CapsoCam Plus (SV-3)

{0}------------------------------------------------ #### 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > · Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {1}------------------------------------------------ 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.<br>18805 Cox Ave, Suite 250<br>Saratoga, CA 95070<br>Phone: (408) 624-1488<br>Fax: (408) 370-4795 | | Registration No.: | 3008062894 | | Contact Person: | Azimun Jamal<br>Director, Quality Assurance & Regulatory Affairs<br>CapsoVision, Inc.<br>Phone: (408) 866-6358<br>E-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<br>(21 CFR § 876.1300) | | Predicate Devices: | CapsoCam Plus (SV-3) System, 510 (k) # K161773), cleared on<br>10/21/16 | #### 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 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. {2}------------------------------------------------ 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 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. | 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<br>(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 {3}------------------------------------------------ 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 and<br>reporting only)<br>Intel Core i5 (4+ threads for<br>downloading, reviewing and reporting) | Intel Core i7 Quad-Core (8+ threads for<br>optimal downloading performance) | | Memory | Minimum Required | Recommended | | | 4GB (64-bit) | 8GB (64-bit) | | Operating System | Minimum Required | Recommended | | | PC: Windows 7 (Service Pack 1)<br>Mac: OS X El Capitan | PC: Windows 10<br>Mac: macOS Sierra or macOS<br>High Sierra | | Display | Minimum Required | Recommended | | | Display Resolution of: 1366x768<br>for Windows 1280x800 for Mac<br>For low-resolution monitors, it is<br>not recommended to set Scaling<br>over 100%. | Display Resolution: 1920x1080 Panel<br>Type: IPS (In-Plane Switching) Color<br>Gamut: 100% sRGB with Delta-E <2<br>(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. {4}------------------------------------------------ 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). {5}------------------------------------------------ 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. {6}------------------------------------------------ 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. {7}------------------------------------------------ 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