(387 days)
Not Found
No
The device description and performance studies focus on mechanical resistance and biocompatibility, with no mention of AI/ML terms or data processing.
Yes
The device is described as correcting "urinary incontinence in women" through exercise, which is a therapeutic purpose.
No
Explanation: The device description and intended use clearly state that it is an exercise device designed to strengthen pelvic floor muscles. There is no mention of it being used to diagnose any condition or collect diagnostic data.
No
The device description explicitly states it is a "one-piece, silicone intravaginal pelvic-floor exercise device" with an "enclosed spring," indicating it is a physical hardware device, not software only.
Based on the provided information, the Inner Peace™ pelvic exercise device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for strengthening pelvic floor muscles through exercise to correct urinary incontinence. This is a therapeutic and rehabilitative purpose, not a diagnostic one.
- Device Description: The device is a physical object used for exercise, not for analyzing biological samples (like blood, urine, or tissue) to diagnose a condition.
- Lack of Diagnostic Function: There is no mention of the device performing any tests or providing diagnostic information about the patient's condition.
IVD devices are specifically designed to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. The Inner Peace™ device does not fit this description.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
HIR
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Vagina
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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)
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)
1
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.
2
K122800
Page 3 of 5
.
| COMPARISON OF TECHNICAL CHARACTERISTICS 807.92(a)(6) | ||||
|---|---|---|---|---|
| Device | Subject Device | |||
| Inner Peace | Predicate Device | |||
| Gyneflex | Predicate Device | |||
| Pelvic Muscle Therapy | ||||
| Colonial Medical Supply | Predicate device | |||
| Kegelmaster | ||||
| KegelMaster 2000 Ltd | ||||
| Manufacturer | Kamabry, Inc. | Naissance Holdings, LLC | K002830 | K023305 |
| K Number | K021115 | |||
| Common or Usual | ||||
| 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™ | |||
| Exercise Device is | ||||
| intended to assist | ||||
| women in performing | ||||
| Kegel Exercises by | ||||
| offering resistance, | ||||
| which may help control | ||||
| urinary incontinence. | The Gyneflex Exercise | |||
| Device is intended to | ||||
| assist women in | ||||
| performing Kegel | ||||
| Exercises by offering | ||||
| resistance, which may | ||||
| help control urinary | ||||
| incontinence. | Pelvic muscle trainer | |||
| assists the user to | ||||
| perform Kegel exercises, | ||||
| by offering resistance, | ||||
| which may help in the | ||||
| treatment of urinary | ||||
| incontinence. | The Kegelmaster 2000 is | |||
| intended to assist | ||||
| women in performing | ||||
| Kegel Exercises, which | ||||
| may help to control | ||||
| stress incontinence. | ||||
| OTC | Yes | Yes | yes | yes |
| Feature | Resistive vaginal | |||
| exerciser | Resistive vaginal | |||
| exerciser | Resistive vaginal | |||
| exerciser | Resistive vaginal | |||
| exerciser | ||||
| Target Population | Women with mild | |||
| incontinence | Women with mild | |||
| incontinence | Women with mild | |||
| incontinence | Women with mild | |||
| 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 | ||||
| information | no | no | Numerical response to | |
| muscle contraction | ||||
| strength | no |
DESCRIPTION OF TECHNICAL CHARACTERISTICS - 80726
3
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 |
.
:
4
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.
5
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.
6
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
7
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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