(293 days)
Not Found
No
The description focuses on a mechanical device and a behavioral program, with no mention of AI or ML technologies.
Yes
The device is described as "intended to assist women in performing Kegel Exercises which may help control stress urinary incontinence" and for "Treatment of stress and /or Urge incontinence in women," indicating a therapeutic purpose to modify a physiological function.
No
The device is intended to assist women in performing Kegel Exercises and does not diagnose any condition. Its purpose is therapeutic rather than diagnostic.
No
The device description explicitly states that the PelvicFlexer is a "hand-held and inserted into the vagina" device with "stainless steel springs," indicating a physical hardware component. The performance studies also discuss biocompatibility and safety testing of the "material used in the device," further confirming it is not software-only.
Based on the provided information, the PelvicFlexer is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- PelvicFlexer's Function: The PelvicFlexer is a physical device inserted into the vagina to assist with performing Kegel exercises. It measures the strength of muscle contractions using springs. It does not analyze any biological specimens.
- Intended Use: The intended use is to assist with Kegel exercises for stress urinary incontinence and treat stress and/or urge incontinence. This is a behavioral and physical therapy approach, not a diagnostic one based on analyzing bodily fluids or tissues.
Therefore, the PelvicFlexer falls under the category of a physical therapy or exercise assistance device, not an IVD.
N/A
Intended Use / Indications for Use
The PelvicFlexer is intended to assist women in peforming Kegel Exercises which may help control stress urinary incontinence.
Treatment of stress and /or Urge incontinence in women
Product codes
85 HIR
Device Description
The PelvicFlexer is a comprehensive, behaviorally based program designed for independent use by incontinence people at home. The program includes a PelvicFlexer device, instructional manual and direct support via phone and internet. The PelvicFlexer is hand-held and inserted into the vagina. The strength of the muscle contraction is reflected by the stainless steel springs.
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
independent use by incontinence people at home.
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
Non-Clinical Tests:
- ISO 10993 Biocompatibility evaluation of medical device. Extensive biocompatibility and safety testing of the material used in the device was performed by NAMSA. The following tests were performed:
- Cytotoxicity Using ISO Elution Method
- Muscle Implantation Test (7 day)
- Acute Systemic Toxicity
- Delayed Contact Sensitization (Maximization Method)
- Hemolysis Test (USP) - Direct Contact Method, Extraction Method
- Safety Testing (spring load testing) to assure safety and effectiveness.
Clinical Tests: Not applicable
Key Metrics
Not Found
Predicate Device(s)
K# 002830
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
MAR 2 0 2002
Attachment #2
510(K) SUMMARY
This summary of 5l0(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is: KO 11688
1. Submitter's Identification:
PelvicFlex Inc. 7350 South Tamiami Trail Suite 215 Sarasota, Florida 34231
Date Summary Prepared: May 23, 2001
Contact Person: Mr. Richard C. Blackford Tel #: 941-650-2740 Fax #: 941-484-0149 Email: richard@pelvicflex.com
2. Name of the Device:
Pelvic Flexer Exercise Device
3. Predicate Device Information:
Pelvic Muscle Therapy, Colonial Medical Supply, Las Vegas, Nevada, K# 002830
4. Device Description:
The PelvicFlexer is a comprehensive, behaviorally based program designed for independent use by incontinence people at home. The program includes a PelvicFlexer device, instructional manual and direct support via phone and internet. The PelvicFlexer is hand-held and inserted into the vagina. The strength of the muscle contraction is reflected by the stainless steel springs.
1
5. Intended Use:
The PelvicFlexer is intended to assist women in peforming Kegel Exercises which may help control stress urinary incontinence.
6. Comparison to Predicate Devices:
Please refer to the attached "Table of Substantial Equivalence Comparison Chart".
7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
- The Pelvic Flexer system was designed and tested to meet the following A. standards:
ISO 10993 Biocompatibility evaluation of medical device. Extensive biocompatibility and safety testing of the material used in the device was performed by NAMSA. The following tests were performed:
- ISO 10993
Cytotoxicity Using ISO Elution Method Muscle Implantation Test (7 day) Acute Systemic Toxicity
- Delayed Contact Sensitization (Maximization Method)
- Hemolysis Test (USP)
Direct Contact Method Extraction Method
- Safety Testing (spring load testing) to assure safety and effectiveness. B.
