(186 days)
Not Found
No
The description focuses on standard video processing and imaging techniques (WLI, NBI) and does not mention any AI or ML capabilities. The performance studies listed are standard tests for medical devices and do not indicate the use of AI/ML.
No
The device is used for endoscopic diagnosis, treatment, and observation, which includes providing images for diagnosis and facilitating treatment by offering visualization, but it does not directly perform a therapeutic action. Its primary function is image acquisition, processing, and display to assist with procedures.
Yes
The "Intended Use / Indications for Use" section explicitly states that the video system center and camera heads are intended for "endoscopic diagnosis."
No
The device description clearly details hardware components like a video system center with a light source and video processor, and camera heads with imagers, cables, and connectors. While software is involved in processing, the device is fundamentally a hardware system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the system is for "endoscopic diagnosis, treatment, and video observation." This involves visualizing internal body structures directly, not analyzing samples taken from the body.
- Device Description: The description details how the system captures and processes light reflected from internal tissues to produce images on a monitor. This is a form of in-vivo imaging, not in-vitro testing of biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), using reagents, or performing tests on specimens outside the body.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is an endoscopic imaging system used for direct visualization within the body.
N/A
Intended Use / Indications for Use
VISERA ELITE II VIDEO SYSTEM CENTER OLYMPUS OTV-S200
This video system center is intended to be used with OLYMPUS camera heads, endoscopes, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation.
VISERA ELITE IT HD 3CMOS AUTOCLAVABLE CAMERA HEAD OL YMPUS CH-S200-XZ-EA
The camera head has been designed to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment, and observation.
VISERA ELITE II HD 3CMOS CAMERA HEAD OLYMPUS CH-S200-XZ-EB
The camera head has been designed to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment, and observation.
Product codes (comma separated list FDA assigned to the subject device)
FET, NWB
Device Description
The OTV-S200 is intended to be used with OLYMPUS camera heads, endoscopes, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation. The OTV-S200 has a light source and video processor function. The endoscope light guide cable is connected to the output socket on the subject device and the endoscope video connector or camera head is connected to video connector socket. The OTV-S200 emits light to the endoscope via the light guide cable and receives the electrical signal from the endoscope or camera head via the video connector. After processing, the OTV-S200 outputs endoscopic images on the monitor. The subject device provides white light imaging (WLI) and narrow band imaging (NBI). The OTV-S200 function is operated by a touch panel screen.
The CH-S200-XZ-EA and CH-S200-XZ-EB have been designed to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment, and observation. The CH-S200-XZ-EA and CH-S200-XZ-EB are compatible with Olympus rigid endoscopes to be used to observe various anatomical locations. The subject devices are constructed with a camera head (body), camera cable and video connector and connected to an endoscope by the lock ring on the camera head. Light is supplied from the video system center to the rigid endoscope via a light guide cable and emitted from the distal end of the endoscope. The objective lens on the distal end of the endoscope receives the light from the object and the light guide inside the endoscope transfers the light to the eyepiece and 3CMOS (imager) inside the subject device. The imagers convert the light to an electrical signal and the signal is transferred to a video system center via the camera cable and video connector. Finally, an endoscopic image is outputted on the monitor after processing in the video system center. The subject devices provide white light imaging (WLI) and narrow band imaging (NBI). Zoom and focus are controlled by switches or rings on the camera head for the CH-S200-XZ-EA or CH-S200-XZ-EB, respectively. Three remote switches on the camera head provide operation of the video system center function by setting the functions prior to the procedure.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Healthcare facility/hospital. Prescription Use.
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)
- Reprocessing validation testing: Reprocessing instruction and reprocessing method validation testing for the CH-S200-XZ-EA and CH-S200-XZ-EB were conducted and documentation was provided as recommended by Guidance for Industry and Food and Drug Administration Staff, "Reprocessing Medical Devices in Health Care Setting: Validation Methods and Labeling".
- Software verification and validation testing: Software verification and validation testing for the OTV-S200 were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices".
- Electrical safety and electromagnetic compatibility (EMC): Electrical safety and EMC testing were conducted on the OTV-S200, CH-S200-XZ-EA and CH-S200-XZ-EB. The subject devices comply with the ANSI/AAMI ES 60601-1:2005/(R)2012 and A1:2012 and IEC 60601-2-18:2009 standards for safety and the IEC 60601-1-2:2014 standards for EMC.
