(29 days)
Not Found
No
The description focuses on the camera's hardware and basic image signal conversion and transmission, with no mention of AI or ML for image analysis or processing.
No
The device is a camera head used for endoscopic diagnosis, treatment, and observation by converting optical images into electronic signals; it does not directly provide therapeutic effects.
Yes
The "Intended Use / Indications for Use" section explicitly states that the camera head is "for endoscopic diagnosis, treatment, and observation," indicating its role in the diagnostic process.
No
The device description explicitly states it is a "Camera Head" and describes physical components like an endoscopic coupler, camera cable, video connector, CMOS image sensor, and laser diodes, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "endoscopic diagnosis, treatment, and observation" by receiving optical images from endoscopes. This is a direct observation of the body's internal structures, not the examination of specimens derived from the human body.
- Device Description: The device functions by converting optical images into electronic signals for further processing. It does not analyze biological samples or substances.
- Lack of IVD Characteristics: There is no mention of analyzing blood, tissue, urine, or any other biological specimen. The device is focused on capturing and transmitting visual information from within the body.
IVD devices are specifically designed to examine specimens (like blood, tissue, or urine) to provide information about a person's health status. This device operates on the principle of capturing and transmitting visual data from within the body, which falls under the category of medical imaging or visualization devices, not IVDs.
N/A
Intended Use / Indications for Use
The camera head has been designed to be used with Olympus endoscopes, camera control unit, and other ancillary equipment for endoscopic diagnosis, treatment, and observation.
Product codes (comma separated list FDA assigned to the subject device)
FET, NWB
Device Description
Olympus intends to introduce two new models of 4K CAMERA HEAD OLYMPUS CH-S400-XZ-EB and 4K AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S400-XZ-EA to mainly add sterilization methods to the predicate device 4K CAMERA HEAD which has been cleared as part of VISERA 4K UHD System (K151011).
Both 4K CAMERA HEAD OLYMPUS CH-S400-XZ-EB and 4K AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S400-XZ-EA are structurally consisted of endoscopic coupler end, camera cable and video connector end.
The 4K Camera Heads function as receiving optical image from a variety of endoscopes that are attached to it via coupler and using incorporated complementary metal oxide semiconductor (CMOS) image sensor to convert optical image into electronic signal. The signal is subsequently transformed into laser by laser diodes and input to VISERA 4K UHD CAMERA CONTROL UNIT by optical fiber for further processing with other ancillary equipment on endoscopic diagnosis, treatment, and observation.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
optical image
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The design verification tests were conducted and validated to be in accordance with ISO 14971:2007, and the design control procedure complies with requirements as specified in 21 CFR 820.30.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
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October 17, 2017
Olympus Medical Systems Corp. % Sheri L. Musgnung Regulatory Affairs Manager Olympus Corporation of the Americas 3500 Corporate Parkway P.O. Box 610 Center Valley, PA 18034-0610
Re: K172817 Trade/Device Name: 1) 4K CAMERA HEAD OLYMPUS CH-S400-XZ-EB 2) 4K AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S400-XZ-EA Regulation Number: 21 CFR& 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FET, NWB Dated: September 15, 2017 Received: September 18, 2017
Dear Sheri L. Musgnung:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
1
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Charles Viviano -S
For Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K172817
Device Name
- 4K CAMERA HEAD OLYMPUS CH-S400-XZ-EB 2) 4K AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S400-XZ-EA
Indications for Use (Describe)
The camera head has been designed to be used with Olympus endoscopes, camera control unit, and other ancillary equipment for endoscopic diagnosis, treatment, and observation.
| Type of Use ( Select one or both, as applicable ) |
|---|
| ---------------------------------------------------------- |
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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510(k) SUMMARY
4K CAMERA HEAD OLYMPUS CH-S400-XZ-EB 4K AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S400-XZ-EA
September 15, 2017
I. General Information Olympus Medical Systems Corp. Applicant: . 2951 Ishikawa-cho, Hachioji-shi, Tokyo, 192-8507, Japan Establishment Registration No: 8010047 Sheri L. Musgnung, . Official Correspondent: Regulatory Affairs Manager Olympus Corporation of the Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610, USA Phone: 484-896-3147 FAX: 484-896-7128 Shirakawa Olympus Co., Ltd. . Manufacturer: 3-1 Okamiyama, Odakura, Nishigo-mura, Nishirakawa-gun, Fukushima 961-8061, Japan Registration Number: 3002808148
Device Identification II.
