METERED DOSE INHALER ADAPTER-DISPOSABLE, ADAPTER REUSABLE

K991355 · Instrumentation Industries, Inc. · CAF · Jan 27, 2000 · Anesthesiology

Device Facts

• Record ID: K991355
• Device Name: METERED DOSE INHALER ADAPTER-DISPOSABLE, ADAPTER REUSABLE
• Applicant: Instrumentation Industries, Inc.
• Product Code: CAF · Anesthesiology
• Decision Date: Jan 27, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The RTC Series Metered Dose Inhaler (MDI) Adapters are actuators for intermittent delivery of prescribed aerosol medications dispensed in metered dose inhalers. The RTC Series MDI Adapters are intended for use only when connected to ventilator tubing or tracheal tubes. The RTC 15-D, RTC 22-D, and RTC 23-D models are intended for single patient use. The RTC 22-A and RTC 23-A models are reusable and may be reprocessed.

Device Story

Device acts as interface between metered dose inhaler (MDI) and ventilator/tracheal tubing; facilitates delivery of aerosolized medication to patient airway. Used in clinical settings (e.g., ICU, respiratory care) by healthcare professionals. Models include single-patient use (15-D, 22-D, 23-D) and reusable/reprocessable (22-A, 23-A) versions. Device does not contain electronics or software; purely mechanical adapter.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Mechanical MDI adapter/actuator. Models 15-D, 22-D, 23-D are single-patient use; 22-A, 23-A are reusable. No energy source, software, or electronic components.

Indications for Use

Indicated for patients requiring intermittent delivery of prescribed aerosol medications via metered dose inhalers while connected to ventilator tubing or tracheal tubes.

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 27 2000

Ms. Tricia Wood Instrumentation Industries, Inc. 2990 Industrial Boulevard Bethel Park, PA 15102

Re: K991355 Metered Dose Inhaler Adapter Regulatory Class: II (two) Product Code: 73 CAF November 9, 1999 Dated: Received: November 15, 1999

Dear Ms. Wood:

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 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 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 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 - Ms. Tricia Wood

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,

foran AWesterhausen for,

elia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 510 (k) NUMBER (IF KNOWN): K991355

## DEVICE NAME:

Metered Dose Inhaler Adapter

## INDICATION FOR USE:

The RTC Series Metered Dose Inhaler (MDI) Adapters are actuators for intermittent delivery of prescribed aerosol medications dispensed in metered dose inhalers. The RTC Series MDI Adapters are intended for use only when connected to ventilator tubing or tracheal tubes.

The RTC 15-D, RTC 22-D, and RTC 23-D models are intended for single patient use.

The RTC 22-A and RTC 23-A models are reusable and may be reprocessed.

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---------------------------------------------------------------------------------------|-----------------------------------------------|
| Prescription Use (Per 21 CFR 801.109) | <div> <img alt="checkbox" src=""/> </div> |
| | OR |
| | Over-The-Counter-Use (Optional Format 1-2-96) |
| (Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices | |

510(k) Number _