(105 days)
No
The description focuses on the hardware components and their functions for visualization, irrigation, and access, with no mention of AI or ML for image analysis or other tasks.
Yes
The device is intended for "endoscopic observation, diagnosis and treatment," which includes therapeutic applications. The A4907 Lens Cleaning Sheath, A4908 Valve, and trocar tubes also facilitate these therapeutic and diagnostic procedures.
Yes.
The "Intended Use / Indications for Use" section states that the device has been designed for "endoscopic observation, diagnosis and treatment within the thoracic and abdominal cavity."
No
The device description clearly outlines physical components such as a videoscope with a distal tip, insertion tube, CCDs, lens cleaning sheath, valve, trocar tubes, and trocars. These are all hardware components, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "endoscopic observation, diagnosis and treatment within the thoracic and abdominal cavity." This describes a procedure performed on the patient's body, not on a sample taken from the patient.
- Device Description: The description details a videoscope and associated accessories (cleaning sheath, valve, trocar tubes, trocars) used for visualization and manipulation within the body. It focuses on the mechanics of the device and its function in a surgical setting.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, urine, etc.), detecting specific analytes, or providing information for diagnosis based on in vitro testing.
The device is a surgical instrument used for direct visualization and intervention within the body, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The OES Laparo- Thoraco Videoscope Type V has been designed for endoscopic observation, diagnosis and treatment within the thoracic and abdominal cavity.
The A4907 Lens Cleaning Sheath has been specifically designed to be used with an OES Laparo-Thoraco Videoscope Type V to clean the objective lens surface.
The A4908 Valve has been specifically designed for use in conjunction with the A4907 Cleaning Sheath to provide irrigation and aspiration of liquids when connected to the insertion tube of the Olympus videoscope.
The trocar tubes are intended to provide a passageway for the endoscope or hand instruments, and permit the insufflation of CO, during the endoscopic procedure. The subject trocar tubes are specifically designed to use in conjunction with the OES Laparo-Thoraco Videoscope Type V.
The trocars are intended to pierce the abdominal wall tissue layer during the endoscopic procedure. The subject trocars are specifically designed to use in conjunction with the Laparo-Thoracoscope.
Product codes
Not Found
Device Description
OES Laparo-Thoraco Videoscope Type V
The OES Laparo-ThoracoVideoscope Type V is substantially equivalent in design to the predicate Olympus OES LTF Flexible Tip Thoracoscope/Laparoscope which was cleared in 510(k) # K915857. The predicate LTF Flexible Tip Thoracoscope/Laparoscope is a fiberscope. The only difference between these two endoscopes is that the predicate device which has a image guide (fiber bundle) to transmit an endoscopic image to the surgeon's eye or the CCD of of the video camera. The subject device is a videoscope that places the CCD at the distal end of the endoscope. The subject OES Laparo-Thoraco Videoscope Type V has an 11 mm distal tip, 10.6 mm diameter insertion tube. 70° forward viewing field of view, depth of field of 18mm ~100mm, and 90° angulation in all four (Up-Down-Left-Right) directions. It contains the color Charged Couple Devices (CCD) for image transmission to the video monitor.
When compared to the previously cleared predicate scope, the subject OES Laparo-Thoraco Videoscope Type V does not raises any new questions of safety or effectiveness.
A4907 Lens Cleaning Sheath
The A 4907 Lens Cleaning Sheath has been specifically designed for use in conjunction with the Olympus OES Laparo-Thoraco Videoscope Type V. It will be included in the standard set of Laparo-Thoraco Videoscope and will also be marketed separately.
When connected to the main body of videoscope, it offers lens cleaning, irrigation, and suction capabilities to the user during endoscopic procedures. It is substantially equivalent in design, intended use, and method of operation to the "Lens Cleaner" manufactured by Cook, "Optic Shaft" manufactured by Wiest, and "Lap Wash System" manufactured by DevMed Group Inc.
A4908 Valve
The A4908 Valve has been specifically designed for use in conjunction with the Olympus OES Laparo-Thoraco Videoscope Type V and A4907 lens cleaning sheath. It will be included in the standard set of the OES Laparo-Thoraco Videoscope Type V and will also be marketed separately.
