INVACARE PRO, COMPACT AND PORTABLE DESKTOP
Device Facts
| Record ID | K042483 |
|---|---|
| Device Name | INVACARE PRO, COMPACT AND PORTABLE DESKTOP |
| Applicant | Invacare Corporation |
| Product Code | CAF · Anesthesiology |
| Decision Date | Jan 6, 2005 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5630 |
| Device Class | Class 2 |
| Attributes | Therapeutic, Pediatric |
Indications for Use
The intended use of the Invacare Pro Nebulizer and the Invacare Compact Nebulizer is to spray liquids in aerosol form into gases that are delivered directly to adult or pediatric patients who have been prescribed inhalation therapy or medication. The Invacare Pro Nebulizer and Compact Nebulizer are indicated for use with any commercially available nebulizer and mouthpiece. The Invacare Pro Nebulizer and Compact Nebulizer are intended for home health care use. The intended use of the Invacare Portable Desktop Nebulizer is to spray liquids in aerosol form into gases that are delivered directly to adult or pediatric patients who have been prescribed inhalation therapy or medication. The Invacare Portable Desktop Nebulizer is used exclusively with its own nebulizer and mouthpiece. The Invacare Portable Desktop Nebulizer is intended for home health care use.
Device Story
Invacare Pro, Compact, and Portable Desktop Nebulizers are aerosol compressor systems for home health care. Pro and Compact models use piston compressors to supply pressurized air to commercially available nebulizer mouthpieces. Portable Desktop model uses a DC-powered piston compressor, compatible with AC/DC adapters or rechargeable batteries, and is used exclusively with its own venturi-based nebulizer mouthpiece. Devices convert liquid medication into fine aerosol mist (approx. 5 microns) via venturi effect for patient inhalation. Systems include motor-driven compressors, cooling fans, and thermal/current overload protection. Portable Desktop includes a circuit board for power management (preventing double feed) and thermistor protection. Healthcare providers prescribe these devices; patients operate them at home to manage respiratory conditions. Output is aerosolized medication delivered to the patient's airway.
Clinical Evidence
Bench testing only. Performance testing included particle size analysis (using Budesonide, Albuterol, BDP, and NaCl), flow/pressure characterization, and nebulization rate testing across multiple nebulizer/mouthpiece combinations (e.g., Turbostream, Sidestream, Salter, Medjet, Pari, Westmed, Clenny). Testing conducted per EN 13544:2001. All devices performed according to specifications.
Technological Characteristics
Piston-type air compressors; ABS flame-retardant casing. Pro/Compact: AC powered. Portable Desktop: DC powered (battery/adapter). Sensing: Thermal/current overload protection. Standards: IEC 60601-1-2:2001, EN60601-1-1 1998, ISO 10993:1999, EN 13544:2001, UL 1431, UL 2601-1, CISPR 11 Class B, CSA 22.2 No.68. No software.
Indications for Use
Indicated for adult or pediatric patients prescribed inhalation therapy or medication for respiratory disorders.
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
Submission Summary (Full Text)
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 9 2005
Ms. Carroll Martin Regulatory Affairs Generalist Invacare Corporation One Invacare way Elyria, Ohio 44035-4190
Re: K042483
Trade/Device Name: Invacare Pro Nebulizer, Invacare Compact Nebulizer, Invacare Portable Desktop Nebulizer Regulation Number: 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: December 1, 2004 Received: December 1, 2004
Dear Ms. Martin:
This letter corrects our substantially equivalent letter of December 1, 2004 regarding the trade name.
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 (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 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 Ms. Martin
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 requirements as set forth in the quality systems (OS) 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 continue 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 (240) 276-0120. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Chiu-Lin, Ph.D.
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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# Indications for Use
#### 510(k) Number (if known): K042483
Device Name: Invacare Pro Nebulizer Invacare Compact Nebulizer
Indications for Use:
The intended use of the Invacare Pro Nebulizer and the Invacare Compact Nebulizer is to spray liquids in aerosol form into gases that are delivered directly to adult or pediatric patients who have been prescribed inhalation therapy or medication.
The Invacare Pro Nebulizer and Compact Nebulizer are indicated for use with any commercially available nebulizer and mouthpiece.
The Invacare Pro Nebulizer and Compact Nebulizer are intended for home health care use.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
10(k) Number
Over-The-Counter Use (21 CFR 807 Subpart C)
## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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## Indications for Use
510(k) Number (if known): K042483
Device Name: Invacare Portable Desktop Nebulizer
Indications for Use:
The intended use of the Invacare Portable Desktop Nebulizer is to spray liquids in aerosol form into gases that are delivered directly to adult or pediatric patients who have been prescribed inhalation therapy or medication.
