(247 days)
Not Found
No
The summary describes a breathing coordination device and does not mention AI, ML, or related concepts.
No
The "Intended Use" describes the device as assisting in breathing coordination during nebulization treatments and connecting with medication delivery systems. This device acts as an accessory to medication delivery, but it does not itself directly provide therapy or treat a medical condition. It facilitates the delivery of therapeutic agents or acts as a trainer, but is not therapeutic itself.
No
The device is described as an "Inspiratory/Expiratory Muscle Trainer" and its intended use is to "assist the patient in the coordination of breathing during nebulization treatments." This suggests a therapeutic or assistive function, not one that identifies or diagnoses a condition.
No
The device description explicitly states "The Breather (Inspiratory/Expiratory Muscle Trainer)", which is a physical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to assist the patient in coordinating breathing during nebulization treatments. This is a therapeutic and assistive function related to drug delivery, not a diagnostic test performed on samples from the human body.
- Device Description: The device is described as an "Inspiratory/Expiratory Muscle Trainer." This further reinforces its role in physical therapy or respiratory assistance, not in vitro testing.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
Therefore, based on the provided text, the device's function is related to respiratory assistance and training, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The new intended use of this product is to assist the patient in the coordination of breathing during nebulization treatments via hooking the device up with medication delivery systems. i.e., metered dose inhalers, electronic nebulization therapy. It is to be used in addition to and not in place of the delivery device provided by the manufacturer.
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
Not Found
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)
Not Found
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
Image /page/0/Picture/2 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 abstract shapes that resemble human figures or birds in flight, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 3 1000
Ms. Peggy Nicholson PN Medical, Inc. 214 N. Goldenrod Road, Suite 6 Orlando, FL 32807
Re: K972824 The Breather (Inspiratory/Expiratory Muscle Trainer Regulatory Class: II (two) Product Code: 73 BWF Dated: January 9, 1998 Received: January 12, 1998
Dear Ms. Nicholson:
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, 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 A substantially equivalent determination assumes compliance to 895. 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 requlatory 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.
、ソファ :
1
Page 2 - Ms. Peggy Nicholson
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/dsmamain.html".
Sincerely yours,
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
2
| 510(k) Number (if known): | Seeking new # - Original # K944412 |
|---|---|
| Device Name: | The Breather |
Indications For Use:
The new intended use of this product is to assist the patient in the coordination of breathing during nebulization treatments via hooking the device up with medication delivery systems. i.e., metered dose inhalers, electronic nebulization therapy. It is to be used in addition to and not in place of the delivery device provided by the manufacturer.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular, Respiratory, and Neurological Devices | |
| 510(k) Number | K972824 |
| Prescription Use (Per 21 CFR 801.109) | |
|---|---|
| --------------------------------------- | -- |
OR
| Over-The-Counter Use | |
|---|---|
| ---------------------- | -- |
(Optional Formal 1-2-96)
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