4K CAMERA HEAD OLYMPUS CH-S400-XZ-EB, 4K AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S400-XZ-EA

K172817 · Olympus Medical Systems Corp. · FET · Oct 17, 2017 · Gastroenterology, Urology

Device Facts

• Record ID: K172817
• Device Name: 4K CAMERA HEAD OLYMPUS CH-S400-XZ-EB, 4K AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S400-XZ-EA
• Applicant: Olympus Medical Systems Corp.
• Product Code: FET · Gastroenterology, Urology
• Decision Date: Oct 17, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended 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.

Device Story

Camera heads capture optical images from endoscopes via an integrated coupler; CMOS sensor converts optical images into electronic signals; signals transformed into laser via laser diodes; transmitted via optical fiber to VISERA 4K UHD Camera Control Unit for processing. Used in clinical settings by physicians for endoscopic diagnosis, treatment, and observation. Output displayed to healthcare providers to facilitate clinical decision-making during endoscopic procedures. Benefits include high-resolution 4K visualization for improved diagnostic and therapeutic accuracy.

Clinical Evidence

Bench testing only. Design verification tests conducted in accordance with ISO 14971:2007 and 21 CFR 820.30.

Technological Characteristics

Components: endoscopic coupler, camera cable, video connector. Sensing: CMOS image sensor. Energy: laser diodes for signal transmission via optical fiber. Connectivity: connects to VISERA 4K UHD Camera Control Unit. Sterilization: supports user-performed sterilization methods.

Indications for Use

Indicated for use with Olympus endoscopes, camera control unit, 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.

Predicate Devices

• 4K CAMERA HEAD OLYMPUS CH-S400-XZ-EB (K151011)

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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

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## Indications for Use

510(k) Number (if known) K172817

Device Name

1) 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 ( <i>Select one or both, as applicable</i> ) |
|----------------------------------------------------------|
|----------------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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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: [phone] FAX: [phone] 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<br>2) 4K AUTOCLAVABLE CAMERA HEAD<br>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.

K172817

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<br>510(k) No. |
|----------------------------------------------------------------------------------|-----------------------------------|
| 4K CAMERA HEAD<br>OLYMPUS CH-S400-XZ-EB<br>(as cleared via VISERA 4K UHD System) | K151011<br>(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.

K172817

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:

1) Addition of sterilization methods for reprocessing the device by user

- 2) 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.