(153 days)
Not Found
No
The description focuses on the physical components and function of a traditional laparoscope, with no mention of AI, ML, image processing, or related performance metrics.
No
The device is a laparoscope intended for visualization within the body, not for treating any condition or disease.
No
A laparoscope is used for visualization, not for diagnosing conditions. Its primary function is to provide a view inside the body.
No
The device description clearly states it is a reusable device with a glass rod lens assembly, stainless steel shaft, and light fibers, indicating it is a physical hardware device, not software-only.
Based on the provided information, the GeniCon Laparoscope 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.
- GeniCon Laparoscope Function: The description clearly states that the GeniCon Laparoscope is used to "establish visualization for viewing an interior cavity of the body." It's a tool for direct visual inspection inside the body, not for analyzing samples outside the body.
- Lack of IVD Indicators: The description does not mention any analysis of biological samples, detection of biomarkers, or any other activities typically associated with IVD devices.
Therefore, the GeniCon Laparoscope is a surgical instrument used for visualization during endoscopic procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The GeniCon Laparoscope is available in 3.5mm and 10mm diameters with working lengths of 28cm to 44cm This device has applications in gynecologic, general, thoracic and urology Endoscopic procedures to establish visualization for viewing an interior cavity of the body.
Product codes
GCJ
Device Description
The GeniCon Platinum Series Laparoscope is a reusable device with a qlass rod lens assembly that connects an evepiece to a viewing lens on the distal end of the scope encompassed within a stainless steel shaft. Surrounding the glass rod assembly and contained with the stainless steel iaft is a series of light fibers that transfer light energy to illumination into the body cavity being viewed.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Surgical Image Laparoscope
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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 a stylized font. The "C" in "Genicon" is stylized to look like a surgical instrument. The letters are in black and the background is white.
JUN 1 9 2003
"New Ideas for Modern Healthcare"
K 030174
Section II: 510(k) Summary
GeniCon, L.C. Contact: Gary Haberland P.O. Box 780038 Orlando, Florida 32878-0038 Telephone: 407.273.7619 Facsimile: 407.306.9356
Date Prepared: April 3rd, 2003
Trade Name: GeniCon Platinum Series Laparoscope Common Name: Laparoscope
Classification Name: According to Section 513 of the Federal Food, Druq, Cosmetic Act, the device classification is Class II, performance Standards (21 CFR 878.4800)
Predicate Device: Surgical Image Laparoscope
Product Description: The GeniCon Platinum Series Laparoscope is a reusable device with a qlass rod lens assembly that connects an evepiece to a viewing lens on the distal end of the scope encompassed within a stainless steel shaft. Surrounding the glass rod assembly and contained with the stainless steel iaft is a series of light fibers that transfer light energy to illumination into the body cavity being viewed.
Indications for Use: The GeniCon Laparoscope is available in 3.5mm and 10mm diameters with working lengths of 28cm to 44cm This device has applications in gynecologic, general, thoracic and urology Endoscopic procedures to establish visualization for viewing an interior cavity of the body.
Performance: The FDA has not adopted performance standards for this product.
Conclusion: Based on the indications for use and technological characteristics, the GeniCon Platinum Series Laparoscope has been shown to be effective for its intended use and substantially equivalent to the predicate device.
US Office GeniCon L.C. P.O. Box 780038 Orlando, Florida U.S.A. 32878 Telephone: (321) 662-8603 Telefax: (407) 306-9356 E-Mail: USA@geniconendo.com
EU Office GeniCon Europe Ltd. 44 Airedale Avenue Chiswick, London U.K. '4 2NW Lurope@geniconendo.com
Latin America Office GeniCon Calle 10 Sur No 50FF-28 Off 209 Medellin, Columbia Telephone: 57.4.361.7557 Telefax: 57.4.285.2287 E-Mail: Latin@geniconendo.com
Image /page/0/Picture/17 description: The image contains a series of scattered black dots on a white background. The dots are not arranged in any discernible pattern. The density of the dots varies across the image, with some areas having more dots than others.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the circumference. Inside the circle is a stylized image of an eagle or bird-like figure, composed of three curved lines that suggest the shape of a bird in flight.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 9 2003
Mr. Gary Haberland Product Manager GeniCon L.C. P.O. Box 780038 Orlando, Florida 32878-0038
Re: K030174
Trade/Device Name: Laparoscope Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: April 3, 2003 Received: April 7, 2003
Dear Mr. Haberland:
We have reviewed your Section 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.
2
Page 2 - Mr. Gary Haberland
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. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained 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,
Muriam 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
510(k): K030174
Section I. Indications for Use
Page: I-1
Device Name: Laparoscope
Indications for Use:
The GeniCon Laparoscope is available in 3.5mm, 5mm and 10mm diameters with working lengths of 28cm to 44cm. This device has applications in gynecologic, general, thoracic and urology Endoscopic procedures to establish visualization for viewing an interior cavity of the body.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Prescription Use V
OR
Over the Counter Use
(Optional Format 1-2-96)
Muriam C. Provost
(Division Sign-Division of General, Restorative and Neurological Devices
510(k) Number K630174