Who is the manufacturer of COMPRESSOR/NEBULIZER #3650?

Devilbiss Health Care, Inc. filed the 510(k) submission for COMPRESSOR/NEBULIZER #3650 (K970289).

What is the FDA product code for COMPRESSOR/NEBULIZER #3650?

CAF. It is classified under 21 CFR 868.5630 as a Class 2 device in the Anesthesiology panel.

What is the regulatory pathway for COMPRESSOR/NEBULIZER #3650?

510(k) clearance (submission type: Traditional).

What are the predicate devices for COMPRESSOR/NEBULIZER #3650?

DeVilbiss Model 5650 (K923888); Healthdyne, Inc. 323 (K922623).

Who can help prepare an FDA 510(k) submission like COMPRESSOR/NEBULIZER #3650?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

COMPRESSOR/NEBULIZER #3650

K970289 · Devilbiss Health Care, Inc. · CAF · Apr 15, 1997 · Anesthesiology

Device Facts

Record ID	K970289
Device Name	COMPRESSOR/NEBULIZER #3650
Applicant	Devilbiss Health Care, Inc.
Product Code	CAF · Anesthesiology
Decision Date	Apr 15, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.5630
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The DeVilbiss Model 3650 Compressor / Nebulizer is designed for use on the order of a physician for the treatment of respiratory diseases such as asthma, cystic fibrosis and chronic obstructive pulmonary disease.

Device Story

System comprises compressor and jet (pneumatic) nebulizer; converts liquid medication into aerosol for inhalation. Used in clinical or home settings under physician order. Compressor generates pneumatic pressure to drive nebulizer; produces aerosol with majority of mass in particles < 5 microns diameter. Healthcare provider prescribes device; patient self-administers aerosolized medication. Benefits include targeted delivery of medication to respiratory tract for disease management.

Clinical Evidence

Bench testing only. Performance evaluation confirms aerosol output with majority of mass in particles < 5 microns diameter, meeting BSI standard requirements. Comparison of safety and effectiveness data against predicate devices provided.

Technological Characteristics

Pneumatic compressor/nebulizer system. Materials: metal and plastic. Energy source: electrical. Output: aerosolized medication. Particle size: >50% mass < 5 microns. Compliance: UL1431 (electrical/mechanical safety), BSI standard (aerosol performance).

Indications for Use

Indicated for patients with respiratory diseases including asthma, cystic fibrosis, and chronic obstructive pulmonary disease requiring aerosolized medication delivery.

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

DeVilbiss Model 5650 (K923888)
Healthdyne, Inc. 323 (K922623)

Related Devices

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K161586 — The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS) · Shenzhen Homed Medical Device Co., Ltd. · Sep 6, 2017
K993492 — DEVILBISS NEBULIZER MODEL 800 · Sunrise Medical Hhg, Inc. · Apr 21, 2000
K103635 — CONTINUOUS NEBULIZATION TUBE SET (CNTS) TUBING: AG-AS3075 + SYRINGE: AG-AS3085; CONTINOUS NEBULIZATION TUBE SET (CNTS) S · Aerogen, Ltd. · May 13, 2011

Submission Summary (Full Text)

{0} K970289 APR 15 1997 # 3.0 Summary of Safety and Effectiveness The DeVilbiss Model 3650 Compressor / Nebulizer is designed for use on the order of a physician for the treatment of respiratory diseases such as asthma, cystic fibrosis and chronic obstructive pulmonary disease. In terms of function, safety and effectiveness this device is substantially equivalent to other legally marketed compressor / nebulizers commonly used for the treatment of respiratory diseases. The compressor is constructed of materials, both metal and plastic, that are similar or identical to legally marketed devices. The unit is designed and manufactured to comply with electrical and mechanical safety standards applicable to this type of device (Underwriter's Laboratory Standard UL1431, Attachment D). Used in conjunction with a jet (pneumatic) nebulizer, the system converts liquid medication into an aerosol form that can be inhaled by the patient for the treatment of a variety of respiratory disorders. The DeVilbiss Model 3650 compressor / nebulizer system produces an aerosol output with the majority of the aerosol by mass contained in particles less than 5 microns in diameter (per the requirements of the BSI standard, Attachment E). This aerosol particle size performance is comparable to other legally marketed devices as noted in the Table of Comparison and the Discussion of Similarities and Performance Data (Sections 6.0 & 7.0). The Table of Comparison and the Performance Evaluations (Sections 6.0 & 7.0) show that in terms of safety and effectiveness, the new DeVilbiss Model 3650 Compressor / Nebulizer is substantially equivalent to legally marketed predicate devices. Legally Marketed Predicate Devices DeVilbiss Model 5650 Healthdyne, Inc. 323 510(k) Registration # K 923888 K 922623 3650pt3.doc 01/23/97