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 Color Detection Function is intended to mark frames of the video suspected of containing blood or red areas.
The OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM may be used as a tool in the detection of abnormalities of the small intestine.

Device Description

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 devices comprising this system, device design, and specifications are identical with the legally marketed predicate device. K142680. with the exception of minor modications that did not trigger the need for a new 510(k) and were documented internally at Olympus.

The ENDOCAPSULE SMALL INTESTINAL CAPSULE ENDOSCOPE (OLYMPUS EC-10) is operated by mercury-free silver oxide batteries while the batteries for the predicate device contain mercury.
The ENDOCAPSULE SOFTWARE 10 UPGRADE PACKAGE (MAJ-2190) is an upgraded software version to the previous models listed below:
ENDOCAPSULE SOFTWARE 10 SERVER-CLIENT (Ver.1.00 and Ver.1.01)
ENDOCAPSULE SOFTWARE 10 CLIENT (Ver.1.00 and Ver.1.01)
Expanding the indications for use to include the detection of Crohn's disease, obscure bleeding, and iron deficiency anemia (IDA) for this system is the scope of this submission.

AI/ML Overview

The provided text is a 510(k) summary for the OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM. It focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing (battery changes, software upgrades) and a literature review to support expanded indications for use.

Crucially, the document does NOT describe an AI or algorithm-based device that requires acceptance criteria based on performance metrics (e.g., sensitivity, specificity, AUC) from a test set of data. Instead, the "Red Color Detection Function" is mentioned as an intended function to mark frames suspected of containing blood or red areas, but there's no performance study data provided for this function.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer questions related to sample size, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance, as these elements are not present in the provided document.

The "study that proves the device meets the acceptance criteria" in this context refers to the summary of non-clinical testing and the summary of clinical literature review aiming to support the expanded indications for use by demonstrating safety and efficacy comparable to the predicate device and the broader class of capsule endoscopy devices.

Here's an analysis based on the information available:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria for Device Functionality (Non-Clinical): The document implies acceptance criteria related to the testing for battery life, temperature and humidity tolerance (medical environment, transportation, storage), and software validation (functional, performance, security, usability engineering, database, operation/maintenance requirements).
Reported Device Performance (Non-Clinical):
- Battery Change Validation: "the following tests were conducted. - Battery Life - Test on Temperature and Humidity in Medical Environment - Test on Temperature and Humidity During Transportation and Storage" (Implies successful completion, but no specific performance metrics like 'battery life > X hours' are given).
- Software Upgrade Validation: "The software validation activities were performed in accordance with the FDA Guidance... The validation tests were performed against each function in regards to the following points [listed]." (Implies successful completion according to requirements, but no specific software performance metrics are provided).
Acceptance Criteria for Expanded Indications (Clinical Literature Review): The implicit acceptance criteria for the expanded indications (Crohn's disease, obscure bleeding, IDA) are that the device, being technologically identical to the predicate (except for minor changes not affecting safety/efficacy) and similar to other clinically accepted CE devices, should demonstrate comparable safety and diagnostic utility as evidenced by existing clinical literature.
Reported Device Performance (Clinical Literature Review):
- Iron Deficiency Anemia (IDA): Meta-analysis of four studies (264 IDA patients) revealed a higher diagnostic yield of 66.6% (95% CI, 61.0%-72.3%) for detecting sources of IDA using CE (specifically the reference device PillCam™ SB1). Complication rates were low (0-5%, pooled 1.4% retention).
- Obscure Gastrointestinal Bleeding (OGIB): Diagnostic yield generally ranges from <60% to >70%, with an overall positive diagnostic yield of ~50% for CE.
- Crohn's Disease (CD):
  - Chong et al. (established CD): CE diagnostic yield 77.3% (17/22 patients), leading to change in clinical management in 76%.
  - Dubcenco et al.: CE sensitivity 89.6%, specificity 100% (compared to histopathology in 39 patients with established/suspected CD), diagnostic yield 66.6%.
  - CE for post-ileocolonic surgery CD: Diagnostic findings in 68% of patients, therapeutic modification recommended in 72.7%.
  - Voderholzer et al.: CE diagnostic findings in 60.9% of patients. Therapy changed in 24% of patients.
- Safety: Low complication rates reported across studies (e.g., 1.4% retention for all indications, 1 in 800-1,000 procedures for aspiration).