The Invacare Portable Desktop Nebulizer is used exclusively with its own nebulizer and mouthpiece.
The Invacare Portable Desktop Nebulizer is intended for home health care use.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Auyplbom
Vision Sign-Off)
meion of Anesthesgogy, General Hospita
nection Control, Dental Devices
V(k) Number
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JAN - 6 2005
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## 510(K) SUMMARY FOR INVACARE CORPORATION'S PRO, COMPACT AND PORTABLE DESKTOP NEBULIZERS
This summary of 510(k) safety and effectiveness information is being supplied in accordance with the requirements of the SMDA of 1990 and 21 CFR 807.92
The assigned 510(k) number is K042483.
Date: September 9, 2004
Submitted by: Invacare Corporation One Invacare Way Elyria. Ohio 44035-4190
Telephone: 440-329-6356 Fax: 440-326-3607
Contact Person: Carroll L. Martin, Regulatory Affairs Generalist
Trade Name: Invacare Pro Invacare Compact Invacare Portable Desktop
Common Name: Nebulizer
Classification Name: Nebulizer (Direct Patient Interface)
Legally Marketed Predicate Device(s): 56 Series Aerosol Generator, K980074, June 12, 1998 Transneb Compressor w/Nebulizer, Model 5000, K032170, May 28, 2004
### Device Description:
Invacare Pro Nebulizer: The Invacare Pro Nebulizer is a lightweight, self-contained basic aerosol compressor system intended to provide compressed air to a nebulizer mouthpiece. It is designed to operate with any commercially available, small volume disposable nebulizer mouthpiece.
The Invacare Pro Nebulizer supplies pressurized air to the nebulizer mouthpiece. A small piston air compressor provides the compressed air necessary to drive the nebulizer. The Invacare Pro Nebulizer has a maximum output pressure of 39 psi. The maximum flow rate is 8.5 LPM and the operating flow rate is 4.8 LPM @ 16 psi. Air is drawn into the compressor through a filter and exits the unit through a barbed tubing connection. The compressor is kept cool by drawing air across the motor coil using an integral fan.
A permanently attached mains power cord supplies AC power for the unit and power is controlled by the use of an ON/OFF switch. The motor incorporates a current/temperature overload protector, which
One Invacare Way P.O. Box 4028 Elyna. OH 44036-2125 USA 440 329 6000 Fax: 440-366-1803 www.invacare.com
Invacare Corporation 510(k) Submission Page 9
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opens the electrical circuit in the event of high current draw or high temperature in the motor winding. The casing for the unit is constructed of ABS flame retardant material.
Invacare Compact Nebulizer: The Invacare Compact is a smaller version of the Invacare Pro. It is a lightweight, self-contained basic aerosol compressor system intended to provide compressed air to a nebulizer's mouthpiece. It is designed to operate with any commercially available, small volume disposable nebulizer mouthpiece.
The Invacare Compact Nebulizer supplies pressurized air to the nebulizer mouthpiece. A small piston air compressor provides the compressed air necessary to drive the nebulizer. It has a maximum output pressure of 33 psi. The maximum flow rate is 8 LPM and the operating flow rate is 4.0 LPM (@ 16 PSI. Air is drawn into the compressor through a filter and exits the unit through a barbed tubing connection. The compressor is kept cool by drawing air across the motor coil using an integral fan.
A permanently attached mains power cord supplies AC power for the unit and power is controlled by the use of an ON/OFF switch. The motor incorporates a current/temperature overload protector, which opens the electrical circuit in the event of high current draw or high temperature in the motor winding. The casing for the unit is constructed of ABS flame retardant material.
Invacare Portable Desktop Nebulizer: The Invacare Portable Desktop Nebulizer system consists of a nebulizer and a DC powered piston-type compressor that generates compressed air. Small, lightweight and designed for convenience, the Invacare Portable Nebulizer device offers the user a choice of running off of AC power via a universal adapter or DC power via a 12 volt auto adapter or an optional rechargeable battery pack.
The compressor unit consists of a motor driven piston compressor, printed circuit board and a switch. The circuit board does not incorporate a microprocessor, but serves as a means to prevent double feed of power. This is a safety feature that allows power draw from either the battery or the input adapter, but not both. There is a thermistor incorporated into the circuit board that provides protection by opening the electrical circuit in the event of high motor temperature. The circuit board is not part of the charging circuit for the battery pack. The unit has a maximum pressure of 36 psi and an operating pressure of 10 psi. The maximum flow rate is 5.2 LPM and the operating flow rate is 2.5 LPM @ 10 psi.
