(90 days)
The TheyFit male condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
The TheyFit Male 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. TheyFit condoms are available in 34 sizes, of different length/width combinations. TheyFit Condoms are provided pre-lubricated with a silicone-based lubricant. TheyFit condoms are not provided with spermicide. The user must use a fitting kit (FitKit) to select the appropriate size TheyFit Condom.
The provided text describes the 510(k) summary for the TheyFit Male Condom, detailing its performance data and substantial equivalence to a predicate device. Here's an analysis to extract the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Not explicitly stated (leveraged predicate data) | Device identical to predicate in material composition and manufacturing; predicate device's biocompatibility testing leveraged. |
| Airburst | Met ASTM D3492-14 and ISO 4074:2014 | Acceptance criteria met. |
| Water Leak | Met ASTM D3492-14 and ISO 4074:2014 | Acceptance criteria met. |
| Dimensional Analysis | Met ASTM D3492-14 and ISO 4074:2014 | Acceptance criteria met. |
| Clinical Performance (Total Clinical Failure Rate) | < 5% (pre-specified endpoint) | Scenario 1 (3 slippages during withdrawal counted as clinical):- Clinical breakage rate: 1.5% (3/203)- Clinical slippage rate: 3.0% (6/203)- Total clinical failure rate: 4.4% (9/203)Scenario 2 (3 slippages during withdrawal not counted as clinical):- Clinical breakage rate: 1.5% (3/203)- Clinical slippage rate: 1.5% (3/203)- Total clinical failure rate: 3.0% (6/203)In both scenarios, the total clinical failure endpoint of <5% was met. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: 203 condom use surveys (for the clinical performance study).
- Data Provenance: The study was a "customer survey clinical study" with participants "recruited from TheyFit customers who had ordered a condom in the eligible size range." This indicates a prospective, real-world usage study, likely originating from TheyFit's customer base, which would be international given the global nature of product sales but no specific country of origin is mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Number of Experts: Not applicable. The clinical performance study was a self-report survey conducted by customers.
- Qualifications of Experts: Not applicable. The data was based on user self-reports.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable in the traditional sense of expert adjudication. The study relied on customer self-reports. However, there was an interpretation of the self-reported data regarding slippage during withdrawal (whether to count it as clinical or user error), referencing ISO/DIS 29943-1:2014 guidance. This could be considered a form of interpretation or categorization based on a standard, rather than expert adjudication of individual cases.
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:
- MRMC Study: No, this type of study was not conducted. The device is a male condom, not an AI-powered diagnostic or interpretive tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. The device is a physical medical device (condom), not an algorithm. The clinical performance study evaluated the device's physical function in human use.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Ground Truth: For clinical performance, the ground truth was based on self-reported outcomes data from users regarding breakages and slippages during actual use.
8. The sample size for the training set:
- Sample Size for Training Set: Not applicable. The document describes studies for a physical medical device (condom), not a machine learning model that would require a training set.
9. How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable, as there is no training set for this type of device and study.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The symbol is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 14, 2015
TheyFit % Penny Northcutt Regulatory Consultant REGSolutions, LLC 174 Watercolor Wav. Suite 103-403 Santa Rosa Beach, FL 32459
Re: K150072
Trade/Device Name: TheyFit Male Condom Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: HIS Dated: January 12, 2015 Received: January 14, 2015
Dear Penny Northcutt,
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.
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 device
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related 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 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 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 yours,
Image /page/1/Picture/8 description: The image shows the name "Herbert P. Lerner -S" in a large, bold font. The name is written in black and is centered on a white background. The letters are clear and easy to read. The image is simple and straightforward, with the focus on the name.
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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name
TheyFit Male Condom
Indications for Use (Describe)
The TheyFit male condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
| TheyFit Male CondomModel Number Chart | |||
|---|---|---|---|
| E55 | B55 | S55 | |
| E66 | B66 | S66 | M66 |
| E77 | B77 | S77 | M77 |
| E88 | B88 | S88 | M88 |
| E99 | B99 | S99 | M99 |
| E11 | B11 | S11 | M11 |
| E17 | B17 | S17 | M17 |
| E21 | B21 | S21 | M21 |
| B22 | S22 | M22 |
Legend
| Condom Length | Condom Lay Flat Width |
|---|---|
| E = 123mm | 55 = 45mm |
| B = 133mm | 66 = 47mm |
| S = 143mm | 77 = 49mm |
| M = 153mm | 88 = 51mm |
| 99 = 53mm | |
| 11 = 55mm | |
| 17 = 57mm | |
| 21 = 60mm | |
| 22 = 64mm |
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is a response, including the time to review instructions, search existing data sources, gather and maintain the data needed and review the collection of information. Send comments reqarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration
Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/14)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
TheyFit Male Condoms
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THEYFIT
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| DATE: | March 19, 2015 |
|---|---|
| APPLICANT: | TheyFitMichael Cecil, MD4140 Tate StreetCovington, GA 30014Tel: 678-964-2072Email: mpcecil@earthlink.net |
| OFFICIALcorrespondent: | Penny Northcutt, FRAPS, RAC, CQARegulatory Consultant for TheyFitREGSolutions, LLCTel: 678-428-6978Fax: 866-630-4082Email: pennynorthcutt@theregsolutions.com |
| TRADE NAME: | TheyFit Male Condom |
| CLASSIFICATION NAME: | Condom |
| COMMON OR USUAL NAME: | Condom |
| DEVICE CLASSIFICATIONAND PRODUCT CODE: | Class II per 21 CFR §884.5300Obstetrics/GynecologyProduct Code: HIS |
| PREDICATE DEVICE NAME: | TheyFit Male Condom, K122219 |
DESCRIPTION OF THE DEVICE:
The TheyFit Male 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. TheyFit condoms are available in 34 sizes, of different length/width combinations.
