HOSPITAL SPACER

K032809 · Respironics Healthscan, Inc. · CAF · Nov 13, 2003 · Anesthesiology

Device Facts

• Record ID: K032809
• Device Name: HOSPITAL SPACER
• Applicant: Respironics Healthscan, Inc.
• Product Code: CAF · Anesthesiology
• Decision Date: Nov 13, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric, 3rd-Party Reviewed

Intended Use

ProChamber™ Valved Holding Chamber is intended for use in combination with Metered Dose Inhalers (MDI's) to assist in respiratory drug delivery. All patients using MDI's, i.e., children and adults, may use ProChamber ™. Settings for use include the home, clinics and hospitals. This device is intended for prescription use.

Device Story

ProChamber Valved Holding Chamber is a non-electrical accessory for Metered Dose Inhalers (MDIs). It consists of an MDI adapter, chamber, mouthpiece, duckbill valve, exhaust valve, and silicone cap. The device functions by attaching to an MDI to facilitate drug delivery; the one-way valve system and chamber design help minimize aerosol deposition in the oropharynx and ensure reproducible dose delivery. It is used by patients (children and adults) in homes, clinics, and hospitals under prescription. The device utilizes the MDI's own actuator to direct the aerosol plume toward the patient. It benefits patients by improving the efficiency of respiratory medication delivery compared to using an MDI alone.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, specifically particle size distribution and dose delivery reproducibility compared to the predicate device and MDI alone, following FDA guidance for spacers and actuators.

Technological Characteristics

Non-electrical valved holding chamber. Components include MDI adapter, chamber, mouthpiece, duckbill valve, exhaust valve, and silicone cap. Features one-way valve mechanism. Portable, manual operation. No software or electronic components.

Indications for Use

Indicated for children and adults using Metered Dose Inhalers (MDIs) to assist in respiratory drug delivery in home, clinic, or hospital 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

• Aerochamber Plus™ Valved Holding Chamber (K992917)

Submission Summary (Full Text)

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# NOV 1 3 2003

## Attachment #1

## 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is:_ K032809

#### Submitter's Identification: 1.

Respironics HealthScan, Inc. 41 Canfield Road Cedar Grove, NJ 07009

Contact: Ms. Lauren R. Ziegler

### Date Summary Prepared:

July 31, 2003

#### 2. Name of the Device:

ProChamber ™ Valved Holding Chamber

#### 3. Predicate Device Information:

K#992917, Aerochamber Plus™ Valved Holding Chamber, Trudell Medical International, London, Ontario, Canada

#### 4. Device Description:

The device consists of an MDI Adapter, a Chamber, a Mouthpiece, a Duckbill Valve, an Exhaust Valve and a Silicone Cap. There are no electrical or electronic components.

#### ട. Intended Use:

ProChamber™ Valved Holding Chamber is intended for use in combination with Metered Dose Inhalers (MDI's) to assist in respiratory drug delivery. All patients using MDI's, i.e., children and adults, may use ProChamber ™. Settings for use include the home, clinics and hospitals.

This device is intended for prescription use.

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#### Comparison to Predicate Devices: 6.

The subject (ProChamber™) and predicate device (AeroChamber Plus™ – K#992917) are indicated for the same intended use. The devices are of similar size and shape and performance characteristics are basically the same. The main difference is the valve design. The subject device and predicate devices share the following characteristics:

- Similar dimensions .
- Portable .
- Reproducible dose delivery .
- Minimization of aerosol disposition in oropharynx .
- Spray direction of aerosol plume is toward patient .
- . One-way valve
- Utilizes MDI's own actuator .

### 7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:

The ProChamber ™ and the predicate device, the AeroChamber Plus™ , were tested for particle size distribution testing, as well as directly compared to and MDI alone without the spacer attached. A particle size comparison between the subject spacer and the attached MDI alone was tested, according to the methodology outlined in the FDA "Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators, 10/93". Testing documentation showed that particle size range and reproducibility compared to the predicate device, was acceptable.

#### Discussion of Clinical Tests Performed: 8.

Not applicable

#### 9. Conclusions:

The subject device, the ProChamber™ Metered Dose Inhaler (MDI) Valved Holding Chamber, has a similar intended use and similar characteristics as the predicate device, the AeroChamber Plus™ Valved Holding Chamber. Moreover, non-clinical testing included in this submission demonstrated that any differences in their characteristics do not raise any new questions of safety or effectiveness. Thus, the subject device is substantially equivalent to the predicate device.

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### Exhibit B

Page __ 1 __ of __ 1 __

510(k) Number (if known): __ K03 2809

Device Name ProChamber™ Valved Holding Chamber

### Indications For Use:

ProChamber™ Valved Holding Chamber is intended for use in combination with Metered Dose Inhalers (MDI's) to assist in respiratory drug delivery. All patients using MDI's, i.e., children and adults, may use ProChamber ™. Settings for use include the home, clinics and hospitals.

This device is intended for prescription use.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The Counter Use (Optional Format 1-2-96)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract image of a bird-like figure, possibly representing an eagle or other national symbol. The image is in black and white.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 3 2003

Respironics Healthscan Inc. C/O Mr. Robert Mosenkis President CITECH 5200 Butler Pike Plymouth Meeting, PA 19462

Re: K032809

Trade/Device Name: ProChamber Valved Holding Chamber Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: Class II Product Code: CAF Dated: October 28, 2003 Received: October 29, 2003

Dear Mr. Mosenkis:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice

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Page 2 - Mr. Robert Mosenkis

requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours.

Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Exhibit B

Page 1 of

K032809 510(k) Number (if known): __

Device Name ProChamber™ Valved Holding Chamber

Indications For Use:

ProChamber™ Valved Holding Chamber is intended for use in combination with Metered Dose Inhalers (MDI's) to assist in respiratory drug delivery. All patients using MDI's, i.e., children and adults, may use ProChamber ™. Settings for use include the home, clinics and hospitals.

This device is intended for prescription use.

bthul
Division Sign-Off

esiology. General Hr

510(k) Number: K032809

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Prescription Use
(Per 21 CFR 801.109) √

Over-The Counter Use (Optional Format 1-2-96)