(90 days)
Not Found
No
The device description and performance studies focus on physical properties and standard testing for condoms, with no mention of AI or ML.
No
The device is described as being used for contraceptive and prophylactic purposes, which are preventative measures rather than therapeutic treatments for an existing condition.
No
The device is a condom, used for contraception and prevention of STIs. It does not perform any diagnostic function.
No
The device description clearly states it is a "natural rubber latex sheath" and describes its physical dimensions and material, indicating it is a physical hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for contraceptive and prophylactic purposes, which are physical barriers to prevent pregnancy and STIs. This does not involve testing samples taken from the human body to provide information about a physiological state, disease, or condition.
- Device Description: The device is a physical sheath. IVDs are typically reagents, instruments, or systems used to examine specimens.
- Performance Studies: The performance studies focus on physical properties like airburst, water leakage, shelf life, and biocompatibility. IVD performance studies would involve metrics like sensitivity, specificity, accuracy, etc., related to detecting analytes or conditions in biological samples.
- Key Metrics: The key metrics are physical measurements (pressure, volume, leakage). IVD key metrics would be related to the performance of a diagnostic test.
This device is a medical device, specifically a condom, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
0.04 Zero Zero Four Male Latex Condom is used for contraceptive and prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
Product codes
HIS
Device Description
The 0.04 ZERO ZERO FOUR Male Latex Condom is a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The subject condom is smooth surfaced with a reservoir tip, silicone lubricated, with a nominal length of 180 mm, nominal flat width of 54 mm, and nominal thickness of 0.042 mm. This condom conforms to current established national standard ASTM D3492: 2016.
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
Over-The-Counter Use (21 CFR 801 Subpart C)
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)
Physical Testing: Three (3) lots of 0.04 ZERO ZERO FOUR Male Latex Condom were tested at baseline and met airburst specifications of ASTM D3492-16 Standard Specifications for Rubber Contraceptives (Male Condoms).
Shelf Life: Stability of the 0.04 ZERO ZERO FOUR Male Latex Condom was established from results of physical testing data using a protocol that followed 21 CFR 801.435 and met the requirements of both ASTM D3492-16. Based on the evaluation of the results of the physical testing data, the expiration date has been initially set at 5 years and will be then verified through real-time stability through five (5) years in compliance with FDA expiration labeling requirements in 21 CFR 801.435.
Biocompatibility: Biocompatibility evaluations were performed on the 0.04 ZERO ZERO FOUR Male Latex Condom in accordance with the FDA guidance document "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" dated September 2023. The results of these evaluations demonstrate that the subject device is not cytotoxic, non-irritating, nonsensitizing, and not systemically toxic.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 18, 2025
Okamoto USA, Inc. % Jeff Gibbs Director Hyman, Phelps & McNamara, P.C. 700 Thirteenth St. NW Suite 1200 Washington, District of Columbia 20005
Re: K243584
Trade/Device Name: 0.04 ZERO ZERO FOUR Male Latex Condom Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: HIS Dated: November 20, 2024 Received: November 20, 2024
Dear Jeff Gibbs:
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 (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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrb/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See
2
the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Monica D. Garcia -S
Monica D. Garcia, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology, and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K243584
Device Name 0.04 ZERO ZERO FOUR Male Latex Condom
Indications for Use (Describe)
0.04 Zero Zero Four Male Latex 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)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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4
510(k) Summary - K243584
| Submitter Name: | OKAMOTO USA, INC. | |||
|---|---|---|---|---|
| Submitter Address: | 3130 West Monroe Street Sandusky OH 44870 United States | |||
| Submitter Contact Person: Mr. Kenji Komatsu | ||||
| Tel: 973-261-9055 | ||||
| Email: kenjikomatsu(@okamotousa.com | ||||
| Preparer Name: Mr. Jeff Gibbs | ||||
| Hyman, Phelps & McNamara, P.C. | ||||
| 700 Thirteenth St. NW Suite 1200 Washington DC 20005 United States | ||||
| Tel: 202-737-4288 | ||||
| Email: jgibbs@hpm.com | ||||
| Date Prepared: | February 18, 2025 | |||
| Trade Name: | 0.04 ZERO ZERO FOUR Male Latex Condom | |||
| Common Name: | Natural rubber latex male condom | |||
| Regulation Name: | Condom | |||
| Regulation Number: | 21 CFR 884.5300 | |||
| Product Code: | HIS (condom) | |||
| Regulatory Class: | Class II | |||
| Predicate Device: | K140379: Mega Big Boy Condom | |||
| The predicate device has not been subject to a design related recall. |
Description of Device:
The 0.04 ZERO ZERO FOUR Male Latex Condom is a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The subject condom is smooth surfaced with a reservoir tip, silicone lubricated, with a nominal length of 180 mm, nominal flat width of 54 mm, and nominal thickness of 0.042 mm. This condom conforms to current established national standard ASTM D3492: 2016.
