(118 days)
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:
- Transferable air tight penile seal.
- Constriction device with controllable inward radial pressure.
- Automatic vacuum release.
- Transferring device.
- 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 dysfunctionandto 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 highlightsnovelty elementswhich are presented assuperior performancefeatures 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.
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CONS. Inc
66 Overlook Terrace, suite 2E New York, NY, 10040 Tel. 1-212-927 3275 Fax. 1-212-927 7387
evsum31o
510(k) Summary
NOV - 3 1997
for
ERCO-VAC™
External Penile Rigidity System
Submitter: Dr. Yakov Altshuler, Vice President
Date: July 3, 1997
Trade name - Erco-Vac™
Common name external penile rigidity device
Equivalence is claimed to:
Code of Federal Regulation (CFR) Number:
Product Code:
78 LKY
Unclassified
SECTION 514 SPECIAL CONTROLS
Special Controls under Section 514 of the Act have not been developed for these devices. Reference is made in later sections of this document to voluntary industry standards.
Ercons, Inc. PATENT PENDING Erco-Vac™ CONFIDENTIAL Oct. 1997
{1}------------------------------------------------
DEVICE DESCRIPTION
Intended Use
Erco-Vac™ is used to create an erection in men with erectile dysfunction
Erco-Vactm can be used for patients with following conditions:
Diabetes
Venous leakage
Prostatectomy
Hypertension
保
Psychogenic condition
Impotence due to radiation therapy
Spinal cord injury
CAUTION: Federal Law restricts this device to sale by or on the order of a physician.
Erco-Vac™ CONFIDENTIAL Ercons, Inc. PATENT PENDING Oct. 1997
{2}------------------------------------------------
Structure features
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:
-
- Transferable air tight penile seal.
-
- Constriction device with controllable inward radial pressure.
-
- Automatic vacuum release.
-
- Transferring device.
-
- Vacuum chamber with a domed closed end
{3}------------------------------------------------
Comparison of technological characteristics
-
- Air tight seal.
Predicate devices:
The air tight seal is provided by pressing the open end of the vacuum chamber against the abdomen. To adjust to different penile sizes and to prevent scrotal tissue from sucking in, adapter inserts are needed.
Erco- Vac™:
Transferable air tight penile seal allows adjustment to different penile girth without additional inserts.
2. Constriction devices
Predicate devices:
Constriction device generally comprise ings of elastic rubber with C-shaped handles for removal from erected penis. To provide sufficient inward pressure, one or more of constriction rings with different durometer have to be placed at the edge of an open end of the vacuum chamber. Despite high cost due to a number of expensive molds, there is no way to provide smooth control of the inward pressure, which happens to be excessive and may cause discomfort, numbness, bruises.
Ercons, Inc. PATENT PENDING Erco-Vac ™ CONFIDENTIAL Oct. 1997
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Erco-Vac™:
Constriction device is an elastic ribbon wrapped with multiple turns ("Erco-The user may prearrange desirable inward pressure by Ribbon™"). changing the tension and number of turns during wrapping. It is much easier to mount the Erco-Ribbon on the vacuum chamber than a solid constriction ring. It is also easier to remove it from erected penis.
Other advanced features substantially improve performance of Erco-Vac™:
- Automatic vacuum release.
During simultaneous transfer of penile air tight seal and constricting device the vacuum in the chamber is instantly released as there is no seal between the chamber and the atmosphere.
- Transfering device provides easy slip off of the constriction device and transferable penile seal onto erected penis.
SUMMARY:
Erco-Vac™ has the same intended use as Predicate devices.
Technological differences provide superior performance.
Ercons, Inc. PATENT PENDING Erco-Vac™ CONFIDENTIAL Oct. 1997
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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 3 1997
Yakov Altshuler, Ph.D. Vice President ERCONS, Inc. 66 Overlook Terrace, Suite 2E New York, New York 10040 Re: K972537
ERCO-VACTM External Penile Rigidity System Dated: September 30, 1997 Received: October 2, 1997 Regulatory class: unclassified Product code: 78 LKY
Dear Dr. Altshuler:
We 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, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Reveleting, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 5100k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".
Sincerely vours.
Wiliau Yu
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number K972537 Erco-Vac"" Device Name:
Indications for use:
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
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert D. Nothing
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number [K972537]
Prescription Use (Per 21 CFR 801-109)
OR
Over-The-Counter Use
§ 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.