(169 days)
Not Found
No
The summary describes a 4K imaging system with a camera control unit, light source, and camera head. It focuses on image quality, resolution, and hardware components. There is no mention of AI, ML, or any advanced image processing that would suggest the use of these technologies for analysis or interpretation.
No
The device is described as being used for "endoscopic diagnosis, treatment, and observation," but its function is to provide images and light for these procedures. It does not directly perform a therapeutic action; it supports therapeutic actions by providing visual information.
Yes
The "Intended Use / Indications for Use" section explicitly states that the devices are designed for "endoscopic diagnosis."
No
The device description explicitly lists multiple hardware components including a camera control unit, light source, and camera head, which are the primary components of the submission.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for "endoscopic diagnosis, treatment, and observation." This describes a system used for visualizing internal body structures during medical procedures.
- Device Description: The description details a system that captures and processes optical images from endoscopes. It focuses on the hardware components (camera control unit, light source, camera head) and their function in providing high-quality visual information.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device operates in vivo (inside the body) by providing visual access. There is no mention of analyzing biological samples or performing tests on them.
The system described is a medical imaging system used for direct visualization during endoscopic procedures, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
VISERA 4K UHD CAMERA CONTROL UNIT OLYMPUS OTV-S400
The camera control unit has been designed to be used with Olympus endoscopes, camera heads, light source, monitors, and other ancillary equipment for endoscopic diagnosis, treatment, and observation.
VISERA 4K UHD XENON LIGHT SOURCE OLYMPUS CLV-S400
The light source has been designed to be used with Olympus endoscopes, camera control unit, light guide cables, and other ancillary equipment for endoscopic diagnosis, treatment, and observation.
4K CAMERA HEAD OLYMPUS CH-S400-XZ-EB
The camera head has been designed to be used with Olympus endoscopes, camera control unit, and other ancillary equipment for endoscopic diagnosis, treatment, and observation.
Product codes (comma separated list FDA assigned to the subject device)
HET, EOB, EOO, FGB, GCJ, NWB
Device Description
The VISERA 4K Ultra-High Definition (UHD) SYSTEM has been designed to be used with Olympus camera heads, endoscopes, camera control unit, light source, monitors, light guide cables and other ancillary equipment for endoscopic diagnosis, treatment and observation. The VISERA 4K UHD SYSTEM consists of a camera control unit (CCU), light source, camera head, endoscope, monitors, printer, medical image storage device, cables and workstation.
The primary components of the subject system, which are part of this submission, are:
-
VISERA 4K UHD CAMERA CONTROL UNIT OLYMPUS OTV-S400
-
VISERA 4K UHD XENON LIGHT SOURCE OLYMPUS CLV-S400
-
4K CAMERA HEAD OLYMPUS CH-S400-XZ-EB
The VISERA 4K UHD SYSTEM receives optical image from a variety of endoscopes that are attached to the camera head via coupler and use image sensor to convert optical image into electronic signal. The CCU acts as the the control center of the system. The light source supplies light.
The VISERA 4K UHD SYSTEM can provide high quality 4K images. The VISERA 4K UHD SYSTEM supports wider color gamut. The new 4K camera heads incorporate a complementary metal oxide semiconductor (CMOS) image sensor. A camera control unit introduces a touch panel graphical interface.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
optical image
Anatomical Site
Not Found
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)
A performance testings were conducted to demonstrate that the VISERA 4K UHD SYSTEM performs according to specifications and functions as intended. Tests results obtained verified the safety and effectiveness of the devices in accordance with design specifications and applicable standards.
The instructions for reprocessing of the subject devices include Cleaning, Disinfection, and Sterilization. All cleaning, disinfection, and sterilization methods have been validated.
The software validation activities were performed in accordance with the FDA Guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
Electromagnetic compatibility, electric safety, and thermal safety had been confirmed.
Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verification tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment.
