The FAMA Male Latex Condoms are used for contraception and prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).

Device Description

The FAMA Male Latex Condoms are single-use, non-sterile condoms made of a natural rubber latex sheath, which covers the penis with a closely fitted membrane. The condoms have a smooth, dotted or ribbed surface and have a straight-walled nipple-end (SWNE) style within specifications listed in ASTM D3492-16, Standard Specification for Rubber Contraceptives (Male Condoms are lubricated with no colorants and fragrances added. The product is made of natural rubber latex, additives are sulfur, zinc oxide, promoter PX, promoter ZDC, antioxidant 264, stabilizer casein, and silicone oil as lubricant. These condoms conform with FDA-recognized standards ASTM D3492-16 and ISO 4074:2015.

AI/ML Overview

The provided text is a 510(k) summary for the FAMA Male Latex Condoms, a medical device. This document details the device's technical specifications, intended use, and its comparison to a predicate device to establish substantial equivalence for FDA clearance.

Crucially, the request asks for "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/ML medical devices, specifying aspects like sample size for test/training sets, expert ground truth establishment, MRMC studies, and standalone performance.

However, the FAMA Male Latex Condoms are not an AI/ML medical device. They are a physical product (condoms) whose performance is evaluated based on physical and biological properties (e.g., length, width, thickness, burst pressure/volume, biocompatibility, shelf-life), not on an algorithm's diagnostic or predictive capabilities.

Therefore, the specific information requested regarding AI/ML device testing (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone algorithm performance, and adjudication methods) is not applicable to this document. The "studies" mentioned in the document are physical and biological performance tests, not AI model evaluations.

Summary of Device Performance and Acceptance Criteria (as applicable to a physical device):

The document provides acceptance criteria and performance data for the FAMA Male Latex Condoms based on physical and biological testing to meet established standards.

1. Table of Acceptance Criteria and Reported Device Performance:

Parameter	Acceptance Criteria (from referenced standards ISO 4074:2015 & ASTM D3492-16)	Reported Device Performance (from K220576 510(k) Summary)
Nominal Length	180 ± 10 mm (ASTM D3492-16)	180 ± 10 mm
Nominal Width	53 ± 2 mm (ASTM D3492-16)	53 ± 2 mm
Nominal Thickness (Plain)	(Specific range within standards)	0.046 - 0.047 mm
Nominal Thickness (Dotted)	(Specific range within standards)	0.068 - 0.069 mm
Nominal Thickness (Ribbed)	(Specific range within standards)	0.074 - 0.075 mm
Burst Pressure	≥ 1.0 kPa (ISO 4074:2015 & ASTM D3492-16)	≥ 1.0 kPa
Burst Volume	≥ 18 dm³ (ISO 4074:2015 & ASTM D3492-16)	≥ 18 dm³
Biocompatibility	Non-cytotoxic, non-irritating, non-sensitizing, not systemically toxic	Met all requirements (non-cytotoxic, non-irritating, non-sensitizing, not systemically toxic)
Shelf Life	Predefined acceptance criteria for stability (21 CFR 801.435)	5 years (samples met predefined acceptance criteria)

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

The document states that "The FAMA Male Latex Condoms were tested at baseline and met all the requirements of ISO 4074:2015 -Natural rubber latex male condoms – Requirements and test methods and ASTM D3492-16 - Standard Specification for Rubber Contraceptives (Male Condoms)."
For Biocompatibility, "Biocompatibility studies... were performed in accordance with... ISO 10993-1, -5, -10, -11."
For Shelf-Life, "accelerated stability evaluations conducted as required in 21 CFR 801.435."
Specific sample sizes for each test are not detailed in this 510(k) summary. These details would typically be found in the full test reports referenced by the standards (e.g., how many condoms were burst-tested).
Data Provenance: The manufacturing entity is "Shanghai Personage Hygiene Products Co.,Ltd." located in Shanghai, China. The testing was conducted by or on behalf of this company, presumably according to international standards. The nature of the physical and stability testing is inherently prospective in the sense that the manufactured devices are subjected to these tests to evaluate their properties.

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. "Ground truth" for physical and biological properties is established by adherence to validated test methods and measurement protocols defined in international standards (ISO, ASTM, FDA regulations), not by expert consensus on interpretations of complex data like medical images.

4. Adjudication method for the test set:

Not Applicable. As a physical device, testing involves quantitative measurements (e.g., length, burst pressure) and standardized biological assays, not subjective interpretations 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 not an AI device.

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

Not Applicable. This is not an AI device.

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

For physical properties (length, width, thickness, burst pressure/volume): The "ground truth" is defined by the objective, measurable parameters specified in the ASTM and ISO standards, measured using calibrated equipment and standardized test methods.
For biocompatibility: The "ground truth" is established by the results of validated biological assays (e.g., cytotoxicity, sensitization, irritation, systemic toxicity tests) as per ISO 10993 series. These tests have defined endpoints and criteria for determining toxicity.
For shelf-life: The "ground truth" is established through stability testing that demonstrates the device maintains its performance and safety characteristics over time under specified conditions, according to 21 CFR 801.435.

8. The sample size for the training set:

Not Applicable. This is not an AI/ML device, so there is no "training set."

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

Not Applicable. This is not an AI/ML device, so there is no "training set."

