(664 days)
Not Found
No
The device description and intended use focus on mechanical instruments for endoscopic procedures and do not mention any software, algorithms, or data processing capabilities indicative of AI/ML.
Yes
The device is described as being used for "endoscopic and treatment within the urethra," indicating it performs a therapeutic function rather than solely diagnostic or assistive.
No
The device is described as an "Otis Urethrotome" intended for "endoscopic treatment within the urethra," indicating a therapeutic rather than diagnostic purpose.
No
The device description clearly outlines physical components like a urethrotome and replacement blades, which are hardware. There is no mention of software as the primary or sole component.
Based on the provided text, these devices are not IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended use is for "endoscopic and treatment within the urethra." This describes a surgical or interventional procedure performed directly on the patient's body.
- Device Description: The devices are described as "rigid endoscopes, hand instruments, associated accessories, and ancillary equipment for Urological Endoscopy." These are tools used for visualization and treatment inside the body.
- Lack of IVD Characteristics: There is no mention of the devices being used to examine specimens (like blood, urine, or tissue) outside the body to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to be used in vitro (outside the living organism) to analyze biological samples. The devices described here are used in vivo (within the living organism) for direct visualization and treatment.
N/A
Intended Use / Indications for Use
Olympus 00216 Otis Urethrotome and 02160 Replacement Blade are intended to be used for endoscopic and treatment within the urethra in adults. When compared with the intended use of predicate devices, the intended use of the subject devices has not been changed.
Olympus 02161 Otis Urethrotome and 02162 Replacement Blade are intended to be used for endoscopic treatment within the urethra in children. When compared with the predicate devices, the Olympus subject devices are intended for pediatric use, while the Olympus predicate devices were cleared for Infant Use in 510(k) # K904940.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
Olympus America Inc. has been marketing rigid endoscopes, hand instruments, associated accessories, and ancillary equipment for Urological Endoscopy since 1979. The Olympus Urethrotomy System includes the following products.
-
- Otis Urethrotome for Adult Use
- 00216 Otis Urethrotome, 16 cm -
- Replacement Blade for 00216 Urethrotome -02160
-
- Otis Urethrotome for Pediatric Use
- 02161 Otis Urethrotome, 10.5 cm -
- 02162 Replacement Blade for O2162 Urethrotome ・
When these subject devices are compared with the predicate devices, which were cleared in 510(k)s # K790071 and K904940, no significant changes or modifications in intended use, design, material, function, method of operation, or reprocessing that could affect the safety and efficacy of the devices have occurred.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Urethra
Indicated Patient Age Range
Adult, Children
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.
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
§ 876.4770 Urethrotome.
(a)
Identification. A urethrotome is a device that is inserted into the urethra and used to cut urethral strictures and enlarge the urethra. It is a metal instrument equipped with a dorsal-fin cutting blade which can be elevated from its sheath. Some urethrotomes incorporate an optical channel for visual control.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
510 (k) SUMMARY FOR OLYMPUS OTIS URETHROTOME SYSTEM
8172
| Device Name: | Olympus Otis Urethrotome System
DEC 11 1998 |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Endoscopic Accessories for Urology |
| Classification Name: | Endoscope and Accessories |
| Predicate Devices: | Olympus Urology System (K790071)
Olympus Infant Resectoscope and Accessories (K904940)
Olympus Flexible & Rigid Urethrotome System (K904339) |
| | Karl Storz Endoscopes & Accessories for Urology
(Unknown). |
| Submitted By: | Mr. Barry Sands |
| (Contact Person) | Olympus America Inc. |
| | Endoscope Division |
| | Two Corporate Center Drive |
| | Melville, New York 11747-3157 |
| | (516) 844-5474 |
| Summary Preparation Date: | October 1, 1996 (Revised) |
Statement of Intended Use:
Otis Urethrotome for Adult Use
Olympus 00216 Otis Urethrotome and 02160 Replacement Blade are intended to be used for endoscopic and treatment within the urethra in adults. When compared with the intended use of predicate devices, the intended use of the subject devices has not been changed.
Otis Urethrotome for Pediatric Use
Olympus 02161 Otis Urethrotome and 02162 Replacement Blade are intended to be used for endoscopic treatment within the urethra in children. When compared with the predicate devices, the Olympus subject devices are intended for pediatric use, while the Olympus predicate devices were cleared for Infant Use in 510(k) # K904940.
1
Device Description
K950719 0202
Olympus America Inc. has been marketing rigid endoscopes, hand instruments, associated accessories, and ancillary equipment for Urological Endoscopy since 1979. The Olympus Urethrotomy System includes the following products.
-
- Otis Urethrotome for Adult Use
- 00216 Otis Urethrotome, 16 cm -
- Replacement Blade for 00216 Urethrotome -02160
-
- Otis Urethrotome for Pediatric Use
- 02161 Otis Urethrotome, 10.5 cm -
- 02162 Replacement Blade for O2162 Urethrotome ・
When these subject devices are compared with the predicate devices, which were cleared in 510(k)s # K790071 and K904940, no significant changes or modifications in intended use, design, material, function, method of operation, or reprocessing that could affect the safety and efficacy of the devices have occurred.
General Safety
When compared with the predicate devices, Olympus Otis Urethrotome System does not incorporate any significant change in intended use, method of operation, material, or design that could affect the safety or effectiveness of the subject device.