(226 days)
Biofeedback/monitoring vaginal probe intended for:
- Treatment of stress, urge, and mixed incontinence.
- Facilitation in identification of the pubococcygeus muscles.
- Strengthening of the pelvic floor muscles through biofeedback-assisted pelvic floor exercises.
The Periform® is a vaginal perineometric probe designed specifically for the acquisition of the naturally present superficial EMG signals of the human vaginal wall. Surface electromyography (sEMG) is the technique of measuring and filtering the electrical impulse (action potential) signals generated by muscle fibers during contraction. The probe conducts these signals to a biofeedback device for further processing. The anatomy of the pelvic floor presents a difficulty in obtaining these signals. The use of a perineometric probe overcomes this difficulty. The purpose of the Periform® is to improve the voluntary control and strength of the pelvic floor muscles with the aid of biofeedback equipment.
The provided text describes the Periform® Perineometric Probe and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a specific study proving the device meets those criteria in the way typically expected for a detailed performance study with statistical endpoints.
Instead, the submission focuses on:
- Substantial Equivalence: Demonstrating that the Periform® is as safe and effective as previously approved devices (Verimed Electromyographic Perineometer™ and PerryVaginal™ Sensor) through a detailed feature comparison.
- Non-Clinical Performance Data: Providing basic engineering and material testing rather than clinical effectiveness.
- Biocompatibility Testing: Ensuring the materials are safe for human contact.
Here's an breakdown of the information that is available related to your request categories, and where the information is absent:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Explicitly Stated in Document) | Reported Device Performance |
|---|---|
| Material Biocompatibility: | |
| USP Class VI Plastics (for Polystyrene type 564) | Meets the requirements |
| Nontoxic (for Medical Grade Stainless Steel 316S31) | Nontoxic |
| Electrical Signal Transport: | |
| Low impedance values (below 200 Hz) | Around 10 ohms at all tested frequencies |
| Premarket Approval: | |
| Substantially equivalent to predicate devices | Determined substantially equivalent by FDA |
Missing: The document does not define specific clinical acceptance criteria for effectiveness (e.g., a target percentage reduction in incontinence episodes, or a threshold improvement in pelvic floor muscle strength). The "performance" described is primarily about safety and technical specifications that demonstrate it functions as a perineometric probe.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. The document describes non-clinical performance and biocompatibility testing, not a clinical trial with a test set of human subjects for effectiveness.
- Impedance Test: "Various frequencies were used" (no sample size provided beyond this qualitative statement).
- Biocompatibility Tests: Performed on the materials themselves, not human subjects.
- Data Provenance: Not applicable for these types of tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. No clinical test set with human subjects requiring expert ground truth establishment is described.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set with human subject data requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. A MRMC comparative effectiveness study was not conducted or reported. The device's approval is based on substantial equivalence to existing devices and non-clinical testing, not a study comparing performance with and without AI assistance or human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This device is a sensor (perineometric probe) and does not involve an "algorithm" in the sense of AI or image analysis. Its function is to acquire biological signals for a biofeedback device or for a Pelvic Floor Contraction Indicator. The "standalone" performance here refers to its ability to acquire signals, which is addressed by the impedance test.
7. The Type of Ground Truth Used
For the non-clinical tests:
- Biocompatibility: Established by compliance with recognized standards (e.g., USP Class VI Plastics, confirmation of medical grade material toxicity).
- Electrical Signal Transport (Impedance): Established by demonstrating low impedance values across relevant frequencies, indicating effective signal transmission.
Missing: No clinical ground truth (e.g., pathology, clinical outcomes, expert consensus on patient improvement) is mentioned because no clinical effectiveness study was reported.
8. The Sample Size for the Training Set
Not applicable. This device does not use machine learning or AI that would require a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, no training set is relevant for this device.
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Image /page/0/Picture/1 description: The image shows the logo for Verimed International Inc. The logo is black and white and features a stylized "V" followed by the word "ERIMED" in bold, sans-serif font. Below the word "ERIMED" is the text "International Inc." in a smaller font size.
K98/277
510(k) Summary
Summary of Safety and Effectiveness
Periform® Perineometric Probe and Pelvic Floor Contraction Indicator
Manufactured by:
NEEN HealthCare Old Pharmacy Yard, Church Street Dereham, Norfolk NR19 1DJ England, United Kingdom.
Sold by:
Verimed International, Inc. 11950 NW 39 St., Suite D Coral Springs, FL 33065 {USA}
Telephone: (954) 344-2454 Fax: (954) 340-8812
Contact Person:
Signature
Kishore Puppala, Product Manager, Verimed International, Inc.
April 2, 1998.
