(115 days)
Not Found
No
The summary describes a video capsule system for visualization and image storage, with software for review. It mentions "image processing improvements" but does not mention AI, ML, or any related terms, nor does it describe any automated analysis or interpretation of images using such technologies. The performance studies focus on image quality, landmark identification, and reader agreement, not on the performance of an AI/ML algorithm.
No.
The device is described as a diagnostic tool for visualizing the small bowel mucosa to detect abnormalities, not for treating conditions.
Yes
The "Intended Use / Indications for Use" states that the device "may be used as a tool in the detection of abnormalities of the small bowel" and the "Device Description" explicitly mentions "diagnostic visualization of the adult small bowel."
No
The device description explicitly states that the system includes an ingestible capsule containing hardware components such as a camera, batteries, light sources, laser diode, and memory. While it includes software for data access and review, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "visualization of the small bowel mucosa" and as a "tool in the detection of abnormalities of the small bowel." This describes a diagnostic imaging tool used to directly observe the internal anatomy, not a test performed in vitro (outside the body) on biological samples to diagnose a condition.
- Device Description: The description details an ingestible video capsule that captures images within the body. This is consistent with an in-vivo imaging device, not an in-vitro diagnostic.
- Mechanism: The device works by capturing images as it passes through the gastrointestinal tract, which is an in-vivo process. IVDs typically involve analyzing biological samples like blood, urine, or tissue in a laboratory setting.
- Performance Studies: The performance studies focus on image quality, landmark identification, and agreement between readers on the presence of pathologies based on the captured images. These are typical evaluations for imaging devices, not IVDs which would focus on metrics like sensitivity, specificity, and accuracy in detecting specific analytes or markers in samples.
In summary, the CapsoCam Plus video capsule system is an in-vivo diagnostic imaging device, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
The CapsoCam® Plus video capsule system is intended for visualization of the small bowel mucosa in adults. It may be used as a tool in the detection of abnormalities of the small bowel.
Product codes (comma separated list FDA assigned to the subject device)
NEZ
Device Description
CapsoCam Plus (SV-3) Capsule Endoscope System is a single-use, ingestible video capsule that acquires and stores video images in on-board memory while moving through the gastrointestinal tract, propelled by natural peristalsis. The patient retrieves the capsule using the provided retrieval kit and returns it to the physician who downloads and reviews the images on a computer. The capsule is typically excreted within 3 to 30 hours after swallowing.
The overall system consists of an ingestible CapsoCam (SV-3), the CapsoRetrieve® (CVR1) Capsule Retrieval Kit, the CapsoAccess® Capsule Data Access System (CDAS) and the CapsoView® (CVV) software. The capsule contains a panoramic color digital video camera, two silver-oxide watch batteries, white-LED light sources, a laser diode for data download and system-control and nonvolatile flashmemory data-storage electronics.
Optics: The capsule contains four wide-angle optical objectives oriented at 90° intervals around the circumference of the capsule. The four objectives are assembled in a monolithic lens mount with four bores. Each objective has a longitudinal field of view of 74°and a transverse field of view of 162°. Taken together, the four lenses image the 360° circumference of the capsule over a length of 5± 1 mm.
Imaging sensor: The four optical objectives produce images on a single custom CMOS image sensor that has four separate pixel arrays. A color filter mosaic produces pixels sensitive to red, green, or blue light respectively.
Multi-chip Package (MCP): molded package containing multiple silicon chips:
- ASIC: Includes voltage regulator. RAM, CPU, and dedicated circuitry for functions such as IPEG image compression and motion detection.
- Flash Memory: Two chips. The capacity of each chip is 4Gb.
Illumination: 16 independently controlled "white" LEDs. Each LED is an AIGaN blue LED packaged with a phosphor epoxy in a lead-frame package.
Battery/Switch Pack: Subassembly with two 1.55V SR927W silver-oxide watch batteries and a magnetically-actuated switch that activates the capsule when removed from the package. Printed circuit board (PCB): All electronic components are soldered onto a rigid-flex PCB that is folded inside the capsule.
Capsule housing: The capsule is cylindrical with hemispheric domes at each end. The capsule is 30.5 mm long and 11.3mm in diameter. The capsule housing comprises two thermoplastic parts joined and sealed with an adhesive.
