(90 days)
Not Found
No
The summary describes a physical medical device (condom) and a fitting kit. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML. The performance study is a clinical survey, not an evaluation of an AI/ML model.
No
The device is used for contraceptive and prophylactic (disease prevention) purposes, not for treating a disease or condition.
No
No
The device description clearly states the device is a natural rubber latex sheath, which is a physical hardware component. The summary also describes a "fitting kit (FitKit)" which is also a physical component used to select the condom size.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The TheyFit Male Condom is a physical barrier device used externally on the penis for contraception and prevention of STIs. It does not analyze any biological specimens.
- Intended Use: The intended use clearly states "for contraceptive and for prophylactic purposes," which are not diagnostic functions.
The information provided describes a medical device, specifically a condom, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The TheyFit male condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
Product codes (comma separated list FDA assigned to the subject device)
HIS
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
penis
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility: The TheyFit Condoms are identical with regard to material composition and manufacturing process as the predicate device. Therefore, biocompatibility testing completed on the predicate device was leveraged to support the biocompatibility of the TheyFit Condoms.
Airburst: ASTM D3492-14 and ISO 4074:2014 Acceptance criteria met
Water Leak: ASTM D3492-14 and ISO 4074:2014 Acceptance criteria met
Dimensional Analysis: ASTM D3492-14 and ISO 4074:2014 Acceptance criteria met
Clinical Performance: A customer survey clinical study was conducted to confirm performance of the TheyFit Male Condom in smaller sizes.
Study Design: A prospective study by surveying customers who used a minimum total of 200 condom uses was conducted to assess the clinical performance of TheyFit condoms in length dimensions less than 160mm and greater than 120mm (TheyFit sizes M, S, B, E). The pre-specified end point was a total clinical failure rate
§ 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.
0
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
1
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
2
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 Condom
| Model 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
3
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: | TheyFit |
| Michael Cecil, MD | |
| 4140 Tate Street | |
| Covington, GA 30014 | |
| Tel: 678-964-2072 | |
| Email: mpcecil@earthlink.net | |
| OFFICIAL | |
| correspondent: | Penny Northcutt, FRAPS, RAC, CQA |
| Regulatory Consultant for TheyFit | |
| REGSolutions, LLC | |
| Tel: 678-428-6978 | |
| Fax: 866-630-4082 | |
| Email: pennynorthcutt@theregsolutions.com | |
| TRADE NAME: | TheyFit Male Condom |
| CLASSIFICATION NAME: | Condom |
| COMMON OR USUAL NAME: | Condom |
| DEVICE CLASSIFICATION | |
| AND PRODUCT CODE: | Class II per 21 CFR §884.5300 |
| Obstetrics/Gynecology | |
| Product 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.
4
510(K) Summary
The sizes available are as follows:
| TheyFit Male Condom
| Model 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).
5
510(K) Summary
PERFORMANCE DATA:
| Description | Summary and Conclusion |
|---|---|
| Biocompatibility | The TheyFit Condoms are identical with regard to |
| material composition and manufacturing process as the | |
| predicate device. Therefore, biocompatibility testing | |
| completed on the predicate device was leveraged to | |
| support the biocompatibility of the TheyFit Condoms. | |
| Airburst | ASTM D3492-14 and ISO 4074:2014 |
| Acceptance criteria met | |
| Water Leak | ASTM D3492-14 and ISO 4074:2014 |
| Acceptance criteria met | |
| Dimensional Analysis | ASTM D3492-14 and ISO 4074:2014 |
| Acceptance criteria met | |
| Clinical Performance | A customer survey clinical study was conducted to |
| confirm performance of the TheyFit Male Condom in | |
| smaller sizes. | |
| Clinical Performance | Study Design |
| A prospective study by surveying customers who used a | |
| minimum total of 200 condom uses was conducted to | |
| assess the clinical performance of TheyFit condoms in | |
| length dimensions less than 160mm and greater than | |
| 120mm (TheyFit sizes M, S, B, E). The pre-specified end | |
| point was a total clinical failure rate |