The JUD custom fit condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

Device Description

The JUD custom fit condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The condom is shaped with a reservoir end and is flat with a cylindrical shape. JUD custom fit condoms are available in 23 sizes of different length/width combinations. There is a fitting kit and instructions included as part of safe and effective usage of the condom.

JUD custom fit condoms are provided pre-lubricated with a silicone-based lubricant. JUD custom fit condoms are not provided with spermicide, and contain no flavors or color additives. The user must use a fitting kit to select the appropriate size of the JUD custom fit condom.

AI/ML Overview

The document describes the JUD custom fit condom and its clearance via a 510(k) premarket notification. The study primarily relies on nonclinical bench testing and biocompatibility testing to demonstrate substantial equivalence to predicate devices, rather than a clinical study evaluating human-AI interaction or diagnostic accuracy.

Here's an breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

Test Description	Acceptance Criteria (Standard)	Reported Device Performance
Dimensional	ISO 4074:2015	Acceptance criteria met; dimensions conform to standards.
Lubricant Quantity	ISO 4074:2015	Acceptance criteria met.
Burst Volume and Pressure	ISO 4074:2015	Acceptance criteria met; conform to standards.
Freedom from Holes and Visible Defects	ISO 4074:2015	Acceptance criteria met; no visible defects identified.
Package Seal Integrity	ISO 4074:2015	Acceptance criteria met; no damaged package seal identified.
Shelf Life	Maintain specifications for 5 years	Each condom variant maintained specifications for 5 years.
Cytotoxicity	ISO 10993-5:2009	No cytotoxic reactivity found.
Acute Systemic Toxicity	ISO 10993-11:2006	No mortality or evidence of systemic toxicity.
Vaginal Irritation	ISO 10993-10:2010	Non-irritating; no signs of vaginal irritation.
Skin Sensitization	ISO 10993-10:2010	Did not induce skin sensitization.

While not explicitly called "acceptance criteria" in the text, the "Summary and Conclusion" column effectively reports that the device met the requirements of the specified ISO standards, which represent the acceptance criteria for these tests.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document refers to "tested samples" for bench testing and a "single condom variant" for biocompatibility testing. Specific sample sizes are not provided in the excerpt for any of the nonclinical tests. The data provenance (country of origin, retrospective/prospective) is also not specified, though the manufacturer is located in Malaysia.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as the evaluation relies on objective bench testing and biocompatibility rather than expert interpretation of a test set related to medical imaging or diagnostics.

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

This is not applicable for the type of testing described (bench and biocompatibility).

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

No MRMC comparative effectiveness study was performed or described. This device is a condom, not an AI-assisted diagnostic tool for human readers.

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

This is not applicable as the device is a medical device (condom) and not an algorithm or AI system. The testing performed was standalone for the device itself (e.g., burst pressure of the condom).

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

The "ground truth" for the bench tests was adherence to established international standards (ISO 4074:2015 and WHO 2010) for physical properties. For biocompatibility, the ground truth was biological response in animal models or in-vitro tests as defined by ISO 10993 series standards.

8. The sample size for the training set

This is not applicable as the device is not an AI/ML algorithm that requires a training set.

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

This is not applicable as the device is not an AI/ML algorithm that requires a training set.

Summary

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510(k) SUMMARY

Date of Summary:	September 26, 2017
510(k) Applicant:	Global Mailer Partners, LLC50 South Pointe Drive,Suite 1401,Miami Beach, LF 33139Jud Ireland, CEO516-279-7745jp.ireland@gmail.com
Contact Person:	Adam Harris, MM, RACRegulatory ConsultantAssociate Director, Regulatory AffairsTarget Health Inc.261 Madison Ave 24th FloorNew York, NY 10016Phone: 646-218-2009Fax: 212-682-2105aharris@targethealth.com
Proprietary/Trade Name:	JUD custom fit condom
Common Name:	Male Latex Condom
Classification Name:	Condom
Device Classification	Class II per 21 CFR §884.5300
Product Code	HIS, Condom
Predicate Device	They Fit Condom K150072
Reference Device	They Fit Condom K122219

The predicate and reference devices have not been subject to a design-related recall.

Device Description:

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Indications for Use

The JUD custom fit condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

	SIZECODE	LENGTH(mm)	WIDTH (mm)
1.	54W	130	45
2.	54E	130	47
3.	54J	130	51
4.	36J	150	51
5.	75J	173	51
6.	54M	130	49
7.	36M	150	49
8.	54N	130	57
9.	36N	150	57
10.	75N	173	57
11.	29N	199	57
	SIZE CODE	LENGTH (mm)	WIDTH (mm)
12.	36P	150	60
13.	75P	173	60
14.	29P	199	60
15.	75R	173	64
16.	29R	199	64
17.	54S	130	53
18.	36S	150	53
19.	75S	173	53
20.	54U	130	55
21.	36U	150	55
22.	75U	173	55
23.	29U	199	55

Comparison of Technological Characteristics

Characteristic	Subject Device	Predicate Device	Reference Device	Comparison
Device Name	Jud custom fit condom	They Fit Condom	They Fit Condom	N/A
510(k) Number	K172414	K150072	K122219	N/A
Common Name	Male Latex Condom	Male Latex Condom	Male Latex Condom	N/A
Manufacturer	Richter Rubber Technology, Sdn. Bhd.Plot 33 Kuala Ketil Industrial Estate, 09300 Kuala Ketil, Malaysia	They Fit Condom Michael Cecil, MD4140 Tate Street Covington, GA 30014	They Fit Condom Michael Cecil, MD4140 Tate Street Covington, GA 30014	N/A
Indications for Use	The JUD custom fit condom is used for contraception and for prophylactic purposes (to help	The condom is used for contraception and for prophylactic purposes to help	The condom is used for contraception and for prophylactic purposes (to help	Same