Intended Use of the Device:
0.04 Zero Zero Four Male Latex Condom is used for contraceptive and prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
Comparison of Intended Use and Technological Characteristics of the Subject Device and Predicate Device:
5
The table below compares the intended use and technological characteristics of the subject device and predicate device.
| | Subject Device
0.04 Zero Zero Four
Condom (K243584) | Predicate Device
MEGA BIG BOY
CONDOM (K140379) | Discussion |
|--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Indications
for Use | 0.04 Zero Zero Four Male
Latex Condom is used for
contraceptive and
prophylactic purposes (to
help prevent pregnancy and
the transmission of sexually
transmitted infections). | Mega big boy condom
is used for
contraceptive and
prophylactic purpose (to
help prevent pregnancy,
hiv/aids and the
transmission of sexually
transmitted infections). | Similiar |
| Principal
Raw Material
of Condom
Sheath | Natural Rubber Latex | Natural Rubber Latex | Identical |
| Color | No color | No color | Identical |
| Raw Material
of Lubricant | Silicone | Silicone | Identical |
| Shape | Parallel side with
Reservoir-ended | Flared shape &
Reservoir-ended | Different |
| Surface
Texture | Smooth Surface | Smooth Surface | Identical |
| Mean Length
(mm) | 180 | 200 | Different |
| Mean Width
at 30mm
from open
end (mm) | રત | 57 | Different |
| Mean
Thickness
(mm) | 0.042 | 0.063 | Different |
| Air Burst Test
Pressure | > 1.0 kPa | > 1.0 kPa | Identical |
| Air Burst Test
Volume | 17 dm3 | 17 dm3 | Identical |
| Water
Leakage | No leakage | No leakage | Identical |
| Shelf Life | 5 Years | 5 years | Identical |
6
The subject device and predicate device have similar indications for use statements and the same intended use - to prevent pregnancy and the transmission of sexually transmitted infections.
The subject and predicate devices have different technological characteristics, including different dimensions and shapes. However, the different technological characteristics of the subject device do not raise different questions of safety and effectiveness.
Summary of Non-Clinical Performance Testing
Physical Testing: Three (3) lots of 0.04 ZERO ZERO FOUR Male Latex Condom were tested at baseline and met airburst specifications of ASTM D3492-16 Standard Specifications for Rubber Contraceptives (Male Condoms).
Shelf Life: Stability of the 0.04 ZERO ZERO FOUR Male Latex Condom was established from results of physical testing data using a protocol that followed 21 CFR 801.435 and met the requirements of both ASTM D3492-16. Based on the evaluation of the results of the physical testing data, the expiration date has been initially set at 5 years and will be then verified through real-time stability through five (5) years in compliance with FDA expiration labeling requirements in 21 CFR 801.435.
Biocompatibility: Biocompatibility evaluations were performed on the 0.04 ZERO ZERO FOUR Male Latex Condom in accordance with the FDA guidance document "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" dated September 2023.
| Table 1: Biocompatibility Evaluations Conducted | |||
|---|---|---|---|
| ------------------------------------------------- | -- | -- | -- |
| Evaluation (biological endpoint) | ISO Standard |
|---|---|
| Cytotoxicity ISO Elution Method | ISO 10993-5:2009 |
| Vaginal Irritation | ISO 10993-23:2021 |
| Guinea Pig Maximization Sensitization | ISO 10993-10:2021 |
| Acute Systemic Toxicity | ISO 10993-11:2017 |
The results of these evaluations demonstrate that the subject device is not cytotoxic, non-irritating, nonsensitizing, and not systemically toxic.
Conclusion:
Based on the results of the non-clinical testing described above, the 0.04 ZERO ZERO FOUR Male Latex Condom is as safe and effective as the predicate device and supports a determination of substantial equivalence.