K261260 · Olympus Medical Systems Corporation · FET · Jun 24, 2026 · Gastroenterology, Urology
Device Facts
Record ID
K261260
Device Name
HD Camera Head OLYMPUS CH-S200-08-LB
Applicant
Olympus Medical Systems Corporation
Product Code
FET · Gastroenterology, Urology
Decision Date
Jun 24, 2026
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.1500
Device Class
Class 2
Attributes
Therapeutic, PCCP
Indications for Use
The HD Camera Head OLYMPUS CH-S200-08-LB has been designed to be used with endoscopes, video system center, and other ancillary equipment for endoscopic observation, diagnosis and treatment.
Device Story
HD Camera Head OLYMPUS CH-S200-08-LB is a visualization component for endoscopic systems; captures light via distal endoscope objective lens; CCD sensor converts light to electrical signals; signals transmitted via cable to video system center (OTV-S500) for monitor display. Used in clinical settings by physicians for observation, diagnosis, and treatment. Device features integrated remote switch and focus adjustment. Benefits include smaller, thinner, lighter form factor compared to predicate for improved user comfort. PCCP included for future compatibility with OTV-S700 video system center.
Clinical Evidence
Bench testing (FOV, resolution, noise, dynamic range, color, latency, distortion, depth of field) confirmed performance. Animal study (pig model) verified NBI color performance equivalence. Human factors validation (operation and reprocessing) showed 95.5-100% success rates for physicians and technicians, complying with IEC 62366-1.
Technological Characteristics
CCD image sensor; L-shape form factor (φ32×L 87mm); 90g weight; card edge connector; ETO/STERRAD/V-PRO sterilization compatibility. Complies with IEC 60601-1, IEC 60601-2-18, and ISO 8600-3. Software documentation provided at Enhanced level.
Indications for Use
Indicated for endoscopic observation, diagnosis, and treatment when used with compatible endoscopes, video system centers, and ancillary equipment.
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.
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**FDA** **U.S. FOOD & DRUG**
ADMINISTRATION
June 24, 2026
Olympus Medical Systems Corporation
% Eve Smith
Regulatory Affairs Specialist II
Olympus Corporation of the Americas
3500 Corporate Pkwy.
Center Valley, Pennsylvania 18034
Re: K261260
Trade/Device Name: HD Camera Head OLYMPUS CH-S200-08-LB
Regulation Number: 21 CFR 876.1500
Regulation Name: Endoscope And Accessories
Regulatory Class: Class II
Product Code: FET, NWB
Dated: April 16, 2026
Received: April 16, 2026
Dear Eve Smith:
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 (the 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 available 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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K261260 - Eve Smith
Page 2
FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP). Under section 515C(b)(1) of the Act, a new premarket notification is not required for a change to a device cleared under section 510(k) of the Act, if such change is consistent with an established PCCP granted pursuant to section 515C(b)(2) of the Act. Under 21 CFR 807.81(a)(3), a new premarket notification is required if there is a major change or modification in the intended use of a device, or if there is a change or modification in a device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process. Accordingly, if deviations from the established PCCP result in a major change or modification in the intended use of the device, or result in a change or modification in the device that could significantly affect the safety or effectiveness of the device, then a new premarket notification would be required consistent with section 515C(b)(1) of the Act and 21 CFR 807.81(a)(3). Failure to submit such a premarket submission would constitute adulteration and misbranding under sections 501(f)(1)(B) and 502(o) of the Act, respectively.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled 'Deciding When to Submit a 510(k) for a Change to an Existing Device' (https://www.fda.gov/media/99812/download) and 'Deciding When to Submit a 510(k) for a Software Change to an Existing Device' (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ('UDI Rule'). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device
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K261260 - Eve Smith
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Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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,
Tanisha L. Hithe
Assistant Director
DHT4A: Division of General Surgery Devices
OHT4: Office of Surgical and
Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
# Indications for Use
510(k) Number (if known)
K261260
Device Name
HD Camera Head OLYMPUS CH-S200-08-LB
Indications for Use (Describe)
The HD Camera Head OLYMPUS CH-S200-08-LB has been designed to be used with endoscopes, video system center, and other ancillary equipment for endoscopic observation, diagnosis and treatment.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (6/20)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
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OLYMPUS®
TRADITIONAL 510(K) NOTIFICATION
HD Camera Head OLYMPUS CH-S200-08-LB
### 510(k) Summary
### K261260
### General Information
Applicant: OLYMPUS MEDICAL SYSTEMS CORP.
