(113 days)
No
The document describes image processing techniques (Narrow Band Imaging) but does not mention AI or ML.
Yes
The device is described as being used for "treatment" in several instances across its intended use, indications for use, and device description sections.
Yes
The "Intended Use / Indications for Use" section explicitly states that the devices are "intended for endoscopic diagnosis".
No
The device description clearly outlines multiple hardware components including a light source, video system center, endoscopes, and monitors. While there is software involved in image processing, the device is not solely software.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states the system is for "endoscopic diagnosis, treatment and video observation" within the airways and related anatomical sites. This involves direct visualization of internal body structures.
- Device Description: The description details components like light sources, video system centers, and endoscopes, all of which are used for imaging and visualization in vivo (within the living body).
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or treatment. This system does not perform such analysis on specimens.
The system is an endoscopic imaging system used for direct visualization and potentially therapeutic interventions within the body.
N/A
Intended Use / Indications for Use
EVIS EXERA II XENON LIGHT SOURCE OLYMPUS CLV-180: "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 II VIDEO SYSTEM CENTER OLYMPUS CV-180: "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 II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P180, BF TYPE 1T180, BF TYPE Q180: "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 biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree."
VISERA RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF TYPE V2: "This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, display monitor, and other ancillary equipment for endoscopic diagnosis within the nasal lumens and airway anatomy (including nasopharyngeal and trachea)."
VISERA RHINO-LARYNGO VIDEOSCOPE OLYMPUS XENF TYPE VTY1: "This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, display monitor, endo-therapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the nasal lumens and airway anatomy (including nasopharyngeal and trachea)."
Product codes (comma separated list FDA assigned to the subject device)
EOQ,EOB,NWB
Device Description
The EVIS EXERA II 180 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 airways, tracheobronchial tree, nasal lumens and airway anatomy.
The primary components of the subject system, which are part of this submission, are:
- EVIS EXERA II Xenon Light Source Olympus CLV-180. •
- EVIS EXERA II Video System Center Olympus CV-180, t
- EVIS EXERA II Bronchovideoscope Olympus BF -P180, BF -1T180, BF -Q180 .
- VISERA Rhino-Laryngo Videoscope Olympus ENF-V2, XENF-VTY1 》
The EVIS EXERA II Xenon Light Source Olympus CLV-180 is intended for endoscopic diagnosis, treatment and video observation. The CLV-180 is identical to the predicate device, EVIS EXERA Xenon Light Source CLV-160A cleared under K051645 except that the device size has been slightly changed. The CLV-180 has an optional fitter 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-180. In comparison to conventional white light observation, NBI observation provides greater visual contrast of the surface structure and fine capillary patterns of the mucous membranes.
The EVIS EXERA II Video System Center Olympus CV-180 is a video processing system intended for use with Olympus endoscopes such as the subject endoscopes. The CV-180 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-180 is identical to the predicate device, EVIS EXERA Video System Center CV-160A, cleared under K051645 except that the device size has been slightly changed.
The CV-180 incorporates the following features:
The CV-180 is compatible with any specified Olympus flexible, both video and fiberoptic, 1. and rigid endoscope.
The CV-180 processes the NBI image, generated by the CLV-160A light source and 2 captured by the endoscope's Charged Coupled Device (CCD), creating an enhanced image of the tissue's vasculature.
Both the CLV-180 and CV-180 can be used with any specified Olympus flexible and ridid endoscope models, including gastroscopes, ultrasound gastroscopes, colonoscopes, sigmoidscopes, choledochoscopes, 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 bronchoscope and rhino-laryngoscope models listed in Table 16-2.
Additionally, when they are combined with the new bronchovideoscopes (BF-P180, BF-1T180, BF-Q180), and rhino-laryngo videoscopes (ENF-V2, XENF-VTY1), 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-180 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-180 identifies an NBI-compatible scope when it is connected by using the Scope ID function provided with the scopes.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Endoscopic Video Imaging
Anatomical Site
airways, tracheobronchial tree, nasal lumens and airway anatomy (including nasopharyngeal and trachea)
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): 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.
K051645, K023984, K031648, K052452
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
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.
0
AUG 8 0 2006
510(k) SUMMARY
:
EVIS EXERA II 180 SYSTEM
1. General Information
1. General Information
| Applicant | OLYMPUS MEDICAL SYSTEMS CORP.
2951 Ishikawa-cho, Hachioji-shi,
Tokyo, 192-8507, Japan
Establishment Registration No.: 8010047 |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Correspondent | Laura Storms-Tyler
Executive Director
Regulatory Affairs & Quality Assurance
Olympus America Inc.
