(70 days)
The Okamoto Studded Condom is used for contraceptive and prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This condom is textured surface (dotted), tapered shape with reservoir tip, silicone lubricated condom with nominal length 180 mm, nominal flat width 54 mm measured at 30 mm from the open end, a maximum width of 58 mm at the closed end, and nominal thickness of 0.070 mm. The air burst pressure is ≥ 1 kPa and air burst volume is ≥ 17 dm3. It is lubricated with silicone (viscosity 200 cps) and cornstarch is used as a dressing material. This condom conforms to current established national standard ASTM D3492: 2008. The term Studded refers to the irregular surface of the irregular surface is not applied externally but is achieved in the molding process. The glass mold has an engraved pattern of semispherical pits replicated as a pattern of small round tips on the surface of the condom. This results in an exterior surface that has a pattern of small raised areas best described as a dotted pattern. The new condom is defined as a condom of increased thickness relative to some of other Okamoto condoms (e.g., Crown condom, K893039).
The provided text is a 510(k) summary for the Okamoto Studded Condom. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and device performance results in the context of an AI/medical device study. Therefore, most of the requested information regarding acceptance criteria and study details cannot be extracted from this text.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document indicates that the device "Complied with ASTM D3492:2008". The specific acceptance criteria within this standard are not explicitly listed in the 510(k) summary, nor are detailed quantitative performance results for each criterion. The document states that "The air burst pressure is ≥ 1 kPa and air burst volume is ≥ 17 dm3," which are performance metrics, but not framed as "acceptance criteria" in a table alongside reported device performance.
| Acceptance Criteria (Implied by ASTM D3492:2008 & mentioned specifics) | Reported Device Performance (from summary) |
|---|---|
| Compliance with ASTM D3492:2008 (general) | Complied with ASTM D3492:2008 |
| Air burst pressure | ≥ 1 kPa |
| Air burst volume | ≥ 17 dm3 |
| Biocompatibility (cytotoxicity, irritation, sensitization, acute systemic toxicity) | Non-toxic, non-sensitizing, and non-irritating (conforms to ISO 10993) |
| Shelf life | 5 years (established on similar condoms) |
2. Sample Size for Test Set and Data Provenance:
The document does not detail specific sample sizes for particular tests (e.g., air burst pressure, biocompatibility). It mentions "studies conducted on the similar condoms" for shelf life. Data provenance (country of origin, retrospective/prospective) is not mentioned.
3. Number of Experts and Qualifications for Ground Truth:
This information is not applicable to this type of device submission. The evaluation is based on compliance with established standards and direct physical testing, not expert consensus on interpretations.
4. Adjudication Method:
Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This device is not an AI algorithm for diagnostic interpretation where human reader improvement would be measured.
6. Standalone (Algorithm Only) Performance:
Not applicable. This is a physical medical device (condom), not an algorithm.
7. Type of Ground Truth Used:
The "ground truth" for this device is based on objective measurements conforming to established industry standards (ASTM D3492:2008, ISO 10993). For example, air burst pressure is a direct physical measurement.
8. Sample Size for Training Set:
Not applicable, as this is a physical device, not an AI model.
9. How Ground Truth for Training Set was Established:
Not applicable.
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K141256 page 1 of 3
JUL 2 3 2014
II. 510(k) SUMMARY
| Submitted by: | OKAMOTO U.S.A., INC.3130 West Monroe StreetSandusky, OH 44870Phone: 419-626-1633 |
|---|---|
| Contact Person: | Joseph W. Cormier, JD, PhD / Hyman, Phelps & McNamaraMr. Hirofumi Chiba, Okamoto USA., Inc. |
| Date Prepared: | July 21, 2014 |
| Proprietary Name: | Okamoto Studded Condom |
| Common Name: | Male Latex Condom |
| Classification Name: | Condom (21 C.F.R. § 884.5300) |
| Predicate Device: | |
| Brand Name: | BillyBoy Dotted (Beaded) condom |
| 1) |
Company Name: MAPA GmbH
510(k) Document Control Number: K111093
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 condom is textured surface (dotted), tapered shape with reservoir tip, silicone lubricated condom with nominal length 180 mm, nominal flat width 54 mm measured at 30 mm from the open end, a maximum width of 58 mm at the closed end, and nominal thickness of 0.070 mm. The air burst pressure is ≥ 1 kPa and air burst volume is ≥ 17 dm3. It is lubricated with silicone (viscosity 200 cps) and cornstarch is used as a dressing This condom conforms to current established national standard ASTM D3492: 2008. material.
