(82 days)
The Charger is used to cause engorgement of the penis for men that are having difficulty with organic or psychological impotence.
The Charger is used by impotent men to allow them to resume having sexual intercourse. It consists of a clear polycarbonate cylinder used as a vacuum chamber, that fits over the penis, and a vacuum pump with vacuum release trigger to evacuate air from the cylinder. As the air is removed from the chamber the negative pressure allows blood engorgement of the penis. When a sufficient erection occurs for vaginal penetration a Reliant constriction ring (K980567) is slipped over the base of the penis to act as a partial tourniquet retaining the erection. The ring may be worn for a maximum of thirty minutes before it MUST be removed. The kit comes with a set of 4 ring sizes. The pumps' ability to create a vacuum is limited by an automatic vacuum release valve so it cannot exceed the known safe limit of 17 in. Hg. The rings are elastic pharmaceutical quality material. The ring safety removal loops were performance tested for strength.
The provided text describes a 510(k) summary for a medical device called "Charger" (VCD - vacuum constriction device) and its corresponding FDA clearance letter. However, it does not contain information about specific acceptance criteria for device performance, nor details about a study designed to prove the device meets such criteria.
The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Reliant VCD) and confirming safety aspects.
Here's an analysis based on the provided text, highlighting the absence of the requested information:
Key Takeaways from the Text:
- Device Purpose: The Charger is used by impotent men to allow them to resume sexual intercourse.
- Mechanism: It's a vacuum constriction device that creates negative pressure to engorge the penis with blood. A constriction ring retains the erection.
- Safety Features:
- Automatic vacuum release valve limits pressure to a safe limit of 17 in. Hg.
- Constriction rings are made of elastic pharmaceutical quality material.
- Ring safety removal loops were "performance tested for strength." (Details of this "performance test" are not provided).
- All warnings and precautions from the FDA internet address are included.
- Equivalence: The device is deemed substantially equivalent to the Reliant VCD (K980567). This regulatory assessment does not typically require a new, full-scale clinical trial to establish performance against pre-defined acceptance criteria, but rather a demonstration that the new device is as safe and effective as the predicate.
Given this, I cannot fill out the requested table for acceptance criteria and reported device performance, nor can I answer many of the specific questions about a performance study, because the document does not contain this information.
Missing Information/Cannot Answer Based on Provided Text:
- Acceptance Criteria Table: No specific performance metrics (e.g., success rate of achieving erection, duration of erection, user satisfaction scores) or acceptance criteria for those metrics are mentioned.
- Sample Size (Test Set) and Data Provenance: No clinical study involving a "test set" to evaluate device performance is described. The mention of "ring safety removal loops were performance tested for strength" refers to a mechanical test, not a clinical one.
- Number of Experts/Qualifications (Ground Truth): Not applicable, as no clinical study with ground truth established by experts is described.
- Adjudication Method: Not applicable.
- MRMC Comparative Effectiveness Study: No information suggests such a study was performed, or any effect size for human readers improving with AI assistance (which is irrelevant for this non-AI device).
- Standalone Performance Study: No details on a standalone performance study in a clinical setting against specified criteria are provided. The "performance test" of the loops is a partial engineering test, not a full device performance study.
- Type of Ground Truth: Not applicable, as no clinical ground truth is established or discussed.
- Sample Size for Training Set: Not applicable, as this is not an AI/ML device requiring a training set.
- How Ground Truth for Training Set was Established: Not applicable.
What the Text Does Tell Us (Limited Scope):
The provided text describes a 510(k) premarket notification which focuses on demonstrating substantial equivalence to a previously legally marketed device (Reliant VCD). This regulatory pathway generally relies on demonstrating that the new device has the same intended use, technological characteristics, and safety/effectiveness profile as the predicate device, rather than requiring a detailed clinical performance study with predefined acceptance criteria.
The only "performance test" mentioned is for the "ring safety removal loops for strength," which is a device component's mechanical integrity test, not a study of the overall clinical performance of the VCD system in achieving erections in patients. The text states the pump could not exceed 17 in. Hg., which is a safety limit, not a performance criterion for efficacy.
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6 1998 MAY
WALLING MEDICAL EQUIPMENT, INC. 3000 Candide Ln., McKinney, Tx 75070 Telephone(972)562-3230 Fax (972)542-0446
Kazost
91011
510K SUMMARY Prepared 3-19-98 Submitted By: Allan Walling Contact Person: Allan Walling
Device Trade Name: Charger Common name: vacuum constriction device Classification name: external penile rigidity device Legally marketed device to which this device is equivalent: Reliant VCD
Summary: The Charger is used by impotent men to allow them to resume having sexual intercourse. It consists of a clear polycarbonate cylinder used as a vacuum chamber, that fits over the penis, and a vacuum pump with vacuum release trigger to evacuate air from the cylinder. As the air is removed from the chamber the negative pressure allows blood engorgement of the penis. When a sufficient erection occurs for vaginal penetration a Reliant constriction ring (K980567) is slipped over the base of the penis to act as a partial tourniquet retaining the erection. The ring may be worn for a maximum of thirty minutes before it MUST be removed. The kit comes with a set of 4 ring sizes.
The pumps' ability to create a vacuum is limited by an automatic vacuum release valve so it cannot exceed the known safe limit of 17 in. Hg. The rings are elastic pharmaceutical quality material. The ring safety removal loops were performance tested for strength. . All warnings and precautions from the FDA internet address. www.fda.gov/cdrh/ode/gxpenrig.html, are included in the premarket notification.
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Image /page/1/Picture/0 description: The image shows a logo for the Department of Health. The logo features three stylized human figures with flowing lines, stacked on top of each other. The text "DEPARTMENT OF HEALTH" is vertically oriented and wraps around the left side of the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
e 1008 MAY
Mr. Allan Walling President Walling Medical Equipment, Inc. 3000 Candide Lane McKinney, TX 75070
Re: K980567
Charger VCD (Over-the-Counter Use) Dated: March 20, 1998 Received: March 23, 1998 Unclassified/Procode: 78 LKY
Dear Mr. Walling:
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, 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 (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 (2) 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/cdrh/dsmadsmam.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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Indications for Use
510(k) Number: K980567 Device Name: Charger (ED)
Indications for Use:
The Charger is used to cause engorgement of the penis for men that are having difficulty with organic or psychological impotence.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Peter Sutling
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K980567
Prescription Use (Per 21 CFR 801.109) Or
Over-The-Counter
§ 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.