(46 days)
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.
Not Found
This document is a 510(k) clearance letter from the FDA, which states that the device, FloSense II, Model 29-8040, is substantially equivalent to a legally marketed predicate device.
It does not contain specific acceptance criteria, detailed device performance data from a study, or information about sample sizes, ground truth establishment, or expert involvement in a study. The letter itself is part of a regulatory process and refers to a premarket notification, but the notification details are not provided here.
Therefore,Based on the provided document, the following information cannot be extracted:
- A table of acceptance criteria and the reported device performance: This document is the FDA's clearance letter, not the premarket notification submission itself. It states that the device is "substantially equivalent" to predicate devices, but does not provide specific performance criteria or a table of results.
- Sample size used for the test set and the data provenance: Not available in this document.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available in this document.
- Adjudication method for the test set: Not available in this document.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, the effect size of how much human readers improve with AI vs without AI assistance: This information is not typically found in a 510(k) clearance letter, and is not present here. The device described is a spirometer accessory, not an AI-assisted diagnostic tool.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not available in this document. As above, this is a spirometer accessory, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not available in this document.
- The sample size for the training set: Not available in this document.
- How the ground truth for the training set was established: Not available in this document.
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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.
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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. 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
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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:
§ 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).