(345 days)
The Nanma constriction rings (adjustable and stretchable) are external penile rigidity devices used for the treatment or management of erectile dysfunction/impotence. The Nanma constriction ring can be used alone or with a vacuum pump. This device is intended for over-the-counter use (OTC)
Nanma Adjustable and Stretchable Constriction Rings
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance described in a table, or any study details that prove the device meets acceptance criteria. The document is a 510(k) clearance letter from the FDA for a device called "Nanma Adjustable and Stretchable Constriction Rings."
The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices and therefore can be marketed. It discusses regulatory classifications, general controls, and other compliance requirements, but does not include any performance data or study results.
To answer your request, I would need a document that specifically details the device's technical specifications, performance metrics, testing methods, and the results of studies conducted to demonstrate its efficacy and safety.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
and the 2 2 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 -
Nanma Manufacturing Co., Ltd. c/o Ms. Yolanda Smith Smith Associates FDA Consultants P.O. Box 4341 CROFTON MD 21114
Re: K013051
Trade/Device Name: Nanma Adjustable and Stretchable Constriction Rings Regulation Number: None
Regulatory Class: Unclassified Product Code: 78 LKY Dated: June 5, 2002 Received: June 11, 2002
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 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this 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 Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and 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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K013051 510(k) Number (if known):
...
Device Name: Nanma Adjustable constriction ring
Classification Panel:
,
Indications for Use:
The Nanma constriction rings (adjustable and stretchable) are external penile rigidity devices used for the treatment or management of erectile dysfunction/impotence. The Nanma constriction ring can be used alone or with a vacuum pump.
This device is intended for over-the-counter use (OTC)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_____________ Use
or
Over-the-Counter
Nancy C. Broadon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K013051
§ 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.