The CapsoCam Plus SV-3 capsule endoscopy system is intended for visualization of the small bowel mucosa in adults and children older than two years of age. It may be used as a tool in the detection of abnormalities of the small bowel.

Device Description

The primary component of the CapsoCam Plus (SV-3) capsule endoscopy system is the eponymous single-use, ingestible capsule that acquires and stores video images in on-board memory while moving through the gastrointestinal tract, propelled by natural peristalsis. It is administered under medical supervision either in-person or remotely under video guidance (available for adult patients only). The capsule is typically excreted within 3 to 30 hours after swallowing. Upon excretion, the patient/authorized caregiver retrieves the capsule using the provided retrieval kit and returns it to the capsules to the download center in a pre-paid envelope) where the capsule is processed and data is downloaded.

The system consists of the following hardware components and accessories:

CapsoCam Plus (SV-3) capsules, which are intended for visualization of the small bowel mucosa.
CapsoRetrieve (CVR1) Capsule Retrieval Kit, a kit of non-powered tools used for the collection, storage, and transportation of the excreted CapsoCam Plus (SV-3) capsules.
CapsoAccess (CDAS) Capsule Data Access System, a dock which facilitates download/access of data from the SV-3 capsules.

The system also includes software that is unchanged from K192662.

AI/ML Overview

The provided text does not contain information about acceptance criteria for device performance, nor details about a study that proves the device meets specific performance criteria through metrics like sensitivity, specificity, or accuracy.

The document is an FDA 510(k) clearance letter for the CapsoCam Plus (SV-3) Capsule Endoscopy System. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed performance metrics from a specific clinical or technical validation study with acceptance criteria.

The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section states that:

"performance testing was conducted per the appropriate FDA Recognized Consensus Standards and required bench testing specifically included 1) verification and validation of hardware changes to confirm that, upon the design changes these continue to meet the applicable product specifications, and 2) transportation and shelf-life testing..."
"A human factors evaluation was conducted and supported by real world evidence to demonstrate that there the safely and effectively administered to adult patients in a remote setting."
"The clinical evidence provided in the submission include (1) a subgroup analysis of the pivotal study for CapsoCam (K151635), which enrolled both transitional adolescents (n=3, age: 19-21) and adult subjects, (2) an analysis of real world data on the pediatric use of CapsoCam in a pediatric gastroenterology clinic in Australia (n=26, age: 3-18), and (3) a review of the clinical literature on the pediatic use of the reference device and other capsule endoscopes cleared by the FDA indicated for use for in patients 2 years and above."

However, it does not provide the specific acceptance criteria (e.g., minimum sensitivity or specificity values) or the reported device performance against such criteria. It also lacks details on:

The *sample size used for the test set beyond the general mention of "subgroup analysis of the pivotal study for CapsoCam (K151635)" and "analysis of real world data on the pediatric use of CapsoCam in a pediatric gastroenterology clinic in Australia (n=26)". The data provenance is described as "real world data on the pediatric use of CapsoCam in a pediatric gastroenterology clinic in Australia" and a "subgroup analysis of the pivotal study for CapsoCam (K151635)". It implies retrospective analysis of existing data.
The number of experts used to establish ground truth or their qualifications.
The adjudication method used.
Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done or any effect size of human reader improvement with AI assistance. (Note: This is a capsule endoscopy system, not an AI-assisted reading device, so MRMC with AI assistance would likely not be relevant here).
Whether a standalone (algorithm only) performance study was done.
The type of ground truth used beyond "facilitate diagnostic evaluation."
The sample size for the training set (as it refers to minor design changes and clinical evidence from existing data, it doesn't describe a new AI model training process).
How ground truth for the training set was established.

In summary, the provided document is a 510(k) clearance letter confirming substantial equivalence, and it does not contain the detailed performance study information with specific acceptance criteria, reported metrics, and study design elements regarding ground truth establishment, expert adjudication, or AI model training/testing that your request asks for. This type of information is typically found in the full 510(k) submission, specifically the performance data section, which is not fully included in this clearance letter.

Summary

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December 4, 2024

CapsoVision Inc. Zane Liu Director, Regulatory Affairs 18805 Cox Avenue Suite 250 Saratoga, California 95070

Re: K242643

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: Class II Product Code: NEZ Dated: September 3, 2024 Received: September 3, 2024

Dear Zane Liu:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).

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Sincerely,

Shanil P. Haugen -S

Shanil P. Haugen, Ph.D. 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

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K242643

Device Name

CapsoCam Plus (SV-3) Capsule Endoscopy System

Indications for Use (Describe)

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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510(k) #:

