(449 days)
Not Found
No
The device description and performance studies focus on the physical properties and barrier function of a male condom, with no mention of AI or ML technology.
No.
The device is indicated for contraception and prophylactic purposes (reducing risk of pregnancy and STI transmission), which aligns with preventative rather than therapeutic use.
No
The device is a condom, used for contraception and reduction of STI transmission, which are prophylactic and preventive functions, not diagnostic.
No
The device description clearly states it is a physical condom made of polyurethane, a hardware component. The performance studies focus on physical properties and barrier effectiveness, not software validation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for contraception and reducing the risk of STIs. This is a preventative and barrier method, not a diagnostic test that analyzes samples from the human body to provide information about a physiological state, disease, or condition.
- Device Description: The description details the physical characteristics and materials of a condom, which is a physical barrier.
- Performance Studies: The performance studies focus on physical properties (tensile strength, air burst, etc.), barrier effectiveness against viruses (as a physical barrier), biocompatibility, and clinical performance (slip/break rates). These are all related to the device's function as a physical barrier and preventative measure, not as a diagnostic tool.
- Key Metrics: The key metrics mentioned (or the lack thereof) are not typical for IVDs. IVDs are evaluated based on metrics like sensitivity, specificity, PPV, and NPV, which are relevant to the accuracy of a diagnostic test.
In summary, the Okamoto 002 Lubricated Polyurethane Male Condom is a medical device used for contraception and disease prevention, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Okamoto 002 Lubricated Polyurethane Male Condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections, STIs).
Product codes (comma separated list FDA assigned to the subject device)
MOL
Device Description
This condom is made of a polyurethane sheath, which completely covers the penis with a closely fitted membrane. This device is a smooth-surfaced, straight-walled, silicone-lubricated condom with nominal length 180 ± 10 mm, nominal width 57 ± 2 mm, and nominal thickness of 0.028 ± 0.008 mm with dimensions evaluated per ISO 23409-2011, Male condoms - Requirements and test methods for condoms made from synthetic materials. This condom also conforms to ASTM D6324-11 (2017) Standard Test Methods for Male Condoms Made from Polyurethane. This product has a shelf life of 5 years. Device specifications are listed in Table 1 below.
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)
- Biocompatibility: Biocompatibility studies, including Acute Systemic Toxicity, Vaginal Irritation Testing, Cytotoxicity and Sensitization testing were performed in accordance with the 2020 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" and ISO 10993-1:2009. The results demonstrate that the subject device is non-irritating, non-sensitizing, and not acutely, systemically toxic.
- Physical Performance Testing: The subject condom was tested for compliance with the ASTM D6324-11 (2017) Standard Test Methods for Male Condoms Made from Polyurethane for dimensional, tensile strength, force at break, lubricant quantity, visible defects, elongation, air burst volume and air burst pressure requirements. Condoms were also tested for tear resistance according to ASTM D624-00 (2020) and the 1995 FDA guidance document "Testing Guidance for Male Condoms Made From New Material (Non-Latex)." The subject condom met the predefined acceptance criteria.
- Package Integrity: An evaluation of seal integrity was performed on three lots (3) of the subject device according to ASTM D6324-11 with satisfactory results.
- Barrier Properties/Permeability: A viral penetration study was performed on three (3) test lots of the subject polyurethane condom, one lot of the commercially available predicate device, and a natural rubber latex condom comparator per ISO 23409: 2011. The cumulative results demonstrate the barrier effectiveness of the subject device as compared to the predicate device and natural rubber latex control condom for viral penetration under conditions of the in vitro study.
- Shelf Life: The Okamoto 002 Lubricated Polyurethane Male Condom has a five-year shelf life based on the results of accelerated stability evaluations conducted as required in 21 CFR 801.435 and ASTM D6324-11. All samples met predefined acceptance criteria.
- Clinical In-Use Slip/Break: Clinical testing completed on the predicate device was leveraged. The subject and predicate device have an identical formulation, but dimensionally differ. Physical performance testing showed the subject device had comparable physical performance to the predicate device in tensile strength, force at break, tensile elongation, airburst volume, and tear resistance. A slippage and breakage study following a protocol prepared to meet the FDA guidance "Clinical Testing Guidance for New Material Male Condoms" was conducted using the predicate condom with a standard natural rubber latex condom serving as control. The predicate condom was statistically no different from the control latex condom in both clinical breakage and slippage rate. This testing is adequate to support the clinical slip/break performance for the subject device.
