(71 days)
Not Found
No
The device description details a purely mechanical vacuum pump and constriction ring system with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended to treat erectile dysfunction, which is a medical condition.
No
The device is described as creating an erection and maintaining penile rigidity, which are therapeutic functions, not diagnostic ones. It is designed to treat erectile dysfunction, not to identify or assess it.
No
The device description explicitly details physical components like a vacuum tube, pump sleeve, spacer ring, O-Rings, stopper, vacuum ring, and constriction ring, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Vacurect Function: The Vacurect device works externally on the body to create a physical effect (an erection) by applying a vacuum. It does not analyze any biological samples.
The description clearly states its purpose is to physically create and maintain an erection, not to diagnose or monitor a condition through the analysis of biological specimens.
N/A
Intended Use / Indications for Use
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.
Product codes
78 LKY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
penis
Indicated Patient Age Range
Not Found
Intended User / Care Setting
over-the-counter use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing was performed to determine that the pumping mechanism does not create a vacuum greater than 0.57 bar = 17 inches.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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 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
March 25, 2002
1
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
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.
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.
2
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
4
KO20969 510(k) Number (if known):
Device Name: Vacurect Vacuum Constriction Device
Indications for Use:
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.
(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