ERCO-VAC

K981357 · Ercons, Inc. · LKY · Nov 24, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K981357
• Device Name: ERCO-VAC
• Applicant: Ercons, Inc.
• Product Code: LKY · Gastroenterology, Urology
• Decision Date: Nov 24, 1998
• 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-Vac™ can be used for patients with following conditions: Diabetes Venous leakage Prostatectomy Hypertension Psychogenic impotence Impotence due to radiation therapy Spinal cord injury

Device Story

Erco-Vac™ is an external penile rigidity system for men with erectile dysfunction. The device consists of a vacuum chamber with a domed end, a transferable air-tight penile seal, and a constriction device (Erco-Ribbon™). Operation involves placing the vacuum chamber over the penis to create a vacuum, which induces blood inflow and engorgement. The user then transfers the constriction device—an elastic ribbon with adjustable tension—to the base of the penis to maintain the erection by restricting blood outflow. The system features an automatic vacuum release mechanism that triggers when the seal and constriction device are transferred. The device is intended for patient self-use. It provides a non-invasive alternative to sex therapy, injections, surgery, or implants, aiming to facilitate intercourse by sustaining an erection.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

System comprises a vacuum chamber with a domed closed end, a transferable air-tight penile seal, and an elastic ribbon (Erco-Ribbon™) for constriction. The constriction mechanism allows for adjustable inward radial pressure based on tension and number of wraps. The device is a manual, non-powered system. No specific materials or ASTM standards are cited.

Indications for Use

Indicated for men with erectile dysfunction, including those with diabetes, venous leakage, post-prostatectomy, hypertension, psychogenic impotence, 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 (K841257)
• VED (K901223)
• Pos-T-Vac POS-T-VAC (K960828, K960342)

Submission Summary (Full Text)

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NOV 2 4 1998

K98/1357

144

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

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# 510(k) SUMMARY for ERCO-VAC™

External Penile Rigidity System

Submitter: Dr. Yakov Altshuler, Vice President Date: April 7, 1998 Trade name - Erco-VacTM 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: Unclassified Product Code: 78 LKY

## 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™ Apr. 1998

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K981357
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### DEVICE DESCRIPTION

#### Intended Use

Erco-Vac™ is used to create an erection in men with erectile dysfunction

Erco-Vac™ can be used by patients with following conditions:

## Diabetes

Venous leakage Prostatectomy Hypertension Psychogenic impotence Impotence due to radiation therapy Spinal cord injury

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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.

PATENT PENDING Erco-Vac™ Ercons, Inc. Apr. 1998

2

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K981357
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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 releas
- 4. Transferring device

5.Vacuum chamber with a domed closed end

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 rings 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™ Apr. 1998

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K981357
414

Erco-Vac™ :

Constriction device is an elastic ribbon wrapped with multiple turns (Erco-Ribbon™). The user may prearrange desirable inward pressure by 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. Transferring 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™

**Erco-Vac**™

C= Apr. 1998

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Image /page/4/Picture/2 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" around the border. Inside the circle is a symbol consisting of three stylized human figures with their arms raised, resembling a bird in flight. The seal is black and white and appears to be a logo or emblem.

13588 NOV 24

Yakov Altshuler, Ph.D. Vice President Ercons, Inc. 66 Overlook Terrace, Suite 2E New York, NY 10040

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Re: K981357 Erco - Vac™ - OTC Dated: September 24, 1998 Received: September 25, 1998 Regulatory Class: Unclassified Unclassified/Procode: LKY 78

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 the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cometic Act (Act). You may, therefore, market the device, 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 practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) 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/cdrb/dsmaln.html".

Sincerely you

Lillian Yin, Ph.D.

Director, Division of Reproducti Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number 981357 Page 1 of 1

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Device Name:

Erco-Vac tm

Indications for use: ▲ #

Erco-Vac tril is used to create an erection in men with erectile dysfunction. Erco-Vac tm can be used for patients with following conditions:

Diabetes Venous leakage Prostatectomy Hypertension Psychogenic impotence Impotence due to radiation therapy Spinal cord injury

Concurrence of CDRH, Office of Device Evaluation (ODE) ﺮ .
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| Prescription Use | OR | Over-The-Counter Use |
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(Per 21 CFR 801-109)

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT,

and Radiological Devices

| 510(k) Number | K981357 |
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|---------------|---------|