- Performance testing - Bench: Bench testing for the OTV-S200, CH-S200-XZ-EA and CH-S200-XZ-EB as listed below was conducted to ensure that the subject device performs as intended and meet design specifications.
- Difference for Emergency Lamp
- NBI Observation
- Image Quality
- Photobiological safety
- NBI Color Adjustment
- Function of Switching of the "iris area"
- Laser mode
- Confirmation of Full HD image
- FOV
- Performance testing - Animal: No animal study was performed to demonstrate substantial equivalence.
- Performance testing - Clinical: No clinical study was performed to demonstrate substantial equivalence.
- Risk analysis: Risk analysis for the OTV-S200, CH-S200-XZ-EA and CH-S200-XZ-EB was conducted 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
§ 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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 30, 2019
Olympus Medical Systems Corp. % Daphney Germain-Kolawole Senior Project Manager, Regulatory Affairs Olympus Corporation of the Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610
Re: K190449
Trade/Device Name: Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable Camera Head, Visera Elite II 3CMOS Camera Head Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FET, NWB Dated: July 17, 2019 Received: July 19, 2019
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Martha Betz, Ph.D. Acting Assistant Division Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190449
Device Name
VISERA ELITE II VIDEO SYSTEM CENTER VISERA ELITE IT HD 3CMOS AUTOCLAVABLE CAMERA HEAD VISERA ELITE II HD 3CMOS CAMERA HEAD
Indications for Use (Describe)
VISERA ELITE II VIDEO SYSTEM CENTER OLYMPUS OTV-S200
This video system center is intended to be used with OLYMPUS camera heads, endoscopes, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation.
VISERA ELITE IT HD 3CMOS AUTOCLAVABLE CAMERA HEAD OL YMPUS CH-S200-XZ-EA
The camera head has been designed to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment, and observation.
VISERA ELITE II HD 3CMOS CAMERA HEAD OLYMPUS CH-S200-XZ-EB
The camera head has been designed to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment, and observation.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Image /page/3/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The font is sans-serif and the letters are closely spaced together. There is a yellow line underneath the word. The logo is simple and modern.
Date Prepared: August 29, 2019
Section 5
510(k) Summary
5.1 GENERAL INFORMATION
■ 510(k) Submitter: OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507
- Contact Person: Daphney Germain-Kolawole 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 Email: daphney.germain-kolawole@olympus.com
- Manufacturing site: Shirakawa Olympus Co., Ltd. 3-1 Okamiyama, Odakura, Nishigo-mura, Nishishirakawa-gun, Fukushima 961-8061, Japan
5.2 DEVICE IDENTIFICATION
5.2.1 OTV-S200
| ■ Device Name | VISERA ELITE II VIDEO SYSTEM CENTER |
|---|---|
| ■ Model Name | OTV-S200 |
| ■ Common Name | Endoscopic Video Imaging System/Component |
| ■ Regulation Number | 876.1500 |
| ■ Regulation Name | Endoscope and accessories |
| ■ Regulatory Class | II |
| ■ Product Code | FET; Endoscopic Video Imaging System/Component, |
| Gastroenterology-Urology | |
| NWB; Endoscope, Accessories, Narrow Band Spectrum | |
| ■ Classification Panel | Gastroenterology/Urology |
4
Image /page/4/Picture/0 description: The image features the word "OLYMPUS" in large, bold, blue letters. The font is sans-serif and appears to be a custom typeface. A registered trademark symbol is present to the right of the letter "S", indicating that the brand name is legally protected.
