Vibrant System
Device Facts
| Record ID | K223031 |
|---|---|
| Device Name | Vibrant System |
| Applicant | Vibrant, Ltd. |
| Product Code | QTN · Gastroenterology, Urology |
| Decision Date | Jan 13, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.5940 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
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.
Device Story
Vibrant System is an orally ingested, transient device for treating chronic idiopathic constipation. It consists of a reusable Pod and a single-use Capsule. The Capsule is ingested and travels to the colon, where it mechanically stimulates the colon wall at programmed times (afternoon/evening) to induce peristaltic activity, promoting transit and defecation. The Capsule is expelled naturally. The Pod communicates with the Capsule via RF to manage stimulation protocols. The subject device adds GSM cellular connectivity to a cloud platform for data storage and firmware-over-the-air (FOTA) updates. The system is intended for home use by the patient. The healthcare provider uses the system to provide a non-pharmacological treatment option for patients refractory to laxatives.
Clinical Evidence
No clinical data provided. Substantial equivalence is supported by bench performance testing, software validation per IEC 62304, cybersecurity validation, and compliance with electrical safety and electromagnetic compatibility standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, FCC Part 15).
Technological Characteristics
System comprises a reusable Pod and single-use Capsule. Capsule material: PC Makrolon 2458. Pod-Capsule communication: RF. Pod-Cloud communication: GSM. Connectivity: Cloud-hosted, FOTA updates. Standards: ASTM D4332-14, ASTM D4169-22, IEC 62304, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, FCC Part 15. Software: Firmware-based with cloud integration.
Indications for Use
Indicated for adults with chronic idiopathic constipation who have not experienced relief of bowel symptoms after at least one month of laxative therapy.
Regulatory Classification
Identification
An orally ingested transient device for constipation is an electric swallowable capsule that naturally passes through the gastrointestinal tract for the treatment of constipation. The Vibrant System 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.
Special Controls
In combination with the general controls of the FD&C Act, an orally ingested transient device for constipation is subject to the following special controls:
Predicate Devices
- Vibrant System (DEN210052)
Submission Summary (Full Text)
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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
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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
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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: 06/30/2023 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)
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.
| <span> <span style="font-size: 12px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
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FORM FDA 3881 (6/20)
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## 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 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.
#### Intended Use/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.
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# 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<br>(DEN210052) | Subject Vibrant System<br>(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 mm<br>Diameter: 11.20 mm<br>Weight: 4.0 g | Length: 24.5 mm<br>Diameter: 11.20 mm<br>Weight: 4.0 g |
| Capsule External Material | PC Makrolon 2458 | PC Makrolon 2458 |
### Vibrant System Comparison Table
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# 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,
