KEGEL SMART, KEGELSMART PEARL

K140780 · Regulatory Insight, Inc. · HIR · Sep 10, 2014 · Obstetrics/Gynecology

Device Facts

• Record ID: K140780
• Device Name: KEGEL SMART, KEGELSMART PEARL
• Applicant: Regulatory Insight, Inc.
• Product Code: HIR · Obstetrics/Gynecology
• Decision Date: Sep 10, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1425
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Pelvic floor muscle exercise device for home use by women. Device consists of a vaginal probe covered in medical-grade silicone. Input: device registers user's pelvic floor muscle contraction strength via electric resistance strain gauge. Transformation: device automatically sets a strength level (1-5) for subsequent sessions and generates exercise routines consisting of rapid and longer contract/release cycles. Output: device communicates exercise guidance to user via gentle vibrations. Benefit: strengthens pelvic floor muscles to treat urinary incontinence. User operates device independently without medical personnel assistance.

Clinical Evidence

Bench testing only. Device performance verified against Instructions for Use. Conformity demonstrated with ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation/sensitization), IEC 60601-1 (safety), and IEC 60601-1-2 (EMC). Literature cited supports efficacy of pelvic floor muscle training for urinary incontinence.

Technological Characteristics

Vaginal probe constructed of medical-grade silicone. Sensing via electric resistance strain gauge. Powered by 1 x 1.5V AAA battery. Compliance with IEC 60601-1 3rd ed. and IEC 60601-1-2:2007. Non-variable resistance. 5 strength levels.

Indications for Use

Indicated for women experiencing pelvic floor muscle weakness and stress and/or urge urinary incontinence.

Regulatory Classification

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.

Predicate Devices

• The Reflex Treatment System (K994079)

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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

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#### 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)

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

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## 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: [e-mail] Phone: [phone]

#### 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

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.

#### 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.

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| Name of the device | KegelSmart and KegelSmart<br>Pearl | The Reflex Treatment System |
|--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| FDA classification | Class II, perineometer<br>884.1425 (HIR) | Class II, perineometer<br>884.1425 (HIR) |
| Intended use | For the treatment of stress<br>and/or urge urinary<br>incontinence in females | For the treatment of stress<br>and/or urge urinary<br>incontinence in females |
| Target population | Women experiencing<br>symptoms of pelvic floor<br>muscle weakness and mild<br>incontinence | Women experiencing<br>symptoms of pelvic floor<br>muscle weakness and mild<br>incontinence |
| Anatomical site | Probe inserted vaginally | Probe inserted vaginally |
| Method of function | Registers the user's pelvic<br>strength and assigns a<br>strength level. Guides the user<br>through exercise routines<br>(with vibration). | Registers the user's pelvic<br>strength and assigns a strength<br>level. Guides the user through<br>exercise routines (with visual<br>cues). |
| System components | Vaginal probe covered in<br>medical grade silicone | Balloon sensor vaginal probe<br>plus LCD monitor |
| Biofeedback<br>mechanism | Electric resistance strain<br>gauge | MEMS Air pressure sensor |
| Prescription device | No | No |
| Medical practice or<br>home use? | Home use | Home use |
| Is the device provided<br>sterile? | Clean but not sterile | Clean but not sterile |
| Does the device use<br>software? | Yes | Yes |
| Assistance from<br>medical personnel<br>required | 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 KegelSmart<br>Pearl | The Reflex Treatment System |
| Electrical safety | ETL/cETL<br>IEC/EN 60601-1 3rd ed.,<br>IEC/EN 60601-1-2:2007 | UL2601-1, 2nd Edition,<br>EN60601-1-2:1993 |
| Pelvic floor muscle<br>exercise routine | Combination of rapid contract<br>and release exercises and<br>longer contract and release<br>exercises. Routine difficulty<br>increases with strength levels. | Combination of rapid contract<br>and release exercises and<br>longer contract and release<br>exercises |
| Strength levels | 5 levels (can move up and<br>down levels) | 3 levels (can move up and<br>down levels) |
| Resistance | Non-variable resistance | Non-variable resistance |

### Comparison of Technological Characteristics with the Predicate Device

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#### 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.

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#### 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 and<br>skin sensitization |
| IEC 60601-1 3rd<br>ed. | Medical electrical equipment -Part 1: General requirements for basic<br>safety and essential performance |
| IEC 60601-1-2:<br>2007 | Medical electrical equipment -Part 1-2:General requirements for safety<br>-Collateral standard: Electromagnetic compatibility -Requirements and<br>tests |

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.