REFLEX TREATMENT SYSTEM

K994079 · Deschutes Medical Products, Inc. · HIR · Mar 1, 2000 · Obstetrics/Gynecology

Device Facts

• Record ID: K994079
• Device Name: REFLEX TREATMENT SYSTEM
• Applicant: Deschutes Medical Products, Inc.
• Product Code: HIR · Obstetrics/Gynecology
• Decision Date: Mar 1, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1425
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The ReFlex Treatment System is intended for the treatment of stress incontinence and/or urge incontinence in females.

Device Story

ReFlex Treatment System is a behavioral program for home-based treatment of female urinary incontinence. The system includes a handheld, pneumatically-based ReFlex Trainer, an informational video, and an instructional journal. The user connects the trainer to a vaginal sensor; the device measures pelvic muscle contractions and displays the magnitude on an LCD screen. The system provides biofeedback to assist users in performing pelvic muscle exercises. It is designed for independent, over-the-counter use by patients without requiring regular visits to medical personnel. Clinical support is available via phone and internet. By providing visual feedback on contraction strength, the device helps patients improve muscle control, potentially reducing or curing symptoms of incontinence.

Clinical Evidence

Clinical study of the ReFlex Treatment System involved self-selected healthy women with stress and/or urge incontinence. Participants followed a 16-week self-directed home program. Results showed 100% of participants who completed the study experienced some symptom improvement. 43% were completely cured, and 36% reported >50% improvement, for an overall improvement rate of 79%. Safety was supported by extensive biocompatibility testing (ISO 10993) of the silicone sensor material, including cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, and muscle implantation studies.

Technological Characteristics

Perineometer using pneumatic sensing. Sensor material: medical-grade silicone (polydimethylsiloxane). Energy source: 3 AAA batteries. Display: LCD. Standards: ISO 10993 (biocompatibility), UL 2601-1 (safety), EN 60601-1-2 (EMC). Reusable, non-sterile device. Form factor: handheld trainer with vaginal sensor.

Indications for Use

Indicated for females with stress and/or urge incontinence.

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

• PeriPump Pelvic Muscle Exercise Biofeedback device (K934552)

Submission Summary (Full Text)

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K994079 ReFlex 510(k)

# SECTION 5 - 510(k) SUMMARY

# 510(k) SUMMARY THE REFLEX TREATMENT SYSTEM

DesChutes Medical Products, Inc. 1011 SW Emkay Drive, Suite 104 Bend. OR 97702 Date Prepared: December 2, 1999

# 1. CONTACT PERSON

Denise Bestwick : [phone] Phone -Fax : [phone]

## 2. NAME OF THE MEDICAL DEVICE

| Proprietary name : | THE REFLEX TREATMENT SYSTEM |
|-----------------------|-----------------------------|
| Classification name : | PERINEOMETER |
| Common/usual name : | PELVIC MUSCLE EXERCISER |

## 3. DEVICE CLASSIFICATION

The ReFlex System is classified by the FDA under the heading of Perineometer (21 CFR Section 884.1425) as a Class II device with Product Code: 85HIR.

# 4. STATEMENT OF SUBSTANTIAL EQUIVALENCE

The ReFlex Treatment System is substantially equivalent to the DesChutes Medical Products' PeriPump Pelvic Muscle Exercise Biofeedback device (510(k) K934552).

A comparison of The ReFlex Treatment System versus The PeriPump is presented in Tables 5.1 and 5.2.

# 5. DESCRIPTION OF DEVICE

The ReFlex Treatment System is a comprehensive, behavioraliy-based program designed for independent use by incontinent people in their own home. The product kit includes a personal training device, an informational video, instructional journal, and direct clinical support via phone and internet. At the program's core is the pneumatically-based ReFlex Trainer, a handheld device which when connected to the vaginal sensor displays the magnitude of pelvic muscle contractions.

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# 6. INTENDED USE/INDICATIONS

The ReFlex Treatment System is intended for the treatment of stress incontinence and/or urge incontinence in females.

# 7. SUBSTANTIAL EQUIVALENCE COMPARISON

Tables 5.1 and 5.2 demonstrate the relative regulatory classifications and technological characteristics of the two devices.

| Category | DesChutes Medical<br>Products' ReFlex<br>Treatment System | DesChutes Medical<br>Products'<br>PeriPump (K934552) |
|--------------------------|----------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| Common or usual name | Pelvic muscle exerciser | Pelvic muscle exerciser |
| Classification name | 884.1425 Perineometer | 884.1425 Perineometer |
| Product Code | 85HIR | 85HIR |
| Intended Use/Indications | Treatment of stress<br>incontinence and/or urge<br>incontinence in females | Treatment of stress<br>incontinence and/or urge<br>incontinence in males and<br>females |
| Prescription device | No | Yes |

# Table 5.1 Comparison of Regulatory Classifications

# Table 5.2 Comparison of Device Technological Characteristics

| Feature | DesChutes Medical Products<br>OTC ReFlex | DesChutes Medical Products<br>PeriPump (K934552) |
|-------------------------------------------------|---------------------------------------------------------|----------------------------------------------------------------------------|
| Target population | Women with mild incontinence | Women and men with mild<br>incontinence |
| Single patient device | Yes | Yes |
| Single use or reusable? | Reusable | Reusable |
| Requires regular visits<br>to medical personnel | No | No |
| Sterilization status | Clean, but not sterile | Clean, but not sterile |
| Biofeedback display<br>information | LCD displays magnitude of pelvic<br>muscle contractions | LED displays magnitude of pelvic<br>muscle contractions |
| Performance | Clinical Study; Balloon Volume-to-<br>Burst Testing | Performance Testing - Simulated<br>Use; Balloon Volume-to-Burst<br>Testing |

