The Vibrant System is an orally administered Capsule that is indicated for the treatment of adults with chronic idiopathic constipation who have not experienced relief of their bowel symptoms by using laxative therapies at the recommended dosage for at least one month.

Device Description

The Vibrant System is designed to mechanically induce peristaltic activity in the colon, thus aiding in relieving constipated patients. Constipation relief is achieved by the Capsule's stimulation in the colon, consequently inducing peristaltic activity which promotes transit and facilitates defecation. The stimulation protocol is designed to activate at specific times during the day (i.e., afternoon and evening). The Vibrant System is comprised of two components: a reusable Pod and a single use capsule. The Capsule is expelled from the body during the patient's bowel movements.

AI/ML Overview

The provided text does not contain specific acceptance criteria or a detailed study of the device's performance against such criteria. Instead, it describes general compliance with standards and the substantial equivalence to a predicate device.

However, based on the Performance Data section, we can infer the types of criteria that were considered and the studies conducted to demonstrate compliance, even if specific metrics are not given.

Here's a breakdown of what can be extracted and what information is missing:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Reported Device Performance (as inferred from the document)	Specific Metrics/Results Provided in Document?
Mechanical/Physical	Transportation and distribution validation per ASTM D4332-14 and ASTM D4169-22. Bench performance testing to verify Pod meets visual and functional specifications.	No specific metrics (e.g., pass/fail rates, specific functional parameters).
Software	Software documentation and validation per IEC 62304:2006/A1:2016.	No specific metrics or validation results.
Cybersecurity	Cybersecurity validation.	No specific metrics or validation results.
Electrical Safety	Compliance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-1-11.	No specific test results or safety margins.
Electromagnetic	Compliance with FCC Part 15, Sub-part C, section 15.209 (Radiated emission limits).	No specific emission levels or compliance details.
Functional	Bench performance testing to verify Pod meets functional specifications.	No specific functional parameters or performance curves.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not specified for any of the listed performance data. For example, it's not mentioned how many packages were tested for transportation validation or how many Pods were used for bench testing.
Data Provenance: Not specified. It does not mention country of origin or whether studies were retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided because the document focuses on engineering and regulatory compliance tests rather than clinical performance based on expert review. There is no mention of ground truth establishment in this context.

4. Adjudication method for the test set

Not applicable as this document describes technical and regulatory compliance testing, not a clinical study involving human readers and ground truth adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not conducted or described. The device is not an AI-assisted diagnostic tool for human readers; it's an orally administered capsule system for constipation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device itself is a standalone system (the capsule and pod). The performance data listed are for the device's technical and safety aspects. There isn't an "algorithm only" performance reported in the sense of a diagnostic AI system, but the software validation (IEC 62304) is a standalone evaluation of the device's software.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the technical and safety performance data listed, the "ground truth" would be defined by the standards themselves (e.g., a package either passed ASTM D4332-14 or it didn't; the device either met IEC 60601-1 safety requirements or it didn't). These are objective engineering and regulatory standards rather than clinical ground truth established by medical experts or pathology.

8. The sample size for the training set

Not applicable. The document describes a medical device, not an AI/machine learning model that requires a "training set" in the conventional sense.

9. How the ground truth for the training set was established

Not applicable, as there is no "training set" for this device's performance evaluation as described.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 13, 2023

Vibrant Ltd. % Janice Hogan Partner Hogan Lovells US LLP 1735 Market Street Suite 2300 Philadelphia, PA 19103

Re: K223031

Trade/Device Name: Vibrant System Regulation Number: 21 CFR 876.5940 Regulation Name: Orally ingested transient device for constipation Regulatory Class: Class II Product Code: OTN Dated: October 24, 2022 Received: October 24, 2022

Dear Janice Hogan:

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

{1}------------------------------------------------

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 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 medical devices and radiation-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).

Sincerely,

Image /page/1/Picture/5 description: The image shows the text "Je An -S" in a simple, sans-serif font. The letters are black and bolded, and they are arranged horizontally. The background is white, and there is a faint, light blue watermark behind the text.