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.
Not Found
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
Image /page/0/Picture/0 description: The image contains 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 25, 2022
Okamoto U.S.A. Inc. % Jeff N. Gibbs Director Hyman, Phelps & McNamara, P.C. 700 Thirteenth Street N.W., Suite 1200 Washington, DC 20005
Re: K203541
Trade/Device Name: Okamoto 002 Lubricated Polyurethane Male Condom Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: MOL Dated: January 25, 2022 Received: January 26, 2022
Dear Jeff N. 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 (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 located at https://www.accessdata.fda.gov/scripts/cdrh/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.
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov
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Page 2
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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 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,
for 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
2
Indications for Use
510(k) Number (if known) K203541
Device Name
Okamoto 002 Lubricated Polyurethane Male Condom
Indications for Use (Describe)
The Okamoto 002 Lubricated Polyurethane Male Condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections, STIs).
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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K203541 Page 1 of 4
510(k) Summarv K203541 Okamoto 002 Lubricated Polyurethane Male Condom
1. Submitter Information
| Applicant: | Okamoto USA, INC. |
|---|---|
| Address: | 18 King Street |
| Stratford, CT 06615 | |
| Phone: | (203) 378-0003 |
2. Correspondent Information
| Company: | Hyman Phelps & McNamara, P.C. |
|---|---|
| Contact: | Jeffrey N. Gibbs |
| Email: | jgibbs@hpm.com |
3. Date prepared: February 25, 2022
4. Device Information
| Device Name: | Okamoto 002 Lubricated Polyurethane Male Condom |
|---|---|
| Common Name: | Polyurethane Condom |
| Regulation Number: | 21 CFR 884.5300 |
| Regulation Name: | Condom |
| Product Code: | MOL (Condom, Synthetic) |
| Regulatory Class: | Class II |
| Predicate Device Information |
5. P
| Device Name: | Trojan Supra Lubricated Polyurethane Male Condom |
|---|---|
| 510(k) Number: | K100767 |
| Sponsor: | Church & Dwight Co, Inc. |
The predicate device has not been subject to a design-related recall.
6. Device Description
This condom is made of a polyurethane sheath, which completely covers the penis with a closely fitted membrane. This device is a smooth-surfaced, straight-walled, silicone-lubricated condom with nominal length 180 ± 10 mm, nominal width 57 ± 2 mm, and nominal thickness of 0.028 ± 0.008 mm with dimensions evaluated per ISO 23409-2011, Male condoms - Requirements and test methods for condoms made from synthetic materials. This condom also conforms to ASTM D6324-11 (2017) Standard Test Methods for Male Condoms Made from Polyurethane. This product has a shelf life of 5 years. Device specifications are listed in Table 1 below.
7. Indications for Use Statement
The Okamoto 002 Lubricated Polyurethane Male Condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections, STIs).
4
8. Comparison of Intended Use and Technological Characteristics with the Predicate Device
The table below includes a comparison of the intended use and technological characteristics of the subject and predicate devices.
| Subject Device | Predicate Device | |
|---|---|---|
| Okamoto 002 Lubricated | ||
| Polyurethane Male Condom | ||
| K203541 | Trojan Supra Lubricated | |
| Polyurethane Male Condom | ||
| K100767 | ||
| Device & Predicate Device | Okamoto 002 Lubricated | |
| Polyurethane Male Condom | Trojan Supra Lubricated | |
| Polyurethane Male Condom | ||
| 510(K) Number | K203541 | K100767 |
| Product Code | MOL | MOL |
| Regulation Number | 21 CFR 884.5300 | 21 CFR 884.5300 |
| Regulation Name | Condom | Condom |
| Indications for Use | The Okamoto 002 Lubricated | |
| Polyurethane Male Condom | ||
| is used for contraception and | ||
| for prophylactic purposes (to | ||
| help reduce the risk of | ||
| pregnancy and the | ||
| transmission of sexually | ||
| transmitted infections, STIs). | The TROJAN SUPRA® | |
| Lubricated Polyurethane | ||
| Male Condom is used for | ||
| contraception and for | ||
| prophylactic purposes (to | ||
| help reduce the risk of | ||
| pregnancy and the | ||
| transmission of sexually | ||
| transmitted infections, STIs). | ||
| Prescription or Over-The- | ||
| Counter Use | Over-The-Counter | Over-The-Counter |
| Condom Material | Polyurethane | Polyurethane |
| Nominal Width | $57 \pm 2$ mm | $58 \pm 2$ mm |
| Nominal Length | $180 \pm 10$ mm | $190 \pm 10$ mm |
| Nominal Thickness | $0.028 \pm 0.008$ mm | $0.040 \pm 0.010$ mm |
| Lubricant | Silicone Oil | Silicone Oil |
| Sterilization | Non-Sterile | Non-sterile |
| Shape | Straight-walled & Reservoir- | |
| ended | Straight-walled & Reservoir- | |
| ended | ||
| Texture | Smooth Surface | Smooth Surface |
| Shelf Life | 5 Years | 5 Years |
| Color Additives | N/A | N/A |
| Flavor Additives | N/A | N/A |
The subject and predicate device have similar indications for use and have the same intended use. The technological characteristics of the subject and predicate devices are similar in that they are polyurethanebased, are lubricated with silicone oil, and have the same shelf-life duration. The subject and predicate condoms also have identical formulations. There are differences in dimensions and specifications; the subject device has reduced thickness and length compared to the predicate device. These differences do not raise different questions of safety and effectiveness.