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
§ 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized graphic of three human profiles facing right, layered on top of each other. The profiles are connected by a flowing ribbon-like shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the graphic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 1, 2015
Olympus Medical Systems Corp. Daphney Germain-Kolawole Project Manager, Regulatory Affairs 3500 Corporate Parkway P.O. Box 610 Center Valley, PA 18034-0610
Re: K151011
Trade/Device Name: VISERA 4K UHD SYSTEM Regulation Number: 21 CFR 884.1720 Regulation Name: Gynecologic laparoscope and accessories Regulatory Class: Class II Product Code: HET, EOB, EOO, FGB, GCJ, NWB Dated: August 31, 2015 Received: September 1, 2015
Dear Daphney Germain-Kolawole,
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device
1
related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Herbert P. Lerner -S
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K151011
Device Name
VISERA 4K UHD SYSTEM
Indications for Use (Describe)
VISERA 4K UHD CAMERA CONTROL UNIT OLYMPUS OTV-S400
The camera control unit has been designed to be used with Olympus endoscopes, camera heads, light source, monitors, and other ancillary equipment for endoscopic diagnosis, treatment, and observation.
VISERA 4K UHD XENON LIGHT SOURCE OLYMPUS CLV-S400
The light source has been designed to be used with Olympus endoscopes, camera control unit, light guide cables, and other ancillary equipment for endoscopic diagnosis, treatment, and observation.
4K CAMERA HEAD OLYMPUS CH-S400-XZ-EB
The camera head has been designed to be used with Olympus endoscopes, camera control unit, and other ancillary equipment for endoscopic diagnosis, treatment, and observation.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Image /page/3/Picture/1 description: The image shows the logo for Olympus. The word "OLYMPUS" is written in large, bold, blue letters. Below the word is a thin, horizontal, yellow line. Underneath the line, the words "Your Vision, Our Future" are written in a smaller, lighter font.
October 1, 2015
I. General Information
- . Applicant: Olympus Medical Systems Corp. 2951 Ishikawa-cho, Hachioji-shi, Tokyo, 192-8507, Japan Establishment Registration No: 8010047
- Daphney Germain-Kolawole . Official Correspondent: Project Manager, Regulatory Affairs Olympus Corporation of the Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610, USA Phone: 484-896-5691 FAX: 484-896-7128
- Shirakawa Olympus Co., Ltd. . Manufacturer: 3-1 Okamiyama, Odakura, Nishigo-mura, Nishirakawa-gun, Fukushima 961-8061, Japan Registration Number: 3002808148
II. Device Identification
| Device Trade Name: | VISERA 4K UHD SYSTEM |
|---|---|
| Common Name: | ENDOSCOPIC IMAGING SYSTEM |
| Regulation Number: | 884.1720 |
| 876.1500 | |
| 874.4680 | |
| Regulation Name: | Gynecologic laparoscope and accessories |
| Endoscope and Accessories | |
| Bronchoscope (flexible or rigid) and accessories | |
| Regulatory Class: | II |
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Image /page/4/Picture/0 description: The image displays the logo for Olympus. The word "OLYMPUS" is written in large, bold, blue letters. A thin, yellow line is underneath the word. Below the line, the words "Your Vision, Our Future" are written in a smaller font.
| ■ Classification Panel: | General and plastic surgery,
Obstetrics/Gynecology
Ear Nose & Throat |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ■ Product Code: | HET; Laparoscope, Gynecologic (And Accessories)
EOB; Nasopharyngoscope (Flexible Or Rigid)
EOQ; Bronchoscope (Flexible Or Rigid)
FGB; Ureteroscope And Accessories, Flexible/Rigid
GCJ; Laparoscope, General & Plastic Surgery
NWB; Endoscope, Accessories, Narrow Band Spectrum |
Predicate Device Information III.
