MISTER NEB NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS123

K013027 · Respironics Healthscan, Inc. · BTI · Dec 6, 2001 · Anesthesiology

Device Facts

• Record ID: K013027
• Device Name: MISTER NEB NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS123
• Applicant: Respironics Healthscan, Inc.
• Product Code: BTI · Anesthesiology
• Decision Date: Dec 6, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.6250
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric, 3rd-Party Reviewed

Intended Use

This nebulizer compressor is an AC-powered air compressor intended to provide a source of compressed air for medical purposes for use in home health care. This device is used in conjunction with a pneumatic nebulizer to produce a fine aerosol mist of medication for respiratory therapy, for both children and adults suffering from respiratory disorders such as asthma, allergies, COPD, etc.

Device Story

Mister Neb™ Model HS123 is a line-powered piston compressor for home respiratory therapy. Device consists of motor-driven piston, in-line fuse, and switch; housed in plastic cabinet. Operates on 115 VAC, 60 Hz. User connects pneumatic nebulizer tubing to device hose barb; inlet air passes through replaceable filter. Device produces compressed air to drive nebulizer, creating fine aerosol mist of medication for patient inhalation. Intended for home use by patients or caregivers. No microprocessors or electronic components present. Provides therapeutic benefit by facilitating delivery of respiratory medications.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing including electrical safety (leakage current, dielectric withstand), mechanical performance (pressure/flow under varying voltage/temperature), environmental stress (vibration, impact, fluid spill), and EMC (CISPR 11, MIL-STD-462D).

Technological Characteristics

AC-powered piston compressor; plastic housing; 7.3 x 6.9 x 4.0 inches; 3.3 lbs. Operates at 115 VAC, 60 Hz. Includes replaceable air filter. No microprocessors or electronic components. Mechanical sensing/actuation. Not networked.

Indications for Use

Indicated for children and adults suffering from respiratory disorders (e.g., asthma, allergies, COPD) requiring aerosolized medication therapy via a pneumatic nebulizer.

Regulatory Classification

Identification

A portable air compressor is a device intended to provide compressed air for medical purposes, e.g., to drive ventilators and other respiratory devices.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.

Predicate Devices

• InvaCare Envoy Jr. (K914251)

Submission Summary (Full Text)

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EXHIBIT #1

# 510(K) SUMMARY

This summary of 5l0(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 5l0(k) number is: KO13 0 2 7

### 1. Submitter's Identification:

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

Contact: Ms. Lauren R. Ziegler, Senior Manager, Technical Services

Date Summary Prepared: August 8, 2001

### 2. Name of the Device:

Mister Neb™ Nebulizer Compressor, with Nebulizer, Model HS123

### Predicate Device Information: 3.

InvaCare Envoy Jr., K# 914251

### 4. Device Description:

This line-powered piston compressor is housed in a plastic cabinet (case). Dimensions are 7.3 in. x 6.9 in. x 4.0 in. and weighs 3.3 lbs. It consists of a motor-driven piston compressor, an in-line fuse, and a switch; it contains no microprocessors or other electronic components. It operates from 115 VAC, 60 Hz. It is supplied with tubing, an instruction manual, and a 510(k) cleared nebulizer.

In use, the compressor is placed on a flat surface and the nebulizer tubing is connected to the hose barb. The unit is then turned on. Inlet air to the compressor passes through a replaceable filter.

### 5. Intended Use:

This nebulizer compressor is an AC-powered air compressor intended to provide a source of compressed air for medical purposes for use in home health care.

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This device is used in conjunction with a pneumatic nebulizer to produce a fine This as nos to t medication for respiratory therapy, for both children and adults suffering from respiratory disorders such as asthma, allergies, COPD, etc.

### Comparison to Predicate Devices: 6.

The subject (Mister Neb™) and predicate device (InvaCare Envoy Jr., 110 Sabjoon (microl for the same intended use, are AC-powered, meet Environmental Safety and EMC requirements, and have similar compressor operating pressure and flow ranges. Performance characteristics are basically the same, and both units are lightweight.

