(88 days)
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Not Found
No
The 510(k) summary describes a simple physical device (a condom) and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML.
No.
The primary stated uses are contraception and prevention of STD transmission, which are not considered therapeutic actions.
No
The device is described as a condom used for contraception and prevention of STDs, which are prophylactic purposes, not diagnostic. There is no indication that it measures, detects, or monitors any health condition.
No
The device description clearly states it is a "Male Latex Condom," which is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for contraception and prevention of sexually transmitted diseases. This is a physical barrier method used in vivo (within the body), not a test performed in vitro (outside the body) on biological samples to diagnose or monitor a condition.
- Device Description: The description is of a physical barrier device (a condom).
- Lack of IVD Characteristics: The document lacks any mention of typical IVD characteristics such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing diagnostic or monitoring information
Therefore, this device falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
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
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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): 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.
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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.
0
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 Pingiran Subang, Shah Alam, Selangor Darul Ehsan, MALAYSIA
Re: K012664
Trade Name: Ultra Thick Male Latex Condom with Silicone Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulation 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 above and we 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 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 (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
Page 2 - Mr. Ah-Kau
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 Electronic Product 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.
Please be advised that, as of March 25, 1998, labeling for latex condoms (21 CFR §884.5300 and §884.5310) must comply with Use Labeling for Latex Condoms: Expiration Dating, 21 CFR $801.435. Therefore, an expiration date, supported by test data developed under the conditions specified in §801.435(d), must be displayed prominently and legibly on condom labeling. For condoms with spermicidal lubricant, the effective shelf life of the spermicide must be compared with the shelf life of the condom and labeled with the earlier of the two expiration dates. Although supporting data is not to be provided in your 510(k) submission, §801.435(j) requires that you maintain this data and that it be available for inspection by FDA. Furthermore, §801.435(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.
Condoms are not to be labeled with 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 contact the Office of Compliance at (301) 594-4616. 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 §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
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NOV 0 9 2001 INDICATIONS FOR USE STATEMENT
KD12664
510(k) Number: K012664
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
unter Use
Nancy Richardson
(Division S Division of Re and Radiological D 510(k) Number