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.

AI/ML Overview

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

Here's an analysis of the provided information regarding the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative format as would typically be seen for a medical device seeking to demonstrate specific performance metrics (e.g., sensitivity, specificity, accuracy). However, the overall goal of the clinical study was to demonstrate the safety and efficacy of the device for its intended use and its ability to be used without licensed practitioner supervision. The reported performance is based on the outcomes of this clinical study.

Acceptance Criteria (Inferred from study goals)	Reported Device Performance and Outcomes
Efficacy in alleviating stress and/or urge incontinence symptoms.	"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... All study participants who completed the study saw some degree of symptom improvement." This indicates overall efficacy. Specific outcomes: - 43% of participants were completely cured of their symptoms of incontinence. - 36% had over 50% improvement of their symptoms. - This results in an overall improvement rate of 79%.
Safety of the device, particularly regarding biocompatibility and electrical safety.	Biocompatibility: "Extensive biocompatibility and safety testing of the silicone material used in the balloon sensors was performed... 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." (Tests included Cytotoxicity, Sensitization, Vaginal Irritation, Acute Systemic Toxicity, Pyrogen, and Muscle Implantation Studies).Electrical Safety: The device was designed and tested to meet UL2601-1, 2nd Edition, and EN 60601-1-2:1993, indicating adherence to relevant electrical safety standards.
Ability to be used independently by incontinent individuals in their own home (without licensed supervision).	"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."

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: The document does not specify the exact number of participants in the clinical study. It generally refers to "all study participants who completed the study," "self-selected healthy women of a wide age-range," and percentages of "participants."
Data Provenance: The document does not explicitly state the country of origin. The sponsor, DesChutes Medical Products, Inc., is based in Bend, OR, USA, suggesting the study was likely conducted in the US. The study is described as "clinical testing," implying a prospective nature where data was collected specifically for this evaluation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This section is not applicable as the study evaluates the effectiveness of a treatment system directly on patient symptoms and outcomes, rather than requiring expert assessment to establish a "ground truth" for diagnostic accuracy. The ground truth, in this context, is the reported improvement or cure of incontinence symptoms by the patients themselves, likely supported by other clinical assessments, though details are not provided.

4. Adjudication Method for the Test Set:

Not applicable. This was a clinical efficacy study for a treatment device, not a diagnostic accuracy study requiring adjudication of expert readings. Patient self-reporting of symptoms and/or clinical assessments (e.g., severity index) would have formed the basis of outcome measurement.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance:

Not applicable. The ReFlex Treatment System is a biofeedback device for pelvic muscle exercises, not an AI-powered diagnostic tool requiring human reader interpretation or assessment. Therefore, an MRMC study related to AI assistance is not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. The ReFlex Treatment System is a treatment device used by individuals, not an algorithm. Its performance is inherent in its design and the patient's interaction with it, not a standalone algorithmic output.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

The ground truth for the clinical performance data appears to be based on patient-reported outcomes (symptom improvement/cure) and potentially objective clinical assessments of symptom severity. The summary states, "All study participants who completed the study saw some degree of symptom improvement" and refers to "improve their symptoms and lower their severity index." This points towards outcomes data as the primary ground truth.

8. The Sample Size for the Training Set:

Not applicable. There is no mention of a "training set" for the ReFlex Treatment System. It is a physical treatment device, not a machine learning model that requires training data. The "training" that occurs is for the patient learning to use the device.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set mentioned for the device itself.

Summary

{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

{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 MedicalProducts' ReFlexTreatment System	DesChutes MedicalProducts'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 stressincontinence and/or urgeincontinence in females	Treatment of stressincontinence and/or urgeincontinence in males andfemales
Prescription device	No	Yes

Table 5.1 Comparison of Regulatory Classifications

Table 5.2 Comparison of Device Technological Characteristics

Feature	DesChutes Medical ProductsOTC ReFlex	DesChutes Medical ProductsPeriPump (K934552)
Target population	Women with mild incontinence	Women and men with mildincontinence
Single patient device	Yes	Yes
Single use or reusable?	Reusable	Reusable
Requires regular visitsto medical personnel	No	No
Sterilization status	Clean, but not sterile	Clean, but not sterile
Biofeedback displayinformation	LCD displays magnitude of pelvicmuscle contractions	LED displays magnitude of pelvicmuscle contractions
Performance	Clinical Study; Balloon Volume-to-Burst Testing	Performance Testing - SimulatedUse; Balloon Volume-to-BurstTesting

{2}------------------------------------------------

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

Material - Sensor	Medical grade silicone(polydimethylsiloxane)	Medical grade silicone(polydimethylsiloxane)
Color additives	None	None
Biocompatibility	Balloon sensor testing exceedsguidelines set forth in ISO 10993.Testing results indicate material isbiocompatible, non-toxic and well-tolerated by mucosal membranes.	Balloon sensor testing exceedsguidelines set forth in ISO 10993.Testing results indicate material isbiocompatible, non-toxic and well-tolerated by mucosal membranes.
Chemical Safety	Addressed by biocompatibilitytesting (ISO 10993)	Addressed by biocompatibilitytesting (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/orDelivered	Energy supplied by 3 AAAreplaceable batteries	Energy supplied by 2 AAreplaceable batteries
Standards met	ISO 10993; UL2601-1, 2nd Editionand 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 cardboardbox	Sensors inside plastic bag; trainer,sensors and journal inside cardboardbox

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

Over-The-Counter Use

Regulation Number and Section

§ 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).