2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507
Phone: (+81) 42-642-2111
Fax: (+81) 42-642-2307
Establishment Registration Number: 8010047
Applicant Contact: Mr. Shinichiro Kawachi
Correspondent : Olympus Corporation of America
3500 Corporate Parkway
Center Valley, PA 18034
Date Prepared: June 23, 2026
### Device Description
Device Name: HD Camera Head OLYMPUS CH-S200-08-LB
Generic/Common Name: HD Camera Head
Regulation Number: 21 CFR 876.1500
Regulatory Class: Class II
Classification Name: Endoscope and accessories
Product Codes: FET, NWB
Review Panel: Gastroenterology/Urology
### Predicate Device
| Device Name | 510(k) Submitter | 510(k) No. |
| --- | --- | --- |
| Visera Elite II HD 3CMOS Camera Head | Olympus Medical Systems Corporation | K190449 |
### Reference Device
| Device Name | 510(k) Submitter | 510(k) No. |
| --- | --- | --- |
| VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500) | Olympus Medical Systems Corporation | K241371 |
510(k) Summary
Page 1 of 9
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OLYMPUS®
TRADITIONAL 510(K) NOTIFICATION
HD Camera Head OLYMPUS CH-S200-08-LB
## Indications for Use
The HD Camera Head OLYMPUS CH-S200-08-LB has been designed to be used with endoscopes, video system center, and other ancillary equipment for endoscopic observation, diagnosis and treatment.
## Device Description
The HD Camera Head OLYMPUS CH-S200-08-LB is part of a visualization system used for endoscopic observation, diagnosis and treatment. The camera head delivers a high definition (HD) image of the targeted area from the endoscope, which is transferred to the monitor for viewing the image of the targeted area. The Charge Coupled Device (CCD) Sensor is located within the camera head and measures the intensity of light and outputs an electrical signal in a proportional relationship with the light image.
The camera head consists of a CCD image sensor, remote switch, focus adjustment mechanism, camera cable and a video connector for connecting with the video system center OTV-S500.
Light is supplied from the video system center OTV-S500 to the endoscope via a light guide cable and emits back 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 image guide or the relay lens inside the endoscope transfers the light to the eyepiece and CCD sensor, which is inside the subject device. The CCD sensor converts the light to an electrical signal and then the signal is transferred to a video system center via the cable and connector. Finally, an endoscopic image is displayed on the monitor after processing by the video system center.
510(k) Summary
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OLYMPUS®
TRADITIONAL 510(K) NOTIFICATION
HD Camera Head OLYMPUS CH-S200-08-LB
# Comparison of Technological Characteristics
Table 1 compares the subject device to the predicate device with respect to indications for use and technological characteristics, providing detailed information regarding the basis for the determination of substantial equivalence.
