(123 days)
Not Found
Unknown
The document mentions a "Red Lesion Detector" which processes images to mark suspected lesions. While this could potentially be implemented using traditional image processing techniques, the description lacks explicit mention of AI, ML, or deep learning, and there is no information about training or test sets, which are common indicators of ML use. The performance metrics (sensitivity and specificity) are also applicable to non-AI image processing algorithms. Therefore, it's not possible to definitively confirm or deny the presence of AI/ML based on this summary alone.
No
Explanation: The device is intended for visualization and detection of abnormalities, not for treatment or therapy. It is an imaging system for diagnostic purposes.
Yes
The device is described as being intended for "visualization of the small intestine mucosa" and for "visualization and monitoring of lesions" that may indicate various conditions like Crohn's disease, obscure bleeding, or iron deficiency anemia. It also states it "may be used as a tool in the detection of abnormalities of the small intestine." These uses directly align with the purpose of diagnostics, which is to identify medical conditions. Additionally, the presence of a "Red Lesion Detector" that marks frames suspected of containing active bleeding, angioectasia, red spot, ulcer, or erosion further supports its diagnostic nature.
No
The device description explicitly states that the system consists of hardware components (capsule endoscopes, antenna unit, recorder) in addition to the workstation software.
Based on the provided information, the OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM is an imaging system that is swallowed by the patient to visualize the small intestine mucosa in vivo (within the living body). It captures images directly from the internal environment.
- Lack of Sample Analysis: The system does not analyze samples taken from the body. It is a direct visualization tool.
Therefore, while it is a medical device used for diagnosis, it falls under the category of an in vivo diagnostic imaging system, not an in vitro diagnostic device.
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 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.
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. The components of this SYSTEM are listed below in Table 5-1.
Mentions image processing
downloads the image data from the recorder and processes images for visualization.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Capsule endoscopy
Anatomical Site
small intestine
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
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.
Key Metrics
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
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
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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) |
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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 ENDOSCOPE
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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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 INTESTINAL | ||
| CAPSULE ENDOSCOPE SYSTEM | OLYMPUS MEDICAL | |
| 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
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 |
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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
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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.
-
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.