(219 days)
The Karex condom is used for contraceptive and for Prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This condom is straight sided or contoured , textured or non textured ,with a reservoir tip; nominal length 180mm, nominal width 53mm, and nominal thickness 0.07mm. It is nonlubricated or lubricated with silicone and cornstarch is used as a dressing material. The condom is either colored or non colored, flavored or non flavored, and designed to conform to established national and international voluntary standards including ASTM D3492 and ISO 4074.
The provided text describes a 510(k) premarket notification for a Male Natural Rubber Latex Condom, not a device that utilizes AI or requires complex studies with ground truth or expert adjudication to establish performance. The document focuses on demonstrating substantial equivalence to pre-existing predicate devices.
Therefore, many of the requested categories (such as sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable to this type of regulatory submission. The performance criteria for a condom are physical and biological, verified through laboratory testing and material analysis, rather than clinical or AI-based assessments.
Here's how the information that is applicable can be extracted and presented, with explanations for the non-applicable sections:
Acceptance Criteria and Device Performance for Male Latex Condom
The acceptance criteria for this male latex condom are based on conformance to established national and international voluntary standards, specifically ASTM D3492 and ISO 4074, for its physical properties and biocompatibility. The performance is demonstrated by stating compliance with these standards and by establishing substantial equivalence to predicate devices that have already met these standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria / Standards Achieved | Reported Device Performance |
|---|---|---|
| Physical Characteristics & Design | Conformance to ASTM D3492 and ISO 4074 for nominal length (180mm), nominal width (53mm), nominal thickness (0.07mm), shape (straight-sided or contoured), texture (textured or non-textured), and reservoir tip. | The device's design (length, width, thickness, shape, texture) is stated to be in conformance with ASTM D3492 and ISO 4074. It is described as having a reservoir tip. |
| Material Composition | Made of natural rubber latex. | Made of a natural rubber latex sheath. |
| Lubrication/Dressing Material | Non-lubricated or lubricated with silicone; cornstarch used as dressing material. | Non-lubricated or lubricated with silicone and cornstarch is used as a dressing material. |
| Biocompatibility | Conformance with ISO 10993 for cytotoxicity and sensitization. Color pigments and flavorings compliant with ISO 10993 and acceptable limits for oral toxicity. | The base formula was evaluated and confirmed to be in conformance with ISO 10993 biocompatibility requirements for cytotoxicity and sensitization. Color pigments and flavorings have also been evaluated and confirmed to be compliant with ISO 10993 and acceptable limits for oral toxicity. |
| Colors and Flavorings (Safety) | Use of specific color pigments (Colanyl Yellow FGL 130, Colanyl Red FGRG 100, Colanyl Green GG 131, Colanyl Brown BM 100-ID) and flavorings (Banana Flavor Concentrate #8500, Strawberry Flavor Concentrate # 4837, Peppermint Flavor Oil #4608, Chocolate Flavor Oil # 2141) with confirmed compliance to ISO 10993 and oral toxicity limits. | The specific color pigments and flavorings listed are confirmed to be compliant with ISO 10993 and oral toxicity limits, as part of predicate device formulations. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated in the provided text. For physical and biocompatibility testing of condoms, various sample sizes would be used for each specific test (e.g., burst tests, tensile strength, cytotoxicity). These are typically defined by the standards (ASTM D3492, ISO 4074) themselves.
- Data Provenance: The device manufacturer, Karex Industries Sdn. Bhd., is based in Johor, Malaysia. The testing would have been conducted by or for this company, likely in Malaysia or accredited labs adhering to international standards. The evaluation of color pigments and flavorings is noted to have occurred "as part of the Predicate Device formulations," implying reliance on prior data or testing reports for those components.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. For a male latex condom, "ground truth" is established through standardized laboratory testing against international specifications (ASTM, ISO), rather than expert consensus on clinical or imaging data. The experts involved would be engineers, chemists, and quality assurance specialists performing the tests according to the established protocols.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 typically apply to interpretation of complex data (e.g., medical images) by multiple human readers. For condom testing, results are objective measurements (e.g., burst pressure, elongation, presence/absence of cytotoxic effects) that either meet or fail the specified criteria.
5. 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
Not applicable. This is a medical device (condom) and not an AI-powered diagnostic or assistive tool. MRMC studies are irrelevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. There is no algorithm involved in the performance of a latex condom.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is based on objective measurements from physical, chemical, and biological laboratory tests against the specific requirements and thresholds defined by international and national standards (ASTM D3492, ISO 4074, ISO 10993). This is analogous to a standard for a material property, rather than an interpretation of complex data.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI model, this question is not relevant.