| Subject Device
(Part of this submission) | Predicate Device | Predicate Device
510(k) No. |
|----------------------------------------------------------|---------------------------------------------------------|--------------------------------|
| VISERA 4K UHD
CAMERA CONTROL UNIT
OLYMPUS OTV-S400 | VISERA ELITE
VIDEO SYSTEM CENTER
OLYMPUS OTV-S190 | K111425 |
| VISERA 4K UHD
XENON LIGHT SOURCE
OLYMPUS CLV-S400 | VISERA ELITE
XENON LIGHT SOURCE
OLYMPUS CLV-S190 | K111425 |
| 4K CAMERA HEAD
OLYMPUS CH-S400-XZ-EB | AUTOCLAVABLE CAMERA
HEAD
OTV-Y0017 | K102059 |
IV. Device Description
The VISERA 4K Ultra-High Definition (UHD) SYSTEM has been designed to be used with Olympus camera heads, endoscopes, camera control unit, light source, monitors, light guide cables and other ancillary equipment for endoscopic diagnosis, treatment and observation. The VISERA 4K UHD SYSTEM consists of a camera control unit (CCU), light source, camera head, endoscope, monitors, printer, medical image storage device, cables and workstation.
The primary components of the subject system, which are part of this submission, are:
-
VISERA 4K UHD CAMERA CONTROL UNIT OLYMPUS OTV-S400
-
VISERA 4K UHD XENON LIGHT SOURCE OLYMPUS CLV-S400
-
4K CAMERA HEAD OLYMPUS CH-S400-XZ-EB
5
Image /page/5/Picture/1 description: The image shows the logo for Olympus. The word "OLYMPUS" is written in large, bold, blue letters. Below the word is a thin, horizontal, yellow line. Below the line is the text "Your Vision, Our Future".
The VISERA 4K UHD SYSTEM receives optical image from a variety of endoscopes that are attached to the camera head via coupler and use image sensor to convert optical image into electronic signal. The CCU acts as the the control center of the system. The light source supplies light.
The VISERA 4K UHD SYSTEM can provide high quality 4K images. The VISERA 4K UHD SYSTEM supports wider color gamut. The new 4K camera heads incorporate a complementary metal oxide semiconductor (CMOS) image sensor. A camera control unit introduces a touch panel graphical interface.
V. Indications for Use
VISERA 4K UHD CAMERA CONTROL UNIT OLYMPUS OTV-S400
The camera control unit has been designed to be used with Olympus endoscopes, camera heads, light source, monitors, and other ancillary equipment for endoscopic diagnosis, treatment, and observation.
VISERA 4K UHD XENON LIGHT SOURCE OLYMPUS CLV-S400
The light source has been designed to be used with Olympus endoscopes, camera control unit, light guide cables, and other ancillary equipment for endoscopic diagnosis, treatment, and observation.
4K CAMERA HEAD OLYMPUS CH-S400-XZ-EB
The camera head has been designed to be used with Olympus endoscopes, camera control unit, and other ancillary equipment for endoscopic diagnosis, treatment, and observation.
VI. Comparison of Technological Characteristics
The VISERA 4K UHD SYSTEM has the same technological characteristics and design as the predicate device except the following new features:
- The VISERA 4K UHD SYSTEM can provide high quality 4K images
- The VISERA 4K UHD SYSTEM supports wider color gamut
- New 4K camera head incorporate a CMOS image sensor
- The CCU introduces touch panel graphical interface
As shown in the comparison tables at the end of this section, all other technological characteristics of both subject and predicate deveices are identical.
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Image /page/6/Picture/0 description: The image shows the logo for Olympus. The word "OLYMPUS" is written in large, bold, dark blue letters. A thin, gold line is underneath the word. Below the line, the words "Your Vision, Our Future" are written in a smaller, dark font.
VII. Summary of non-clinical testing
The differences of technological characteristics between the predicate device and the subject device are confirmed that they are substantially equivalent through the following tests and standards.
