INNER PEACE

K122800 · Kamabry, Inc., Dba Inner Peace For Women · HIR · Oct 4, 2013 · Obstetrics/Gynecology

Device Facts

• Record ID: K122800
• Device Name: INNER PEACE
• Applicant: Kamabry, Inc., Dba Inner Peace For Women
• Product Code: HIR · Obstetrics/Gynecology
• Decision Date: Oct 4, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1425
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Inner Peace™ pelvic exercise device is recommended for the strengthening of perineal pelvic floor muscles by offering resistance to an individual's voluntary contractions of these muscles. It seeks to correct, through exercise, urinary incontinence in women.

Device Story

Inner Peace™ is a one-piece, silicone intravaginal pelvic-floor exercise device. User inserts device into vagina; device springs back to original shape to fit snugly against vaginal walls. Embedded spring provides resistance during voluntary Kegel exercises. Device is intended for OTC use by women to strengthen pelvic floor muscles and treat urinary incontinence. No electronic components, sensors, or software involved. Healthcare provider does not interact with device output; user performs exercises independently. Benefit is improved pelvic floor muscle tone through resistive training.

Clinical Evidence

Bench testing only. Biocompatibility testing conducted in accordance with ISO 10993 standards confirmed the material is non-toxic and well-tolerated by mucosal membranes. Mechanical performance testing was conducted to establish safe use.

Technological Characteristics

One-piece silicone (polydimethylsiloxane) overmold with embedded spring. Resistive pelvic floor strengthener. Dimensions/form factor: intravaginal, squeezable for insertion. No energy source. Non-sterile. Biocompatibility per ISO 10993.

Indications for Use

Indicated for women with mild urinary incontinence to strengthen perineal pelvic floor muscles via resistance during voluntary muscle contractions.

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

• GyneFlex (K021115)
• Pelvic Muscle Therapy (K002830)
• Kegelmaster (K023305)

Submission Summary (Full Text)

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## 510(k) Summary 807.92(c)

#### SPONSOR

Company Name:

Kamabry, Inc.

42 Colonial Lane

Bellport, NY 11713

Company Address

631-803-6800 Telephone: Fax: [phone]

Contact Person: Caryn Horsley Summary Preparation Date: July 16, 2013

### DEVICE NAME

| Trade Name: | Inner Peace™ |
|----------------------|------------------------|
| Common/Usual Name: | Pelvic floor exerciser |
| Classification Name: | Perineometer |
| Regulation Number: | 21 CFR 884.1425 |
| Product Code: | HIR |
| Device Class: | Class II |

#### 807.92(a)(3)

Legally Marketed Equivalent Device Company Naissance Holdings L.C. Colonial Medical Supply KegelMaster 2000 Ltd

#### Product 510/k) # GyneFlex 021115 Pelvic Muscle Therapy 002830 K023305 Kegelmaster

#### DEVICE DESCRIPTION

PREDICATE DEVICE

807.92(a)(4)

Inner Peace™ is a one-piece, silicone intravaginal pelvic-floor exercise device that squeezes down to be easily inserted, only to spring back to its original shape to fit comfortably and snugly against the vaginal walls. The enclosed spring provides resistance as the User performs kegel exercises to strengthen and tone the pelvic floor muscles

**OCT 04 2013**

#### 807.92(a)(2)

807.92(a)(1)

607.52(a)(2)

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## DEVICE INTENDED USE

#### 807.92(a)(5)

The Inner Peace™ pelvic exercise device is recommended for the strengthening of perineal pelvic floor muscles by offering resistance to an individual's voluntary contractions of these muscles. It seeks to correct, through exercise, urinary incontinence in women.

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K122800
Page 3 of 5

.