5.2.2 CH-S200-XZ-EA, CH-S200-XZ-EB
- Device Name VISERA ELITE II HD 3CMOS AUTOCLAVABLE CAMERA HEAD
VISERA ELITE II HD 3CMOS CAMERA HEAD
- Model Name CH-S200-XZ-EA
CH-S200-XZ-EB
- Common Name Endoscopic Video Imaging System/Component
- Regulation Number 876.1500
- Regulation Name Endoscope and accessories
- Regulatory Class II
- Product Code FET; Endoscopic Video Imaging System/Component, Gastroenterology-Urology NWB; Endoscope, Accessories, Narrow Band Spectrum
- Classification Panel Gastroenterology/Urology
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5.3 PREDICATE DEVICE
5.3.1 OTV-S200
| Subject Device
(Part of this submission) | Predicate Device | Predicate Device
510(k) No. |
|------------------------------------------------------------|---------------------------------------------------------|--------------------------------|
| VISERA ELITE II VIDEO
SYSTEM CENTER
OLYMPUS OTV-S200 | VISERA ELITE
VIDEO SYSTEM CENTER
OLYMPUS OTV-S190 | K111425 |
| | VISERA ELITE
XENON LIGHT SOURCE
OLYMPUS CLV-S190 | K111425 |
5.3.2 CH-S200XZ-EA, CH-S200-XZ-EB
| Subject Device
(Part of this submission) | Predicate Device | Predicate Device
510(k) No. |
|----------------------------------------------------------------------------------|---------------------------------------|--------------------------------|
| VISERA ELITE II HD
3CMOS AUTOCLAVABLE
CAMERA HEAD
OLYMPUS CH-S200-XZ-EA | AUTOCLAVABLE CAMERA
HEAD OTV-Y0017 | K102059 |
| VISERA ELITE II HD
3CMOS CAMERA HEAD
OLYMPUS CH-S200-XZ-EB | AUTOCLAVABLE CAMERA
HEAD OTV-Y0017 | K102059 |
6
K190449 page 4 of 11
5.4 DEVICE DESCRIPTION
5.4.1 OTV-S200
The OTV-S200 is intended to be used with OLYMPUS camera heads, endoscopes, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation. The OTV-S200 has a light source and video processor function. The endoscope light guide cable is connected to the output socket on the subject device and the endoscope video connector or camera head is connected to video connector socket. The OTV-S200 emits light to the endoscope via the light guide cable and receives the electrical signal from the endoscope or camera head via the video connector. After processing, the OTV-S200 outputs endoscopic images on the monitor. The subject device provides white light imaging (WLI) and narrow band imaging (NBI). The OTV-S200 function is operated by a touch panel screen.
| |
OTV-S200 |
OTV-S190 |
CLV-S190 |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | - | K111425 | K111425 |
| Regulation number | 884.1720 | 884.1720 | 884.1720 |
| Regulatory Class | II | II | II |
| Product code | HET, FET,NWB, EOB, EOQ, FGB, GCJ | HET,EOB,EOQ, FGB,GCJ,NWB | HET,EOB,EOQ, FGB,GCJ,NWB |
| Manufacturer | Olympus Medical Systems Corp | Olympus Medical Systems Corp | Olympus Medical Systems Corp |
| Indications for use | This video system center is
intended to be used with
OLYMPUS camera heads,
endoscopes, monitors,
EndoTherapy accessories,
and other ancillary
equipment for endoscopic
diagnosis, treatment, and
video 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. | 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. |
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Image /page/7/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are slightly blurred, giving them a soft appearance. A thin, horizontal, yellow line is visible beneath the word, adding a subtle accent to the logo.
| |
OTV-S200 |
OTV-S190 |
CLV-S190 |
|-------------------------|------------------------------|------------------------------------------|---------------------------------------------|
| Environment of use | Healthcare facility/hospital | Healthcare facility/hospital | Healthcare facility/hospital |
| Single/repeat use | Repeat use | Repeat use | Repeat use |
| Sterile/non-sterile | Marketed as non-sterile | Marketed as non-sterile | Marketed as non-sterile |
| Rated voltage | 120V AC
50/60Hz | 120V AC
50/60Hz | 120V AC
50/60Hz |
| Rated input | 400VA | 150VA | 500A |
| Dimension (maximum) | W383×H199×D506 (mm) | W382×H91×D489 (mm) | W383×H162×D536 (mm) |
| Weight | 19.0kg | 8.8kg | 14.9kg |
| AGC(Auto gain control) | Provided | Provided | Provided |
| Front panel (Operation) | Touch panel | Push button | Push button |
| Examination Lamp | LED | Not provided | Xe lamp |
| NBI | Provided | Provided | Provided |
5.4.2 CH-S200-XZ-EA, CH-S200-XZ-EB
The CH-S200-XZ-EA and CH-S200-XZ-EB have been designed to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment, and observation. The CH-S200-XZ-EA and CH-S200-XZ-EB are compatible with Olympus rigid endoscopes to be used to observe various anatomical locations. The subject devices are constructed with a camera head (body), camera cable and video connector and connected to an endoscope by the lock ring on the camera head. Light is supplied from the video system center to the rigid endoscope via a light guide cable and emitted from the distal end of the endoscope. The objective lens on the distal end of the endoscope receives the light from the object and the light guide inside the endoscope transfers the light to the eyepiece and 3CMOS
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K190449 page 6 of 11
(imager) inside the subject device. The imagers convert the light to an electrical signal and the signal is transferred to a video system center via the camera cable and video connector. Finally, an endoscopic image is outputted on the monitor after processing in the video system center. The subject devices provide white light imaging (WLI) and narrow band imaging (NBI). Zoom and focus are controlled by switches or rings on the camera head for the CH-S200-XZ-EA or CH-S200-XZ-EB, respectively. Three remote switches on the camera head provide operation of the video system center function by setting the functions prior to the procedure.
