(160 days)
HPM-6000UF is intended to provide entirely non-invasive electromagnetic stimulation of pelvic floor musculature for the purpose of rehabilitation of weak pelvic muscles and restoration of neuromuscular control for the treatment of male and female urinary incontinence.
The HPM-6000UF is a non-invasive therapeutic device. The device produces electromagnetic field that interacts with the tissues of the human body. The electromagnetic field delivered in the muscular or neuronal tissue area is triggering the stimulation and tonisation.
The HPM-6000UF is equipped with a color touch screen with wide view angle that significantly facilitates the use of the device. The on-screen information guides the user stepby-step through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen, buttons and knob on the device. During the therapy the device keeps information about the applied therapy type, remaining therapy time and main therapy parameters on the screen.
The HPM-6000UF device and its predicates are comprised of a system console and applicator. The system consists of the electromagnetic field generators, computer, and the touch-screen control panel. Applicator Chair is designed for non-invasive therapy of urinal incontinence. The coil is located in the middle of the seat and air cooled. Running therapy is indicated by illuminated segments in armrests. For precise patient positioning prior to the therapy, the seat height can be electronically adjusted by a remote control.
This document, K181497, is a 510(k) summary for the HPM-6000UF device, a non-invasive electromagnetic stimulator for pelvic floor muscles, intended for the treatment of male and female urinary incontinence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Key Takeaway: The provided document is a 510(k) summary for premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a standalone clinical trial that defines and meets specific acceptance criteria for performance. The "clinical testing" mentioned is specifically to address temperature safety in males for an expanded indication, and not for efficacy.
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) clearance process for this device (HPM-6000UF) is based on demonstrating substantial equivalence to a predicate device, not on meeting predefined performance acceptance criteria (like sensitivity, specificity, accuracy for a diagnostic device) through a comparative study against a ground truth.
Therefore, a table of acceptance criteria and reported device performance in the context of clinical efficacy is not directly provided or the primary focus of this submission. The "performance" demonstrated for clearance is primarily about safety and equivalent technological characteristics and intended use compared to the predicates.
The closest thing to a "performance" metric related to a study is the thermal safety for male subjects:
| Acceptance Criteria (Implied for expanded indication) | Reported Device Performance |
|---|---|
| Safety regarding scrotal surface temperature in males | No meaningful rise in scrotal surface temperature during treatment (Page 5) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document states: "In order to demonstrate safety of the HPM-6000UF in the treatment of males (specifically, thermal safety to the testes), a clinical study has been conducted." However, the sample size for this clinical study is NOT specified in the provided text.
- Data Provenance: The document does not explicitly state the country of origin or whether the study was retrospective or prospective. Given it's a "clinical study conducted" for safety, it would typically be a prospective study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- This information is not applicable in the traditional sense for this 510(k) submission. The clinical study mentioned was for thermal safety demonstration, not for establishing a ground truth for efficacy using expert consensus. The "ground truth" for safety would be measured physiological parameters (temperature).
4. Adjudication Method for the Test Set
- This information is not applicable as the clinical study described is for thermal safety, not for evaluating device performance against an adjudicated ground truth for efficacy.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done according to the provided information. This type of study is more common for diagnostic imaging devices where human readers interpret images with and without AI assistance. The HPM-6000UF is a therapeutic device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
- This concept is not applicable to the HPM-6000UF. This device is a physical instrument for therapeutic use, not a diagnostic algorithm. Its "performance" is its ability to deliver the electromagnetic field and achieve neuromuscular stimulation for the stated indication. The closest "standalone" performance would be its technical specifications and safety profile, which are covered by non-clinical testing and the thermal safety study.
7. Type of Ground Truth Used
- The "ground truth" for the single clinical study mentioned was physiological measurement (scrotal surface temperature) to demonstrate thermal safety.
- For the overall substantial equivalence claim, the "ground truth" is effectively the performance and safety profile of the legally marketed predicate devices. The new device (HPM-6000UF) is asserted to be "identical in design" to its primary predicate (HPM-6000U) with the only difference being an expanded indication for use to include males, which prompted the specific thermal safety study.
8. Sample Size for the Training Set
- This device is not an AI/ML algorithm that requires a "training set" in the computational sense. The "HPM-6000UF is identical in design to the HPM-6000U predicate." The design and engineering would be based on established principles and the prior device's development, not a data-driven training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable as there is no "training set" for an AI/ML algorithm in this context.
Summary of Device Performance and Equivalence Claim:
The HPM-6000UF's acceptance for market is based on its substantial equivalence to the HPM-6000U and InToneMV predicate devices. The key arguments for equivalence are:
- Identical Design to Primary Predicate: The HPM-6000UF is stated to be "identical in design to the HPM-6000U predicate."
- Expanded Indications Addressed: The only difference from the HPM-6000U is the expansion of the indication to include males.
- Clinical Study for Safety (Males): A specific clinical study was conducted only to address the safety concern of thermal effects on male testes when expanding the indication. This study concluded there was "no meaningful rise in scrotal surface temperature."
- Similar Principle of Action: While the HPM-6000UF uses a magnetic field and InToneMV uses direct current, both lead to "induction of electrical stimulus in the neuromuscular tissue resulting in the muscle contraction."
- No New Safety/Effectiveness Questions: The technological differences are asserted not to "raise any new types of safety or effectiveness questions."
In essence, the device's "performance" for regulatory purposes in this 510(k) is primarily its demonstrated safety for the expanded indication and its technological and intended use similarity to already cleared devices. It is not presenting novel efficacy data in a comparative trial setting against a clinical "ground truth."
§ 876.5320 Nonimplanted electrical continence device.
(a)
Identification. A nonimplanted electrical continence device is a device that consists of a pair of electrodes on a plug or a pessary that are connected by an electrical cable to a battery-powered pulse source. The plug or pessary is inserted into the rectum or into the vagina and used to stimulate the muscles of the pelvic floor to maintain urinary or fecal continence. When necessary, the plug or pessary may be removed by the user. This device excludes an AC-powered nonimplanted electrical continence device and the powered vaginal muscle stimulator for therapeutic use (§ 884.5940).(b)
Classification. Class II (performance standards).