PELVICFLEXER EXERCISE DEVICE

K011688 · Pelvicflex, Inc. · HIR · Mar 20, 2002 · Obstetrics/Gynecology

Device Facts

• Record ID: K011688
• Device Name: PELVICFLEXER EXERCISE DEVICE
• Applicant: Pelvicflex, Inc.
• Product Code: HIR · Obstetrics/Gynecology
• Decision Date: Mar 20, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1425
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PelvicFlexer is intended to assist women in peforming Kegel Exercises which may help control stress urinary incontinence.

Device Story

Hand-held vaginal exercise device; designed for independent home use by women with mild incontinence. Device utilizes stainless steel springs (302 A313) to provide resistance during pelvic muscle contractions. User performs Kegel exercises; device provides physical resistance to strengthen pelvic floor muscles. Program includes instructional manual and support via phone/internet. No biofeedback display or electronic components. Intended to help control stress urinary incontinence through behavioral exercise.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing and biocompatibility evaluation (ISO 10993) including cytotoxicity, muscle implantation, acute systemic toxicity, sensitization, and hemolysis testing.

Technological Characteristics

Perineometer; hand-held vaginal insert. Materials: stainless steel springs (302 A313). Biocompatibility: ISO 10993 compliant. Non-sterile. No electronic components, sensors, or biofeedback display. Mechanical resistance-based operation.

Indications for Use

Indicated for women with mild stress and/or urge urinary incontinence to assist in performing Kegel exercises.

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

• Pelvic Muscle Therapy, Colonial Medical Supply (K002830)

Submission Summary (Full Text)

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# 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 #: [phone] Fax #: [phone] Email: [e-mail]

#### 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.

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### 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.

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# TABLE OF SUBSTANTIAL EQUIVALENCE COMPARISON CHART

| Category | | |
|-----------------------------|--------------------------------------------------------------|---------------------------------------------------------------|
| | PelvicFlex Inc.<br>PelvicFlexer | Colonial Medical Supply<br>Pelvic Muscle Therapy<br>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<br>Indications | Treatment of stress and /or<br>Urge incontinence in<br>women | Treatment of stress and / or<br>Urge incontinence in<br>women |
| Prescription Use | NO | NO |

| Feature | PelvicFlex Inc.<br>PelvicFlexer | Colonial Medical Supply<br>Pelvic Muscle Therapy |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Target Population | Women with mild<br>incontinence | Women with mild<br>incontinence |
| Single Patient Device | YES | YES |
| Single User of Reusable | Reusable | Reusable |
| Requires Medical visits<br>to Medical Personnel | No | NO |
| Sterilization Status | Clean, but not sterile | Clean, but not sterile |
| Biofeedback display<br>information | NO | Numerical response to<br>muscle contraction strength |
| Material Device | YES | NO |
| Material Sensor | No | Medical grade silicone<br>(polydmethylsiloxane) |
| Biocompatibility | Guidelines set forth in ISO<br>10993 testing results<br>indicated material is<br>Biocompatible, nontoxic<br>and well tolerated by<br>mucosal membranes | Guidelines set forth in ISO<br>10993 testing results<br>indicated material is<br>Biocompatible, nontoxic<br>and well tolerated by<br>mucosal membranes |
| Chemical Safety | Address by biocompatibility<br>testing (ISO 10993) | Address by biocompatibility<br>testing (ISO 10993) |
| Number of models | One (Female) | One (Female) |
| Anatomical Sites | Vagina | Vagina |
| Instructions | Patient Instruction manual<br>for home use | Patient Instruction for home<br>use Video and manual |
| Stainless Steel Spring | 302 A313 | NO |
| Packaging | Device in sealed plastic bag<br>and manual in card board<br>box | Sensors in sealed Monitor,<br>Video, manual in card<br>board box |

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## 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.

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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 | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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## 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