Table 1. Subject and Predicate Device Comparison Table
| Feature / Characteristic | Subject Device (SD) | Predicate Device (PD) |
| --- | --- | --- |
| | HD Camera Head OLYMPUS CH-S200-08-LB | Visera Elite II HD 3CMOS Camera Head (K190449) |
| Indications for Use | The HD Camera Head OLYMPUS CH-S200-08-LB has been designed to be used with endoscopes, video system center, and other ancillary equipment for endoscopic observation, diagnosis and treatment. | 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. |
| Regulation No. | 21 CFR 876.1500 | 21 CFR 876.1500 |
| Regulation Name | Endoscope and accessories | Endoscope and accessories |
| Regulatory Class | Class II | Class II |
| Product Code | FET, NWB | FET, NWB |
| Classification Panel | Gastroenterology/Urology | Gastroenterology/Urology |
| Dimensions – Camera Head | φ32×L 87mm (L-Shape) | W44×H49×L113mm (Straight Shape) |
| Dimensions – Cable | φ3.4mm×3.5m | φ6.8mm×3m |
| Head Weight | 90g (excluding cable) | 220g(excluding cable) |
| Video Plug | Card edge connector | Card edge connector |
| Remote Control | Embedded | Embedded |
| Observation Pickup System | CCD | CMOS |
| Sterilization | End-user sterilized ETO/STERRAD/V-PRO | End-user sterilized STERRAD/V-PRO |
The HD Camera Head OLYMPUS CH-S200-08-LB is substantially equivalent to the legally marketed predicate device given the similarities in indications for use and technological features with the predicate device:
- similar indications for use
- device characteristics (design and operations) are similar or identical to the predicate device, and
- does not introduce any new or novel treatments or standard of care that differs from predicate device in commercial use.
510(k) Summary
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OLYMPUS
TRADITIONAL 510(K) NOTIFICATION
HD Camera Head OLYMPUS CH-S200-08-LB
The Subject Device is smaller, thinner and lighter than the Predicate Device. This is intended for the comfort and convenience of the end user (physician). Additionally, the Subject Device contains a CCD Image Sensor, vs the CMOS Image Sensor found in the Predicate. Olympus conducted NonClinical (Bench) Performance Testing to demonstrate substantial equivalence of the subject device to the predicate device.
# Summary of Performance Testing
The following performance testing was conducted in support of substantial equivalence determination.
- Performance Testing – Bench (Non-Clinical)
The following performance bench tests were conducted to demonstrate substantial equivalence between the subject and predicate devices. All test samples passed pre-defined acceptance criteria.
- Field of View/Direction of View (confirmed to comply with ISO 8600-3 Second edition 2019-08 Endoscopes - Medical endoscopes and endotherapy devices Part 3: Determination of field of view and direction of view of endoscopes with optics)
- Resolution
- Noise and Dynamic Range
- Image Intensity Uniformity
- Color Performance
- Latency
- Distortion
- Depth of Field
- Animal Study
Olympus conducted animal testing to verify that the NBI Color Performance of the Subject Device is substantially equivalent to that of the Predicate Device.
In the animal test, an endoscope (connected to the camera head) was inserted transvaginally or transurethrally into a living pig, and evaluation videos were acquired for bladder, ureter and/or cervix. User assessment of the videos confirmed that the Subject and Predicate devices are substantially equivalent with respect to NBI Color Performance.
- Human Factors Testing
Human factors validation studies were conducted to evaluate and assess the usability of the HD Camera Head OLYMPUS CH-S200-08-LB and its representative instruction manuals during both operation and reprocessing tasks ensuring it can be used safely and effectively by the intended users in the intended use environment.
510(k) Summary
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OLYMPUS
TRADITIONAL 510(K) NOTIFICATION
HD Camera Head OLYMPUS CH-S200-08-LB
Two human factors validation studies were completed to evaluate the CH-S200-08-LB. The first validation study evaluated the usability of the HD Camera Head specifically during operational use. The second validation study evaluated the usability of the reprocessing instructions for use (IFU) for the HD Camera Head. Each study assessed usability with representative physicians and technicians who would use the device to perform tasks in their respective environments either during operation or reprocessing.
The Operation Validation Study yielded the following results:
- Physician participants: The critical task success rate was 95.5%. Across these critical tasks, 1.8% were classified as success with difficulty, 0.0% close calls, and 2.3% use errors.
- RN/technician participants: The success rate was 100%. No instances of success with difficulty, close calls, or use errors were observed for this group.
The Reprocessing Validation study yielded an overall 99.15% success rate, 0.17% success with difficulty rate, 0.0% close call rate, and a 0.68% use error rate.