- A performance testings were conducted to demonstrate that the VISERA 4K UHD SYSTEM performs according to specifications and functions as intended. Tests results obtained verified the safety and effectiveness of the devices in accordance with design specifications and applicable standards..
- The instructions for reprocessing of the subject devices include Cleaning, • Disinfection, and Sterilization. All cleaning, disinfection, and sterilization methods have been validated.
- The software validation activities were performed in accordance with the FDA Guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
- Electromagnetic compatibility, electric safety, and thermal safety had been confirmed.
- Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verification tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment.
The following voluntary standards to comply with have been applied to the VISERA 4K UHD System;
- IEC 60601-1: 2005+A1, -
- IEC 60601-1-2: 2007, -
- IEC 60601-2-18: 2009, -
- IEC 60825-1: 2007, -
- ISO 14971: 2007. -
VIII. Conclusion
The VISERA 4K UHD SYSTEM has the same intended use and similar indications for use, technological characteristics, and principal operations. The technological differences raised no new issues of safety or effectiveness as compared to its predicate device. Performance tests demonstrate that the VISERA 4K UHD SYSTEM performs according to specifications and functions as intended. Therefore, the VISERA 4K UHD SYSTEM is substantially equivalent to its predicate device.
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Image /page/7/Picture/0 description: The image shows the logo for Olympus. The word "OLYMPUS" is written in large, bold, blue letters. Below the word is a thin, horizontal, yellow line, and below that is the text "Your Vision, Our Future" in a smaller, blue font.
Device Comparison Tables
Table1 :Comparison table of the OTV-S400
| | | Subject device: OTV-S400
VISERA 4K UHD CAMERA CONTROL UNIT | Predicate device: OTV-S190
VISERA ELITE VIDEO SYSTEM CENTER |
|-------------------------------------------------------------|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | | K151011 | K111425 |
| Regulation number | | Same | 884.1720, 874.4680, 876.1500 |
| Device class | | Same | II |
| Product code | | Same | HET, EOB, EOQ, FGB, GCJ, NWB |
| Indications for use | | The camera control unit has been designed to
be used with Olympus endoscopes, camera
heads, light source, monitors and other
ancillary equipment for endoscopic diagnosis,
treatment, and observation. | 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. |
| Power Supply | | Same | 100-240V~ ±10%
50/60Hz±1Hz |
| Dimension | | 390(W) × 160(H) × 506(D) mm | 375(W) × 91(H) × 489(D) mm |
| Weight | | 13.5Kg | 8.8Kg |
| Input power | | 350 VA | 150VA |
| Resolution | | 4K (4096pxl×2160pxl) | SD/HD (1920pxl×1080pxl) |
| Image observation | Image signal output | SDI (3G/HD) | RGB : 2, Y/C : 2, VBS : 2, SDI : 2, DVI : 1 |
| | Iris mode selection | AUTO/CENTER | AUTO/PEAK/AVE |
| | Standard Color Chart Output | Same | Color bar image |
| | Color Tone Adjustment | Same | R,B,C:±8 steps |
| Operating
Environme | Observation light imaging | Same | WLI (white light imaging)
NBI (narrow band imaging) |
| | Ambient temperature | 10 - 35°C(50 - 95°F) | 10 to 40°C |
| | Humidity | Same | 3085% RH |1060 hPa |
| Atmosphere | | Same | 700
| Electric safety | | Comply to IEC 60601-1: 2005+A1,
IEC 60601-2-18: 2009 | Comply to IEC 60601-1: 1998+A1,A2,
IEC 60601-2-18: 1996+A1 |
| | | Same | Class I |
| Type of Protection against Electric Shock | | Comply to IEC 60825-1: 2007 | N/A |
| Laser Product | | Type BF applied part | Type BF or CF applied part
(Depends on applied part) |
| Degree of Protection against Electric Shock of Applied Part | | Same | Comply to IEC 60601-1-2: 2007 |
| EMC | | | |
8
Image /page/8/Picture/1 description: The image shows the logo for Olympus. The word "OLYMPUS" is written in large, bold, blue letters. Below the word is a thin, yellow line, and below that is the text "Your Vision, Our Future" in a smaller, blue font.
