(142 days)
Not Found
No
The summary describes a video capsule system for image acquisition and viewing, with no mention of AI or ML for image analysis or interpretation.
No
The device is described as a diagnostic tool for visualization and detection of abnormalities, not for treating conditions.
Yes
The "Intended Use / Indications for Use" section states: "It may be used as a tool in the detection of abnormalities of the small bowel." The "Device Description" section also explicitly states: "CapsoCam® Plus (SV-3) capsule endoscope is a single-use ingestible capsule system for diagnostic visualization of the adult small bowel." Both statements confirm its use for diagnosis.
No
The device description clearly lists several hardware components, including the ingestible video capsule, the Capsule Data Access System, and the Capsule Retrieval Kit, in addition to the software components.
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. The CapsoCam Plus system is an ingestible device that captures images within the human body. It visualizes the small bowel mucosa directly.
- The intended use is visualization and detection of abnormalities in situ. The device is used to see what's happening inside the small bowel, not to analyze a biological sample like blood, urine, or tissue in a lab setting.
- The device description focuses on image acquisition and viewing. The components are related to capturing, storing, downloading, and viewing video images from within the body.
Therefore, the CapsoCam Plus video capsule system falls under the category of an in vivo diagnostic 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
NEZ
Device Description
CapsoCam® Plus (SV-3) capsule 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 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.
CapsoCam® Plus (SV-3) capsule endoscope is a single-use ingestible capsule system for diagnostic visualization of the adult small bowel. The system consists of the following accessories:
- CapsoCam® Plus (SV-3) capsules, which are intended for visualization of the small bowel mucosa in adults and used as a tool in the detection of abnormalities of the small bowel.
- CapsoView (CVV) software program, which is used to download and view CapsoCam® Plus ● (SV-3) capsule images and to generate capsule endoscopy reports.
- CapsoAccess (CDAS) Capsule Data Access System, which accesses data from the ● CapsoCam® Plus (SV-3) capsules.
- CapsoRetrieve (CVR1) Capsule Retrieval Kit, which is used for the collection, storage, and ● transportation of the excreted CapsoCam® Plus (SV-3) capsules.
- CapsoCloud (CLD), which is a cloud-based software application used to manage procedures ● and to review and analyze images from the CapsoCam® Plus (SV-3) capsule.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Video
Anatomical Site
small bowel mucosa
Indicated Patient Age Range
adults
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)
The CapsoCam® Plus (SV-3) Capsule Endoscope System performance testing was conducted per the appropriate FDA Recognized Consensus Standards and required bench testing. The modified CapsoCam® Plus (SV-3) Capsule Endoscopy System was tested for the CapsoCloud Software application related changes including in-vivo testing for the image comparison from the proposed and the predicate software and Image Substantial Equivalence Analysis. No additional testing was performed since no other changes were made to the subject device.
The result of this testing concludes that the material and technological characteristics of the CapsoCam® Plus (SV-3) Capsule Endoscopy System do not raise different questions of safety or effectiveness when compared to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.”
0
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February 14, 2020
CapsoVision, Inc. Azimun Jamal Sr. Director of OA/RA 18805 Cox Avenue Suite 250 Saratoga, CA 95070
Re: K192662
Trade/Device Name: CapsoCam® Plus (SV-3) Capsule Endoscopy System Regulation Number: 21 CFR 876.1300 Regulation Name: Ingestible telemetric gastrointestinal capsule imaging system Regulatory Class: II Product Code: NEZ Dated: October 10, 2019 Received: October 11, 2019
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. 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.
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
1
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Shanil Haugen, Ph.D. Acting Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K192662
Device Name
CapsoCam® Plus (SV-3) Capsule Endoscopy 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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | □ Over The Counter Use (21 CFR 801 Subpart |
|X | Prescription Use (Part 21 CFR 801 Subpart D)
|_ | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
K192662 Page 1 of 5
Image /page/3/Picture/1 description: The image contains the logo for CapsoVision. The logo features a blue and green swirl graphic above the company name, which is written in a modern, sans-serif font. Below the company name is the tagline "empowering through innovation" in a smaller, handwritten-style font.
5. 510(k) Summary:
Date Prepared: September 24, 2019
| Manufacturer: | CapsoVision, Inc.
18805 Cox Ave, Suite 250
Saratoga, CA 95070
Phone: (408) 624-1488
Fax: (408) 370-4795 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Azimun Jamal
Director, Quality Assurance & Regulatory Affairs
CapsoVision, Inc.
Phone: (408) 866-6358
E-mail: azimun.jamal@capsovision.com |
| Device Information: | |
| Classification: | Class II |
| Trade Name: | CapsoCam® Plus (SV-3) Capsule Endoscopy System |
| Common Name: | System Imaging, Gastrointestinal Wireless Capsule |
| Classification Name: | Ingestible telemetric gastrointestinal capsule imaging system
(21 CFR § 876.1300) |
| Product Code: | NEZ |
| Predicate Device: | CapsoCam® Plus (SV-3) System, 510(k) # K183192, cleared on 04/19/19 |
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
Device Description
CapsoCam® Plus (SV-3) capsule 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 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.
CapsoCam® Plus (SV-3) capsule endoscope is a single-use ingestible capsule system for diagnostic visualization of the adult small bowel. The system consists of the following accessories:
- CapsoCam® Plus (SV-3) capsules, which are intended for visualization of the small bowel mucosa in adults and used as a tool in the detection of abnormalities of the small bowel.
- CapsoView (CVV) software program, which is used to download and view CapsoCam® Plus ● (SV-3) capsule images and to generate capsule endoscopy reports.
4
Image /page/4/Picture/0 description: The image shows the logo for CapsoVision. The logo features a blue and green swirl design above the company name. Below the company name is the tagline "empowering through innovation" in a cursive font.
K192662 Page 2 of 5
- CapsoAccess (CDAS) Capsule Data Access System, which accesses data from the ● CapsoCam® Plus (SV-3) capsules.
- CapsoRetrieve (CVR1) Capsule Retrieval Kit, which is used for the collection, storage, and ● transportation of the excreted CapsoCam® Plus (SV-3) capsules.
- CapsoCloud (CLD), which is a cloud-based software application used to manage procedures ● and to review and analyze images from the CapsoCam® Plus (SV-3) capsule.
Software Description and System Requirements
CapsoView CVV:
Capso View is Capso Vision's proprietary software program used to download and view CapsoCam images and to generate capsule endoscopy reports.
| CPU | Minimum Required | Recommended |
|---|---|---|
| Intel Core i3, 4th generation (for image reviewing and reporting only) | ||
| Intel Core i5, 4th generation (4+ threads for downloading, reviewing and reporting) | Intel Core i7 Quad-Core, 6th generation (8+ threads for optimal downloading performance) | |
| Memory | Minimum Required | Recommended |
| 4GB | 8GB | |
| Operating System | Minimum Required | Recommended |
| PC: Windows 7 (Service Pack 1) (64-bit) | ||
| Mac: OS X El Capitan | PC: Windows 10 (64-bit) | |
| Mac: macOS Sierra or macOS High Sierra | ||
| Display | Minimum Required | Recommended |
| Display Resolution of: 1366x768 for Windows 1280x800 for Mac | ||
| For low-resolution monitors, it is not recommended to set Scaling over 100%. | Display Resolution: 1920x1080 Panel Type: IPS (In-Plane Switching) Color Gamut: 100% sRGB with Delta-E |