POCKET CHAMBER VALVED AEROSOL HOLDING CHAMBER

K993199 · Ferraris Medical, Inc. · CAF · Mar 28, 2000 · Anesthesiology

Device Facts

• Record ID: K993199
• Device Name: POCKET CHAMBER VALVED AEROSOL HOLDING CHAMBER
• Applicant: Ferraris Medical, Inc.
• Product Code: CAF · Anesthesiology
• Decision Date: Mar 28, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2

Intended Use

The Pocket Chamber Valved Aerosol Holding Chamber is intended to assist with the delivery of aerosolized medications when used in conjunction with commercialized MDI canisters with the associated activator elbow. The spacer device is indicated to assist in the treatment of patients with lung disease such as, but not limited to, asthma, emphysema, chronic bronchitis, and cystic fibrosis.

Device Story

The Pocket Chamber is a cylindrical valved aerosol holding chamber (spacer) used to facilitate medication delivery from metered-dose inhaler (MDI) canisters. The device features a cylindrical tube (approx. 3.1 inches long by 4.5 cm wide) with an MDI receptacle designed to prevent off-center actuations and a one-way valve located between the mouthpiece and the body. It is used by patients to improve the efficiency of aerosolized drug delivery. The device acts as an interface between the MDI and the patient's airway, ensuring consistent medication delivery. It is a non-powered, mechanical accessory.

Clinical Evidence

Bench testing only. Performance was evaluated using a Cascade Impactor Test comparing the subject device to the predicate AeroChamber and an MDI actuator without a spacer. Metrics included total dose, respirable dose, mass median aerodynamic diameter, and geometric standard deviation. Results showed comparable performance. Resistance to flow testing on the one-way valve and validation of cleaning instructions were also performed.

Technological Characteristics

Cylindrical tube, 3.1 inches long by 4.5 cm wide. Features a one-way valve at the mouthpiece-body junction and an MDI receptacle. Non-powered, mechanical device. No software or electronic components.

Indications for Use

Indicated for patients with lung disease, including asthma, emphysema, chronic bronchitis, and cystic fibrosis, requiring assistance with aerosolized medication delivery via MDI canisters.

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

• AeroChamber Aerosol Holding Chamber (Monaghan Medical Corporation)

Submission Summary (Full Text)

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MAR 2 8 2000

K993199

## 510(k) SUMMARY

## Ferraris Medical. Inc. Pocket Chamber Valved Aerosol Holding Chamber

# Submitter's Name. Address. Telephone Number. Contact Person and Date Prepared

| Mr. David R. Malys | Jonathan S. Kahan, Esq. |
|-------------------------|-----------------------------|
| President | Hogan & Hartson L.L.P. |
| Ferraris Medical, Inc. | 555 Thirteenth Street, N.W. |
| 9681 Wagner Road | Washington, DC 20004-1109 |
| Post Office Box 344 | Telephone: [phone] |
| Holland, New York 14080 | Facsimile: [phone] |

## Date Prepared:

September 23, 1999

#### Name of Device and Name/Address of Sponsor

Ferraris Medical, Inc. Pocket Chamber Valved Aerosol Holding Chamber

Mr. David R. Malys President Ferraris Medical, Inc. 9681 Wagner Road Post Office Box 344 Holland, New York 14080

## Common or Usual Name

Spacer; Aerosol Holding Chamber

### Classification Name

Accessory to a nebulizer

#### Predicate Devices

Monaghan Medical Corporation's AeroChamber Aerosol Holding Chamber

### Intended Use

The Pocket Chamber Valved Aerosol Holding Chamber is intended to assist with the delivery of aerosolized medications when used in conjunction with commercialized MDI canisters with the associated activator elbow. The spacer device is indicated to assist in the treatment of patients with lung disease such as, but not limited to, asthma, emphysema, chronic bronchitis, and cystic fibrosis.

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## Technological Characteristics and Substantial Equivalence

The Pocket Chamber Valved Aerosol Holding Chamber is a cvlindrical tube. approximately 3.1 inches long by 4.5 cm wide, and accepts the MDI manufacturer's mouthpiece. The MDI receptacle has an orifice of size and shape similar to the MDI mouthpiece. The device is designed to prevent offcenter actuations. A one-way valve is located at the juncture between the mouthpiece and the body. The Pocket Chamber Valved Aerosol Holding Chamber is substantially equivalent to the AeroChamber.

#### Performance Data

Ferraris performed the Cascade Impactor Test comparing the Pocket Chamber Valved Aerosol Holding Chamber with the AeroChamber and an MDI actuator without a spacer device for four categories of drugs. The Pocket Chamber Valved Aerosol Holding Chamber performed comparably in terms of total dose, respirable dose, mass median aerodynamic diameter; and geometric standard deviation. In addition, resistance to flow testing on the one-way valve, and validation of the cleaning instructions demonstrate that the Pocket Chamber performs in accordance with the device's specifications.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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# MAR 2 8 2000

Mr. Jonathan S. Kahan Ferraris Medical, Inc. c/o Hogan & Hartson L.L.P. 555 Thirteenth Street, N.W. Washington, DC 20004-1109

Re : K993199 Pocket Chamber Valved Aerosol Holding Chamber Regulatory Class: II (two) 73 CAF Product Code: Dated: December 30, 1999 Received: December 30, 1999

Dear Mr. Kahan:

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 reqistration, 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 requlation 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 - Mr. Jonathan S. Kahan

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,

Jean-Nicholas fer,

James E. Dillard III 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): ____________________________________________________________________________________________________________________________________________________

#### Ferraris Medical, Inc.'s Pocket Chamber Valved Aerosol Device Name: Holding Chamber

Indications for Use:

The Pocket Chamber Valved Aerosol Holding Chamber is intended to assist with the delivery of aerosolized medications when used in conjunction with commercialized MDI canisters with the associated activator elbow. The spacer device is indicated to assist in the treatment of patients with lung disease such as, but not limited to, asthma, emphysema, chronic bronchitis, and cystic fibrosis.

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. A. Whitten

Prescription Use (Per 21 C.F.R. 801.109)

OR

Over-The-Counter Use_

(Optional Format 1-2-96)