From the results of both studies, Olympus determined that the HD Camera Head OLYMPUS CH-S200-08-LB is safe for the intended users, uses, and use environments.
Human Factors testing for HD Camera Head OLYMPUS CH-S200-08-LB is confirmed to comply with IEC 62366-1 Edition 1.1 2020-06 Medical devices - Part 1: Application of usability engineering to medical devices.
- Reprocessing, Sterilization, and Shelf Life
The HD Camera Head OLYMPUS CH-S200-08-LB is distributed non-sterile to the end user. Before using the instrument for the first time and after each use, the device must be reprocessed according to the instructions in the companion Reprocessing Manual. The HD Camera Head OLYMPUS CH-S200-08-LB is validated as safe and effective for reprocessing as detailed in the Reprocessing Manual with the following:
- Manual Cleaning with Endozime AW
- Delayed Manual Cleaning with Endozime AW
- High Level Disinfection
510(k) Summary
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**OLYMPUS**
**TRADITIONAL 510(K) NOTIFICATION**---^{}[] **HD Camera Head OLYMPUS CH-S200-08-LB**
- • Sterilization with:
- o STERRAD 100S
- Short Cycle o STERRAD
- NX Standard Cycle o
- STERRAD 100NX DUO
- Cycle o V-PRO max
- o V-PRO max2 o
- Ethylene Oxide Gas
The HD Camera Head OLYMPUS CH-S200-08-LB has a low likelihood of time-dependent product degradation. Therefore, shelf life testing and data was not applicable for the HD Camera Head OLYMPUS CH-S200-08-LB.
Reprocessing and Sterilization for HD Camera Head OLYMPUS CH-S200-08-LB is confirmed to comply with the following standards as noted below.
- • ASTM F3321-19 Standard Guide for Methods of Extraction of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices
- • ASTM F3208-20 Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices
- • ISO 14937 Second Edition 2009-10-15 Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
- • ANSI AAMI ST77:2013/(R)2018 Containment devices for reusable medical device sterilization
- • ANSI AAMI ST58:2013/(R)2018 Chemical sterilization and high-level disinfection in health care facilities
- • ASTM F3293-18 Standard Guide for Application of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices
- • ISO 11135 Second edition 2014-07-15 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2018)]
- • ANSI AAMI ST79:2017 & 2020 Amendments A1, A2, A3, A4 Comprehensive guide to steam sterilization and sterility assurance in health care facilities
- • ISO 11737-1 Third edition 2018-01 Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on product [Including Amendment 1 (2021)]
- • ISO 17664-1 First edition 2021-07 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices Part 1: Critical and semi-critical medical devices
- • ISO 17664-2 First edition 2021-02 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices.
---510(k) Summary
Page 6 of 9
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OLYMPUS®
TRADITIONAL 510(K) NOTIFICATION
HD Camera Head OLYMPUS CH-S200-08-LB
- ANSI AAMI ST98:2022 Cleaning validation of health care products - Requirements for development and validation of a cleaning process for medical devices
- ISO 22421 First edition 2022-08 ISO 22421 First edition 2022-08 Sterilization of health care products — Low temperature vaporized hydrogen peroxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
- AAMI TIR12:20 Designing testing and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers
# • Software and Cybersecurity
Software verification and validation testing of the HD Camera Head OLYMPUS CH-S20008-LB has been performed and documented in compliance with the FDA guidance “Guidance for the Content of Premarket Submissions for Device Software Functions” and “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.” An Enhanced level of software documentation is provided for the subject device.
Software and Cybersecurity for HD Camera Head OLYMPUS CH-S200-08-LB is confirmed to comply with the following standards as noted below.
