SUPRAFLOW CONSOLE

K040239 · Neomedix Corp. · BTA · Feb 17, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K040239
• Device Name: SUPRAFLOW CONSOLE
• Applicant: Neomedix Corp.
• Product Code: BTA · General, Plastic Surgery
• Decision Date: Feb 17, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4780
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The NeoMedix SupraFlow Console is an aspiration pump intended for use in general surgery applications where aspiration of irrigation and waste fluid from a surgical site is desired. The device is not indicated for liposuction use.

Device Story

SupraFlow Console is a powered suction pump for general surgery. Device utilizes a roller pump to generate aspiration via peristaltic action and a pinch valve to control irrigation fluid flow. Operated via optional foot switch. Used in surgical settings to remove irrigation and waste fluids from surgical sites. Healthcare providers use the device to maintain a clear surgical field. Benefits include efficient fluid management during procedures.

Clinical Evidence

Bench testing only. Electrical safety demonstrated via compliance with IEC 60601-1. Performance specifications and functionality verified through NeoMedix test protocols.

Technological Characteristics

Powered suction pump; peristaltic roller pump mechanism; pinch valve for irrigation control. Powered by 12VDC via external 90-240 VAC, 50/60 Hz medical-grade power supply. Complies with IEC 60601-1 electrical safety standards.

Indications for Use

Indicated for general surgery patients requiring aspiration of irrigation and waste fluid from surgical sites. Not indicated for liposuction.

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

• Karl Storz KSEA Unimat 45 (K981703)
• thatSaMS: Tissue Aspiration System (K984363)
• Lysonix Aspiration Pump (K980454)

Submission Summary (Full Text)

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

# EB 1 7 2004

NeoMedix Corporation SupraFlow Console Aspiration Pump

K040239 1/2

## SECTION 2 - 510 (k) SUMMARY

#### SUMMARY INFORMATION

Manufacturer and Submitter

NeoMedix Corporation 27452 Calle Arroyo San Juan Capistrano, California 92675 Phone: [phone] Fax: [phone]

Contact Person

Dr. Soheila Mirhashemi

### Common, Classification and Proprietary Names

Common Name: Suction Pump

Classification names: Powered suction pump.

Proprietary Name: SupraFlow Console

#### Predicate Devices

The NeoMedix SupraFlow Console Model numbers 550014, 550019, 550020 are similar in indications, function and features to the following Devices: The Karl Storz KSEA Unimat 45 (K981703), thatSaMS: Tissue Aspiration System (K984363) and the Lysonix Aspiration Pump (K980454 ).

#### Indications for Use

The NeoMedix SupraFlow Console is to be used in general surgery applications where aspiration of irrigation fluid from a surgical site is desired. The device is not indicated for liposuction use.

#### Device Description

The Console contains a roller pump to provide aspiration from the surgical site and a pinch valve to initiate the flow of irrigation fluid simultaneously with the optional foot switch con switch con be used to activate both actions.

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

K040239 2/2-

#### Technological Characteristics Comparison

The Console is similar in function to currently marketed aspiration/suction pumps. The aspiration capabilities are similar to those in the predicate devices with the exception is generated via peristialic action rather than a direct vacuum source. The Console is powered by 12VDC provided by a medical grade external 90 - 240 VAC, 50/60 Hz power supply.

#### Performance and Safety

Electical safety has been demonstrated by compliance to applicable requirements defined in consensus standard IEC 60601-1. Product testing was performed to demonstrate stated performance specifications and functionality in compliance with NeoMedix test protocols. The supplied Operations Manual provides the user with the applicable warnings and cautions during use.

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

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 7 2004

Neomedix Corporation c/o Mr. Marc M. Mouser Underwriters Laboratories, Inc. 2600 N.W. Lake Road Camas, Washington 98607-8542

Re: K040239

Trade/Device Name: SupraFlow Console Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: II Product Code: BTA Dated: January 29, 2004 Received: February 2, 2004

Dear Mr. Mouser:

We have reviewed your Scction 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.

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

Page 2 - Mr. Marc M. Mouscr

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 yours.

Miriam C. Provost

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

Enclosure

{4}------------------------------------------------

## INDICATIONS FOR USE STATEMENT

| 510(k) Number (if known): | K040239 |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | SupraFlow Console |
| Indications for use: | The NeoMedix SupraFlow Console is an aspiration pump<br>intended for use in general surgery applications where<br>aspiration of irrigation and waste fluid from a surgical site is<br>desired. |
| | The device is not indicated for liposuction use. |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: \checkmark OR Over-the-counter: **__**

Miriam C Provost
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

**510(k) Number** K0406239