(180 days)
AUR-8, AUR-9, AUR-PN, 11274AA, PF-28, URF-P2
Not Found
No
The document describes a flexible fiberscope and its accessories for various endoscopic procedures. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the provided text. The performance studies focus on mechanical and electrical safety aspects.
Yes
The indications for use explicitly state that the device, along with additional accessories, is used to "perform various diagnostic and therapeutic procedures" within various anatomical sites like the urinary tract, bile ducts, ureter, and kidney. The accessories listed, such as biopsy forceps, grasping forceps, button electrode for coagulation, and stone extractors, further support its therapeutic capabilities.
Yes
The intended use explicitly states that the device is used to "perform various diagnostic and therapeutic procedures," and in some cases, specifically to "examine" anatomical sites. Additionally, accessories like "Flexible Biopsy Forceps" are used to obtain biopsies, which are diagnostic in nature.
No
The device description explicitly states "The flexible mini-fiberscopes are endoscopes with working channels," indicating a physical hardware component (the endoscope) is the primary device. The accessories also describe physical instruments.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that these are flexible mini-fiberscopes used to examine internal anatomical sites (urinary tract, bile ducts, ureter, kidney) within the body. They are used for visualization and to facilitate procedures using accessories.
- Lack of Specimen Analysis: There is no mention of the device being used to analyze specimens or perform tests on samples taken from the body. The accessories are for obtaining biopsies (tissue samples), grasping calculi, or performing coagulation, which are all procedures performed in vivo or to collect samples for subsequent analysis (which would be done by a separate IVD device).
Therefore, the intended use and device description align with an endoscopic device used for visualization and intervention within the body, not an IVD device used for testing specimens outside the body.
N/A
Intended Use / Indications for Use
The flexible mini-fiberscopes are intended to be used in various Gastroenterology/Urology Procedures. These uses are:
- Cystoscope Used to examine the urinary tract, and, 1) using additional accessories, to perform various diagnostic and therapeutic procedures.
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- Choledochoscope - Used to examine the bile ducts, and using, additional accessories, to perform various diagnostic and therapeutic procedures.
- Ureteroscope Used to examine the ureter, and using 3) additional accessories, to perform various diagnostic and therapeutic procedure.
- 4 ) Nephroscope - Used to examine the kidney, and with additional accessories, to perform various diagnostic and therapeutic accessories.
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- Uretero-renoscope - Used to examine the ureter and kidney, and additional accessories, to perform various diagnostic and therapeutic procedures.
Accessory Indications for use.
- Uretero-renoscope - Used to examine the ureter and kidney, and additional accessories, to perform various diagnostic and therapeutic procedures.
-
- Flexible Biopsy Forceps - Used to obtain small biopsies from tissue.
- Flexible Grasping Forceps For grasping calculi, both 7) renal and biliary.
- Button Electrode Used for unipolar coagulation. 8)
- ರಿ ) Dormia Stone Extractor - Used for grasping and removal of calculi, both renal and biliary.
- Three Pronged Grasper Used for grasping and removal of 10) calculi, both renal and biliary.
Product codes
Not Found
Device Description
The flexible mini-fiberscopes are endoscopes with working channels that allow physician control of the tip position and accessory instruments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Urinary tract, bile ducts, ureter, kidney, ureter and kidney.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician
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)
Tests were performed to assure: (a) continued flexibility after repeated (2000) flexs (b) ability to withstand repeated (10,000) insertions (c) that no thermal hazard exists, and (d) that the fiberscopes do not present a High Frequency Hazard.
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.
Circon ACMI Models AUR-8, AUR-9, AUR-PN, Karl Storz Model 11274AA, Olympus Models PF-28, URF-P2
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
Richard Wolf Medical Instruments Corporation
Summary of Safety and Effectiveness 510 (K) Summary of Safety and Effectiveness Fax: 847.913.1488
- Classification Name: 1.0
DEC - 2 1996
942172
Endoscope, Flexible
2.0 Common/Usual Name:
Flexible Endoscope
3.0 Trade Name
Flexible Mini-Fiberscopes
4.0 Equivalence:
The submitted devices are equivalent to the following devices already on the market:
Circon ACMI Models AUR-8, AUR-9, AUR-PN Karl Storz Model 11274AA Olympus Models PF-28, URF-P2
5.0 Description:
The flexible mini-fiberscopes are endoscopes with working channels that allow physician control of the tip position and accessory instruments.
6.0 Intended Use:
The flexible mini-fiberscopes are intended to be used in various Gastroenterology/Urology Procedures. These uses are:
- Cystoscope Used to examine the urinary tract, and, 1) using additional accessories, to perform various diagnostic and therapeutic procedures.
-
- Choledochoscope - Used to examine the bile ducts, and using, additional accessories, to perform various diagnostic and therapeutic procedures.
- Ureteroscope Used to examine the ureter, and using 3) additional accessories, to perform various diagnostic and therapeutic procedure.
- 4 ) Nephroscope - Used to examine the kidney, and with additional accessories, to perform various diagnostic and therapeutic accessories.
Image /page/0/Picture/22 description: The image shows the words "RICHARD WOLF" in a bold, sans-serif font. The words are stacked on top of each other, with "RICHARD" on top and "WOLF" below. To the right of the words is a square with rounded corners, inside of which is a stylized letter "A" with a line through it. The image is in black and white.
1
Richard Wolf Medical Instruments Corporation
11962172 0292
Summary of Safety and Effectiveness (cont.)
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- Uretero-renoscope - Used to examine the ureter and kidney, and additional accessories, to perform various diagnostic and therapeutic procedures.
Accessory Indications for use.
- Uretero-renoscope - Used to examine the ureter and kidney, and additional accessories, to perform various diagnostic and therapeutic procedures.
-
- Flexible Biopsy Forceps - Used to obtain small biopsies from tissue.
-
Flexible Grasping Forceps For grasping calculi, both 7) renal and biliary.
-
Button Electrode Used for unipolar coagulation. 8)
-
ರಿ ) Dormia Stone Extractor - Used for grasping and removal of calculi, both renal and biliary.
-
Three Pronged Grasper Used for grasping and removal of 10) calculi, both renal and biliary.
7.0 Technological Characteristics:
The only variation of the submitted devices, when compared to existing scopes on the market, is their smaller size.
8.0 Performance Data:
Tests were performed to assure: (a) continued flexibility after repeated (2000) flexs (b) ability to withstand repeated (10,000) insertions (c) that no thermal hazard exists, and (d) that the fiberscopes do not present a High Frequency Hazard.
9.0 Clinical Data:
No clinical data was obtained.
10.0 Data Conclusion:
The flexible mini-fiberscopes provide expected durability, biocompatably safe materials; and when uses cleaned, disinfected/sterilized as recommended will provide a patient ready instrument.
By: Robert L. Caracaus
Date: Nov 22 1996
Robert L. Casarsa Quality Assurance Manager