(126 days)
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 and is intended for use in adults only.
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. After the visualization, the diagnostic review (also known as reading) of images would start with user selectable OMNI mode feature. OMNI mode is an algorithm that assists the physician in reviewing the Capsule Endoscopy(CE) case data.
The provided text describes the OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM and its performance. However, it does not explicitly define specific "acceptance criteria" in a quantitative table or directly state that the device meets pre-defined acceptance criteria in all aspects. The document focuses on demonstrating substantial equivalence to a predicate device and presenting the results of a clinical study for the OMNI mode.
Based on the provided text, here's an attempt to answer your request, highlighting where information is directly available and where it's inferred or not explicitly stated:
1. Table of acceptance criteria and the reported device performance
The provided text does not contain a specific table of quantitative acceptance criteria for the entire device or the OMNI mode, nor does it explicitly state that the device "meets" acceptance criteria in a comparative table.
However, the clinical study's outcome regarding reading efficiency can be considered a performance metric and, implicitly, a criterion for the OMNI mode's improvement claim.
| Criterion Type (Inferred) | Acceptance Criteria (Not explicitly stated in a quantitative manner) | Reported Device Performance (OMNI Mode) |
|---|---|---|
| Reading Efficiency (for OMNI mode) | Claims for "improvement of capsule reading efficiency and the reduction of redundant images" (implicit acceptance criteria is significant improvement) | OMNI mode required, on average, 27.3 minutes for review, while Normal mode required 75.1 minutes, on average (p<0.001). This represents a 64% reduction in review time. The result "supports the claims for improvement of capsule reading efficiency and the reduction of redundant images." |
For other performance aspects (Software verification, Electrical safety, EMC, Radio signal communication, Radio Interference, FCC Test, Risk Management), the document states that tests were conducted "to demonstrate that the OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM performs according to specifications and functions as intended" and "Test results verified the safety and effectiveness of the devices in accordance with design specifications and applicable standards." Risk management was conducted "in accordance with established in-house acceptance criteria based on ISO 14971:2007." However, the specific quantitative acceptance criteria and their corresponding results are not detailed.
2. Sample size used for the test set and the data provenance
- Sample Size for the Test Set: Not explicitly stated as a number of cases or patients from the clinical trial description. It mentions "the cases" were reviewed, implying multiple cases, but a specific number is not provided.
- Data Provenance: Not explicitly stated (e.g., country of origin). It is described as a "multicenter, randomized trial," suggesting prospective data collection.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: "Seven different expert CE physicians".
- Qualifications of Experts: They are described as "expert CE physicians" (CE likely stands for Capsule Endoscopy). Further specific qualifications (e.g., years of experience, board certification) are not provided.
- Ground Truth for Test Set: The study compares "Normal mode" (conventional review of all CE images) to "OMNI mode" by having experts review the cases. While "Normal mode" reading time is a baseline, the document doesn't detail how the ground truth for pathology or lesions within these cases was established. The focus of the study was on review efficiency, not diagnostic accuracy against a separate gold standard.
4. Adjudication method for the test set
- The study states, "Seven different expert CE physicians, blinded to the reading mode, reviewed the cases in randomized order." This implies that each physician independently reviewed the cases under both conditions (Normal mode and OMNI mode), and their review times were compared. There is no mention of an adjudication process among these seven experts to establish a single "ground truth" diagnosis for the cases themselves, as the primary endpoint was reading time rather than diagnostic consensus.
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
- MRMC Study: Yes, a "multicenter, randomized trial" was conducted comparing "Normal mode" (without OMNI mode assistance) and "OMNI mode" (with OMNI mode assistance) among "seven different expert CE physicians." This fits the description of a multi-reader, multi-case study.
- Effect Size of Improvement: The human readers (physicians) improved their reading efficiency with OMNI mode assistance.
- Average review time for OMNI mode (with assistance): 27.3 minutes
- Average review time for Normal mode (without assistance): 75.1 minutes
- Improvement (reduction in time): 64% reduction in review time (75.1 - 27.3 = 47.8 minutes reduction). This is a substantial effect size for efficiency.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, the study described is an evaluation of the OMNI mode as an "algorithm that assists the physician" and measures the physician's review time with the assistance versus without it. There is no mention of testing the OMNI mode in a standalone capacity (i.e., automatically detecting lesions without human review) or reporting its performance metrics independent of human interaction. The "Red Color Detection Function" is described as "intended to mark frames of the video suspected of containing blood or red areas," which implies an assistive, not standalone, role.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The ground truth for the efficiency comparison was the measured time taken by the expert physicians to review the cases under different modes. The study's endpoint was not diagnostic accuracy or lesion detection against a separate gold standard like pathology. The OMNI mode's purpose is to "remove and store redundant images," and the study evaluates its success in improving review time.
8. The sample size for the training set
- Not provided. The document focuses on the clinical validation study of the OMNI mode. Information about the training set used to develop the OMNI algorithm (which is a form of AI/algorithm assistance) is not included in this 510(k) summary.