Mentions image processing
Yes, "Image processing improvements" under CapsoView CVV-3.2 software changes.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found. (Infer: Video imaging from ingestible capsule)
Anatomical Site
Small bowel mucosa
Indicated Patient Age Range
Adults
Intended User / Care Setting
Physician (for review and diagnosis), technician (for data retrieval), patient (for capsule ingestion and retrieval). Care setting: clinic/health facility (for data download and review) and patient's home (for ingestion and excretion).
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
Study 1: Protocol CVI-006 "Validation of CapsoCam® SV-3 Capsule Endoscopy System"; 49 healthy volunteers were enrolled. 42 Per-Protocol subjects for evaluation. The principal investigator was asked to identify key landmarks, completion of exam, identify any pathologies, assess image quality.
Study 2: Comparisons of reads of select video clips from the study CVI-006 by Independent Blinded readers. Images of landmarks and pathologies were extracted from the complete video clips. These video clips were randomized and sent to independent readers who were blind to the nature of the CVI-006 study. Readers were asked to assess landmark video quality, pathologies identified and subjective questions on video/diagnostic quality.
Study 3: From the original SV-1 Study, a total of 40 video clips (both normal (11) and with pathology (29)).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study 1: Validation of CapsoCam® SV-3 Capsule Endoscopy System (clinical study). 42 per-protocol subjects.
Key results:
- Image Diagnostic Quality: Yes 40, No 2
- Small Bowel Complete: Yes 41, No 1
- Pathologies Identified (grouped by type): Blood 0, Angiectasia 2, Ulcer 2, Polyp/Mass 0, Other 4. None of the pathological findings were considered clinically significant.
- Landmarks Identified: 1st Esophageal 40, 1st Gastric 42, 1st Duodenal 42, 1st Cecal 41, Papilla 35.
- Overall Image Quality: Images better than previous generation: Yes 4, No 38.
Study 2: Comparisons of reads of select video clips from study CVI-006 by Independent Blinded readers. N=42.
Key results:
- Consensus Amongst readers with video clips of Landmarks: 1st Duodenal 15, 1st Cecal/IC Valve 12, None 15. All blinded readers were in consensus regarding landmark video clips.
- Overall Consensus for Readers: Excellent 26, N/A 15, Discordant amongst Readers 1.
- Consensus agreement on pathologies found in CVI-006: Blood 0, Ulcer 0, Vascular 5, Polyp/Mass 1, Other 2, None 34.
- Consensus when comparing to the original pathologies identified in CVI-006: Ulcer 2/0, Vascular 2/5, Other 4/2, None 34/34.
- Subjective questions on video Quality: Were Images of Diagnostic Quality: Yes 42, No 0. Better Diagnostic Quality from Earlier Generation: Yes 25, No 17.
Study 3: Comparison of SV-1 and SV-3 software. 40 video clips (11 normal, 29 with pathology).
Key results:
- Consensus agreement: 35 of 40 clips (87.5%) were in agreement with landmark or clinical pathology findings. 100% agreement between old and new software versions.
- For video clips with landmarks identified in original SV-1 study: consensus in 10 of 11 clips (90.9%).
- For video clips with significant clinical pathology identified in original SV-1 study: consensus in 25 of 29 clips (86.2%).
- Subjective Evaluation Questions (SV-3 vs SV-1 software):
- Video Image Quality: 28 (70%) Ranked the SV-3 image as better, 12 (30%) Ranked both as comparable.
- Clinical Assessment Quality: 1 (2.5%) Ranked the SV-3 image as better, 39 (97.5%) Ranked both as comparable.
- Ease of use: 39 (97.5%) Ranked both as equal, 1 (2.5%) Ranked the SV-3 software as easier.
- Reviewing Experience: 38 (95.0%) Ranked both software versions as the same, 2 (5.0%) Ranked the SV-1 software as a worse reviewing experience.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of three stylized human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 21, 2016
CapsoVision, Inc Azimun Jamal Director of QA/RA 18805 Cox Avenue, Suite 250 Saratoga, California 95070
Re: K161773
Trade/Device Name: Capsocam Plus (SV-3) Capsule Endoscope System Regulation Number: 21 CFR 876.1300 Regulation Name: Ingestible Telemetric Gastrointestinal Capsule Imaging System Regulatory Class: Class II Product Code: NEZ Dated: September 20, 2016 Received: September 21, 2016
Dear Azimun Jamal:
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. 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
1
forth in the quality systems (OS) 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/Resourcesfor You/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,
Joyce M. Whang -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) K161773
Device Name
CapsoCam Plus (SV-3) Capsule Endoscope System
Indications for Use (Describe)
The CapsoCam® Plus video capsule system is intended for visualization of the small bowel mucosa in adults. It may be used as a tool in the detection of abnormalities of the small bowel.
| 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 CapsoVision. The logo consists of a blue and green circular design at the top, followed by the word "CapsoVision" in a bold, sans-serif font. Below the company name is the tagline "empowering through innovation" in a cursive font.
