(429 days)
Not Found
No
The summary describes a physical medical device (condom) and a fitting kit, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The intended use of the device is for contraceptive and prophylactic (prevention of STIs) purposes, not for treating a disease or condition.
No
The device description clearly states its purpose as "contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections)," which are not diagnostic functions.
No
The device description clearly states it is a physical natural rubber latex condom, which is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. These tests are performed outside of the body.
- Device Description and Intended Use: The TheyFit male condom is a physical barrier device used on the body for contraception and preventing the transmission of STIs. It does not involve testing samples from the body.
The provided information clearly describes a physical barrier device for external use, not a diagnostic test performed on biological samples.
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
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 22 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
| 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 D3492-08 and ISO 4074:2002 Acceptance criteria met |
| Water Leak | ASTM D3492-08 and ISO 4074:2002 Acceptance criteria met |
| Freedom from Holes | ASTM D3492-08 and ISO 4074:2002 Acceptance criteria met |
| Dimensional Analysis | ASTM D3492-08 and ISO 4074:2002 Acceptance criteria met |
| Clinical Performance | Clinical performance data was provided for sizes O77-Z22 via a published clinical study (Reece M, Herbenick D, Sanders SA et al, Breakage, slippage and acceptability outcomes of a condom fitted to penile dimensions. Sex Transm Infect 2008; 84(2):143-149.) |
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
510(k) Summarv
SEP 2 7 2013
Image /page/0/Picture/3 description: The image shows the logo for TheyFit condoms. The logo is in black and white, with the word "TheyFit" in a bold, sans-serif font. The "I" in "Fit" is replaced by a condom shape. There is a registered trademark symbol to the right of the "T".
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: | September 24, 2013 |
|---|---|
| APPLICANT: | TheyFit |
| Michael Cecil, MD | |
| 4140 Tate Street | |
| Covington, GA 30014 | |
| Tel: 404-441-4435 | |
| Email: mpcecil@earthlink.net | |
| OFFICIAL CORRESPONDENT: | Penny Northcutt, RAC, FRAPS, CQA |
| Regulatory Consultant for TheyFit | |
| REGSolutions, LLC | |
| Tel: 678-428-6978 | |
| Fax: 678-513-0937 | |
| 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: | Karex Large and Extra Large Natural Rubber Latex |
| Condoms, K113061 |
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 22 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 sizes available are as follows:
1
510(k) Summary
| TheyFit Male Condom | ||
|---|---|---|
| Model Number Chart | ||
| O77 | N17 | Z22 |
| O88 | N21 | Z21 |
| O99 | N22 | |
| O11 | N77 | |
| O17 | D11 | |
| O21 | D17 | |
| O22 | D21 | |
| N88 | D22 | |
| N99 | Z11 | |
| N11 | Z17 |
Legend
| Condom Length | Condom Lay Flat Width |
|---|---|
| O = 163mm | 77 = 49mm |
| N = 178mm | 88 = 51mm |
| D = 193mm | 99 = 53mm |
| Z = 208mm | 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 devices have different technological characteristics. The different technological characteristics of the subject device include its available size range compared to the predicate device and the inclusion of a fitting kit to help the user select his condom size. These different characteristics of the subject device could affect safety and effectiveness, (e.g., clinical slippage and breakage rates and selection of an appropriate condom size). However, the different technological characteristics of the subject device do not raise new types of safety and effectiveness questions because FDA has cleared condoms with different characteristics than previously cleared male condoms that could affect condom failure rates, including new condom material, size, and performance claims (e.g., extra strength).
2
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 D3492-08 and ISO 4074:2002 |
| Acceptance criteria met | |
| Water Leak | ASTM D3492-08 and ISO 4074:2002 |
| Acceptance criteria met | |
| Freedom from Holes | ASTM D3492-08 and ISO 4074:2002 |
| Acceptance criteria met | |
| Dimensional Analysis | ASTM D3492-08 and ISO 4074:2002 |
| Acceptance criteria met | |
| Clinical Performance | Clinical performance data was provided for sizes 077- |
| Z22 via a published clinical study (Reece M, Herbenick D, | |
| Sanders SA et al, Breakage, slippage and acceptability | |
| outcomes of a condom fitted to penile dimensions. Sex | |
| Transm Infect 2008; 84(2):143-149.) |
CONCLUSION:
The TheyFit Male Condoms (sizes O77-Z22) are substantially equivalent to their proposed predicate devices.
.
3
Image /page/3/Picture/1 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" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 0903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 27, 2013
TheyFit % Penny Northcutt, RAC, FRAPS, COA Executive Director REGSolutions, LLC 717 Lakeglen Drive Suwanee, GA 30024
Re: K122219
Trade/Device Name: TheyFit Male Condom (sizes 077-222) Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: Class II Product Code: HIS Dated: September 19, 2013 Received: September 20, 2013
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 r ou may, therefore, manns of the Act include requirements for annual registration, listing of general oonline profice, 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
4
Page 2 - Penny Northcutt
device-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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher -S
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
5
510(k) Number (if known): K122219
Device Name: TheyFit Male Condom
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).
| TheyFit Male Condom
| Model Number Chart | ||
|---|---|---|
| O77 | N17 | Z22 |
| O88 | N21 | Z21 |
| O99 | N22 | |
| O11 | N77 | |
| O17 | D11 | |
| O21 | D17 | |
| O22 | D21 | |
| N88 | D22 | |
| N99 | Z11 | |
| N11 | Z17 |
Legend
| Condom Length | Condom Lay Flat Width |
|---|---|
| O = 165mm | 77 = 49mm |
| N = 180mm | 88 = 51mm |
| D = 195mm | 99 = 53mm |
| Z = 210mm | 11 = 55mm |
| 17 = 57mm | |
| 21 = 60mm | |
| 22 = 64mm |
AND/OR
Prescription Use _
(Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Benjamin R. Fisher -5 2013.09.27 13:29:57 -04'00'
Page 1 of 1
Traditional 510(k) TheyFit
TheyFit Male Condoms