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 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.

CapsoCam Plus (SV-3) capsule endoscope is a single-use ingestible capsule system for diagnostic visualization of the adult small bowel. The overall system consists of an ingestible Capsule 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 flash-memory data-storage electronics.

AI/ML Overview

The provided text is a 510(k) summary for the CapsoCam Plus (SV-3) video capsule system. This document outlines the device's indications for use, its description, and its substantial equivalence to a previously cleared predicate device. It also briefly mentions non-clinical and clinical testing performed.

However, the document does not contain specific acceptance criteria, study details demonstrating performance against criteria, sample sizes for test or training sets, ground truth establishment methods, expert qualifications, adjudication methods, or information about AI assistance or standalone algorithm performance.

The clinical summary states that the testing demonstrated:

Images are captured throughout an entire small bowel exam, with complete small bowel exam defined as the ability of the capsule to reach the cecum while still recording images.
Images are correctly downloaded using the CapsoAccess® capsule data access system (CDAS3).
Small bowel images of diagnostic quality are able to be reviewed using the CapsoView® CVV Software and determined to be effective for diagnostic purposes by the study investigator.

It concludes that "the results of this clinical testing demonstrate that it meets the primary endpoints per the study protocol and the performance of the CapsoCam Plus (SV-3) Capsule Endoscope System does not raise new issues of safety or effectiveness when compared to the predicate device (K161773)."

The purpose of this 510(k) submission appears to be related to minor changes or reaffirmation of substantial equivalence to an already cleared device (K161773). Therefore, the detailed performance study information, including specific acceptance criteria and quantitative results, would have been part of the original K161773 submission, not this K183192 summary.

Therefore, based solely on the provided text, I cannot provide the requested information in detail because it is not present. The document focuses on showing substantial equivalence rather than detailing a de novo performance study with specific metrics and acceptance criteria.

Summary

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) 510(k) # is not assigned yet K183192

Device Name CapsoCam Plus (SV-3)

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 C)

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Image /page/1/Picture/1 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 handwritten-style font.

1) 510(k) Summary:

General Information

Submission Date:	April 16, 2019
Manufacturer:	CapsoVision, Inc.18805 Cox Ave, Suite 250Saratoga, CA 95070Phone: (408) 624-1488Fax: (408) 370-4795
Registration No.:	3008062894
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)
Common Name:	System Imaging, Gastrointestinal Wireless Capsule
Product Code:	NEZ
Classification Name:	Ingestible telemetric gastrointestinal capsule imaging system(21 CFR § 876.1300)
Predicate Devices:	CapsoCam Plus (SV-3) System, 510 (k) # K161773), cleared on10/21/16

1.1 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.

This is the same intended use as previously cleared for the CapsoCam Plus (SV-3) under 510(k) K161773, cleared on October 21, 2016.

1.2 Device Description

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Image /page/2/Picture/1 description: The image shows the logo for CapsoVision. The logo features a stylized, circular graphic in shades of blue and green, positioned above the company name. Below the name, there is a tagline in cursive that reads "empowering through innovation."

The device is contraindicated in patients:

· Who have known or suspected gastrointestinal obstructions, strictures or fistula
Who are pregnant
· Who have gastroparesis
· Who have a swallowing disorder

Capsule Physical:
Length:	30.5mm
Diameter:	11.3mm
Weight	3.74g
Optical:
Field of View:	74° x 360°
Depth of field:	0 - 18mm.
Object resolution:	0.1 mm
Illumination:	16 independently controlled white light-emitting diodes(LEDs).
Capsule image storage format:
Video format:	JPEG color images
Video resolution:	4 x 288 x 206 pixels
Operational:
Frame rate:	3-5 fps
Operating time:	15 hours

CapsoCam System Technical Specifications:

Software Description 1.3

CapsoView is CapsoVision's proprietary software program used to download and view CapsoCam images and to generate capsule endoscopy reports.

1.3.1 Software Level of Concern:

The software is determined to be "MODERATE" level of concern. This is unchanged from the cleared device CapsoCam Plus (SV-3) K161773. 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. 1.3.2 Image Review Software

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Image /page/3/Picture/1 description: The image shows the logo for CapsoVision. The logo consists of a blue and green circular design above the word "CapsoVision" in a sans-serif font. Below the word "CapsoVision" is the phrase "empowering through innovation" in a cursive font.

1.3.2 System requirements

CapsoView can be installed on a computer that meets the following requirements:

CPU	Minimum Required	Recommended
	Intel Core i3 (for image reviewing andreporting only)Intel Core i5 (4+ threads fordownloading, reviewing and reporting)	Intel Core i7 Quad-Core (8+ threads foroptimal downloading performance)
Memory	Minimum Required	Recommended
	4GB (64-bit)	8GB (64-bit)
Operating System	Minimum Required	Recommended
	PC: Windows 7 (Service Pack 1)Mac: OS X El Capitan	PC: Windows 10Mac: macOS Sierra or macOSHigh Sierra
Display	Minimum Required	Recommended
	Display Resolution of: 1366x768for Windows 1280x800 for MacFor low-resolution monitors, it isnot recommended to set Scalingover 100%.	Display Resolution: 1920x1080 PanelType: IPS (In-Plane Switching) ColorGamut: 100% sRGB with Delta-E <2(For maximum color accuracy)
Additional Software	PDF Reader (e.g. Adobe Reader)

1.3.3 Report Output Format

Portable Document Format (PDF) and DICOM compatible PDF

1.4 Substantial Equivalence

The characteristics of the modified CapsoCam Plus (SV-3) Capsule Endoscope System is substantially equivalent to the following currently approved predicate device based on the indications for use, typical clinical use, and operational and fundamental technological characteristics.

