Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable Camera Head, Visera Elite II 3CMOS Camera Head
K190449 · Olympus Medical Systems Corp. · FET · Aug 30, 2019 · Gastroenterology, Urology
Device Facts
Record ID
K190449
Device Name
Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable Camera Head, Visera Elite II 3CMOS Camera Head
Applicant
Olympus Medical Systems Corp.
Product Code
FET · Gastroenterology, Urology
Decision Date
Aug 30, 2019
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.1500
Device Class
Class 2
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.
Device Story
System comprises OTV-S200 video system center and CH-S200-XZ-EA/EB camera heads; used in healthcare facilities by clinicians. OTV-S200 integrates video processor and LED light source; connects to endoscopes/camera heads to receive electrical signals; outputs endoscopic images to monitors. Camera heads (3CMOS) attach to rigid endoscopes via lock ring; convert light from endoscope to electrical signals; feature zoom/focus controls and remote switches for system operation. Supports White Light Imaging (WLI) and Narrow Band Imaging (NBI). System provides visualization for diagnosis and treatment; benefits patient through high-definition endoscopic observation.
Clinical Evidence
No clinical data. Substantial equivalence supported by bench testing, including electrical safety (ANSI/AAMI ES 60601-1), EMC (IEC 60601-1-2), reprocessing validation, and performance testing (NBI observation, image quality, photobiological safety, FOV, and full HD image confirmation).
Technological Characteristics
System includes OTV-S200 (LED light source, video processor, touch panel) and 3CMOS camera heads. Connectivity via card edge connector. Reprocessing via autoclave, V-PRO, or STERRAD. Standards: ANSI/AAMI ES 60601-1, IEC 60601-2-18, IEC 60601-1-2, ISO 14971, ISO 17665-1, ISO 14937, IEC 62304.
Indications for Use
Indicated for use with Olympus endoscopes, camera heads, monitors, and ancillary equipment for endoscopic diagnosis, treatment, and video observation in a healthcare facility/hospital setting.
Regulatory Classification
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.
Special Controls
*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.
In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls:
1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following:
1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures.
2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use.
3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use.
2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes.
3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches
4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error.
5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.
(6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms.
(7) Labeling must include:
(i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified;
(ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA;
(iii) Identification of compatible devices;
(iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification;
(v) Reprocessing instructions for reusable components;
(vi) A shelf life for any sterile components;
(vii) A description of the device-specific use training program;
(viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and
(ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance.
(8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:
(i) Device motion accuracy and repeatability;
(ii) System testing;
(iii) Instrument reliability;
(iv) Crosstalk;
(v) Table motion control;
(vi) Thermal effects on tissue;
(vii) User-device interface performance;
(viii) Workspace access testing; and
(ix) Performance testing with compatible devices.
(9) Software verification, validation, and hazard analysis must be performed.
(10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(11) Performance data must demonstrate the sterility of all patient-contacting device components.
(12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(13) Performance data must validate the reprocessing instructions for the reusable components of the device.
(14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.
(16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information:
(i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and
(ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.
Predicate Devices
VISERA ELITE VIDEO SYSTEM CENTER OLYMPUS OTV-S190 (K111425)
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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.
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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
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# 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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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,<br>Gastroenterology-Urology<br>NWB; Endoscope, Accessories, Narrow Band Spectrum |
| ■ Classification Panel | Gastroenterology/Urology |
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# 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<br>(Part of this submission) | Predicate Device | Predicate Device<br>510(k) No. |
|------------------------------------------------------------|---------------------------------------------------------|--------------------------------|
| VISERA ELITE II VIDEO<br>SYSTEM CENTER<br>OLYMPUS OTV-S200 | VISERA ELITE<br>VIDEO SYSTEM CENTER<br>OLYMPUS OTV-S190 | K111425 |
| | VISERA ELITE<br>XENON LIGHT SOURCE<br>OLYMPUS CLV-S190 | K111425 |
# 5.3.2 CH-S200XZ-EA, CH-S200-XZ-EB
| Subject Device<br>(Part of this submission) | Predicate Device | Predicate Device<br>510(k) No. |
|----------------------------------------------------------------------------------|---------------------------------------|--------------------------------|
| VISERA ELITE II HD<br>3CMOS AUTOCLAVABLE<br>CAMERA HEAD<br>OLYMPUS CH-S200-XZ-EA | AUTOCLAVABLE CAMERA<br>HEAD OTV-Y0017 | K102059 |
| VISERA ELITE II HD<br>3CMOS CAMERA HEAD<br>OLYMPUS CH-S200-XZ-EB | AUTOCLAVABLE CAMERA<br>HEAD OTV-Y0017 | K102059 |
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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.
