(106 days)
Not Found
No
The description focuses on mechanical stimulation and timed activation, with no mention of AI/ML terms or data processing that would suggest its use.
Yes
The device is indicated for the "treatment of adults with chronic idiopathic constipation" and aims to "mechanically induce peristaltic activity in the colon, thus aiding in relieving constipated patients." These descriptions explicitly state its purpose is to treat a medical condition.
No
Explanation: The device is described as a treatment for chronic idiopathic constipation, mechanically inducing peristaltic activity. It is not mentioned anywhere that it is used to diagnose a medical condition or ailment.
No
The device description explicitly states the system is comprised of a reusable Pod and a single-use capsule, which are hardware components. The performance studies also include hardware-related testing (transportation, distribution, electrical safety, bench performance).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to monitor therapeutic measures.
- Vibrant System Function: The Vibrant System is an orally administered capsule that mechanically stimulates the colon to induce peristalsis and relieve constipation. It acts directly within the body to achieve a physical effect.
- Lack of Specimen Analysis: The description does not mention the analysis of any biological specimens (blood, tissue, etc.).
Therefore, the Vibrant System falls under the category of a therapeutic medical device, not an In Vitro Diagnostic.
N/A
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.
Product codes
OTN, QTN
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
colon
Indicated Patient Age Range
Adults
Intended User / Care Setting
Not Found
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
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
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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)
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.
| ☑ 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:
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"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 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.
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 mm | |
| Diameter: 11.20 mm | ||
| Weight: 4.0 g | Length: 24.5 mm | |
| Diameter: 11.20 mm | ||
| Weight: 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,