(184 days)
The Mercator 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-walled with a reservoir tip; nominal length 180-mm, nominal width 52-mm, and nominal thickness 0.06mm. It is lubricated with silicone and cornstarch is used as a dressing material. The condom has either a smooth or textured (dotted and/or ribbed) surface. This condom is designed to conform to established national and international voluntary standards including ASTM D3492 and ISO 4074.
Here's an analysis of the provided text regarding acceptance criteria and study details for the Mercator Male Latex Condom:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly list a table of acceptance criteria with corresponding performance data from a specific study. Instead, it states that the device's design "is in conformance with ASTM Latex Condom Standard D3492" and "ISO 4074." These standards inherently contain acceptance criteria for various condom properties (e.g., burst strength, leakage, dimensions).
Therefore, the table below represents the implied acceptance criteria based on the referenced standards and the device's claim of conformance. The "Reported Device Performance" is inferred from the device's substantial equivalence claim and compliance with these standards.
| Acceptance Criteria Category (Implied from Standards) | Specific Acceptance Criteria (Example from D3492/ISO 4074) | Reported Device Performance (Inferred) |
|---|---|---|
| Dimensions | Nominal length, nominal width, nominal thickness (e.g., ASTM D3492 requirements) | Nominal length 180-mm, nominal width 52-mm, nominal thickness 0.06mm (Conforms to D3492 and ISO 4074) |
| Physical Properties (Water Leakage Test) | No leakage when subjected to specified test methods (e.g., ASTM D3492) | Conforms to ASTM D3492 and ISO 4074 (implies no leakage beyond acceptable limits) |
| Physical Properties (Burst Pressure/Volume) | Meets specified burst pressure and volume requirements (e.g., ASTM D3492/ISO 4074) | Conforms to ASTM D3492 and ISO 4074 (implies meeting burst strength) |
| Lubrication | Acceptable lubrication properties (e.g., type and amount) | Lubricated with silicone (Conforms to D3492 and ISO 4074) |
| Material | Made of natural rubber latex | Made of natural rubber latex (Conforms to D3492 and ISO 4074) |
| Absence of Defects | Free from holes, tears, and other visible defects | Conforms to ASTM D3492 and ISO 4074 |
| Packaging & Labeling | Conforms to relevant labeling regulations for expiry dating (per FDA letter) | Compliant with 21 CFR 801.435 (Expiration Dating), data maintained by manufacturer |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective) for the studies that demonstrate conformance to ASTM D3492 and ISO 4074. The submission primarily relies on the claim of conformance to established voluntary standards.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable or not provided in the context of this 510(k) notification. The evaluation of condom performance against standards like ASTM D3492 and ISO 4074 typically relies on standardized laboratory testing protocols, not expert consensus on individual "cases" in the medical sense.
4. Adjudication Method for the Test Set
This information is not applicable or not provided. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies involving interpretation of medical images or diagnostic results by human readers to establish a "ground truth" when a gold standard is not immediately available. For a device like a condom, performance is assessed through objective physical and material testing against predefined criteria in standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or mentioned. This type of study is relevant for diagnostic devices where human readers interpret data, often with and without AI assistance, to assess improvements in diagnostic accuracy. It is not relevant for a male latex condom.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
No, a standalone "algorithm only" study was not conducted or mentioned. This concept applies to AI/ML software as a medical device (SaMD) where the algorithm performs a diagnostic or predictive task without direct human intervention. This device is a physical medical device (condom), not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance, as established by its conformance to ASTM D3492 and ISO 4074, is based on objective, standardized physical and mechanical test results. For example:
- Physical Testing: Water leakage tests, burst pressure and volume tests using specialized equipment.
- Dimensional Measurements: Using calipers or other precision measuring tools.
- Material Analysis: Ensuring the material is natural rubber latex.
These tests are the "ground truth" for determining if the condom meets the performance requirements of the standards.
8. The Sample Size for the Training Set
This information is not applicable or not provided. "Training set" refers to data used to train an AI/ML algorithm. This device is a physical product, not an AI/ML system.
9. How the Ground Truth for the Training Set was Established
This information is not applicable or not provided for the reasons stated above (not an AI/ML device).
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OCT 3 1 2003
Abbreviated 510 (k) Notification for a Male Latex Condom
II. 510(k) SUMMARY
| Submitted By: | Anil J. JainDirector of OperationsMercator Healthcare Limited83-87, Mittal Tower, B-WingNariman Point, Mumbai MH 400 021India |
|---|---|
| Contact Person: | Eli J. CarterTechnical Consultant1219 Little Creek RoadDurham, NC 27713 |
| Date Prepared: | April 28, 2003 |
| Proprietary Name: | Various Brand Names |
| Common Name: | Male Latex Condom |
| Classification Name: | Male Latex Condom |
| Predicate Device: | INDUS Male Condom - K993693 |
| Description of Device: | This condom is made of a natural latex sheath, which completely covers the erect penis with a closely fitted membrane. This condom is straight-walled with a reservoir tip; nominal length 180-mm, nominal width 52-mm, and nominal thickness 0.06mm. It is lubricated with silicone and cornstarch is used as a dressing material. The condom has either a smooth or textured (dotted and/or ribbed) surface. This condom is designed to conform to established national and international voluntary standards including ASTM D3492 and ISO 4074. |
| 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 condom identified above. The design is in conformance with ASTM Latex Condom Standard D3492 and that the condom is made of natural |
rubber latex.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure in profile, composed of three curved lines. The figure is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 31 2003
Mercator Healthcare Limited % Mr. Eli J. Carter Technical Consultant 1219 Little Creek Road DURHAM NC 27713
Re: K031369
Trade Name/Device: Male Latex Condom Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: HIS Dated: September 4, 2003 Received: September 9, 2003
Dear Mr. Carter:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed
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predicate device results in a classification for your device and thus, permits your device to proceed to the market.
Please be advised that, as of March 25, 1998, labeling for latex condoms (21 CFR §884.5300 and §884.5310) must comply with Use Labeling for Latex Condoms: Expiration Dating, 21 CFR 801.435. Therefore, an expiration date, supported by test data developed under the conditions specified in $801.435(d), must be displayed prominently and legibly on condom labeling. For condoms with spermicidal lubricant, the effective shelf life of the spermicide must be compared with the shelf life of the condom and labeled with the earlier of the two expiration dates. Although supporting data is not to be provided in your 510(k) submission, §801.435(i) requires that you maintain this data and that it be available for inspection by FDA. Furthermore, §801.435(e) requires that if your real-time test data fails to confirm the shelf life estimated by the methods in §801.435(d), then you must relabel all product to reflect the actual shelf life. Condoms are not to be labeled with an expiration date that gives a shelf life more than five years.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4616. 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/dsma/dsmamain.html".
Sincerely yours,
David A. Leggman
for
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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INDICATIONS FOR USE STATEMENT VII.
| 510(k) Number | Not Known K031369 |
|---|---|
| Device Name | Male Natural Rubber Latex Condom |
| Indications for Use: | The Mercator male latex condom is used for contraceptive and forprophylactic purposes (to help prevent pregnancy and the transmissionof 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 OR Over-the-Counter Use 1 (Per 21 CFR 801.109)
David A. Bergman
(Division Sign-Off)
Division of Reproductive, Abdominal. and Radiological Devic 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.