(123 days)
Not Found
Not Found
No
The summary explicitly states "Not Found" for mentions of AI, DNN, or ML, and there is no description of training or test sets, which are typical for AI/ML devices.
No
The device is used for illumination, visual observation, and surgical manipulation, which are diagnostic and interventional functions, not therapeutic.
No.
The device's intended use is to provide illumination and allow visual observation and/or surgical manipulation, which are functional purposes rather than diagnostic. It does not mention analyzing or interpreting data for diagnosis.
No
The device description explicitly mentions "Flexible Fiberoptic Endoscopes" and "Flexible Video-Endoscopes," which are hardware devices used for visualization and manipulation.
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 illumination to, and allow visual observation and/or surgical manipulation of body cavities, hollow organs and canals in the Gastrointestinal tract." This describes a device used for direct visualization and intervention within the body.
- Device Description: The device is described as "Flexible Fiberoptic Endoscopes; Flexible Video-Endoscopes." Endoscopes are instruments used to look inside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide diagnostic information. IVDs typically involve tests performed on biological samples.
Therefore, this device falls under the category of a medical device used for direct visualization and potentially surgical procedures, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
Provide illumination to, and allow visual observation and/or surgical manipulation of body cavities, hollow organs and canals in the Gastrointestinal tract.
Product codes
78 FDS, 78 FDT, 78 FDF, 78 FAM, 78 FEM
Device Description
Fiegert Endotech Flexible Fiberoptic Endoscopes (Gastroscope, Duodenoscope, Colonoscope, Sigmoidoscope), Videoscopes, (Gastroscope, Sigmoidoscope, Signo-Rectoscope, Colonoscope), and Erocam-Pro Color Videocamera, Image Processor and Accessories
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body cavities, hollow organs and canals in the Gastrointestinal tract.
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
§ 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 contains a logo for the Department of Health. The logo features the words "DEPARTMENT OF HEALTH &" in a circular arrangement on the left side of the image. To the right of the text is a symbol consisting of three stylized, curved lines that resemble human profiles facing to the right. The logo is printed in black ink.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Michael Ashby Direct of Operations Fiegert-Endotech Two Oakwood Boulevard Suite 160 Hollywood, FL 33020
Re: K974493
Fiegert Endotech Flexible Fiberoptic Endoscopes (Gastroscope, Duodenoscope, Colonoscope, Sigmoidoscope), Videoscopes, (Gastroscope, Sigmoidoscope, Signo-Rectoscope, Colonoscope), and Erocam-Pro Color Videocamera, Image Processor and Accessories Dated: February 26, 1998 MAR 3 1 1998 Received: February 27, 1998 Regulatory Class: II 21 CFR 876.1500
Procodes: 78 FDS, 78 FDT, 78 FDF, 78 FAM, 78 FEM
Dear Mr. Ashby:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 III (Premarket Aproval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 (2) CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/odrh/dsmaldsmamain.html".
Sincerely yours
Lillian Yin, Ph.D.
Director, Division of Reproductive
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
1
SECTION 5
FIEGERT ENDOTECH, INC 510(K) NOTIFICATION FLEXIBLE FIBEROPTIC AND VIDEO ENDOSCOPES
INDICATIONS FOR USE
510(k) Number (if known):
Device Name:
Fiegert Endotech Flexible Fiberoptic Endoscopes
Fiegert Endotech Flexible Video-Endoscopes
INDICATIONS FOR USE:
Provide illumination to, and allow visual observation and/or surgical manipulation of body cavities, hollow organs and canals in the Gastrointestinal tract.
Cocurrence of CDRH, Office of Device Evaluation (ODE)
Prescritption use (21CFR801.109)
17
Over-the-Counter
Peter R. Sething/
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number_K974493