5.0 510(k) Summary
This traditional 510(k) summary for the CapsoCam Plus (SV-3) Capsule Endoscope System is submitted in accordance with the requirements of 21 C.F.R. § 807.92.
5.1 General Information:
| Date: | October 21, 2016 |
|---|---|
| Manufacturer: | CapsoVision, Inc. |
| 18805 Cox Ave, Suite 250 | |
| Saratoga, CA 95070 | |
| Phone: (408) 624-1488 | |
| Fax: (408) 370-4795 | |
| Registration No.: | 3008062894 |
| Contact Person: | Azimun Jamal |
| Director, Quality Assurance & Regulatory Affair | |
| CapsoVision, Inc. | |
| Phone: (408) 866-6358 | |
| E-mail: azimun.jamal@capsovision.com |
Device Information:
| Classification: | Class II |
|---|---|
| Trade Name: | CapsoCam Plus (SV-3) Capsule Endoscope System |
| Common Name: | System Imaging, Gastrointestinal Wireless Capsule |
| Classification Name: | Ingestible telemetric gastrointestinal capsule imaging system |
| (21 CFR § 876.1300) | |
| Predicate Devices: | CapsoCam (SV-1) (K151635) |
Intended Use:
The CapsoCam Plus video capsule system is intended for visualization of the small bowel mucosa in adults. It may be used as a tool in the detection of abnormalities of the small bowel.
Device Description:
CapsoCam Plus (SV-3) Capsule Endoscope System is a single-use, ingestible video capsule that acquires and stores video images in on-board memory while moving through the gastrointestinal tract, propelled by natural peristalsis. The patient retrieves the capsule using the provided retrieval kit and returns it to the physician who downloads and reviews the images on a computer. The capsule is typically excreted within 3 to 30 hours after swallowing. The device is contraindicated in patients:
- · Who have known or suspected gastrointestinal obstructions, strictures or fistula
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Image /page/4/Picture/0 description: The image shows the logo for CapsoVision. The logo consists of a blue and green circular design above the company name. Below the company name is the tagline "empowering through innovation" in a handwritten-style font.
- · Who are pregnant
- · Who have gastroparesis
- · Who have a swallowing disorder
CapsoCam Plus (SV-3) capsule endoscope system is a single-use ingestible capsule system for diagnostic visualization of the adult small bowel. The overall system consists of an ingestible CapsoCam (SV-3), the CapsoRetrieve® (CVR1) Capsule Retrieval Kit, the CapsoAccess® Capsule Data Access System (CDAS) and the CapsoView® (CVV) software. The capsule contains a panoramic color digital video camera, two silver-oxide watch batteries, white-LED light sources, a laser diode for data download and system-control and nonvolatile flashmemory data-storage electronics.
5.2 Comprehensive Description of the Product:
Optics: The capsule contains four wide-angle optical objectives oriented at 90° intervals around the circumference of the capsule. The four objectives are assembled in a monolithic lens mount with four bores. Each objective has a longitudinal field of view of 74°and a transverse field of view of 162°. Taken together, the four lenses image the 360° circumference of the capsule over a length of 5± 1 mm.
Imaging sensor: The four optical objectives produce images on a single custom CMOS image sensor that has four separate pixel arrays. A color filter mosaic produces pixels sensitive to red, green, or blue light respectively.
Multi-chip Package (MCP): molded package containing multiple silicon chips:
- . ASIC: Includes voltage regulator. RAM, CPU, and dedicated circuitry for functions such as IPEG image compression and motion detection.
- . Flash Memory: Two chips. The capacity of each chip is 4Gb.
Illumination: 16 independently controlled "white" LEDs. Each LED is an AIGaN blue LED packaged with a phosphor epoxy in a lead-frame package.
