(110 days)
Not Found
Not Found
No
The summary describes a mechanical device for fluid irrigation and does not mention any AI or ML terms or functionalities.
No
Explanation: A therapeutic device is used to treat a disease, injury, or other medical condition. The Flo-Assistant™ is used to provide increased capacity fluid irrigation, which is a supportive function, not a direct treatment.
No
The device description states its purpose is to provide a squeezing mechanism to a tubing set for increased fluid irrigation, which is a therapeutic or assistive function, not a diagnostic one. There is no mention of identifying, detecting, or monitoring a disease or condition.
No
The device description explicitly states it is comprised of a main unit, cable, and foot pedal assembly, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide a squeezing mechanism for a tubing set to increase fluid irrigation capacity during arthroscopic procedures. This is a mechanical function used during a medical procedure on a patient.
- Device Description: The description confirms it's a mechanical device (main unit, cable, foot pedal) designed to work with a tubing set.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVDs are devices used to perform tests on samples taken from the human body to diagnose, monitor, or screen for diseases or conditions. This device's function is entirely focused on facilitating a surgical procedure on the body.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
HIF
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image is a black and white photograph. The image is mostly black, with a few white spots scattered throughout. The white spots are small and irregular in shape. The image is blurry and out of focus.
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.
1
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.
2
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
3
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