The Intimina KegelSmart and Intimina KegelSmart Pearl are intended for independent use by women at home to strengthen pelvic floor muscles to treat stress and/or urge urinary incontinence.

Device Description

The Intimina KegelSmart and KegelSmart Pearl are pelvic floor muscle exercise devices that provides biofeedback and exercise guidance. Each time the device is used it registers the user's pelvic floor muscle contraction strength and automatically sets a strength level, from 1 to 5, for the following session. Each level has a corresponding exercise routine that is communicated to the user with gentle vibrations.

AI/ML Overview

The provided text is a 510(k) Summary for the Intimina KegelSmart and KegelSmart Pearl devices. It describes the device, its intended use, and argues for its substantial equivalence to a predicate device. However, it does not contain a specific study proving the device meets acceptance criteria in terms of clinical performance metrics like sensitivity, specificity, accuracy, or effect size for improvement in human readers with AI assistance.

Instead, the document focuses on:

Substantial Equivalence: Comparing the technological characteristics of the new device to a predicate device (The Reflex Treatment System).
Safety and Performance Standards: Stating conformity with biological evaluation (ISO 10993) and electrical safety (IEC 60601) standards, and software guidance.
Functional Performance Testing: A brief mention that functional performance testing was provided to demonstrate the device operates per its Instructions for Use, without detailing the results or acceptance criteria for this testing.
Literature Review: A general statement about evidence in published literature regarding the effectiveness of pelvic floor muscle training for urinary incontinence.

Therefore, I cannot populate the requested table (1) or address points 2-7, 9 in detail based solely on the provided text, as this information is not present. The document describes a regulatory submission for substantial equivalence based on technological similarity and compliance with general safety/performance standards, not a clinical study demonstrating specific performance metrics against defined acceptance criteria for the new device.

Here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Metric / Acceptance Criteria	Reported Device Performance
Technological Equivalence (Implicit Acceptance Criteria for 510(k) substantial equivalence)
* FDA Classification: Class II, perineometer 884.1425 (HIR)	Conforms (Same as predicate)
* Intended Use: For the treatment of stress and/or urge urinary incontinence in females	Conforms (Same as predicate)
* Target Population: Women experiencing symptoms of pelvic floor muscle weakness and mild incontinence	Conforms (Same as predicate)
* Anatomical Site: Probe inserted vaginally	Conforms (Same as predicate)
* Method of Function (General): Registers user's pelvic strength, assigns strength level, guides through exercise routines.	Conforms (Similar to predicate, differing in feedback mechanism - vibration vs. visual, and specific exercise routines/levels)
* Key safety/materials: Medical grade silicone, 1xAAA battery, cleaned but not sterile, single patient device.	Conforms (Comparable to predicate)
* Electrical Safety Standards (e.g., IEC/EN 60601-1, IEC/EN 60601-1-2): Compliance with relevant electrical safety and EMC standards.	Conforms (Stated conformity with IEC/EN 60601-1 3rd ed., IEC/EN 60601-1-2:2007)
* Biocompatibility Standards (e.g., ISO 10993-5, ISO 10993-10): Compliance with relevant standards for in vitro cytotoxicity, irritation, and skin sensitization.	Conforms (Stated conformity with ISO 10993-5 and ISO 10993-10)
* Software Guidance: In line with FDA guidance for software in medical devices.	Conforms (Stated compliance with "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued May 11, 2005)
* Functional Performance: Operates per its Instructions for Use.	"Functional performance testing was provided... demonstrating that it operates per its Instructions for Use." (No specific metrics or acceptance criteria for this functional performance testing are detailed in the document).
Clinical Efficacy (Based on literature, not a specific device study outlined here): Regular pelvic floor muscle training results in a significant increase in pelvic floor muscle strength and is an effective treatment for stress or mixed urinary incontinence. (Implicit expectation for similar devices, not a specific acceptance criterion for this device's clinical trial).	"There is evidence in the published literature that regular pelvic floor muscle training results in a significant increase in pelvic floor muscle strength, is an effective treatment for stress or mixed urinary incontinence." (This refers to the general efficacy of the therapy, not a clinical trial of the specific device meeting its individual performance criteria.)

2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.
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: Not applicable, as this is not an AI-assisted diagnostic device, and no MRMC study or AI component in that context is discussed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an algorithm-only device in the diagnostic sense. The device itself (hardware and embedded software) provides guidance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned for any specific study of the device. The "ground truth" for the device's efficacy is largely derived from the existing medical literature on pelvic floor muscle training.
8. The sample size for the training set: Not applicable; this device is not a machine learning model that requires a training set in the typical sense for image analysis or diagnostics. Its "training" happens internally as it adapts to the user's strength.
9. How the ground truth for the training set was established: Not applicable for the reasons mentioned in point 8.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name in a circular arrangement around a stylized image of three human profiles facing to the right. The profiles are connected and appear to be flowing into each other, creating a sense of unity and collaboration. The seal is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 10, 2014

LELO, Inc. % Kevin Walls Principal Consultant Regulatory Insight, Inc. 33 Golden Eagle Lane Littleton, CO 80127

Re: K140780

Trade/Device Name: Kegel Smart, KegelSmart Pearl Regulation Number: 21 CFR§ 884.1425 Regulation Name: Perineometer Regulatory Class: II Product Code: HIR Dated: June 17, 2014 Received: June 18, 2014

Dear Kevin Walls,

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.

{1}------------------------------------------------

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); 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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.

Herbert P. Lerner -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

510(k) Number (if known) K140780

Device Name

Intimina KegelSmart and Intimina KegelSmart Pearl

Indications for Use (Describe)

The Intimina KegelSmart and Intimina KegelSmart Pearl are intended for independent use by women at home to strengthen pelvic floor muscles to treat stress and/or urge urinary incontinence.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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."

