(220 days)
Not Found
No
The summary describes a mechanical device for respiratory therapy and makes no mention of AI or ML.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "may be helpful in loosening and removal of mucus," which is a therapeutic function. Additionally, it is described as a "Positive Expiratory Pressure (PEP) device and Inspiratory Muscle Trainer (IMT)," both of which are therapeutic interventions for respiratory conditions.
No
Explanation: The device is described as a Positive Expiratory Pressure (PEP) device and Inspiratory Muscle Trainer (IMT), intended for loosening and removal of mucus. These are therapeutic functions, not diagnostic ones. There is no mention of the device being used to identify or analyze a condition.
No
The device description explicitly states it is a "Positive Expiratory Pressure (PEP) device and Inspiratory Muscle Trainer (IMT) in one device," which are physical devices used for respiratory therapy, not software.
Based on the provided information, the Mini-Ciser is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to help loosen and remove mucus and for inspiratory muscle training. This is a therapeutic and training function, not a diagnostic one.
- Device Description: It's described as a PEP and IMT device, which are physical therapy/respiratory devices.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a disease or condition.
- Predicate Device: The predicate device (Breather) is also a respiratory therapy device, not an IVD.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Mini-Ciser does not fit this description.
N/A
Intended Use / Indications for Use
The Mini-Ciser is a Positive Expiratory Pressure (PEP) device and Inspiratory Muscle Trainer (IMT) in one device.
The Mini-Ciser may be helpful in loosening and removal of mucus.
Product codes
73 BWF
Device Description
Not Found
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
Adult & Children.
Intended User / Care Setting
Not Found
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)
Our bench testing has demonstrated substantial equivalence to another marketed device (Breather).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5690 Incentive spirometer.
(a)
Identification. An incentive spirometer is a device that indicates a patient's breathing volume or flow and that provides an incentive to the patient to improve his or her ventilation.(b)
Classification. Class II (performance standards).
0
AUG 6 1998
510 (k) SUMMARY
| 510 (k) SUMMARY | K974848 | |
|---|---|---|
| Date: | April 29, 1998 | |
| Contact Person: | Jeffery R. Miller | |
| Classification Name: | (PEP) Device/Inspiratory Muscle Trainer | |
| Common/Usual Name: | (PEP) Device/Inspiratory Muscle Trainer | |
| Proprietary Name: | Mini-Ciser® | |
| Claiming Equivalence To: | Breather (K944412) | |
| Intended Uses: | (PEP) Positive Expiratory Pressure | |
| (IMT) Inspiration Muscle Trainer |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half. Inside the circle is a stylized image of an eagle or bird with three curved lines representing its wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 6 1998
Mr. Jeffery R. Miller Hougen MFG., Inc. 3001 Hougen Drive Swartz Creek, MI 48473
K974848 Re: Mini-Ciser Requlatory Class: II (two) Product Code: 73 BWF Dated: May 12, 1998 May 15, 1998 Received:
Dear Mr. Miller:
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, 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 reqistration, 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 (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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (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 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. Jeffery R. Miller
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 diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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/dsma/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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STATEMENT OF INDICATIONS
Mini-Ciser
The Mini-Ciser is a Positive Expiratory Pressure (PEP) device and Inspiratory Muscle Trainer (IMT) in one device.
Our bench testing has demonstrated substantial equivalence to another marketed device (Breather).
The Mini-Ciser may be helpful in loosening and removal of mucus.
Patient population: Adult & Children.
Single patient use and reusable.
Caution: Federal law restricts this device to sale by or on the order of a physician.
Lark Madoo 8-6-98
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number
Prescription