K150558 · Pelvalon, Inc. · PJH · Nov 12, 2015 · Gastroenterology, Urology
Device Facts
Record ID
K150558
Device Name
Eclipse System
Applicant
Pelvalon, Inc.
Product Code
PJH · Gastroenterology, Urology
Decision Date
Nov 12, 2015
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.5930
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The Eclipse System is indicated for the treatment of fecal incontinence in adult women. It is intended for prescription use.
Device Story
The Eclipse System is a rectal control system for adult women with fecal incontinence. It consists of a vaginal insert with an inflatable balloon and a hand-held pump with a pressure regulator. The patient inserts the device vaginally; the balloon is inflated to exert posterior pressure against the rectal wall, reducing the rectal lumen and decreasing the frequency of incontinence events. The system includes a sizing kit (reusable sizers) for clinical fitting, a short-term trial insert for evaluation, and a long-term insert for daily use. The patient operates the pump to inflate/deflate the balloon to manage bowel movements. The device is intended for prescription use in a home setting. Clinical benefit is achieved through mechanical compression of the rectum to improve bowel control.
Clinical Evidence
No new clinical data were generated for this 510(k). The clinical performance data submitted for the predicate device (DEN140020) are sufficient to support the safety and effectiveness of the subject device. Bench testing included dimensional/visual inspections, leak testing, cycle testing, inflation/deflation testing, valve-pump attachment testing, tube stretch, base folding, biocompatibility per ISO 10993-1, and validation of high-level disinfection and steam sterilization.
Technological Characteristics
The system comprises silicone vaginal inserts and a pump with a pressure regulator. Materials are identical to the predicate, with additional pigments used for identification. The device is non-powered (mechanical inflation). Sizers are reusable and require high-level disinfection or steam sterilization. Inserts are single-patient use. No software or electronic components are described.
Indications for Use
Indicated for treatment of fecal incontinence in adult women.
Regulatory Classification
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.
Special Controls
*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.
In combination with the general controls of the FD&C Act. the rectal control system is subject to the following special controls:
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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
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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
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## INDICATIONS FOR USE STATEMENT (FORM FDA 3881)
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | | Form Approved: OMB No. 0910-0120 | |
|--------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|---------------------------------------------------------------|--|
| Food and Drug Administration<br>Indications for Use | | Expiration Date: January 31, 2017<br>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) | | | |
| <label><input checked="checked" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> | | |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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<br>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-<br>related recall. | |
| | No reference devices were used in this submission. | |
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Image /page/4/Picture/0 description: The image contains the word "Pelvalon" in a dark gray sans-serif font. To the left of the word is a curved, crescent-shaped graphic in a shade of purple. The graphic appears to be a stylized representation of a bracket or parenthesis, adding a visual element to the logo.
#### 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 (<60 minutes) and are not intended to be taken home.
- -Trial Insert (Insert): Single-patient-use vaginal insert intended for short term use (approximately 1 week, but no more than 2 weeks) during the fitting and evaluation process. Multiple Trial Inserts may be attempted to achieve a correct fit. The Trial Inserts are identifiable by their white color.
- Eclipse Insert (Insert): Single-patient-use vaginal insert intended for longer-term use (up to 1 year). The Eclipse Inserts are identifiable by their indigo color.
- -Pump, including Regulator: The pump is used by the patient for inflating and deflating the balloon with a goal of improving control over bowel movements. The Pump includes a replaceable Regulator which regulates the maximum pressure of the Insert's Balloon. Regulators are available for different pressure levels, and can be replaced to adjust the maximum pressure of the Insert's Balloon.
### E. Intended Use/Indications for Use
The Eclipse System is indicated for the treatment of fecal incontinence in adult women. It is intended for prescription use. The indications for use are unchanged from the predicate.
### F. Comparison of Technological Characteristics with the Predicate Device
The Eclipse System has the same fundamental scientific technology as the predicate device and is substantially equivalent to the predicate device with respect to design, materials, and intended use.
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Image /page/5/Picture/0 description: The image shows the logo for Pelvalon. The logo consists of a purple crescent shape on the left and the word "Pelvalon" in gray text on the right. The crescent shape is curved and points towards the right. The text is in a simple, sans-serif font.
