DEVILBISS SUCTION UNIT

K982304 · Sunrise Medical Hhg, Inc. · JCX · Sep 25, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K982304
• Device Name: DEVILBISS SUCTION UNIT
• Applicant: Sunrise Medical Hhg, Inc.
• Product Code: JCX · General, Plastic Surgery
• Decision Date: Sep 25, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4780
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The device is to be used to remove fluids from the airway or respiratory support system and infectious materials from wounds. The device creates a negative pressure (vacuum) that draws fluids through disposable tubing that is connected to a collection bottle. The fluids are trapped in the collection bottle for proper disposal. It is for use on the order of a physician only.

Device Story

Portable AC/DC suction pump; creates negative pressure (vacuum) to aspirate fluids. Components include pump unit, collection bottle, relief valve, vacuum gauge, bacteria filter, suction tubing, and internal battery. Used in home, institutional, and field/transport settings. Operated by physicians, nurses, or licensed practitioners (e.g., EMTs). Input is manual activation; output is suction force drawing fluids into a disposable collection bottle. Healthcare providers use the device to clear airways or remove wound exudate, facilitating patient respiratory function or wound management.

Clinical Evidence

Bench testing only. Device performance verified against ISO 10079-1:1991 standards, including vacuum level, flow, construction, life test, and sound level.

Technological Characteristics

Portable AC/DC suction pump. Components: pump, collection bottle, relief valve, vacuum gauge, bacteria filter, tubing, battery, AC/DC adapter. Complies with UL 2601-1, CAN/CSA-C22.2 No. 601.1 M90, and ISO 10079-1:1991.

Indications for Use

Indicated for removal of fluids from airway, respiratory support systems, or infectious materials from wounds. Intended for home, institutional, and field/transport environments. Use restricted to order of physician or licensed practitioner (e.g., EMT).

Regulatory Classification

Identification

A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.

Predicate Devices

• DeVilbiss 7304 (K8720094)
• Schuco-Vac (K935218)

Submission Summary (Full Text)

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

| 510(k) SUMMARY STATEMENT | |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Sunrise Medical HHG Inc.<br>Respiratory Products Division<br>100 DeVilbiss Drive<br>P.O. Box 635<br>Somerset, Pa. 15501-0635<br>Matt Smith<br>814-443-7531<br>814-443-7571 Fax |
| Date of 510(k) Submittal: | June 12, 1998 |
| Classification Name: | Apparatus, Suction, Ward Use, Portable, AC-Powered |
| Product Code: | JCX |
| FDA Regulation: | 878.4780 |
| FDA Classification: | Class II |
| Common Name: | Suction Pump/Aspirator |
| Proprietary Model #/Name: | DeVilbiss Suction Unit |
| Equivalent to Device(s): | DeVilbiss 7304 FDA 510(k)#K8720094<br>Schuco-Vac FDA 510(k)#K935218 |

### Description of Device:

The DeVilbiss Suction Unit is a portable AC/DC powered suction pump. It consists of (depending on configuration) a pump unit, collection bottle, relief valve, vacuum gage, bacteria filter, suction tubing, internal battery, and an AC to DC adapter. The device is designed and manufactured to comply with UL 2601-1 and/or CAN/CSA-C22.2 No. 601.1 M90 safety standards.

## Intended Use of Device:

The device is to be used to remove fluids from the airway or respiratory support system and infectious materials from wounds. The device creates a negative pressure (vacuum) that draws fluids through disposable tubing that is connected to a collection bottle. The fluids are trapped in the collection bottle for proper disposal. It is for use on the order of a physician only.

### Performance Testing:

The DeVilbiss Suction Unit (depending on configuration) will meet performance standards per ISO 10079-1:1991, Medical Suction Equipment, including vacuum level, flow, construction, life test, and sound level.

### Conclusion:

In terms of construction, function, safety, and effectiveness this device is substantially equivalent to other legally marketed suction pumps used for this application.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 5 1998

Mr. Matt Smith Senior Project Engineer Sunrise Medical HHG, Inc. 100 Devilbiss Dr. Somerset, Pennsylvania 15501

K982304 Re: Trade Name: DeVilbiss Suction Unit Requlatory Class: II Product Code: JCX Dated: June 16, 1998 Received: July 01, 1998

Dear Mr. Smith:

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, Drug, 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 registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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. ਸ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 requlation may result in regulatory In addition, FDA may publish further announcements action. 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.

{2}------------------------------------------------

Page 2 - Mr. Matt Smith

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 diagnostic 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.qov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D.

Ph.D., M.D. M. Witten, Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

Page 1 of 1

510(k) Number: (if known) Not yet assigned

982304

Device Name: DeVilbiss Suction Unit

# Indications for Use:

The DeVilbiss Suction Unit is used to remove fluids from the airway or respiratory support system and infectious materials from wounds. Configurations of the device will be intended for the home, institutional, and field/transport environments. The device is for use only on the order of a physcian or other lincensed practitioner (e.g. EMT-field use).

Prescription Use
(Per 21 CFR 801.109)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K982304