(263 days)
The condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
The condom is used for contraception and for prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted diseases, including HIV.
This condom is made of a natural rubber latex sheath, which completely covers the erect penis with a closely fitted membrane. This condom design features a patented illuminated ring on the underneath side of the rolled condom. It is lubricated with silicone and cornstarch is used as a dressing material.
This condom is a straight walled with a reservoir tip; nominal length 180mm, nominal flat width 52mm, and nominal thickness 0.07 +/- 0.01 mm.
This condom is designed to conform to established national and international voluntary standards (ISO 4074).
The provided text is a 510(k) summary for the O-RING Condom, a male natural rubber latex condom. It outlines the device's characteristics, intended use, and performance testing to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (meets...) | Reported Device Performance |
|---|---|---|
| Burst Volume | ISO 4074 requirements | meets ISO 4074 requirements |
| Burst Pressure | ISO 4074 requirements | meets ISO 4074 requirements |
| Water Leakage | ISO 4074 requirements | meets ISO 4074 requirements |
| Visual Defects | ISO 4074 requirements | meets ISO 4074 requirements |
| Package Integrity | ISO 4074 requirements | meets ISO 4074 requirements |
| MEM Elution (Cytotoxicity) | non-cytotoxic | non-cytotoxic |
| Guinea Pig Maximization Sensitization | no elicit sensitization response | no elicit sensitization response |
| Mucosal (Vaginal) Irritation | non-irritant | non-irritant |
| Acute Systemic Injection (Toxicity) | no signs of toxicity | no signs of toxicity |
| Shelf Life | Per 21 CFR 801.435 guidelines | 5 years |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each performance test (Burst Volume, Burst Pressure, Water Leakage, Visual Defects, Package Integrity, and biocompatibility tests). It only states that the tests conformed to ISO 4074 requirements for the physical tests and GLP reports for biocompatibility.
The data provenance is not explicitly stated in terms of country of origin. The study is retrospective in the sense that the testing has already been completed and the results are being presented.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable as the device is a condom, and the performance criteria are based on physical and biological standards (ISO 4074 and GLP for biocompatibility), not expert interpretation of outputs like radiological images. Therefore, "ground truth" as established by experts in a diagnostic context is not relevant here.
4. Adjudication method for the test set
Not applicable. As noted above, the performance assessment relies on objective physical and biological tests against established standards, not on expert adjudication of interpretations.
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 medical device (condom), not an AI-powered diagnostic tool. Therefore, MRMC studies and AI assistance for human readers are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The O-RING Condom is a physical medical device, not an algorithm.
7. The type of ground truth used
The "ground truth" for the performance tests used verifiable, measurable standards:
- Physical Strength and Integrity: ISO 4074 requirements. These are internationally recognized standards for latex condoms, which define performance thresholds for burst properties, leakage, and visual defects.
- Biocompatibility: GLP (Good Laboratory Practice) compliant studies (MEM Elution, Guinea Pig Maximization Sensitization, Mucosal Irritation, Acute Systemic Injection) with defined endpoints (non-cytotoxic, no sensitization, non-irritant, no signs of toxicity).
8. The sample size for the training set
Not applicable. This is a physical device, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As this is not an AI/ML device, there is no training set or associated ground truth establishment process in that context.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, often associated with medicine and healthcare. The seal is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 18, 2015
O-RING Products LLC William Mistler President 4012 Grand Manor Court, #208 Raleigh, NC 27612
Re K150828 Trade/Device Name: O-RING Condom Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: Class II Product Code: HIS Dated: November 20, 2015 Received: November 25, 2015
Dear William Mistler,
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K150828
Device Name O-RING Condom
Indications for Use (Describe)
The condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| ☐ Research Use Only (21 CFR 201.26) Select One | ☒ Over-The-Counter Use Only (21 CFR 201.26) Select One |
|---|---|
| ------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------- |
__ Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
| Submitted by: | O-Ring Products, LLC4012 Grand ManorCourtRaleigh, NC 27612 |
|---|---|
| Contact Persons: | William Mistler,PresidentO-Ring Products, LLC4012 Grand Manor CourtRaleigh, NC 27612Tel: 919-327-7186Email:wmistler@mac.com |
| Date Prepared: | December 14, 2015 |
| Proprietary Name: | O-Ring Condom |
| Common Name: | Male Natural Rubber Latex Condom |
| Classification Name: | Condom |
| Regulation: | 21 CFR §884.5300 |
| Product Code: | HIS |
| Device Class: | Class II |
| Predicate Device: | M.Dior Brand male latexK083817 |
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 design features a patented illuminated ring on the underneath side of the rolled condom. It is lubricated with silicone and cornstarch is used as a dressing material.
This condom is a straight walled with a reservoir tip; nominal length 180mm, nominal flat width 52mm, and nominal thickness 0.07 +/- 0.01 mm.
This condom is designed to conform to established national and international voluntary standards (ISO 4074).
Intended Use of the Device:
This natural rubber latex condom has the same intended use as the predicate condom.
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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:
The 510(k) subject condom, O-RING Condom, has the same technological characteristics as the predicate condom K083817.
Performance Testing:
The following performance testing was completed on the subject condom.
STRENGTH AND INTEGRITY TESTING RESULTS:
| Burst Volume | meets ISO 4074 requirements |
|---|---|
| Burst Pressure | meets ISO 4074 requirements |
| Water Leakage | meets ISO 4074 requirements |
| Visual Defects | meets ISO 4074 requirements |
| Package integrity | meets ISO 4074 requirements |
BIOCOMPATABILITY TESTS
NLI #735574 MEM Elution GLP Report
non-cytotoxic
RESULTS
NLI #737876 ISO Guinea Pig Maximization Sensitization Test GLP
no elicit sensitization response
NLI #737877 ISO Mucosal (Vaginal) Irritation Test GLP
non-irritant
NLI #772222 ISO Acute Systemic Injection Test GLP
no signs of toxicity
Shelf Life:
The O-RING Condom has a shelf life of 5 years based on studies conducted per 21 CFR 801.435 guidelines.
Conclusion:
The O-RING Condom is substantially equivalent to the proposed predicate device.
§ 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.