(146 days)
HPM-6000U 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 urinary incontinence in women.
The HPM-6000U 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-6000U 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 step-by-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 provided document is a 510(k) Premarket Notification for the HPM-6000U device, which is an electromagnetic stimulator for treating urinary incontinence in women. The document explicitly states that the substantial equivalence determination for the HPM-6000U is NOT based on clinical testing. Instead, its safety and efficacy were demonstrated by comparing its technical characteristics with a predicate device, the Neotonus Model 1000 Muscle Stimulator System (K973096).
Therefore, there is no study described in this document that proves the device meets specific acceptance criteria related to its clinical performance (e.g., sensitivity, specificity, accuracy) using a test set against a ground truth.
However, the document does contain information about non-clinical testing for compliance with safety standards and a comparison table of technical specifications between the HPM-6000U and the predicate device, which serves as the basis for its substantial equivalence claim.
Given the information provided in the document:
1. A table of acceptance criteria and the reported device performance:
Since no clinical efficacy study with specific performance acceptance criteria is detailed, the "acceptance criteria" here relate to technical specifications and safety standards compliance.
| Acceptance Criteria (Technical/Safety Standard) | Reported Device Performance (HPM-6000U) |
|---|---|
| Technical Specifications (Compared to Predicate Device) | |
| Primary Function: Stimulation of pelvic floor musculature | Stimulation of pelvic floor musculature |
| Principle of Action: Initiating action potential of nerves results in muscle contraction | Initiating action potential of nerves results in muscle contraction |
| Type of Energy: Magnetic field | Magnetic field |
| Energy Source | 100 - 240 V AC, 50 - 60 Hz, max 14 A |
| Type of Coil: Single magnetic coil | Single magnetic coil |
| Number of Magnetic Coils in the Applicator: 1 | 1 |
| Type of Applicator: Chair | Chair |
| Number of Applicators: 1 | 1 |
| Patient Position during Therapy: Sitting position | Sitting position |
| Position of Coil: Center of applicator seat | Center of applicator seat |
| Type of Operation: Continuous | Continuous |
| Magnetic Field Intensity | 0.7 - 2.5 T |
| Pulse Repetition Rate | 1 - 150 Hz |
| Step of Frequency Setting: 1 Hz | 1 Hz |
| Pulse Duration | 280 μs (± 20%) |
| Pulse Amplitude | 0 – 100 % |
| Shape of Stimulation Pulse: Sine, biphasic | Sine, biphasic |
| Therapy Time: 30 min | 30 min |
| Operating Temperature | +10 to +30 °C (50 - 86 °F) |
| Interface: Touch-screen | Touch-screen |
| Firmware controlled: Yes | Yes |
| Environmental Specifications: For indoor use only | For indoor use only |
| Clinical Use: Prescription Use | Prescription Use |
| External Exchangeable Fuse: Yes | Yes |
| Main Unit Dimensions: 500x970x580 mm (20x38x23 in) | 500x970x580 mm (20x38x23 in) |
| Applicator Dimensions: 730x730x730 mm (29x29x29 in) | 730x730x730 mm (29x29x29 in) |
| System Weight | 46 kg (101 lb) |
| Position: Vertical - On castors | Vertical - On castors |
| Electrical Protection | Class II, BF |
| Compliance with Safety Standards | |
| ISO 14971 (Risk Management) | Compliant |
| IEC 62304 (Software Life Cycle Processes) | Compliant |
| IEC 60601-1 (Basic Safety and Essential Performance) | Compliant |
| IEC 60601-1-2 (EMC Requirements and Tests) | Compliant |
| IEC 60601-1-6 (Usability) | Compliant |
| ISO 10993-1 (Biological Evaluation) | Compliant |
| ISO 10993-5 (In vitro Cytotoxicity) | Compliant |
| ISO 10993-10 (Irritation and Skin Sensitization) | Compliant |
2. Sample size used for the test set and the data provenance:
- Not applicable. No clinical test set data is provided as clinical testing was not performed for substantial equivalence. The comparison is based on the technical specifications of the device and its predicate.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No clinical test set or ground truth established by experts is described.
4. Adjudication method for the test set:
- Not applicable.
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. This device is a therapeutic device, not an AI-assisted diagnostic tool for human readers. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. The device is a physical therapeutic device, not an algorithm. Its performance is based on its physical/electromagnetic output, not an algorithm's classification or detection capabilities.
7. The type of ground truth used:
- Not applicable. For the substantial equivalence, the "ground truth" is implied to be the established safety and effectiveness of the legally marketed predicate device, as demonstrated through its technical specifications and intended use.
8. The sample size for the training set:
- Not applicable. No training set for an algorithm is mentioned as this is a physical medical device.
9. How the ground truth for the training set was established:
- Not applicable.
§ 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).