- INCITS ISO IEC 30111 First edition 2013-11-01 (R2019) Information technology - Security techniques - Vulnerability handling processes
- IEC 62304 Edition 1.1 2015-06 Medical device software - Software life cycle processes
- FIRST CVSS v3.0 Common Vulnerability Scoring System version 3.0
- IEC 81001-5-1 Edition 1.0 2021-12 Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle
- ANSI NEMA HN 1-2019 American National Standard Manufacturer Disclosure Statement for Medical Device Security
# • Electrical Safety and Electromagnetic Compatibility
Electrical safety and EMC performance testing for HD Camera Head OLYMPUS CH-S20008-LB is confirmed to comply with the following standards as noted below.
- ANSI AAMI ES 60601-1:2005+A1:2012+A2:2021 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2:2014+A1:2020 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests (Edition 4.1)
- IEC 60601-2-18: Edition 3.0 2009-08 Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
510(k) Summary
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OLYMPUS®
TRADITIONAL 510(K) NOTIFICATION
HD Camera Head OLYMPUS CH-S200-08-LB
- IEC 60601-1-6 Edition 3.2 2020-07 Medical electrical equipment - Part 1-6: General Requirements for basic safety and essential performance – Collateral standard: Usability
- IEC 62471 First Edition 2006-07 Photobiological Safety of lamps and lamp systems
- IEC TR 60601-4-2 Edition 1.0 2016-05 Medical electrical equipment - Part 4-2: Guidance and Interpretation – Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
## Conclusion
In summary, HD Camera Head OLYMPUS CH-S200-08-LB is substantially equivalent to the predicate device.
## Predetermined Change Control Plan
A Predetermined Change Control Plan (PCCP) is accompanying Olympus' 510(k) for the Subject Device. This plan proposes the compatibility of the HD Camera Head OLYMPUS CH-S200-08-LB with the Video System Center OTV-S700 (in addition to the Video System Center presented in the context of the 510(k), OTV-S500). The compatibility with the OTV-S700 (K251336) is intended to increase the device's usefulness in the clinical setting.
The modification requires no software or hardware changes. No additional modifications are proposed. No physical changes will be applied to the device itself.
The validation activities and performance requirements aim to confirm the compatibility of the camera head with the OTV-S700 and are as follows:
- Non-Clinical Bench Testing (PCCP)
Olympus will perform Verification tests utilizing the video system center OTV-S700 to demonstrate compatibility of the camera head with the system.
Comparison testing (CH-S200-08-LB connected to the OTV-S700 vs. CH-S200-08-LB connected to the OTV-S500) will be performed to demonstrate the similarity between the two.
- Software and Cybersecurity Testing (PCCP)
No changes are planned to the software/software function of the CH-S200-08-LB as result of this Predetermined Change Control Plan. Software Requirement Specifications (SRS) will be updated for the combination with the OTV-S700, and Software Testing as part of Verification and Validation (with OTV-S700) will be performed.
Cybersecurity will be evaluated where the outcome is reliant upon the subject device being connected to the OTV-S700 video system.
510(k) Summary
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OLYMPUS®
TRADITIONAL 510(K) NOTIFICATION
HD Camera Head OLYMPUS CH-S200-08-LB
• Electrical Safety/EMC (PCCP)
The EMC considerations of the device will remain the same as in the 510(k). The level of harm will stay as “Non-Serious Adverse Events” and the Electrical Safety and EMC testing will be performed as they were for compatibility with the OTV-S500 Video System Center.
• Animal Study (PCCP)
Olympus will conduct animal testing to verify that the NBI Color Performance of the Subject Device when connected to the video system center OTV-S700 is comparable to that of the Subject Device when connected to the video system center OTV-S500.
The CH-200-08-LB Operations Manual will be updated to add OTV-S700 as a compatible video system center. The changes will be made to the Appendix section, where the equipment compatible with the camera head is described.
Olympus will notify users of this update as follows:
- Existing Customers: The CH-200-08-LB Operations Manual on Olympus’ website will be updated and accessible to users. Olympus sales representatives will provide customers with the updated IFU as needed.
- New customers: The updated CH-S200-08-LB Operations Manual will be provided to customers with the Subject Device.
510(k) Summary
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