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| DesChutes Medical Products, Inc. | | | |
|----------------------------------|--|--|--|
|----------------------------------|--|--|--|

| Material - Sensor | Medical grade silicone<br>(polydimethylsiloxane) | Medical grade silicone<br>(polydimethylsiloxane) |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Color additives | None | None |
| Biocompatibility | Balloon sensor testing exceeds<br>guidelines set forth in ISO 10993.<br>Testing results indicate material is<br>biocompatible, non-toxic and well-<br>tolerated by mucosal membranes. | Balloon sensor testing exceeds<br>guidelines set forth in ISO 10993.<br>Testing results indicate material is<br>biocompatible, non-toxic and well-<br>tolerated by mucosal membranes. |
| Chemical Safety | Addressed by biocompatibility<br>testing (ISO 10993) | Addressed by biocompatibility<br>testing (ISO 10993) |
| Number of models | One (female) | Two (male/female) |
| Anatomical Sites | Vagina | Vagina (female), rectum (male) |
| Instructions | Patient instructions for home use --<br>The ReFlex Journal | Patient instructions for home use -<br>User Guide |
| Energy Used and/or<br>Delivered | Energy supplied by 3 AAA<br>replaceable batteries | Energy supplied by 2 AA<br>replaceable batteries |
| Standards met | ISO 10993; UL2601-1, 2nd Edition<br>and EN 60601-1-2:1993 | ISO 10993; UL 544, 3rd Edition |
| Electrical safety | UL2601-1, 2nd Edition, EN 60601-1-<br>2:1993 | UL 544, 3rd Edition |
| Packaging | Sensors inside plastic bag; trainer,<br>sensors and journal inside cardboard<br>box | Sensors inside plastic bag; trainer,<br>sensors and journal inside cardboard<br>box |

#### 8. SUMMARY OF SAFETY AND EFFICACY TESTING

A. Non-Clinical Performance Data (In-Vitro and Electrical Testing)

The ReFlex Treatment System was designed and tested to meet the following standards: ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing; Emissions and Immunity Testing (EN60601-1-2: 1993); Medical Electrical Equipment, Part 1: General Requirements for Safety (UL 2601-1, 2nd Edition).

Extensive biocompatibility and safety testing of the silicone material used in the balloon sensors was performed for DesChutes Medical Products by NamSA. The following tests were performed:

> Cytotoxicity Study Using the ISO Elution Method ISO Sensitization Study in the Guinea Pig (Maximization Method) Vaginal Irritation Study in the Rabbit with Histopathology - 14 Days Acute Systemic Toxicity Study in the Mouse (Extract) Rabbit Pyrogen Study (Material Mediated) ISO Muscle Implantation Study in the Rabbit with Histopathology (1 week)

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DesChutes Medical Products, Inc.

ISO Muscle Implantation Study in the Rabbit with Histopathology (4 weeks) ISO Muscle Implantation Study in the Rabbit with Histopathology (12 weeks)

This testing regime was compared to requirements in "General Purpose Memorandum G95-1 Use of International Standard ISO-10993." The test results from all tests support the position that this material is substantially equivalent to the material used in the predicate device and indicate that the material is biocompatible, non-toxic and well tolerated by mucosal membranes.

B. Clinical Performance Data

The ReFlex Treatment System has been extensively tested for its safety and efficacy in alleviating symptoms of stress and/or urge incontinence. In addition, clinical testing of the product demonstrated that the device can be used outside the supervision of a licensed practitioner, and adequate directions for use have been prepared.

The conclusive data from this clinical study demonstrated that self-selected healthy women of a wide age-range with symptoms of urge and/or stress incontinence can improve their symptoms and lower their severity index with a minimal intervention, comprehensive, self-directed home biofeedback continence system. All study participants who completed the study saw some degree of symptom improvement. A remarkable 43% of participants were completely cured of their symptoms of incontinence. Another 36% had over 50% improvement of their symptoms for an overall improvement rate of 79%.

# 9. CONCLUSION

The ReFlex Treatment System has been shown to be safe and efficacious for its intended use through extensive biocompatibility testing of the material that comes into contact with the mucosal membranes, the study conducted to demonstrate the efficacy of the selfdirected instructions and the resulting data demonstrating that all study participants who completed the 16 week program realized some degree of improvement of their incontinent symptoms.

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Public Health Service

Image /page/4/Picture/2 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 image of an eagle with three lines representing its wings.

1 2000 MAR

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Denise Bestwick Director, Regulatory Affairs DesChutes Medical Products, Inc. 1011 SW Emkay Drive, Suite 104 Bend, OR 97702

Re: K994079 The ReFlex Treatment System (for Females) Requiatory Class: II Dated: December 2, 1999 Received: December 2, 1999 21 CFR §884.1425/Procode: 85 HIR

Dear Ms. Bestwick:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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. 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions, Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [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" (21CFR 807.97). Other fgeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Daniel G. Schultz, M.D.

Captain, USPHS Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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DesChutes Medical Products, Inc.

CONFIDENTIAL

# SECTION 4 - STATEMENT OF INDICATIONS FOR USE

# Statement of Indications for Use

DesChutes Medical Products, Inc. Applicant:

510(K) Number (if known): K994079_

The ReFlex Treatment System Device name:

Indications for Use:

The ReFlex Treatment System is intended for the treatment of stress incontinence and/or urge incontinence in females.

and the same of the same of the same of the same of the same of the states of the states of the states of the states of the states of the states of the states of the states o

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Concurrence of CDRH, Office of Device Evaluation (ODE) (Per 21 CFR 801.109)

Prescription Use

OR

Over-The-Counter Use