(115 days)
The EVIS EXERA 160A system consists of Olympus camera heads, endoscopes, video system center, light source, monitors, endo-therapy accessories and other ancillary equipment. This system is intended for endoscopic diagnosis, treatment and video observation of the upper and lower digestive tract.
EVIS EXERA Xenon Light Source Olympus CLV-160A: This light source has been designed to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation.
EVIS EXERA Video System Center Olympus CV-160A: This video system center has been designed to be used with Olympus camera heads, endoscopes, light source, monitors, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis, treatment and video observation.
EVIS EXERA Gastrointestinal Videoscope XGIF-N160Y2: This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, video monitor, endo-therapy accessories (such as a biopsy forceps) and other ancillary equipment for transoral or transnasal observation and surgery within the upper digestive tract (including the esophagus, stomach and duodenum).
EVIS EXERA Gastrointestinal Videoscope XGIF-Q160Y5, XGIF-H160Y2: These instruments have been designed to be used with an Olympus video system center, light source, documentation equipment, video monitor, endo-therapy accessories (such as a biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the upper digestive tract (including the esophagus, stomach and duodenum).
EVIS EXERA Colonovideoscope XCF-Q160W6L, XCF-H160AY2L, XPCF-Q160AY2L: These instruments have been designed to be used with an Olympus video system center, light source, documentation equipment, video monitor, endo-therapy accessories (such as a biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve).
The EVIS EXERA 160A System consists of Olympus camera heads, endoscopes, video system center, light source, monitors, endo-therapy accessories and other ancillary equipment. This system is intended for endoscopic diagnosis, treatment and video observation of the upper and lower digestive tract.
The primary components of the subject system, which are part of this submission, are:
- EVIS EXERA Xenon Light Source Olympus CLV-160A,
- EVIS EXERA Video System Center Olympus CV-160A,
- EVIS EXERA Gastrointestinal Videoscopes XGIF-N160Y2, XGIF-Q160Y5, XGIF-H160Y2.
- EVIS EXERA Colonovideoscopes XCF-Q160W6L, XCF-H160AY2L, XPCF-Q160AY2L
The EVIS EXERA Xenon Light Source Olympus CLV-160A is intended for endoscopic diagnosis, treatment and video observation. The CLV-160A is basically identical to the predicate device, EVIS Universal Light Source CLV-U40, with the exception that the CLV-160A has an optional filter which allows the user to enhance endoscopic white light images by selective processing of green and blue light. This feature, referred to as Narrow Band Imaging (NBI) employs an optical filter to filter the white light spectrum, changing it from a broad band to a narrow band. Both an endoscopic image by standard white light illumination and that by NBI illumination can be obtained. The user can select either the standard observation mode by pressing the scope switch on the scope or the NBI mode switch on the CLV-160A. In comparison to conventional white light observation provides greater visual contrast of the surface structure and fine capillary patterns of the mucous membranes.
The EVIS EXERA Video System Center Olympus CV-160A is a video processing system intended for use with Olympus endoscopes such as the subject endoscopes. The CV-160A Video System Center contains the video signal processing technology which enables the endoscope to illuminate, enhance, view, record and transmit video data of endoscopic images.
The provided document is a 510(k) summary for the Olympus EVIS EXERA 160A System, which is a premarket notification to the FDA for medical devices. This type of document is intended to demonstrate substantial equivalence to a predicate device, rather than proving that a new device meets specific acceptance criteria through a clinical study with quantitative performance metrics.
Therefore, the document does not contain the acceptance criteria or a study that proves the device meets specific performance acceptance criteria in the way you've outlined for things like AI/ML models. It focuses on demonstrating that the new device is as safe and effective as previously cleared devices.
Here's why your requested information isn't present in this type of submission and what information is available:
- Acceptance Criteria and Reported Device Performance: This document describes comparisons of specifications between the new device and its predicate devices (Tables 16-3 to 16-10). It highlights similarities in intended use, specifications, performance, and materials, with the key difference being the addition of the Narrow Band Imaging (NBI) function. It asserts that the clinical literature supports the safety and efficacy of NBI imaging in endoscopy, but it does not provide a specific table of acceptance criteria a new study had to meet for the overall system or its NBI function.
- Sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, and training set ground truth: These details are typically associated with performance studies, especially for new diagnostic algorithms or AI/ML components. The provided document is for a hardware system (endoscopic video imaging system) and focuses on demonstrating substantial equivalence through comparison to existing products and referencing existing clinical literature. It does not describe a specific clinical performance study with these parameters for the EVIS EXERA 160A System itself. The NBI function is presented as an additional feature, and its safety and efficacy are supported by "clinical literatures" (plural), implying existing published research rather than a de novo study conducted for this 510(k).
Conclusion from the document:
The conclusion explicitly states: "When compared to the predicate devices, the EVIS EXERA 160A System does not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the system." This is the core of a 510(k) submission – to show that the new device is substantially equivalent to already legally marketed devices, rather than establishing entirely new performance metrics via a dedicated study.
In summary, the provided 510(k) summary is not a clinical study report that would answer your specific questions about acceptance criteria and performance study details. It is a regulatory submission for substantial equivalence.
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K05/645
OCT 1 3 2005
510(k) SUMMARY EVIS EXERA 160A SYSTEM
1. General Information
| Applicant | Olympus Medical Systems Corp. |
|---|---|
| 2951 Ishikawa-cho, Hachioji-shi, | |
| Tokyo, 192-8507, Japan | |
| Establishment Registration No.: 8010047 |
Laura Storms-Tyler I Official Correspondent Executive Director Regulatory Affairs & Quality Assurance Olympus America Inc. Two Corporate Center Drive, Melville, NY 11747-9058, USA Phone: 631-844-5688 FAX: 631-844-5554 Email: Laura.storms-tyler @olympus.com Establishment Registration No.: 2429304
■ Manufacturer
| Light source/Video system center: | Shirakawa Olympus Co., Ltd. |
|---|---|
| 3-1, Aza-Ookamiyama, Ooaza-Odakura, Nishigo-mura,Nishishirakawa-gun, Fukushima, Japan 961-8061Establishment Registration No.: 3002808148 | |
| Gastrointestinal scope/Colonoscope: | Aizu Olympus Co., Ltd. |
| 500 Aza-Muranishi, Ooaza-Iidera, Monden-cho,Aizuwakamatsu-shi, Fukushima, Japan 965-8520Establishment Registration No.: 9610595 |
2. Device Identification
| Device Name: | EVIS EXERA 160A System |
|---|---|
| Common Name: | Endoscopic Video Imaging System |
- il ■ Class:
- Classification:
| Table 16-1. Classification of the EVIS EXERA 160A System | |||
|---|---|---|---|
| RegulationNumber | Regulation Name | Product Code | Classification Panel |
|---|---|---|---|
| 876.1500 | Endoscope and accessories | FDS- Gastroscope, Gastro-UrologyFDF- Colonoscope, Gastro-UrologyKOG- Endoscope and accessoriesGCT- Light Source, Endoscope,Xenon Arc | Gastroenterology &Urology |
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3. Legally Marketed Device to which Substantial Equivalence is Claimed
The following table shows the primary components (part of this submission) of the EVIS EXERA 160A System and each device to which we claim substantial equivalence (predicate device).
| Subject Device(Part of this Submission) | Predicate Device | PD's 510(k) No. |
|---|---|---|
| EVIS EXERA Xenon Light SourceOlympus CLV-160A | EVIS Universal Light Source CLV-U40 | K954451 |
| EVIS EXERA Video System CenterOlympus CV-160A | EVIS Video System Center CV-140 | K954451 |
| EVIS EXERA GastrointestinalVideoscope XGIF-N160Y2 | XGIF-N200HGastrointestinal Videoscope | K001766 |
| EVIS EXERA GastrointestinalVideoscope XGIF-Q160Y5 | EVIS EXERA GastrointestinalVideoscopeGIF-Q160Z | K011151 |
| EVIS EXERA GastrointestinalVideoscope XGIF-H160Y2 | ||
| EVIS EXERA ColonovideoscopeXCF-Q160W6L | EVIS EXERA Colonoscope CF-Q160AL | |
| EVIS EXERA ColonovideoscopeXCF-H160AY2L | K001241 | |
| EVIS EXERA ColonovideoscopeXPCF-Q160AY2L | EVIS EXERA Colonovideoscope PCF-160AL |
Table 16-2 Primary Components & Predicate Devices of the EVIS EXERA 160A System
4. Device Description
The EVIS EXERA 160A System consists of Olympus camera heads, endoscopes, video system center, light source, monitors, endo-therapy accessories and other ancillary equipment. This system is intended for endoscopic diagnosis, treatment and video observation of the upper and lower digestive tract.
