(98 days)
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).
Not Found
The provided text is related to the FDA's acceptance of "Black Colored Condoms" by Karex Industries Sdn. Bhd. for marketing. It is a 510(k) premarket notification, which establishes substantial equivalence to a legally marketed predicate device.
This document is not a study report for a medical device that uses algorithms or AI, so many of the requested criteria are not applicable. This document is for a physical product (condoms), not a software-based medical device.
Therefore, I cannot provide information for most of the requested points, as they pertain to the evaluation of AI/algorithm-based medical devices. However, I can extract the relevant information from the provided text.
Here's the information that can be extracted or deduced:
1. A table of acceptance criteria and the reported device performance
Based on the document, the "acceptance criteria" are not explicitly stated in a quantitative performance table like one would expect for an AI/algorithm. Instead, the acceptance is based on meeting regulatory requirements and demonstrating "substantial equivalence" to a predicate device. The performance is implied by the generic indications for use of condoms.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device | The FDA determined the device is substantially equivalent to legally marketed predicate devices. |
| Indications for Use: | |
| Contraceptive Purposes | "The Karex condom is used for contraceptive purposes (to help prevent pregnancy...)" (Implied performance consistent with predicate condoms) |
| Prophylactic Purposes (STD prevention) | "...and for prophylactic purposes (to help prevent...the transmission of sexually transmitted diseases)." (Implied performance consistent with predicate condoms) |
| Physical Characteristics: | Black Colored Condoms |
| Parallel sided smooth, 53mm black colored condom | |
| Parallel sided dotted, 53mm black colored condom | |
| Parallel sided ribbed, 53mm black colored condom | |
| Parallel sided smooth, 56mm black colored condom | |
| Contoured studded, 53mm black colored condom | |
| Contoured ribbed & studded, 53mm black colored condom | |
| Contoured ribbed, 52mm black colored condom | |
| Flared smooth, 56mm black colored condom |
For the following points (2-9), the information is not present in the provided document because it describes the regulatory clearance of a physical consumer product (condoms), not an AI/algorithm medical device study.
-
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- N/A. This document does not describe a study involving a test set of data for an AI/algorithm.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- N/A. This document does not describe a study involving experts establishing ground truth for an AI/algorithm.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. This document does not describe a study involving adjudication for an AI/algorithm.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- N/A. This is not an AI/algorithm device.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is not an AI/algorithm device.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- N/A. This document does not describe a study involving ground truth for an AI/algorithm. For condoms, performance is typically assessed through physical testing methods (e.g., burst tests, water leak tests) and clinical studies for efficacy. These details are not in this 510(k) letter.
-
The sample size for the training set
- N/A. This document does not describe an AI/algorithm device with a training set.
-
How the ground truth for the training set was established
- N/A. This document does not describe an AI/algorithm device with a training set.
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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.
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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
{2}------------------------------------------------
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)
§ 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.