The term Studded refers to the irregular surface of the irregular surface is not applied externally but is achieved in the molding process. The glass mold has an engraved pattern of semispherical pits replicated as a pattern of small round tips on the surface of the
{1}------------------------------------------------
This results in an exterior surface that has a pattern of small raised areas best condom. described as a dotted pattern. The new condom is defined as a condom of increased thickness relative to some of other Okamoto condoms (e.g., Crown condom, K893039),
Intended Use of the Device:
This Okamoto Studded condom is used for contraceptive and prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
Technological Characteristics:
The subject condom has nearly identical technological characteristics to the predicate condom. It is identical in terms of additives and manufacturing process. The subject and predicate condoms have the same indications for use. As indicated in the table below, the only differences are the shape, nominal width and length, the quantity of lubrication, and the latex formulation. These differences do not affect the safety or effectiveness or affect performance of the subject condom as compared to the predicate. Testing on the subject condom demonstrates conformance with ISO 10993, Biological Evaluation of Medical Devices for a device in contact for 24 hours or less for cytotoxicity, irritation and sensitization, acute systemic toxicity testing, and sample preparation and reference material. Testing shows these condoms are non-toxic, non-sensitizing, and non-irritating. Stability studies conducted on the similar condoms established a shelf life of the device at 5 years. The differences in dimension, latex formulation, and quantity of lubrication do not affect cytotoxicity, irritation, sensitization, or shelf life. Furthermore, because the differences in characteristics are common for natural rubber latex male condoms, the differences do not raise new questions of safety or effectiveness.
The results of biocompatibility testing for cytotoxicity, irritation and sensitization, and acute systemic toxicity as well as airburst testing demonstrate that the subject device is substantially equivalent to the predicate device in term of safety and effectiveness.
The similarities and differences of the features and technological characteristics of the condom as compared to the predicate condom are shown in the table below.
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.
| Table 1- Characteristics of Submission Device and Predicate Device | ||
|---|---|---|
| Submission device:Okamoto Studded Male LatexCondom | Predicate device:Billy Boy Male Latex CondomK111093 | |
| FDA Classification | Class II; 884.5300 | Identical |
| Classification code | HIS | Identical |
| Intended Use | For contraceptive andprophylactic purposes (to helpprevent pregnancy and thetransmission of sexuallytransmitted infections). | Identical |
| Material | Natural rubber latex | Identical |
| Performance | Complied with ASTMD3492:2008 | Identical |
| Type | Dotted | Dotted (beaded) |
| Shape | Tapered shape with reservoir tip;dotted | Straight walled with reservoirtip; cylindrical; dotted/beaded |
| Length | 170-190 mm | > 175 mm |
| Width | 54 ± 2 mm measured 30 mmfrom open end,Maximum width of 58 ± 2 mmat the closed end | 52 mm |
| Thickness | 0.070 ± 0.010 mm | 0.100 ± 0.010 mm |
| Lubricant | 0.550 g silicone oil | 0.49 g silicone oil |
| Color | None | Identical |
| Scent | None | Identical |
| Latex Formulation | Natural Rubber Latex | Comparable |
| Dusting Agent | Cornstarch and MgO | Identical |
.
.
and the comments of the comments of
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake entwined around it, and three horizontal bars above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the caduceus symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 23, 2014
Okamoto USA, Inc. % Joseph W. Cormier Law Offices of Hyman, Phelps & McNamara, P.C. 700 Thirteenth Street N.W., Suite 1200 Washington, DC 20005-5929
Re: K141256 Trade Name: Okamoto Studded Condom Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: HIS Dated: May 14, 2014 Received: May 14, 2014
Dear Joseph W. Cormier,
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 general bonders profisions 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 (21CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
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Page 2 - Joseph W. Cormier
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21CFR 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Image /page/4/Picture/8 description: The image shows the name "Benjamin R Fisher -S" in a bold, sans-serif font. The letters are black against a white background, making them easily readable. The text appears to be a signature or a nameplate.
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K 141256
Device Name Okamoto Studded Condom
Indications for Use (Describe)
The Okamoto Studded Condom is used for contraceptive and prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
2 Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY -------------------------------------------------------------------------------------------------------------------------------------------------------------
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
11
. : ... .
Benjamin R. Fisher -S 2014.07.23 15:57:22 -04'00'
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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.