(142 days)
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.
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.
Here's a breakdown of the acceptance criteria and study information for the CapsoCam® Plus (SV-3) Capsule Endoscopy System, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" with numerical targets for clinical performance. Instead, it focuses on demonstrating substantial equivalence to a predicate device (CapsoCam® Plus (SV-3) System, K183192).
The key performance aspect tested for the new CapsoCloud software application was image comparison and Image Substantial Equivalence Analysis between the proposed and predicate software.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Image Substantial Equivalence | Demonstrated substantial equivalence through testing of the CapsoCloud software application and in-vivo image comparison. |
| Safety and Effectiveness | The material and technological characteristics do not raise different questions of safety or effectiveness compared to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The document states "in-vivo testing for the image comparison from the proposed and the predicate software."
- Sample Size: Not explicitly stated.
- Data Provenance: "in-vivo testing" suggests data from live subjects, but details like country of origin or whether it was retrospective or prospective are not provided.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided in the document.
4. Adjudication Method
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not conducted or reported in this document. The focus was on demonstrating substantial equivalence to a predicate device, specifically regarding the addition of a new cloud-based software. There is no mention of human reader performance improvement with or without AI assistance.
6. Standalone (Algorithm Only) Performance
A standalone performance study focused purely on the algorithm's diagnostic capabilities without human interaction was not explicitly described for this submission. The validation focused on the CapsoCloud software and image equivalence to the predicate system, which implies the system as a whole maintains its performance characteristics when the cloud software is introduced.
7. Type of Ground Truth Used
The ground truth for the "image comparison from the proposed and the predicate software" would be rooted in the images generated by the predicate device's software. The goal was to show that the new software (CapsoCloud) processes and presents images that are substantially equivalent to those processed by the predicate's CapsoView software. The document doesn't detail how the ground truth for actual abnormalities or diagnoses in these images was established, as the primary comparison was between software versions, not necessarily clinical diagnostic accuracy.
8. Sample Size for the Training Set
This information is not provided in the document.
9. How the Ground Truth for the Training Set Was Established
This information is not provided in the document.
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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
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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
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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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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 250Saratoga, CA 95070Phone: (408) 624-1488Fax: (408) 370-4795 |
|---|---|
| Contact Person: | Azimun JamalDirector, Quality Assurance & Regulatory AffairsCapsoVision, Inc.Phone: (408) 866-6358E-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.
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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 MacFor 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 <2 (For maximum color accuracy) | |
| Additional Software | PDF Reader (e.g. Adobe Reader) |
CapsoView® can be installed on a computer that meets the following requirements:
CapsoCloud CLD
CapsoCloud is a cloud-based software application used to manage procedures and to review and analyze images from the CapsoCam® Plus capsule endoscopy system.
CapsoCloud is a web-based interface that can be accessed on a device that meets the following requirements:
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Image /page/5/Picture/0 description: The image shows the logo for CapsoVision. The logo features a circular graphic with blue and green swirls at the top. Below the graphic is the company name, "CapsoVision," with the first letter capitalized and the rest in lowercase. Underneath the company name is the tagline "empowering through innovation" in a smaller, handwritten-style font.
SYSTEM REQUIREMENTS
1. Computer
| CPU | Recommended |
|---|---|
| Intel Core i7 Quad-Core, 6th generation | |
| Memory | Recommended |
| 8GB | |
| Operating System | Recommended |
| PC: Windows 10 (64-bit) | |
| Mac: macOS Sierra or macOS High Sierra | |
| Display | Recommended |
| Display Resolution: 1920x1200 Panel Type: IPS (In-PlaneSwitching) Color Gamut: 100% sRGB with Delta-E <2 (Formaximum color accuracy) | |
| Network | Recommended |
| 25 Mbps, 100ms latency | |
| Chrome | Supported Versions |
| 75.0.3770 - 79.0.3945 | |
| Additional Software | PDF Reader (e.g. Adobe Reader) |
2. Mobile device (iPhone, Android phone, iPad, Android tablet)
a. Procedure management and shipping label generation
| Processor | Recommended |
|---|---|
| iPhone: A9Android Phone: Qualcomm Snapdragon 425 | |
| Memory | Recommended |
| 2GB | |
| iOS | Supported Versions |
| 9.0 and above | |
| Android OS | Supported Versions |
| 4.1.x and above |
b. Video Streaming (iPad)
| Memory | Recommended |
|---|---|
| -------- | ------------- |
CONFIDENTIAL
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Image /page/6/Picture/0 description: The image shows the logo for CapsoVision. The logo features a circular graphic with swirling blue and green colors at the top left. Below the graphic is the company name, "CapsoVision," written in a modern, handwritten-style font. Underneath the company name is the tagline "empowering through innovation" in a smaller, cursive font.
| 1.4GB | |
|---|---|
| iOS | Supported Versions |
| 9.0 and above | |
| iPad Model | Recommended |
| iPad 6 2018, iPad air 2019, iPad Pro all models |
Comparison of the Technological Characteristic with the Predicate Device:
The characteristics of the modified CapsoCam® Plus (SV-3) Capsule Endoscopy System is substantially equivalent to the predicate device based on the indications for use and technological characteristics.
The CapsoCam® Plus (SV-3) capsule endoscopy system that supports the Capsule endoscopy procedure consists of the following:
- CapsoCam® Plus (SV-3) capsules, which is 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) 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.
The modified CapsoCam® Plus (SV-3) Capsule Endoscopy System has the following similarities to the predicate device:
- Has the same intended use and Indications for Use ●
- Uses the same operating principle ●
- Incorporates the same capsule design ●
- Incorporates the same materials
- Has the same shelf life
- Is packaged and cleaned using the same material and processes
The modified CapsoCam® Plus (SV-3) Capsule Endoscopy System is different from the predicate system in that it includes a new cloud-based software application to manage procedures and review and analyze images from the CapsoCam capsule.
Performance Data
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.
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Image /page/7/Picture/0 description: The image shows the logo for CapsoVision. The logo features a stylized blue and green swirl 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.
K192662 Page 5 of 5
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.
Note: Since the material is the same as the cleared device CapsoCam® Plus (SV-3) Capsule Endoscopy System under K183192, no additional testing was performed for the Biocompatibility, EMC or electrical Safety test for the subject device.
Conclusions:
The subject and predicate device share the same intended use, Indications for Use, and similar technological characteristics. The differences in technological characteristics do not impact safety or effectiveness and verification and validation data demonstrate that the subject device is as safe and effective as the predicate device. The subject device is substantially equivalent to the predicate device that is currently marketed for the same intended use.
§ 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.”