K262079 · Olympus Medical Systems Corp. · FET · Sep 10, 2026 · Gastroenterology, Urology
Device Facts
Record ID
K262079
Device Name
4K Camera Head OLYMPUS CH-S700-08-LB
Applicant
Olympus Medical Systems Corp.
Product Code
FET · Gastroenterology, Urology
Decision Date
Sep 10, 2026
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.1500
Device Class
Class 2
Indications for Use
The 4K CAMERA HEAD OLYMPUS CH-S700-08-LB is intended to be used with endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment, and observation.
Device Story
The 4K Camera Head OLYMPUS CH-S700-08-LB is a component of the VISERA ELITE III Surgical Imaging System. It captures endoscopic images using a single CMOS sensor and transmits signals optically to a video system center for display. Operated by physicians in clinical settings, the device provides high-definition 4K visualization, digital zoom, Narrow Band Imaging (NBI), and Extended Depth of Field (EDOF). It features electrical manual focus and one-touch autofocus via remote switches. The device is designed to be lighter and more compact than its predecessor. Output is displayed on a monitor to assist clinicians in real-time endoscopic diagnosis, treatment, and observation. The device is non-sterile and requires reprocessing between uses.
Clinical Evidence
Bench testing only. Performance evaluations included autofocus, brightness, color performance, distortion, depth of field, durability, field of view, HDR, image intensity, latency, magnification, noise, photobiological safety, and resolution. An animal study was conducted to validate Narrow Band Imaging (NBI) performance, confirming equivalence to the predicate.
Technological Characteristics
Single CMOS image sensor (4,152 x 3,062 pixels); optical digital signal transmission; electrical manual focus and one-touch autofocus; 3 remote switches; Type CF electrical safety; compatible with EtO, V-PRO, and STERRAD sterilization systems. Dimensions: 30 x 55 x 110 mm; Weight: 230 g.
Indications for Use
Indicated for use with endoscopes, video system center, and ancillary equipment for endoscopic diagnosis, treatment, and observation in patients undergoing endoscopic procedures.
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.
{0}
**FDA** U.S. FOOD & DRUG
ADMINISTRATION
September 10, 2026
Olympus Medical Systems Corp.
% Jillian Connery
Program Manager Regulatory Affairs
Olympus Corporation of the Americas
3500 Corporate Pkwy.
Center Valley, Pennsylvania 18034
Re: K262079
Trade/Device Name: 4K Camera Head OLYMPUS CH-S700-08-LB
Regulation Number: 21 CFR 876.1500
Regulation Name: Endoscope and accessories
Regulatory Class: Class II
Product Code: FET, NWB
Dated: June 19, 2026
Received: June 22, 2026
Dear Jillian Connery:
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
{1}
K262079 - Jillian Connery
Page 2
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 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.
{2}
K262079 - Jillian Connery
Page 3
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
Digitally signed by
TANISHA L. HITHE -S
L. HITHE -S
Date: 2026.09.10
13:43:21 -04'00'
Tanisha 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
{3}
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
# **Indications for Use**
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known)
K262079
Device Name
4K Camera Head OLYMPUS CH-S700-08-LB
Indications for Use (Describe)
The 4K CAMERA HEAD OLYMPUS CH-S700-08-LB is intended to be used with endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment, and observation.
Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
**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
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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 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
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OLYMPUS®
TRADITIONAL 510(K) NOTIFICATION
4K CAMERA HEAD OLYMPUS CH-S700-08-LB
# 4K CAMERA HEAD Olympus CH-S700-08-LB
# 510(k) SUMMARY
510(k) Summary: K262079
# 1. COMPANY INFORMATION
# • Applicant
OLYMPUS MEDICAL SYSTEMS CORPORATION
2951 Ishikawa-cho, Hachioji-shi
Tokyo 192-8507, Japan
FDA Establishment Registration #: 8010047
# • Official Correspondent
Jillian Connery
c/o OLYMPUS Surgical Technologies of the Americas
800 West Park Drive
Westborough, MA 01581
Cell: 404-542-5854
Email: jillian.connery@olympus.com
# • Manufacturing Site
SHIRAKAWA OLYMPUS CO., LTD
3-1 Okamiyama, Odakura
NISHIGO-MURA
NISHISHIRAKAWA-GUN Fukushima, JP 961-8061
FDA Registration Number: 3002808148
• Date Prepared: 02-September-2026
# 2. PRODUCT INFORMATION
- Trade Name: 4K CAMERA HEAD
- Model: OLYMPUS CH-S700-08-LB
- Common Name: Endoscopic Camera Head
- Classification Name: Endoscopic Video Imaging System / Component
510(k) Summary
Page 1 of 4
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OLYMPUS®
TRADITIONAL 510(K) NOTIFICATION
4K CAMERA HEAD OLYMPUS CH-S700-08-LB
• Product Code: FET, NWB
• Regulation Number: 21 CFR 876.1500
• Regulation Name: Endoscope and accessories
• Device Class: II
### 3. PREDICATE DEVICE
• Trade Name: 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA
• Model: OLYMPUS CH-S700-XZ-EA
• 510(k) Number: K242067
### 4. DEVICE DESCRIPTION
The subject device of this premarket notification (510(k)) submission is the 4K CAMERA HEAD (Model Number: OLYMPUS CH-S700-08-LB), which is intended to be used with ancillary equipment for endoscopic diagnosis, treatment, and observation. OLYMPUS CH-S700-08-LB is part of the VISERA ELITE III Surgical Imaging System.