In conclusion, the document successfully demonstrates that the FAMA Male Latex Condoms meet the required physical and biological acceptance criteria by adhering to recognized international standards and FDA regulations for medical devices, thereby establishing substantial equivalence to the predicate device. The detailed questions regarding AI/ML device performance are not relevant to this product.

Summary

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August 5, 2022

Shanghai Personage Hygiene Products Co.,Ltd. % Vincent Zhou Regulatory Manager Medwheat. Inc. 7900 International Drive, Suite 300 Bloomington, MN 55425

Re: K220576

Trade/Device Name: FAMA Male Latex Condoms Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: HIS Dated: June 30, 2022 Received: July 6, 2022

Dear Vincent Zhou:

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,

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

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Indications for Use

510(k) Number (if known) K220576

Device Name FAMA Male Latex Condoms

Indications for Use (Describe)

The FAMA Male Latex Condoms are used for contraception and 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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K220576 Page 1 of 4

510(k) Summary - K220576

1. Submitter Information

Applicant:	Shanghai Personage Hygiene Products Co., Ltd
Address:	88 Tianchen Road, Qingpu District,
	Shanghai, 201700, China
Phone:	86-021-69214099
Email:	haijiang_song@shbon.com

2. Correspondent Information

Contact:	Vincent Zhou
Phone:Email:	Medwheat Inc.001-612-806-2995Info@medwheat.com

3. Date prepared: August 03, 2022

4. Device Information

Device/Trade Name:	FAMA Male Latex Condoms
Common Name:	Male Natural Rubber Latex Condom
Regulation Number:	21 CFR 884.5300
Regulation Name:	Condom
Regulatory Class:	Class II
Product Code:	HIS (Condom)

5. Predicate Device Information

Device Name:	Male Latex Condoms
510(k) Number:	K162919
Manufacturer:	Zhejiang Xiangban Latex Products Co., Ltd.
Regulatory Class:	Class II
Product Code:	HIS (Condom)

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

6. Device Description

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The device specifications are listed in the table below.

Parameter	Specification
Nominal length	180 ± 10 mm
Nominal width	53 ± 2 mm
Nominal thickness	0.046 - 0.047 mm (Plain)0.068 - 0.069 mm (Dotted)0.074 - 0.075 mm (Ribbed)
Burst pressure	≥ 1.0 kPa
Burst volume	≥ 18 dm³
Primary packagematerial	Aluminum film
Lubricant	Silicone oil
Dusting	Silicon dioxide

Table 1: Condom specifications

7. Indications for Use

The FAMA Male Latex Condoms are used for contraception and prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).

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 DeviceK220576	Predicate DeviceK162919	Comparison
Trade Name	FAMA Male Latex Condoms	Male Latex Condom	N/A
Product Code	HIS	HIS	Same
Regulation Number	21 CFR 884.5300	21 CFR 884.5300	Same
Regulation Name	Condom	Condom	Same
Indications for Use	The FAMA Male Latex Condomsare used for contraception andprophylactic purposes (to helpprevent pregnancy and thetransmission of sexuallytransmitted infections).	The Latex Condom for Men isused for contraception and forprophylactic purposes (to helpprevent pregnancy and thetransmission of sexuallytransmitted diseases).	Same
Prescription or Over-The- Counter-Use	Over-The-Counter-Use	Over-The-Counter-Use	Same

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Materials	Natural Rubber Latex	Natural Rubber Latex	Same
Lubricant Coating	Silicone	Silicone	Same
Design	Straight walled with nipple end;smooth, ribbed and dotted texture	Straight walled with nipple end;smooth, ribbed and dotted texture	Similar
Length	180 ± 10 mm	180 ± 10 mm	Same
Width	53 ± 2 mm	52 ± 2 mm	Different
Thickness	0.046 - 0.047 mm (Plain)0.068 – 0.069 mm (Dotted)0.074 - 0.075 mm (Ribbed)	0.06 - 0.07 mm	Different
Burst Pressure	≥ 1.0 kPa	Not publicly available	N/A
Burst Volume	≥ 18 dm3	Not publicly available	N/A
Sterilization	Non-sterile	Non-sterile	Same
Shelf Life	5 years	3 years	Different

The subject and predicate devices have similar indications for use and have the same intended use. The subject device has the same basic technological characteristics of the base material (NRL), shape, texture and silicone lubricant. The differences in technological characteristics (dimensions, shelf-life, minor variation in composition) do not raise different questions of safety and effectiveness.

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 this testing demonstrated that the subject devices are non-cytotoxic, non-irritating, non-sensitizing, and not systemically toxic.

Physical Testing

The FAMA Male Latex Condoms were tested at baseline and met all the requirements of ISO 4074:2015 -Natural rubber latex male condoms – Requirements and test methods and ASTM D3492-16 - Standard Specification for Rubber Contraceptives (Male Condoms).

Shelf-Life

The FAMA Male Latex Condoms have a five-year shelf life based on the results of accelerated stability

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evaluations conducted as required in 21 CFR 801.435. All samples met predefined acceptance criteria.

10. Conclusion

The results of the performance testing described above demonstrate that the FAMA Male Latex Condoms are as safe and effective as the predicate device and supports a determination of substantial equivalence.

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.