Je Hi An, PhD 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

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement on last page

510(k) Number (if known)

K223031

Device Name

Vibrant 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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including
the time to review instructions, search existing data sources, gather and maintain the data needed and
complete and review the collection of information. 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

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."

FORM FDA 3881 (6/20)

{3}------------------------------------------------

510(k) SUMMARY Vibrant System (K223031)

Submitter

Vibrant Ltd. Hakochav P.O. Box 516 Yokneam, Israel 2069206

Phone: +972.46.662379 Facsimile: +972.46.664424 Contact Person: Lior Ben Tsur Date Prepared: January 9, 2023

Trade Name: Vibrant System

Classification Name: Orally Ingested Transient Device For Constipation, 21 CFR 876.5940

Regulatory Class: II

Product Code: QTN

Predicate Device: Vibrant System (DEN210052)

Device Description

The Vibrant System is comprised of two components: a reusable Pod and a single use capsule. The Capsule is expelled from the body during the patient's bowel movements.

Intended Use/Indications for Use

{4}------------------------------------------------

Summary of Technological Characteristics

The following changes were made:

. Addition of cellular network communication that connects through GSM to Vibrant cloud
Addition of cloud data storage and Pod's firmware update over the air (FOTA) ●
Pod microcontroller change .
Pod outer design change ●

Otherwise, the device materials, principle of operation, and intended use remain the same as the predicate. Additionally, the changes do not raise different questions of safety or effectiveness.

Vibrant System Comparison Table
	Predicate Vibrant System(DEN210052)	Subject Vibrant System(K223031)
Indications for Use	The Vibrant System is an orally administered Capsule that is indicated for the treatment of adults with chronic idiopathic constipation who have not experienced relief of their bowel symptoms by using laxative therapies at the recommended dosage for at least one month.	The Vibrant System is an orally administered Capsule that is indicated for the treatment of adults with chronic idiopathic constipation who have not experienced relief of their bowel symptoms by using laxative therapies at the recommended dosage for at least one month.
Population	Adults	Adults
Components	Pod, capsule	Pod, capsule, cloud software
Pod	Image: Predicate Vibrant System Pod	Image: Subject Vibrant System Pod
Pod Specifications, mm	86x83x38	65(dia.)x65(ht.)
ON Indicator	Green LED	Blue LED
Pod-Capsule Communication	RF	RF
Pod-Cloud Communication	None	GSM
Capsule Calibration	Upon placement in designated groove	During capsule production
Capsule Specifications	Length: 24.5 mmDiameter: 11.20 mmWeight: 4.0 g	Length: 24.5 mmDiameter: 11.20 mmWeight: 4.0 g
Capsule External Material	PC Makrolon 2458	PC Makrolon 2458

Vibrant System Comparison Table

{5}------------------------------------------------

Performance Data

The following performance data was provided in support of the device modifications:

. Transportation and distribution validation per ASTM D4332-14, Standard Practice For Conditioning Containers, Packages, or Packaging Components for Testing and ASTM D4169-22, Package Integrity Testing
. Software documentation and validation per IEC 62304:2006/A1:2016 - Medical Device Software - Software Life Cycle Processes
. Cybersecurity validation
IEC 60601-1, General Requirements for Basic Safety and Essential Performance .
IEC 60601-1-2. General Requirements for Basic Safety and Essential Performance -. Collateral Standard: Electromagnetic Disturbances - Requirements and Tests
. IEC 60601-1-11, General Requirements for Basic Safety and Essential Performance -Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment
. FCC Part 15, Sub-part C, section 15.209, Radiated emission limits; general requirements
. Bench performance testing to verify Pod meets visual and functional specifications

Conclusions

The provided performance testing demonstrates that the Vibrant System is as safe, as effective, and performs as the predicate device. Therefore, the Vibrant System is substantially equivalent,

Regulation Number and Section

N/A