MERCURY MEDICAL EXPIRATORY RESISTANCE EXERCISER, RESISTEX

K954492 · Mercury Medical · BWF · Oct 21, 1996 · Anesthesiology

Device Facts

• Record ID: K954492
• Device Name: MERCURY MEDICAL EXPIRATORY RESISTANCE EXERCISER, RESISTEX
• Applicant: Mercury Medical
• Product Code: BWF · Anesthesiology
• Decision Date: Oct 21, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

PERMITS RESISTANCE BREATHING DURING AEROSOL TREATMENT

Device Story

Mercury Expiratory Resistance Exerciser (RESISTEX) is a therapeutic spirometer accessory used in-line with aerosol treatment systems. Device features a rotating resistance orifice and one-way valve positioned between a nebulizer and an exhalation resistor. Operates by providing variable positive expiratory pressure (PEP) during aerosol drug delivery. Used in clinical or home settings to facilitate resistance breathing exercises during medication administration. Healthcare providers or patients use the device to combine aerosol therapy with expiratory resistance, potentially improving respiratory muscle function or drug deposition.

Clinical Evidence

No clinical data provided; substantial equivalence is based on descriptive comparison of technological characteristics and intended use.

Technological Characteristics

Materials: Styrene and Low-Density Polyethylene (LDPE). Mode of operation: Rotating resistance orifice with in-line nebulizer. Includes one-way valve between nebulizer and exhalation resistor. Provides variable resistance adjustment for positive expiratory pressure (PEP). Patient connection via LDPE mouthpiece.

Indications for Use

Indicated for patients requiring resistance breathing during aerosol treatment.

Regulatory Classification

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.

Predicate Devices

• Circulaire™ Aerosol Drug Delivery System (Westmed)

Submission Summary (Full Text)

{0}

DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

OCT 21 1996

Ms. Kathy L. Hann
QA/Regulatory Manager
Mercury Medical®
11300A-49th Street North
Clearwater, Florida 34622-4800

Re: K954492
Trade Name: Mercury Expiratory Resistance Exerciser
Regulatory Class: II
Product Code: 73BWF
Dated: July 9, 1996
Received: July 17, 1996

Dear Ms. Hann:

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 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 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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.

{1}

Page 2 - Ms. Kathy L. Hann

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 [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 at [phone].

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D.
Director
Division of Cardiovascular, Respiratory, and Neurological Devices
Office of Device Evaluation
Center for Devices and Radiological Health

{2}

OCT-18-1996 08:35 FROM MERCURY MEDICAL
TO 13015943076 P.02
MERCURY MEDICAL®
K954492

# REVISED ENCLOSURE I
510 (k) SUMMARY

OCT 21 1996

- Mercury Expiratory Resistance Exerciser (RESISTEX®)
- Common Name - Expiratory Resistance Exerciser and Adapter
- Classification Name - Spirometer, Therapeutic

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act 1990 and 21CFR897.92. The Mercury Expiratory Resistance Exerciser, when placed in-line with an aerosol treatment, permits resistance breathing during aerosol treatment in a manner consistent with the Circulaire™ Aerosol Drug Delivery System by Westmed.

## TABLE OF COMPARISON

| | MERCURY
EXPIRATORY RESISTANCE
EXERCISER | WESTMED
CIRCULAIRE™ AEROSOL
DRUG DELIVERY SYSTEM |
| --- | --- | --- |
| INTENDED USE | PERMITS RESISTANCE
BREATHING DURING
AEROSOL TREATMENT | PERMITS RESISTANCE
BREATHING DURING
AEROSOL TREATMENT |
| MATERIALS
MODE OF OPERATION | STYRENE & LDPE
ROTATING RESISTANCE
ORIFICE WITH IN-LINE
NEBULIZER | POLYPROPYLENE
ROTATING RESISTANCE
ORIFICE WITH IN-LINE
NEBULIZER |
| ONE WAY VALVE | BETWEEN NEBULIZER AND
EXHALATION RESISTOR | BETWEEN NEBULIZER AND
EXHALATION RESISTOR |
| PROVIDES POSITIVE
EXPIRATORY PRESSURE
BENEFIT DURING
TREATMENT | HAS VARIABLE
RESISTANCE ADJUSTMENT | HAS VARIABLE RESISTANCE
ADJUSTMENT |
| PATIENT CONNECTION | LDPE MOUTHPIECE | LDPE MOUTHPIECE |
| PACKAGING | SINGLE PACKED 20/BOX | SINGLE PACKED 25/BOX |

Arthur J. Ward
10/18/96
Date

11300A-49th Street North • Clearwater, Florida 34622-4800 • 813-573-0088