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Found 11 results
510(k) Data Aggregation
(69 days)
The intended use of the device is to assist users by supporting the penis during intimacy. Used by men with the inability to achieve vaginal penetration, due to a flaccid or partially erect penis.
Support Sleeve
This document is a 510(k) clearance letter from the FDA for a device called "Support Sleeve." It does not contain information about acceptance criteria or a study proving the device meets said criteria.
The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..." This means the device was cleared based on its substantial equivalence to an existing device, not on new performance data against specific acceptance criteria.
Therefore, I cannot provide the requested information from the provided text.
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(77 days)
The intended use of the device is to assist users in achieving a full erection, i.e., to create an erection in men with Erectile dysfunction by means of an applied vacuum to the penis, which draws blood to the penile corpora cavernosa, causing the penis to become erect and rigid. The constriction bands are then placed around the base of the erect penis to restrict the flow of venous blood leaving the penis.
Not Found
This is a 510(k) premarket notification for the VT-1 Vacuum Erection Device. The provided text is a letter from the FDA to the manufacturer, confirming that the device is substantially equivalent to legally marketed predicate devices. It does not contain information about acceptance criteria or a study proving the device meets them.
Therefore, I cannot answer your request based on the provided text. To answer your questions, I would need a document that describes the clinical or performance study conducted for this device, including details about its methodology, results, and acceptance criteria.
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(88 days)
The intended use of the device is to assist users in achieving a full erection, i.e., to create an erection in men with Erectile dysfunction by means of an applied vacuum to the penis, which draws blood to the penile corpora cavernosa, causing the penis to become erect and rigid. The constriction bands are then placed around the base of the erect penis to restrict the flow of venous blood leaving the penis.
Not Found
The provided document is a 510(k) premarket notification approval letter for the "Boss-2000-2 Vacuum Erection Device." It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.
This letter primarily focuses on the regulatory determination of substantial equivalence to a legally marketed predicate device, allowing the manufacturer to market the device. It outlines general regulations and responsibilities but does not detail performance data, study designs, or acceptance metrics.
Therefore, I cannot provide the requested information based on the given input text.
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(88 days)
The intended use of the device is to assist users in achieving a full erection, i.e., to create an erection in men with Erectile dysfunction by means of an applied vacuum to the penis, which draws blood to the penile corpora cavernosa, causing the penis to become erect and rigid. The constriction bands are then placed around the base of the erect penis to restrict the flow of venous blood leaving the penis.
Not Found
This document package is a 510(k) premarket notification decision letter from the FDA regarding a vacuum erection device. It does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The letter primarily states that the device, named "Boss-2000-3 Vacuum Erection Device (Over-the-Counter Use)", is substantially equivalent to legally marketed predicate devices and can therefore be marketed.
Therefore, I cannot provide the requested information.
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(47 days)
The intended use of the device is to assist users in achieving a full erection, i.e., to create an erection in men with erectile dysfunction by means of an applied vacuum to the penis, which draws blood to the penile corpora cavernosa, causing the penis to become erect and rigid. The constriction bands are then placed around the base of the erect penis to restrict the flow of venous blood leaving the penis.
Not Found
The provided document is a 510(k) clearance letter from the FDA for the POS-T-VAC (AVP-1000) Vacuum Erection Device. It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
The 510(k) process is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predicate device, and does not require clinical studies in all cases, especially for well-established device types like vacuum erection devices.
Therefore, I cannot provide the requested information from the given text. The document focuses on regulatory clearance, not detailed performance studies or their associated acceptance criteria.
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(47 days)
The intended use of the device is to assist users in achieving a full erection, i.e., to create an erection in men with erectile dysfunction by means of an applied vacuum to the penis, which draws blood to the penile corpora cavernosa, causing the penis to become erect and rigid. The constriction bands are then placed around the base of the erect penis to restrict the flow of venous blood leaving the penis.
Not Found
I am sorry, but based on the provided text, there is no information available regarding the acceptance criteria for the POS-T-VAC (IVP-600) Vacuum Erection Device or any studies conducted to prove it meets such criteria.
The document is a 510(k) clearance letter from the FDA, indicating that the device has been found substantially equivalent to a legally marketed predicate device. This letter primarily focuses on the regulatory authorization to market the device and its indications for use. It does not contain detailed performance data, study designs, sample sizes, expert qualifications, or ground truth establishment relevant to the questions asked.
Therefore, I cannot provide the requested table or answer the specific questions about the study design, ground truth, or expert involvement based solely on this document.
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(149 days)
All four sets of constriction rings, the Rejoyn Constriction Ring Kit, B-100, B-25, and B-10, are used to maintain penile rigidity in men with erectile dysfunction by restricting penile venous outflow after the patient has obtained an erection (either with the aid of a vacuum pump, or naturally). The constriction band is placed around the base of the erect penis to restrict the flow of venous blood leaving the penis.
Not Found
The provided documents are a 510(k) clearance letter and an "Indications for Use" statement for the Rejoyn, B-100, B-25, and B-10 Constriction Ring Kits. These documents confirm that the devices have received market clearance based on substantial equivalence to predicate devices, but they do not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.
Therefore, I cannot provide the requested information. The documents are purely regulatory approval notices and do not detail any performance evaluation studies.
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(163 days)
The intended use of the Rejoyn Vacuum Erection Device is to assist users in achieving a full erection, i.e., to create an erection in men with erectile dysfunction by means of an applied vacuum to the penis, which draws blood to the penile corpora cavernosa, causing the penis to become erect and rigid. The constriction bands are then placed around the base of the erect penis to restrict the flow of venous blood leaving the penis.
Not Found
I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving that a device meets such criteria. The document is a letter from the FDA regarding a 510(k) submission for the "Rejoyn Vacuum Erection Device." It addresses the substantial equivalence of the device and its indications for use but does not include performance data, study results, or ground truth establishment.
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(67 days)
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(8 days)
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