The Vacurect vacuum component is intended to create an erection in men with erectile dysfunction by means of an applied vacuum to the penis. The constriction ring is intended to maintain penile rigidity in men with erectile dysfunction. The Vacurect Vacuum Constriction Device is intended for over-the-counter use.

Device Description

The Vacurect Vacuum Constriction Device is an over the counter device that consists of two main components: the vacuum tube and the constriction ring. The vacuum tube consists of the pump sleeve, spacer ring, dome/sleeve O-Rings, dome/valve stopper, and vacuum ring. The Vacurect Vacuum Constriction Device works by creating a vacuum in the vacuum tube. This is accomplished by moving the pump sleeve up and down along the vacuum tube. The flexible rubber constriction ring when placed onto the vacuum tube (open end), forms an airtight seal with the vacuum tube. Once the opening of the constriction ring is placed on the penis head, the vacuum chamber is sealed and operation of the pump sleeve will immediately draw the penis into the vacuum tube. Once the required penis rigidity is reached, the vacuum pump may be removed and the ring can remain on the penis for up to 30 minutes.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Vacurect Vacuum Constriction Device:

Based on the provided 510(k) summary, the device and its associated performance testing are extremely limited in scope for what would typically be expected for a detailed AI/ML device study. This device is a mechanical medical device, not an AI/ML diagnostic or therapeutic system. Therefore, many of the requested fields are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Pumping mechanism does not create a vacuum greater than 0.57 bar (17 inches)	Study indicates this was met. The text explicitly states, "Testing was performed to determine that the pumping mechanism does not create a vacuum greater than 0.57 bar = 17 inches." This implies the device met this specific criterion.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not specified. The document only mentions "Testing was performed," without details on the number of devices tested or the conditions.
Data Provenance: Not specified. It's likely an in-house engineering test conducted by the manufacturer, Vacurect Manufacturing (PTY) Ltd. The country of origin would be the Republic of South Africa, where the sponsor is located. The description does not indicate if it was retrospective or prospective, but for an engineering test of this nature, it would typically be prospective (i.e., conducted specifically for this submission).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:

Number of Experts: Not applicable. For a direct measurement of vacuum pressure, expert opinion is not typically required. It's a quantitative engineering measurement.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable. The "ground truth" is a direct physical measurement. There is no mention of human interpretation or a need for adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

MRMC Study: No. This device is a mechanical vacuum pump system, not an AI/ML diagnostic device that would involve human readers interpreting output.

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

Standalone Performance: Not applicable as this is not an AI/ML algorithm. The "performance testing" described is the standalone functional testing of the mechanical pumping mechanism.

7. The Type of Ground Truth Used:

Type of Ground Truth: Direct physical measurement of vacuum pressure using appropriate calibration equipment.

8. The Sample Size for the Training Set:

Sample Size: Not applicable. This device does not use machine learning, so there is no "training set."

9. How the Ground Truth for the Training Set was Established:

Ground Truth for Training Set: Not applicable. As there's no training set for an AI/ML model, this question is irrelevant to the provided information.

Summary and Caveats:

The provided 510(k) summary is for a mechanical medical device (Vacuum Constriction Device), not an AI or machine learning-enabled device. Therefore, the bulk of your questions, which are highly relevant to AI/ML device studies (e.g., sample sizes for training/test sets, expert ground truth, MRMC studies, standalone performance), do not apply to this submission.

The "performance testing" mentioned is a basic engineering test to ensure the device operates within safe vacuum limits, which is a critical safety parameter for this type of device. The acceptance criterion is a maximum vacuum pressure, and the document states that testing was performed to determine that this limit was met. This implies compliance, though no raw data or detailed test reports are provided in this summary.

Summary

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510(k) Summary for Vacurect Vacuum Constriction Device

1. SPONSOR

Vacurect Manufacturing (PTY) Ltd. 730 Tetra Avenue Moreletapark, Pretoria Republic of South Africa Postal Address: P.O. Box 39385 Moreletapark 0044 Republic of South Africa

2. DEVICE NAME

Proprietary Name:	Vacurect Vacuum Constriction Device
Common/Usual Name:	External Penile Rigidity Device
Classification Name:	Vacuum Pump and Constriction Rings
Submission Date:	March 25, 2002

3. PREDICATE DEVICES

Repro-Med Restore Vacuum Erection Device (K981506)

Imagyn Medical Technologies, Inc. Impower System Vacuum Erection System (K980291)

4. DEVICE DESCRIPTION

The Vacurect Vacuum Constriction Device works by creating a vacuum in the vacuum tube. This is accomplished by moving the pump sleeve up and down along the vacuum tube. The flexible rubber constriction ring when placed onto the vacuum tube (open end), forms an airtight seal with the vacuum tube. Once the opening of

March 25, 2002

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the constriction ring is placed on the penis head, the vacuum chamber is sealed and operation of the pump sleeve will immediately draw the penis into the vacuum tube.

Once the required penis rigidity is reached, the vacuum pump may be removed and the ring can remain on the penis for up to 30 minutes.

5. INTENDED USE

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

The Vacurect Vacuum Constriction Device and the predicate devices all use a vacuum tube and constriction ring to create and maintain an erection in men with erectile dysfunction. The Vacurect vacuum tube is similar to the predicate devices in that it is made of a smooth plastic material that provides an airtight seal with the penis during use. The constriction ring is also similar to the predicate devices in that they are all designed to restrict penis venous outflow after the patient has obtained an erection with the aid of a vacuum pump.

7. PERFORMANCE TESTING

Testing was performed to determine that the pumping mechanism does not create a vacuum greater than 0.57 bar = 17 inches.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image contains the words "Public Health Service" in bold black font. The words are stacked on top of each other. The words are left-aligned and the font size is relatively large.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 0 5 2002

Mary McNamara-Cullinane, RAC Staff Consultant Medical Device Consultants, Inc. 49 Plain Street NORTH ATTELBORO MA 02760 Re: K020969 Trade/Device Name: Vacurect Vacuum Constriction Device Regulation Number: None Regulatory Class: Unclassified Product Code: 78 LKY Dated: March 25, 2002 Received: March 26, 2002

Dear Ms. McNamara-Cullinane:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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. Iisting 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

Image /page/2/Picture/10 description: The image shows a partial view of a seal or emblem, likely from a government or organizational entity. The visible text reads "DEPARTMENT OF HEALTH & HUMA", suggesting it is part of a larger phrase such as "Department of Health & Human Services". The emblem also features a stylized graphic element consisting of three curved lines, possibly representing a symbol or logo associated with the organization.

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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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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KO20969 510(k) Number (if known):

Device Name: Vacurect Vacuum Constriction Device

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Manauze Brogdow

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devies
510(k) Number K020969

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use レ

(Optional Format 1-2-96)

Vacurect Manufacturing 510(k) Vacurect Vacuum Constriction Device March 25, 2002

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.