(90 days)
Not Found
No
The description focuses on a pneumatically-based biofeedback device and a behavioral program, with no mention of AI or ML technologies.
Yes
The device is intended for the treatment of stress and/or urge incontinence, and the description mentions its efficacy in alleviating symptoms and achieving improvement or cure in clinical studies.
No
The ReFlex Treatment System is described as a "treatment system" intended for "treatment of stress incontinence and/or urge incontinence." While it includes a training device that displays the magnitude of pelvic muscle contractions, its primary stated purpose and overall description point to it being a therapeutic device designed for home use to improve symptoms, rather than a device for diagnosing a medical condition. It's a biofeedback device for training, not diagnosis.
No
The device description explicitly states the product kit includes a "personal training device" and a "pneumatically-based ReFlex Trainer, a handheld device which when connected to the vaginal sensor displays the magnitude of pelvic muscle contractions." This indicates the presence of physical hardware components beyond just software.
Based on the provided information, the ReFlex Treatment System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of stress and/or urge incontinence in females. IVDs are used to diagnose or aid in the diagnosis of a condition by examining samples taken from the human body (like blood, urine, tissue).
- Device Description: The device is a behavioral program with a personal training device that measures pelvic muscle contractions. This is a therapeutic device, not a diagnostic one.
- Mechanism of Action: The device works by providing biofeedback to help users strengthen their pelvic muscles, which is a treatment approach. It does not analyze biological samples to identify a disease or condition.
The device is clearly intended for therapeutic purposes, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The ReFlex Treatment System is intended for the treatment of stress incontinence and/or urge incontinence in females.
Product codes
85HIR
Device Description
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.
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 incontinent people in their own 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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%.
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
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 : (541) 385-0350 Phone -Fax : (541) 382-2079
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.
1
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
Products' ReFlex
Treatment System | DesChutes Medical
Products'
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
incontinence and/or urge
incontinence in females | Treatment of stress
incontinence and/or urge
incontinence in males and
females |
| Prescription device | No | Yes |
Table 5.1 Comparison of Regulatory Classifications
Table 5.2 Comparison of Device Technological Characteristics
| Feature | DesChutes Medical Products
OTC ReFlex | DesChutes Medical Products
PeriPump (K934552) |
|-------------------------------------------------|---------------------------------------------------------|----------------------------------------------------------------------------|
| Target population | Women with mild incontinence | Women and men with mild
incontinence |
| Single patient device | Yes | Yes |
| Single use or reusable? | Reusable | Reusable |
| Requires regular visits
to medical personnel | No | No |
| Sterilization status | Clean, but not sterile | Clean, but not sterile |
| Biofeedback display
information | LCD displays magnitude of pelvic
muscle contractions | LED displays magnitude of pelvic
muscle contractions |
| Performance | Clinical Study; Balloon Volume-to-
Burst Testing | Performance Testing - Simulated
Use; Balloon Volume-to-Burst
Testing |
2
| DesChutes Medical Products, Inc. | |||
|---|---|---|---|
| ---------------------------------- | -- | -- | -- |
| Material - Sensor | Medical grade silicone
(polydimethylsiloxane) | Medical grade silicone
(polydimethylsiloxane) |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Color additives | None | None |
| Biocompatibility | Balloon sensor testing exceeds
guidelines set forth in ISO 10993.
Testing results indicate material is
biocompatible, non-toxic and well-
tolerated by mucosal membranes. | Balloon sensor testing exceeds
guidelines set forth in ISO 10993.
Testing results indicate material is
biocompatible, non-toxic and well-
tolerated by mucosal membranes. |
| Chemical Safety | Addressed by biocompatibility
testing (ISO 10993) | Addressed by biocompatibility
testing (ISO 10993) |
| Number of models | One (female) | Two (male/female) |
| Anatomical Sites | Vagina | Vagina (female), rectum (male) |
| Instructions | Patient instructions for home use --
The ReFlex Journal | Patient instructions for home use -
User Guide |
| Energy Used and/or
Delivered | Energy supplied by 3 AAA
replaceable batteries | Energy supplied by 2 AA
replaceable batteries |
| Standards met | ISO 10993; UL2601-1, 2nd Edition
and EN 60601-1-2:1993 | ISO 10993; UL 544, 3rd Edition |
| Electrical safety | UL2601-1, 2nd Edition, EN 60601-1-
2:1993 | UL 544, 3rd Edition |
| Packaging | Sensors inside plastic bag; trainer,
sensors and journal inside cardboard
box | Sensors inside plastic bag; trainer,
sensors and journal inside cardboard
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)
3
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.
4
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 (301) 594-4591. 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" (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 (800) 638-2041 or (301) 443-6597 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)
5
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
(Please do not write below this line) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Concurrence of CDRH, Office of Device Evaluation (ODE) (Per 21 CFR 801.109)
Prescription Use
OR
Over-The-Counter Use