Battery/Switch Pack: Subassembly with two 1.55V SR927W silver-oxide watch batteries and a magnetically-actuated switch that activates the capsule when removed from the package. Printed circuit board (PCB): All electronic components are soldered onto a rigid-flex PCB that is folded inside the capsule.
Capsule housing: The capsule is cylindrical with hemispheric domes at each end. The capsule is 30.5 mm long and 11.3mm in diameter. The capsule housing comprises two thermoplastic parts joined and sealed with an adhesive.
| Capsule Physical: | |
|---|---|
| Length: | 30.5mm |
| Diameter: | 11.3mm |
| Weight | 3.74g |
| Optical: | |
| Field of View: | 74° x 360° |
CapsoCam System Technical Specifications:
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Image /page/5/Picture/0 description: The image shows the logo for CapsoVision. The logo consists of a blue and green swirl above the company name, which is written in a simple, sans-serif font. Below the company name is the tagline "empowering through innovation" in a cursive font.
| Depth of field: | 0 – 18mm. |
|---|---|
| Object resolution: | 0.1 mm |
| Illumination: | 16 independently controlled white light-emitting diodes (LEDs). |
| Capsule image storage format: | JPEG color images |
| Video format: | 4 x 288 x 206 pixels |
| Operational: | |
| Frame rate: | 3-5 fps |
| Operating time: | 15 hours |
Upon excretion, the capsule is retrieved by the patient using Capsole retrieval system. The system includes a strainer, which is placed in the patient's toilet to retrieve the capsule while passing fecal matter, a cup for rinsing, a magnetic rod for grasping the capsule and a vial for storing and transporting the excreted capsule. The patient then returns the capsule to the clinic. where a technician disinfects the capsule and retrieves the data using the CapsoAccess, Capsule Data Access System (CDAS). The data is transferred to the workstation over the link, shown schematically in Figure 4 under the executive summary, from the capsule to the docking system by a serial interface and to the workstation by a Universal Serial Bus (USB).
The reviewing workstation is a computer with the CapsoView image review software installed. The CapsoView (CVV) software displays the video and employs a variety of image enhancement, video navigation, and image analysis features to facilitate the physician's diagnosis. The software allows the physician to efficiently annotate individual frames from the video and compile a procedure report.
The battery life for the CapsoCam is approximately 15 hours in order to allow complete imaging of the small bowel. Battery-life data collected during the clinical trial was provided with the predicate device (SV-1-K151635). Software Description:
CapsoView is CapsoVision's proprietary software program used to download and view CapsoCam images and to generate capsule endoscopy reports.
5.2.1 Software Level of Concern:
The software is determined to be "MODERATE" level of concern. This is unchanged from the cleared device SV-1 K161535. The software does not directly cause, control and/or mitigate hazards that could result in injury to the patient or the operator. The risk of malfunctions of the software that leads to an erroneous diagnosis or a delay in delivery of appropriate medical care is minimal.
5.2.2Image Review Software
5.2.2.1 System requirements
CapsoView can be installed on a computer that meets the following requirements:
| CPU | Minimum Required | Recommended |
|---|---|---|
| Intel Core i3 (for image review | ||
| and reporting only) | Intel Core i7 Quad-Core (for optimal | |
| downloading performance) |
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Image /page/6/Picture/0 description: The image shows the logo for CapsoVision. The logo consists of a blue and green swirl above the company name. Below the company name is the tagline "empowering through innovation" in a cursive font.
| | Intel® Core™ i5 (for
downloading, review and
reporting) | |
|---------------------|---------------------------------------------------------------|--------------------------------------|
| | | |
| Memory | For 32-bit Operating System | For 64-bit Operating System |
| | Minimum 2GB | Minimum 4GB |
| Operating System | For PC | For Mac |
| | Windows 7 (Service Pack 1) | OS X Yosemite |
| | Windows 8.1 | OS X El Capitan |
| | Windows 10 (Recommended for | |
| | optimal downloading | |
| | performance) | |
| Display | Minimum Required | Recommended |
| | Display Resolution of:
1366x768 for Windows | Display Resolution: 1920x1080 |
| | 1280x800 for Mac | Panel Type: IPS (In-Plane Switching) |
| | | Color Gamut: 100% sRGB with Delta-E |
| | |