SPACE CHAMBER FOR MODEL NUMBER AND ACCESSORIES

K971808 · Monarch Medical · CAF · Sep 26, 1997 · Anesthesiology

Device Facts

• Record ID: K971808
• Device Name: SPACE CHAMBER FOR MODEL NUMBER AND ACCESSORIES
• Applicant: Monarch Medical
• Product Code: CAF · Anesthesiology
• Decision Date: Sep 26, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The space chamber obtains maximum benefit from your M.D.I. It improves delivery to lungs and reduces the amount of drug deposited in the throat. The space chamber can be used by all patients from the youngest neonate to an adult. The device can be used in hospital, home and is portable and can be carried by the patient. The space chamber is a multipatient use device. Please follow cleaning instructions between patient use.

Device Story

Space Chamber is a valved holding chamber (VHC) designed for use with Metered Dose Inhalers (MDIs). Device acts as a spacer between MDI and patient airway; slows aerosol velocity; allows evaporation of propellant; increases respirable fraction of medication reaching lungs; reduces drug deposition in throat. Used in hospital or home settings; portable for patient transport. Multi-patient use device requiring cleaning between users. Benefits include optimized drug delivery and reduced side effects associated with oropharyngeal deposition.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Valved holding chamber (spacer) for MDI. Portable, multi-patient use design. Materials and specific dimensions not detailed in provided text.

Indications for Use

Indicated for all patients, from neonates to adults, requiring improved delivery of medication from a Metered Dose Inhaler (MDI) to the lungs while reducing oropharyngeal deposition.

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)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are abstract and formed by flowing lines. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 6 1997

Mr. Mo Shariff Monarch Medical, Inc. 4550 Birch Bay/Lynden Road Suite B138 Blaine, Washington 98230

Re: K971808 Space Chamber™ Requlatory Class: II (two) Product Code: 73 CAF August 14, 1997 Dated: Received: August 20, 1997

Dear Mr. Shariff:

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 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). Yoll 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 Requlation (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.

{1}------------------------------------------------

Page 2 - Mr. Mo Shariff

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/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

{2}------------------------------------------------

Page ***/*** of *_*/

510(k) Number (if known): K971808

Davica Name:

Indications For Us

The space chamber obtains maximum benefit from your M.D.I. It improves delivery to lungs and reduces the amount of drug deposited in the throat.

The space chamber can be used by all patients from the youngest neonate to an adult. The device can be used in hospital, home and is portable and can be carried by the patient.

The space chamber is a multipatient use device. Please follow cleaning instructions between patient use.

(PLEASE DO NOT WRITE BELOW THIS UNE-CONTINUE ON ANOTHER PAGE IF NEEDED!

(Division Sign-Off)
Division of Cardiovascular

(Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number _

OR

Over-The-Counter Us

Prescription Use (Per 21 CFR 801.109)

(Optional Format 1-2-96)