(220 days)
Not Found
No
The summary describes a mechanical device for respiratory therapy and does not mention any computational or data-driven features indicative of AI/ML.
Yes
The device functions as a Positive Expiratory Pressure (PEP) device, Inspiratory Muscle Trainer (IMT), and Percussor, all of which are common therapeutic interventions for respiratory conditions. It is also indicated for sale by or on the order of a physician, further suggesting its therapeutic nature.
No.
The intended use describes the device as a therapeutic tool (PEP device, IMT, and percussor) for loosening and removing mucus, rather than for diagnosing a condition or disease.
No
The description clearly states the device is a "Positive Expiratory Pressure (PEP) device, Inspiratory Muscle Trainer (IMT) and Percussor all in one device," implying a physical device with mechanical functions, not solely software.
Based on the provided information, the X-Air-Ciser is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use describes the device as a Positive Expiratory Pressure (PEP) device, Inspiratory Muscle Trainer (IMT), and Percussor. These functions are related to respiratory therapy and physical manipulation, not the examination of specimens derived from the human body.
- Device Description: While the description is "Not Found," the intended use clearly points away from IVD activities.
- Lack of IVD Indicators: There is no mention of analyzing samples, detecting substances, or providing diagnostic information based on biological specimens.
IVD devices are used to examine specimens (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The X-Air-Ciser's described functions do not fall into this category.
N/A
Intended Use / Indications for Use
(PEP) Positive Expiratory Pressure
(IMT) Inspiration Muscle Trainer
The X-Air-Ciser is a Positive Expiratory Pressure (PEP) device, Inspiratory Muscle Trainer (IMT) and Percussor all in one device.
The X-Air-Ciser can also function as a percussor, that may be helpful loosening and removing mucus.
Product codes
73 BYI
Device Description
The X-Air-Ciser is a Positive Expiratory Pressure (PEP) device, Inspiratory Muscle Trainer (IMT) and Percussor all in one device.
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
Prescription Use
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Breather (K944412)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5665 Powered percussor.
(a)
Identification. A powered percussor is a device that is intended to transmit vibration through a patient's chest wall to aid in freeing mucus deposits in the lung in order to improve bronchial drainage and that may be powered by electricity or compressed gas.(b)
Classification. Class II (performance standards).
0
ic9 4849
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- Province Comment
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6 1998 AUG
ກະລັດຖະກຳລັງທີ່ 2004 ເດີຍ 2001 ເປັນ 2001 ເປັນ 200
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510 (k) SUMMARY
| 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: | X-Air-Ciser® |
| Claiming Equivalence To: | Breather (K944412) |
| Intended Uses: | (PEP) Positive Expiratory Pressure |
| (IMT) Inspiration Muscle Trainer |
14
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an emblem featuring a stylized representation of three human profiles facing to the right, stacked on top of each other.
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
K974849 Re: X-AIR-CISER Regulatory Class: II (two) Product Code: 73 BYI Dated: May 12, 1998 Received: May 15, 1998
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 leqally 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 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 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 requlation (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. Collellon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
STATEMENT OF INDICATIONS
X-AIR-CISER
The X-Air-Ciser is a Positive Expiratory Pressure (PEP) device, Inspiratory Muscle Trainer (IMT) and Percussor all in one device.
The X-Air-Ciser can also function as a percussor, that may be helpful loosening and removing 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.
Prescription Use
llame
q74849
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number