Olympus Small Intestinal Capsule Endoscope System

K183053 · Olympus Medical Systems Corp. · NEZ · Mar 5, 2019 · Gastroenterology, Urology

Device Facts

• Record ID: K183053
• Device Name: Olympus Small Intestinal Capsule Endoscope System
• Applicant: Olympus Medical Systems Corp.
• Product Code: NEZ · Gastroenterology, Urology
• Decision Date: Mar 5, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1300
• Device Class: Class 2

AI Performance

Output	Algorithm	Acceptance	Observed	Dev DS	Dev Readers	Test DS	Test Readers
Red Lesion Detection	—	—	Equal to or higher than Red Color Detection function of predicate device; all active bleedings detected	—	—	Clinical performance testing for Red Lesion Detector	—

Indications for Use

The OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM is intended for visualization of the small intestine mucosa. - It may be used in the visualization and monitoring of lesions that may indicate Crohn's disease not detected by upper and lower endoscopy. - It may be used in the visualization and monitoring of lesions that may be a source of obscure bleeding (either overt or occult) not detected by upper and lower endoscopy. - It may be used in the visualization and monitoring of lesions that may be potential causes of iron deficiency anemia(IDA) not detected by upper and lower endoscopy. The Red Lesion Detector is intended to mark frames of the video suspected of containing active bleeding. angioectasia, red spot, ulcer or erosion. The OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM may be used as a tool in the detection of abnormalities of the small intestine and is intended for use in adults only.

Device Story

System consists of ingestible capsule endoscope, external antenna unit/recorder, and workstation software. Capsule captures and transmits small intestine images to recorder worn by patient. Workstation software downloads and processes images for clinician review. Red Lesion Detector algorithm automatically marks video frames suspected of containing red lesions (bleeding, angioectasia, ulcers, erosions). Used in clinical settings by physicians to detect small intestine abnormalities. Output assists clinical decision-making by highlighting potential pathology, aiding diagnosis of Crohn's disease, obscure bleeding, and iron deficiency anemia. Benefits include non-invasive visualization of small intestine mucosa.

Clinical Evidence

Clinical performance testing evaluated the Red Lesion Detector against the predicate device's Red Color Detection function. Metrics included sensitivity and specificity for red lesions (active bleeding, angioectasia, red spots, ulcers, erosions) and specificity for active bleeding. Results showed performance equal to or higher than the predicate; all active bleedings were detected.

Technological Characteristics

System includes ingestible capsule, antenna unit, recorder, and workstation software. Connectivity via wireless transmission from capsule to external recorder. Software-based Red Lesion Detector algorithm. Risk management per ISO 14971:2007. Cybersecurity controls implemented. No specific materials or energy standards cited beyond general regulatory compliance.

Indications for Use

Indicated for visualization of small intestine mucosa in adults. Used for monitoring lesions associated with Crohn's disease, obscure gastrointestinal bleeding (overt/occult), and iron deficiency anemia not detected by upper/lower endoscopy. Includes Red Lesion Detector for marking suspected active bleeding, angioectasia, red spots, ulcers, or erosions.

Regulatory Classification

Identification

An ingestible telemetric gastrointestinal capsule imaging system is used for visualization of the small bowel mucosa as an adjunctive tool in the detection of abnormalities of the small bowel. The device captures images of the small bowel with a wireless camera contained in a capsule. This device includes an ingestible capsule (containing a light source, camera, transmitter, and battery), an antenna array, a receiving/recording unit, a data storage device, computer software to process the images, and accessories.

Special Controls

*Classification.* Class II (special controls). The special control is FDA's guidance, “Class II Special Controls Guidance Document: Ingestible Telemetric Gastrointestinal Capsule Imaging Systems; Final Guidance for Industry and FDA.”