TheyFit Condoms are provided pre-lubricated with a silicone-based lubricant. TheyFit condoms are not provided with spermicide. The user must use a fitting kit (FitKit) to select the appropriate size TheyFit Condom.
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510(K) Summary
The sizes available are as follows:
| TheyFit Male CondomModel Number Chart | |||
|---|---|---|---|
| E55 | B55 | S55 | |
| E66 | B66 | S66 | M66 |
| E77 | B77 | S77 | M77 |
| E88 | B88 | S88 | M88 |
| E99 | B99 | S99 | M99 |
| E11 | B11 | S11 | M11 |
| E17 | B17 | S17 | M17 |
| E21 | B21 | S21 | M21 |
| B22 | S22 | M22 |
Legend
| Condom Length | Condom Lay Flat Width |
|---|---|
| E = 123mm | 55 = 45mm |
| B = 133mm | 66 = 47mm |
| S = 143mm | 77 = 49mm |
| M = 153mm | 88 = 51mm |
| 99 = 53mm | |
| 11 = 55mm | |
| 17 = 57mm | |
| 21 = 60mm | |
| 22 = 64mm |
INTENDED USE/INDICATIONS FOR USE:
The subject and predicate device have the same Indications for Use statement, which is, "The TheyFit Male Condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections)."
TECHNOLOGICAL CHARACTERISTICS:
The subject and predicate device have different technological characteritstics. The different technological characteristics of the subject device include its available size range compared to the predicate device. These different characteristics of the subject device could affect safety and effectiveness, (e.q., clinical slippage and breakage rates).
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510(K) Summary
PERFORMANCE DATA:
| Description | Summary and Conclusion |
|---|---|
| Biocompatibility | The TheyFit Condoms are identical with regard tomaterial composition and manufacturing process as thepredicate device. Therefore, biocompatibility testingcompleted on the predicate device was leveraged tosupport the biocompatibility of the TheyFit Condoms. |
| Airburst | ASTM D3492-14 and ISO 4074:2014Acceptance criteria met |
| Water Leak | ASTM D3492-14 and ISO 4074:2014Acceptance criteria met |
| Dimensional Analysis | ASTM D3492-14 and ISO 4074:2014Acceptance criteria met |
| Clinical Performance | A customer survey clinical study was conducted toconfirm performance of the TheyFit Male Condom insmaller sizes. |
| Clinical Performance | Study DesignA prospective study by surveying customers who used aminimum total of 200 condom uses was conducted toassess the clinical performance of TheyFit condoms inlength dimensions less than 160mm and greater than120mm (TheyFit sizes M, S, B, E). The pre-specified endpoint was a total clinical failure rate < 5%. |
| Clinical Performance | MethodsParticipants for the study were recruited from TheyFitcustomers who had ordered a condom in the eligible sizerange and agreed to be contacted regarding the study.For individual condom use episodes to be eligible forinclusion into the study dataset, participants had to reportusing the condom only for vaginal sex at each condomuse event. |
| Clinical Performance | ResultsThe final sample included a total of 203 condom usesurveys. There were three clinical breakages, threeclinical slippages during vaginal intercourse, and threeslippages during withdrawal. Based on the informationprovided in the survey responses, it is unknown whetherthe three slippages during withdrawal occurred as a resultof user error. |
| Clinical Performance | ISO/DIS 29943-1:2014, Condoms -- Guidance on clinicalstudies -- Part 1: Male condoms, clinical function studiesbased on self-reports defines clinical slippage as whenthe condom "slips completely off during intercourse or |
| Description | Summary and Conclusion |
| during withdrawal from the vagina.” However, ISO/DIS29943-1:2014 also states the "slippage occurringbecause the user failed to hold onto the condom at thebase of the penis during withdrawal and/or becausedelayed withdrawal are considered user failures andshould be recorded as non-clinical slippage." | |
| Based on the results of this study, the clinical breakagerate of the TheyFit Male Condoms (sizes E55-M22) is1.5% (3/203). If the three slippages that occurred duringwithdrawal are counted as clinical slippages, then theclinical slippage rate is 3.0% (6/203), and the total clinicalfailure rate is 4.4% (9/203). If the three slippages thatoccurred during withdrawal are not counted as clinicalslippages, then the clinical slippage rate is 1.5% (3/203),and the total clinical failure rate is 3.0% (6/203). In eithercase, the TheyFit Male Condoms (sizes E55-M22) metthe pre-defined total clinical failure endpoint of <5%. |
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510(K) Summary
CONCLUSION:
The TheyFit Male Condoms (sizes E55-M22) are substantially equivalent to the proposed predicate device or K122219.
§ 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.