PENUMBRA ASPIRATION PUMP, MODEL 115V

K051758 · Penumbra, Inc. · BTA · Aug 17, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K051758
• Device Name: PENUMBRA ASPIRATION PUMP, MODEL 115V
• Applicant: Penumbra, Inc.
• Product Code: BTA · General, Plastic Surgery
• Decision Date: Aug 17, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4780
• Device Class: Class 2

Intended Use

The Penumbra Aspiration Pump is intended for general suction use in hospitals or clinics.

Device Story

The Penumbra Aspiration Pump is a portable, AC-powered suction device designed for use in hospitals or clinics. It provides a vacuum of up to 558 mmHg to facilitate general suction. The device is operated by healthcare professionals to assist in clinical procedures requiring suction. It functions as a standard powered suction pump, similar to existing predicate devices, to support clinical workflows.

Clinical Evidence

Bench testing only. The device was evaluated through internal performance requirements and electrical safety/electromagnetic compatibility testing to demonstrate equivalence to the predicate device.

Technological Characteristics

Portable, AC-powered suction pump. Provides vacuum up to 558 mmHg. Materials and construction are similar to the predicate device. Meets electrical safety and electromagnetic compatibility standards.

Indications for Use

Indicated for general suction use in hospital or clinical settings.

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

• Gomco Aspiration Pump, Model 405

Submission Summary (Full Text)

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

## AUG 1 6 2005

1 . . . . . .

## 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in This Sammary with the requirements of 21 CFR 807.92(c)

Submitted by: Penumbra, Inc. 2401 Merced Street, Suite 200 San Leandro, CA 94577

Contact Person: Theresa Brander-Allen VP of Regulatory and Quality Tel: [phone] Fax: [phone] [e-mail]

Date summary prepared: 27 June 2005

Trade Name: Aspiration Pump

Common Name: Powered Suction Pump

Classification Name: 21 CFR Part 878.4780, Apparatus, Suction, Ward Use, Portable, AC-Powered

Device Description:

Device Deseriblion.
The Aspiration Pump is designed to provide general suction for use in hospitals or The Aspiration Pump is designed to the Power supply and is designed to be portable if needed. The Aspiration Pump provides vacuum of up to 558 mmHg.

Indication for Use: The Aspiration Pump is intended for general suction use in hospitals or clinics.

Predicate Devices: Gomco Aspiration Pump, Model 405

Comparison to Predicate Devices to Support Substantial Equivalence Determination: Comparison to Preareds made of similar materials and construction to the predicate The Asphation Fump is made of othe same intended use as the predicate device. The Aspiration Pump meets both internal performance requirements and Underwriters Asphation I unip meets over nectrical safety and electromagnetic compatibility testing.

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

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with stylized lines representing its wings and body. The logo is black and white.

Public Health Service

AUG 1 6 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Theresa Brandner-Allen VP of Regulatory and Quality Penumbra, Inc. 2401 Merced Street, Suite 200 San Leandro, California 94577

Re: K051758

Trade/Device Name: Penumbra Aspiration Pump Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: II Product Code: BTA, JCX Dated: August 8. 2005 Received: August 10, 2005

Dear Ms. Brandner-Allen:

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 application (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 such 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.

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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

## Page 2- Ms. Theresa Brandner-Allen

This letter will allow you to begin 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Barbara Brelund for

Mark N. Melkerson, MS Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Image /page/3/Picture/0 description: The image shows the word "Penumbra" in a bold, sans-serif font. Above the word is a curved line, and below the word are the words "stroke intervention" in a smaller font. The logo is simple and modern.

## Indications for Use

| 510(k) Number (if known): | K051758 |
|---------------------------|----------------------------------------------------------------------------------------------|
| Device Name: | Penumbra Aspiration Pump |
| Indications for Use: | The Penumbra Aspiration Pump is intended for general<br>suction use in hospitals or clinics. |

Prescription Use _X_ (Per 21 CFR 801 Subpart D)

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

AND/OR

Over-The-Counter Use (Per 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

*Barbara Buell for Melkerson*

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

| Page | of |
|------|----|
|------|----|

| 510(k) Number | K051758 |
|---------------|---------|
|---------------|---------|

Penumbra Aspiration Pump

Page ii of 32

Penumbra Aspiration Pump
Traditional 510(k): June 28, 2005