3500 Corporate Parkway
PO Box 610
Center Valley PA 18034-0610
Phone: 484-896-5688
FAX: 484-896-7128
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 961-8061
Establishment Registration No.: 3002808148 |
| Bronchoscope/Rhino-Laryngoscope: | Aizu Olympus Co., Ltd.
500 Aza-Muranishi, Ooaza-lidera, Monden-cho,
Aizuwakamatsu-shi, Fukushima, Japan 965-8520
Establishment Registration No.: 9610595 |
| Suction valve/Biopsy valve: | OLYMPUS MEDICAL SYSTEMS CORP. Hinode Plant
34-3 Hirai Hinode-machi, Nishitama-gun,
Tokyo, Japan 190-0182
Establishment Registration No.: 3003637092 |
| Date Prepared | April 1, 2006 |
.
1
. . . . . . . . . .
2. Device Identification
| ■ Device Name: | EVIS EXERA II 180 System |
|---|---|
| ---------------- | -------------------------- |
- Common Name: Endoscopic Video Imaging System
- Class: 11 ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴ . . . ......... . ....... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
- Classification:
.
| Table 16-1. Classification of the EVIS EXERA 160A System | ||
|---|---|---|
| INFORMATION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTURAL CONSULTURATION CONSULTURATION CONSULTURATION |
| Regulation
Number | Regulation Name | Product Code | Classification
Panel |
|----------------------|----------------------------------------------------------|------------------------------------------------------|-------------------------------|
| 874. 4680 | Bronchoscope (flexible or rigid)
and accessories | EOQ- Bronchoscope
(Flexible or rigid) | Ear, Nose &
Throat |
| 874.4760 | Nasopharyngoscope (flexible or
rigid) and accessories | EOB- Nasopharyngoscope
(Flexible or rigid) | Throat |
| 876.1500 | Endoscope and accessories | NWB- Endoscope, accessories,
narrow band spectrum | Gastroenterology
& Urology |
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 II 180 System and each device to which we claim substantial equivalence (predicate device).
| Table 16-2. Primary Components & Predicate Devices of the EVIS EXERA II 180 Systen. |
|---|
| ------------------------------------------------------------------------------------- |
| Subject Device
(Part of this Submission) | Predicate Device | PD's
510(k) No. |
|-----------------------------------------------------------|--------------------------------------------------------|--------------------|
| EVIS EXERA II XENON LIGHT SOURCE
OLYMPUS CLV-180 | EVIS EXERA XENON LIGHT SOURCE
OLYMPUS CLV-160A | K051645 |
| EVIS EXERA II VIDEO SYSTEM CENTER
OLYMPUS CV-180 | EVIS EXERA VIDEO SYSTEM CENTER
OLYMPUS CV-160A | |
| EVIS EXERA II BRONCHOVIDEOSCOPE
OLYPUS BF TYPE P180 | EVIS EXERA BRONCHOVIDEOSCOPE | |
| EVIS EXERA II BRONCHOVIDEOSCOPE
OLYPUS BF TYPE Q180 | OLYPUS BF TYPE 160 | K023984 |
| EVIS EXERA II BRONCHOVIDEOSCOPE
OLYPUS BF TYPE 1T180 | EVIS EXERA BRONCHOVIDEOSCOPE
OLYPUS BF TYPE 1T160 | |
| VISERA RHINO-LARYNGO VIDEOSCOPE
OLYMPUS ENF TYPE V2 | VISERA RHINO-LARYNGO VIDEOSCOPE
OLYMPUS ENF TYPE V | K031648 |
| VISERA RHINO-LARYNGO VIDEOSCOPE
OLYMPUS XENF TYPE VTY1 | VISERA RHINO-LARYNGO VIDEOSCOPE
OLYMPUS ENF TYPE VT | K052452 |
2
4. Device Description
The EVIS EXERA II 180 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 airways, tracheobronchial tree, nasal lumens and airway anatomy.
The primary components of the subject system, which are part of this submission, are:
- EVIS EXERA II Xenon Light Source Olympus CLV-180. •
- EVIS EXERA II Video System Center Olympus CV-180, t
- EVIS EXERA II Bronchovideoscope Olympus BF -P180, BF -1T180, BF -Q180 .
- VISERA Rhino-Laryngo Videoscope Olympus ENF-V2, XENF-VTY1 》
The EVIS EXERA II Xenon Light Source Olympus CLV-180 is intended for endoscopic diagnosis, treatment and video observation. The CLV-180 is identical to the predicate device, EVIS EXERA Xenon Light Source CLV-160A cleared under K051645 except that the device size has been slightly changed. The CLV-180 has an optional fitter 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-180. In comparison to conventional white light observation, NBI observation provides greater visual contrast of the surface structure and fine capillary patterns of the mucous membranes.
