ERCO-VAC

K972537 · Ercons, Inc. · LKY · Nov 3, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K972537
• Device Name: ERCO-VAC
• Applicant: Ercons, Inc.
• Product Code: LKY · Gastroenterology, Urology
• Decision Date: Nov 3, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5020
• Device Class: Class 2
• Attributes: Therapeutic

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 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.

Device Story

External penile rigidity system; uses vacuum chamber to induce blood engorgement in penis; constriction device (elastic ribbon) applied to base to sustain erection. Device features transferable air-tight seal, adjustable radial pressure ribbon, automatic vacuum release, and domed chamber. Used by patients at home; physician-prescribed. Replaces traditional solid constriction rings with adjustable ribbon to prevent excessive pressure, bruising, or numbness. Benefits include non-invasive, instant results for erectile dysfunction management.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Vacuum chamber with domed closed end; elastic ribbon constriction device; transferable air-tight penile seal. Operates via manual vacuum application. No electronic or software components. Materials include elastic rubber for constriction ribbon.

Indications for Use

Indicated for men with erectile dysfunction, including those with diabetes, venous leakage, post-prostatectomy, hypertension, psychogenic conditions, radiation-induced impotence, or spinal cord injury.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Erercaid Osbon Medical Systems, Ltd. (K841257)
• VED Mission Pharmacal Co. (K901223)
• Pos-T-Vac POS-T-VAC (K960828, K960342)

Submission Summary (Full Text)

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CONS. Inc

66 Overlook Terrace, suite 2E New York, NY, 10040 Tel. [phone] Fax. [phone]

K972537

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:

- 1. Erercaid Osbon Medical Systems, Ltd. K841257
- 2. VED Mission Pharmacal Co. K901223
- 3. Pos-T-Vac POS-T-VAC K960828, K960342

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

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## 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

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## 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:

- 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

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# Comparison of technological characteristics

- 1. 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™:

3. 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.

4. 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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