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510(k) Data Aggregation
(294 days)
The malleable penile prosthesis is indicated for implantation into the corpora cavernosa of the penis in men who are diagnosed with erectile dysfunction. The prosthesis is implanted to provide adequate penile rigidity for sexual intercourse. The prosthesis is designed for the treatment of organic erectile dysfunction in men due to:
Pelvic fracture, Spinal cord injury or disease, Prostatectomy,Multiple sclerosis, Diabetes
mellitus, Arteriosclerosis, Hypertensive vascular disease, Priapism, Peyronie's disease, Selectively for psychogenic impotence.
Rigi10 malleable penile prosthesis is a sterile, non-pyrogenic, single-use surgical implant.
The device core consists of a malleable stainless-steel core, with titanium caps on both ends, and a PTFE (Polytetrafluoroethylene) tube cover. The entire outside surface of the cylinder is made out of silicone. The malleable stainlesssteel core enables the prosthesis to be moved into an erect position when desired and also enables the concealment of the prosthesis under clothing. All components consist of implantable, biocompatible materials.
The device consists of two cylinders, and extenders. The cylinders are surgically implanted, one into each corpus cavernosum, to provide penile rigidity.
The prosthesis comes in two lengths. This includes 23 cm and 25 cm. The length is determined by the diameter of the prosthesis. Rigi10 Malleable Penile Prosthesis is available in five different diameter sizes; 9 mm, 10 mm, 11 mm, 12 mm, and 13 mm. Cylinders with 9 mm and 10 mm diameters are available in 23 cm length while cylinders with 11mm, 12 mm and 13 mm diameters are available in 25 cm length. There are four extenders (two pieces of 0.5 cm and two pieces of 1.0 cm) included in each product package. The extenders are accessories of the device and are available for adjusting the length of the prosthesis to match the total corporal measurement of the patient.
The document describes the acceptance criteria and the study conducted for the Rigi10 Malleable Penile Prosthesis.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Type | Acceptance Criteria (Established Prior to Testing) | Reported Device Performance |
|---|---|---|
| Biocompatibility Tests | Adherence to ISO 10993-1 "Biological evaluation of medical devices" guideline. | Device met all biocompatibility test specifications. |
| In Vitro Cytotoxicity | Not explicitly stated, but implied to meet ISO 10993-1 requirements. | Met specifications. |
| Skin Sensitization | Not explicitly stated, but implied to meet ISO 10993-1 requirements. | Met specifications. |
| Intracutaneous Reactivity | Not explicitly stated, but implied to meet ISO 10993-1 requirements. | Met specifications. |
| Acute Systemic Toxicity | Not explicitly stated, but implied to meet ISO 10993-1 requirements. | Met specifications. |
| Pyrogen | Not explicitly stated, but implied to meet ISO 10993-1 requirements. | Met specifications. |
| Bacterial Endotoxin | Not explicitly stated, but implied to meet ISO 10993-1 requirements. | Met specifications. |
| Implantation | Not explicitly stated, but implied to meet ISO 10993-1 requirements. | Met specifications. |
| Chemical Characterization | Not explicitly stated, but implied to meet ISO 10993-1 requirements. | Met specifications. |
| Toxicological Risk Assessment | Not explicitly stated, but implied to meet ISO 10993-1 requirements. | Met specifications. |
| Rabbit Blood Hemolysis | Not explicitly stated, but implied to meet ISO 10993-1 requirements. | Met specifications. |
| Bench Performance Tests | Adherence to "Guidance for the Content of Premarket Notifications for Penile Rigidity Implants" January 16, 2000. Demonstrate statistically significant substantial equivalence to the predicate device. | Device met all performance test specifications and passed all tests. |
| Simulated Life/Fatigue | Not explicitly stated, but acceptance criterion established prior to testing for substantial equivalence. | Met acceptance criteria. |
| Positioning/Concealability | Not explicitly stated, but acceptance criterion established prior to testing for substantial equivalence. | Met acceptance criteria. |
| Buckling | Not explicitly stated, but acceptance criterion established prior to testing for substantial equivalence. | Met acceptance criteria. |
| Tip Extender Joint Strength | Not explicitly stated, but acceptance criterion established prior to testing for substantial equivalence. | Met acceptance criteria. |
| Sterilization | Validated for ethylene oxide sterilization. | Validated for ethylene oxide sterilization. |
2. Sample Size for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for the biocompatibility or bench performance tests. However, it indicates that the tests were conducted in accordance with recognized standards (ISO 10993-1 for biocompatibility and FDA guidance for penile rigidity implants for bench tests). The data provenance is laboratory testing conducted by Rigicon, Inc. or their designated testing facilities. It does not mention any human patient data for the purpose of primary device evaluation, as a clinical study was not conducted.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable as the studies described are bench (laboratory) and biocompatibility tests, not clinical studies involving human experts to establish ground truth on patient outcomes or diagnoses. The "ground truth" for these tests are the established specifications within the relevant ISO standards and FDA guidance documents.
4. Adjudication Method for the Test Set:
Not applicable. As described above, these were laboratory tests against established physical/chemical/biological specifications, not human expert adjudication of clinical findings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance:
Not applicable. The document describes a medical device (penile prosthesis), not an AI-powered diagnostic or assistive technology that would involve human readers or MRMC studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
Not applicable. This device is a physical medical implant, not an algorithm or software.
7. The Type of Ground Truth Used:
The ground truth for the biocompatibility tests was established by the specifications and methodologies outlined in ISO 10993-1 "Biological evaluation of medical devices" guideline.
The ground truth for the bench performance tests was established by the specifications and methodologies outlined in the "Guidance for the Content of Premarket Notifications for Penile Rigidity Implants" January 16, 2000, and the need to demonstrate "statistically significant substantial equivalence to the predicate device."
8. The Sample Size for the Training Set:
Not applicable. This device is not an AI/machine learning model, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set for this device.
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