The EVIS EXERA II Video System Center Olympus CV-180 is a video processing system intended for use with Olympus endoscopes such as the subject endoscopes. The CV-180 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-180 is identical to the predicate device, EVIS EXERA Video System Center CV-160A, cleared under K051645 except that the device size has been slightly changed.
The CV-180 incorporates the following features:
The CV-180 is compatible with any specified Olympus flexible, both video and fiberoptic, 1. and rigid endoscope.
The CV-180 processes the NBI image, generated by the CLV-160A light source and 2 captured by the endoscope's Charged Coupled Device (CCD), creating an enhanced image of the tissue's vasculature.
Both the CLV-180 and CV-180 can be used with any specified Olympus flexible and ridid endoscope models, including gastroscopes, ultrasound gastroscopes, colonoscopes, sigmoidscopes, choledochoscopes, 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 bronchoscope and rhino-laryngoscope models listed in Table 16-2.
Additionally, when they are combined with the new bronchovideoscopes (BF-P180, BF-1T180, BF-Q180), and rhino-laryngo videoscopes (ENF-V2, XENF-VTY1), 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
3
mode switch on the CLV-160A; the NBI filter in the CLV-180 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-180 identifies an NBI-compatible scope when it is connected by using the Scope ID function provided with the scopes.
5. Indications for Use
EVIS EXERA II XENON LIGHT SOURCE OLYMPUS CLV-180
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 II VIDEO SYSTEM CENTER OLYMPUS CV-180
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 II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P180, BF TYPE 1T180, BF TYPE Q180
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 biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree.
VISERA RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF TYPE V2
This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, display monitor, and other ancillary equipment for endoscopic diagnosis within the nasal lumens and airway (including nasopharyngeal and trachea).
VISERA RHINO-LARYNGO VIDEOSCOPE OLYMPUS XENF TYPE VTY1
This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, display monitor, endo-therapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the nasal lumens and airway anatomy (including nasopharyngeal and trachea).
6. Comparison of Technological Characteristics
Each primary component of the EVIS EXERA II 180 System is basically identical to its predicate device in intended use, and similar in specifications except for the NBI function. Comparison between the subject and predicate devices is shown in Table 16-3 to 16-9.
4
Table 16-3. Comparison of Specifications Subject Device: EVIS EXERA II Xenon Light Source Olympus CLV-180 Predicate Device: EVIS EXERA Xenon Light Source Olympus CLV-160A (K051645)
・・・・・・
| Specifications | Subject Device
CLV-180 | Predicate Device
CLV-160A | |
|-------------------------------------------------------------------|---------------------------------|--------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Power Supply | 100-120V ~ ± 10%, 50/60Hz ± 1Hz | 100-240V~ ±10%, 50/60Hz±1Hz | |
| Over-current Protection | Same as PD. | Fuse type | |
| Input Current | Same as PD. | 500VA (at observation) | |
| Size | 383(W) × 162(H) × 536(D)mm | 381(W)×162(H)×536(D)mm | |
| Weight | Same as PD. | 15.4kg | |
| Compatible Endoscopes | Same as PD. | Videoscope Fiberscope Rigid scope | |
| Examination Lamp | Same as PD. | Xenon short-arc lamp (ozone-free)300W | |
| Average Lamp Life | Same as PD. | Approximately 500 hours of continuous use | |
| Emergency Lamp | Same as PD. | Halogen lamp 12V 35W | |
| Average Emergency Lamp
Life | Same as PD. | Approximately 500 hours | |
| NBI Filter | Same as PD | Provided. | |
| Brightness Control | Same as PD | Automatic and Manual | |
| Automatic Exposure | Same as PD | 17 steps | |
| Photography Function | Same as PD. | Not provided | |
| Air Feeding | Same as PD | 4 levels available (off, low, mid, high) | |
| Air Feeding Pump | Same as PD | Diaphragm type pump | |
| System Connector | Same as PD | Provided | |
| Foot Switch Connector | Same as PD | Provided | |
| CV Connector | Same as PD | Provided | |
| Cooling Air Direction | Same as PD | Rear | |
| Type of Protection against
Electric Shock | Same as PD. | Class I | |
| Degree of Protection
against Electric Shock of
Applied Part | Same as PD | TYPE BF or CF applied part
(Depend on applied part) | |
| Applicable Standard | Same as PD | UL60601-1 | |
| Specifications | Subject Device
CV-180 | Predicate Device
CV-160A | |
| Power Supply | Same as PD. | 100-240V~ ±10%、 50/60Hz ± 1Hz | |
| Over-current Protection | Same as PD. | Fuse type | |
| Input Current | Same as PD. | 150VA | |
| Size | 382(W) × 91(H) × 490
(D)mm | 370(W) ×91(H) × 462 (D)mm | |
| Weight | 10 kg | 10.6 kg | |
| Compatible Endoscopes | Same as PD. | • Fiber/rigid scope via camera head
• Videoscope | |
| Observation | Video Signal
Output | Same as PD. | RGB:3 Y/C:4 VBS:4 HDTV:1 |
| | Auto White
Balance | Same as PD. | Automatically adjusted using the white
balance switch.
