CapsoCam Plus (SV-3) Capsule Endoscopy System

K192662 · CapsoVision, Inc. · NEZ · Feb 14, 2020 · Gastroenterology, Urology

Device Facts

• Record ID: K192662
• Device Name: CapsoCam Plus (SV-3) Capsule Endoscopy System
• Applicant: CapsoVision, Inc.
• Product Code: NEZ · Gastroenterology, Urology
• Decision Date: Feb 14, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1300
• Device Class: Class 2

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 Story

Single-use ingestible video capsule; acquires/stores video images in on-board memory during transit through GI tract via natural peristalsis. Patient uses retrieval kit to collect excreted capsule; physician downloads/reviews images via CapsoView software or CapsoCloud web-based application. System includes capsule, data access system, retrieval kit, and software for image review/reporting. Used in clinical settings; operated by physicians. Cloud-based software manages procedures, reviews, and analyzes images. Output allows visualization of small bowel mucosa to assist in detecting abnormalities, aiding clinical diagnosis.

Clinical Evidence

Bench testing only. Performance testing conducted per FDA recognized consensus standards. Included in-vivo testing for image comparison between proposed and predicate software and image substantial equivalence analysis. No additional biocompatibility, EMC, or electrical safety testing performed as materials and design remain unchanged from predicate.

Technological Characteristics

Single-use ingestible capsule; telemetric imaging system. Components: capsule, data access system, retrieval kit, CapsoView software, CapsoCloud software. Connectivity: cloud-based software application (CapsoCloud) and local software (CapsoView). Software-based image review and reporting. Materials and sterilization processes identical to predicate (K183192).

Indications for Use

Indicated for visualization of small bowel mucosa in adults; used as a tool for detection of small bowel abnormalities.

Regulatory Classification

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.

Special Controls

*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.”

Predicate Devices

• CapsoCam® Plus (SV-3) System (K183192)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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) | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| <div> <span style="font-size: 10pt;"> <b> <span style="font-family: Symbol;">☑</span> </b> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span style="font-size: 10pt;"> <b>□</b> </span> Over The Counter Use (21 CFR 801 Subpart </div> |

|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.<br>18805 Cox Ave, Suite 250<br>Saratoga, CA 95070<br>Phone: [phone]<br>Fax: [phone] |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Azimun Jamal<br>Director, Quality Assurance & Regulatory Affairs<br>CapsoVision, Inc.<br>Phone: [phone]<br>E-mail: [e-mail] |
| 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<br>(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)<br>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)<br>Mac: OS X El Capitan | PC: Windows 10 (64-bit)<br>Mac: macOS Sierra or macOS High Sierra |
| Display | Minimum Required | Recommended |
| | Display Resolution of: 1366x768 for Windows 1280x800 for Mac<br>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 <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-Plane<br>Switching) Color Gamut: 100% sRGB with Delta-E <2 (For<br>maximum 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: A9<br>Android 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.