(303 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of a standard condom, with no mention of AI or ML.
No
The device is used for contraception and preventing the transmission of sexually transmitted infections, which are prophylactic purposes, not therapeutic.
No
The device is a condom, intended for contraception and prevention of sexually transmitted infections, which are prophylactic and contraceptive functions, not diagnostic ones.
No
The device description clearly states 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 perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Condom Function: The described device is a condom, which is a barrier device used for contraception and preventing the transmission of sexually transmitted infections. It does not perform any tests on bodily samples to diagnose or provide information about a person's health status.
- Intended Use: The intended use clearly states "contraception and for prophylactic purposes (preventing transmission of sexually transmitted infections)". This aligns with a barrier device, not an IVD.
- Device Description: The description details the physical characteristics and materials of a condom.
- Performance Studies: The performance studies focus on biocompatibility, physical integrity (airburst), and shelf life, which are relevant to the safety and effectiveness of a barrier device, not an IVD.
Therefore, based on the provided information, this device is a medical device, but it falls under a different classification than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The condom is used for contraception and for prophylactic purposes (preventing transmission of sexually transmitted infections).
Product codes (comma separated list FDA assigned to the subject device)
HIS
Device Description
The device is a condom that is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This device is a smooth-surfaced, straight-walled, teat-ended, silicone-lubricated condom with nominal length 180 ± 2mm, nominal width 53.5 ± 2mm, and nominal thickness of 0.04 mm. This condom conforms to the recognized standards ASTM D3492-16 and ISO 4074:2015.
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 testing was conducted as follows:
- Cytotoxicity testing per ISO 10993-5:2009 O
- Guinea pig maximization sensitization testing per ISO 10993-10:2010 O
- Vaginal irritation testing per ISO 10993-10:2010 O
- Acute systemic toxicity testing for ISO 10993-11:2006 O
The device was demonstrated to be biocompatible.
-
Physical Testing Data: Three lots of devices were tested at baseline and met airburst ● specifications of ISO 4074:2015 - Natural rubber latex male condoms - Requirements and test methods and ASTM D3492:2016 - Standard Specification for Rubber Contraceptives (Male Condoms).
-
Shelf Life: Stability testing to support a shelf-life of five years per the ● requirements of 21 CFR §801.435 was conducted. All samples met predefined acceptance criteria.
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 shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 24, 2020
Okamoto U.S.A., Inc. % Jeffrey N. Gibbs Official Correspondent Hyman, Phelps & McNamara, P.C. Washington, DC 20005
K192669 Re:
Trade/Device Name: Extremely Thin 003, ZERO ZERO THREE Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: HIS Dated: June 25, 2020 Received: June 26, 2020
Dear Jeffrey 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.
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.
1
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 (QS) 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 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 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,
Jason R. Roberts, Ph.D. Acting 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) K192669
Device Name Extremely Thin 003, ZERO ZERO THREE
Indications for Use (Describe)
The condom is used for contraception and for prophylactic purposes (preventing 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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3
510(k) SUMMARY
| Submitted by: | OKAMOTO U.S.A., INC.
18 King Street
Stratford, CT 06615
Phone: 203-378-0003 |
|--------------------------------------------------------|---------------------------------------------------------------------------------------|
| Contact Person: | Jeffrey N. Gibbs, Hyman Phelps & McNamara, P.C.
Yu Tadano, Okamoto USA., Inc. |
| Date Prepared: | July 23, 2020 |
| Device/Trade Name: | Extremely Thin 003, ZERO ZERO THREE |
| Common Name: | Male Latex Condom |
| Product code: | HIS |
| Classification Name: | Condom (21 C.F.R. § 884.5300) |
| Predicate Device:
Brand Name: | OKAMOTO ULTRA THIN Male Natural Latex
Condom, now marketed as 0.04 ZERO ZERO FOUR® |
| Company Name: | OKAMOTO U.S.A., INC. |
| Predicate Device
510(k) Document
Control Number: | K090259 |
The predicate device has not been subject to a design-related recall.