The 4K CAMERA HEAD OLYMPUS CH-S700-08-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.
### 5. INDICATIONS FOR USE
The 4K CAMERA HEAD OLYMPUS CH-S700-08-LB is intended to be used with endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment, and observation.
Predicate device: The 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA is intended to be used with endoscopes, video system center and other ancillary equipment for endoscopic diagnosis, treatment, and observation.
### 6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
The subject device and the predicate device have the same intended use for operation with endoscopes, a video system center, and associated ancillary equipment to support endoscopic diagnosis, treatment, and observation. Both devices are regulated under 21
510(k) Summary
Page 2 of 4
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OLYMPUS®
TRADITIONAL 510(K) NOTIFICATION
4K CAMERA HEAD OLYMPUS CH-S700-08-LB
CFR 876.1500 (Endoscope and accessories), are classified as Class II, and are reviewed under the Gastroenterology/Urology panel.
Both devices exhibit identical fundamental technological characteristics, including:
- 2D observation mode
- 4K compatibility
- A single CMOS image sensor with equivalent pixel count and pixel size
- Optical digital image signal transmission
- Digital zoom capability
- Comparable field of view when used with representative rigid endoscopes
- Support for Narrow Band Imaging (NBI)
- Support for Extended Depth of Field (EDOF)
- Electrical manual focus control
- Equivalent connector design and cable characteristics
- Three remote switches
- Type CF electrical safety classification
- Compatibility with legacy 2D endoscopes
- Reprocessing compatibility with EtO, V-PRO, and STERRAD systems
These shared characteristics demonstrate that the subject and predicate devices operate on the same principles of technology and utilize the same fundamental imaging, optical, and electrical components.
The devices differ with respect to physical dimensions and camera head weight, with the subject device presenting a smaller and lighter profile.
Additionally, differences are noted in autofocus functionality, wherein the subject device incorporates electrical autofocus via remote switch, whereas the predicate device provides one-touch and continuous autofocus capability.
The subject device does not support continuous autofocus.
These differences represent modifications in design that do not alter the intended use of the device and do not affect the fundamental scientific technology upon which the device operates.
| Feature / Technological Characteristic | Subject Device 4K CAMERA HEAD Olympus CH-S700-08-LB | Predicate Device 4K CAMERA HEAD Olympus CH-S700-XZ-EA | Comparison |
| --- | --- | --- | --- |
| Intended Use | The 4K CAMERA HEAD OLYMPUS CH-S700-08-LB is intended to be used with endoscopes, | The 4K CAMERA HEAD OLYMPUS CH-S700-08-LB is intended to be used with endoscopes, video system | Identical |
510(k) Summary
Page 3 of 4
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OLYMPUS®
TRADITIONAL 510(K) NOTIFICATION
4K CAMERA HEAD OLYMPUS CH-S700-08-LB
| | video system center, and other ancillary equipment for endoscopic diagnosis, treatment, and observation. | center, and other ancillary equipment for endoscopic diagnosis, treatment, and observation. | |
| --- | --- | --- | --- |
| Regulation Number | 21 CFR §876.1500 | 21 CFR §876.1500 | Identical |
| Regulation Name | Endoscope and accessories | Endoscope and accessories | Identical |
| Product Code | FET, NWB | FET, NWB | Identical |
| Device Class | Class II | Class II | Identical |
| Observation Mode | 2D | 2D | Identical |
| 4K Compatibility | Yes | Yes | Identical |
| Image Sensor Type | Single CMOS sensor | Single CMOS sensor | Identical |
| Pixel Count | 4,152 (H) × 3,062 (V) (~12.7 MP) | 4,152 (H) × 3,062 (V) (~12.7 MP) | Identical |
| Pixel Size | 1.55 μm × 1.55 μm | 1.55 μm × 1.55 μm | Identical |
| Image Signal Transmission | Optical (digital) | Optical (digital) | Identical |
| Zoom Function | Digital zoom | Digital zoom | Identical |
| Field of View | 90° | 90° | Identical |
| Narrow Band Imaging (NBI) | Available | Available | Identical |
| Extended Depth of Field (EDOF) | Available | Available | Identical |