The primary components of the subject system, which are part of this submission, are:
- EVIS EXERA Xenon Light Source Olympus CLV-160A, •
- EVIS EXERA Video System Center Olympus CV-160A, .
- EVIS EXERA Gastrointestinal Videoscopes XGIF-N160Y2, XGIF-Q160Y5, . XGIF-H160Y2.
- EVIS EXERA Colonovideoscopes XCF-Q160W6L, XCF-H160AY2L, ، XPCF-Q160AY2L
The EVIS EXERA Xenon Light Source Olympus CLV-160A is intended for endoscopic diagnosis, treatment and video observation. The CLV-160A is basically identical to the predicate device, EVIS Universal Light Source CLV-U40, with the exception that the CLV-160A has an optional filter which allows the user to enhance endoscopic white light images by selective processing of green and blue light. This feature, referred to as Narrow Band Imaging (NBI) employs an optical filter to filter the white light spectrum, changing it from a broad band to a narrow band. Both an endoscopic image by standard white light illumination and that by NBI illumination can be obtained. The user can select either the standard observation mode by pressing the scope switch on the scope or the NBI mode switch on the CLV-160A. In comparison to conventional white light observation provides greater visual contrast of the surface structure and fine capillary patterns of the mucous membranes.
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The EVIS EXERA Video System Center Olympus CV-160A is a video processing system intended for use with Olympus endoscopes such as the subject endoscopes. The CV-160A Video System Center contains the video signal processing technology which enables the endoscope to illuminate, enhance, view, record and transmit video data of endoscopic images. The CV-160A Video System Center is equivalent to predicate Olympusdevices which have the same basic functionality. Predicate Olympus devices include the EVIS Video System Center CV-140. The Video System Center CV-140 enabled the physician to utilize a variety of Olympus flexible endoscopes, including colonoscopes, gastroscopes, sigmoidscopes, duodenoscopes and bronchoscopes. The EVIS Video System Center CV-140 contains the video signal processor technology which allowed the various endoscopes to illuminate, enhance, view, record, and transmit video data of endoscopic images.
Compared to these predicate devices, the subject CV-160A incorporates the following changes: 1. The CV-160A is compatible with any specified Olympus flexible, both video and fiberoptic, and rigid endoscope.
-
- The CV-160A processes the NBI image, generated by the CLV-160A light source and captured by the endoscope's Charged Coupled Device (CCD), creating an enhanced image of the tissue's vasculature.
Both the CLV-160A and CV-160A can be used with any specified Olympus flexible and rigid endoscope models, including gastroscopes, ultrasound gastroscopes, duodenoscopes, colonoscopes, sigmoidscopes, choledochoscopes, bronchoscopes, rhino-laryngoscopes, tracheal intubation scopes, transnasal esophago scopes, hysteroscopes, cystoscopes, ureterorenoscopes, laparo-thoracoscopes for conventional white light endoscopy. The flexible endoscopes which are the subject of this premarket notification are gastroscope and colonoscope models listed in Table 16-2.
- The CV-160A processes the NBI image, generated by the CLV-160A light source and captured by the endoscope's Charged Coupled Device (CCD), creating an enhanced image of the tissue's vasculature.
Additionally, when they are combined with the new Gastrointestinal Videoscopes (XGIF-N160Y2, XGIF-Q160Y5, XGIF-H160Y2), and Colonovideoscopes (XCF-Q160W6L, XCF-H160AY2L, XPCF-Q160AY2L), both an endoscopic image by white light illumination and that by NBI illumination can be obtained. The user can select either the NBI mode or normal mode by pressing the scope switch on the scope or the NBI mode switch on the CLV-160A; the NBI filter in the CLV-160A is inserted on the light axis when the NBI mode is selected.
The new endoscopes are basically identical to each predicate device shown in Table 16-2 in intended use, and similar in specifications, performance and materials. The CV-160A identifies an NB+compatible scope when it is connected by using the Scope ID function provided with the scopes.