Description of the Device:
The device is a condom that is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This device is a smooth-surfaced, straight-walled, teat-ended, silicone-lubricated condom with nominal length 180 ± 2mm, nominal width 53.5 ± 2mm, and nominal thickness of 0.04 mm. This condom conforms to the recognized standards ASTM D3492-16 and ISO 4074:2015.
Indications for Use of the Device:
The condom is used for contraception and for prophylactic purposes (preventing transmission of sexually transmitted infections).
4
The subject device indications for use are identical to that of the predicate.
Technological Characteristics:
The subject condom has the same technological characteristics as the predicate condom, differing in the compounded latex formulation and having minor dimensional differences. The design of this condom is in conformance with ASTM Standard D3492-16 Specification for Rubber Contraceptives (Male Condoms), and the condoms are made of natural rubber latex.
The following comparison table summarizes the similarities and differences of the features and technological characteristics of the condom in comparison to the predicate condom.
| Characteristics | Proposed Condom | Predicate Condom
K090259 | |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Indications for Use | The condom is used
for contraception and
for prophylactic
purposes (preventing
transmission of
sexually transmitted
infections.) | The condom is used
for contraception
and for prophylactic
purposes
(preventing
transmission of
sexually transmitted
infections.) | Same |
| Condom Material | Natural rubber latex | Natural rubber latex | Same |
| Nominal Width | 53.2 ± 2 mm | 54 ± 0.3 mm | Different |
| Nominal Length | 180 ± 10 mm | 184 ± 1.5 mm | Different |
| Nominal Thickness | 30 mm from closed
end: 0.039 ± 0.0013
90 mm from closed
end:
0.039 ± 0.001
150 mm from closed
end:
0.039 ± 0.001 | 30 mm from closed
end: 0.042 ± 0.0014
90 mm from closed
end:
0.043 ± 0.0012
150 mm from
closed end:
0.045 ± 0.001 | Different |
| Lubricant | Silicone | Silicone | Same |
| Color Additives | No color | No color | Same |
| Flavor Additives | No flavor | No flavor | Same |
| Shape | Straight-walled &
reservoir-ended | Straight-walled &
reservoir-ended | Same |
| Texture | Smooth surface | Smooth surface | Same |
| Bursting Pressure (kPa) | 1.42 ± 0.10 | 1.33 ± 0.12 | Different |
| Bursting Volume (dm3) | 35.4 ± 3.83 | 37.2 ± 4.28 | Different |
| Shelf-life | 5 years | 5 years | Same |
Table 1 - Summary of Similarities and Differences
As noted in the table above, the technological characteristics of the subject device
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and predicate are similar in that they are natural rubber latex-based, do not contain colorants, and are pre-lubricated with silicone oil. Differences between the subject and predicate device include dimensions of the condoms (e.g., width and thickness), formulation and burst pressure. The subject and predicate condom specifications lie within the specifications of ASTM D3492-16 and ISO 4074:2015. The differences in condom dimensions do not raise different questions of safety and effectiveness as compared to the predicate device.. The difference in ingredients also does not raise different questions of safety and effectiveness. The differences can be evaluated through biocompatibility and performance testing.
Summary of Performance Testing
- Biocompatibility testing was conducted as follows:
- Cytotoxicity testing per ISO 10993-5:2009 O
- Guinea pig maximization sensitization testing per ISO 10993-10:2010 O
- Vaginal irritation testing per ISO 10993-10:2010 O
- Acute systemic toxicity testing for ISO 10993-11:2006 O
The device was demonstrated to be biocompatible.
- Physical Testing Data: Three lots of devices were tested at baseline and met airburst ● specifications of ISO 4074:2015 - Natural rubber latex male condoms - Requirements and test methods and ASTM D3492:2016 - Standard Specification for Rubber Contraceptives (Male Condoms).
- Shelf Life: Stability testing to support a shelf-life of five years per the ● requirements of 21 CFR §801.435 was conducted. All samples met predefined acceptance criteria.
Conclusion:
Based on the results of the testing and safety data described above, the Extremely Thin 003, ZERO ZERO THREE male natural rubber latex condom is as safe and effective as the predicate device. Therefore, the subject device is substantially equivalent to the predicate.