| CH-S200-XZ-EA | OTV-Y0017 | |
| AUTOCLAVABLE CAMERA | ||
| HEAD | ||
| 510(k) | ||
| Number | - | K102059 |
| Regulation | ||
| number | 876.1500 | 876.1500 |
| Regulatory | ||
| Class | II | II |
| Product code | FET,NWB | FET,NWB |
| Manufacturer | Olympus Medical Systems Corp | Olympus Medical Systems Corp |
| Indications for | ||
| use | The camera head has been designed to | |
| be used with Olympus endoscopes, | ||
| video system center, 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. | ||
| Environment | ||
| of use | Healthcare facility/hospital | Healthcare facility/hospital |
| Single/repeat | Repeat use | Repeat use |
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Image /page/9/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. There is a registered trademark symbol to the right of the word. The word is likely a logo for the company Olympus.
| CH-S200-XZ-EA | OTV-Y0017 | |
| AUTOCLAVABLE CAMERA | ||
| HEAD | ||
| Sterile/non-sterile | Marketed as non-sterile | Marketed as non-sterile |
| Head dimension (mm) | W44 × H52 × L120 | φ38mm×L106mm |
| NBI | Available | Available |
| Focus control | Electrical manual focus with focus control switches | Manual focus ring |
| Head weight | 295g | 215g |
| Image module | CMOS image sensor × 3 | CCD image sensor × 1 |
| Optical zoom | Provided | Not provided |
| Connector surface | Card edge connector | Card edge connector |
| Reprocessing | End user sterilized | |
| AUTOCLAVE/V-PRO/ STERRAD | End user sterilized | |
| AUTOCLAVE |
| CH-S200-XZ-EB | OTV-Y0017 | |
| AUTOCLAVABLE CAMERA | ||
| HEAD | ||
| 510(k) | ||
| Number | - | K102059 |
| Regulation | ||
| number | 876.1500 | 876.1500 |
| Regulatory | ||
| Class | II | II |
| Product code | FET,NWB | FET,NWB |
| Manufacturer | Olympus Medical Systems Corp | Olympus Medical Systems Corp |
| Indications for | ||
| use | The camera head has been designed to | |
| be used with Olympus endoscopes. | This camera head has been designed | |
| to be used with the CV-180 EXERA | ||
| CH-S200-XZ-EB | OTV-Y0017 | |
| AUTOCLAVABLE CAMERA | ||
| HEAD | ||
| video system center, and other | II video system center or OTV-S7Pro | |
| ancillary equipment for endoscopic | VISERA Pro video system center, | |
| diagnosis, treatment, and observation. | endoscopes, light sources, video | |
| monitors and other ancillary | ||
| equipment for endoscopic diagnosis | ||
| and treatment. | ||
| Environment | Healthcare facility/hospital | Healthcare facility/hospital |
| of use | ||
| Single/repeat | Repeat use | Repeat use |
| use | ||
| Sterile/non-ster | Marketed as non-sterile | Marketed as non-sterile |
| ile | ||
| Head | W44 × H49 × L113 | φ38mm×L106mm |
| dimension | ||
| (mm) | ||
| NBI | Available | Available |
| Focus control | Electrical manual focus with focus | Manual focus ring |
| control switches | ||
| Head weight | 220g | 215g |
| Image module | CMOS image sensor × 3 | CCD image sensor × 1 |
| Optical zoom | Provided | Not provided |
| Connector | Card edge connector | Card edge connector |
| surface | ||
| Reprocessing | End user sterilized | End user sterilized |
| V-PRO/STERRAD | AUTOCLAVE |
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Image /page/10/Picture/0 description: The image displays the word "OLYMPUS" in large, bold, blue capital letters. The font is sans-serif and appears to be a custom typeface. A registered trademark symbol is located at the upper right of the word.
