(65 days)
The NRS Global Partners male latex 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 latex sheath, which completely covers the erect penis with a closely fitted membrane. This condom is straight sided, contoured or flared in shape, either textured or non-textured, with a reservoir tip; nominal length 180-mm, nominal width 53-mm, and nominal thickness 0.07mm. It is lubricated with silicone or Astroglide™, and USP grade cornstarch is used as a dressing material. This condom is designed to conform to established national and international voluntary standards including ASTM D3492 and ISO 4074. This condom is identical to the predicate device with respect to design, physical properties, and formulation.
The provided document is a 510(k) premarket notification for a male latex condom. It is a regulatory submission for a medical device and, therefore, does not contain information about a clinical study with acceptance criteria, device performance, sample sizes, expert ground truth, or MRMC studies in the context of AI/algorithm performance.
Instead, the submission aims to demonstrate "substantial equivalence" to a legally marketed predicate device (Innolatex Male Latex Condom; K002393). This typically involves showing that the new device has the same intended use and technological characteristics as the predicate device, and that any differences do not raise new questions of safety or effectiveness.
The "acceptance criteria" in this context would generally refer to the standards that the condom must meet (e.g., burst strength, freedom from holes) to be considered safe and effective, as outlined in recognized national and international voluntary standards like ASTM D3492 and ISO 4074. The "device performance" would be the results of testing conducted against these standards.
Here's how to interpret the request in the context of this document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states: "This condom is designed to conform to established national and international voluntary standards including ASTM D3492 and ISO 4074." and "The design is in conformance with ASTM Latex Condom Standard D3492 and that the condom is made of natural rubber latex."
This indicates that the acceptance criteria are defined by these standards. However, the specific quantitative pass/fail criteria (e.g., minimum burst volume, maximum number of holes per batch) and the actual test results (reported device performance) are not provided in this summary document. Such data would typically be found in the full 510(k) submission, not in the summary or the FDA's decision letter.
2. Sample Sizes Used for the Test Set and Data Provenance:
Not applicable in the context of an AI/algorithm study. The document only references conformance to standards, which would involve testing batches of condoms. No details are given about the number of condoms tested or their origin.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. This is not a study involving expert annotation or ground truth generation in the way an AI study would.
4. Adjudication Method:
Not applicable.
5. MRMC Comparative Effectiveness Study:
Not applicable. This is not an AI-assisted diagnostic device.
6. Standalone (Algorithm Only) Performance:
Not applicable. This is a physical medical device, not an algorithm.
7. Type of Ground Truth Used:
For a latex condom, "ground truth" would be established through physical and mechanical testing against predefined standards (e.g., burst tests, leak tests, dimensional measurements, shelf-life studies). The document implies that such testing was done ("conformance with ASTM Latex Condom Standard D3492"), but does not detail the specific results or the methodology for establishing the "truth" beyond adherence to these standards.
8. Sample Size for the Training Set:
Not applicable. Condoms are not "trained" in the AI sense. The manufacturing process is validated and controlled, and batches are tested for quality.
9. How the Ground Truth for the Training Set Was Established:
Not applicable.
Summary based on the provided text:
The document states that the male latex condom is designed to conform to and is in conformance with ASTM D3492 and ISO 4074 voluntary standards. These standards define the acceptance criteria for various physical and mechanical properties of latex condoms (e.g., burst volume and pressure, dimensions, freedom from holes). However, the specific quantitative "acceptance criteria" from these standards and the "reported device performance" (i.e., the actual test results demonstrating conformance) are not detailed in this 510(k) summary. The submission's core assertion is that the device is "identical to the predicate device with respect to design, physical properties, and formulation," implying that its performance would be substantially equivalent and therefore also conform to these established standards.
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Abbreviated 510 (k) Notification for a Male Latex Condom
APR 8
2005
Page 5 of 13
| 510(k) SUMMARY | |
|---|---|
| Submitted By: | NRS Global Partners Sdn BhdNo. 30, Jalan 3/146, Bandar Tasik Selatan5700 Kuala Lumpur, Malaysia |
| Contact Persons: | Eli J. Carter, Consultant1219 Little Creek RoadDurham, NC 27713 |
| Mr. Anthony Tan Jian LoongChief Operating OfficerNRS Global Partners Shn Bhd | |
| Date Prepared: | January 31, 2005 |
| Proprietary Name: | None |
| Common Name: | Male Latex Condom |
| Classification Name: | Male Latex Condom |
| Predicate Device: | Innolatex Male Latex Condom; K002393 |
| Description of Device: | This condom is made of a natural latex sheath, which completelycovers the erect penis with a closely fitted membrane. This condom isstraight sided, contoured or flared in shape, either textured or non-textured, with a reservoir tip; nominal length 180-mm, nominal width53-mm, and nominal thickness 0.07mm. It is lubricated with siliconeor Astroglide™, and USP grade cornstarch is used as a dressingmaterial. This condom is designed to conform to established nationaland international voluntary standards including ASTM D3492 and ISO4074. |
| This condom is identical to the predicate device with respect todesign, physical properties, and formulation. | |
| 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 tohelp prevent pregnancy and the transmission of sexually transmitteddiseases, including HIV. |
| Technological Characteristics: | This condom has the same technological characteristics as the predicatecondom identified above. The design is in conformance with ASTMLatex Condom Standard D3492 and that the condom is made of naturalrubber latex. |
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Image /page/1/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NRS Global Partners Sdn Bhd % Mr. Eli Carter Consultant 1219 Little Creek Rd. DURHAM NC 27713
Re: K050244
2005
APR 8
Trade/Device Name: Male Natural Latex Condom Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: HIS Dated: January 31, 2005 Received: February 4, 2005
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 (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.
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.
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This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and in your finding of substantial equivalence of your device to a legally promated modicate 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 11 you done 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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Page 11 of 13
INDICATIONS FOR USE
| 510(k) Number: | Not Known K050244 |
|---|---|
| Device Name: | Male Natural Rubber Latex Condom |
| Indications for Use: | The NRS Global Partners male latex condom is used for contraceptiveand for prophylactic purposes (to help prevent pregnancy and thetransmission of sexually transmitted diseases) |
Prescription Use (Per 21 CFR 801 Subpart D) OR
Over-the-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C Brogdon
(Division Sign-Off) Division of Reproductive, Abdominal, And Radiological Devices
510(k) Number K050244
§ 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.