(70 days)
No
The device description and performance studies focus on the physical properties and safety of a condom, with no mention of AI or ML technology.
No
A therapeutic device is used to treat or alleviate a medical condition. This device is described for contraceptive and prophylactic (preventative) purposes, not for treating an existing condition.
No
The device is a condom, used for contraceptive and prophylactic purposes, not for diagnosing any medical condition.
No
The device description clearly indicates it is a physical condom made of natural rubber latex, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states the Okamoto Studded Condom is a physical barrier device used for contraceptive and prophylactic purposes (preventing pregnancy and STIs). It is applied externally to the penis.
- Lack of Specimen Analysis: There is no mention of analyzing any biological specimens from the body. The device itself is the primary mechanism of action.
Therefore, based on the provided information, the Okamoto Studded Condom is a Class II medical device (specifically a condom) and not an IVD.
N/A
Intended Use / Indications for Use
The Okamoto Studded Condom is used for contraceptive and prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
Product codes (comma separated list FDA assigned to the subject device)
HIS
Device Description
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
K141256 page 1 of 3
JUL 2 3 2014
II. 510(k) SUMMARY
| Submitted by: | OKAMOTO U.S.A., INC.
3130 West Monroe Street
Sandusky, OH 44870
Phone: 419-626-1633 |
|----------------------|-------------------------------------------------------------------------------------------------|
| Contact Person: | Joseph W. Cormier, JD, PhD / Hyman, Phelps & McNamara
Mr. 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.
2
.
| Table 1- Characteristics of Submission Device and Predicate Device | ||
|---|---|---|
| Submission device: | ||
| Okamoto Studded Male Latex | ||
| Condom | Predicate device: | |
| Billy Boy Male Latex Condom | ||
| K111093 | ||
| FDA Classification | Class II; 884.5300 | Identical |
| Classification code | HIS | Identical |
| Intended Use | For contraceptive and | |
| prophylactic purposes (to help | ||
| prevent pregnancy and the | ||
| transmission of sexually | ||
| transmitted infections). | Identical | |
| Material | Natural rubber latex | Identical |
| Performance | Complied with ASTM | |
| D3492:2008 | Identical | |
| Type | Dotted | Dotted (beaded) |
| Shape | Tapered shape with reservoir tip; | |
| dotted | Straight walled with reservoir | |
| tip; cylindrical; dotted/beaded | ||
| Length | 170-190 mm | > 175 mm |
| Width | 54 ± 2 mm measured 30 mm | |
| from open end, | ||
| Maximum width of 58 ± 2 mm | ||
| at 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
3
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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
4
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
5
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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