The A4908 Valve is substantially equivalent in intended use, functions, and method of use to the T1020 Multiple Function Tube (Irrigation/Suction Probe) which was approved in 510(k) # K923982. Both devices have separate "plunger-like" valves that permit the operator to control when to activate the suction or irrigation function. The housing of design is such that tubing sets are easily connected to the irrigation/suction source.
Additionally, the A4908 Valve is also substantially equivalent in design, material intended use, functions, and method of use to the Olympus MH-325 Valve which was cleared in 510(k) # K915857 with the exception that the A4908 Valve controls the irrigation and suction of liguids. It has separate irrigation port and suction port connections. The irrigation and aspirations are controlled by separate buttons.
Trocar Tubes
The A5822 and A5824 trocar tubes have been specifically designed for use in conjunction with the Olympus OES Laparo-Thoraco Videoscope Type V. The 5 mm trocar tube is designed to deliver endoscopic accessories into the abdominal cavity
| Model | Diameter | Description |
|---|---|---|
| A5820 | 5 mm | Trocar Tube |
| A5822 | 11 mm | Trocar Tube |
| A5824 | 13 mm | Trocar Tube |
The A5822 and A5824 trocar tubes consist of a metal housing, a stopcock for insufflation of CO2 gas, and a sealing valve. The A5820 trocar tubes does not have a stopcock for insufflation. The sealing valve is specifically designed to prevent damages to the insertion tube of the OES Laparo-Thoraco Videoscope Type V. It can also be purchased separately. These trocar tubes are substantially equivalent in intended use, functions, and method of use to the Olympus A5273 and A5276 Trocar Tubes with the exception that the predicate trocar tubes have a metal valve (flap or plunger type) while the subject trocar tubes have a medical grade silicone rubber valve. The predicate trocar tubes A5273 and A5276 were cleared in 510(k) # K923982.
Trocars
The following trocars have been specifically designed for use in conjunction with the trocar tubes listed above:
| Model | Diameter | Description |
|---|---|---|
| A5821 | 5 mm | Trocar |
| A5823 | 11 mm | Trocar |
| A5825 | 13 mm | Trocar |
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic and abdominal cavity
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)
K942338 & K942339, K915857, K923982
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.1720 Gynecologic laparoscope and accessories.
(a)
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.
0
510 (k) SUMMARY
OLYMPUS OES LAPARO-THORACO VIDEO SCOPE TYPE V
MAR 1 ) 1996
| Device Name: | Olympus OES Laparo-Thoraco Videoscope Type V, its
associated accessories and ancillary equipment |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Laparo-Thoraco Videoscope |
| Classification Name: | Endoscope and Accessories
Mediastinoscope and Accessories
Gynecologic Laparoscope and Accessories |
| Predicate Devices: | Olympus Flexible TipThoracoscope/ Laparoscope
K942338 & K942339 |
| Submitted By:
(Contact Person) | Mr. Barry Sands
Olympus America Inc.
Endoscope Division
Two Corporate Center Drive
Melville, New York 11747-3157
(516) 844-5474 |
| Summary Preparation Date: | November 22, 1995 |
Statement of Intended Use
OES Laparo-Thoraco Videoscope Type V
The OES Laparo- Thoraco Videoscope Type V has been designed for endoscopic observation, diagnosis and treatment within the thoracic and abdominal cavity.
A4907 Lens Cleaning Sheath
The A4907 Lens Cleaning Sheath has been specifically designed to be used with an OES Laparo-Thoraco Videoscope Type V to clean the objective lens surface.
A4908 Valve
The A4908 Valve has been specifically designed for use in conjunction with the A4907 Cleaning Sheath to provide irrigation and aspiration of liquids when connected to the insertion tube of the Olympus videoscope.
Trocar Tube and Trocars
The trocar tubes are intended to provide a passageway for the endoscope or hand instruments, and permit the insufflation of CO, during the endoscopic procedure. The subject trocar tubes are specifically designed to use in conjunction with the OES Laparo-Thoraco Videoscope Type V.
1
The trocars are intended to pierce the abdominal wall tissue layer during the endoscopic procedure. The subject trocars are specifically designed to use in conjunction with the Laparo-Thoracoscope.