The nebulizer mouthpiece employs a venturi effect to convert the medication into a fine aerosol mist. It is used with an extension tube. The nebulizer mouthpiece has a particle size range of ~ 5 microns and a capacity of 7 ml (cc). Providing a connection between the compressor outlet and the nebulizer mouthpiece bottom, the extension tube allows the compressor on a sturdy surface and to simply hold onto the nebulizer mouthpiece. The nebulizer mouthpiece is designed for single patient use, is reusable and intended to be used exclusively with the Invacare Portable Desktop Nebulizer. Use of the nebulizer mouthpiece, compressor or tubing with other compressors, nebulizer mouthpieces or tubing may produce incorrect flow resulting in improper treatment.
INVACARE CORPORATION
Invacare Corporation 510(k) Submission Page 1C
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Intended Use: The intended use of the Invacare Pro Nebulizer and the Invacare Compact Nebulizer is to provide compressed air in order to operate a nebulizer for the production of medical aerosol for respiratory disorders. These units require a nebulizer mouthpiece and medication for operation. The use of the Invacare Pro Nebulizer and the Invacare Compact Nebulizer is for the sole purpose of compressed air production.
The Invacare Portable Desktop Nebulizer includes a DC powered air compressor that provides a source of compressed air for home health care use. The compressor is used exclusively with a venturi (pneumatic nebulizer mouthpiece) to convert certain inhaled drugs into an aerosol form for inhalation by a patient.
All of these devices are single-person use, non-sterile, prescription use devices. None of them contain software nor are they intended to be life-supporting or life-sustaining.
Substantial Equivalence: The Invacare Compact Nebulizer is exactly the same unit in design, intended use, safety and performance specifications as the 56 Series Aerosol Generator cleared by FDA for another company under 510(k) accession number K980074 on June 12, 1998. The Invacare Portable Desktop Nebulizer is exactly the same unit in internal operating components, intended use, safety and performance specifications as the Transneb Compressor w/Nebulizer, Model 5000, cleared by FDA, also for another company, under 510(k) accession number K032170 on May 28, 2004. It does have a different outer casing for cosmetic marketing reasons. The Invacare Pro Nebulizer, to be a larger version of the Invacare Compact Nebulizer, is similar in design, intended use, safety and performance specifications as the 56 Series Aerosol Generator, cleared under 510(k) accession number K980074 on June 12, 1998. Medel S.p.A., Italy, registration number 3003826420, manufactures all of these products, including the predicate devices.
Performance Testing: Particle size testing was performed for the Invacare Compact, Pro and Desktop Portable. For this testing, three separate samples of the Compact and Pro with nine different nebulizer/mouthpieces (Turbostream Disposable, Turbostream Reusable, Sidestream Disposable, Sidestream Reusable, Salter 8900, Salter 8960, Medjet Disposable, Medjet Pro, Pari LC Jet Reusable and the Westmed Vix One) were run along with Budesonide, Albuterol and Beclometasone Dipropionate (BDP) as the substances to be nebulized. The same method was used for the Invacare Portable Desktop with the exception that the nebulizer/mouthpiece (Clenny) used is the one that is exclusive to the Invacare Portable Desktop.
Flow/Pressure testing was performed for the Invacare Compact, Pro and Desktop Portable. For this testing, three separate samples of the Compact and Pro were run with the MedelJet nebulizer/mouthpiece and the flow characteristic graphed for each device sample. For the Invacare Portable Desktop, the same method was used with the exception that the neublizer/mouthpiece used was the one that is exclusive to the Invacare Portable Desktop (Clenny).
Compressor nebulization rate testing was also performed for each device. For the Invacare Compact and Pro, three different samples of each device were run with the ten aforementioned nebulizers and three chemicals. For the Portable Desktop, testing was performed with its exclusive nebulizer/mouthpiece (Clenny) and sodium chloride (NaCI) in accordance with EN 13544:2001.
INVACARE CORPORATION
Invacare Corporation 510(k) Submission Page 11
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In all instances, each of these devices performed according to specification and functioned as intended.
Performance Standards: These nebulizers have been designed and built in accordance with the applicable requirements of IEC 60601-1-2:2001, EN60601-11 1998, ISO 10993:1999, EN 13544:2001, UL 1431, * UL 2601-1, applicable sections of IEC 801, CISPR 11 Class B, CSA 22.2 No.68 and the FDA November 1993 Reviewer's Guidance for Respiratory Devices.
Note: the UL 2601-1 standard is for the adapter used with the Invacare Portable Desktop Nebulizer. The adapter is a step-down transformer and is governed by this standard.
INVACARE CORPORATION
Invacare Corporation 510(k) Submission Page 12