8. Discussion of Clinical Tests Performed:
Not applicable
ு. Conclusions:
The Pelvic Flexer Exercise Device has the same intended use and similar characteristics as the predicate device. Pelvic Muscle Therapy, Colonial Medical Supply. Moreover, biocompatibility and bench testing contained in this submission demonstrates that any difference in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the PelvicFlexer Exercise Device is substantially equivalent to the predicate device.
2
TABLE OF SUBSTANTIAL EQUIVALENCE COMPARISON CHART
| Category | ||
|---|---|---|
| PelvicFlex Inc. | ||
| PelvicFlexer | Colonial Medical Supply | |
| Pelvic Muscle Therapy | ||
| K# 002830 | ||
| Common of usual name | Pelvic Muscle Exerciser | Pelvic Muscle Exerciser |
| Classification Name | 884.1425 Perineometer | 884.1425 Perineometer |
| Product Code | 85 HIR | 85 HIR |
| Intended Use | ||
| Indications | Treatment of stress and /or | |
| Urge incontinence in | ||
| women | Treatment of stress and / or | |
| Urge incontinence in | ||
| women | ||
| Prescription Use | NO | NO |
| Feature | PelvicFlex Inc.
PelvicFlexer | Colonial Medical Supply
Pelvic Muscle Therapy |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Target Population | Women with mild
incontinence | Women with mild
incontinence |
| Single Patient Device | YES | YES |
| Single User of Reusable | Reusable | Reusable |
| Requires Medical visits
to Medical Personnel | No | NO |
| Sterilization Status | Clean, but not sterile | Clean, but not sterile |
| Biofeedback display
information | NO | Numerical response to
muscle contraction strength |
| Material Device | YES | NO |
| Material Sensor | No | Medical grade silicone
(polydmethylsiloxane) |
| Biocompatibility | Guidelines set forth in ISO
10993 testing results
indicated material is
Biocompatible, nontoxic
and well tolerated by
mucosal membranes | Guidelines set forth in ISO
10993 testing results
indicated material is
Biocompatible, nontoxic
and well tolerated by
mucosal membranes |
| Chemical Safety | Address by biocompatibility
testing (ISO 10993) | Address by biocompatibility
testing (ISO 10993) |
| Number of models | One (Female) | One (Female) |
| Anatomical Sites | Vagina | Vagina |
| Instructions | Patient Instruction manual
for home use | Patient Instruction for home
use Video and manual |
| Stainless Steel Spring | 302 A313 | NO |
| Packaging | Device in sealed plastic bag
and manual in card board
box | Sensors in sealed Monitor,
Video, manual in card
board box |
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized symbol resembling an abstract human figure with three flowing lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The text is in all capital letters and is evenly spaced around the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 0 2002
PelvicFlex, Inc c/o Ms. Susan D. Goldstein-Falk Official Correspondent mdi Consultants, Inc. 55 Northern Blvd., Suite 200 GREAT NECK NY 11021
Re: K011688
Trade/Device Name: PelvicFlexer Exercise Device Regulation Number: 21 CFR 8884.1425 Regulation Name: Perineometer Regulatory Class: II Product Code: 85 HIR Dated: December 17, 2001 Received: December 20, 2001
Dear Ms. Goldstein-Falk:
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.
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. 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); 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.
4
Page 2
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours.
Nancy C Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Attachment #1
Page __ 1___ of ___ 1
510(k) Number (if known): _长傅 (1) & & & L
Device Name: Pelvic/Flexer Exercise Device
Indications For Use:
The Pelvic/Flexer is intended to assist women in performing Kegel Exercises in rne Forner lox control stress urinary incontinence.
(Please Do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use _ レ (Optional Format 1-2-96)
Ermit li. Seppom
OR
(Division Sign-Off) Division of Reproductive, Abdomi and Radiological Devices 510(k) Number