ERCO-RIBBON

K972353 · Ercons, Inc. · LKY · Oct 28, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K972353
• Device Name: ERCO-RIBBON
• Applicant: Ercons, Inc.
• Product Code: LKY · Gastroenterology, Urology
• Decision Date: Oct 28, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Erco-Ribbon™ is 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). Erco-Ribbon can be used for patients with following conditions: a) separately: premature ejaculation firm but short lasting erection b) as a part of a vacuum constriction system Diabetes Venous leakage Prostatectorny Hypertension Psychogenic condition Radiation therapy Spinal cord injury

Device Story

Erco-Ribbon is a penile constriction device consisting of an elastic silicone ribbon with a rectangular cross-section and a belt with a release loop. It is used by patients to maintain penile rigidity by restricting venous outflow. The device is applied by wrapping the ribbon multiple times around the base of the penis or a vacuum chamber; tension is adjusted by the user during wrapping. The release loop allows for quick removal. Unlike traditional solid rubber rings that require cone-shaped applicators and fixed sizing, the Erco-Ribbon offers adjustable pressure through variable tension and number of turns. It is intended for use in clinical or home settings to assist in managing erectile dysfunction and related conditions. The device provides a mechanical alternative to standard constriction rings, aiming to reduce discomfort, numbness, and bruising associated with excessive or uneven pressure.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Device consists of elastic, soft silicone ribbon with rectangular cross-section and acrylic mounting tube. Operates via mechanical constriction; tension is manually adjusted by the user through multiple wraps. No energy source or software components. Materials conform to FDA regulations for skin-contacting devices.

Indications for Use

Indicated for men with erectile dysfunction, premature ejaculation, or firm but short-lasting erections. Applicable to patients with diabetes, venous leakage, post-prostatectomy, hypertension, psychogenic conditions, radiation therapy history, or spinal cord injury. Used independently or as part of a vacuum constriction system.

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

• ErecAid (K841257)
• Revive (K844445)
• Confidence (K891125)
• VED (K901223)
• VET (K902240)
• Pos-T-Vac (K960828)

Submission Summary (Full Text)

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ERCONS, Inc.

•••

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

Ka72353

# ersum16s

#### 510(k) SUMMARY

for

OCT 2 8 1997

# ERCO-RIBBON™

Constriction Device for External Penile Rigidity System

Submitter: Dr. Yakov Altshuler, Vice President

Date: July 3, 1997

Trade name - Erco-Ribbon™

Common name - constriction device for external penille rigidity system

Equivalence is claimed to:

| 1. ErecAid | Osbon Medical Systems, Ltd. | K841257 | |
|------------------------------------------|-----------------------------|---------|--------------|
| 2. Revive | Revive System Corp. | K844445 | |
| 3. Confidence | Performance, Inc. | K891125 | |
| 4. VED | Mission Pharmacal Co. | K901223 | |
| 5. VET | VET-CO, Inc. | K902240 | |
| 3. Pos-T-Vac | POS-T-VAC | K960828 | |
| Code of Federal Regulation (CFR) Number: | | | Unclassified |
| Product Code: | | | 78 LKY |

Ercons, Inc.

PATENT PENDING

Erco-Ribbon™

CONFIDENTIAL

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## Intended Use

Erco-Ribbon™ is 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).

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

a) separately:

premature ejaculation

firm but short lasting erection

b) as a part of a vacuum constriction system

Diabetes

Venous leakage

Prostatectorny

Hypertension

Psychogenic condition

Radiation therapy

Spinal cord injury

Ercons, Inc.

PATENT PENDING

Erco-Ribbon™

CONFIDENTIAL

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#### DESCRIPTION

A constriction ribbon is made of elastic and soft silicone with generally rectangular cross section. A belt with release loop is used for keeping the constrictor in a prearranged tightened position and for unlocking the ribbon .

The material conforms FDA regulation for devices contacting human skin.

