FLO-ASSISTANT

K041560 · Northgate Technologies, Inc. · HIF · Sep 28, 2004 · Obstetrics/Gynecology

Device Facts

• Record ID: K041560
• Device Name: FLO-ASSISTANT
• Applicant: Northgate Technologies, Inc.
• Product Code: HIF · Obstetrics/Gynecology
• Decision Date: Sep 28, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1730
• Device Class: Class 2

Indications for Use

The Nortech Flo-Assistant™ product is indicated to provide a squeezing mechanism to a tubing set. increasing capacity fluid and irrigation for arthroscopic procedures.

Device Story

The Flo-Assistant™ is a mechanical irrigation assist device used during arthroscopic procedures. It consists of a main unit, a cable assembly, and a foot pedal. The device functions as a manual squeezing mechanism for a compatible tubing set (Nortech® 7-510-33) to increase fluid irrigation capacity. The operator, typically a clinician, uses the foot pedal to activate a brake caliper within the main unit, which compresses the tubing. This mechanical action allows for controlled fluid delivery to the surgical site. The device is purely mechanical and does not involve electronic processing or software.

Clinical Evidence

Bench testing only.

Technological Characteristics

Materials: Aluminum and stainless steel components with a plastic housing. Principle: Mechanical brake caliper squeezing mechanism activated by a cable and foot pedal. Form factor: Main unit with foot pedal assembly. Energy source: Manual (mechanical). Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for providing a squeezing mechanism to a tubing set to increase fluid irrigation capacity during arthroscopic procedures.

Regulatory Classification

Identification

A laparoscopic insufflator is a device used to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.

Reference Devices

• Microvasive (similar device)
• B. Braun (similar device)

Submission Summary (Full Text)

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K041560

## EP 2 8 2004 SUMMARY OF SAFETY AND EFFECTIVENESS

Common/Usual Name: System, Irrigation, Urological

Proprietary Name: Flo-Assistant™

Classification:

Unclassified

## Materials:

The main unit of the Flo-Assistant™ is fabricated from aluminum and stainless steel within a plastic housing. Enclosed in the main unit is the squeezing mechanism, which is simply a brake caliper manufactured from aluminum. The caliper is activated by a cable assembly that runs down to the pedal mechanism, which is also manufactured from aluminum and stainless steel.

## Description:

The Flo-Assistant™ is designed to be used with the Nortech® 7-510-33 Flo-Assistant™ tubing set for increased fluid capacity. The device is comprised of a main unit, cable and foot pedal assembly.

## Substantial Equivalence:

Northgate's Flo-Assistant™ is a mechanical device that is substantially equivalent in design materials and intended use to numerous currently marketed devices. Other manufacturers of similar devises are Microvasive and B. Braun.

## Intended Use:

The Nortech* Flo-Assistant™ product is indicated to provide a squeezing mechanism to a tubing set. increasing capacity fluid and irrigation for arthroscopic procedures.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/1/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of an eagle.

SEP 2 8 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Casey Kurek Regulatory Manager Northgate Technologies, Inc. 600 Church Road Elgin, Illinois 60123

Re: K041560

Trade/Device Name: Flo-Assistant™ Regulation Number: 21 CFR 884.1730 Regulation Name: Laparoscopic insufflator Regulatory Class: II Product Code: HIF Dated: September 1, 2004 Received: September 3, 2004

Dear Mr. Kurek:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosale) to regars) to regars and the Medical Device Amendments, or to conninered phor to May 20, 1978, the exact ance with the provisions of the Federal Food, Drug, devices that have been recention in asse approval of a premarket approval application (PMA). and Costine Hot (110) that the device, subject to the general controls provisions of the Act. The 1 ou may, mercerere, manel and include requirements for annual registration, listing of gencial controls provisions of tactice, 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 If your device is classified (600 a0070) als. Existing major regulations affecting your device can may or subject to back as a success 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 I lease oc advisou that I Dri of issuantes syour device complies with other requirements of the Act that I DA has made a assoc regulations administered by other Federal agencies. You must or any I cated battler and including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI IC rate 607); advents (21 CFR Part 820); and if applicable, the electronic form in and qualisms wy wysisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Casey Kurek

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

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# Indications for Use

510(k) Number (if known): K041560

Device Name:__Flo-Assistant™

Indications For Use:

The Nortech Flo-Assistant™ Product is indicated to provide a squeezing mechanism to a tubing set, providing increased capacity fluid irrigation for arthroscopic procedures.

Prescription Use

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)

Muriam C. Provost

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

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**510(k) Number** k041560