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.

AI/ML Overview

This document is a 510(k) premarket notification decision letter for the Eclipse System, indicating that the device has been found substantially equivalent to a predicate device. This type of regulatory document is typically focused on demonstrating equivalence rather than presenting an exhaustive clinical study report with detailed acceptance criteria and performance metrics for a novel device.

Therefore, the requested information regarding detailed acceptance criteria, specific study designs (like MRMC studies), ground truth establishment for test and training sets, and expert details are not explicitly contained within this regulatory decision letter. The letter primarily refers to bench testing and the clinical performance data from the predicate device's de novo application.

However, I can extract and infer some information based on the typical requirements for 510(k) submissions, particularly what is mentioned about performance data.

Here's an attempt to answer your questions based only on the provided text, highlighting what is present and what is absent:

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

The document lists types of bench testing performed, but does not provide specific acceptance criteria values or quantitative performance results for these tests. It only states, "The Eclipse System met all specified design, safety, and performance requirements."

Acceptance Criteria Category (Inferred)	Reported Device Performance (General Statement)
Bench Testing:	"The Eclipse System met all specified design, safety, and performance requirements."
- Dimensional/Visual Inspections	(No specific quantitative data provided)
- Leak Testing	(No specific quantitative data provided)
- Cycle Testing	(No specific quantitative data provided)
- Inflation/Deflation Testing	(No specific quantitative data provided)
- Valve-Pump Attachments	(No specific quantitative data provided)
- Tube Stretch	(No specific quantitative data provided)
- Base Folding	(No specific quantitative data provided)
- Basic Function/Performance	(No specific quantitative data provided)
Biocompatibility Testing (per ISO 10993-1)	Met requirements (no specifics given)
High Level Disinfection Validation	Validated (no specifics given)
Steam Sterilization Validation	Validated (as an alternative to HLD, no specifics given)
Clinical Performance (for predicate device)	"sufficient to address safety and effectiveness of the subject device"

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

Test Set Sample Size:
- For the bench testing, the sample sizes are not specified in this document.
- For clinical performance, the document states: "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 sample size for the predicate device's clinical study is not provided in this document.
Data Provenance: The document does not specify the country of origin of the data. The studies mentioned (bench testing and predicate device clinical data) would likely be considered prospective studies at the time they were conducted, but the current 510(k) leverages existing data.

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 in the document. The document primarily focuses on bench testing and referencing the predicate device's clinical data, not the establishment of a ground truth for a test set of an AI or diagnostic device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided as the document does not describe a clinical study for this specific 510(k) submission that would require such 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 MRMC comparative effectiveness study was performed or is mentioned in this document. This device (Eclipse System) is a physical medical device (vaginal insert and pump), not an AI-assisted diagnostic tool.

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

This question is not applicable as the Eclipse System is a physical medical device, not an algorithm or AI.

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

For the bench testing, the "ground truth" would be established by engineering specifications and standards for device performance, not expert consensus or pathology in a clinical sense.

For the predicate device's clinical data, which demonstrated the device's effectiveness in treating fecal incontinence, the "ground truth" would presumably be patient-reported outcomes and objective measures of fecal incontinence events (which are categorized as outcomes data). Details are not provided.

8. The sample size for the training set

This question is not applicable as this document describes a physical medical device and its bench testing and leverage of predicate clinical data, not the development or validation of an AI algorithm using a training set.

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

This question is not applicable as there is no mention of a training set or AI algorithm in this document concerning the Eclipse System.

Summary

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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 AdministrationIndications for Use		Expiration Date: January 31, 2017See 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.

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 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."

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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 PlaceSunnyvale, 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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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

-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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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.

Regulation Number and Section

§ 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.