(291 days)
The Flosense is intended to be used as a disposable pneumotach for Puritan-Bennett spirometers which currently use the Puritan Bennett FS200 Flow Sensor.
Not Found
This is a traditional 510(k) clearance letter for a medical device (Flosense, Model 29-8010) and does not contain the detailed information about acceptance criteria and a study design that you've requested. These sections are typically found in the 510(k) submission itself or in a summary document (like a 510(k) summary or a clinical study report), not in the FDA's clearance letter. The letter primarily states that the device is substantially equivalent to a legally marketed predicate device.
Therefore, I cannot provide the requested information based on the provided text. The document does not describe:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Number or qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study results.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
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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
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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.
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Division Sign-Division of Cardiova and Neurological D 510(k) Number
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§ 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.