5. Indications for Use
The EVIS EXERA 160A system consists of Olympus camera heads, endoscopes, video system center, light source, monitors, endo-therapy accessories and other ancillary equipment. This system is intended for endoscopic diagnosis, treatment and video observation of the upper and lower digestive tract. The indications for use of each primary component are shown below.
EVIS EXERA Xenon Light Source Olympus CLV-160A
This light source has been designed to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation.
EVIS EXERA Video System Center Olympus CV-160A
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This video system center has been designed to be used with Olympus camera heads, endoscopes, light source, monitors, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis, treatment and video observation.
EVIS EXERA Gastrointestinal Videoscope XGIF-N160Y2
This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, video monitor, endo-therapy accessories (such as a biopsy forceps) and other ancillary equipment for transoral or transnasal observation and surgery within the upper digestive tract (including the esophagus, stomach and duodenum).
EVIS EXERA Gastrointestinal Videoscope XGIF-Q160Y5, XGIF-H160Y2
These instruments have been designed to be used with an Olympus video system center, light source, documentation equipment, video monitor, endo-therapy accessories (such as a biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the upper digestive tract (including the esophagus, stomach and duodenum).
EVIS EXERA Colonovideoscope XCF-Q160W6L, XCF-H160AY2L, XPCF-Q160AY2L
These instruments have been designed to be used with an Olympus video system center, light source, documentation equipment, video monitor, endo-therapy accessories (such as a biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve).
6. Comparison of Technological Characteristics
Each primary component of the EVIS EXERA160A System is basically identical to its predicate device in intended use, and similar in specifications except for the addition of the NBI function. Comparison between the subject and predicate devices is shown in Table 16-3 to 16-10. The clinical literatures provided in this submission supports the safety and efficacy of NBI imaging in endoscopy.
| Specifications | Suject Deve | Predicate Device CLV-U40 |
|---|---|---|
| Power Supply | 100-240V~ ±10%,50/60Hz ± 1Hz | 120V~ ±10%,50/60Hz ± 1Hz |
| Over-current Protection | Fuse type | Circuit breaker type |
| Input Current | 500VA (at observation) | 6A ( at observation)8A ( at flash) |
| Size | 381(W) × 162(H) × 536(D)mm | 587(W) × 165(H) × 537(D)mm |
| Weight | 15.4kg | 20kg |
| Compatible Endoscopes | VideoscopeFiberscopeRigid scope | VideoscopeFiberscopeRigid scope |
Table 16-3. Comparison of Specifications Subject Device: EVIS EXERA Xenon Light Source Olympus CLV-160A Predicate Device: EVIS Universal Light Source CLV-U40 (K954451)
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| Examination Lamp | Xenon short-arc lamp(ozone-free)300W | Xenon short-arc lamp(ozone-free)300W | |
|---|---|---|---|
| Average Lamp Life | Approximately 500 hours ofcontinuous use | Approximately 500 hours ofcontinuous use | |
| Emergency Lamp | Halogen lamp 12V 35W | Halogen lamp(without mirror)24V 150W | |
| Average Emergency LampLife | Approximately 500 hours | Approximately 500 hours | |
| NBI Filter | NBI filter | NA | |
| Brightness Control | Automatic and Manual | Automatic and Manual | |
| Automatic Exposure | 17 steps | 17 steps + F | |
| Photography Function | - | Provided | |
| Air Feeding | 4 levels available(off, low, mid, high) | 4 levels available(off, low, mid, high) | |
| Air Feeding Pump | Diaphragm type pump | Linear type pump | |
| System Connector | Provided | Provided | |
| Foot Switch Connector | Provided | Provided | |
| CV Connector | Provided | Provided | |
| Cooling Air Direction | Rear | Left side | |
