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.

AI/ML Overview

The provided text describes the 510(k) summary for the "Extremely Thin 003, ZERO ZERO THREE" male latex condom. It discusses the device's characteristics, its comparison to a predicate device, and performance testing data.

This document does not describe an AI/ML medical device. Therefore, a study proving an AI/ML device meets acceptance criteria, including specifics like sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, or standalone algorithm performance, cannot be extracted from this text. The acceptance criteria and performance data pertain only to the physical properties and biological compatibility of condoms.

However, I can extract the acceptance criteria and reported device performance for the condom itself based on the provided text.

Acceptance Criteria and Device Performance (for the condom)

Based on the provided text, the device is a condom, not an AI/ML-driven medical device. Therefore, the acceptance criteria and performance data relate to the physical and biological properties of the condom.

1. Table of Acceptance Criteria and Reported Device Performance

Criteria	Acceptance Criteria (Standard & Values)	Reported Device Performance
Biocompatibility	- Cytotoxicity: Per ISO 10993-5:2009	Demonstrated to be biocompatible
	- Sensitization: Guinea pig maximization sensitization testing per ISO 10993-10:2010	Demonstrated to be biocompatible
	- Vaginal Irritation: Per ISO 10993-10:2010	Demonstrated to be biocompatible
	- Acute Systemic Toxicity: Per ISO 10993-11:2006	Demonstrated to be biocompatible
Physical Testing	- Airburst specifications: Met ISO 4074:2015 - Natural rubber latex male condoms - Requirements and test methods, and ASTM D3492:2016 - Standard Specification for Rubber Contraceptives (Male Condoms).	Met airburst specifications
Shelf-Life Stability	5 years shelf-life. Per 21 CFR §801.435. All samples must meet predefined acceptance criteria.	All samples met predefined acceptance criteria. (5 years)
Dimensions (Nominal)	- Nominal Width: 53.2 ± 2 mm (Proposed Device Specification)	53.2 ± 2 mm (implicitly met as per device specification)
	- Nominal Length: 180 ± 10 mm (Proposed Device Specification)	180 ± 10 mm (implicitly met as per device specification)
	- Nominal Thickness (30mm): 0.039 ± 0.0013 (Proposed Device Specification)	0.039 ± 0.0013 (implicitly met as per device specification)
	- Nominal Thickness (90mm): 0.039 ± 0.001 (Proposed Device Specification)	0.039 ± 0.001 (implicitly met as per device specification)
	- Nominal Thickness (150mm): 0.039 ± 0.001 (Proposed Device Specification)	0.039 ± 0.001 (implicitly met as per device specification)
Bursting Pressure	1.42 ± 0.10 kPa (Proposed Device Specification)	1.42 ± 0.10 kPa (implicitly met as per device specification)
Bursting Volume	35.4 ± 3.83 dm3 (Proposed Device Specification)	35.4 ± 3.83 dm3 (implicitly met as per device specification)

Study Details (for the condom):

As the product is a condom and not an AI/ML device, the following points address what can be inferred or what is not applicable from an AI/ML perspective.

2. Sample size used for the test set and the data provenance:
* Sample Size: For physical testing, "Three lots of devices were tested at baseline." The specific number of condoms per lot is not stated. For biocompatibility, typical regulatory testing involves a sufficient number of samples as per the respective ISO standards, but the exact count is not provided.
* Data Provenance: Not explicitly stated, however, the testing was conducted to meet international (ISO) and US (ASTM, CFR) standards, implying a controlled laboratory environment typically adhering to Good Manufacturing Practices. The origin isn't specified (e.g., country), but it's for a US-marketed product. The data collection would be prospective, as it's part of the premarket submission process.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not Applicable: For a condom, "ground truth" in the context of expert review (like for image interpretation) is not relevant. Performance is determined by objective physical and biological tests against established standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
* Not Applicable: Adjudication methods are relevant for subjective assessments, typically in clinical readings or image interpretations. Condom performance is assessed through objective measurements against specified criteria.

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 an AI/ML related study type. The product is a physical device (condom).

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Not Applicable: This is an AI/ML related study type. The product is a physical device (condom).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* The "ground truth" for the condom's performance is established by objective measurements and chemical/biological assays according to recognized consensus standards (ASTM D3492-16, ISO 4074:2015, and ISO 10993 series) and regulatory requirements (21 CFR §801.435). This includes measurements for dimensions, bursting pressure/volume, and results from biocompatibility tests (cytotoxicity, sensitization, irritation, systemic toxicity).

8. The sample size for the training set:
* Not Applicable: This pertains to AI/ML model development. For a non-AI/ML device, there is no "training set."

9. How the ground truth for the training set was established:
* Not Applicable: This pertains to AI/ML model development. For a non-AI/ML device, there is no "training set" or corresponding ground truth establishment in this manner.

Summary

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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.

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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/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

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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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510(k) SUMMARY

Submitted by:	OKAMOTO U.S.A., INC.18 King StreetStratford, CT 06615Phone: 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 LatexCondom, now marketed as 0.04 ZERO ZERO FOUR®
Company Name:	OKAMOTO U.S.A., INC.
Predicate Device510(k) DocumentControl Number:	K090259

The predicate device has not been subject to a design-related recall.

Description of the Device:

Indications for Use of the Device:

The condom is used for contraception and for prophylactic purposes (preventing transmission of sexually transmitted infections).

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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 CondomK090259
Indications for Use	The condom is usedfor contraception andfor prophylacticpurposes (preventingtransmission ofsexually transmittedinfections.)	The condom is usedfor contraceptionand for prophylacticpurposes(preventingtransmission ofsexually transmittedinfections.)	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 closedend: 0.039 ± 0.001390 mm from closedend:0.039 ± 0.001150 mm from closedend:0.039 ± 0.001	30 mm from closedend: 0.042 ± 0.001490 mm from closedend:0.043 ± 0.0012150 mm fromclosed 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.

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.