SIDESTREAM NEBULIZER

K991725 · Inspired Medical Products , Ltd. · CAF · Jul 30, 1999 · Anesthesiology

Device Facts

• Record ID: K991725
• Device Name: SIDESTREAM NEBULIZER
• Applicant: Inspired Medical Products , Ltd.
• Product Code: CAF · Anesthesiology
• Decision Date: Jul 30, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

A hand-held nebulizer to aerosolize commonly prescribed liquid drugs (except pentamadine) for inhalation by patients in the Home, Hospital and Nursing Home settings - anywhere aerosolized drug delivery is utilized.

Device Story

Sidestream Drug Nebulizer is a single-patient-use, hand-held device for aerosolizing liquid medications. It utilizes a compressed air gas source to drive a sidestream jet system; the device consists of three components: top, baffle, and base. It is operated by patients or healthcare providers in home, hospital, or nursing home settings. The device transforms liquid drug input into an aerosolized mist for patient inhalation. It is intended to facilitate drug delivery for patients requiring respiratory therapy. The device is provided clean, non-sterile.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on identical design, materials, and technological characteristics to legally marketed predicate devices.

Technological Characteristics

Materials: Polypropylene. Sensing/Actuation: Sidestream jet system using compressed air. Form factor: Three-component assembly (top, baffle, base). Connectivity: None. Sterilization: Provided clean, non-sterile. Software: None.

Indications for Use

Indicated for patients requiring nebulized drug delivery of commonly prescribed liquid medications, excluding pentamidine, in home, hospital, or nursing home settings.

Regulatory Classification

Identification

A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.

Predicate Devices

• Medic-Aid - Sidestream Nebulizer - K924123
• Medic-Aid - Sidestream Nebulizer - K914152B

Submission Summary (Full Text)

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K991725

#### Inspired Medical Products, Ltd. Heath Place Bognor Regis, West Sussex PO22 9SL United Kingdom

Fax - 011-44-1243-846100 Tel - 011-44-1243-840888

#### Non-Confidential Summary of Safety and Effectiveness

page 1 of 3 May 19, 1999

Inspired Medical Products, Ltd.
Heath Place
Bognor Regis, West Sussex PO22 9SL
United Kingdom

| Tel - 011-44-1243-840888 | Fax - 011-44-1243-846100 |
|----------------------------|--------------------------------------------------|
| Official Contact: | Ed Walters, Quality Manager |
| Proprietary or Trade Name: | Sidestream Drug Nebulizer |
| Common/Usual Name: | Nebulizer |
| Classification Name: | Nebulizer, Medicinal, Non-ventilatory (atomizer) |
| Predicate Devices: | Medic-Aid - Sidestream Nebulizer - K924123 |
| | Medic-Aid - Sidestream Nebulizer - K914152B |

Device Description: 2011 - 11 - 11 - 11

The Inspired Medical Products Sidestream Nebulizer is identical to the Medic-Aid Sidestream Nebulizer cleared under K924123.

| 1. Intended use - | Aerosolization of commonly prescribed liquid drugs (except pentamadine) for inhalation by the patient. |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------|
| 2. Environment of Use - | Single patient use for the Home, Hospital and Nursing Home settings - anywhere aerosolized drug delivery is utilized. |
| 3. Patient Population - | Patients requiring nebulized drug delivery. |

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#### Non-Confidential Summary of Safety and Effectiveness

## page 2 of 3

#### May 19, 1999

# Comparison to Other Legally Marketed Predicate Devices

The following comparison table details the primary attributes of the intended device and legally marketed predicate devices. The most significant attributes have been listed.

| | DILE FREELLE CORRENCE CONCELMALE CONSUMERAL | | | |
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| Use | | | |
|------------------------------------------------------------------------------------------------------------|-----|-----|-----|
| Intended to nebulize drugs | Yes | Yes | Yes |
| Utilizes Sidestream jet system<br>to nebulize drug | Yes | Yes | Yes |
| Used in hospitals, home care,<br>nursing home settings - anywhere<br>aerosolized drug delivery is utilized | Yes | Yes | Yes |
| Single Patient Use | Yes | Yes | Yes |
| Design | | | |
| Utilizes same technology<br>to atomize drugs | Yes | Yes | Yes |
| Gas Source - Compressed Air | Yes | Yes | Yes |
| Made of three components -<br>top, baffle, base | Yes | Yes | Yes |

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### Non-Confidential Summary of Safety and Effectiveness

page 3 of 3 May 19, 1999

| Attribute | Inspired Med.<br>Sidestream<br>Nebulizer<br>disposable | Medic-Aid<br>Sidestream<br>Nebulizer<br>disposable<br>K924123 | Medic-Aid<br>Sidestream<br>nebulizer<br>K914152B |
|--------------------------------------------------------------|--------------------------------------------------------|---------------------------------------------------------------|--------------------------------------------------|
| Materials | | | |
| Materials in contact with<br>patient - polypropylene | Yes | Yes | Yes |
| Packaging | | | |
| Provided clean, non-sterile | Yes | Yes | Yes |
| Performance Standards / Specifications | | | |
| None applicable under Section 514 | Yes | Yes | Yes |
| Differences Between Other Legally Marketed Predicate Devices | | | |

There are no differences in performance, safety, or efficacy between the intended device and the predicates.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 30 1999

Mr. Paul Dryden Inspired Medical Product, Ltd. c/o ProMedic, Inc. 6329 W. Waterview Court McCordsville, IN 46055-9501

Re: K991725 Sidestream Drug Nebulizer Requlatory Class: II (two) Product Code: 73 CAF Dated: May 19, 1999 Received: May 20, 1999

Dear Mr. Dryden:

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 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 Failure to comply with the GMP regulation may result in assumptions. 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. Paul Dryden

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 [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

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

Enclosure

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#### INDICATIONS FOR USE AND

Page 1 of 1

Pursuant to the Notice of February 6, 1996 regarding listing of Indications for Use on a separate sheet, the following is per that request.

510(k) Number: K991725 (To be assigned)

Device Name: Sidestream nebulizer

Intended Use : A hand-held nebulizer to aerosolize commonly prescribed
liquid drugs (except pentamadine) for inhalation by
patients in the Home, Hospital and Nursing Home settings -
anywhere aerosolized drug delivery is utilized.

Concurrence of CDRH, Office of Device Evaluation (ODE)

toth Westerhausen 7.30.99

of Cardiovascular. d Neurological Devices 10(k) Number

Prescription Use (Per CFR 801.109)

or

Over-the-counter use ___