| Type of Protection againstElectric Shock | Class? | Class? | |
| Degree of Protectionagainst Electric Shock ofApplied Part | TYPE BF or CF applied part(Depend on applied part) | TYPE BF applied part | |
| Applicable Standard | UL60601-1 | UL544 | |
| Specifications | Subject device CV 160A | Predicate Device CV-140 | |
| Power Supply | 100-240V~ ±10%? 50/60Hz ±1Hz | 120V~ ±10%? 50/60Hz ± 1Hz | |
| Over-current Protection | Fuse type | Circuit breaker type | |
| Input Current | 150VA | 0.8A | |
| Size | 370(W) $\times$ 91(H) $\times$ 462 (D)mm | 450(W) $\times$ 72(H) $\times$ 465(D)mm | |
| Weight | 10.6 kg | 10 kg | |
| Compatible Endoscopes | · Fiber/rigid scope via camerahead· Videoscope | · Gastro/colono/sigmoid/duodeno/broncho videoscope· Fiberscope via video converter | |
| Video SignalOutput | RGB:3 Y/C:4 VBS:4 HDTV:1 | RGB:3 Y/C:3 VBS:4 | |
| Auto Whitebalance | Automatically adjusted using thewhite balance switch.At the time of connection with thescope in which Scope ID isprovided, compensation isperformed automatically. | Automatically adjusted using thewhite balance switch | |
| Observation | Standard ColorChart Output | Color bar image | Color bar image50% white |
| Color ToneAdjustment | R: ±8 stepsB: ±8 stepsCHROMA: ±8steps | R control: ±7 stepsB control: ±7stepsHSR control: ±7steps | |
| AutomaticGain Control(AGC) | Provided | Provided | |
| ImageEnhancement | Edge enhancement: [OFF] [Low][Med] [High] 4 levels availableStructure enhancement:[OFF] [Low][Med] [High] 4 levels available | Image enhancement: [Low] [Med][High] 3 levels available | |
| Iris ModeSelection | AUTO/ PEAK EXPOSUREElectrical shutter | AVE/ PEAK | |
| Optical Zoom | $\times$ 1/ $\times$ 1.2 / $\times$ 1.5: 3-Mode | ||
| NBIObservation | NBI function | ||
| Picture inPicture | The image of an external deviceconnected to this instrument isdisplayed on the main monitortogether with the endoscopic image. | The frozen endoscopic image isdisplayed on the sub screen whenthe freeze mode is selected. | |
| Communication with Scope | Provided | ||
| Foot Switch Connector | Provided | ||
| Record to Memory Card | Provided | ||
| Type of Protection againstElectric Shock | Class? | Class? | |
| Degree of Protection against | TYPE BF or CF applied part(Depend on applied part) | ||
| Electric Shock of Applied Part | TYPE BF applied part | ||
| Applicable Standard | UL60601-1 | UL544 |
:
・
:
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Table 16-4. Comparison of Specifications Subject Device: EVIS EXERA Video System Center Olympus CV -160A Predicate Device: EVIS Video System Center CV-140 (K954451)
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Table 16-5. Comparison of Specifications Subject Device: EVIS EXERA Gastrointestinal Videoscope XGIF-N160Y2 Predicate Device: XGIF-N200H Gastrointestinal Videoscope (K001766)
| Specifications | Subject DeviceXGIF-N160Y2 | Predicate DeviceXGIF-N200H |
|---|---|---|
| Field of View | 120 ° | 120 ° |
| Depth of Field | 3-100mm | 3-100mm |
| Direction of Forward View | 0 ° | 0 ° |
| Type of CCD | Color | Monochrome |
| Outer Diameter of Distal End | 4.9mm | 6mm |
| Outer Diameter of Insertion Tube | 4.9mm | 6mm |
| Bending Section Angulation | UP: 210 °DOWN:120 ° | UP: 180 °DOWN: 180 °RIGHT: 160 °LEFT: 160 ° |
| Working Length | 1100mm | 925mm |
| Inner Diameter of InstrumentChannel | 2.0mm | 2.0mm |
Table 16-6. Comparison of Specifications Subject Device: EVIS EXERA Gastrointestinal Videoscope XGIF-Q160Y5 Predicate Device: EVIS EXERA Gastrointestinal Videoscope GIF-Q160Z (K011151)
| Specifications | Subject DeviceXGIF-Q160Y5 | Predicate DeviceGIF-Q160Z |
|---|---|---|
| Field of View | 140 ° | 140 ° (in WIDE position)75 ° (in TELE position) |
| Depth of Field | 3-100mm | 8-100mm (in WIDE position)1.5-3mm (in TELE position) |
| Direction of Forward View | 0 ° | 0 ° |
| Type of CCD | Color | Color |