| ■ | Device Trade Name: | 1) 4K CAMERA HEAD OLYMPUS CH-S400-XZ-EB
2) 4K AUTOCLAVABLE CAMERA HEAD
OLYMPUS CH-S400-XZ-EA |
|---|-----------------------|----------------------------------------------------------------------------------------------------|
| ■ | Common Name: | Camera Heads |
| ■ | Regulation Number: | 876.1500 |
| ■ | Regulation Name: | Endoscope and Accessories |
| ■ | Regulatory Class: | II |
| ■ | Classification Panel: | Gastroenterology/Urology |
Section 6 510(k) Summary Page 2 of 4
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Image /page/4/Picture/0 description: The image shows the logo for Olympus. The word "OLYMPUS" is written in large, bold, blue letters. Below the word is a thin, horizontal, yellow line. Below the line is the text "Your Vision, Our Future" in a smaller, light-blue font.
FET: Endoscopic video imaging system/component, 1 Product Code: gastroenterology-urology NWB: Endoscope, Accessories, Narrow Band Spectrum
Predicate Device Information III.
| Predicate Device | Predicate Device
510(k) No. |
|----------------------------------------------------------------------------------|-----------------------------------|
| 4K CAMERA HEAD
OLYMPUS CH-S400-XZ-EB
(as cleared via VISERA 4K UHD System) | K151011
(VISERA 4K UHD SYSTEM) |
Device Description IV.
Olympus intends to introduce two new models of 4K CAMERA HEAD OLYMPUS CH-S400-XZ-EB and 4K AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S400-XZ-EA to mainly add sterilization methods to the predicate device 4K CAMERA HEAD which has been cleared as part of VISERA 4K UHD System (K151011).
Both 4K CAMERA HEAD OLYMPUS CH-S400-XZ-EB and 4K AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S400-XZ-EA are structurally consisted of endoscopic coupler end, camera cable and video connector end.
The 4K Camera Heads function as receiving optical image from a variety of endoscopes that are attached to it via coupler and using incorporated complementary metal oxide semiconductor (CMOS) image sensor to convert optical image into electronic signal. The signal is subsequently transformed into laser by laser diodes and input to VISERA 4K UHD CAMERA CONTROL UNIT by optical fiber for further processing with other ancillary equipment on endoscopic diagnosis, treatment, and observation.
Indications for Use V.
4K CAMERA HEAD OLYMPUS CH-S400-XZ-EB
The camera head has been designed to be used with Olympus endoscopes, camera control unit, and other ancillary equipment for endoscopic diagnosis, treatment, and
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Image /page/5/Picture/0 description: The image shows the logo for Olympus. The word "OLYMPUS" is written in large, bold, blue letters. Below the word is a thin, yellow line. Below the line are the words "Your Vision, Our Future" in a smaller, blue font.
observation.
4K AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S400-XZ-EA
The camera head has been designed to be used with Olympus endoscopes, camera control unit, and other ancillary equipment for endoscopic diagnosis, treatment, and observation.
VI. Comparison of Technological Characteristics
The subject devices, 4K CAMERA HEAD OLYMPUS CH-S400-XZ-EB and 4K AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S400-XZ-EA, have the same fundamental scientific technology; indications for use; principal of operation; and energy source as the legally marketed 4K CAMERA HEAD OLYMPUS CH-S400-XZ-EB cleared via the VISERA 4K UHD SYSTEM in K151011. The modifications between subject devices and predicate device are indicated as follows:
- Addition of sterilization methods for reprocessing the device by user
-
- Minor changes on material, dimension, appearance, weight specification
VII. Summary of non-clinical testing
The design verification tests were conducted and validated to be in accordance with ISO 14971:2007, and the design control procedure complies with requirements as specified in 21 CFR 820.30.
VIII. Conclusion
4K CAMERA HEAD OLYMPUS CH-S400-XZ-EB and 4K AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S400-XZ-EA have the same indications for use; fundamental scientific technology; principal of operation; and energy source. The addition of sterilization methods as well as the other minor modifications have been validated and raised no new issues of safety or effectiveness as compared to the predicate device. Therefore, both of the subject devices are considered to be substantially equivalent to their predicate 4K CAMERA HEAD in VISERA 4K UHD system.