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 Description

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

AI/ML Overview

The provided text describes Kamabry, Inc.'s "Inner Peace™" pelvic floor exerciser and its 510(k) submission, K122800. The device is a Class II perineometer intended "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."

The submission primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance criteria through a standalone study. The primary method of demonstrating acceptance is through biocompatibility testing and mechanical performance testing, combined with a comparison to legally marketed predicate devices.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Biocompatibility	Tested in accordance with ISO 10993 Recognized Standards, found to be safe for intended use, biocompatible, non-toxic, and well-tolerated by mucosal membranes.
Mechanical Safety	Various mechanical tests performed to establish safe use. (Specific criteria/results not detailed)
Material	Polydimethylsiloxane (silicone) for the device body, similar to predicate devices.
Operating Principle	Resistive pelvic floor strengthener (embedded spring), similar to predicate devices.
Indications for Use	Strengthens pelvic floor muscles, corrects urinary incontinence in women. Identical to predicate devices.
Sterility	Clean, but not sterile. Similar to predicate devices.
Target Population	Women with mild incontinence. Similar to predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

Biocompatibility Testing: The document states "ISO 10993 testing results indicated material is biocompatible." However, it does not specify the sample size used for this testing or the provenance of the data (e.g., whether it was animal studies, in-vitro, or human clinical data).
Mechanical Performance Testing: The document states "Various mechanical tests were performed to establish safe use." Again, no sample size or data provenance is provided for these tests.
Clinical Efficacy/Effectiveness: No clinical test set or human subject data is mentioned or appears to have been used to prove the device's ability to "correct urinary incontinence in women." The submission relies on substantial equivalence to predicates that claim this indication.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The submission does not describe clinical testing or the establishment of a ground truth through expert consensus for a test set. The claim of efficacy ("correct urinary incontinence") is made based on similarity to predicate devices, not on a study with ground truth established by experts.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set or adjudication process is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices involving human interpretation (e.g., radiologists reading images), which is not relevant to this pelvic floor exerciser.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in a sense, a "standalone" assessment of the device's physical properties and biocompatibility was performed. The biocompatibility and mechanical performance tests were done on the device itself, without human interaction measuring its performance in a clinical setting for efficacy. However, this is not the typical context of a "standalone" study for AI algorithms.

7. The Type of Ground Truth Used

Biocompatibility: The "ground truth" was established by recognized standards (ISO 10993). Compliance with these standards served as the basis for concluding biocompatibility.
Mechanical Safety: The "ground truth" was likely established against engineering specifications or validated internal test methods to ensure safe operation.
Clinical Efficacy (for incontinence): No specific ground truth was established by this submission for clinical efficacy in correcting incontinence. Instead, the device relies on the "ground truth" of the predicate devices' established efficacy when claiming substantial equivalence for this indication.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device, not an AI or algorithm-based product that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. No training set was used.

Summary

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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: 631-286-6842

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)

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)

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K122800
Page 3 of 5

COMPARISON OF TECHNICAL CHARACTERISTICS 807.92(a)(6)
Device	Subject DeviceInner Peace	Predicate DeviceGyneflex	Predicate DevicePelvic Muscle TherapyColonial Medical Supply	Predicate deviceKegelmasterKegelMaster 2000 Ltd
Manufacturer	Kamabry, Inc.	Naissance Holdings, LLC	K002830	K023305
K Number		K021115
Common or UsualName	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™Exercise Device isintended to assistwomen in performingKegel Exercises byoffering resistance,which may help controlurinary incontinence.	The Gyneflex ExerciseDevice is intended toassist women inperforming KegelExercises by offeringresistance, which mayhelp control urinaryincontinence.	Pelvic muscle trainerassists the user toperform Kegel exercises,by offering resistance,which may help in thetreatment of urinaryincontinence.	The Kegelmaster 2000 isintended to assistwomen in performingKegel Exercises, whichmay help to controlstress incontinence.
OTC	Yes	Yes	yes	yes
Feature	Resistive vaginalexerciser	Resistive vaginalexerciser	Resistive vaginalexerciser	Resistive vaginalexerciser
Target Population	Women with mildincontinence	Women with mildincontinence	Women with mildincontinence	Women with mildincontinence
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 displayinformation	no	no	Numerical response tomuscle contractionstrength	no

DESCRIPTION OF TECHNICAL CHARACTERISTICS - 80726

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K122800
Page 4 of 5

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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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 (800) 638-2041 or (301) 796-7100 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:

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'

Page 1 of 1

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).