(92 days)
Not Found
No
The summary describes a capsule endoscopy system that captures and stores video images. There is no mention of AI, ML, or any form of automated image analysis or interpretation using these technologies. The software is noted as unchanged from a previous submission, and the performance studies focus on hardware changes, transportation, shelf-life, and human factors, not on algorithmic performance.
No
The device is intended for visualization and detection of abnormalities, which are diagnostic purposes, not therapeutic. It does not actively treat or alleviate a medical condition.
Yes
The device is described as "intended for visualization of the small bowel mucosa... It may be used as a tool in the detection of abnormalities of the small bowel," which indicates its purpose in identifying medical conditions.
No
The device description explicitly lists multiple hardware components: the ingestible capsule, the retrieval kit, and the data access system. While software is mentioned as part of the system, it is not the sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "visualization of the small bowel mucosa" and as a "tool in the detection of abnormalities of the small bowel." This describes a diagnostic imaging tool used in vivo (within the body) to directly observe the internal anatomy.
- Device Description: The description details an ingestible capsule that acquires and stores video images within the gastrointestinal tract. This is a direct imaging method, not a test performed on a sample in vitro (outside the body).
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. The CapsoCam Plus system does not perform such tests on samples.
The CapsoCam Plus system is a medical device used for diagnostic imaging in vivo, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
NEZ
Device Description
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Video images
Anatomical Site
small bowel mucosa
Indicated Patient Age Range
adults and children older than two years of age
Intended User / Care Setting
medical supervision either in-person or remotely under video guidance (available for adult patients only) (telemedicine setting for adult subjects); inpatient and outpatient healthcare settings
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 labeled 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 pediatric 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 effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.”
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
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"
1
(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).
2
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
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
CapsoCam Plus (SV-3) Capsule Endoscopy System
Indications for Use (Describe)
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.
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 children | |||||
| older 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 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
5
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
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.
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)
21 CFR 807.92(a)(5)
iveness. Furthermore, the
e settings, supports the
21 CFR 807.92(a)(6)
6
effectiveness.