2. Sample sized used for the test set and the data provenance:

Test Set (for expanded indications): Not a single, unified test set. The clinical performance is supported by a review of existing clinical literature.
- For IDA: Four studies summarized, involving 264 IDA patients.
- For CD: Multiple studies cited (e.g., Chong et al. 22 patients; Dubcenco et al. 39 patients).
Data Provenance: The document implies the data is retrospective, drawn from published clinical studies. Countries of origin are not specified but are likely international given the nature of academic publications.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is not applicable as the "test set" is composed of data from numerous existing clinical studies, where ground truth would have been established by the methods, diagnoses, and follow-up defined within each individual study (e.g., endoscopic findings, surgical findings, histopathology, clinical outcomes). The document does not describe a new study where a panel of experts retrospectively reviewed cases for ground truth.

4. Adjudication method for the test set:

Not applicable for the same reasons as #3. Ground truth was established within the original studies cited, not through a unified adjudication process for this 510(k) submission.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No MRMC study was done. This device is a capsule endoscope system, not an AI-assisted reading tool beyond the "Red Color Detection Function" which is not subjected to performance testing in this document. The submission focuses on the performance of the capsule endoscopy system itself for visualization and detection, not on improving human reader performance with AI.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No standalone algorithm performance study was done for the "Red Color Detection Function." The document mentions its intended purpose but provides no performance data for it. The overall device performance is described in terms of its ability to visualize and identify lesions, which generally requires human interpretation of the captured images.

7. The type of ground truth used:

For the clinical literature review, the ground truth types would vary depending on the original study but generally include:
- Histopathology (e.g., from biopsies or surgical resections)
- Other endoscopic findings (upper and lower endoscopy, push enteroscopy)
- Radiological findings (e.g., enteroclysis, small bowel radiology)
- Clinical follow-up and outcomes data
- Consensus diagnoses from the original study's clinical team.

8. The sample size for the training set:

Not applicable. The "Red Color Detection Function" is mentioned, but there is no description of an AI model or machine learning component that would require a distinct training set. The software validation detailed in the document is for the general functionality of the software, not for training a specific image analysis algorithm.

9. How the ground truth for the training set was established:

Not applicable. As per #8, there's no mention of an AI model with a training set.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 19, 2017

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

Re: K163069

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: November 1, 2016 Received: November 2, 2016

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. 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 (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 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. 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 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,

Benjamin R. Fisher -S

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)

K163069

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 Color Detection Function is intended to mark frames of the video suspected of containing blood or red areas. The OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM may be used as a tool in the detection of abnormalities of the small intestine.

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

OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM

January 18, 2017

I.	General Information
	■ Applicant:	OLYMPUS MEDICAL SYSTEMS CORP.2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan192-8507Establishment Registration No: 8010047
	■ Official Correspondent:	Daphney Germain-KolawoleProject Manager, Regulatory AffairsOlympus Corporation of the Americas3500 Corporate ParkwayPO Box 610Center Valley, PA 18034-0610, USAPhone: 484-896-5691Fax: 484-896-7128Email: daphney.germain-kolawole@olympus.com
	■ Manufacturer:	SHIRAKAWA OLYMPUS CO., LTD.3-1, Aza-Ookamiyama, Ooaza-Odakura,Nishigo-mura, Nishishirakawa-gun, Fukushima,961-8061, JapanEstablishment Registration Number: 3002808148OLYMPUS MEDICAL SYSTEMS CORP.HINODE PLANT34-3 Hirai, Hinode-machi, Nishitama-Gun, Tokyo,190-0182, JapanEstablishment Registration Number: 3003637092

Device Identification II.

