CHARGER (ED)

K980567 · Walling Medical Equipment Co. · LKY · May 6, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K980567
• Device Name: CHARGER (ED)
• Applicant: Walling Medical Equipment Co.
• Product Code: LKY · Gastroenterology, Urology
• Decision Date: May 6, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5020
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Charger is used to cause engorgement of the penis for men that are having difficulty with organic or psychological impotence.

Device Story

The Charger is a vacuum constriction device (VCD) used by men with impotence to achieve and maintain an erection. The device consists of a clear polycarbonate cylinder placed over the penis and a manual vacuum pump with a release trigger. Operation involves creating negative pressure within the cylinder to induce blood engorgement. Once an erection is achieved, an elastic constriction ring is applied to the base of the penis to retain blood flow. The ring acts as a partial tourniquet and must be removed within 30 minutes. The device includes an automatic vacuum release valve to limit pressure to 17 in. Hg for safety. It is intended for use by the patient.

Clinical Evidence

No clinical data provided; bench testing only. Performance testing conducted on ring safety removal loops and vacuum pressure limits.

Technological Characteristics

Materials: Polycarbonate (cylinder), elastic pharmaceutical quality material (rings). Sensing/Actuation: Manual vacuum pump with automatic vacuum release valve. Energy Source: Manual. Connectivity: None. Sterilization: Not specified. Software: None.

Indications for Use

Indicated for men experiencing organic or psychological impotence to facilitate penile engorgement for sexual intercourse.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Reliant VCD (K980567)

Submission Summary (Full Text)

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6 1998 MAY

WALLING MEDICAL EQUIPMENT, INC. 3000 Candide Ln., McKinney, Tx 75070 Telephone[phone] Fax [phone]

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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