(110 days)
The Nortech Flo-Assistant™ Product is indicated to provide a squeezing mechanism to a tubing set, providing increased capacity fluid irrigation for arthroscopic procedures.
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.
I am sorry, but the provided text does not contain any information regarding acceptance criteria, device performance, or any studies conducted to prove the device meets specific criteria. The document is a 510(k) summary for the Flo-Assistant™ device, primarily focusing on its description, intended use, and assertion of substantial equivalence to predicate devices. It does not include details about clinical trials, performance specifications, or study methodologies.
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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 (301) 594-4659. 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 (800) 638-2041 or (301) 443-6597 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
Page 1 of _____________
510(k) Number K041560
§ 884.1730 Laparoscopic insufflator.
(a)
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.(b)
Classification. (1) Class II (performance standards).(2) Class I for tubing and tubing/filter kits which include accessory instruments that are not used to effect intra-abdominal insufflation (pneumoperitoneum). The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.