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FEB - 6 2009
Page 5 of 22
1081886
Abbreviated 510(k) Notification for a Male Latex condom
II 510(k) SUMMARY
Submitted by :
Karex Industries Sdn. Bhd. PTD. 7906 & 7907 Taman Pontian Jaya, Bt. 34 Jalan Johor, 82000 Pontian, Johor, Malaysia.
Mr. Leng Kian Goh
Karex Industries Sdn. Bhd.
E-mail: Ik(@karex.com.my
General Manager
December 9, 2008.
Contact Persons :
Date Prepared :
Proprietary Name :
Common Name : Male Latex Condom
N/A.
Classification Name : Male latex Condom
Predicate Devices :
Latex Lubricated Condom Innolatex Sdn. Bhd. 510(k) Number = K012962 510(k) Number = K010919 510(k) Number = K053367
(Dotted Condoms) (Ribbed Condoms) (Non Lubricated Condoms)
Mary Goh
Quality Assurance Manager
Karex Industries Sdn. Bhd.
Karex Industries Sdn. Bhd. 510(k) Number=K070830
(Colored and Flavored Condoms)
Dongkuk Techco Rubber Industries 510(k) Number = K002060 (Ribbed, Dotted & Contoured)
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Description of Device:
This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This condom is straight sided or contoured , textured or non textured ,with a reservoir tip; nominal length 180mm, nominal width 53mm, and nominal thickness 0.07mm. It is nonlubricated or lubricated with silicone and cornstarch is used as a dressing material. The condom is either colored or non colored, flavored or non flavored, and designed to conform to established national and international voluntary standards including ASTM D3492 and ISO 4074.
Condoms will be offered in the following Color and Flavor. Combinations : Color Flavor
| 1. | Yellow | Banana |
|---|---|---|
| 2. | Red | Strawberry |
| 3. | Green | Mint |
| 4. | Brown | Chocolate |
Intended Use of the Device:
This latex condom has the same intended use as the predicate condoms. The condom is used for contraception and for prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted diseases, including HIV.
Technological Characteristics:
This condom has the same technological characteristics as the predicate condoms identified above. The following Table provides a description of these colors and flavorings. The design of this condom is in conformance with ASTM Latex Condom Standard D3492 and the condom is made of natural rubber latex.
| Color Pigments | CI No. | CAS No. |
|---|---|---|
| Colanyl Yellow FGL 130 | 11767 | 12225-21-7 |
| Colany! Red FGRG 100 | 15850: 1 | N/A |
| Colanyl Green GG 131 | 77260 | 12001-99-9 |
| Colanyl Brown BM 100-ID | 77499 | 1317-61-9 |
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Flavorings
Description
Banana Strawberry Mint Chocolate
Banana Flavor Concentrate #8500 Strawberry Flavor Concentrate # 4837 Peppermint Flavor Oil #4608 Chocolate Flavor Oil # 2141
The base formula was evaluated and confirmed to be in conformance with ISO 10993 biocompatibility requirements for cytotoxicity, and sensitization. The color pigments and flavorings have also been evaluated as part of the Predicate Device formulations and have been confirmed to be compliant with ISO 10993; and compliant with acceptable limits for oral toxicity.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized emblem featuring three abstract shapes that resemble human figures or flowing lines. The emblem is black, and the text is also in black.
FEB - 6 2009
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Mary Goh QA Manager Karex Industries SDN. BHD. PTD. 7906 & 7907 Taman Pontian Jaya Bt. 34 Jalan Johor, 82000 Pontian, Johor MALAYSIA
Re: K081886
Trade/Device Name: Male Natural Rubber Latex Condom
(Straight sided or Contoured in shape, either Textured or Non-Textured, Lubricated or Non-Lubricated, Non-colored or Colored and Flavored or Non-Flavored)
Regulation Number: 21 CFR §884.5300
Regulation Narne: Condom Regulatory Class: II Product Code: HIS Dated: January 22, 2009 Received: January 26, 2009
Dear Ms. Goh:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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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. 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; 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding os 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | (240) 276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | (240) 276-0115 |
| 21 CFR 892.xxx | (Radiology) | (240) 276-0120 |
| Other | (240) 276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry.suppot/index.html.
Sincerely yours,
Janine M. Morris
Acting Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Abbreviated 510(k) Notification for a Male latex Condom
INDICATIONS FOR USE STATEMENT VII
510(k) Number K081886
Device Name
Male Natural Rubber Latex Condom . (Straight sided or Contoured in shape, either Textured or Non-Textured, Lubricated or Non-Lubricated, Non-colored or Colored and Flavored or Non-Flavored).
Indications for Use:
Indications for Use: The Karex condom is used for contraceptive 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 NEED Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-the-Counter Use
X
Arzu K. Wum
(Division Sign-Off) Division of Reproductive. Abdominal. and Radiological Devi
510(k) Number.
§ 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.