(82 days)
The Charger is used to cause engorgement of the penis for men that are having difficulty with organic or psychological impotence.
The Charger is used by impotent men to allow them to resume having sexual intercourse. It consists of a clear polycarbonate cylinder used as a vacuum chamber, that fits over the penis, and a vacuum pump with vacuum release trigger to evacuate air from the cylinder. As the air is removed from the chamber the negative pressure allows blood engorgement of the penis. When a sufficient erection occurs for vaginal penetration a Reliant constriction ring (K980567) is slipped over the base of the penis to act as a partial tourniquet retaining the erection. The ring may be worn for a maximum of thirty minutes before it MUST be removed. The kit comes with a set of 4 ring sizes. The pumps' ability to create a vacuum is limited by an automatic vacuum release valve so it cannot exceed the known safe limit of 17 in. Hg. The rings are elastic pharmaceutical quality material. The ring safety removal loops were performance tested for strength.
The provided text describes a 510(k) summary for a medical device called "Charger" (VCD - vacuum constriction device) and its corresponding FDA clearance letter. However, it does not contain information about specific acceptance criteria for device performance, nor details about a study designed to prove the device meets such criteria.
The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Reliant VCD) and confirming safety aspects.
Here's an analysis based on the provided text, highlighting the absence of the requested information:
Key Takeaways from the Text:
- Device Purpose: The Charger is used by impotent men to allow them to resume sexual intercourse.
- Mechanism: It's a vacuum constriction device that creates negative pressure to engorge the penis with blood. A constriction ring retains the erection.
- Safety Features:
- Automatic vacuum release valve limits pressure to a safe limit of 17 in. Hg.
- Constriction rings are made of elastic pharmaceutical quality material.
- Ring safety removal loops were "performance tested for strength." (Details of this "performance test" are not provided).
- All warnings and precautions from the FDA internet address are included.
- Equivalence: The device is deemed substantially equivalent to the Reliant VCD (K980567). This regulatory assessment does not typically require a new, full-scale clinical trial to establish performance against pre-defined acceptance criteria, but rather a demonstration that the new device is as safe and effective as the predicate.
Given this, I cannot fill out the requested table for acceptance criteria and reported device performance, nor can I answer many of the specific questions about a performance study, because the document does not contain this information.
Missing Information/Cannot Answer Based on Provided Text:
- Acceptance Criteria Table: No specific performance metrics (e.g., success rate of achieving erection, duration of erection, user satisfaction scores) or acceptance criteria for those metrics are mentioned.
- Sample Size (Test Set) and Data Provenance: No clinical study involving a "test set" to evaluate device performance is described. The mention of "ring safety removal loops were performance tested for strength" refers to a mechanical test, not a clinical one.
- Number of Experts/Qualifications (Ground Truth): Not applicable, as no clinical study with ground truth established by experts is described.
- Adjudication Method: Not applicable.
- MRMC Comparative Effectiveness Study: No information suggests such a study was performed, or any effect size for human readers improving with AI assistance (which is irrelevant for this non-AI device).
- Standalone Performance Study: No details on a standalone performance study in a clinical setting against specified criteria are provided. The "performance test" of the loops is a partial engineering test, not a full device performance study.
- Type of Ground Truth: Not applicable, as no clinical ground truth is established or discussed.
- Sample Size for Training Set: Not applicable, as this is not an AI/ML device requiring a training set.
- How Ground Truth for Training Set was Established: Not applicable.
What the Text Does Tell Us (Limited Scope):
The provided text describes a 510(k) premarket notification which focuses on demonstrating substantial equivalence to a previously legally marketed device (Reliant VCD). This regulatory pathway generally relies on demonstrating that the new device has the same intended use, technological characteristics, and safety/effectiveness profile as the predicate device, rather than requiring a detailed clinical performance study with predefined acceptance criteria.
The only "performance test" mentioned is for the "ring safety removal loops for strength," which is a device component's mechanical integrity test, not a study of the overall clinical performance of the VCD system in achieving erections in patients. The text states the pump could not exceed 17 in. Hg., which is a safety limit, not a performance criterion for efficacy.
§ 876.5020 External penile rigidity devices.
(a)
Identification. External penile rigidity devices are devices intended to create or maintain sufficient penile rigidity for sexual intercourse. External penile rigidity devices include vacuum pumps, constriction rings, and penile splints which are mechanical, powered, or pneumatic devices.(b)
Classification. Class II (special controls). The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: External Penile Rigidity Devices.” See § 876.1(e) for the availability of this guidance document.