Table2:Comparison table of the CLV-S400
| | Subject device:
CLV-S400
VISERA 4K UHD XENON LIGHT SOURCE | Predicate device:
CLV-S190
VISERA ELITE XENON LIGHT SOURCE |
|----------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | K151011 | K111425 |
| Regulation number | Same | 884.1720, 874.4680, 876.1500 |
| Device class | Same | II |
| Product code | Same | HET, EOB, EOQ, FGB, GCJ, NWB |
| Indications for use | The light source has been designed to be used
with Olympus endoscopes, camera control
unit, light guide cables, and other ancillary
equipment for endoscopic diagnosis, treatment
and observation. | 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. |
| Power Supply | Same | 100-240 V~ ±10%
50/60 Hz±1Hz |
| Dimension | 390 (W)
×162 (H)×551 (D) mm | 383 (W) × 162 (H) × 536(D) mm |
| Weight | 15.5kg | 14.9kg |
| Input power
(Consumption
Electric Power) | 500 VA | 500 VA |
| Examination Lamp | Same | Xenon short-arc lamp
(ozone-free) 300W |
| Average Lamp Life | Same | Approximately 500 hours of
continuous use |
| Emergency Lamp | Same | Halogen Lamp 12V 35W |
| Average Emergency
Lamp Life | Same | Approximately 500 hours |
| Automatic Exposure | Same | 17 steps |
| Electric safety | Comply to IEC 60601-1: 2005+A1,
IEC 60601-2-18: 2009 | Comply to IEC 60601-1: 1998+A1,A2,
IEC 60601-2-18: 1996+A1 |
| Type of Protection
against Electric
Shock | Same | Class I |
| Degree of Protection
against Electric
Shock of Applied
Part | Type BF applied part | Type BF or CF applied part
(Depends on applied part) |
| EMC | Same | Comply to IEC 60601-1-2: 2007 |
9
| Table3 :Comparison table of the CH-S400-XZ-EB | ||
|---|---|---|
| ----------------------------------------------- | -- | -- |
| | | Subject device: CH-S400-XZ-EB
4K CAMERA HEAD | Predicate device: OTV-Y0017
AUTOCLAVABLE CAMERA HEAD |
|--------------------------|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | | K151011 | K102059 |
| Regulation number | | Same | 876.1500 |
| Device class | | Same | II |
| Product code | | Same | FET, NWB |
| Indications for use | | The camera head has been designed to be used with Olympus endoscopes, camera control unit, and other ancillary equipment for endoscopic diagnosis, treatment and observation. | This camera head has been designed to be used with the CV-180 EXERA II video system center or OTV-S7Pro VISERA Pro video system center, endoscopes, light sources, video monitors and other ancillary equipment for endoscopic diagnosis and treatment. |
| Dimension | Camera Head | W43.6 mm × H49.5 mm × L122.5 mm | 38 mm×106 mm |
| | Cable | 5.1 mm × 3 m | 6.8 mm×4 m |
| | Weight | 280 g (excluding cable) | 215 g (excluding cable) |
| Operating
Environment | Ambient temperature | 10 - 35°C(50 - 95°F) | 10 to 40°C |
| | Humidity | Same | 3085% RH |1060 hPa |
| | Atmosphere | Same | 700
| Reprocessing | | End user sterilized
EOG/ STERRAD | End user sterilized
AUTOCLAVE |
| Electric safety | | Comply to IEC 60601-2-18: 2009 | Comply to IEC 60601-2-18: 1996+A1 |
| Laser Product | | Comply to IEC 60825-1: 2007 | N/A |
| EMC | | Comply to IEC 60601-1-2: 2007 | Comply to IEC 60601-1-2: 2001+A1 |