(293 days)
The PelvicFlexer is intended to assist women in performing Kegel Exercises which may help control stress urinary incontinence.
Treatment of stress and /or Urge incontinence in women
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.
Acceptance Criteria and Device Performance Study for the PelvicFlexer Exercise Device
This submission describes the PelvicFlexer Exercise Device and establishes its substantial equivalence to the predicate device, Pelvic Muscle Therapy (K# 002830). The assessment is based on non-clinical tests rather than clinical studies to demonstrate safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated in quantitative metrics within the provided document for device performance. Instead, the "acceptance criteria" appear to revolve around demonstrating biocompatibility, safety, and functional equivalence to the predicate device through non-clinical testing.
| Feature | Acceptance Criteria (Implied) | Reported Device Performance (PelvicFlexer) |
|---|---|---|
| Biocompatibility | Meet ISO 10993 standards for medical devices. | Extensive testing performed by NAMSA against ISO 10993 standards: Cytotoxicity (ISO Elution Method), Muscle Implantation Test (7 day), Acute Systemic Toxicity, Delayed Contact Sensitization (Maximization Method), Hemolysis Test (USP - direct and extraction methods). Results indicated material is biocompatible, nontoxic, and well tolerated by mucosal membranes. |
| Material Safety | Materials used must be safe for patient contact. | Addressed by biocompatibility testing (ISO 10993). |
| Functional Safety (Spring Load) | Assure safety and effectiveness of the spring mechanism. | Safety Testing (spring load testing) performed. (Specific performance metrics not detailed, but states assurance of safety and effectiveness). |
| Intended Use | To assist women in performing Kegel Exercises which may help control stress urinary incontinence. | Identical intended use as the predicate device. |
| Target Population | Women with mild incontinence. | Identical to the predicate device. |
| Reusable/Single Patient Use | Must be reusable and for single patient use. | Reusable, single patient device. |
2. Sample Size Used for the Test Set and Data Provenance
The submission explicitly states, "Discussion of Clinical Tests Performed: Not applicable."
Therefore, there was no human "test set" in the context of clinical performance evaluation. The "test set" for the non-clinical tests would refer to the samples of materials and device components subjected to the biocompatibility and safety testing. The document does not specify the exact number of samples used for these non-clinical tests.
The data provenance for the non-clinical tests would be the testing laboratories (e.g., NAMSA) where the biocompatibility and safety tests were conducted. The country of origin is not specified for these tests. The nature of these tests is laboratory-based (bench testing), not retrospective or prospective clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable, as no clinical test set was used to evaluate device performance against a medical ground truth (e.g., disease diagnosis, treatment efficacy). The "ground truth" for the non-clinical tests was established by adherence to ISO 10993 standards and general engineering safety principles.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set requiring expert adjudication was performed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done, as no clinical studies involving human readers or AI assistance were conducted.
6. Standalone (Algorithm Only) Performance Study
Not applicable, as this device is a physical medical device, not an algorithm or AI software. Therefore, no standalone algorithm performance study was relevant or performed.
7. Type of Ground Truth Used
The "ground truth" for demonstrating the safety and biochemical compatibility of the device's materials was based on internationally recognized standards and guidelines for medical device biocompatibility, specifically ISO 10993. For the functional safety (spring load testing), the "ground truth" was internal engineering specifications and generally accepted safety parameters for mechanical components, aiming to assure safety and effectiveness.
8. Sample Size for the Training Set
Not applicable, as this is a physical medical device and not an AI/ML algorithm requiring a training set of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set was used.
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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 #: 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.
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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.PelvicFlexer | Colonial Medical SupplyPelvic Muscle TherapyK# 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 UseIndications | Treatment of stress and /orUrge incontinence inwomen | Treatment of stress and / orUrge incontinence inwomen |
| Prescription Use | NO | NO |
| Feature | PelvicFlex Inc.PelvicFlexer | Colonial Medical SupplyPelvic Muscle Therapy |
|---|---|---|
| Target Population | Women with mildincontinence | Women with mildincontinence |
| Single Patient Device | YES | YES |
| Single User of Reusable | Reusable | Reusable |
| Requires Medical visitsto Medical Personnel | No | NO |
| Sterilization Status | Clean, but not sterile | Clean, but not sterile |
| Biofeedback displayinformation | NO | Numerical response tomuscle contraction strength |
| Material Device | YES | NO |
| Material Sensor | No | Medical grade silicone(polydmethylsiloxane) |
| Biocompatibility | Guidelines set forth in ISO10993 testing resultsindicated material isBiocompatible, nontoxicand well tolerated bymucosal membranes | Guidelines set forth in ISO10993 testing resultsindicated material isBiocompatible, nontoxicand well tolerated bymucosal membranes |
| Chemical Safety | Address by biocompatibilitytesting (ISO 10993) | Address by biocompatibilitytesting (ISO 10993) |
| Number of models | One (Female) | One (Female) |
| Anatomical Sites | Vagina | Vagina |
| Instructions | Patient Instruction manualfor home use | Patient Instruction for homeuse Video and manual |
| Stainless Steel Spring | 302 A313 | NO |
| Packaging | Device in sealed plastic bagand manual in card boardbox | Sensors in sealed Monitor,Video, manual in cardboard 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 | (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
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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
§ 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).