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	prevent pregnancyand the transmissionof sexuallytransmitteddiseases).	prevent pregnancyand thetransmission ofsexuallytransmitteddiseases.	prevent pregnancyand thetransmission ofsexuallytransmitteddiseases).
Size(s)	Varied sizes withdifferentlength/widthcombinations.	Varied sizes withdifferentlength/widthcombinations.	Varied sizes withdifferentlength/widthcombinations.	Same
Length	130mm, 150mm,173mm, 199mm	123mm, 133mm,143mm, 153mm	163mm, 178mm,193mm, 208mm	Different;subjectdevicelengths fallwithin therange of thepredicateandreferencedevices.
Width	45 mm, 47mm,49mm, 51mm,53mm, 55mm,57mm, 60mm,64mm	45mm, 47mm,49mm, 51mm,53mm, 57mm,60mm, 64mm	49mm, 51mm,53mm, 55mm,57mm, 60mm,64mm	Same
Reservoir tip	yes	yes	yes	Same
Single usedevice	yes	yes	yes	Same
Natural Latex	yes	yes	yes	Same

The principle of operation of the JUD custom fit condoms, placing condom on erect penis before sexual contact to avoid transmission of bodily fluid and infectious organisms within, is identical to predicate. As noted in the table above, JUD custom fit condoms have the same indications for use and basic technological characteristics as the predicate and reference condoms. The JUD custom fit condoms are made of natural rubber latex, are prelubricated, and have similar sizes to the predicate. The JUD custom fit condom dimensions fall within the range of sizes of the predicate and reference devices, though they are offered in different size configurations. The difference in available sizes of the JUD custom fit condoms does not raise different questions of safety and effectiveness.

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Nonclinical Testing Summary

Bench testing

Dimensional tests, burst volume and pressure tests, and freedom from holes and visible defects tests have been conducted per WHO 2010 and ISO 4074:2015. Package seal integrity test has been conducted per ISO 4074:2015. The dimensions and burst volume and pressure of the condoms tested conform to the aforementioned standards. There were no visible defects or damaged package seal identified in the tested samples.

Description	Summary and Conclusion
Dimensional	ISO 4074: Acceptance criteria met
Lubricant quantity	ISO 4074: Acceptance criteria met
Burst Volume and Pressure	ISO 4074: Acceptance criteria met
Freedom from Holes and Visible Defects	ISO 4074: Acceptance criteria met
Package Seal Integrity	ISO 4074: Acceptance criteria met

Shelf Life

The JUD custom fit condom has a shelf-life of 5 years. The results of shelf life testing show that each condom variant maintained its specifications for the proposed shelf-life.

Biocompatibility

The JUD custom fit condom is considered a surface contacting device of category A – limited contact of <24 hours on intact skin/mucosal membrane. The skin contacting component is the latex condom itself made from natural latex rubber. These condoms contain no flavors or color additives.

The following biocompatibility testing was conducted on the JUD custom fit condom:
------------------------------------------------------------------------------------	--

BiologicalEndpoint	Description	ISO Standard	Results	Test article
Cytotoxicity	In-vitro cytotoxicity_usingthe direct contact method	ISO 10993-5:2009	No cytotoxicreactivity was found	Identical tofinisheddevices*
Acutesystemictoxicity	Systemic toxicity in Swissalbino mice	ISO 10993-11:2006	There was nomortality or evidenceof systemic toxicityresulted from the testarticle extract.	Identical tofinisheddevices
Vaginalirritation	Vaginal irritation in rabbits	ISO 10993-10:2010	The test article wasfound to be non-irritating, i.e., did notshow any signs ofvaginal irritation.	Identical tofinisheddevices
Skin	Skin sensitization	ISO 10993-	The test article	Identical to

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sensitization	(maximization) test inGuinea Pigs	10:2010	extract did notinduce skinsensitization.	finisheddevices
---------------	---------------------------------------	---------	--------------------------------------------------	---------------------

*The test article utilized for the biocompatibility testing was a single condom variant. All JUD custom fit condoms undergo the same manufacturing process, have the same chemical, physical, and surface properties, and have the same ratio of component materials as the test article.

Substantial Equivalence Conclusion

The subject device is identical to the predicate devices in intended use. The subject device, predicate and reference devices are constructed out of the same materials (natural rubber latex), and have the same basic technological characteristics. The subject device dimensions fall within those of the predicate and reference devices, though the subject device has slightly different size configurations. Both the subject device and predicate devices conform to the same standards for performance specifications. Differences in technological characteristics between the subject and predicate devices do not raise different questions of safety and effectiveness. The non-clinical testing conducted on the subject device, including dimensional testing, lubricant quantity, burst volume and pressure testing, freedom from holes and visible defects testing, package seal integrity, shelf life, cytotoxicity, acute systemic toxicity, vaginal irritation and skin sensitization demonstrate that the subject device is as safe and effective as the predicate. Therefore, the JUD custom fit condom is substantially equivalent to the predicate, TheyFit.

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Image /page/6/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the seal is a stylized image of three human profiles facing to the right, forming a symbolic representation of people.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 12, 2017

Global Mailer Partners, LLC % Adam Harris. MM. RAC Associate Director, Regulatory Affairs Target Health, Inc. 261 Madison Avenue, 24th Floor New York, NY 10016

Re: K172414 Trade/Device Name: JUD custom fit condom Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: HIS Dated: August 9, 2017 Received: August 10, 2017

Dear Adam Harris:

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. 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.

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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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

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.