{3}------------------------------------------------

510(k) Summary

LELO USA 4320 Stevens Creek Boulevard Suite #205 San Jose, CA 95129 9 September 2014

Contact Person

Pavle Sedic President, LELO Inc. Email: ps@lelo.com Phone: +1 887 872 5356

Device Name

Trade name: Intimina KegelSmart (model 1), Intimina KegelSmart Pearl (model 2) Common name: Pelvic floor muscle exercise device

Device Classification

Obstetrics and gynaecology panel, Perineometer 884.1425, product code HIR, class II device

Indications for Use Statement

The Intimina KegelSmart and Intimina KegelSmart Pearl are intended for independent use by women at home to strengthen pelvic floor muscles to treat stress and/or urge urinary incontinence.

Device Description

Statement of Substantial Equivalence

The Intimina KegelSmart and KegelSmart Pearl are substantially equivalent to The Reflex Treatment System (DesChutes Medical Products, Inc.) clearance number K994079.

{4}------------------------------------------------

Name of the device	KegelSmart and KegelSmartPearl	The Reflex Treatment System
FDA classification	Class II, perineometer884.1425 (HIR)	Class II, perineometer884.1425 (HIR)
Intended use	For the treatment of stressand/or urge urinaryincontinence in females	For the treatment of stressand/or urge urinaryincontinence in females
Target population	Women experiencingsymptoms of pelvic floormuscle weakness and mildincontinence	Women experiencingsymptoms of pelvic floormuscle weakness and mildincontinence
Anatomical site	Probe inserted vaginally	Probe inserted vaginally
Method of function	Registers the user's pelvicstrength and assigns astrength level. Guides the userthrough exercise routines(with vibration).	Registers the user's pelvicstrength and assigns a strengthlevel. Guides the user throughexercise routines (with visualcues).
System components	Vaginal probe covered inmedical grade silicone	Balloon sensor vaginal probeplus LCD monitor
Biofeedbackmechanism	Electric resistance straingauge	MEMS Air pressure sensor
Prescription device	No	No
Medical practice orhome use?	Home use	Home use
Is the device providedsterile?	Clean but not sterile	Clean but not sterile
Does the device usesoftware?	Yes	Yes
Assistance frommedical personnelrequired	No	No
Single patient device	Yes	Yes
Materials	Medical grade silicone	Medical grade silicone
Energy used	1 x AAA battery 1.5V	2 x AA batteries 3.0V
Name of the device	KegelSmart and KegelSmartPearl	The Reflex Treatment System
Electrical safety	ETL/cETLIEC/EN 60601-1 3rd ed.,IEC/EN 60601-1-2:2007	UL2601-1, 2nd Edition,EN60601-1-2:1993
Pelvic floor muscleexercise routine	Combination of rapid contractand release exercises andlonger contract and releaseexercises. Routine difficultyincreases with strength levels.	Combination of rapid contractand release exercises andlonger contract and releaseexercises
Strength levels	5 levels (can move up anddown levels)	3 levels (can move up anddown levels)
Resistance	Non-variable resistance	Non-variable resistance

Comparison of Technological Characteristics with the Predicate Device

{5}------------------------------------------------

Summary of Differences in Technological Characteristics

The subject and predicate device do not have the same technological characteristics. The different technological characteristics between the subject and predicate device are as follows:

Measurement of contraction strength The subject devices use an electric ● resistance strain gauge, and the predicate device uses a MEMS air pressure sensor.
Levels of resistance The subject devices have five levels of resistance, and the . predicate device has three.
Feedback mechanism The subject devices use vibrations to prompt the user to . contract their pelvic floor muscles, whereas the predicate device uses visual cues on an LCD screen.
. Exercise routines - The subject and predicate devices utilize different exercise routines.

The different technological characteristics between the subject and predicate device do not raise different questions of safety and effectiveness, as pelvic floor muscle exercise devices often vary with respect to their measurement of contraction strength, levels of resistance, feedback mechanism, and exercise routines.

{6}------------------------------------------------

Summary of Performance Data of KegelSmart and KegelSmart Pearl

There is evidence in the published literature that regular pelvic floor muscle training results in a significant increase in pelvic floor muscle strength, is an effective treatment for stress or mixed urinary incontinence.

Intimina KegelSmart and KegelSmart Pearl (model 1 and 2) are in conformity with the applicable requirements of the following documents:

Ref. No.	Title
ISO 10993-5	Biological evaluation of medical devices Part 5 Tests in vitro cytotoxicity
ISO 10993-10	Biological evaluation of medical devices. Part 10: Tests for irritation andskin sensitization
IEC 60601-1 3rded.	Medical electrical equipment -Part 1: General requirements for basicsafety and essential performance
IEC 60601-1-2:2007	Medical electrical equipment -Part 1-2:General requirements for safety-Collateral standard: Electromagnetic compatibility -Requirements andtests

The software for the Intimina KegelSmart Pearl is in line with the recommendations outlined in the FDA guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued in final on May 11, 2005.

Functional performance testing was provided on the Intimina KegelSmart and KegelSmart Pearl demonstrating that it operates per its Instructions for Use.

Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the Intimina KegelSmart and Intimina KegelSmart Pearl are substantially equivalent to the proposed predicate device.

Regulation Number and Section

§ 884.1425 Perineometer.

(a)
Identification. A perineometer is a device consisting of a fluid-filled sack for intravaginal use that is attached to an external manometer. The devices measure the strength of the perineal muscles by offering resistence to a patient's voluntary contractions of these muscles and is used to diagnose and to correct, through exercise, uninary incontinence or sexual dysfunction.(b)
Classification. Class II (performance standards).