Date Submitted
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Name of Device
Trade Name: Periform® Common name: Perineometric Probe Classification: Perineometer (per 21 CFR section 884.1425)
Identification of Predicate Device
Verimed contends that the Periform® probe is substantially equivalent to the Verimed Electromvographic Perineometer™ [510(k) number K913912] and the PerryVaginal™ Sensor (also known as the PerryMeter Vaginal Perineometer) {510(k) number K911190].
Description of Device
The Periform® is a vaginal perineometric probe designed specifically for the acquisition of the naturally present superficial EMG signals of the human vaginal wall. Surface electromyography (sEMG) is the technique of measuring and filtering the electrical impulse (action potential) signals generated by muscle fibers during contraction. The probe conducts these signals to a biofeedback device for further processing. The anatomy of the pelvic floor presents a difficulty in obtaining these signals. The use of a perineometric probe overcomes this difficulty.
The purpose of the Periform® is to improve the voluntary control and strength of the pelvic floor muscles with the aid of biofeedback equipment.
Intended Uses
Indications
- Treatment of stress, urge, and mixed incontinence. �
- Sensor for SEMG behavioral training. �
- Facilitation in identification of the pubococcygeus muscles. �
- � Strengthening of the pelvic floor muscles through biofeedbackassisted pelvic floor exercises.
- � Qualitative evaluation of the pelvic floor musculature using the Pelvic Floor Contraction Indicator.
Contraindications/ DO NOT USE
- � Do not use during the menstrual period or when pregnant.
- � Do not use if symptoms of a bladder infection are present.
- Do not use if symptoms of a vaginal infection are present. �
- Do not use if patient has a history of urinary retention or symptoms � thereof.
- Do not use with patients who have diminished mental capacity or � physical competence or who cannot handle the device properly.
- Do not use while pregnant or while attempting to become pregnant. �
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- ♦ Do not use if patient has an anatomical vaginal morphology and/or structure that does not permit proper insertion of the probe.
- ◆ Do not use this device in conjunction with electrical muscle stimulation.
- ♦ Do not use if patient is unable or unwilling to use device as directed and indicated.
| Periform® | VerimedElectromyographicPerineometer™ | PerryVaginal™Sensor | |
|---|---|---|---|
| 510(k) number | K913912 | K911190 | |
| Mode of Use | Reusable for a singlepatient | Same. | Same. |
| Parameter monitored | aggregate surfaceelectromyogram | Same. | Same. |
| User feedback | None | None | None |
| Intended Use | To producebiofeedback signalsfor processing by anexternal biofeedbackdevice. | Same. | Same. |
| Indications for Use | Treatment of stressand urge incontinenceand facilitation ofpelvic floor exercises. | Same. | Treatment of stress,urge, and mixedincontinence. |
| PerformanceStandards | Currently no performance standards exist for sEMG biofeedbackperineometric probes. | ||
| Target Population | Adult female urinaryincontinence patients. | Same. | Same. |
| Anatomical Sitesdesignated for use. | Femalepubococcygeusmuscle area. | Same. | Same. |
| Energy used and/ ordelivered. | No energy delivered orused, onlytransported. | Same. | Same. |
| Compatibility withenvironment and otherdevices | Probe is not known toconflict with otherdevices or causeenvironmentalhazards. | Same. | Same. |
| Where used | Hospitals, Clinics,Doctor's offices, orhome use underclinician'ssupervision. | Same. | Same. |
| Sterility | Probe does not needto be sterile.Appropriate cleaningprocedure includedinstructions for use. | Same. | Same. |
| # of Electrode Contacts | 2 | 2 | 3 |
| # of Lead Cables | 2 | 2 | 1 |
| Transducers | None | None | None |
| Body Material | High ImpactPolystyrene, type 564 | Plastic: Cycolac ABS-GPM-5600-4500-FGE | N / A |
| Biocompatibility ofBody Material | Biocompatible | Biocompatible | Biocompatible |
| 91 | |||
| Pelvic FloorContraction Indicator(PFCI) included? | Yes. | No. | No. |
| PFCI Tip and EndMaterial | High ImpactPolystyrene 564 | N/A | N/A |
| PFCI Shaft Material | 'Stamylan' low densitypolyethylene grade2100 TNOO | N/A | N/A |
| Electrode Material | Medical GradeStainless Steel type316S31 | Series 300 PassivatedStainless Steel | Series 300 PassivatedStainless Steel |
| Biocompatibility ofElectrode Material | Biocompatible | Biocompatible | Biocompatible |
| Electrode Orientation | Longitudinal | Circumferential | Longitudinal |
| Construction | 2-piece mold | 3-piece mold | 3-piece mold |
| Sensing Method | sEMG biofeedbackrecording | Same. | Same. |
| Feedback Modes | No direct feedback touser | Same. | Same. |
| Electrical Safety | Device is passive: Notelectrically powered | Same. | Same. |
| Electrodes andConductive Media | Not applicable. | Not applicable. | Not applicable. |
