(88 days)
Not Found
Not Found
No
The summary describes a condom, a mechanical barrier device, and explicitly states "Mentions AI, DNN, or ML: Not Found".
No
The device is described as a condom used for contraception and prophylactic purposes, which are preventative rather than therapeutic.
No
Explanation: The device is a condom, used for contraception and prophylaxis against STDs. Its stated uses do not involve diagnosing any medical conditions.
No
The device described is a condom, which is a physical barrier device, not a software-only medical device.
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.
- Condom Function: The intended use of a condom is for contraception and preventing the transmission of sexually transmitted diseases through physical barrier. It does not involve testing a sample from the body to diagnose or detect anything.
The provided information clearly states the condom's intended use is for contraception and prophylactic purposes, which are not functions of an IVD.
N/A
Intended Use / Indications for Use
The [No particular brand name] condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
Product codes
85 HIS
Device Description
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Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 0 9 2001
Mr. Chang Ah-Kau Managing Director INNOLATEX SDN. BHD. No 16, Jalan Bulan U5/5, Bandar Pinggiran Subang, Shah Alam, Selangor Darul Ehsan, MALAYSIA
Re: K012665
Trade/Device Name: Ultra Thin Latex Condom with Silicone Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: 85 HIS Dated: August 10, 2001 Received: August 13, 2001
Dear Mr. Ah-Kau:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have 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). You may, therefore, market the device, subject to the general controls Costicions of the Act. The general controls provisions of the Act include requirements for provisions of the read "The 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 (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 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 comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
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 oungation you might 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) prematket notification. The FDA finding of substantial equivalence of your device to a legally marketed notheation. The I Driving of vasion for your device and thus, permits your device to proceed to the market.
Please be advised that, as of March 25, 1998, labeling for latex condoms (21 CFR §884.5300 and I loase be advinced analy with Use Labeling for Latex Condoms: Expiration Dating, 21 CFR $801.435. Therefore, an expiration date, supported by test data developed under the 21 CF N 9001.435. Therefore, an inprint be displayed prominently and legibly on condom conditions specifical in 9001.455(d), mass of the effective shelf life of the spermicide must be compared with the shelf life of the condom and labeled with the earlier of the wood in 1066 dates. Although supporting data is not to be provided in your 510(k) submission, §801.435(j) uates. Andough supporting data and that it be available for inspection by FDA. Furthermore, 1001.435(e) requires that if your real-time test data fails to confirm the shelf life estimated by the methods in §801.435(d), then you must relabel all product to reflect the actual shelf life. medious in you i 193 (4), and your an expiration date that gives a shelf life more than five years.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you don't openite at (301) 594-4616. Additionally, for questions on the promotion connact also of your device, please contact the Office of Compliance at (301) 594-4639. Also, and advertising of your do rees, presso isbranding by reference to premarket notification"(21 CFR S807.97). 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,
Marcy Brogdon
Nancy C. Brogdon Director. Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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INDICATIONS FOR USE STATEMENT
NOV 0 9 2001
510(k) Number: K012665
Male Natural Rubber Latex Condom [No particular brand name] Device Name:
The [No particular brand name] condom is used for Indications For Use: contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR § 801.109) OR
Over-The-Counter Use
Counter Use
Nancy C. Hogdon
Division Sign-on
"sion of Reproduct · Radiological Devi . . (K) Number