NANMA VACUUM PUMP

K993909 · Nanma Mfg Co., Ltd. · LKY · Jul 19, 2000 · Gastroenterology, Urology

Device Facts

• Record ID: K993909
• Device Name: NANMA VACUUM PUMP
• Applicant: Nanma Mfg Co., Ltd.
• Product Code: LKY · Gastroenterology, Urology
• Decision Date: Jul 19, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Nanma Vacuum Pumps are external penile rigidity devices designed to promote penile rigidity and are used to create erections in men with erectile dysfunction.

Device Story

Nanma Vacuum Pump is an external penile rigidity device; creates vacuum environment around penis to induce engorgement and erection. Used by men with erectile dysfunction; intended for over-the-counter use. Device consists of vacuum pump mechanism; manual operation. Assists in achieving erection for sexual intercourse; provides non-invasive treatment option for erectile dysfunction.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

External vacuum pump device; manual operation; non-powered or mechanical vacuum generation. No specific materials or software algorithms described.

Indications for Use

Indicated for men with erectile dysfunction to promote penile rigidity and create erections.

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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 9 2000

Nanma Manufacturing Co., Ltd. c/o Mr. E.J. Smith Smith Associates P.O. Box 4341 Crofton, MD 21114

Re: K993909 Nanma Vacuum Pump Dated: June 8, 2000 Received: June 9, 2000 Regulatory Class: 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 (Act (Art 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 (o such additional controls. Existing major regulations affecting your device can be found in the Code of Forum (1) (1) 10 collect (1 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 regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comby with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concernies in the Eederal 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 Cantrol 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 and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premaket notification" (21CFR 807.97). Other general information on your responsibilities inder 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,

Daniel C. Schaller, M.D.

Daniel G. Schultz, M.D. Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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510(k) Number (if known):

Device Name: Nanma Vacuum Pump

Classification Panel: LKY

Indications for Use:

The Nanma Vacuum Pumps are external penile rigidity devices designed to promote The Namma Vacuun I umps are extenzi points agency and supers are used to create erections in men with erectile dysfunction.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

or

**Over-the-Counter Use**

David A. Seymour
(Division Sign-Off)

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