(240 days)
Not Found
Not Found
No
The summary describes a mechanical device and explicitly states "Not Found" for mentions of AI, DNN, or ML.
Yes
The 'Intended Use / Indications for Use' states that the device is "used for the treatment or management of erectile dysfunction/impotence," which indicates a therapeutic purpose.
No
Explanation: The device is described as an external penile rigidity device used for the treatment or management of erectile dysfunction/impotence. Its function is to provide constriction, which is a therapeutic action, not a diagnostic one.
No
The device description explicitly states "Nanma Adjustable constriction ring," which is a physical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states the Nanma non-adjustable constriction rings are "external penile rigidity devices used for the treatment or management of erectile dysfunction/impotence." This is a physical device applied externally to the body.
- Lack of IVD Indicators: The provided information does not mention any testing of biological samples, analysis of bodily fluids, or any other activity typically associated with in vitro diagnostics.
Therefore, based on the provided information, the Nanma non-adjustable constriction ring is a medical device, but not an IVD.
N/A
Intended Use / Indications for Use
The Nanma non-adjustable constriction rings are external penile rigidity devices used for the treatment or management of erectile dysfunction/impotence.
This device is intended for over-the-counter use (OTC)
Product codes
78 LKY
Device Description
Nanma non-adjustable constriction rings
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
penile
Indicated Patient Age Range
Not Found
Intended User / Care Setting
over-the-counter use (OTC)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Public Health Service
MAY 0 9 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Nanma Manufacturing Company c/o Ms. Yolanda Smith Associate Smith Associates P.O. Box 4341 CROFTON MD 21114
Re: K013053
Trade/Device Name: Non-adjustable Constriction Rings (OTC) Regulation Number: None Regulatory Class: Unclassified Product Code: 78 LKY Dated: March 18, 2002 Received: March 19, 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
2
510(k) Number (if known):
Device Name: Nanma 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.
This device is intended for over-the-counter use (OTC)
and Radiological Devices
510(k) Number _
(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 Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
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