(123 days)
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No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description points to a standard peak flow meter.
No
The device is a peak flow meter, used for monitoring respiratory function in asthma patients, not for treating a condition.
Yes
The device is described as "home monitoring used by the Asthma patient as prescribed by the physician," indicating its use in assessing a patient's physiological state (lung function) related to a medical condition (asthma), which is a diagnostic activity. Peak flow meters measure lung function to help manage asthma, which involves monitoring and diagnosing the severity of the condition.
No
The summary describes a "Peak Flow Meter," which is typically a physical device used to measure lung function. There is no mention of software being the primary or sole component.
Based on the provided information, the IMI Peak Flow Meter is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information about a person's health.
- A peak flow meter measures the maximum speed of expiration (breathing out) directly from the patient's lungs. This is a physiological measurement taken in vivo (within the body), not an analysis of a sample in vitro.
Therefore, the IMI Peak Flow Meter falls under the category of a medical device used for monitoring a physiological function, but it is not an IVD.
N/A
Intended Use / Indications for Use
The intended use of IMI Peak Flow Meter is for Hospital Respiratory Therapy Departments, and home monitoring used by the Asthma patient as prescribed by the physician. The device is for single patient use. However, the home patient can reuse the instrument himself after cleaning. The device is non-sterile. The device is for prescription use. See package lable under Section 3, page 4. The device is not MRI compatible.
Product codes
73 BZH
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
Hospital Respiratory Therapy Departments, and home monitoring used by the Asthma patient as prescribed by the physician.
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
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Key Metrics
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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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§ 868.1860 Peak-flow meter for spirometry.
(a)
Identification. A peak-flow meter for spirometry is a device used to measure a patient's maximum ventilatory flow rate.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name in a circular arrangement around an emblem. The emblem is a stylized representation of a human figure embracing a bird, symbolizing the department's mission to protect and promote the health and well-being of the people.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 13 1991
Mr. Warren V. Bigelow International Medical, Inc. · 14470 Burnsville Parkway Burnšville, Minnesota 55337
Re: K970507 *IMI Peak Flow Meter Requlatory Class: II (two) Product Code: 73 BZH Dated: May 8, 1997 Received: May 12, 1997
Dear Mr. Bigelow:
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 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). 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, qood manufacturing practice, labelinq, and prohibitions aqainst 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (CMP) regulation (21 CFR Part 820) and that, through periodic GME 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 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.
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Page 2 - Mr. Warren V. Bigelow
This letter will allow you to beqin 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 diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/dsmamain.html".
Sincerely yours,
Thomas J. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SECTION 3, STATEMENT OF INTENDED USE
The intended use of IMI Peak Flow Meter is for Hospital Respiratory Therapy Departments, and home monitoring used by the Asthma patient as prescribed by the physician. The device is for single patient use. However, the home patient can reuse the instrument himself after cleaning. The device is non=-sterile. The device is for prescription use. See package lable under Section 3, page 4. The device is not MRI compatible.
Prescription use only
参
(Division Sign-Off) (4-9-05-07)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number