(278 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of a natural rubber latex condom, with no mention of AI or ML technology.
No
The device is used for contraception and the prevention of sexually transmitted infections, which are prophylactic measures, not therapeutic interventions.
No
The device description clearly states its purpose is for contraception and prophylactic purposes, not for diagnosing any medical condition.
No
The device description clearly states it is a "natural rubber latex sheath" and provides physical dimensions and material specifications, indicating it is a physical hardware device.
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.
- Device Function: The One Touch condom is a physical barrier device used for contraception and preventing the transmission of STIs. It does not perform any tests on bodily samples.
- Intended Use: The intended use clearly states its purpose is for contraception and prophylactic purposes, not for diagnostic testing.
- Device Description: The description details its physical characteristics and materials, not any components related to analyzing biological samples.
Therefore, based on the provided information, the One Touch male natural rubber latex condom is not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The One Touch male natural rubber latex condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
Product codes
HIS
Device Description
The One Touch condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitting membrane. The condom is straight-walled with a reservoir tip, and is silicone lubricated. Condom dimensions are length 210 ± 10 mm, width 60 ± 2 mm, and thickness 0.07 ± 0.01 mm. The condom is designed to conform to the requirements of ASTM D3492:2016 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
- Biocompatibility testing as follows:
- Cytotoxicity testing per ISO 10993-5:2009
- Guinea pig maximization sensitization testing per ISO 10993-10:2010
- Vaginal irritation testing per ISO 10993-10:2010
- Acute systemic toxicity testing for ISO 10993-11:2006
- 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.
Key Metrics
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
Indications for Use
510(k) Number (if known) K181844
Device Name One Touch
Indications for Use (Describe)
The One Touch male natural rubber latex condom is used for contraception and for 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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1
510K Summary K181844
| Submitted By: | Thai Nippon Rubber Industry Public Company Ltd
1 Charoenrat Road,
Thungwatdon Sub-district, Sathon,
Bangkok 10120
Thailand |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant Contact: | Mr. Tossaporn Nilkhamhang
Thai Nippon Rubber Industry Public Company Ltd
Phone: +66 38 317-999
Fax: +66 38 317-950
Tossaporn_n@tnrcondom.com |
| Correspondent: | Prabhat Garg
KUPS International
8516 Burning Tree Road
Bethesda, MD 20817
Phone: 301-461-3838
Fax: 301-263-9112
Email: prabhatgarg57@gmail.com |
| Date Prepared: | April 12, 2019 |
| Device Trade Name: | One Touch |
| Device Common Name: | Male Natural Rubber Latex Condom |
| Regulation Name: | Condom |
| Regulation Number: | 884.5300 |
| Product Code: | HIS (Condom) |
| Regulatory Class: | Class II |
| Predicate Device: | K081265: Thai Nippon Male Latex Condom 56 mm
(nominal width), flared, colorless, silicone lubricated |
| | The predicate device has not been subject to a design-
related recall |
Device Description:
The One Touch condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitting membrane. The condom is straight-walled with a
2
reservoir tip, and is silicone lubricated. Condom dimensions are length 210 ± 10 mm, width 60 ± 2 mm, and thickness 0.07 ± 0.01 mm. The condom is designed to conform to the requirements of ASTM D3492:2016 and ISO 4074:2015.
Indications for Use:
The One Touch male natural rubber latex condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
| Characteristic | Subject Device
K181844 | Predicate Device
K081265 | Comparison |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The One Touch male
natural rubber latex
condom is used for
contraception and for
prophylactic purposes
(to help prevent
pregnancy and the
transmission of
sexually transmitted
infections). | The Thai Nippon
Male Latex Condom
is used for
contraception and for
prophylactic
purposes (to help
prevent pregnancy
and transmission of
sexually transmitted
diseases). | Same: Although there
are minor wording
differences, the
indications for use and
intended uses are the
same. |
| Condom
Material | Natural Rubber Latex | Same | Same |
| Design | Straight-walled,
smooth, reservoir tip | Straight-walled,
flared at closed end,
reservoir tip | Different: The subject
device is a standard
straight-walled
condom, while the
predicate has a flared
closed end. This
difference does not
raise different
questions of Safety and
Effectiveness (S&E). |
| Colors | None | None | Same |
| Lubricant | Silicone lubricant | Same | Same |
| Dusting Agent | Corn Starch | Corn Starch | Same |
| Nominal
Length | 210 mm ± 10mm | 200 mm | Different: The subject
device is slightly
longer than the
predicate device.
However, this
difference does not
raise different
questions of S&E. The
length is within the |
| | | | range specified in
ASTM D3492-16. |
| Nominal
Width | $60 \text{ mm } \pm 2\text{mm}$ | 56 mm | Different: The subject
device is slightly wider
than the predicate
device. However, this
difference does not
raise different
questions of S&E. The
width is within the
range specified in
ASTM D3492-16 and
ISO 4074:2015. |
| Nominal
Thickness | $0.07 \pm 0.01 \text{ mm}$ | 0.07 mm | Same |
Substantial Equivalence Comparison
3
As shown above, there are minor differences in the wording of the subject and predicate device indications statements; however, the intended uses are the same. Regarding technological characteristics, the subject and predicate devices have similarities in condom material, lubricant type, and lack of colorants. However, differences do exist as described in the table above (e.g., dimensions, general design, etc.). The differences identified do not raise different questions of safety and effectiveness as compared to the predicate device as stated in the table.
Summary of Performance Testing:
- Biocompatibility testing as follows:
- o Cytotoxicity testing per ISO 10993-5:2009
- Guinea pig maximization sensitization testing per ISO 10993-10:2010 o
- Vaginal irritation testing per ISO 10993-10:2010 o
- o Acute systemic toxicity testing for ISO 10993-11:2006
- 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.
Conclusion:
Based on the results of the testing and safety data described above, the One Touch male natural rubber latex condom is as safe and effective as the predicate device. The performance data support a determination of substantial equivalence.
4
Image /page/4/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
April 15, 2019
Thai Nippon Rubber Industry Public Company Ltd. % Prabhat Garg Registered Agent for Thai Nippon Rubber Industry Public Company Ltd. KUPS International 8516 Burning Tree Road Bethesda, MD 20817
Re: K181844 Trade/Device Name: One Touch Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: HIS Dated: March 6, 2019 Received: March 15, 2019
Dear Prabhat Garg:
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.
5
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 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