NANMA NON-ADJUSTABLE CONSTRICTION RING

K993906 · Nanma Mfg Co., Ltd. · LKY · Jan 31, 2000 · Gastroenterology, Urology

Device Facts

• Record ID: K993906
• Device Name: NANMA NON-ADJUSTABLE CONSTRICTION RING
• Applicant: Nanma Mfg Co., Ltd.
• Product Code: LKY · Gastroenterology, Urology
• Decision Date: Jan 31, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Nanma non-adjustable constriction rings are external penile rigidity devices used for the treatment or management of erectile dysfunction/impotence.

Device Story

Nanma non-adjustable constriction ring is an external device designed to treat erectile dysfunction/impotence. Device functions by applying mechanical constriction to the base of the penis to maintain rigidity. Intended for over-the-counter use by patients. Device provides a physical aid for patients experiencing erectile dysfunction; helps maintain penile rigidity during sexual activity.

Clinical Evidence

No clinical data provided; substantial equivalence based on regulatory classification and comparison to pre-amendment devices.

Technological Characteristics

Non-adjustable constriction ring; mechanical device; no electronic components or software.

Indications for Use

Indicated for patients with erectile dysfunction/impotence requiring external penile rigidity devices.

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.

Submission Summary (Full Text)

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'JAN 3 1 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NANMA Manufacturing Company c/o Mr. E. J. Smith Smith Associates P.O. Box 4341 Crofton, MD 21114

Re: K993906 NANMA Non-adjustable Constriction Ring Dated: November 17, 1999 Received: November 17, 1999

Unclassified/Procode: 78 LKY

Dear Mr. Smith:

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 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). 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 (Special Controls) or class III (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 (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druo Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory 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/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting 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):

K993906

Device Name: Nanma non-adjustable constriction ring

Classification Panel: LKY

Indications for Use:

The Nanma non-adjustable constriction rings are external penile rigidity devices used for the treatment or management of erectile dysfunction/impotence.

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_

or

**Over-the-Counter Use** √

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devic 510(k) Number_