostics, Inc. 10 Hampden Dr. Easton, MA 02375
Re: K990962 Flosense, Model 29-8010 Regulatory Class: II Product Code: JAX Dated: October 5, 1999 Received: October 12, 1999
Dear Mr. Boyle:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The qeneral controls provisions of the Act include requirements for annual registration, listing of devices, qood 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation
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Page 2 - Mr. Michael J. Boyle
you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) Additionally, for questions on the promotion and advertising 594-4586. of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
fearre H. Weitechausen for,
Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
March 19, 1999
SDI Diagnostics, Inc.
Statement of Intended Use
The Flosense is intended to be used as a disposable pneumotach for Puritan-Bennett spirometers which currently use the Puritan Bennett FS200 Flow Sensor.
leAtWutershausen
Division Sign-Division of Cardiova and Neurological D 510(k) Number
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