9. How the ground truth for the training set was established
- Not provided. Since the training set sample size and details are not mentioned, the method for establishing its ground truth is also not elaborated upon in this document.
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March 13, 2018
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: K173459
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, 2018 Received: February 1, 2018
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 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.
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.
For comprehensive regulatory information about medical devices and radiation-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,
Charles Viviano -S
Benjamin R. Fisher, Ph.D. For 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) K173459
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 and is intended for use in adults only.
| 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)
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Image /page/3/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. Underneath the line is the text "Your Vision, Our Future" in a smaller, blue font.
K173459 Page 1 of 4
March 6, 2018
5. 510(k) SUMMARY
5.1 General Information
- 510(k) Submitter: OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507
- Contact Position: ● Daphney Germain-Kolawole Senior Project Manager, Regulatory Affairs 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
5.2 Device Identification
| ● Device Trade Name: | OLYMPUS SMALL INTESTINAL CAPSULEENDOSCOPE SYSTEM |
|---|---|
| ● Common Name: | Capsule Imaging System |
| ● Regulation Number: | 876.1300 |
| ● Regulation Name: | Ingestible telemetric gastrointestinal capsule imagingsystem |
| ● Regulatory Class: | II (Special Controls) |
| ● Classification Panel: | Gastroenterology and urology |
| ● Product Code: | NEZ |
5.3 Predicate Device Information
| Primary Predicate Device (PD1) | ||
|---|---|---|
| Model name | Applicant | 510(k) No. |
| OLYMPUS SMALL INTESTINALCAPSULE ENDOSCOPE SYSTEM | OLYMPUS MEDICALSYSTEMS CORP. | K163069 |
| Additional Predicate Device (PD2) | ||
| Model name | Applicant | 510(k) No. |
| OLYMPUSCAPSULE ENDOSCOPE SYSTEM | OLYMPUS MEDICALSYSTEMS CORP. | K090210 |
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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, yellow line. Underneath the line is the text "Your Vision, Our Future" in a smaller font.
K173459 Page 2 of 4
5.4 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. After the visualization, the diagnostic review (also known as reading) of images would start with user selectable OMNI mode feature. OMNI mode is an algorithm that assists the physician in reviewing the Capsule Endoscopy(CE) case data. The components of this SYSTEM are listed below.(Table 5-1)
| Trade or Proprietary or Model Namefor The Subject Device | ModelNumber | |
|---|---|---|
| ENDOCAPSULE SMALL INTESTINAL CAPSULE 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 | 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 | |
| ANTENNA LEAD COVER | MAJ-1470 | |
| ENDOCAPSULE SOFTWARE 10 | MAJ-2188 | |
| ENDOCAPSULE SOFTWARE 10 LIGHT | MAJ-2189 | |
| ENDOCAPSULE SOFTWARE 10 UPGRADE PACKAGE | MAJ-2190 |
Table 5-1: ENDOCAPSULE SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM
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Image /page/5/Picture/0 description: The image shows the logo for Olympus. The logo is in blue and features the word "OLYMPUS" in a bold, sans-serif font. Below the wordmark is a thin, horizontal yellow line. Underneath the line is the tagline "Your Vision, Our Future" in a smaller, lighter font.
K173459 Page 3 of 4
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 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 and is intended for use in adults only.
5.6 Comparison of Technological Characteristics
The OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM has the same technological characteristics and design as the predicate device except for Addition of Lead Type Antenna.
All other technological characteristics of both the subject and primary predicate devices are identical.
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.
-Performance testing - Bench
Performance testing was conducted to demonstrate that the OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM performs according to specifications and functions as intended. Test results verified the safety and effectiveness of the devices in accordance with design specifications and applicable standards. Conducted performance testings are listed below.
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Image /page/6/Picture/0 description: The image shows the logo for Olympus. The word "OLYMPUS" is written in large, bold, blue letters. A thin, yellow line is underneath the word. Below the line, the words "Your Vision. Our Future" are written in a smaller font.
K173459 Page 4 of 4
- Software verification and validation testing
- Electrical safety and electromagnetic compatibility (EMC) test
- Performance testing of radio signal communication
- Radio Interference testing
- FCC Test
-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 testing was performed to support the claims for improvement of capsule reading efficiency and the reduction of redundant images. A multicenter, randomized trial was conducted to examine the hypothesis that OMNI mode can remove and store redundant images of the same region of the small bowel and is superior to conventional review of all CE images (Normal mode) in terms of the time required to review the case data. Seven different expert CE physicians, blinded to the reading mode, reviewed the cases in randomized order . The review time was compared between Normal mode and OMNI mode. OMNI mode required, on average, 27.3 minutes for review while Normal mode required 75.1 minutes, on average (p<0.001), which is a 64% reduction. The result supports the claims for improvement of capsule reading efficiency and the reduction of redundant images. The conducted performance testing is shown below.
- Evaluation of performance of the Omni mode for detecting video capsule endoscopy images:A multicenter randomized controlled trial
5.8 Conclusion
Compared to the primary 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 primary predicate device.
§ 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.”