(43 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 walled, contoured or flared with a reservoir tip; nominal length 180mm, nominal width 53mm, and nominal thickness 0.06mm. It is lubricated with silicone and cornstarch is used as a dressing material. The condom is colored and 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) summary for a male latex condom. It does not present a study with acceptance criteria and device performance results in the way a typical AI/software device would.
Instead, it focuses on demonstrating substantial equivalence to a predicate device by comparing technological characteristics and adherence to established standards for safety and performance of condoms.
Therefore, many of the requested categories for AI/software devices (like sample size for test/training sets, experts for ground truth, adjudication methods, MRMC studies, standalone performance) are not applicable to this type of medical device submission.
However, I can extract the relevant information regarding acceptance criteria and the methods used to show compliance for this specific device.
Acceptance Criteria and Reported Device Performance
For this male latex condom, the "acceptance criteria" are compliance with established national and international voluntary standards, and the reported "device performance" is its demonstration of conforming to these standards. The device is also evaluated for biocompatibility and oral toxicity of its components.
| Acceptance Criteria / Standard | Reported Device Performance / Compliance |
|---|---|
| ASTM D3492 (Latex Condom Standard) | The device is "designed to conform to established national and international voluntary standards including ASTM D3492." The technological characteristics section explicitly states, "The design of this condom is in conformance with ASTM Latex Condom Standard D3492." |
| ISO 4074 (Natural latex condoms) | The device is "designed to conform to established national and international voluntary standards including... ISO 4074." |
| ISO 10993 Biocompatibility (cytotoxicity, sensitization) | 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." |
| Acceptable limits for oral toxicity | The color pigments and flavorings "have also been evaluated as part of the Predicate Device formulations... and compliant with acceptable limits for oral toxicity." |
| Substantial Equivalence to Predicate Device (K041837) | The FDA reviewed the 510(k) and "determined the device is substantially equivalent... to legally marketed predicate devices." This implies that the device performs similarly to the predicate device in terms of safety and effectiveness for its intended use. |
As this is a physical medical device (condom) and not an AI/software device, the following points are largely not applicable or cannot be extracted from the provided text.
2. Sample size used for the test set and the data provenance:
- Not applicable in the context of AI/software testing. For physical devices like condoms, testing involves batch sampling and physical/chemical tests. The specific sample sizes for material conformance or performance tests (e.g., burst tests) are not detailed in this summary but would be part of the underlying design control documentation. The data provenance would be from manufacturing and testing facilities.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth for a physical product's performance against industry standards is established through standardized testing methodologies, not expert consensus on interpretations.
4. Adjudication method for the test set:
- Not applicable. Standardized tests yield objective results (e.g., a burst pressure, a chemical concentration), not subjective interpretations requiring adjudication.
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 type of study is specific to AI-assisted human interpretation in diagnostic or screening tasks.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. There is no algorithm or software component described that would operate in a standalone manner.
7. The type of ground truth used:
- The "ground truth" here is compliance with established national and international voluntary standards (ASTM D3492, ISO 4074) for condom performance and biocompatibility and toxicity requirements (ISO 10993) for materials. This is based on objective measurements and established thresholds derived from scientific understanding and extensive testing in the field.
8. The sample size for the training set:
- Not applicable. There is no AI/machine learning component requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable. There is no AI/machine learning component.
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Page 4 of 14
2007 MAY 8
| II 510(k) SUMMARY | |||||
|---|---|---|---|---|---|
| Submitted by : | Karex Industries Sdn. Bhd.PTD. 7906 & 7907Taman Pontian Jaya,Bt. 34 Jalan Johor,82000 Pontian,Johor, Malaysia. | ||||
| Contact Persons : | Mr. Leng Kian GohGeneral ManagerKarex Industries Sdn. Bhd.E-mail: lk@karex.com.my | Mary GohQuality Assurance ManagerKarex Industries Sdn. Bhd.mary@karex.com.my | |||
| Date Prepared : | March 7, 2007. | ||||
| Proprietary Name : | N/A. | ||||
| Common Name : | Male Latex Condom | ||||
| Classification Name : | Male latex Condom | ||||
| Predicate Device : | Latex Lubricated CondomInnolatex Sdn. Bhd.510(k) Number = K041837 | ||||
| Description of Device: | This condom is made of a natural rubber latex sheath, whichcompletely covers the penis with a closely fitted membrane.This condom is straight walled, contoured or flared with areservoir tip; nominal length 180mm, nominal width 53mm,and nominal thickness 0.06mm. It is lubricated with siliconeand cornstarch is used as a dressing material. The condom iscolored and flavored, and designed to conform to establishednational and international voluntary standards including ASTMD3492 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 predicatecondoms. The condom is used for contraception and forprophylactic purposes to help prevent pregnancy and thetransmission of sexually transmitted diseases, including HIV. |
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Technological Characteristics: This condom has the same technological characteristics and use the same color pigments and flavorings (scents) 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 | 19140:1 | 12225-21-7 |
| Colanyl Red FGRG 100 | 15850:1 | N/A |
| Colanyl Green GG 131 | 77289 | 12001-99-9 |
| Colanyl Brown BM 100-ID | 77499 | 1317-61-9 |
Flavorings Description
| Banana | Banana Flavor Concentrate #8500 |
|---|---|
| Strawberry | Strawberry Flavor Concentrate #4837 |
| Mint | Peppermint Flavor Oil #4608 |
| Chocolate | 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.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows a circular seal with text around the perimeter and a stylized eagle in the center. The text around the perimeter reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The eagle in the center is depicted with three curved lines representing its body and wings.
MAY 8 2007
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Mr. Leng Kian Goh General Manager Karex Industries Sdn. Bhd. PTD. 7906 & 7907 Taman Pontian Jaya Bt. 34. Jalan Johor 82000 Pontian JOHOR MALAYSIA
K070830 Re:
Trade/Device Name: Non-spermicidal Lubricated Male Latex Condom Colored and Scented Regulation Number: 21 CFR §884.5300 Regulation Name: Condom Regulatory Class: II Product Code: HIS Dated: March 7, 2007 Received: March 26, 2007
Dear Mr. 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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/2/Picture/10 description: The image is a circular logo or seal, likely commemorating a centennial. The text "1906-2006" is at the top, indicating a 100-year period. The letters "FDA" are prominently displayed in the center, suggesting it is related to the Food and Drug Administration. The word "Centennial" is written below the letters, and three stars are underneath that. The text "Science at Your Service and Around" is written around the bottom of the circle.
Protecting and Promoting Public Health
{3}------------------------------------------------
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 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.
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.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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
Enclosure
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K07C836
Abbreviated 510(k) Notification for a Male latex Condom
Page 11 of 14
INDICATIONS FOR USE STATEMENT VII
| 510(k) Number | Not Known K070850 |
|---|---|
| Device Name | Male Natural Rubber Latex Condom (with Coloring and Flavoring) |
| 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
Nancy C. Broadon
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device
Radiological Devices
510(k) Number K70830
§ 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.