(166 days)
Not Found
No
The device uses biofeedback and a simple level-setting algorithm based on contraction strength, which does not meet the criteria for AI/ML.
Yes
Explanation: The device is intended to treat stress and/or urge urinary incontinence by strengthening pelvic floor muscles, which is a therapeutic purpose.
No
The device is described as an exercise device that provides biofeedback and exercise guidance. It measures muscle contraction strength to set an exercise level, rather than to diagnose a condition. Its intended use is to strengthen pelvic floor muscles to treat urinary incontinence, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states it is a "pelvic floor muscle exercise device" that provides biofeedback and exercise guidance through "gentle vibrations," indicating it is a physical device with hardware components, not solely software.
Based on the provided information, the Intimina KegelSmart and Intimina KegelSmart Pearl are not IVD (In Vitro Diagnostic) devices.
Here's why:
- IVD devices are used to examine specimens taken from the human body. This typically involves analyzing blood, urine, tissue, or other bodily fluids to diagnose diseases, monitor health, or screen for conditions.
- The Intimina KegelSmart devices are inserted vaginally and work by providing biofeedback and exercise guidance based on muscle contractions. They do not analyze any bodily fluids or tissues.
- Their intended use is to strengthen pelvic floor muscles to treat urinary incontinence. This is a therapeutic and exercise-based function, not a diagnostic one.
Therefore, the Intimina KegelSmart and KegelSmart Pearl fall under the category of medical devices, but not specifically In Vitro Diagnostic devices.
N/A
Intended Use / Indications for 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.
Product codes
HIR
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Probe inserted vaginally
Indicated Patient Age Range
Not Found
Intended User / Care Setting
independent use by women at home / Home use
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
Functional performance testing was provided on the Intimina KegelSmart and KegelSmart Pearl demonstrating that it operates per its Instructions for Use.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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)
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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
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
Pearl | The Reflex Treatment System |
|--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| FDA classification | Class II, perineometer
884.1425 (HIR) | Class II, perineometer
884.1425 (HIR) |
| Intended use | For the treatment of stress
and/or urge urinary
incontinence in females | For the treatment of stress
and/or urge urinary
incontinence in females |
| Target population | Women experiencing
symptoms of pelvic floor
muscle weakness and mild
incontinence | Women experiencing
symptoms of pelvic floor
muscle weakness and mild
incontinence |
| Anatomical site | Probe inserted vaginally | Probe inserted vaginally |
| Method of function | Registers the user's pelvic
strength and assigns a
strength level. Guides the user
through exercise routines
(with vibration). | Registers the user's pelvic
strength and assigns a strength
level. Guides the user through
exercise routines (with visual
cues). |
| System components | Vaginal probe covered in
medical grade silicone | Balloon sensor vaginal probe
plus LCD monitor |
| Biofeedback
mechanism | Electric resistance strain
gauge | MEMS Air pressure sensor |
| Prescription device | No | No |
| Medical practice or
home use? | Home use | Home use |
| Is the device provided
sterile? | Clean but not sterile | Clean but not sterile |
| Does the device use
software? | Yes | Yes |
| Assistance from
medical personnel
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
Pearl | The Reflex Treatment System |
| Electrical safety | ETL/cETL
IEC/EN 60601-1 3rd ed.,
IEC/EN 60601-1-2:2007 | UL2601-1, 2nd Edition,
EN60601-1-2:1993 |
| Pelvic floor muscle
exercise routine | Combination of rapid contract
and release exercises and
longer contract and release
exercises. Routine difficulty
increases with strength levels. | Combination of rapid contract
and release exercises and
longer contract and release
exercises |
| Strength levels | 5 levels (can move up and
down levels) | 3 levels (can move up and
down 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 and |
| skin sensitization | |
| IEC 60601-1 3rd | |
| ed. | Medical electrical equipment -Part 1: General requirements for basic |
| safety and essential performance | |
| IEC 60601-1-2: | |
| 2007 | Medical electrical equipment -Part 1-2:General requirements for safety |
| -Collateral standard: Electromagnetic compatibility -Requirements and | |
| 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.