| | <Subject device><br>OTV-S200 | <Primary Predicate device 1><br>OTV-S190 | <Additional Predicate device 2><br>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<br>intended to be used with<br>OLYMPUS camera heads,<br>endoscopes, monitors,<br>EndoTherapy accessories,<br>and other ancillary<br>equipment for endoscopic<br>diagnosis, treatment, and<br>video observation. | This video system center<br>has been designed to be<br>used with Olympus camera<br>heads, endoscopes, light<br>source, monitors,<br>endo-therapy accessories<br>and other ancillary<br>equipment for endoscopic<br>diagnosis, treatment, and<br>video observation. | This light source has<br>been designed to be used<br>with Olympus<br>endoscopes, video<br>system center, and other<br>ancillary equipment for<br>endoscopic diagnosis,<br>treatment and video<br>observation. |
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| | <Subject device><br>OTV-S200 | <Primary Predicate device 1><br>OTV-S190 | <Additional Predicate device 2><br>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<br>50/60Hz | 120V AC<br>50/60Hz | 120V AC<br>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.
| | <Subject device> | <Predicate device 1> |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | CH-S200-XZ-EA | OTV-Y0017 |
| | | AUTOCLAVABLE CAMERA<br>HEAD |
| 510(k)<br>Number | - | K102059 |
| Regulation<br>number | 876.1500 | 876.1500 |
| Regulatory<br>Class | II | II |
| Product code | FET,NWB | FET,NWB |
| Manufacturer | Olympus Medical Systems Corp | Olympus Medical Systems Corp |
| Indications for<br>use | The camera head has been designed to<br>be used with Olympus endoscopes,<br>video system center, and other<br>ancillary equipment for endoscopic<br>diagnosis, treatment, and observation. | This camera head has been designed<br>to be used with the CV-180 EXERA<br>II video system center or OTV-S7Pro<br>VISERA Pro video system center,<br>endoscopes, light sources, video<br>monitors and other ancillary<br>equipment for endoscopic diagnosis<br>and treatment. |
| Environment<br>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.
| | <Subject device> | <Predicate device 1> |
|---------------------|-----------------------------------------------------|------------------------------------------|
| | CH-S200-XZ-EA | OTV-Y0017<br>AUTOCLAVABLE CAMERA<br>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<br>AUTOCLAVE/V-PRO/ STERRAD | End user sterilized<br>AUTOCLAVE |
| | <Subject device> | <Predicate device 1> |
|------------------------|--------------------------------------------------------------------------|------------------------------------------------------------------------|
| | CH-S200-XZ-EB | OTV-Y0017<br>AUTOCLAVABLE CAMERA<br>HEAD |
| 510(k)<br>Number | - | K102059 |
| Regulation<br>number | 876.1500 | 876.1500 |
| Regulatory<br>Class | II | II |
| Product code | FET,NWB | FET,NWB |
| Manufacturer | Olympus Medical Systems Corp | Olympus Medical Systems Corp |
| Indications for<br>use | The camera head has been designed to<br>be used with Olympus endoscopes. | This camera head has been designed<br>to be used with the CV-180 EXERA |
| | <Subject device> | <Predicate device 1> |
| | 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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Image /page/12/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are closely spaced together, creating a solid block of text. The word is positioned horizontally in the image. There is a gold line underneath the word.
K190449 page 10 of 11
# 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.
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Learn the FDA Browser
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
