(126 days)
Unknown
The description mentions "OMNI mode is an algorithm that assists the physician in reviewing the Capsule Endoscopy(CE) case data" and that it "can remove and store redundant images". While this is image processing and algorithmic, the summary does not explicitly state if this algorithm utilizes AI or ML techniques. The performance study focuses on efficiency improvement, which could be achieved through various algorithmic approaches, not necessarily AI/ML.
No
The device is described as an imaging system intended for visualization and monitoring of the small intestine mucosa, not for treating or curing a medical condition.
Yes
The device is intended for "visualization of the small intestine mucosa" to identify and monitor lesions that may indicate conditions like Crohn's disease, obscure bleeding, or iron deficiency anemia, which are all diagnostic objectives. The "Red Color Detection Function" also helps in identifying potential blood, aiding in diagnosis. Furthermore, the system includes "diagnostic review" of images by a physician, confirming its role in the diagnostic process.
No
The device description explicitly states that the system consists of hardware components: capsule endoscopes, an antenna unit, and a recorder, in addition to the workstation software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue). This device is an imaging system that visualizes the small intestine within the body using a capsule endoscope.
- The intended use is for visualization and monitoring of lesions, not for analyzing biological samples.
- The device description focuses on image capture, transmission, and processing for visualization.
- There is no mention of analyzing biological markers or substances.
The device is an in vivo imaging system used for diagnostic purposes, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes
NEZ
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)
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Capsule Endoscope
Anatomical Site
small intestine mucosa
Indicated Patient Age Range
adults only
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
§ 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.”
0
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.
1
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
2
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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3
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 CAPSULE
ENDOSCOPE SYSTEM |
|-------------------------|------------------------------------------------------------------|
| ● Common Name: | Capsule Imaging System |
| ● Regulation Number: | 876.1300 |
| ● Regulation Name: | Ingestible telemetric gastrointestinal capsule imaging
system |
| ● 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 INTESTINAL | ||
| CAPSULE ENDOSCOPE SYSTEM | OLYMPUS MEDICAL | |
| SYSTEMS CORP. | K163069 | |
| Additional Predicate Device (PD2) | ||
| Model name | Applicant | 510(k) No. |
| OLYMPUS | ||
| CAPSULE ENDOSCOPE SYSTEM | OLYMPUS MEDICAL | |
| SYSTEMS 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 Name
for The Subject Device | Model
Number | |
|--------------------------------------------------------------|-------------------------------|------------------|
| 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 | OLYMPUS
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 |
| | 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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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