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

The following Environmental and Safety Testing was conducted:

Testing information demonstrating safety and effectiveness of the Mister Neb™ Nebulizer Compressor, with Nebulizer, Model HS123 in the intended environment of use is supported by testing that was conducted in accordance with the FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions", DCRND, which outlines Electrical, Mechanical and Environmental Performance Requirements.

The following testing was conducted:

- Maximum pressure and flow under all combinations of the following: a.
- Temperatures of +5° and +20°C, and 40°C with 95% RH: ।
- Line voltage of 95, 115, and 132 V
- Storage at -20°C and at +60°C b.
- Fluid spill resistance C.
- Surface and air temperatures ರೆ.
- Sinusoidal vibration e.
- Impact (drop) resistance f.
- Leakage current and dielectric withstand (electrical safety) g.

None of the testing demonstrated any design characteristics that violated the requirements of the Reviewer Guidance or resulted in any safety hazards. It was our conclusion that the Mister Neb™ Nebulizer Compressor, with Nebulizer, Model HS123, device sample(s) tested met all relevant requirements of the aforementioned test.

In addition, the following EMC testing was conducted:

- Radiated and Conducted Emission per CISPR 11 a.

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- Magnetic Field Emission per MIL-STD-462D, Method RE101 b.
- Fast surges per Reviewer Guidance document C.

Because the compressor contains no electronic components (e.g., microprocessors), the radiated and conducted immunity tests were not applicable. The device was tested as described in the EMC Testing Results to simulate, as closely as possible, actual operating conditions.

The device tested met the EMC criteria recommended by the FDA

### 8. Discussion of Clinical Tests Performed:

Not Applicable

### 9. Conclusions:

We have demonstrated that the Mister Neb™ Nebulizer Compressor, with Nebulizer, Model HS123 is as safe and effective as predicate devices presently on the market, based on electrical, mechanical, environmental and EMC testing results outlined in the FDA DCRND November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions". We also adhered to FDA's DCRND "Reviewer Guidance for Home Use Respiratory Devices".

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Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 0 6 2001

Respironics HealthScan, Inc. c/o Mr. Robert Mosenkis Citech 5200 Butler Pike Plymouth Meeting, PA 19462-1298

Re: K013027

Mister NebTM Nebulizer Compressor, Model HS123 Regulation Number: 868.6250 Regulation Name: Portable Air Compressor Regulatory Class: Class II (two) Product Code: BTI Dated: November 20, 2001 Received: November 21, 2001

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.

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## Page 2 - Mr. Robert Mosenkis

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r loase of action and i rermination that your device complies with other requirements of the Act that I Dr Has intates and regulations administered by other Federal agencies. You must or any I odotal buttor and including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI K Fat 607); adoning (21 CFR regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality by states (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) This lotter will and in yourse of substantial equivalence of your device to a legally prematic notineatem " rice 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 11 you deelie by cents and 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 Of ICP at 0646. Additionally, for questions on the promotion and advertising of Compliance at (301) 59 - 1 the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

X. Oolga Tell

Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Exhibit B

Page __ 1 __ of __ 1 __ 1 __

510(k) Number (if known): _ K 0 | 3 O2 7

Device Name: Mister Neb™ Nebulizer Compressor, with Nebulizer, Model HS123

## Indications For Use:

This nebulizer compressor is an AC-powered air compressor intended to provide a source of compressed air for medical purposes for use in home health care. This device is used in conjunction with a pneumatic nebulizer to produce a fine aerosol mist of medication for respiratory therapy, for both children and adults suffering from respiratory disorders such as asthma, allergies, COPD, etc.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dale Till
Division of Cardiovascular & Respiratory Devices

| 510(k) Number | K013027 |
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| Prescription Use (Per 21 CFR 801.109) | <div> <br/> </div> |
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OR

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