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 Description

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.

AI/ML Overview

The provided document, a 510(k) summary for the OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM, details the device and its performance testing, specifically focusing on the "Red Lesion Detector" function.

Here's a breakdown of the acceptance criteria and study that proves the device meets them:

Acceptance Criteria and Reported Device Performance

Criteria Category	Specific Criteria (Implicitly based on comparison to predicate device)	Reported Device Performance (Red Lesion Detector)
Red Lesion Detection	Specificity for red lesions (active bleeding, bleeding, angioectasia, red spot, ulcer or erosion) of small intestine should be comparable to or better than the predicate device's Red Color Detection function.	Performance was "equal to or higher than Red Color Detection function of PD" (predicate device).
	Sensitivity for red lesions (active bleeding, bleeding, angioectasia, red spot, ulcer or erosion) of small intestine should be comparable to or better than the predicate device's Red Color Detection function.	Performance was "equal to or higher than Red Color Detection function of PD" (predicate device).
Active Bleeding Detection	Specificity for active bleedings of small intestine should be comparable to or better than the predicate device's Red Color Detection function.	Performance was "equal to or higher than Red Color Detection function of PD" (predicate device). Additionally, "all active bleedings were detected."

Study Details Proving Device Meets Acceptance Criteria

Sample Size and Data Provenance:
- Test Set Sample Size: The document does not explicitly state the sample size of the clinical test set (i.e., the number of patients or capsule endoscopy videos used). It only refers to "the clinical performance testing."
- Data Provenance: Not specified. The document does not mention the country of origin of the data or whether the study was retrospective or prospective.
Number of Experts and Qualifications for Ground Truth:
- The document does not provide details on the number of experts used to establish the ground truth for the test set or their specific qualifications. It only mentions "clinical performance testing" and the evaluation of the Red Lesion Detector's performance.
Adjudication Method:
- The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) used for the test set's ground truth establishment.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC comparative effectiveness study involving human readers is mentioned. The study described focuses on the comparison of the algorithm's performance (Red Lesion Detector) against that of the predicate device's algorithm (Red Color Detection function of PD), not on how AI assistance improves human reader performance.
Standalone (Algorithm Only) Performance:
- Yes, a standalone (algorithm only) performance study was implicitly done. The "clinical performance testing" evaluates the Red Lesion Detector's performance in terms of specificity and sensitivity for various red lesions and specifically for active bleeding, and compares it directly to the predicate device's algorithm. This suggests an evaluation of the algorithm's capability independent of direct human interaction during the detection process.
Type of Ground Truth Used:
- The document does not explicitly state the type of ground truth used (e.g., expert consensus, pathology, outcomes data). However, for a device visualizing lesions, it is highly probable that the ground truth for "red lesions" and "active bleedings" would have been established by expert clinical review (e.g., gastroenterologists or endoscopists) of the capsule endoscopy videos themselves, possibly with additional clinical context or follow-up.
Training Set Sample Size:
- The document does not provide any information regarding the sample size of the training set used for the development or training of the Red Lesion Detector algorithm.
Ground Truth Establishment for Training Set:
- The document does not describe how the ground truth for the training set was established. It only mentions "Updating the software for the workstation - Improvement of the Red Color Detection function by updating the software algorithm (Red Lesion Detector)." This implies that the algorithm was refined or retrained, but the specifics of that process and its ground truth are not provided.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters FDA in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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.

{1}------------------------------------------------

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

{2}------------------------------------------------

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)

☑ 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."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are closely spaced together, creating a solid block of text. A registered trademark symbol is located to the right of the word.

Date Prepared: March 1, 2019

Updated 510(k) Summary

5.1 GENERAL INFORMATION

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

Contact Person: Daphney Germain-Kolawole Olympus Corporation of the Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610, USA Phone: 484-896-5691 Fax: 484-896-7128 Email: daphney.germain-kolawole@olympus.com
. 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 ENDOSCOPESYSTEM
■ 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

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are all capitalized and evenly spaced. A registered trademark symbol is located to the right of the letter "S".

5.3 PREDICATE DEVICE

■ Predicate device

Device name	510(k) Submitter	510(k) No.
OLYMPUS SMALL INTESTINALCAPSULE ENDOSCOPE SYSTEM	OLYMPUS MEDICALSYSTEMS 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.

Table 5-1: ENDOCAPSULE SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM

Trade or Proprietary or Model Namefor The Subject Device		ModelNumber
ENDOCAPSULE SMALL INTESTINAL CAPSULEENDOSCOPE SET		MAJ-2027
(Components)	CAPSULE ENDOSCOPE (5 pcs.)	EC-S10
ENDOCAPSULE RECORDER SET		MAJ-2029
(Components)	CAPSULE ACTIVATOR (2 pcs.)	MAJ-1478
	ENDOCAPSULE RECORDER	OLYMPUSRE-10
	BATTERY PACK	MAJ-2030
	ANTENNA UNIT	MAJ-2031
	CRADLE	MAJ-2032
	RECORDER HOLDER	MAJ-2033
	ANTENNA HOLDER	MAJ-2034
LEAD ANTENNAUNIT		MAJ-2294

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are slightly shadowed, giving them a three-dimensional appearance. A thin, horizontal yellow line is visible beneath the word, adding a subtle contrast to the overall design.

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

{6}------------------------------------------------

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.

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

Regulation Number and Section

§ 876.1300 Ingestible telemetric gastrointestinal capsule imaging system.

(a)
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.(b)
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.”