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9. Summary of Non-Clinical Performance Testing
Biocompatibility:
Biocompatibility studies, including Acute Systemic Toxicity, Vaginal Irritation Testing, Cytotoxicity and Sensitization testing were performed in accordance with the 2020 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" and ISO 10993-1:2009 as follows:
- · Cytotoxicity (ISO 10993-5:2009/R 2014)
- · Sensitization (ISO 10993-10:2010/R 2014)
- · Vaginal Irritation (ISO 10993-10:2010/R 2014)
- · Acute Systemic Toxicity (ISO 10993-11:2017)
The results of testing demonstrate that the subject device is non-irritating, non-sensitizing, and not acutely, systemically toxic.
Physical Performance Testing:
The subject condom was tested for compliance with the ASTM D6324-11 (2017) Standard Test Methods for Male Condoms Made from Polyurethane for dimensional, tensile strength, force at break, lubricant quantity, visible defects, elongation, air burst volume and air burst pressure requirements. In addition, condoms were tested for tear resistance according to ASTM D624-00 (2020) ("Standard Test Methods for Tear Strength of Conventional Vulcanized Rubber and Thermoplastic Elastomers") and the 1995 FDA guidance document "Testing Guidance for Male Condoms Made From New Material (Non-Latex)." The subject condom met the predefined acceptance criteria.
Package Integrity:
An evaluation of seal integrity was performed on three lots (3) of the subject device according to ASTM D6324-11 with satisfactory results.
Barrier Properties/Permeability:
A viral penetration study was performed on three (3) test lots of the subject polyurethane condom, one lot of the commercially available predicate device, and a natural rubber latex condom comparator per ISO 23409: 2011. The cumulative results of the studies demonstrate the barrier effectiveness of the subject device as compared to the predicate device and natural rubber latex control condom for viral penetration under conditions of the in vitro study.
Shelf Life:
The Okamoto 002 Lubricated Polyurethane Male Condom has a five-year shelf life based on the results of accelerated stability evaluations conducted as required in 21 CFR 801.435 and ASTM D6324-11. All samples met predefined acceptance criteria.
Clinical In-Use Slip/Break:
The sponsor leveraged clinical testing completed on the predicate device to support clinical performance of the subject device. The subject and predicate device have an identical formulation, but dimensionally differ in their thickness and length, as noted in Table 1. The physical performance testing described above demonstrated that the subject device had comparable physical performance to the predicate device, in
6
regards to tensile strength, force at break, tensile elongation, airburst volume, and tear resistance. Therefore, clinical testing from the predicate device was leveraged to support the clinical performance of the subject device. A slippage and breakage study following a protocol prepared to meet the FDA guidance "Clinical Testing Guidance for New Material Male Condoms" was conducted using the predicate condom with a standard natural rubber latex condom serving as control. The predicate condom was statistically no different from the control latex condom in both clinical breakage and slippage rate. This testing is adequate to support the clinical slip/break performance for the subject device.
10. Conclusion
The results of the performance testing described above demonstrate that the Okamoto 002 Lubricated Polyurethane Male Condom is as safe and effective as the predicate device and supports a determination of substantial equivalence.