Search Results

Erco-Vac™ is used to maintain penile rigidity in men with erectile dysfunction.

Erco-Vact can be used for patients with following conditions:

Diabetes

Venous leakage

Prostatectomy

Hypertension

Psychogenic condition

Impotence due to radiation therapy

Spinal cord injury

Erco-Vac™ is based on the same scientific concept as known marketable vacuum constriction devices. Vacuum applied to penis causes blood inflow, engorgement and state of erection. Constriction device preliminary installed on the edge of vacuum chamber is forced to slip off on the root of the penis. By hindering blood outflow, constriction device sustains erection and makes intercourse possible.

After releasing of vacuum and vacuum chamber removal, the user is ready to intercourse.

Vacuum constriction treatment is now recognized as the first line remedy, preferable to other treatments of erection dysfunction - sex therapy, self injections, venous and arterial surgery, implantation of penile prosthesis. It is noninvasive, provides instant results and is applicable to almost all kinds of impotence as well as for augmenting male potency.

At the same time, known marketable devices have deficiencies and drawbacks which make them unacceptable to many potential users.

Erco-Vac™ was developed with the goal to overcome known deficiencies and limitations of vacuum constriction devices. Novelty elements, introduced into the system's structure are listed below:

1. Transferable air tight penile seal.
2. Constriction device with controllable inward radial pressure.
3. Automatic vacuum release.
4. Transferring device.
5. Vacuum chamber with a domed closed end

The provided text is a 510(k) Summary for the ERCO-VAC™ External Penile Rigidity System, dated July 3, 1997. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with defined acceptance criteria and studies as one might find for a PMA or de novo submission in contemporary regulatory contexts.

Therefore, the document does not contain a table of acceptance criteria or a study proving the device meets acceptance criteria in the manner one would typically expect for a device seeking a more rigorous approval. The goal of a 510(k) is to show the new device is "substantially equivalent" to an existing predicate device, meaning it has the same intended use and either the same technological characteristics or, if different, that the differences do not raise new questions of safety and effectiveness.

Here's an analysis based on the provided text, highlighting what information is available and what is not available within the scope of your request:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not available in the provided 510(k) summary. A 510(k) submission generally does not include specific acceptance criteria for performance endpoints or a detailed report of a study designed to meet those criteria. The submission focuses on comparing the new device's technological characteristics and intended use to predicate devices to demonstrate substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

This information is not available. The document makes no mention of a "test set" for performance evaluation, nor does it describe sample sizes or data provenance (country of origin, retrospective/prospective). The submission relies on a comparison of technological characteristics to predicate devices.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not available. There is no mention of experts establishing ground truth for a test set.

4. Adjudication Method for the Test Set

This information is not available. No test set or adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

This information is not available. The document does not describe any MRMC study or any study comparing human reader performance with or without AI assistance. The device is a physical medical device, not an AI diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This information is not available. The device is a physical medical device for erectile dysfunction, not an algorithm, so a standalone performance study in this context is not applicable.

7. The Type of Ground Truth Used

This information is not available. As there is no described performance study or test set, there is no mention of how ground truth would be established (e.g., expert consensus, pathology, outcomes data).

8. The Sample Size for the Training Set

This information is not available. The document does not describe any "training set" as it is not a machine learning or AI-based device.

9. How the Ground Truth for the Training Set was Established

This information is not available. As there is no training set mentioned, there is no information on how its ground truth would be established.

Summary of Approach in K972537:

The ERCO-VAC™ 510(k) submission primarily focuses on demonstrating substantial equivalence to predicate devices. This is achieved by:

• Stating the Intended Use: The device's intended use (to create an erection in men with erectile dysfunction and to maintain penile rigidity in men with erectile dysfunction) is stated and confirmed to be the same as predicate devices.
• Comparing Technological Characteristics: The document details how ERCO-VAC™ is based on the same scientific concept as known marketable vacuum constriction devices. It then highlights novelty elements which are presented as superior performance features over predicate devices, such as:
  • Transferable air-tight penile seal (vs. predicate devices requiring adapter inserts).
  • Constriction device with controllable inward radial pressure ("Erco-Ribbon™") (vs. predicate devices using rings with fixed pressure).
  • Automatic vacuum release.
  • Transferring device.
  • Vacuum chamber with a domed closed end.
• Claiming Equivalence to Specific Predicate Devices: The submission explicitly lists three predicate devices (Eréricaid K841257, VED K901223, Pos-T-Vac K960828, K960342) to which equivalence is claimed.

The FDA's letter (Section {5}) confirms that they have "reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..." This approval is based on the comparison provided in the submission and not on a clinical trial with pre-defined acceptance criteria.

Ask a specific question about this device