Who can help prepare an FDA 510(k) submission like JOHN BUNN NEB-U-LITE II MEDICATION COMPRESSOR WITH DISPOSABLE NEBULIZER, MODEL #JBO-112-009?

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.

JOHN BUNN NEB-U-LITE II MEDICATION COMPRESSOR WITH DISPOSABLE NEBULIZER, MODEL #JBO-112-009

Q: Who is the manufacturer of JOHN BUNN NEB-U-LITE II MEDICATION COMPRESSOR WITH DISPOSABLE NEBULIZER, MODEL #JBO-112-009?

Graham-Field, Inc. filed the 510(k) submission for JOHN BUNN NEB-U-LITE II MEDICATION COMPRESSOR WITH DISPOSABLE NEBULIZER, MODEL #JBO-112-009 (K970035).

Q: What is the FDA product code for JOHN BUNN NEB-U-LITE II MEDICATION COMPRESSOR WITH DISPOSABLE NEBULIZER, MODEL #JBO-112-009?

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

Q: What is the regulatory pathway for JOHN BUNN NEB-U-LITE II MEDICATION COMPRESSOR WITH DISPOSABLE NEBULIZER, MODEL #JBO-112-009?

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

Q: What are the predicate devices for JOHN BUNN NEB-U-LITE II MEDICATION COMPRESSOR WITH DISPOSABLE NEBULIZER, MODEL #JBO-112-009?

DeVilbiss Model 4650D Compressor Nebulizer (K931015).

K970035 · Graham-Field, Inc. · CAF · Apr 1, 1997 · Anesthesiology

Device Facts

Record ID	K970035
Device Name	JOHN BUNN NEB-U-LITE II MEDICATION COMPRESSOR WITH DISPOSABLE NEBULIZER, MODEL #JBO-112-009
Applicant	Graham-Field, Inc.
Product Code	CAF · Anesthesiology
Decision Date	Apr 1, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.5630
Device Class	Class 2
Attributes	Therapeutic, Pediatric

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, etc.

Device Story

Piston-driven AC-powered air compressor; provides compressed air to pneumatic nebulizer for aerosolizing medication. Operated by patient or caregiver in home setting. Device features: internal fuse, replaceable air intake filter, double-pole toggle switch. User connects delivery tubing to outlet hose barb. Output is fine aerosol mist for respiratory therapy. Benefits: enables home-based administration of respiratory medications.

Clinical Evidence

No clinical data. Substantial equivalence based on bench testing including electrical supply, thermal safety, temperature/voltage extremes, liquid spillage, mechanical vibration/shock, and electromagnetic compatibility testing per DCRND Reviewer Guidance (November 1993) and IEC standards.

Technological Characteristics

Piston-driven compressor; AC-powered; includes replaceable air filter; double-pole toggle switch; internal fuse; polarized power cord. Meets UL1431, IEC 801-4, and IEC 801-5 standards. Form factor: portable tabletop unit.

Indications for Use

Indicated for children and adults suffering from respiratory disorders, such as asthma and allergies, requiring aerosolized medication therapy via a pneumatic nebulizer in a home health care setting.

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 4650D Compressor Nebulizer (K931015)

Reference Devices

Power Mist™ Disposable Medication Nebulizer (K791536)
Aero/Mist Set (pre-amendment)

Related Devices

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
K992643 — MODEL IRC 1001 AEROSOL COMPRESSOR · Invacare Corp. · Oct 27, 1999
K041974 — MED2000 NEBULIZER COMPRESSOR, MODELS P3, P4, P5 WITH NEBULIZER · Med2000 S.R.L. · Aug 24, 2004
K031908 — MED2000 SPA NEBULIZER COMPRESSORS, MODELS P1 AND P2, WITH NEBULIZER, AND MED2000 SPA NEBULIZER, MODEL A1/C (ANDYFLOW) · Med2000 S.R.L. · Jan 14, 2004
K051260 — SCHUCO MIST AND SCHUCO DELUXE MIST · Allied Healthcare Products, Inc. · Sep 15, 2005

Submission Summary (Full Text)

{0} K970035 APR - 1 1997 EXHIBIT #1 Page 1 of 4 # 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: _______. 1. **Submitter’s Identification:** Graham-Field, Inc. 400 Rabro Drive East Hauppauge, NY 11788 Date Summary Prepared: December 30, 1996 2. **Name of the Device:** John Bunn Neb-U-Lite II™ Medication Compressor with Disposable Nebulizer, Model #JBO-112-009 3. **Predicate Device Information:** DeVilbiss Model 4650D Compressor Nebulizer, K#931015 4. **Device Description:** This piston-driven nebulizer contains vents in the two sides and bottom of the case providing ventilation for the motor. The compressor has only one control - a double pole toggle switch to turn the compressor on and off. The unit has a two-wire power cord with polarized plug, an internal fuse, and no exposed metal that is likely to become energized (two screws that hold the case together are greatly recessed on the bottom surface and are not likely to become energized). In use, the compressor is placed on a flat surface and the cover is opened to reveal an outlet hose barb to which the oxygen (air) delivery tubing {1} EXHIBIT #1 Page 2 of 4 and nebulizer are connected. Inlet air to the compressor passes through a replaceable filter. Distributed with the device will be nebulizers purchased from one of the following two (2) companies: a) Hospitak, Inc. 1144 Route 109 Lindenhurst, NY 11757 K#791536 Product: Power Mist™ Disposable Medication Nebulizer b) B&F Medical Products P.O. Box 3656 1421 N. Expressway Drive Toledo, OH 43608 This nebulizer is pre-amendment for B&F. Product: Aero/Mist Set 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. 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, etc. 6. **Comparison to Predicate Devices:** Both devices are AC-powered, contain the same filter material, meet UL1431 and are in the same compressor operating pressure and liter flow ranges. Performance characteristics are basically the same. Both are fairly lightweight, with the John Bunn compressor being lighter and smaller. {2} EXHIBIT #1 Page 3 of 4 7. **Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:** The following testing was conducted by CITECH: a. Electrical Supply b. Thermal Safety c. High and Low Temperature Operation d. High and Low Power Line Voltages e. Storage at High and Low Temperatures f. Liquid Spillage g. Mechanical Vibration and Shock Resistance h. Mechanical Impact None of the testing demonstrated any design characteristics that violated the requirements of the Reviewer Guidance or resulted in any safety hazards. It was CITECH’s conclusion that the John Bunn Neb-U-Lite II™ Medication Compressor with Disposable Nebulizer, Model #JBO-112-009 device sample tested met all relevant requirements of the aforementioned test. In addition, the following testing was conducted by CITECH: a. Radiated and Conducted Electromagnetic Energy and Magnetic Field Testing on the John Bunn Neb-U-Lite II™ Medication Compressor with Disposable Nebulizer, Model #JBO-112-009. Testing was conducted per the DCRND Reviewer’s Guideline, November 1993. {3} EXHIBIT #1 Page 4 of 4 b. An electrical evaluation performed in accordance with the DCRND Reviewer’s Guideline, November 1993 and IEC 801-4 and IEC-801-5 was performed on the John Bunn Neb-U-Lite II™ Medication Compressor with Disposable Nebulizer, Model #JBO-112-009. 8. **Discussion of Clinical Tests Performed:** Not Applicable 9. **Conclusions:** We have demonstrated that the John Bunn Neb-U-Lite II™ Medication Compressor with Disposable Nebulizer is as safe and effective as predicate devices presently on the market, based on electrical, mechanical and environmental results as well as 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".