| Intentional ElectricalCurrent | Warning included inInstructions for Use.Socket type preventseasy intentionalconnection to ACsource. | Warning included inInstructions for Use. | Warning included inInstructions for Use. |
| UnintentionalElectrical Current | Probe is to be usedwith appropriatebiofeedback device asstated in Basic DesignDescription, or withPFCI only. | Probe is to be usedwith biofeedbackdevices satisfyingcriteria listed in BasicDesign Description. | Probe is to be usedwith biofeedbackdevices satisfyingcriteria listed in BasicDesign Description. |
| Risk of MechanicalInjury | Risk preventionconsidered in designprocess (Attached). | Risk preventionconsidered in designprocess (Attached). | Unknown. |
| Risk of thermal orRadiation Injury | None: probe does notdirect any form ofelectromagneticenergy or heat. | Same. | Same. |
| Chemical Safety | Body and electrodesconstructed ofchemically inertmaterials. | Same. | Same. |
| Shaft Length | 76 mm | 81 mm | 55.9 mm |
| Shaft Diameter | Not applicable (N/A) | 19.1 mm | 17.8 mm |
| Probe Width | 34 mm | N/A | N/A |
| Basal Bulb Diameter(Comparable toPeriform's FlangeDiameter) | N/A | 63.5 mm | 43.2 mm |
| Flange Diameter | 28.2 mm | N/A | N/A |
| Terminal BulbDiameter | N/A | 31.8 mm | 33.0 mm |
| Terminal Bulb Length | N/A | 22.7 mm | 26.7 mm |
| Electrode SpacingDistance | N/A | 9.5 mm | 11.4 mm |
| Spacing Type | Axial Incremental | Radial Incremental | Axial Incremental |
| CU- | |||
| Electrode Surface Area ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | 4.9 cm² x 2 | .5 cm x 2 | 1.2 cm4 x 3 |
Device Comparison
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Non-Clinical Performance Data
An impedance test was performed to demonstrate that the Periform® is capable of transporting electrical signals with minimal attenuation. Various frequencies were used in order to verify that the Periform® would be effective in the range of frequencies encountered in pelvic floor biofeedback (typically less than 200 Hz). The test shows that the Periform® exhibits the low impedance values (around 10 ohms at all tested frequencies) needed for accurate recording of pelvic floor muscle activity.
Biocompatibility Testing
The materials used in the Periform® have undergone safety tests and were found to be safe according to the required standards for each test. Tests performed and results were as follows:
| MATERIAL | TEST PERFORMED | RESULTS |
|---|---|---|
| Polystyrene type 564.Used in Periform® body. | USP tests for Class VIplastics (Systemic Injection,Intracutaneous Toxicity,Implantation Test) | Meets the requirements ofUSP Class VI Plastic |
| Medical Grade StainlessSteel 316S31.Used for Periform®electrodes. | Standard Item used in themanufacture of medicaldevice to contact humantissue for transient periods(less than 2 hours) | Nontoxic. |
| Polythene.Used in Pelvic FloorContraction Indicator.Not in contact withpatient. | No test performed as thisportion is not intended tocontact the body. | N/A |
Conclusion
The Periform® is safe and effective for its intended use and is substantially equivalent to its predicate devices.
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Image /page/5/Picture/0 description: The image shows a logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of a human figure with three flowing lines representing the body and arms. The text "HUMAN SERVICES USA" is arranged in a circular pattern around the figure, indicating the department's focus on human services within the United States.
DEPARTMENT OF HEALTH & HUMAN SERVICES
NOV 20 1908
Kishore Puppala Product Manger Verimed International, Inc. 11950 N.W. 39th Street, Suite D Coral Springs, Florida 33065
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Re: K981277 Periform® Perineometric Probe Dated: August 28, 1998 Received: August 31, 1998 Regulatory Class: II 21 CFR884.1425/Procode: 85 HIR
Dear Mr. Puppala:
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 devices marketed in interstate commerce prior to May 28, 1976, the ensctment 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). 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 (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 (OS) 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) 594-4613. 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 807.97). Other general 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
Lillian Yin, Ph.D.
Director. Division of Reproductive. Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known): K98 1277
Device Name: Periform® Perineometric Probe
Indications For Use:
Biofeedback/monitoring vaginal probe intended for:
- Treatment of stress, urge, and mixed incontinence. .
- Facilitation in identification of the pubococcygeus muscles. .
- . Strengthening of the pelvic floor muscles through biofeedback-assisted pelvic floor exercises.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Seggern
(Division Sign-Off)
ion Sign-Off) Division of Reproductive, Abdominal, El and Radiological De 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 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).