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).

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a male natural rubber latex condom called "One Touch." It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria for an AI/algorithm-driven medical device. Therefore, much of the requested information regarding AI device testing is not applicable.

However, I can extract the relevant information from the document as it pertains to the condom's performance and the testing conducted.

Device Name: One Touch (Male Natural Rubber Latex Condom)
510(k) Number: K181844

The device is a physical product (a condom), not an AI/algorithm-driven device. Therefore, questions 2 through 9 regarding sample sizes, ground truth, expert opinions, adjudication methods, and training sets are not applicable in this context.

Here's the closest information available concerning acceptance criteria and device performance:

1. Table of Acceptance Criteria and Reported Device Performance

For a physical device like a condom, "acceptance criteria" are typically defined by recognized standards (ASTM, ISO) and specific measurements and performance requirements. The document indicates the device conforms to these standards.

Characteristic Category	Acceptance Criteria (Standard / Requirement)	Reported Device Performance (as stated or implied)
Material	Natural Rubber Latex	Natural Rubber Latex (Same as predicate)
Design	Straight-walled, reservoir tip	Straight-walled, smooth, reservoir tip
Color	None	None (Same as predicate)
Lubricant	Silicone lubricant	Silicone lubricant (Same as predicate)
Dusting Agent	Corn Starch	Corn Starch (Same as predicate)
Nominal Length	Range specified in ASTM D3492-16	210 mm ± 10mm (Within range of ASTM D3492-16)
Nominal Width	Range specified in ASTM D3492-16 & ISO 4074:2015	60 mm ± 2mm (Within range of ASTM D3492-16 & ISO 4074:2015)
Nominal Thickness	0.07 mm	0.07 mm ± 0.01 mm (Matches predicate's 0.07 mm)
Biocompatibility	ISO 10993-5:2009 (Cytotoxicity)	Met requirements
	ISO 10993-10:2010 (Sensitization)	Met requirements
	ISO 10993-10:2010 (Vaginal Irritation)	Met requirements
	ISO 10993-11:2006 (Acute Systemic Toxicity)	Met requirements
Physical Performance	Airburst specifications of ISO 4074:2015 and ASTM D3492:2016	Met specifications ("Three lots of devices were tested at baseline and met airburst specifications")
Shelf Life	21 CFR §801.435 (Requirements)	Supported a shelf-life of five years

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets acceptance criteria consists of various performance tests detailed in the "Summary of Performance Testing" section.

Biocompatibility testing:
- 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
- Result: All biocompatibility tests were passed/met requirements.
Physical Testing Data:
- Test: 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).
- Result: "Three lots of devices were tested at baseline and met airburst specifications."
Shelf Life:
- Test: Stability testing per the requirements of 21 CFR §801.435.
- Result: Supported a shelf-life of five years.

2. Sample size used for the test set and the data provenance:

Physical Testing: "Three lots of devices" were tested for airburst specifications. The exact number of condoms per lot is not specified, nor is the country of origin explicitly stated for the testing data (though the manufacturer is Thai Nippon Rubber Industry Public Company Ltd. in Thailand). The data is retrospective, as it's part of a premarket submission.
Biocompatibility/Shelf-life: Not specified in terms of sample size, but general statements indicate tests were conducted and met requirements.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. This is a physical device, and its performance is measured against established international and national standards/specifications (e.g., ISO, ASTM, 21 CFR), not by expert consensus on image interpretation or diagnosis.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not Applicable. The performance tests involve objective physical and chemical measurements rather than subjective expert review requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not Applicable. This is a physical condom, not an AI or algorithm-driven device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not Applicable. This is a physical condom, not an AI or algorithm-driven device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

Ground Truth for Condom Performance: The "ground truth" for condom performance is defined by the objective, measurable requirements specified in established international and national standards such as ISO 4074:2015, ASTM D3492:2016, and FDA regulations like 21 CFR §801.435, as well as specific biocompatibility standards (e.g., ISO 10993 series). These standards provide quantifiable thresholds for properties like burst pressure, tensile strength, and biocompatibility endpoints.

8. The sample size for the training set:

Not Applicable. This is a physical device, not an AI/machine learning model that requires a training set.

9. How the ground truth for the training set was established:

Not Applicable. No training set is used for a physical device.

Summary

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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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510K Summary K181844

Submitted By:	Thai Nippon Rubber Industry Public Company Ltd1 Charoenrat Road,Thungwatdon Sub-district, Sathon,Bangkok 10120Thailand
Applicant Contact:	Mr. Tossaporn NilkhamhangThai Nippon Rubber Industry Public Company LtdPhone: +66 38 317-999Fax: +66 38 317-950Tossaporn_n@tnrcondom.com
Correspondent:	Prabhat GargKUPS International8516 Burning Tree RoadBethesda, MD 20817Phone: 301-461-3838Fax: 301-263-9112Email: 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

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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 DeviceK181844	Predicate DeviceK081265	Comparison
Indications forUse	The One Touch malenatural rubber latexcondom is used forcontraception and forprophylactic purposes(to help preventpregnancy and thetransmission ofsexually transmittedinfections).	The Thai NipponMale Latex Condomis used forcontraception and forprophylacticpurposes (to helpprevent pregnancyand transmission ofsexually transmitteddiseases).	Same: Although thereare minor wordingdifferences, theindications for use andintended uses are thesame.
CondomMaterial	Natural Rubber Latex	Same	Same
Design	Straight-walled,smooth, reservoir tip	Straight-walled,flared at closed end,reservoir tip	Different: The subjectdevice is a standardstraight-walledcondom, while thepredicate has a flaredclosed end. Thisdifference does notraise differentquestions of Safety andEffectiveness (S&E).
Colors	None	None	Same
Lubricant	Silicone lubricant	Same	Same
Dusting Agent	Corn Starch	Corn Starch	Same
NominalLength	210 mm ± 10mm	200 mm	Different: The subjectdevice is slightlylonger than thepredicate device.However, thisdifference does notraise differentquestions of S&E. Thelength is within the
			range specified inASTM D3492-16.
NominalWidth	$60 \text{ mm } \pm 2\text{mm}$	56 mm	Different: The subjectdevice is slightly widerthan the predicatedevice. However, thisdifference does notraise differentquestions of S&E. Thewidth is within therange specified inASTM D3492-16 andISO 4074:2015.
NominalThickness	$0.07 \pm 0.01 \text{ mm}$	0.07 mm	Same

Substantial Equivalence Comparison

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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.

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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.

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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

Regulation Number and Section

§ 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.