(114 days)
Not Found
No
The document describes a purely mechanical suction/irrigation system with no mention of AI, ML, or any computational processing.
No.
The device facilitates surgical procedures by providing suction and irrigation for visualization, but it does not directly treat or diagnose a disease or condition. Its function is supportive to the surgical intervention.
No
The device is used to flush and evacuate fluids and debris during laparoscopic surgery to aid visualization, which is an interventional function, not a diagnostic one.
No
The device description clearly outlines physical components such as a hand piece, probe, and tubing, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The GeniCon Laparoscopic Suction/Irrigation System is a surgical tool used during laparoscopic procedures. Its function is to physically irrigate and suction fluids and debris from the surgical site to improve visualization. It does not analyze samples taken from the body to provide diagnostic information.
- Intended Use: The intended use clearly states its purpose is to facilitate lavage during laparoscopic surgery and aid visualization by flushing blood and tissue debris. This is a surgical support function, not a diagnostic one.
Therefore, the GeniCon Laparoscopic Suction/Irrigation System is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The GeniCon Laparoscopic Suction/Irrigation System is available with an array of probe designs to facilitate lavage during laparoscopic surgery. This device has applications in laparoscopic gynecologic, general, thoracic and urology procedures to provide suction and irrigation functions to help flush blood and tissue debris from the operative site during laparoscopy to aid visualization.
Product codes
GCJ
Device Description
The Genicon Laparoscopic Suction Irrigator System is indicated for use in patients undergoing a laparoscopic surgical procedure. It is designed to deliver sterile irrigation fluids to surgical sites during laparoscopic procedures and to evacuate blood, surgical sites and smoke from the surgical site.
The system consists of a hand piece equipped with two trumpet style valves, a probe, and connecting lines of tubing, one set designed to attach to a supply of irrigation fluid, and the other designed to attach to an aspiration pump. The valves allow controlled irrigation and aspiration during a surgical procedure.
The hand piece of the suction irrigator is designed to allow instruments to be introduced through the Suction Irrigator and can accommodate a variety of instruments and diameters.
It is a single use, disposable device and is sold sterile, and the probes may be available as single use or reusable depending on the purpose.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
Image /page/0/Picture/0 description: The image shows the word "GENICON" in large, bold, black letters. Below the word "GENICON" is the phrase "NEW IDEAS FOR MODERN HEALTH CARE" in smaller, thinner, black letters. The word "GENICON" is the most prominent feature of the image.
Section 2 – 510K Summary
Date Prepared - October 24, 2004
Trade Name – Genicon Laparoscopic Suction Irrigation
Common Name – Suction Irrigation
Classification - Class II -- CFR 878.4400
Predicate Device – Stryker (K963646)
Product Description – The Genicon Laparoscopic Suction Irrigator
Product Description – The Genicon Laparoscopic Product Description - The Genieon andergoing a laparoscopic system is indicated for use in patients and sterile irrigation fluids to
surgical procedure. It is designed to deliver sterile in ovacuate blood surgical procedure. It is designed to deliver s
surgical sites during laparoscopic procedures and to evacuate blood,
surgical sites during laparoscopic procedures and to eva surgledi sites and smoke from the surgical site.
The system consists of a hand piece equipped with two trumpet style
s and consists of a hand piece and set docigned to The system consists of a nand pice of fubing, one set designed to valves, a probe, and connecting lines of tables designed to attach to
attach to a supply of irrigation fluid, and the direction and attach to a supply of inigation frails,
an aspiration pump. The valves allow controlled irrigation and aspiration during a surgical procedure.
The hand piece of the suction irrigator is designed to allow instruments The nand piece of the suction imgation probe to reach the to be introduced through the Saction inguilers (1) and own a variety of instruments and diameters.
It is a single use, disposable device and is sold sterile, and the probes it is a single use, unsposable device arra to s
may be available as single use or reusable depending on the purpose.
1
Image /page/1/Picture/0 description: The image shows the word "GENICON" in bold, black letters. Below the word "GENICON" is the phrase "NEW IDEAS FOR MODERN HEALTH CARE" in a smaller font. The word "GENICON" is the main focus of the image.
Indications for Use – The GeniCon Laparoscopic Suction/lrigation Indications for Use = The Genicon Eaper cape designs to facilitate lavage
System is available with an array of probe designs in lanarosco System is available with an array of probe assigned on the laparoscopic
during laparoscopic surgery. This device has applications in provide during laparoscopic surgery. "This defice we we colores to provide
gynecologic, general, thoracic and urboffees blood and tissue deb gynecologic, general, thoracic and arology h blood and tissue debris
suction and irrigation functions to help finalization suction and imgation runetions to half
from the operative site during laparoscopy to aid visualization.
Trom the operative site during laparoscopy to aid visualization.
Trom
Performance – There are no performance standards for this product.
Conclusion – Based on the indications for use and technological Conclusion – based on the muleations for as shown to be
characteristics, the Genicon Suction Irrigation system is a characteristics, the Genicon Suction ingution of
safe and effective for its intended use and substantially equivalent to the predicate devices.
Regards,
Gary W. Haberland
Product Manager
2
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle or bird symbol, with three curved lines representing the wings or body of the bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 2 2004
Mr. Gary W. Haberland Product Manager GeniCon 427 Lake Howell Maitland, Florida 32751
Re: K041967
Trade/Device Name: GeniCon Laparoscopic Suction Irrigation Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: September 20, 2004 Received: October 5, 2004
Dear:
We have reviewed your Section 510(k) premarket notification of intent to market the device wf nave reviewed your becament be device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use sured in the encrease - 776, the enactment date of the Medical Device Amendments, or to commerce pror to they 2017 11:12 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 r ou may, dicrororo, marret of the Act include requirements for annual registration, listing of general oonline proficiouring 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 may or subject to basil at all 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 f hat FDA has made a determination that your device complies with other requirements of the Act that 1197 how intatutes and regulations administered by other Federal agencies. You must or any reaturer 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 - Gary W. Haberland
This letter will allow you to begin marketing your device as described in your Section 510(k) This iciter will anow you to organization of substantial equivalence of your device to a legally premarket hotification. The President 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 rryou desire of Compliance at (240) 276-0115. Also, please note the regulation entitled, Connect the Office of Course to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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
4
Indications for Use
510(k) Number (if known): K041967
Device Name: GeniCon Laparoscopic Irrigation System
Indications For Use:
The GeniCon Laparoscopic Suction/Irrigation System is available with an array of 1110 Genioch Lapage during laparoscopic surgery. This device has applications in laparoscopic gynecologic, general, thoracic and urology approcedures to provide suction and irrigation functions to help flush blood and tissue debris from the operative site during laparoscopy to aid visualization.
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Myriam C. Provost
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of General, Restorative, and Neurological Devices
510(k) Number K64/967