(88 days)
The Durex 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 penis with a closely fitted membrane. This condom is nipple-ended with minimal dimensions of Width: 52 mm, Length: 160 mm min., Thickness: 0.03 mm min.
This document is not a study; it is a 510(k) premarket notification for a medical device. A 510(k) submission demonstrates that a device is "substantially equivalent" to a legally marketed predicate device, rather than proving its safety and effectiveness through clinical trials. Therefore, the information requested in the prompt regarding acceptance criteria, study design, and performance metrics is not directly applicable or available within this type of regulatory document.
However, based on the provided text, I can infer some aspects related to "acceptance criteria" through the lens of substantial equivalence and identify what is being presented as "device performance."
Here's an interpretation based on the 510(k) submission:
1. Table of Acceptance Criteria and Reported Device Performance
For a 510(k), "acceptance criteria" are not performance metrics in the clinical sense, but rather a demonstration that the new device shares the same fundamental scientific technology and intended use as the predicate device, and any differences do not raise new questions of safety or effectiveness. The "device performance" in this context refers to the characteristics that maintain substantial equivalence.
| Acceptance Criterion (for Substantial Equivalence) | Reported Device Performance (Characteristics) |
|---|---|
| Intended Use: Same as predicate device (contraception and STD prevention). | The Durex Sensidom Male Latex Condom has the same intended use as the predicate: "for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases)." |
| Technological Characteristics: Same fundamental technology as predicate, in conformance with relevant standards (ASTM D3492). | The device has "the same technological characteristics as the predicate device" and its design is in conformance with "ASTM Latex Condom Standard D3492." It is made of natural rubber latex. |
| Physical Dimensions: Equivalent to predicate device. | - Width: 52 mm- Length: 160 mm min.- Thickness: 0.03 mm min.The document states it has "the same dimensions" as the predicate. |
| Material: Same as predicate device (natural rubber latex). | "made of a natural rubber latex sheath." |
| Manufacturing Process & Quality Program: Same as predicate. | "manufactured on identical manufacturing equipment utilizing the same raw materials and formulation." "The same Quality Program is in effect." |
| Differences from Predicate: Any differences do not raise new questions of safety or effectiveness. | The only difference is "the substitution of an alternative lubricant (non-spermicidal)." The submission implies this change does not raise new questions of safety or effectiveness, as it received 510(k) clearance. |
| Labeling Compliance: Adherence to specific labeling regulations for latex condoms, including expiration dating (21 CFR 801.435). (Note: This is post-submission guidance, not pre-market performance data). | Though not explicitly "criteria" for the substantial equivalence determination, the FDA letter informs the applicant that "labeling for latex condoms... must comply with User Labeling for Latex Condoms: Expiration Dating, 21 CFR 801.435." This requires supporting test data for expiration dates (though not submitted in the 510(k)). This is a crucial post-market compliance "acceptance." |
For the remaining points, the information explicitly requested (sample sizes, data provenance, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth types, training set details) is typically found in dedicated performance studies or clinical trials, which are not part of this 510(k) submission.
Regarding the specific questions:
2. Sample sized used for the test set and the data provenance: Not applicable. This document does not describe a clinical study or a test set in the sense of performance evaluation. It refers to "test data developed under the conditions specified in 801.435(d)" for expiration dating, but provides no details on sample size or provenance for this data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no test set or ground truth established by experts described in this regulatory submission.
4. Adjudication method for the test set: Not applicable. No test set requiring adjudication is described.
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 condom, not an AI-assisted diagnostic or imaging device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical medical device (condom), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of a performance study for this device. The "ground truth" for substantial equivalence is primarily the legally marketed predicate device's characteristics and the relevant ASTM standards.
8. The sample size for the training set: Not applicable. There is no "training set" as this is not a machine learning or AI device.
9. How the ground truth for the training set was established: Not applicable.
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NOV 1 6 1998
II. 510(K) SUMMARY
| Submitted By: | London International GroupP.O. Box 83082926 Columbia HighwayDothan, AL 36304 | |
|---|---|---|
| Phone: (334)702-2231 | ||
| Contact Person: | Neil Anderson, RACDirector of Regulatory Affairs for U.S. Operations | |
| Date Prepared: | ||
| Proprietary Name: | Durex Sensidom Male Latex Condom | |
| Common Name: | Latex Condom | |
| Classification Name: | Condom (21 CFR Section 844.5300) | |
| Predicate Device: | Latex Lubricated Condom510(k) K952415 |
Description of the Device
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This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This condom is nipple-ended with minimal dimensions of
| Width: | 52 mm |
|---|---|
| Length: | 160 mm min. |
| Thickness: | 0.03 mm min. |
Intended Use of the Device
This latex condom has the same 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).
Technological Characteristics
The condom has the same technological characteristics as the predicate device identified above. The design is in conformance with ASTM Latex Condom Standard D3492 and is made of natural rubber latex.
It has the same dimensions, the same physical properties, is manufactured on identical manufacturing equipment utilizing the same raw materials and formulation.
The same Quality Program is in effect.
The only difference with this device to the predicate is the substitution of an alternative lubricant (non-spermicidal).
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an image of a stylized eagle with three human profiles incorporated into its design. The eagle's head and neck are formed by the silhouettes of three human faces, symbolizing the department's focus on people and health.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 16 1998
Neil Anderson, RAC Director of Regulatory Affairs, U.S. Operations London International Group (LIG) P.O. Box 8308 2926 Columbia Highway Dothan, Alabama 36304
Re: K982924
Durex® Sensidom Latex Rubber Condoms Regulatory Class: II 21 CFR 884.5300 Product Code: 85 HIS Dated: August 18, 1998 Received: August 20, 1998
Dear Mr. Anderson:
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.
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Page 1 - Mr. Neil Anderson
Please note: This response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 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 User 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(j) 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. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its tollfree number (800) 638-2041 or (301) 443-6597,or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely vours.
Lillian Yin, Ph.D.
Lillian Yin. Ph.D Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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APPENDIX IV
Page 1 of 1
INDICATIONS FOR USE STATEMENT
510(K) Number (if known):
s
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The Durex 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 NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K982924 |
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use V
(Optional Format 1-2-96)
§ 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.