PORT-NEB

K971933 · Medic-Aid , Ltd. · CAF · Aug 1, 1997 · Anesthesiology

Device Facts

• Record ID: K971933
• Device Name: PORT-NEB
• Applicant: Medic-Aid , Ltd.
• Product Code: CAF · Anesthesiology
• Decision Date: Aug 1, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

To provide a portable compressed air source for the nebulization of drugs to be delivered to a patient via a hand-held nebulizer in the home, nursing home or hospital environments.

Device Story

Porta-Neb is an electrically powered compressor providing 6-8 Lpm air flow at 12 psi back pressure. Device serves as portable air source for nebulizing drugs; connects to hand-held nebulizer, mask, or mouthpiece via air delivery tubing. Used in hospitals, nursing homes, and homes; operated by clinicians or patients. Provides compressed air to drive nebulization process; enables drug delivery to patient airways. No device materials contact patient.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Electrically powered compressor; 110V operation. Provides 6-8 Lpm air flow at 12 psi. Portable, compact form factor. Meets EN 60601, UL 2601, IEC 601-1, and CAN/CSA C22.2 No.601.1 safety standards. No patient-contact materials.

Indications for Use

Indicated for patients requiring nebulized drug delivery via a hand-held nebulizer.

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 - Pulmo-Aide K854520

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for Medic-Aid. The logo consists of a stylized mountain range above the text "MEDIC-AID". The mountain range is made up of three black triangles, and the text is also in black. There is a registered trademark symbol to the right of the word "AID".

## Non-Confidential Summary of Safety and Effectiveness

page 1 of 3 May 27, 1997

AUG - 1 1997

Medic-Aid Ltd. Heath Place Bognor Regis, West Sussex PO22 9SL United Kingdom

| Tel - 011-44-1243-840888 | Fax - 011-44-1243-846100 |
|----------------------------|-------------------------------------------------|
| Official Contact: | Ed Walters, Quality Manager |
| Proprietary or Trade Name: | Medic-Aid - Porta-Neb Nebulizer Compressor |
| Common/Usual Name: | Nebulizer compressor |
| Classification Name: | Non-ventilatory, medicinal nebulizer (atomizer) |
| Device: | Medic-Aid Porta-Neb |
| Predicate Devices: | DeVilbiss - Pulmo-Aide K85520 |

#### Device Description:

The Medic-Aid Porta-Neb is an electrically powered compressor which provides 6-8 Lpm of air flow under a back pressure of 12 psi. It is designed to be connected to a hand-held nebulizer to provide the air source to nebulize drugs to be inhaled by a patient.

| Indicated Use -- | To provide a portable compressed air source for the nebulization of drugs to be delivered to a patient via a hand-held nebulizer. |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Environment of Use -- | Hospitals, nursing home and homes. |
| Patient population -- | Patients requiring nebulized drug delivery. |

#### Comparison to Predicate Devices:

Page 3 of 22

Image /page/0/Picture/12 description: The image contains two logos. The first logo on the left is the ISO 9001 quality assured firm logo. The second logo on the right has a crown on top of a check mark with the word "UKAS" below the check mark.

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## Non-Confidential Summary of Safety and Effectiveness

### (continued)

## page 2 of 3

May 27, 1997

| Attribute | | |
|------------------------------------------------------------------------------|----------------------|--------------|
| Porta-Neb | DeVilbiss Pulmo-Aide | |
| | K854520 | |
| Use | | |
| Intended to nebulize drugs | Yes | Yes |
| Utilized with different nebulizers | Yes | Yes |
| Serves as a air source to drive nebulizers | Yes | Yes |
| Portable | Yes | Yes |
| Used in hospital, nursing home, or home | Yes | Yes |
| Design | | |
| Small, compact, portable | Yes | Yes |
| Operates on 110 Volt | Yes | Yes |
| Nebulizer flow rates - | 6-8 Lpm | 5-7 Lpm |
| Has air outlet to connect to air delivery tubing which connects to nebulizer | Yes | Yes |
| Is used with nebulizer, mask or mouthpiece | Yes | Yes |
| Materials | | |
| No materials related to this device are in contact with the patient | Yes | Yes |
| Packaging | | |
| Provided clean | Yes | Yes |
| Performance Standards / Specifications | | |
| None applicable under Section 514 | Yes | Yes |
| | | Page 4 of 22 |

.

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#### Non-Confidential Summary of Safety and Effectiveness

#### (continued)

#### page 3 of 3

May 27, 1997

| Attribute | Porta-Neb | DeVilbiss Pulmo-Aide<br>K854520 |
|--------------------------------------------------------------------------------------------------------------------|-----------|---------------------------------|
| Meets design, safety and performance<br>requirements of EN 60601, UL 2601,<br>IEC 601-1, CAN / CSA C22.2 No.60 1.1 | Yes | Not known, but assumed |
| | | Yes |

### Differences between Other Legally Marketed Predicate Devices

There is no differences between the intended device and the predicate devices which would be significant to patient safety or effectiveness.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

Mr. Ed Walters Medic-Aid, Ltd. c/a ProMedic, Inc. 6329 W. Waterview Court McCordsvile, Indiana 46055-4501

AUG - 1 1997

Re : K971933 Porta-Neb Nebulizer Compressor Regulatory Class: II (two) Product Code: 73 CAF Dated: May 27, 1997 May 27, 1997 Received:

Dear Mr. Walters:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). 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 reqistration, 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Ed Walters

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan', Ph.D Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# SECTION 3

## INDICATIONS FOR USE

Page 1 of 1

Pursuant to the Notice of February 6, 1996 regarding listing of Indications for Use on a separate sheet, the following is per that request.

| 510(k) Number: | K971933 (To be assigned) |
|----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Medic-Aid, Ltd. Porta-Neb, nebulizer compressor system |
| Intended Use : | To provide a portable compressed air source for<br>the nebulization of drugs to be delivered to a patient via a<br>hand-held nebulizer in the home, nursing home or hospital<br>environments. |

Concurrence of CDRH, Office of Device Evaluation (ODE)

**Prescription Use**
(Per CFR 801.109)

or

Over-the-counter use _________________________________________________________________________________________________________________________________________________________

Page 9 of 22

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Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number_