Predicate Devices

• OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM (K173459)

Submission Summary (Full Text)

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March 5, 2019

Olympus Medical Systems Corp. % Daphney Germain-Kolawole Senior Project Manager, Regulatory Affairs Olympus Corporation of the Americas 3500 Corporate Parkway, P.O. Box 610 Center Valley, PA 18034-0610

Re: K183053

Trade/Device Name: OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM Regulation Number: 21 CFR§ 876.1300 Regulation Name: Ingestible Telemetric Gastrointestinal Capsule Imaging System Regulatory Class: II Product Code: NEZ Dated: January 31, 2019 Received: February 1, 2019

Dear Daphney Germain-Kolawole:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Daniel G. Walter Jr -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) K183053

# Device Name

OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM

Indications for Use (Describe)

The OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM is intended for visualization of the small intestine mucosa.

- It may be used in the visualization and monitoring of lesions that may indicate Crohn's disease not detected by upper and lower endoscopy.

- It may be used in the visualization and monitoring of lesions that may be a source of obscure bleeding (either overt or occult) not detected by upper and lower endoscopy.

- It may be used in the visualization and monitoring of lesions that may be potential causes of iron deficiency anemia(IDA) not detected by upper and lower endoscopy.

The Red Lesion Detector is intended to mark frames of the video suspected of containing active bleeding. angioectasia, red spot, ulcer or erosion.

The OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM may be used as a tool in the detection of abnormalities of the small intestine and is intended for use in adults only.

Type of Use (Select one or both, as applicable)

| <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|------------------------------------------------------------------------------------------------|
| □ Over-The-Counter Use (21 CFR 801 Subpart C) |

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Date Prepared: March 1, 2019

# Updated 510(k) Summary

# 5.1 GENERAL INFORMATION

| ■ 510(k) Submitter: | OLYMPUS MEDICAL SYSTEMS CORP.<br>2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-<br>8507 |
|---------------------|---------------------------------------------------------------------------------------------|
|---------------------|---------------------------------------------------------------------------------------------|

- Contact Person: Daphney Germain-Kolawole Olympus Corporation of the Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610, USA Phone: [phone] Fax: [phone] Email: [e-mail]
- . Manufacturing site: Shirakawa Olympus Co., Ltd. 3-1 Okamiyama, Odakura, Nishigo-mura, Nishishirakawagun, Fukushima 961-8061, Japan

Olympus Medical Systems Corp. Hinode Plant 34-3 Hirai, Hinode-machi, Nishitama-gun, Tokyo 190-0182, Japan

# 5.2 DEVICE IDENTIFICATION

| ■ Device Name | OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE<br>SYSTEM |
|------------------------|---------------------------------------------------------------|
| ■ Common Name | Capsule Imaging System |
| ■ Regulation Number | 876.1300 |
| ■ Regulation Name | Ingestible telemetric gastrointestinal capsule imaging system |
| ■ Regulatory Class | II (Special Controls) |
| ■ Product Code | NEZ |
| ■ Classification Panel | Gastroenterology and urology |

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# 5.3 PREDICATE DEVICE

## ■ Predicate device

| Device name | 510(k) Submitter | 510(k) No. |
|------------------------------------------------------|----------------------------------|------------|
| OLYMPUS SMALL INTESTINAL<br>CAPSULE ENDOSCOPE SYSTEM | OLYMPUS MEDICAL<br>SYSTEMS CORP. | K173459 |

# 5.4 DEVICE DESCRIPTION

## ■ General Description of the subject device

The OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM is a capsule imaging system used for visualization of the small intestine mucosa.

This system consists of capsule endoscopes which capture images and transmit the data, an antenna unit and a recorder which are secured around the patient and receive data from the capsule, and workstation software which downloads the image data from the recorder and processes images for visualization. The components of this SYSTEM are listed below in Table 5-1.