| Focus Control – Manual | Electrical manual focus | Electrical manual focus | Identical |
| Focus Control – Auto Focus | One-touch auto focus via remote | One-touch auto focus | Minor difference; does |
510(k) Summary
Page 4 of 4
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OLYMPUS®
TRADITIONAL 510(K) NOTIFICATION
4K CAMERA HEAD OLYMPUS CH-S700-08-LB
| | switch | | not affect intended use or performance |
| --- | --- | --- | --- |
| Continuous Auto Focus | Not available | Available | Difference does not raise new safety or effectiveness concerns |
| Camera Head Dimensions (Max.) | 30 (W) × 55 (H) × 110 (L) mm | 44 (W) × 54 (H) × 133 (L) mm | Different physical dimensions; no impact on performance |
| Camera Head Weight | 230 g (excluding cable) | 280 g (excluding cable) | Subject device is lighter; no safety impact |
| Cable | Ø 5.1 mm × 3 m | Ø 5.1 mm × 3 m | Identical |
| Connector Type | Card-edge connector with optical connection | Card-edge connector with optical connection | Identical |
| Number of Remote Switches | 3 | 3 | Identical |
| Electrical Safety Classification | Type CF | Type CF | Identical |
| Compatible Endoscopes | Legacy 2D endoscopes | Legacy 2D endoscopes | Identical |
| Reprocessing Methods | EtO, V-PRO, STERRAD | Autoclave, V-PRO, STERRAD | Similar; both devices utilize validated sterilization methods that achieve an equivalent sterility assurance level and are therefore substantially |
510(k) Summary
Page 5 of 4
{9}
OLYMPUS®
TRADITIONAL 510(K) NOTIFICATION
4K CAMERA HEAD OLYMPUS CH-S700-08-LB
| | | | equivalent. |
| --- | --- | --- | --- |
### 7. PERFORMANCE DATA
Performance testing was conducted to demonstrate the safety and effectiveness of the 4K CAMERA HEAD OLYMPUS CH-S700-08-LB. The following tests were performed and passed the acceptance criteria:
- Performance Bench
- Auto focus (Comparison/Verification)
- Brightness
- Color Performance (Comparison/Verification)
- Distortion (Comparison/Verification)
- DOF (Comparison/Verification)
- Durability
- FOV/DOV (Comparison/Verification)
- High Dynamic Range (HDR) Observation
- Image Intensity Uniformity (Comparison/Verification)
- Iris Area Function Observation
- Laser Mode Function Observation
- Latency
- Magnification
- Noise and Dynamic Range (Comparison/Verification)
- Photobiological Safety
- Resolution (Comparison/Verification)
- Human Factors Validation
- An animal study was conducted to evaluate the performance of the Narrow Band Imaging (NBI) observation. In all video sets, this test met the pass criteria. Therefore, the NBI color performance of the subject device was shown to be substantially equivalent to that of the predicate device.
### 8. STERILIZATION REPROCESSING AND SHELF LIFE
HD CAMERA HEAD OLYMPUS CH-S700-08-LB reprocessing is substantially equivalent to the predicate device, OLYMPUS CH-S200-XZ-EB as demonstrated through validation. HD Camera Head
510(k) Summary
Page 6 of 4
{10}
OLYMPUS®
TRADITIONAL 510(K) NOTIFICATION
4K CAMERA HEAD OLYMPUS CH-S700-08-LB
OLYMPUS CH-S700-08-LB is validated as safe and effective for reprocessing with the following:
- Manual Cleaning with Endozime AW
- Delayed Manual Cleaning with Endozime AW
- High Level (Manual) Disinfection with 2.0 – 3.4% Glutaraldehyde
- Sterilization with:
- STERRAD 100S Short Cycle
- STERRAD NX Standard Cycle
- STERRAD 100NX DUO Cycle
- V-PRO maX
- V-PRO maX2
- EO
### 9. SUBSTANTIAL EQUIVALENCE
Based on the intended use, technological characteristics, performance testing, and comparison to the predicate device, the 4K CAMERA HEAD OLYMPUS CH-S700-08-LB raises no new issues of safety and effectiveness and are substantially equivalent to the predicate device 4K CAMERA HEAD Olympus CH-S700-XZ-EA.
### 10. CONCLUSION
Based on the results of the comparison of the indications for use, technological characteristics, and performance testing of the Subject and Predicate devices, the Subject device 4K CAMERA HEAD OLYMPUS CH-S700-08-LB raises no new issues of safety and effectiveness and the device is substantially equivalent to the Predicate device 4K CAMERA HEAD Olympus CH-S700-XZ-EA.
510(k) Summary
Page 7 of 4
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Narrow by SaMD (Software as a Medical Device), 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.