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Image /page/11/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are slightly stylized, with a subtle gradient effect. Below the word, there is a horizontal yellow bar that spans the width of the word. The logo is clean and simple, with a focus on the brand name.
5.5 INDICATIONS FOR USE VISERA ELITE II VIDEO SYSTEM CENTER OLYMPUS OTV-S200
This video system center is intended to be used with OLYMPUS camera heads, endoscopes, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation.
VISERA ELITE II HD 3CMOS AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S200-XZ-EA
The camera head has been designed to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment, and observation.
VISERA ELITE II HD 3CMOS CAMERA HEAD OLYMPUS CH-S200-XZ-EB
The camera head has been designed to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment, and observation.
5.6 COMPARISON OF TECHNOLOGY CHARACTERISTICS WITH THE
PREDICATE DEIVCE
5.6.1 OTV-S200
The OTV-S200 has the same technological characteristics and design as the predicate device except for the following new features:
- Integration of the video processor and light source ।
- New LED construction -
5.6.2 CH-S200-XZ-EA, CH-S200-XZ-EB
The CH-S200-XZ-EA and CH-S200-XZ-EB have the same technological characteristics and design as the predicate device except for the following new features: - Adoption of 3CMOS
All other technological characteristics of both the subject and predicate devices are identical. Validation from non-clinical testing demonstrated that these technological features do not raise any new issues of safety or effectiveness of the subject device.
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5.7 PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
1) Reprocessing validation testing
Reprocessing instruction and reprocessing method validation testing for the CH-S200-XZ-EA and CH-S200-XZ-EB were conducted and documentation was provided as recommended by Guidance for Industry and Food and Drug Administration Staff, "Reprocessing Medical Devices in Health Care Setting: Validation Methods and Labeling".
2) Software verification and validation testing
Software verification and validation testing for the OTV-S200 were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices".
3) Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the OTV-S200, CH-S200-XZ-EA and CH-S200-XZ-EB. The subject devices comply with the ANSI/AAMI ES 60601-1:2005/(R)2012 and A1:2012 and IEC 60601-2-18:2009 standards for safety and the IEC 60601-1-2:2014 standards for EMC.
4) Performance testing - Bench
Bench testing for the OTV-S200, CH-S200-XZ-EA and CH-S200-XZ-EB as listed below was conducted to ensure that the subject device performs as intended and meet design specifications.
- Difference for Emergency Lamp
- NBI Observation
- Image Quality
- Photobiological safety
- NBI Color Adjustment
- Function of Switching of the "iris area"
- Laser mode
- Confirmation of Full HD image
- FOV
5) Performance testing - Animal
No animal study was performed to demonstrate substantial equivalence.
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6) Performance testing - Clinical
No clinical study was performed to demonstrate substantial equivalence.
7) Risk analysis
Risk analysis for the OTV-S200, CH-S200-XZ-EA and CH-S200-XZ-EB was conducted 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 OTV-S200, CH-S200-XZ-EA and CH-S200-XZ-EB, respectively:
OTV-S200
- AAMI / ANSI ES 60601-1 -
- IEC 60601-1-2 -
- IEC 60601-2-18 -
- ISO 14971 -
- -IEC 62304
CH-S200-XZ-EA
- AAMI / ANSI ES 60601-1 -
- -IEC 60601-1-2
- IEC 60601-2-18 -
- ISO 14971 -
- ISO 17665-1 -
- ISO 14937 -
CH-S200-XZ-EB
- AAMI / ANSI ES 60601-1 -
- IEC 60601-1-2 -
- IEC 60601-2-18 -
- ISO 14971 -
- ISO 14937 -
5.8 CONCLUSIONS
Based on the indications for use, technological characteristics, performance testing and technological comparison to the predicate devices, the OTV-S200, CH-S200-XZ-EA and CH-S200-XZ-EB raise no new issue of safety and effectiveness and are substantially equivalent to the predicate devices in terms of safety, efficacy and performance.