At the time of connection with the
scope in which Scope ID is provided,
compensation is performed
automatically. |
| | Standard Color
Chart Output | Same as PD. | Color bar image |
| | Color Tone
Adjustment | Same as PD. | R: ±8 steps B: ±8 steps
CHROMA : ±8steps |
| | Automatic Gain
Control (AGC) | Same as PD. | MAX gain: 18dB |
| | Image
Enhancement | Same as PD. | Edge enhancement: [OFF] [Low] [Med]
[High] 4 levels available
Structure enhancement:[OFF] [Low]
[Med] [High] 4 levels available |
| | Iris Mode
Selection | Same as PD. | AUTO/PEAK
EXPOSURE Electrical shutter |
| | Optical Zoom | Same as PD. | × 1/× 1.2 / × 1.5: 3-Mode |
| | NBI Observation | Same as PD. | NBI function |
| | Picture in
Picture | Same as PD. | The image of an external device
connected to this instrument is
displayed on the main monitor together
with the endoscopic image. |
| | Communication with Scope | Same as PD. | Provided |
| Foot Switch Connector | | Same as PD. | Provided |
| Record to Memory Card | | Same as PD. | Provided |
| Type of Protection
against Electric Shock | Same as PD. | Class I | |
| Degree of Protection against
Electric Shock of Applied Part | Same as PD. | TYPE BF or CF applied part
(Depend on applied part) | |
| Applicable Standard | | Same as PD. | UL60601-1 |
5
Table 16-4. Comparison of Specifications Subject Device: EVIS EXERA II Video System Center Olympus CV-180 Predicate Device: EVIS EXERA Video System Center Olympus CV-160A (K051645)
... ..........................................................................................................................................................................
6
Table 16-5. Comparison of Specifications Subject Device: EVIS EXERA II Bronchovideoscope BF-P180 Predicate Device: EVIS EXERA Bronchovideoscope BF-160 (K023984)
| Specifications | Subject Device
BF-P180 | Predicate Device
BF-160 |
|-----------------------------------------|---------------------------|----------------------------|
| Field of View | 120° | 120° |
| Depth of Field | 3-100 mm | 3-100 mm |
| Direction of View | 0° Forward Viewing | 0° Forward Viewing |
| Type of CCD | Color | Color |
| Outer Diameter of Distal End | 4.9 mm | 5.3 mm |
| Outer Diameter of Insertion
Tube | 4.9 mm | 5.2 mm |
| Bending Section Angulation
UP/DOWN | 180° /130° | 180° /130° |
| Working Length | 600 mm | 600 mm |
| Inner Diameter of Instrument
Channel | 2.0 mm | 2.0 mm |
Table 16-6. Comparison of Specifications Subject Device: EVIS EXERA II Bronchovideoscope BF-1T180 Predicate Device: EVIS EXERA Bronchovideoscope BF-1T160 (K023984)
| Specifications | Subject Device
BF-1T180 | Predicate Device
BF-1T160 |
|-----------------------------------------|----------------------------|------------------------------|
| Field of View | 120° | 120° |
| Depth of Field | 3-100 mm | 3-100 mm |
| Direction of View | 0° Forward Viewing | 0° Forward Viewing |
| Type of CCD | Color | Color |
| Outer Diameter of Distal End | 6.0 mm | 6.0 mm |
| Outer Diameter of Insertion
Tube | 6.0 mm | 6.0 mm |
| Bending Section Angulation
UP/DOWN | 180° /130° | 180° /130° |
| Working Length | 600 mm | 600 mm |
| Inner Diameter of Instrument
Channel | 3.0 mm | 2.8 mm |
7
Table 16-7. Comparison of Specifications Subject Device: EVIS EXERA II Bronchovideoscope BF-Q180 Predicate Device: EVIS EXERA Bronchovideoscope BF-160 (K023984)
| Specifications | Subject Device
BF-Q180 | Predicate Device
BF-160 |
|-----------------------------------------|---------------------------|----------------------------|
| Field of View | 120° | 120° |
| Depth of Field | 3-100 mm | 3-100 mm |
| Direction of View | 0° Forward Viewing | 0° Forward Viewing |
| Type of CCD | Color | Color |
| Outer Diameter of Distal End | 5.5 mm | 5.3 mm |
| Outer Diameter of Insertion
Tube | 5.1 mm | 5.2 mm |
| Bending Section Angulation
UP/DOWN | 180° /130° | 180° /130° |
| Working Length | 600 mm | 600 mm |
| Inner Diameter of Instrument
Channel | 2.0 mm | 2.0 mm |
Table 16-8. Comparison of Specifications