510(k) Summary

Prepared on: 2024-11-22

Contact Details

21 CFR 807.92(a)(1)

Applicant Name		CapsoVision Inc.
Applicant Address		18805 Cox Avenue Suite 250 Saratoga CA 95070 United States
Applicant Contact Telephone		(408) 624-1488
Applicant Contact		Azimun Jamal
Applicant Contact Email		azimun.jamal@capsovision.com
Correspondent Name		CapsoVision Inc.
Correspondent Address		18805 Cox Avenue Suite 250 Saratoga CA 95070 United States
Correspondent Contact Telephone		(408) 624-1488
Correspondent Contact		Zane Liu
Correspondent Contact Email		zane.liu@capsovision.com
Device Name			21 CFR 807.92(a)(2)
Device Trade Name		CapsoCam Plus (SV-3) Capsule Endoscopy System
Common Name		Ingestible telemetric gastrointestinal capsule imaging system
Classification Name		System, Imaging, Gastrointestinal, Wireless, Capsule
Regulation Number		876.1300
Product Code(s)		NEZ
Legally Marketed Predicate Devices			21 CFR 807.92(a)(3)
Predicate #	Predicate Trade Name (Primary Predicate is listed first)		Product Code
K192662	CapsoVision, Inc., CapsoCam Plus (SV-3) Capsule Endoscopy		NEZ
K211684	Given Imaging Ltd. (Medtronic) PillCam SB3 Capsule Endoscopy		NEZ
Device Description Summary			21 CFR 807.92(a)(4)
The CapsoCam Plus (SV-3) Capsule Endoscopy System is intended for visualization of the small bowel mucosa in adults and childrenolder than two years of age. It may be used as a tool in the detection of abnormalities of the small bowel.
The primary component of the CapsoCam Plus (SV-3) capsule endoscopy system is the eponymous single-use, ingestible capsule thatacquires and stores video images in on-board memory while moving through the gastrointestinal tract, propelled by natural peristalsis.It is administered under medical supervision either in-person or remotely under video guidance (available for adult patients only). The

capsule is typically excreted within 3 to 30 hours after swallowing. Upon excretion, the patient/authorized caregiver retrieves the capsule using the provided retrieval kit and returns it to the capsules to the download center in a pre-paid

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envelope) where the capsule is processed and data is downloaded.

The system consists of the following hardware components and accessories:

· CapsoCam Plus (SV-3) capsules, which are intended for visualization of the small bowel mucosa.
· CapsoRetrieve (CVR1) Capsule Retrieval Kit, a kit of non-powered tools used for the collection, storage, and transportation of the excreted CapsoCam Plus (SV-3) capsules.
· CapsoAccess (CDAS) Capsule Data Access System, a dock which facilitates download/access of data from the SV-3 capsules.

The system also includes software that is unchanged from K192662.

Intended Use/Indications for Use

Indications for Use Comparison

The proposed device and predicate device have intended use as capsule endoscopy systems for the visualization of the small bowel mucosa. The Indications for Use of the devices are likewise similar. Whereas both devices are indicated for use in adults, the proposed device is also indicated for use in children older than two years of age. Whereas both devices may be administered (i.e., ingested by the patient) in inpatient and outpatient healthcare settings, the proposed device may also be administered in a telemedicine setting for adult subjects. These changes do not alter the general purpose of the device or its function; they do not constitute a new intended use, and furthernore do not raise different questions of safety and effectiveness. Furthermore, the reference device, which is likewise indicated for use in subjects above the age of two and in telemedicine settings, supports the appropriateness of the use of the proposed device in these conditions.

Technological Comparison

The proposed device represents the incorporation of minor design changes to the cleared predicate device, limited to minor design and packaging changes to the CapsoCam Plus SV-3 capsoRetrieve CVR1 Kit, and Capsule Access Data System CDAS. The differences in technological characteristics do not raise different questions of safety and all necessary testing have been conducted to support the changes.

Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

The CapsoCam Plus (SV-3) Capsule Endoscope System performance testing was conducted per the appropriate FDA Recognized Consensus Standards and required bench testing specifically included 1) verification and validation of hardware changes to confirm that, upon the design changes these continue to meet the applicable product specifications, and 2) transportation and shelf-life testing which demonstrated that, in the updated package configuration, the devices can withstand the abeled transportation and environmental conditions and shelf life. Therefore, the results of these tests support that the proposed device, considering the design changes to the components and packaging, is as safe and as effective as the predicate device for the same intended use.

A human factors evaluation was conducted and supported by real world evidence to demonstrate that there the safely and effectively administered to adult patients in a remote setting.

The results of this testing and analysis support that the changes presented with the proposed device do not raise new questions of safety or effectiveness when compared to the predicate device, and that the proposed device performs as intended.

The clinical evidence provided in the submission include (1) a subgroup analysis of the pivotal study for CapsoCam (K151635), which enrolled both transitional adolescents (n=3, age: 19-21) and adult subjects, (2) an analysis of real world data on the pediatric use of CapsoCam in a pediatric gastroenterology clinic in Australia (n=26, age: 3-18), and (3) a review of the clinical literature on the pediatic use of the reference device and other capsule endoscopes cleared by the FDA indicated for use for in patients 2 years and above. Overall, across the reviewed pediatric clinical case data for CapsoCam specifically, the device functioned in all cases to facilitate diagnostic evaluation, and no adverse events occurred. This is consistent with findings from clinical literature, which suggests that small bowel capsule endoscopes perform similarly in adult and pediatric subjects with respect to both safety (ade) and effectiveness characteristics (diagnostic yield). This evidence thus supports the use of the device in pears of age.

The non-clinical test results and clinical evidence support that the proposed device function as intended use and Indications for Use. These results further support that the proposed device performs at least as well as the predicate devices for the same intended use and confirm that any differences in technological characteristics do not raise of safety or

21 CFR 807.92(a)(5)

iveness. Furthermore, the
e settings, supports the

21 CFR 807.92(a)(6)

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effectiveness.

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.”