(44 days)
The VTU-E is intended to aid in the production and maintenance of a penile erection in individuals suffering from impotence.
The VTU-E™ consists of four silicone rubber constriction rings and a plastic penile cylinder attached to a battery-powered vacuum pump. The penis is placed into the penile cylinder and the vacuum pump is used to reduce the air pressure within the cylinder and thus cause a penile erection. Once the penis is erect, the silicone rubber ring is placed around the base of the penis in order to maintain the erection.
This 510(k) summary for the VTU-E™ Vacuum Erection System does not contain detailed acceptance criteria or a specific study proving the device meets them in the way modern AI/ML device submissions typically do.
The submission focuses heavily on demonstrating substantial equivalence to a predicate device (VTU-1™) by highlighting their identical technological characteristics, except for the type of vacuum pump. Because of this, the "acceptance criteria" here are implicitly based on the predicate device's established safety and effectiveness.
However, I can extract and infer information relevant to your request based on the provided document.
Here's the breakdown:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| A. Intended Use Equivalence: Aid in the production and maintenance of a penile erection in individuals suffering from impotence. | The VTU-E™ has the identical intended use as the predicate VTU-1™. |
| B. Technological Equivalence (except vacuum pump): Consists of silicone rubber constriction rings and a plastic penile cylinder. | The VTU-E™ has these components, identical to the predicate device. |
| C. Vacuum Pump Functionality: Effectively reduces air pressure within the penile cylinder to cause erection. | The battery-powered pump in VTU-E™ serves the same purpose and has similar performance characteristics to the manually operated pump in VTU-1™. |
| D. Erection Maintenance: Silicone rubber ring maintains the erection. | This functionality is inherent in the design and identical to the predicate device. |
Explanation: The "acceptance criteria" are not formally stated with numerical targets as they would be for a novel device. Instead, acceptance is predicated on demonstrating that the VTU-E™ is functionally equivalent to a legally marketed predicate device (VTU-1™) and thus shares its safety and effectiveness profile. The core "proof" is the statement that the battery-powered pump has similar performance characteristics to the manually operated pump. No specific performance metrics (e.g., vacuum pressure achieved, time to erection, duration of erection) are mentioned.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable/Not provided.
- Data Provenance: Not applicable/Not provided.
Explanation: There is no mention of a "test set" in the context of clinical trials or performance testing for this specific submission. The submission relies on the established safety and effectiveness of the predicate device (VTU-1™).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable/Not provided.
- Qualifications: Not applicable/Not provided.
Explanation: No "ground truth" was established based on expert consensus for a test set as described. The determination of substantial equivalence was made by the FDA's Office of Device Evaluation.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/Not provided.
Explanation: No clinical study or test set requiring an adjudication method is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was it done?: No.
- Effect size: Not applicable.
Explanation: This type of study is entirely irrelevant to this device and submission type. The VTU-E™ is a mechanical medical device, not an imaging diagnostic AI.
6. Standalone (Algorithm Only) Performance Study
- Was it done?: No.
Explanation: This is not an AI/algorithm-based device. No standalone algorithm performance was assessed.
7. Type of Ground Truth Used
- Type of Ground Truth: Historical performance and regulatory acceptance of the predicate device (VTU-1™).
Explanation: The "ground truth" for this submission is implicitly the established safety and effectiveness of the previously cleared VTU-1™. The VTU-E™ is deemed safe and effective because it is substantially equivalent to a device already deemed safe and effective.
8. Sample Size for the Training Set
- Sample Size: Not applicable/Not provided.
Explanation: This device does not involve machine learning; therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- How Established: Not applicable/Not provided.
Explanation: No training set was used.
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Appendix C
510(k) Summary JAN - 9 1998 Encore, Inc. VTU-E™ Vacuum Erection System
General Information on Submitter: I.
Encore, Inc. Name: 2300 Plantside Drive, Louisville, KY 40299-1928 Address: (502) 499-1556 Telephone: (502) 499-1840 Fax: Name of Contact Person: Mr. Boyd Bennett Date Summary Prepared: November ______________________________________________________________________________________________________________________________________________
General Information on Device II.
VTU-ETM Vacuum Erection System Name:
External Penile Rigidity Device Classification Name:
Predicate Device: VTU-1™ (510(k) No. K971257) III.
Description of the Device: IV.
The VTU-E™ consists of four silicone rubber constriction rings and a plastic penile cylinder attached to a battery-powered vacuum pump. The penis is placed into the penile cylinder and the vacuum pump is used to reduce the air pressure within the cylinder and thus cause a penile erection. Once the penis is erect, the silicone rubber ring is placed around the base of the penis in order to maintain the erection.
V. Intended Use:
The VTU-E™ is intended to aid in the production and maintenance of a penile erection in individuals suffering from impotence.
Technological Characteristics of Device Compared to Predicate Device: VI. The VTU-E™ and the VTU-1™ have identical technological
characteristics with the exception of the type of vacuum pump used to reduce the air pressure within the penile cylinder. The VTU-1™ used a manually operated pump, while the VTU-E™ uses a battery-powered pump. Both pumps serve the same purpose and have similar perfomance characteristics.
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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with flowing lines, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the left side of the emblem.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 9 1998
ENCORE, Inc. c/o Donald R. Stone McKenna & Cuneo, L.L.P. 1900 K. Street, N.W. Washington, DC 20006-1108 Re: K974470
VTU-E™ Vacuum Erection System Dated: November 26, 1997 Received: November 26, 1997 Unclassified/Procode: 78 LKY
Dear Mr. Stone:
We have reviewed your Section 510(k) notification of intent to market the device 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 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 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 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 yitts diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question 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/cdrh/dsmamain.html".
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
Enclosure
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510(k) Number (if known):
VTU-E Vacuum Erection System Device Name:
Indications For Use:
The VTU-E is intended to aid in the production and maintenance of a penile erection in individuals suffering from impotence.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert D. Satting/
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices K974970 510(k) Number _
State Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use ✓
(Optional Format 1-2-96)
§ 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.