(298 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or related concepts, and the device description is not available to provide further clues.
No
The device is described as a "diagnostic system for recording and assessing inspiratory and expiratory pulmonary function (spirometry)," which indicates its purpose is to identify or measure a condition, not to treat it.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The FlowScreen is a diagnostic system".
Unknown
The provided summary lacks a device description, which is crucial for determining if the device is software-only or includes hardware components.
Based on the provided information, the FlowScreen device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- FlowScreen's Function: The description states the FlowScreen is a "diagnostic system for recording and assessing inspiratory and expiratory pulmonary function (spirometry)." Spirometry involves measuring lung function by having the patient breathe into a device. This is a direct measurement of a physiological process within the body, not a test performed on a sample taken from the body.
Therefore, the FlowScreen falls under the category of a medical device used for physiological measurement and diagnosis, but not specifically an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The FlowScreen is a diagnostic system for recording and assessing inspiratory and expiratory pulmonary function (spirometry). Measurements will be performed under the direction of a physician in the clinic, doctor's office or hospital. It can be utilized for patients from 4 years on and older as long as they can cooperate in the performance.
Product codes
BTY
Device Description
The FlowScreen is a diagnostic system for recording and assessing inspiratory and expiratory pulmonary function (spirometry). The FlowScreen is powered from 115V/60Hz wall outlets. No energy is transferred to the patient.
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
from 4 years on and older
Intended User / Care Setting
Physician in the clinic, doctor's office or hospital.
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.1890 Predictive pulmonary-function value calculator.
(a)
Identification. A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 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 words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three curved lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Viasys Healthcare GmbH C/O Ms. Yvette Lloyd Viasys Respiratory Care, Incorporated 22745 Savi Ranch Parkway Yorba Linda, California 92887
MAY 1 1 2007
Re: K062011
Trade/Device Name: FlowScreen Regulation Number: 21 CFR 868.1890 Regulation Name: Predictive Pulmonary-Function Value Calculator Regulatory Class: II Product Code: BTY Dated: April 12, 2007 Received: April 13, 2007
Dear Ms. Lloyd:
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 - Ms. Lloyd
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. You must comply 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 requirements as set forth 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 proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours,
Clive S
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
Indications for Use
510(k) Number (if known): K062011
Device Name: FlowScreen
Indications for Use:
The FlowScreen is a diagnostic system for recording and assessing inspiratory and expiratory pulmonary function (spirometry).
Measurements will be performed under the direction of a physician in the clinic, doctor's office or hospital. It can be utilized for patients from 4 years on and older as long as they can cooperate in the performance.
The FlowScreen is powered from 115V/60Hz wall outlets. No energy is transferred to the patient.
November-16-2006 Elmar Niedermeyer (Regulatory Affairs)
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Chlutto
nesthesiology, General H trol, Dental Devic
K86201
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