Device Description
OES Laparo-Thoraco Videoscope Type V
The OES Laparo-ThoracoVideoscope Type V is substantially equivalent in design to the predicate Olympus OES LTF Flexible Tip Thoracoscope/Laparoscope which was cleared in 510(k) # K915857. The predicate LTF Flexible Tip Thoracoscope/Laparoscope is a fiberscope. The only difference between these two endoscopes is that the predicate device which has a image guide (fiber bundle) to transmit an endoscopic image to the surgeon's eye or the CCD of of the video camera. The subject device is a videoscope that places the CCD at the distal end of the endoscope. The subject OES Laparo-Thoraco Videoscope Type V has an 11 mm distal tip, 10.6 mm diameter insertion tube. 70° forward viewing field of view, depth of field of 18mm ~100mm, and 90° angulation in all four (Up-Down-Left-Right) directions. It contains the color Charged Couple Devices (CCD) for image transmission to the video monitor.
When compared to the previously cleared predicate scope, the subject OES Laparo-Thoraco Videoscope Type V does not raises any new questions of safety or effectiveness.
A4907 Lens Cleaning Sheath
The A 4907 Lens Cleaning Sheath has been specifically designed for use in conjunction with the Olympus OES Laparo-Thoraco Videoscope Type V. It will be included in the standard set of Laparo-Thoraco Videoscope and will also be marketed separately.
When connected to the main body of videoscope, it offers lens cleaning, irrigation, and suction capabilities to the user during endoscopic procedures. It is substantially equivalent in design, intended use, and method of operation to the "Lens Cleaner" manufactured by Cook, "Optic Shaft" manufactured by Wiest, and "Lap Wash System" manufactured by DevMed Group Inc.
A4908 Valve
The A4908 Valve has been specifically designed for use in conjunction with the Olympus OES Laparo-Thoraco Videoscope Type V and A4907 lens cleaning sheath. It will be included in the standard set of the OES Laparo-Thoraco Videoscope Type V and will also be marketed separately.
The A4908 Valve is substantially equivalent in intended use, functions, and method of use to the T1020 Multiple Function Tube (Irrigation/Suction Probe) which was approved in 510(k) # K923982. Both devices have separate "plunger-like" valves that permit the operator to control when to activate the suction or irrigation function. The housing of design is such that tubing sets are easily connected to the irrigation/suction source.
Additionally, the A4908 Valve is also substantially equivalent in design, material intended use, functions, and method of use to the Olympus MH-325 Valve which was cleared in 510(k) # K915857 with the exception that the A4908 Valve controls the irrigation and suction of liguids. It has separate irrigation port and suction port connections. The irrigation and aspirations are controlled by separate buttons.
2
Trocar Tubes
The A5822 and A5824 trocar tubes have been specifically designed for use in conjunction with the Olympus OES Laparo-Thoraco Videoscope Type V. The 5 mm trocar tube is designed to deliver endoscopic accessories into the abdominal cavity
| Model | Diameter | Description |
|---|---|---|
| A5820 | 5 mm | Trocar Tube |
| A5822 | 11 mm | Trocar Tube |
| A5824 | 13 mm | Trocar Tube |
The A5822 and A5824 trocar tubes consist of a metal housing, a stopcock for insufflation of CO2 gas, and a sealing valve. The A5820 trocar tubes does not have a stopcock for insufflation. The sealing valve is specifically designed to prevent damages to the insertion tube of the OES Laparo-Thoraco Videoscope Type V. It can also be purchased separately. These trocar tubes are substantially equivalent in intended use, functions, and method of use to the Olympus A5273 and A5276 Trocar Tubes with the exception that the predicate trocar tubes have a metal valve (flap or plunger type) while the subject trocar tubes have a medical grade silicone rubber valve. The predicate trocar tubes A5273 and A5276 were cleared in 510(k) # K923982.
Trocars
The following trocars have been specifically designed for use in conjunction with the trocar tubes listed above:
| Model | Diameter | Description |
|---|---|---|
| A5821 | 5 mm | Trocar |
| A5823 | 11 mm | Trocar |
| A5825 | 13 mm | Trocar |
General Safety
When compared to the predicate devices, Olympus OES Laparo-Thoraco Videoscope Type V, its associated accessories and ancillary equipment do not incorporate any significant change in intended use, method of operation, material, or design that could affect the safety or effectiveness. device.