X-AIR-CISER

K974849 · Hougen Mfg., Inc. · BYI · Aug 6, 1998 · Anesthesiology

Device Facts

• Record ID: K974849
• Device Name: X-AIR-CISER
• Applicant: Hougen Mfg., Inc.
• Product Code: BYI · Anesthesiology
• Decision Date: Aug 6, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5665
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

(PEP) Positive Expiratory Pressure (IMT) Inspiration Muscle Trainer

Device Story

X-Air-Ciser is a multi-functional respiratory device combining Positive Expiratory Pressure (PEP), Inspiratory Muscle Trainer (IMT), and percussor capabilities. Designed for single-patient, reusable use by adults and children. Device functions as a percussor to assist in loosening and removing mucus from airways. Operated under physician prescription. No complex electronics or software; mechanical operation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical respiratory device; functions as PEP, IMT, and percussor. Single-patient, reusable design. No energy source or software components.

Indications for Use

Indicated for adults and children as a Positive Expiratory Pressure (PEP) device, Inspiratory Muscle Trainer (IMT), and percussor to assist in loosening and removing mucus. Federal law restricts this device to sale by or on the order of a physician.

Regulatory Classification

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.

Predicate Devices

• Breather (K944412)

Submission Summary (Full Text)

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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<br>(IMT) Inspiration Muscle Trainer |

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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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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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

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### 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.

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Prescription Use

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(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number