| COMPARISON OF TECHNICAL CHARACTERISTICS 807.92(a)(6) | | | | |
|------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Device | Subject Device<br>Inner Peace | Predicate Device<br>Gyneflex | Predicate Device<br>Pelvic Muscle Therapy<br>Colonial Medical Supply | Predicate device<br>Kegelmaster<br>KegelMaster 2000 Ltd |
| Manufacturer | Kamabry, Inc. | Naissance Holdings, LLC | K002830 | K023305 |
| K Number | | K021115 | | |
| Common or Usual<br>Name | Pelvic Muscle Exerciser | Pelvic Muscle Exerciser | Pelvic Muscle Exercised | Pelvic Muscle Exercised |
| Regulation Number | 884.1425 | 884.1425 | 884.1425 | 884.1425 |
| Product Code | 85 HIR | 85 HIR | 85 HIR | 85 HIR |
| Indications for Use | The Inner Peace™<br>Exercise Device is<br>intended to assist<br>women in performing<br>Kegel Exercises by<br>offering resistance,<br>which may help control<br>urinary incontinence. | The Gyneflex Exercise<br>Device is intended to<br>assist women in<br>performing Kegel<br>Exercises by offering<br>resistance, which may<br>help control urinary<br>incontinence. | Pelvic muscle trainer<br>assists the user to<br>perform Kegel exercises,<br>by offering resistance,<br>which may help in the<br>treatment of urinary<br>incontinence. | The Kegelmaster 2000 is<br>intended to assist<br>women in performing<br>Kegel Exercises, which<br>may help to control<br>stress incontinence. |
| OTC | Yes | Yes | yes | yes |
| Feature | Resistive vaginal<br>exerciser | Resistive vaginal<br>exerciser | Resistive vaginal<br>exerciser | Resistive vaginal<br>exerciser |
| Target Population | Women with mild<br>incontinence | Women with mild<br>incontinence | Women with mild<br>incontinence | Women with mild<br>incontinence |
| Anatomical Site | Vagina | Vagina | Vagina | Vagina |
| Single Patient device | Yes | Yes | Yes | Yes |
| Reusable | Yes | Yes | Yes | Yes |
| Sterile | Clean, but not sterile | Clean, but not sterile | Clean, but not sterile | Clean, but not sterile |
| Biofeedback display<br>information | no | no | Numerical response to<br>muscle contraction<br>strength | no |

# DESCRIPTION OF TECHNICAL CHARACTERISTICS - 80726

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K122800
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| Material Design | Material | Operating Principle | Resistive component | Biocompatibility | Instructions for use | Packaging |
|--------------------------------------------------------------------------------------------|-------------------------------------|-------------------------------------|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|----------------------|------------------------------------------------------------------------|
| One-piece, silicone overmold with attached string and with an embedded spring inside unit. | polydimethysiloxane | Resistive pelvic floor strengthener | Embedded spring | Guidelines set forth in ISO 100993 testing results indicated material is biocompatible, nontoxic and well tolerated by mucosal membranes | Manual | Device in sealed plastic bag and manual in cardboard box |
| V shaped Polymer plastic | Polymer plastic | Resistive pelvic floor strengthener | V- shape in 6 graduated ranges of resistance | Guidelines set forth in ISO 100993 testing results indicated material is biocompatible, nontoxic and well tolerated by mucosal membranes | Manual | Device in sealed plastic bag and manual in cardboard box |
| Handheld pneumatically based device with vaginal silicone sensor | polydimethysiloxane | Resistive pelvic floor strengthener | Balloon silicone sensor | Guidelines set forth in ISO 100993 testing results indicated material is biocompatible, nontoxic and well tolerated by mucosal membranes | Manual | Sensors in sealed plastic bag, Monitor, Video, manual in cardboard box |
| Plastic and stainless steel spring progressive resistance pelvic exerciser | Plastic and stainless steel springs | Resistive pelvic floor strengthener | Stainless steel springs | Guidelines set forth in ISO 100993 testing results indicated material is biocompatible, nontoxic and well tolerated by mucosal membranes | Manual | Manual |

.

:

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807.92(b)(1)

#### NON-CLINICAL PERFORMANCE DATA

#### BIOCOMPATIBILITY

The Inner Peace™ was tested in accordance with the testing requirements of the ISO 10993 Recognized Standards and found to be safe for its intended use.

#### PERFORMANCE TESTING

Various mechanical tests were performed to establish safe use.

#### CONCLUSION

#### 807.92(b)(3)

The Inner Peace™ pelvic exerciser is similar to the predicate devices in:

- . Indications for Use
- Operating Principle .
- . Materials

After analyzing Biocompatibility results, performance bench testing and colorant studies, Kamabry, Inc. has concluded that Inner Peace™ pelvic exerciser is substantially equivalent to the predicate devices and introduces no new issues of safety and efficacy.

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Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. 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 emblem featuring three overlapping shapes that resemble an abstract bird or wing design.

#### Public Health Service

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

October 4, 2013

Kamabry, Inc. % Yolanda Smith Regulatory Consultant Smith Associates 1468 Harwell Avenue Crofton, MD 21114

Re: K122800

Trade/Device Name: Inner PeaceTM Regulation Number: 21 CFR 884.1425 Regulation Name: Perineometer Regulatory Class: II Product Code: HIR Dated: September 24, 2013 Received: September 25, 2013

Dear Yolanda Smith.

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 Mav 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 docs 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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Page 2 - Yolanda Smith

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-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/Industrv/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): K122800

Device Name: Inner Peace™

Indications for Use:

The Inner Peace™ pelvic exercise device is recommended for the strengthening of perineal pelvic floor muscles by offering resistance to an individual's voluntary contractions of these muscles. It seeks to correct, through exercise, urinary incontinence in women.

Prescription Use _ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use V (21 CFR 807 Subpart C)

## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

## Concurrence of CDRH, Office of Device Evaluation (ODE)

Herbert P. Lerner -2013.10.04 10:58:29 -04'00'

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