■ Device Trade Name:	OLYMPUS SMALL INTESTINAL CAPSULEENDOSCOPE SYSTEM
■ Common Name:	Capsule Imaging System
■ Regulation Number:	876.1300

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. Regulation Name: Ingestible telemetric gastrointestinal capsule imaging system . Regulatory Class: II (Special Controls) I Classification Panel: Gastroenterology and urology . Product Code: NEZ

Predicate Device Information III.

Model name	Applicant	510(k) No.
OLYMPUS CAPSULE ENDOSCOPESYSTEM (ENDOCAPSULE SOFTWARE10, ENDOCAPSULE SOFTWARE 10LIGHT)	OLYMPUS MEDICALSYSTEMS CORP.	K142680

Device Description IV.

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 devices comprising this system, device design, and specifications are identical with the legally marketed predicate device. K142680. with the exception of minor modications that did not trigger the need for a new 510(k) and were documented internally at Olympus.

The ENDOCAPSULE SMALL INTESTINAL CAPSULE ENDOSCOPE (OLYMPUS EC-10) is operated by mercury-free silver oxide batteries while the batteries for the predicate device contain mercury.
. The ENDOCAPSULE SOFTWARE 10 UPGRADE PACKAGE (MAJ-2190) is an upgraded software version to the previous models listed below:
- ENDOCAPSULE SOFTWARE 10 SERVER-CLIENT (Ver.1.00 and Ver.1.01) - ENDOCAPSULE SOFTWARE 10 CLIENT (Ver.1.00 and Ver.1.01)

Expanding the indications for use to include the detection of Crohn's disease, obscure bleeding, and iron deficiency anemia (IDA) for this system is the scope of this submission.

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Indications for Use V.

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 Color Detection Function is intended to mark frames of the video suspected of containing blood or red areas.

The OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM may be used as a tool in the detection of abnormalities of the small intestine.

VI. Comparison of Technological Characteristics

Compared to the legally marketed predicate device, technological characteristics of the subject device are identical to the predicate device .

VII. Summary of Non-Clinical Testing

[Change in batteries]

To validate the change to mercury-free silver oxide batteries, the following tests were conducted.

Battery Life •
Test on Temperature and Humidity in Medical Environment
Test on Temperature and Humidity During Transportation and Storage

[Software upgrade]

The software validation activities were performed in accordance with the FDA Guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The device software is considered a Moderate Level of Concern.

The validation tests were performed against each function in regards to the following points.

Detail information on functional requirements
Performance requirements
Security requirements

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Usability engineering requirements •
Database requirements
Operation and maintenance requirements

The purpose of this submission is to expand the indications of this system which includes labeling changes. There are no design changes from the legally marketed system in which safety and effectiveness were already confirmed under K142680 except for the software changes.

VIII. Summary of Clinical Testing

A review of Capsule Endoscopy (CE) clinical literature was conducted in order to show the safety and efficacy of the reference device, Given Imaging's PillCam™ SB1 (PillCam™ M2A), in the evaluation of iron-deficiency anemia (IDA), obscure gastrointestinal bleeding (OGIB), and Crohn's disease (CD). In support of the expanding indications for use and desired marketing claims, the following is a summary of referenced literature.

A sub-set of the studies in the Koulaouzidis meta-analysis that focused exclusively on IDA patients (four studies, 264 IDA patients)1-3-4, as opposed to IDA patients within the entire cohort receiving CE, revealed a higher diagnostic vield of 66.6% (95% CI, 61.0%-72.3%). All four of these studies explicitly defined IDA based on hemoglobin and ferritin measurements and were performed with the reference device. For comparison, the indication of OGIB for CE has a diagnostic yield ranging from <60% to >70% depending on the reported study size and timing of examination after a bleeding event, and the authors conclude that the overall positive diagnostic vield is ~50%. Both the reference (PillCamTM SB1) and subject (ENDOCAPSULE EC-10) devices are indicated for OGIB.

