(98 days)
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Not Found
No
The 510(k) summary describes condoms and their intended use for contraception and disease prevention. There is no mention of AI, ML, image processing, or any other technology that would suggest the use of AI/ML.
No.
The document states the device is used for contraceptive and prophylactic purposes, not for treating a disease or condition.
No
The device, a condom, is described for contraceptive and prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases), not for diagnosing conditions.
No
The device described is a physical medical device (condoms) and does not involve any software component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of the Black Colored Condoms is clearly stated as "for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases)." This is a physical barrier method used externally.
- Definition of IVD: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Lack of IVD Characteristics: The provided information does not mention any testing of biological samples, analysis of bodily fluids, or any diagnostic purpose.
Therefore, based on the provided information, these condoms are not IVDs. They are medical devices, but they fall under a different category (likely Class II medical devices for contraception and disease prevention).
N/A
Intended Use / Indications for Use
Black Colored Condoms [Parallel Sided or Contoured or Flared or Non-textured, Lubricated or Non-lubricated] a) Parallel sided smooth, 53mm Black colored condom b) Parallel sided dotted, 53mm Black colored condom c} Parallel sided ribbed, 53mm Black colored condom d) Parallel sided smooth, 56mm Black colored condom e) Contoured studded, 53mm Black colored condom f) Contoured ribbed & studded, 53mm Black colored condom g) Contoured ribbed, 52mm Black colored condom h) Flared smooth, 56mm Black colored condom The Karex condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
Product codes
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 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 25, 2013
Karex Industries Sdn. Bhd. Mary Goh Yin Quality Assurance Director PTD 7906 & 7907, Taman Pontian Jaya, Batu 34, Jalan Johor Pontian Johor Darul Takzim 82000 Malaysia
K132597 Re:
Trade/Device Name: Black Colored Condoms Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: HIS Dated: September 5, 2013 Received: October 1, 2013
Dear Mary Goh Yin,
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
1
Page 2 - Mary Goh Yin
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 1 1 5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm.
Sincerely yours,
Herbert P. Lerner -S
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known) K132597
Device Name Black Colored Condoms
Indications for Use (Describe)
Black Colored Condoms [Parallel Sided or Contoured or Flared or Non-textured, Lubricated or Non-lubricated]
a) Parallel sided smooth, 53mm Black colored condom
b) Parallel sided dotted, 53mm Black colored condom
c} Parallel sided ribbed, 53mm Black colored condom
d) Parallel sided smooth, 56mm Black colored condom
e) Contoured studded, 53mm Black colored condom
f) Contoured ribbed & studded, 53mm Black colored condom
g) Contoured ribbed, 52mm Black colored condom
h) Flared smooth, 56mm Black colored condom
The Karex condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
Type of Use (Select one or both, as applicable)
] Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY ·
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)