(529 days)
The Thai Nippon Male Latex Condom is used for contraception 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 erect penis with a closely fitted membrane. This condom is colorless, smooth, flared at the closed end with a reservoir tip; nominal lav flat width 56mm, nominal length 200 mm, and nominal thickness 0.07mm. It is lubricated with silicone (viscosity 250 cps), and cornstarch is used as a dressing material. This condom conforms to current established national and international voluntary standards including ASTM D3492:2008 and ISO 4074:2002.
The provided text is a 510(k) summary for a male latex condom. It does not describe a study involving an algorithm or AI. Therefore, it is not possible to extract information about acceptance criteria or a study that proves a device meets acceptance criteria in the context of AI or algorithm performance, nor can I provide details related to sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance of an algorithm.
The document discusses the substantial equivalence of their male latex condom to a predicate device, focusing on its physical characteristics and adherence to established industry standards for condoms (ASTM D3492:2008 and ISO 4074:2002).
However, I can extract the acceptance criteria (standards) that the physical device is designed to meet as per the document's reference to industry standards:
| Acceptance Criteria (Standard) | Reported Device Performance (Conformance) |
|---|---|
| ASTM D3492:2008 | Conforms |
| ISO 4074:2002 | Conforms |
Further information regarding this specific device:
- Sample size used for the test set and the data provenance: Not applicable to an AI or algorithm study in this context. The document implicitly refers to testing done to conform to the ASTM and ISO standards, but does not provide specific sample sizes or data provenance for these physical tests.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is a physical product and not an AI or algorithm.
- Adjudication method for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: For a physical condom, "ground truth" would be established by physical testing against the parameters defined in the ASTM and ISO standards (e.g., burst pressure, leakage, dimensions).
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a regulatory submission for a physical medical device (male latex condom) and does not contain information relevant to AI or algorithm performance studies.
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Abbreviated 510 {k} Notification for a Male Latex Condom
I. 510(k) SUMMARY
Submitted By: Thai Nippon Rubber Industry Co., Ltd. Laem Chabang Industrial Estate, 49-49/1 Export Processing Zone 1 Thungsukla, Sriracha, Chonburi Thailand
66 38 490258 Tel: Fax: 66 38 490414 Email: tnrfact(@tnrcondom.com
Contact Person: Eli J. Carter, Consultant PO Box 12139 Durham. NC 27709 Tel: 919 544 4098; Fax: 919 544 5849 Email: carterej@aol.com
Date Prepared: April 28, 2008
Proprietary Name: None
Common Name: Male Latex Condom: Flared, 56mm (nominal width)
Classification Name: Male Latex Condom
Predicate Devices: Church & Dwight Male Latex Condom - K001212
Description of Device:
This condom is made of a natural rubber latex sheath, which completely covers the erect penis with a closely fitted membrane. This condom is colorless, smooth, flared at the closed end with a reservoir tip; nominal lav flat width 56mm, nominal length 200 mm, and nominal thickness 0.07mm. It is lubricated with silicone (viscosity 250 cps), and cornstarch is used as a dressing material. This condom conforms to current established national and international voluntary standards including ASTM D3492:2008 and ISO 4074:2002.
OCT 1 6 2009
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Intended Use of the Device:
This latex condom has the same intended use as the predicate condom. 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. It is made from natural rubber latex and the design is in conformance with current versions of ASTM D3492 and ISO 4074 Male Latex Condom Standards. The Thai Nippon condom is designed with a wider width of 56mm for the man who needs a larger size condom. This condom is intended for men who feel that current regular size condoms are too small.
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of an abstract symbol, possibly representing a person or a flame.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Thai Nippon Rubber Industry c/o Mr. Eli Carter Consultant Eli Carter and Associates PO Box 12139 DURHAM NC 27709
OCT 1 6 2009
Re: K081265
Trade/Device Name: Thai Nippon Malc Latex Condom 56mm (nominal width), flared, Colorless, silicone lubricated
Regulation Number: 21 CFR §884.5300 Regulation Name: Condom Regulatory Class: II Product Code: HIS Dated: September 28, 2009 Received: October 5, 2009
Dear Mr. Carter:
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 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. 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
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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/ucm115809.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/ReportaProblem/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/Resourcesfor You/Industry/default.htm.
Singerely 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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Information for a Male Latex Condom 510(k) Submission
II. INDICATIONS FOR USE STATEMENT
K081265 510(k) Number:
Device Name:
Thai Nippon Male Latex Condom 56mm (nominal width), flared, colorless, silicone lubricated
Indications for Use: The Thai Nippon Male Latex Condom is used for 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 NEED Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Over-the-Counter Use or
X
formh
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 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.