In the IDA studies, complications arising from the use of CE were rare and ranged from 0-5% of participants enrolled for all indications. The most common complication was retention of the capsule and in some cases this was noted to be caused by a stricture. The pooled complication rate (of those reporting complications) for the studies was 1.4% (40/2819). A 2010 systemic review estimated the overall retention rate for capsule endoscopy for all indications at 1.4%. A second, rare complication of CE is aspiration, occurring in 1 out of 800-1.000 procedures', but this adverse event was not reported in the IDA studies. Therefore CE is safe to use for the indication of IDA, and IDA patients do not pose any unusual risk for complication.

Collectively, the comparable diagnostic yield of CE for IDA and OGIB, the similar findings under CE when performed for either of these two indications, the useful diagnostic information resulting from CE that can help modify care in IDA patients and the low rates of complication for CE in IDA patients shows that the reference (PillCam SB1) and subject (ENDOCAPSULE EC-10) devices can be used effectively and safely for the indication of IDA.

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Multiple studies show that CE has been used in CD patients to safely and effectively provide diagnostic information or monitor lesions in patients with an established diagnosis. Chong et al.8 compared CE with push enteroscopy and enteroclysis in suspected and established CD patients. In patients with established CD, CE had a diagnostic yield of 77.3% (17/22 patients) compared with 13.6% for push enteroscopy and 19% for enteroclysis, and importantly lead to a change in clinical management in 76% (13/17) of the patients with positive CE findings. In patients with suspected CD, CE had a higher diagnostic vield of 19% compared with 0% for push enterosocpy and 6% for enteroclysis, but this was not statistically significant. Dubcenco et al." demonstrated that CE has high diagnostic accuracy with 89.6% sensitivity and 100% specificity when compared with histopathology results in a group of 39 patients with established or suspected CD. In this same study, CE had a diagnostic yield of 66.6%, compared with 20.5% for small bowel radiology. In patients with established CD undergoing CE following ileocolonic surgery, CE had diagnostic findings in 68% of patients and therapeutic modification could be recommended in 72.7% of the patients. 10 Lastly, in consecutive established CD patients, CE revealed diagnostic findings in 60.9% of patients while enteroclysis showed diagnostic findings in 29.3%.11 In 24% of all patients that underwent CE, therapy was changed and all improved clinically. Diagnostic findings in all of the studies included features such as aphthous mucosal lesions, ulcers, luminal narrowing, erythema, villous denudation, erosions and mucosal scarring. These results and the remaining studies establish that the reach of CE and the sensitivity of this procedure for subtle mucosal changes of the small intestine make it an effective tool for evaluation of lesions consistent with CD.

Collectively, the high diagnostic vield and sensitivity/specificity (when reported) of CE in CD patients, the similar performance of CE compared with other diagnostic modalities commonly used in the CD workup, the useful diagnostic information resulting from CE that can help modify care in CD patients, and the low rates of complication for CE in CD patients shows that the reference (PillCam SB1) and subject (ENDOCAPSULE EC-10) devices can be used effectively and safely for the indication of CD.

1 Apostolopoulos P. et al. Endoscopy. 2006. 38:1127-1132.
2 Riccioni ME. et al. Dig Liver Dis. 2010. 42:560-566.
4 Yamada A. et al. Hepatogastroenterology. 2011. 58:1240-1243.
5 Gupta and Reddy. World J Gastroenterol. 2007. 13:4551-4553.
6 Liao Z et al. Gastrointest. Endosc. 2010. 71:280-286.
7 Lucendo AJ et al. Dig. Dis. Sci. 2011. 56:2758-2762.
8 Chong AK et al. Gastrointest. Endosc. 2005. 61:255-261.
2 Dubcenco E et al. Gastrointest. Endosc. 2005. 62:538-544.
10 Pons Beltran V et al. Gastrointest. Endosc. 2007. 66:533-540.
11 Voderholzer WA et al. Gut. 2005. 54:369-373.

3 Milano A. et al. Gastrointest. Endosc. 2011. 73:1002-1008.

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IX. Conclusion

Based on the technological characteristics and clinical performance of the devices, Olympus believes that the OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM and the cited predicate device are substantially equivalent and do not change the scientific technology.

The proposed indications for use is expanding the device description to permit use for visualization and monitoring of additional disease states. Therefore, the subject device has essentially the same indications for use as the 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.”