(72 days)
The Nanma Vacuum Pump is an external penile rigidity device designed to promote sufficient penile rigidity for sexual intercourse. The vacuum pump is used to create erections in men with erectile dysfunction. This device is intended for over-the-counter use (OTC)
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This document is a marketing clearance letter for a medical device called the "Nanma Vacuum Pump ProXZEK, Model 2M9498S". It is a 510(k) clearance, which means the FDA has determined the device is substantially equivalent to legally marketed predicate devices, and therefore does not require a premarket approval (PMA) application.
A 510(k) clearance does not typically involve a new clinical study to establish acceptance criteria and prove performance in the same way a PMA does. Instead, it relies on demonstrating equivalence to an existing device. Therefore, the information requested regarding acceptance criteria and a study proving the device meets them, particularly with details like sample sizes, ground truth establishment, and MRMC studies, is not contained within this particular document.
This document primarily states the device's Indications for Use:
"The Nanma Vacuum Pump is an external penile rigidity device designed to promote sufficient penile rigidity for sexual intercourse. The vacuum pump is used to create erections in men with erectile dysfunction. This device is intended for over-the-counter use (OTC)."
The basis for this clearance is a comparison to a predicate device, and the "proof" is the demonstration of substantial equivalence, not a direct clinical trial with specified acceptance criteria as would be found in a PMA.
Therefore, for your specific request, most of the information cannot be extracted from this 510(k) clearance letter.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 5 2004
Nanma Manufacturing Co., LTD c/o Ms. Yoland Smith Smith & Associates P.O. Box 4341 CROFTON MD 21114
Re: K041573
Trade/Device Name: Nanma Vacuum Pump ProXZEK, Model 2M9498S Regulation Number: None Regulatory Class: Unclassified Product Code: 78 LKY Dated: August 6, 2004 Received: August 9, 2004
Dear Ms. Smith:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA), 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 510(k) Premarket notification The FDA finding of substantial equivalence of your device to a legally premate creatived. " www.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 CIFR Part 801), please If you desire speativ as not of the following numbers, based on the regulation number at the top of the letter :
| 8xx 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Addition of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding Other of Somphanes as (21CFR Part 807.97) you may obtain. Other general of relevence to promative news. It is a may be obtained from the Division of Small Intormation on your rosponsional Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K0411573
Device Name: Nanma Vacuum Pump ProXZEK Model 2M9498S
Indications for Use:
The Nanma Vacuum Pump is an external penile rigidity device designed to promote sufficient penile rigidity for sexual intercourse. The vacuum pump is used to create erections in men with erectile dysfunction.
This device is intended for over-the-counter use (OTC)
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use V (21 CFR 807 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Humm
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number K041573
§ 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.