Subject Device: VISERA Rhino-Laryngo Videoscope Olympus ENF type V2 Predicate Device: VISERA Rhino-Laryngo Videoscope Olympus ENF type V (K031648)
| Specifications | Subject Device
ENF-V2 | Predicate Device
ENF-V |
|----------------------------------|--------------------------|---------------------------|
| Field of View | 90° | 90° |
| Depth of Field | 5-50mm | 5-50mm |
| Direction of Forward View | 0° | 0° |
| Type of CCD Chip | Color | Color |
| Outer Diameter of Distal End | $\$3.2mm | $\$3.9mm |
| Outer Diameter of Insertion Tube | $\$3.4mm | $\$3.9mm |
| Bending Section Angulation | Up: 130°
Down: 130° | Up: 130°
Down: 130° |
| Working Length | 300mm | 365mm |
To Laura: The ENF-V2 and ENF-V do not have an instrument channel, so I have deleted this column.
8
Table 16-9. Comparison of Specifications
Subject Device: VISERA Rhino-Laryngovideoscope Olympus XENF type VTY1 Predicate Device: VISERA Rhino-Laryngovideoscope Olympus ENF type VT (K052452)
| Specifications | Subject Device
XENF-VTY1 | Predicate Device
ENF-VT |
|-----------------------------------------|-----------------------------|----------------------------|
| Field of View | 90° | 90° |
| Depth of Field | 5-50mm | 5-50mm |
| Direction of Forward View | 0° | 0° |
| Type of CCD Chip | Color | Color |
| Outer Diameter of Distal End | $\phi$ 4.8mm | $\phi$ 4.8mm |
| Outer Diameter of Insertion Tube | $\phi$ 4.9mm | $\phi$ 4.9mm |
| Bending Section Angulation | Up: 130°
Down: 130° | Up: 130°
Down: 130° |
| Working Length | 365mm | 365mm |
| Inner Diameter of Instrument
Channel | $\phi$ 2.0mm | $\phi$ 2.0mm |
6. Conclusion
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
When compared to the predicate devices, the EVIS EXERA II 180 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 3 0 2006
Olympus America, Inc c/o Laura Storms-Tyler Executive Director, Regulatory Affairs and Quality Assurance 3500 Corporate Parkway P.O. Box 610 Center Valley, PA 18034-0610
Re: K061313
Trade/Device Name: Olympus Evis Exera 180 System Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: EOQ,EOB,NWB Dated: August 1, 2006 Received: August 2, 2006
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 include requirements 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be 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); 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) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
M.B. Eychlemin SiWD
Malvina B. Fydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K061313 Device Name: EVIS EXERA II 180 SYSTEM Indications for Use:
VISERA RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF TYPE V2
This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, display monitor, and other ancillary equipment for endoscopic diagnosis within the nasal lumens and airway anatomy (including nasopharyngeal and trachea).
VISERA RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF TYPE VTY1
This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, display monitor, endo-therapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the nasal lumens and airway anatomy (including nasopharyngeal and trachea).
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)
Voren A. Baker
Division Sign-Off
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
Page 1 of 2
510(k) Number K061313
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Indications for Use
510(k) Number (if known):
Device Name: EVIS EXERA II 180 SYSTEM
Indications For Use:
EVIS EXERA II XENON LIGHT SOURCE OLYMPUS CLV-180
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 II VIDEO SYSTEM CENTER OLYMPUS CV-180
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 II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P180, BF TYPE 1T180, BF TYPE Q180
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 biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree.
Prescription Use V (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)
510(k) Number
Page 1 of 2
Prescription Use (Per 21 CFR 801.109)