# Table 5-1: ENDOCAPSULE SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM

| Trade or Proprietary or Model Name<br>for The Subject Device | | Model<br>Number |
|--------------------------------------------------------------|----------------------------|------------------|
| ENDOCAPSULE SMALL INTESTINAL CAPSULE<br>ENDOSCOPE SET | | MAJ-2027 |
| (Components) | CAPSULE ENDOSCOPE (5 pcs.) | EC-S10 |
| ENDOCAPSULE RECORDER SET | | MAJ-2029 |
| (Components) | CAPSULE ACTIVATOR (2 pcs.) | MAJ-1478 |
| | ENDOCAPSULE RECORDER | OLYMPUS<br>RE-10 |
| | BATTERY PACK | MAJ-2030 |
| | ANTENNA UNIT | MAJ-2031 |
| | CRADLE | MAJ-2032 |
| | RECORDER HOLDER | MAJ-2033 |
| | ANTENNA HOLDER | MAJ-2034 |
| LEAD ANTENNAUNIT | | MAJ-2294 |

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| ANTENNA LEAD COVER | MAJ-1470 |
|-----------------------------------------|----------|
| ENDOCAPSULE SOFTWARE 10 | MAJ-2188 |
| ENDOCAPSULE SOFTWARE 10 LIGHT | MAJ-2189 |
| ENDOCAPSULE SOFTWARE 10 UPGRADE PACKAGE | MAJ-2190 |

# 5.5 INDICATIONS FOR USE

The OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM is intended for visualization of the small intestine mucosa.

- It may be used in the visualization and monitoring of lesions that may indicate Crohn's disease not detected by upper and lower endoscopy.

- It may be used in the visualization and monitoring of lesions that may be a source of obscure bleeding (either overt or occult) not detected by upper and lower endoscopy.

- It may be used in the visualization and monitoring of lesions that may be potential causes of iron deficiency anemia (IDA) not detected by upper and lower endoscopy.

The Red Lesion Detector is intended to mark frames of the video suspected of containing active bleeding, bleeding, angioectasia, red spot, ulcer or erosion.

The OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM may be used as a tool in the detection of abnormalities of the small intestine and is intended for use in adults only.

# 5.6 COMPARISON OF TECHNOLOGY CHARACTERISTICS WITH THE PREDICATE DEIVCE

The OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM has the same technological characteristics and design as the predicate device except for the minor technological modifications listed below.

- a. Updating the software for the workstation
- Improvement of the Red Color Detection function by updating the software algorithm (Red Lesion Detector)
- Software update for strengthening cybersecurity
- Deletion of the Express mode (playback function of the workstation)
- Minor modification regarding the Observation function, Data Output function, and the software failure
- b. Material change of the product package

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Image /page/6/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are slightly condensed and have a sans-serif font. A registered trademark symbol is located to the right of the letter "S".

# 5.7 PERFORMANCE DATA

# 5.7.1 Summary of Non-Clinical Testing

The following performance data were provided in support of the substantial equivalence determination.

# 1) Software Verification and Validation Testing

Software verification and validation testing for the OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices".

# 3) Risk Management

Risk management was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verification tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment.

# 5.7.2 Summary of Clinical Testing

The clinical performance testing has been completed to support substantial equivalence. The clinical performance testing was conducted to demonstrate the performance of the Red Lesion Detector. In the clinical performance testing, the performance of the Red Lesion Detector were evaluated and compared with the Red Color Detection function of PD in following perspective.

1) specificity for red lesions (active bleeding, bleeding, angioectasia, red spot, ulcer or erosion) of small intestine

2) sensitivity for red lesions (active bleeding, bleeding, angioectasia, red spot, ulcer or erosion) of small intestine

3) specificity for active bleedings of small intestine

As a result, Red Lesion Detector had performances equal to or higher than Red Color Detection function of PD. Furthermore, all active bleedings were detected in the clinical performance testing.

# 5.8 CONCLUSION

Compared to the predicate device, the OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM does not incorporate any significant changes in the indications for use, method of operation, material, or design that could affect the safety or effectiveness of the subject device. Therefore, the subject device is substantially equivalent to the cited predicate device.