CapsoCam Imaging Systems with the following product information:
- 510(k) #: K161773. O
  - Product name: CapsoCam Plus (SV-3) Endoscope System o
  - Classification: Class II O
  - Classification Regulation:21 CFR § 876.1300 O
  - Panel: Gastroenterology: Urology O
  - Product Code: NEZ O
  - Common Name: Capsule Imaging System O
  - Classification Name: Ingestible Telemetric Gastrointestinal Capsule O Imaging System.

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Image /page/4/Picture/1 description: The image shows the logo for CapsoVision. The logo features a stylized, circular graphic in shades of blue and green above the company name. Below the company name is the tagline "empowering through innovation" in a handwritten-style font.

Predicate Device Description (K161773) 1.5

CapsoCam Plus (SV-3) capsule endoscope is a single-use ingestible capsule system for diagnostic visualization of the adult small bowel. The overall system consists of an ingestible Capsule 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 systemcontrol and nonvolatile flash-memory data-storage electronics. The capsule is typically excreted within 3 to 30 hours after swallowing.

The modified CapsoCam Plus (SV-3) has the following similarities to the cleared version CapsoCam Plus (SV-3) 510(k) # K161773), cleared on October 21, 2016:

Have the same indicated use ●
Use the same operating principle ●
Incorporate the same capsule design
Incorporate the same materials
Have the same shelf life
Are packaged and cleaned using the same material and processes. and
The modified CapsoCam Plus (SV-3) capsules have identical indication for use ● and same operating principles.

1.6 Capsule Data Access System

No design changes were made to the system except for the Instruction for Use (IFU) and a firmware bug fix. Slight modifications were made to the IFU, mainly for formatting and clarification.

1.7 CapsoRetrieve Capsule Retrieval Kit

No design changes were made to the system except for the Instruction for Use (IFU). Slight modifications were made to the IFU, mainly for formatting and clarification and a second source was qualified for the assembly of the retrieval wand without any material change.

1.8 Non-Clinical Testing

The CapsoCam Plus Capsule Endoscope System performance testing includes electrical safety testing, software life cycle validation to the appropriate FDA Recognized Consensus Standards and bench testing which includes LED verification test. Seal Integrity test. Firmware verification test, MCP verification test, Battery life test, Structural, mechanical integrity, camera image test, capsule internal compressive load test, Magnetic field verification test, Shorted battery swelling & force test and Capsule Heating Due to Short Circuit test. The results of this performance testing conclude that the material and technological characteristics of the CapsoCam Plus (SV-3) Capsule Endoscope System device do not raise new issues of safety or effectiveness when compared to the predicate device (K161773).

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Image /page/5/Picture/1 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 word "CapsoVision" in a stylized font, with "Capso" in a larger, bolder font than "Vision". Underneath the company name is the tagline "empowering through innovation" in a smaller, handwritten-style font.

1.9 Clinical Summary

System clinical validation testing of the CapsoCam Plus Capsule Endoscope System was performed with healthy human subjects. The testing demonstrated the following:

· Images are captured throughout an entire small bowel exam, with complete small bowel exam defined as the ability of the capsule to reach the cecum while still recording images.
· Images are correctly downloaded using the CapsoAccess® capsule data access system (CDAS3).
· Small bowel images of diagnostic quality are able to be reviewed using the CapsoView® CVV Software and determined to be effective for diagnostic purposes by the study investigator.

The results of this clinical testing demonstrate that it meets the primary endpoints per the study protocol and the performance of the CapsoCam Plus (SV-3) Capsule Endoscope System does not raise new issues of safety or effectiveness when compared to the predicate device (K161773).

2.0 Conclusion:

Based on the similarities in the indications for use, functional, and operational features as evaluated through clinical and non-clinical performance testing the modified CapsoCam Plus (SV-3) Capsule Endoscope System has demonstrated substantial equivalence to the listed cleared version device (CapsoCam Plus (SV-3) 510(k) 161773) and differences, if any, do not affect the product's safety or effectiveness.

All required testing and analyses were completed on the modified CapsoCam Plus (SV-3) Capsule Endoscope System to ensure that the device is safe and effective for its intended use. The modifications discussed in this submission does not affect the intended use of the device nor alters the fundamental scientific technology of this device.

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Image /page/6/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font below.

April 19, 2019

CapsoVision, Inc. Azimun Jamal Director of QA/RA 18805 Cox Avenue, Suite 250 Saratoga, CA 95070

Re: K183192

Trade/Device Name: CapsoCam Plus (SV-3) Regulation Number: 21 CFR§ 876.1300 Regulation Name: Ingestible Telemetric Gastrointestinal Capsule Imaging System Regulatory Class: II Product Code: NEZ Dated: March 20, 2019 Received: March 22, 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.

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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.htm); 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,

for Beniamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

Regulation Number and Section

§ 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.”