(253 days)
No reference devices were used in this submission.
No
The device description and performance studies focus on mechanical components and physical properties, with no mention of AI or ML algorithms for data analysis, decision-making, or control.
Yes
The device is intended for "treatment of fecal incontinence," which indicates a therapeutic purpose.
No
The device is indicated for treatment of fecal incontinence, not diagnosis. It's a treatment device designed to physically reduce the lumen of the rectum to decrease incontinence events.
No
The device description clearly outlines physical components including an Insert, Pump, Sizing Kit, and Trial Insert, which are hardware.
Based on the provided information, the Eclipse System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the treatment of fecal incontinence in adult women. This is a therapeutic purpose, not a diagnostic one.
- Device Description: The device is a physical system (Insert and Pump) that exerts mechanical force to treat a condition. It does not analyze biological samples (like blood, urine, or tissue) to provide diagnostic information.
- Lack of Diagnostic Activities: The description focuses on the physical components, their function in providing compression, and the fitting process. There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic results.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Eclipse System does not fit this definition.
N/A
Intended Use / Indications for Use
The Eclipse System is indicated for treatment of fecal incontinence in adult women. It is intended for prescription use.
Product codes
PJH
Device Description
The Eclipse System includes two main components, an Insert and a Pump. The Insert is used intra-vaginally, is insertable/removable by the patient, and includes a balloon that when inflated, exerts a force posteriorly (trans-vaginally) against the wall in the rectum resulting in a decrease in the lumen of the rectum. The compression of the rectal space results in decreased frequency of fecal incontinence events. The Eclipse System also contains two tools for the fitting process: a Sizing Kit, consisting of Sizers in each available Insert Base size, and a Trial Insert. Each component is described below.
- -Sizing Kit / Sizers: Reusable (multi-patient) Insert Bases (Sizers), intended to aid in selecting appropriate Trial Insert Sizes. Sizers are only used in a clinical setting (
§ 876.5930 Rectal control system.
(a)
Identification. A rectal control system is a prescription device intended to treat fecal incontinence by controlling the size of the rectal lumen. The device is inserted in the vagina and includes a portion that expands to reduce the rectal lumen to prevent stool leakage and retracts to allow normal passage of stool. The device includes an external regulator to control the state of expansion.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical testing must document the device acceptance data and the adverse event profile associated with clinical use, and demonstrate that the device performs as intended under anticipated conditions of use.
(2) The elements of the device that contact vaginal tissue must be demonstrated to be biocompatible.
(3) The cleaning and disinfection instructions for the device must be validated.
(4) Non-clinical (bench) testing must demonstrate that the device performs as intended under anticipated conditions of use.
(5) Non-clinical (bench) testing must demonstrate that the device does not:
(i) Enhance the growth of
Staphylococcus aureus. (ii) Increase production of Toxic Shock Syndrome Toxin-1 by
S. aureus. (iii) Alter the growth of normal vaginal flora.
(6) Labeling must include:
(i) Specific instructions, contraindications, warnings, cautions, limitations, and the clinical training needed for the safe use of the device.
(ii) The intended patient population and the intended use environment.
(iii) Information on how the device is to be fitted, how the device operates, and recommendations on device maintenance.
(iv) A detailed summary of the clinical testing pertinent to the use of the device, including a summary of the device- and procedure-related complications or adverse events related to use of the device, as well as relevant safety and performance information.
(7) Patient labeling must be provided and must include:
(i) Relevant contraindications, warnings, precautions, and adverse events/complications.
(ii) Information on how the device operates and the recommended device maintenance (
i.e. , care instructions), including cleaning and disinfection.(iii) Information on the patient population for which there was a favorable benefit/risk assessment.
(iv) The potential risks and benefits associated with the use of the device.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol of a human figure in profile, with three overlapping heads suggesting community and support.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 12, 2015
Pelvalon, Inc. % Cindy Domecus Principal Domecus Consulting Services LLC 1171 Barroilhet Dr Hillsborough, CA 94010
Re: K150558
Trade/Device Name: Eclipse System Regulation Number: 21 CFR 876.5930 Regulation Name: Rectal Control System Regulatory Class: II Product Code: PJH Dated: November 2, 2015 Received: November 3, 2015
Dear Cindy Domecus,
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. 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 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 (reporting of medical device
1
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Joyce M. Whang -S
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
INDICATIONS FOR USE STATEMENT (FORM FDA 3881)
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 | ||
|---|---|---|---|
| Food and Drug Administration | |||
| Indications for Use | Expiration Date: January 31, 2017 | ||
| See PRA Statement below. | |||
| 510(k) Number (if known) | Unknown K150558 | ||
| Device Name | Eclipse System | ||
| Indications for Use (Describe) | The Eclipse System is indicated for treatment of fecal incontinence in adult women. | ||
| It is intended for prescription use. | |||
| 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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The burden time for this collection of information is estimated to average 79 hours per response, including the
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Image /page/3/Picture/0 description: The image contains the word "Pelvalon" in a gray sans-serif font. To the left of the word is a curved, crescent-shaped graphic in purple. The graphic appears to be a stylized representation of a boomerang or a curved checkmark. The overall design is clean and modern.
A. Submitter
| Company Name: | Pelvalon, Inc. |
|---|---|
| Company Address: | 923 Thompson Place |
| Sunnyvale, CA 94085 | |
| Company Phone: | 650-276-0130 |
| Company Fax: | 650-646-2213 |
| Contact Person: | Cindy Domecus, R.A.C. (US & EU) |
| Contact Phone: | Office: 650-343-4813 |
| Contact Fax: | 650-343-7822 |
| Contact e-mail: | domecusconsulting@comcast.net |
| Date Prepared: | February 27, 2015 |
B. Device
| Name of Device: | Eclipse System |
|---|---|
| Model Number: | 4.1 |
| Common Name: | Rectal Control System |
| Classification Name: | 21 CFR 876.5930 |
| Regulatory Class: | II |
| Product Code: | PJH |
C. Predicate Device
| DEN140020 | Eclipse System, 3.2 | |
|---|---|---|
| The predicate device has not been subject to a design- | ||
| related recall. | ||
| No reference devices were used in this submission. |
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D. Device Description
Eclipse System Components
The Eclipse System includes two main components, an Insert and a Pump. The Insert is used intra-vaginally, is insertable/removable by the patient, and includes a balloon that when inflated, exerts a force posteriorly (trans-vaginally) against the wall in the rectum resulting in a decrease in the lumen of the rectum. The compression of the rectal space results in decreased frequency of fecal incontinence events. The Eclipse System also contains two tools for the fitting process: a Sizing Kit, consisting of Sizers in each available Insert Base size, and a Trial Insert. Each component is described below.
- -Sizing Kit / Sizers: Reusable (multi-patient) Insert Bases (Sizers), intended to aid in selecting appropriate Trial Insert Sizes. Sizers are only used in a clinical setting (