(21 days)
Not Found
None
No
The summary contains no mention of AI, ML, or related concepts, and the device description is not available to provide further clues.
No
The device is indicated for video visualization, which is a diagnostic function, not a therapeutic one. It assists in viewing during endoscopic procedures rather than treating a condition.
No
The device is used for video visualization, which is a tool for observation rather than making a diagnosis. It helps in viewing sites during endoscopic procedures, but it does not intrinsically perform diagnostic analysis.
Unknown
The provided 510(k) summary lacks a device description, making it impossible to determine if the device is software-only or includes hardware components. The intended use mentions "video visualization of sites in conjunction with endoscopic devices," which could imply a hardware component for image capture or processing, but this is not explicitly stated.
Based on the provided information, the Scholly Flexiscope IQ 101 is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "video visualization of sites in conjunction with endoscopic devices." This describes a device used for direct visualization within the body, not for testing samples (like blood, urine, or tissue) outside the body.
- Anatomical Site: The anatomical site is "sites in conjunction with endoscopic devices," which again points to internal visualization.
- Lack of IVD Characteristics: The description doesn't mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in samples.
- Providing information for diagnosis, monitoring, or screening based on sample analysis.
The Scholly Flexiscope IQ 101 appears to be a medical device used for endoscopic visualization, which is a different category than IVDs.
N/A
Intended Use / Indications for Use
The Scholly Flexiscope IQ 101 is indicated for video visualization of internal sites in conjunction with endoscopic devices.
Product codes
FET
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Video
Anatomical Site
Internal sites of the body in conjunction with endoscopic devices.
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)
Not Found
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings outstretched, composed of three thick, curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Schoelly Fiberoptic, GMBH % Mr. Joseph Ress Medical Device Regulatory Consultants 45 Pontiac Road Newton, MA 02168
JUL 2 7 2015
Re: K992362 Trade/Device Name: Flexiscope IQ 101 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FET Dated (Date on orig SE ltr): July 13, 1999 Received (Date on orig SE ltr): July 15, 1999
Dear Mr. Ress,
This letter corrects our substantially equivalent letter of August 5, 1999.
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 for associated in the 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be
1
Page 2 -
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
STATEMENT FOR INDICATIONS FOR USE
Page 1 of 1
510(K) Number: K992362
Device Name: Scholly Flexiscope IQ 101
Indications for Use:
The Scholly Flexiscope IQ 101 is indicated for video visualization The Scholly Frexiscope IQ 101 10 Indicated sites in conjunction with endoscopic devices.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED )
Concurrance of CDRH, Office of Device Evaluation (ODE) Over-The-Counter Use NO Perscription Use yes OR