(651 days)
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No
The summary describes a latex condom with fluorescent pigment and does not mention any AI or ML capabilities.
No
The device is described as a contraceptive and is intended to reduce the risk of transmission of STDs and pregnancy, which are preventative rather than therapeutic actions for an established disease or condition.
No
The intended use of this device is for contraception and reducing the risk of sexually transmitted diseases, not for diagnosing a medical condition.
No
The device description explicitly states "Latex Condoms with Fluorescent Pigment," indicating a physical hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use of the KNIGHT LIGHT™ CONTRACEPTIVES is to be used during sexual activity to reduce the risk of transmission of STDs and pregnancy. It does not involve testing or analyzing samples taken from a person.
- The device description is a physical barrier. Latex condoms are a physical barrier device, not a diagnostic test.
- The intended use is preventative and contraceptive. While it helps reduce the risk of disease transmission, it's not a test to diagnose a disease.
Therefore, based on the provided information, the KNIGHT LIGHT™ CONTRACEPTIVES are not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
KNIGHT LIGHT™ CONTRACEPTIVES, if properly used, are intended to reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases. In addition, if properly used, KNIGHT LIGHT™ CONTRACEPTIVES can reduce the risk of pregnancy.
Product codes
85 HIS
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 884.5300 Condom.
(a)
Identification. A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). The device may also be used to collect semen to aid in the diagnosis of infertility.(b)
Classification. (1) Class II (special controls) for condoms made of materials other than natural rubber latex, including natural membrane (skin) or synthetic.(2) Class II (special controls) for natural rubber latex condoms. The guidance document entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300” will serve as the special control. See § 884.1(e) for the availability of this guidance document.
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Image /page/0/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with its wings spread, surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The eagle is depicted with flowing lines, giving it a sense of movement and dynamism. The text is in a simple, sans-serif font, and the overall design is clean and professional.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 20 1997
Mr. Davin Wedel Global Protection Corporation 323 New Boston Street, #2 Wilmington, Massachusetts 01887 Re: K960552
Latex Condoms with Fluorescent Pigment (Knight Light®; KL 101) Dated: August 28, 1997 Received: September 2, 1997 Regulatory class: II 21 CFR §884.5300/Product code: 85 HIS
Dear Mr. Wedel:
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 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, 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 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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory 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 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 (301) 594-4613. Additionally, for question 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 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Wiliau Yu
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
1
Indications For Use Statement
510(k) Number if known): K960552
Device Name: KNIGHT LIGHT™ CONTRACEPTIVES
Indications For Use:
KNIGHT LIGHT™ CONTRACEPTIVES, if properly used, are intended to reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases. In addition, if properly used, KNIGHT LIGHT™ CONTRACEPTIVES can reduce the risk of pregnancy.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, ENT, | |
| and Radiological Devices | |
| 510(k) Number | K960552 |
| Prescription Use | OR | Over-The-Counter Use |
|---|---|---|
| ------------------ | ---- | --------------------------------------------------------- |
Prescription Use (Per 21 CFR 801.109)
OR
The-Counter Use _1/
(Optional Format 1-2-96)