(204 days)
This Durex latex condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted disease).
This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This device is a shaped, teat ended, transparent condom lubricated with a spearmint scented lubricant, and is designed to conform to national and international voluntary standards, including ISO 4074:2002 and ASTM D3492 except where noted.
The provided text is a 510(k) premarket notification for a Durex 'Tingling Pleasure' Male Latex Condom. It is a submission for a medical device that claims substantial equivalence to previously approved devices, rather than a study proving performance against acceptance criteria for a novel device. Therefore, much of the requested information regarding acceptance criteria, study design, expert ground truth, sample sizes, and comparative effectiveness studies is not applicable to this type of regulatory submission as presented in the provided document.
This submission focuses on demonstrating that the new condom is essentially the same as already legally marketed condoms with minor modifications (primarily the addition of a spearmint scent). The FDA's letter states they have determined the device to be "substantially equivalent" to predicate devices, which means it meets the general controls provisions of the Act.
Here's an attempt to address the request based on the provided text, indicating where information is not applicable:
1. A table of acceptance criteria and the reported device performance
Since this is a substantial equivalence claim for a condom, the acceptance criteria are based on established standards for condoms (ISO 4074:2002 and ASTM D3492) and similarity to predicate devices. The document does not explicitly list numerical acceptance criteria in a table or present new experimental performance data for this specific device beyond its physical description and intended use.
| Acceptance Criteria Category | Acceptance Criteria (Implicit from Predicate/Standards) | Reported Device Performance |
|---|---|---|
| Intended Use | Same as predicate devices: contraception and prophylactic purposes (prevent pregnancy and STDs). | Meets intended use; stated to have the "same intended use as the predicate condoms." |
| Technological Characteristics | Same as predicate devices: natural rubber latex sheath, specified dimensions, silicone lubricant. | "Same technological characteristics as the predicate condoms identified." Major differences noted: addition of spearmint scent (vs. K980319), increased lubricant dosage (vs. K900679). All three condoms share the "same base latex formulation." |
| Voluntary Standards Conformance | Conforms to ISO 4074:2002 and ASTM D3492 (except where noted). | Stated to "conform to national and international voluntary standards, including ISO 4074:2002 and ASTM D3492 except where noted." (Specific exceptions not detailed in the provided text). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The provided document is a 510(k) summary for premarket approval based on substantial equivalence to existing devices. It does not describe a new clinical or laboratory study with a specific test set, sample size, or data provenance in the way a novel device might. The "data" here refers to the comparison of the new device's characteristics to those of its predicates, and its conformance to established standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth, in the context of device performance studies, is not a concept directly applied to this 510(k) submission. The "ground truth" for a condom is its ability to prevent pregnancy and STDs, which is well-established for latex condoms. The submission relies on this existing knowledge and the performance of predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no test set requiring expert adjudication for this type of regulatory submission.
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 not a study involving human readers or AI assistance. It's a submission for a physical medical device (condom).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for a condom's effectiveness is established through historical data and extensive use of similar devices for contraception and STD prevention, reflecting long-term outcomes for devices conforming to established standards. This submission leverages that pre-existing understanding rather than generating new outcomes data.
8. The sample size for the training set
Not applicable. There is no "training set" in the context of this 510(k) submission for a physical device.
9. How the ground truth for the training set was established
Not applicable. There is no "training set" or explicit ground truth establishment process described for this regulatory submission.
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Durex 'Tingling Pleasure' Male Latex Condom Premarket approval [510(k)]
Section II Summary
A. Submitter Information
SSL Americas 3585 Engineering Dr. Suite 200 Norcross, GA 30092-9214 Phone: 770 - 582 - 2222 Fax: 770 - 582 - 2233
B. Contact Person
Chris Robinson: Controller Head of Global Regulatory Affairs.
C. Date Prepared
July 26, 2004
D. Proprietary Name
Durex spearmint scented lubricated Male Latex Condom Trade name Durex 'Tingling Pleasure'
E. Common Name
Male Latex Condom
F. Classification Name
માર્ડ
G. Predicated Device
Durex Ultra Comfort Latex Rubber Condom [510(k) Number K980319]. Spearmint scented green condom [510(k) Number K900679].
H. Description of the Device
This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This device is a shaped, teat ended, transparent condom lubricated with a spearmint scented lubricant, and is designed to conform to national and international voluntary standards, including ISO 4074:2002 and ASTM D3492 except where noted.
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Durex 'Tingling Pleasure' Male Latex Condom Premarket approval [510(k)]
K042470
Page 2 of 2
I. Intended Use of the Device
This latex condom has the same intended use as the predicate condoms. The condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
J. Technological Characteristics
This condom has the same technological characteristics as the predicate condoms identified. The condoms described in K980319 are shaped. transparent Durex manufactured natural rubber latex condoms with silicone lubricant, and are of the same dimensions, and have the same lubricant dosage as the condom in this application. The only difference between these two condoms is the addition of the spearmint scent in 'Tingling Pleasure'.
The condom described in K900679 is a green pigmented, parallel sided condom which is lubricated with the same spearmint scented silicone fluid lubricant as the 'Tingling Pleasure' condom. The dosage of spearmint scented lubricant on the Tingling Pleasure condom is 520mg. (400mg for the parallel sided condom in K900679).
All three condoms are of the same base latex formulation (with addition of green pigment in the case of K900679).
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Image /page/2/Picture/11 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" arranged around the perimeter. Inside the circle is a stylized graphic of an abstract human figure with three wavy lines extending from the head, resembling hair or a flowing garment.
Public Health Service
APR - 5 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Chris Robinson Controller Head of Global Regulatory Affairs SSL Americas, Inc. Office of Regulatory Affairs 3585 Engineering Drive, Suite 200 NORCROSS GA 30092-9214
Re: K042470 Trade/Device Name: Durex® Spearment Scented Lubricated Male Latex Condom (Durex® 'Tingling Pleasure') Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: HIS Dated: February 7, 2005 Received: February 10, 2005
Dear Mr. Robinson:
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) This letter witi anow you'lo organ massage of your device of your device to a legally prematics notification: "The PDF Pinaning sification 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 If you desire specific advice for your de root 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 Also, please note the regulation entired, "Series" information on your responsibilities under the Act from the 807.97). Tour may obtain other general missance 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. Hogdon
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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Indications for Use
K042470 510(k) Number (if known):
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use: This Durex latex condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted disease).
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use ﺎ (21 CFR 807 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, Abdo and Radiological Devices 510(k) Number
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§ 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.