Key similarities of the Eclipse System to the predicate device are as follows:
- System Components: ●
- o The Eclipse System of the subject device includes the Eclipse Insert, which is identical to the Eclipse Insert of the predicate device with respect to geometry, dimensions, and use.
- The Eclipse System of the subject device includes the Pump, which o is identical to the Pump of the predicate device.
- Design/Materials: ●
- The Eclipse Insert of the subject device shares the same geometry o and dimensions as the Eclipse Insert of the predicate device and is manufactured from the same material families, and many identical materials.
- The Trial Insert of the subject device shares the same geometry, o dimensions, and surface material families as the Eclipse Insert of the predicate device.
- o The Sizers that comprise the Sizing Kit of the subject device share the same base dimensions and are manufactured from the same materials families as the Eclipse Insert of the predicate device.
- Use:
- The fitting procedure for the subject device is similar to the O process used for the predicate device.
- The patient interacts with the Inserts of the subject device in an O identical fashion as the predicate device.
- Cleaning and Disinfection: ●
- o The cleaning process/instructions for the Eclipse Insert, Trial Insert, and Sizer of the subject device are identical to the predicate device.
- The disinfection process/instructions for the Eclipse Insert and o Trial Insert of the subject device are identical to the predicate device.
- Packaging:
- The packaging used for the Sizer, Trial Insert, and Eclipse Insert of о the subject device is identical to that of the predicate device
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Image /page/6/Picture/0 description: The image features the logo for Pelvalon. The logo consists of a stylized purple crescent shape on the left, followed by the word "Pelvalon" in a dark gray sans-serif font. The crescent shape is thick and curves inward, creating a dynamic and modern feel.
Key differences of the Eclipse System from the predicate device are as follows:
- System Components: ●
- o In addition to the Eclipse Insert and Pump, which were present in the predicate device, the subject device also contains two tools for the fitting process: a Sizing Kit (Sizers) and a Trial Insert.
- Design/Materials: ●
- The Eclipse Insert, Trial Insert, and Sizer of the subject device o utilize additional pigments to color the silicone for ease of identification.
- The short term use Trial Insert of the subject device uses a o different internal support material than the predicate device Eclipse Insert.
- Use: ●
- Sizing Kits (Sizers) of the subject device are used to aid in selecting O appropriate Trial Insert Sizes. They are re-useable and require high-level disinfection.
- o The Trial Insert of the subject device is provided for short-term use to aid in confirmation of fit before longer term use of the Eclipse Insert.
- Cleaning and Disinfection:
- The Sizers of the subject device are re-usable and require high o level disinfection between uses. A high-level disinfection process/instructions and alternative steam sterilization validation process/instructions were validated
- Packaging: ●
- There are no differences in packaging between the subject device o and the predicate device
### G. Performance Data
The following performance data were provided in support of substantial equivalence:
- . Bench Testing
- o Dimensional/Visual Inspections
- Leak Testing O
- Cycle Testing O
- Inflation/Deflation Testing O
- Valve-Pump Attachments O
CONFIDENTIAL
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Image /page/7/Picture/0 description: The image contains the logo for Pelvalon. The logo consists of a purple crescent shape on the left and the word "Pelvalon" in gray text on the right. The crescent shape is curved and points towards the right. The text is in a sans-serif font and is slightly larger than the crescent shape.
- o Tube Stretch
- Base Folding o
- Basic Function/Performance o
- Biocompatibility Testing per ISO 10993-1
- High Level Disinfection Validation ●
- . Steam Sterilization Validation (as an alternative to high-level disinfection)
Cleaning and Low Level Disinfection validations performed on the predicate device support the cleaning and low level disinfection for the Eclipse Insert. Pump, and Trial Insert that are the subject of this 510(k). No additional cleaning/low level disinfection testing was required to support substantial equivalence.
The clinical performance data submitted in support of the de novo application for the predicate device are sufficient to address safety and effectiveness of the subject device. The modifications to the predicate device that are the subject of this 510(k) application are not significant enough to require clinical performance data to demonstrate substantial equivalence.
The Eclipse System met all specified design, safety, and performance requirements. Collectively the performance data support safety, effectiveness, and substantial equivalence of the Eclipse System to the predicate device.
#### H. Conclusions
The information and data provided in the 510(k) demonstrate that the subject Eclipse System is as safe and effective and substantially equivalent to the predicate Eclipse System.
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