| Outer Diameter of Distal End | 8.8mm | 10.8mm |
| Outer Diameter of Insertion Tube | 8.8mm | 10.9mm |
| Bending Section Angulation | UP:210 °DOWN:90 °RIGHT:100 °LEFT:100 ° | UP: 210°DOWN: 90 °RIGHT:100 °LEFT:100 ° |
| Working Length | 1030mm | 1030mm |
| Inner Diameter of InstrumentChannel | 2.8mm | 2.8mm |
| Zoom Magnification Function | No | Yes |
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Table 16-7. Comparison of Specifications Subject Device: EVIS EXERA Gastrointestinal Videoscope XGIF-H160Y2 Predicate Device: EVIS EXERA Gastrointestinal Videoscope GIF-Q160Z (K011151)
| Specifications | Subject DeviceXGIF-H160Y2 | Predicate DeviceGIF-Q160Z |
|---|---|---|
| Field of View | 140 ° | 140 ° (in WIDE position)75 ° (in TELE position) |
| Depth of Field | 2-100mm | 8-100mm (in WIDE position)1.5-3mm (in TELE position) |
| Direction of Forward View | 0 ° | 0 ° |
| Type of CCD | Color | Color |
| Outer Diameter of Distal End | 9.8mm | 10.8mm |
| Outer Diameter of Insertion Tube | 9.8mm | 10.9mm |
| Bending Section Angulation | UP: 210 °DOWN: 90 °RIGHT:100 °LEFT:100 ° | UP: 210 °DOWN: 90 °RIGHT:100 °LEFT:100 ° |
| Working Length | 1030mm | |
| Inner Diameter of Instrument Channel | 2.8mm | 2.8mm |
| Zoom Magnification Function | No | Yes |
Table 16-8. Comparison of Specifications Subject Device: EVIS EXERA Colonovideoscope XCF-Q160W6L Predicate Device: EVIS EXERA Colonovideoscope CF-Q160AL (K001241)
| Specifications | Subject DeviceXCF-Q160W6L | Predicate DeviceCF-Q160AL |
|---|---|---|
| Field of View | 170 ° | 140 ° |
| Depth of Field | 3-100mm | 3 -100mm |
| Direction of Forward View | 0 ° | 0 ° |
| Type of CCD | Color | Color |
| Outer Diameter of Distal End | 13.2mm | 12.8mm |
| Outer Diameter of Insertion Tube | 12.8mm | 12.8mm |
| Bending Section Angulation | UP: 180 ° | UP: 180 ° |
| DOWN: 180 ° | DOWN: 180 ° | |
| RIGHT:160 ° | RIGHT:160 ° | |
| LEFT:160 ° | LEFT:160 ° | |
| Working Length | 1680mm | 1680mm |
| Inner Diameter of InstrumentChannel | 3.7mm | 3.7mm |
| Flexibility of Insertion Tube | Adjustable by the user. | Adjustable by the user. |
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Table 16-9. Comparison of Specifications Subject Device: EVIS EXERA Colonovideoscope XCF-H160AY2L Predicate Device: EVIS EXERA Colonovideoscope CF-Q160AL (K001241)
| Specifications | Subject DeviceXCF-H160AY2L | Predicate DeviceCF-Q160AL |
|---|---|---|
| Field of View | 170 ° | 140 ° |
| Depth of Field | 2 -100mm | 3 -100mm |
| Direction of Forward View | 0 ° | 0 ° |
| Type of CCD | Color | Color |
| Outer Diameter of Distal End | 13.9mm | 12.8mm |
| Outer Diameter of Insertion Tube | 12.8mm | 12.8mm |
| Bending Section Angulation | UP: 180 °DOWN:180 °RIGHT:160 °LEFT:160 ° | UP: 180 °DOWN:180 °RIGHT:160 °LEFT:160 ° |
| Working Length | 1680mm | 1680mm |
| Inner Diameter of InstrumentChannel | 3.7mm | 3.7mm |
| Flexibility of Insertion Tube | Adjustable by the user. | Adjustable by the user. |
Table 16-10. Comparison of Specifications Subject Device: EVIS EXERA Colonovideoscope XPCF-Q160AY2L Predicate Device: EVIS EXERA Colonovideoscope PCF-160AL (K001241)
| Specifications | Subject DeviceXPCF-Q160Y2L | Predicate DevicePCF-160AL |
|---|---|---|
| Field of View | 140 ° | 140 ° |
| Depth of Field | 3-100mm | 3-100mm |
| Direction of Forward View | 0 ° | 0 ° |
| Type of CCD | Color | Color |
| Outer Diameter of Distal End | 11.3mm | 11.3mm |
| Outer Diameter of Insertion Tube | 11.5mm | 11.5mm |
| Bending Section Angulation | UP: 180 ° | UP: 180 ° |
| DOWN: 180 ° | DOWN: 180 ° | |
| RIGHT:160 ° | RIGHT:160 ° | |
| LEFT:160 ° | LEFT:160 ° | |
| Working Length | 1680mm | 1680mm |
| Inner Diameter of InstrumentChannel | 3.2mm | 3.2mm |
| Flexibility of Insertion Tube | Adjustable by the user | Adjustable by the user |
6. Conclusion
When compared to the predicate devices, the EVIS EXERA 160A System does not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the system.