For unlocking of the constrictor. the belt's release loop is pulled forward. The belt slips off, allowing easy unwrapping of the constricting ribbon.

A mounting tube comprises a segment of acrylic tube.

For arrangement of Erco-Ribbon™ penile constriction device, the ribbon is wrapped with the tension by multyple turns over the segment of the proximal end of the mounting tube. (or a vacuum chamber, when Erco-Ribbon ™ is used as a part of a vacuum constriction system),

#### SUBSTANTIAL EQUIVALENCY COMPARISON

Comparison of design and performance of marketable constriction rings and Erco-Ribbon is made with consideration of the impact of device's design on its safety and effectiveness .

marketable Predicate devices and Erco-Ribbon™ are constriction Considered with the same intended use, but have different technological devices characteristics.

Ercons, Inc. Inc. Come

PATENT PENDING

Erco-Ribbon™

CONFIDENTIAL

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Predicate devices:

To provide sufficient inward pressure on erected penis, one or more of constriction rings have to be placed at the edge of an open end of the vacuum chamber.

Rings are molded of natural or synthetic rubber with different durometer numbers, usually in the range of 30 to 60 and are manufactured in large, medium and small sizes. To provide acceptable inward pressure, selection for individual users is based on size, durometer and a number of constriction rings used together. Despite high cost due to a number of expensive molds, there is no way to provide smooth control of the pressure which happens to be excessive and causes discomfort, numbness, bruises.

Placement of rings presents certain technical difficulties. Recognizing this problem, special cone-shaped applicators are added to the system. Applicators facilitate the problem, but complicate the system and increase its cost.

Discomfort and pain may be caused by twisting of doubled rings during their transfer onto the penis and because of intertwining with pubic hair.

Removal of constriction ring from erected penis could be painful too, especially when two or more rings are used together. In this case after removal of the first ring the penis is still engorged, as the remaining ring prevents blood outflow.

Erco-Ribbon ™:

There are countless possibilities of providing proper pressure of the constricting device during fabrication: by selection of constricting ribbon's material, cross section, length.

Erco-Ribbon™ PATENT PENDING Ercons, Inc. CONFIDENTIAL

4

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With the constrictor of given properties and dimensions, the user may prearrange desirable pressure by changing the tension and number of turns during wrapping.

The present design radically reduces major technical difficulties of constriction ring associated with its placement on the vacuum chamber. A multyturn constriction ribbon is much easier to apply than a solid constriction ring as the force necessary to extend multyturn constrictor is much lower than for solid ring.

### SUMMARY:

Erco-Ribbon ™ has the same intended use as Predicate devices.

Technological differences of Erco-Ribbon™ provide superior safety and

performance.

Erco-Ribbon™ is substantially equivalent to constriction devices that have been marketed for many years.

Ercons, Inc.

PATENT PENDING

Erco-Ribbon™

CONFIDENTIAL

5

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Public Health Service . . . . . . .

DEPARTMENT OF HEALTH & HUMAN USA

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 8 1997

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

Dear Dr. Altshuler:

Re: K972353

Erco-Ribbon™ Dated: September 18, 1997 Received: September 22, 1997 Regulatory class: unclassified Product code: 78 LKY

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 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 practice, labeling, 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 Regulations, 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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 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 yitro 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 yours.

Sincerely yours,

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

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510(k) Number K972353 Erco-Ribbon "" Device Name:

### Indications for use:

Erco-Ribbon™ is 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).

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

a) separately:

premature ejaculation

firm but short lasting erection

b) as a part of a vacuum constriction system

#### Diabetes

Venous leakage

Prostatectomy

Hypertension

Psychogenic condition

Radiation therapy

Spinal cord injury

Concurrence of CDRH2 Office of Device Evaluation (ODE)

Amed H.P.

(Division Sign, Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices K972353 510(k) Number.

**Prescription Use**
(Per 21 CFR 801-109)

OR

Over-The-Counter Use