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 Description

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.

AI/ML Overview

The provided text for the Erco-Vac™ primarily focuses on describing the device, its intended use, and claiming substantial equivalence to predicate devices for regulatory approval (510(k) submission). It does not contain a detailed study demonstrating that the device meets specific acceptance criteria based on quantifiable performance metrics.

Therefore, many of the requested sections about acceptance criteria, study details, sample sizes, and ground truth establishment cannot be extracted from the provided text. The document is a regulatory submission, not a clinical trial report.

Here's a breakdown of what can and cannot be answered:

1. A table of acceptance criteria and the reported device performance

Cannot be provided. The document does not specify quantitative acceptance criteria (e.g., "device must achieve X level of rigidity in Y% of patients") nor does it report specific device performance against such criteria. It generally states "superior performance" compared to predicate devices due to technological differences, but this is not data-driven.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Cannot be provided. The document does not describe any specific test set, clinical trial, or patient data used to evaluate the device's performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Cannot be provided. Since there's no described test set or performance study, there's no mention of experts establishing a ground truth for such a study.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Cannot be provided. No test set is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Cannot be provided. This question is highly relevant to AI/imaging devices. The Erco-Vac™ is an external penile rigidity system, a mechanical medical device, not an AI or imaging device. Therefore, an MRMC study is not applicable, and no such study is mentioned.

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

Cannot be provided. As above, the device is a mechanical system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Cannot be provided. No performance study with ground truth establishment is described.

8. The sample size for the training set

Cannot be provided. The device is not an AI/machine learning model, so there is no concept of a "training set."

9. How the ground truth for the training set was established

Cannot be provided. Not applicable due to the nature of the device.

Summary of what the document does provide:

Intended Use: To create an erection in men with erectile dysfunction, applicable to various conditions like diabetes, venous leakage, prostatectomy, hypertension, psychogenic impotence, impotence due to radiation therapy, and spinal cord injury. (From Section 510(k) Summary and Indications for Use).
Device Description: An external penile rigidity system (vacuum constriction device) that uses vacuum to draw blood into the penis, and a constriction device to retain the erection. (From Device Description section).
Technological Improvements claimed:
- Transferable air-tight penile seal (adjusts to girth without inserts).
- Constriction device with controllable inward radial pressure (Erco-Ribbon™ allows user to prearrange pressure).
- Automatic vacuum release upon transfer of seal/constriction device.
- Transferring device for easy slip-off.
- Vacuum chamber with a domed closed end. (From Device Description section).
Comparison to Predicate Devices: Claims "superior performance" due to the novel elements, addressing "deficiencies and drawbacks" of known marketable devices, such as the need for adapter inserts, lack of smooth control over inward pressure, and discomfort/bruises with predicate constriction rings. (From Device Description section).
Regulatory Classification: Unclassified (78 LKY). (From 510(k) Summary).
Substantial Equivalence: Claimed to Erercaid (K841257), VED (K901223), and Pos-T-Vac (K960828, K960342). (From 510(k) Summary and FDA letter).

The document is a regulatory submission for premarket notification (510(k)), which typically focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than providing detailed clinical trial data with specific acceptance criteria and performance metrics.

Summary

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NOV 2 4 1998

K98/1357

144

ERCONS, Inc. 66 Overlook Terrace, suite 2E New York, NY, 10040 Tel. 1-212-927 3275 Fax. 1-212-927 7387

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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
204

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

r t

Structure features

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

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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
1. Constriction device with controllable inward radial pressure
1. Automatic vacuum releas
1. 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.

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 (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/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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evint8aa

510(k) Number 981357 Page 1 of 1

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 .
ﺩﺭ

Prescription Use	OR	Over-The-Counter Use
------------------	----	----------------------

(Per 21 CFR 801-109)

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT,

and Radiological Devices

510(k) Number	K981357
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Regulation Number and Section

§ 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.