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Image /page/9/Picture/1 description: The image shows a black and white logo of the Department of Health & Human Services. The logo is circular in shape, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" written around the perimeter of the circle. Inside the circle is a stylized image of a bird with three lines extending from its body.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 3 2005
Ms. Laura Storms-Tyler Executive Director, Regulatory Affairs and Quality Assurance Olympus America, Inc. Two Corporate Center Drive MELVILLE NY 11747-3157
Re: K051645
Trade/Device Name: EVIS EXERA 160A System Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Codes: NWB, FDS and FDF Dated: September 2, 2005 Received: September 6, 2005
Dear Ms. Storms-Tyler:
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 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) 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 actively subjects to the 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 II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your I tpp. o tal), it 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 I or 's requirements, including, but not limited to registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.
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This letter will allow you to begin marketing your device as described in your Section 510(k) I ins icter with anow you're ought mains of substantial equivalence of your device to a legally prematication. "The I Drivination 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 (21 CFR Part 801), please If you desire specific actifice for your ac ween the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 | |
|---|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 | |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 | |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, picaso note the regulation entitled, formation on your responsibilities under the Act from the 807.97). Tou may obtain outer general missistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): Device Name: EVIS EXERA 160A System Indications For Use:
EVIS EXERA Xenon Light Source Olympus CLV-160A
This light source has been designed to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation.
EVIS EXERA Video System Center Olympus CV-160A.
This video system center has been designed to be used with Olympus camera heads, endoscopes, light source, monitors, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis, treatment and video observation.
EVIS EXERA Gastrointestinal Videoscope XGIF-N160Y2
This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, video monitor, endo-therapy accessories (such as a biopsy forceps) and other ancillary equipment for transoral or transnasal observation and surgery within the upper digestive tract (including the esophagus, stomach and duodenum).
Prescription Use_ (Part 21 CFR 801 Subpart D) ANDIOR
Over-The-Counter Use_ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)
of Reproductive, Abdomin and Radiological Dev 510(k) Number
Page 1 of 2_
{12}------------------------------------------------
Indications for Use
510(k) Number (if known):
Device Name: EVIS EXERA 160A System
Indications For Use:
EVIS EXERA Gastrointestinal Videoscope XGIF-Q160Y4, XGIF-Q160Y5, XGIF-H160Y1, XGIE-H160Y2
These instruments have been designed to be used with an Olympus video system center, light source, documentation equipment, video monitor, endo-therapy accessories (such as a biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the upper digestive tract (including the esophagus, stomach and duodenum).
EVIS_EXERA_Colonovideoscope_XCF_Q160W3L,_XCF-Q160W6L,_XCF-H160AYL,_XCE-H160AY2L, XPCF-Q160AYL, XPCF-Q160AY2L
These instruments have been designed to be used with an Olympus video system center, light source, documentation equipment, video monitor, endo-therapy accessories (such as a biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve).
Prescription Use_ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use_ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Larson
(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Device
Page 2 of 2_______________________________________________________________________________________________________________________________________________________________
510(k) Number
§ 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.