(89 days)
Not Found
No
The device description and performance studies focus on the chemical composition, biocompatibility, and condom compatibility of a personal lubricant, with no mention of AI or ML technologies.
No.
The intended use of the device is to lubricate and moisturize to enhance sexual activity, which is not a therapeutic purpose.
No
The device is a personal lubricant intended to enhance comfort during sexual activity, not to diagnose a condition.
No
The device description clearly states it is a "non-sterile anhydrous, clear silicone-based... personal lubricant," which is a physical substance, not software. The performance studies also focus on biocompatibility and condom compatibility, which are tests for a physical product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "penile and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication." This describes a topical application for physical comfort and enhancement of sexual activity.
- Device Description: The description details a "non-sterile anhydrous, clear silicone-based... personal lubricant." This is a physical substance applied externally.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not involve the examination of such specimens.
- Anatomical Site: The anatomical site is "penile and/or vaginal," which are external or accessible body surfaces for topical application.
- Performance Studies: The performance studies focus on biocompatibility and condom compatibility, which are relevant to a topical lubricant, not an IVD.
In summary, the device's function, application method, and intended use clearly align with a personal lubricant for external use, not a diagnostic test performed on biological samples.
N/A
Intended Use / Indications for Use
Trojan™ Chain Reaction™ Personal Lubricant is a personal lubricant for penile and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. Not compatible with polyurethane or other condoms.
Product codes (comma separated list FDA assigned to the subject device)
NUC
Device Description
The Trojan™ Chain Reaction™ Personal Lubricant is a non-sterile anhydrous, clear silicone-based (Dimethicone, Dimethiconol) personal lubricant with sensate that is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane or other condoms. This product is not a spermicide or contraceptive.
The specifications for the subject lubricant include the following:
- Appearance
- Odor
- Viscosity
- Total microbial count (total aerobic microbial count (TAMC) and )
- Fungal/yeast/mold limits (total combined yeast and mold count (TYMC) and )
- Absence of pathogenic organisms (Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans per USP )
The Chain Reaction™ Personal Lubricant is packaged in a polyethylene terephthalate (PET) bottle with a screw on, flip top polypropylene (PP) closure. An induction seal will be placed over the bottle for tamper resistance. One bottle is packed in a carton.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
penile and/or vaginal
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: Biocompatibility testing was performed on the final 510(k)-subject device in accordance with ISO 10993, Biological Evaluation of Medical Devices, 2009. The subject lubricant is biocompatible based on the results of the following biocompatibility studies: Cytotoxicity (ISO 10993-5:2009), Acute Systemic Toxicity (ISO 10993-11:2006), Primary Rabbit Skin Irritation (ISO 10993-10:2010), Rabbit Vaginal Irritation (ISO 10993-10:2010), Rabbit Penile Irritation (ISO 10993-10:2010), Guinea Pig Maximum Sensitization (ISO 10993-10:2010).
Condom compatibility: Condom Compatibility Testing was performed with Chain Reaction™ Personal Lubricant according to ASTM D7761-10 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms" with a modification to include pre-lubricated and un-lubricated dry condoms. Three marketed brands of natural rubber latex condoms and two brands of polyisoprene condoms were tested. Condoms made from polyisoprene were included to represent an alternative to natural rubber latex that may be used with the 510(k)- subject lubricant. Condom compatibility testing demonstrates that Chain Reaction™ Personal Lubricant is compatible with natural rubber latex and polyisoprene condoms.
Shelf Life: Chain Reaction™ Personal Lubricant has a two year (24 month) shelf-life based on the results of an accelerated stability study. Evaluation of viscosity, odor, color and appearance was conducted. Microbial evaluation was conducted via USP testing for Total Microbial Count (USP and , Total Yeast and Mold count (USP and ), and Absence of Pathogens (USP ). The results were satisfactory for all parameters.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is simple and recognizable, and it is used to represent the U.S. Department of Health & Human Services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 31, 2016
Church & Dwight Co., Inc. Lisa Burns Regulatory Affairs Manager 500 Charles Ewing Boulevard Ewing, NJ 08628
Re: K161544
Trade/Device Name: Trojan™ Chain Reaction™ Personal Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: June 2, 2016 Received: June 3, 2016
Dear Lisa Burns:
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
1
medical 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 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.
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
2
Indications for Use
510(k) Number (if known) K161544
Device Name
Trojan™ Chain Reaction™ Personal Lubricant
Indications for Use (Describe)
Trojan™ Chain Reaction™ Personal Lubricant is a personal lubricant for penile and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. Not compatible with polyurethane or other condoms.
Type of Use (Select one or both, as applicable)
| Residential Use (Part 21 CFR 201.326) - Subject to Discretion | Over-The-Counter Use (21 CFR 201.66) - Subject to Discretion |
|---|---|
| ---------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------- |
__ Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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 estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding 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 required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary - K161544
| Submitter Name: | Church & Dwight Co., Inc. |
|---|---|
| Submitter Address: | 500 Charles Ewing Boulevard |
| Ewing, NJ 08628 | |
| Contact Person: | Lisa Burns |
| Manager, Regulatory Affairs | |
| Church & Dwight Co., Inc. | |
| 469 North Harrison Street | |
| Princeton, NJ 08543 | |
| Tel: (609) 806.1997 | |
| Fax: (609) 403.7411 | |
| Date Prepared: | August 30, 2016 |
| Device Trade Name: | Trojan™ Chain Reaction™ Personal Lubricant |
| Device Common Name: | Personal Lubricant |
| Classification Name: | Condom (21 CFR § 884.5300) |
| Product Code: | NUC (lubricant, personal) |
| Classification: | Class II |
| Predicate Device: | Trojan™ Tingly Warmth Personal Lubricant (K120706), |
| Church & Dwight Co., Inc. | |
| Indications for Use: | Trojan™ Chain Reaction™ Personal Lubricant is a |
| personal lubricant for penile and/or vaginal application, | |
| intended to lubricate and moisturize, to enhance the ease | |
| and comfort of intimate sexual activity and supplement the | |
| body's natural lubrication. This product is compatible | |
| with natural rubber latex and polyisoprene condoms. Not | |
| compatible with polyurethane or other condoms. |
Device Description:
The Trojan™ Chain Reaction™ Personal Lubricant is a non-sterile anhydrous, clear silicone-based (Dimethicone, Dimethiconol) personal lubricant with sensate that is compatible with natural rubber latex and
4
polyisoprene condoms. This product is not compatible with polyurethane or other condoms. This product is not a spermicide or contraceptive.
The specifications for the subject lubricant include the following:
- . Appearance
- Odor ●
- Viscosity
- Total microbial count (total aerobic microbial count (TAMC) and )
- Fungal/yeast/mold limits (total combined yeast and mold count (TYMC) and >
- Absence of pathogenic organisms (Pseudomonas aeruginosa, ● Staphylococcus aureus, Candida albicans per USP )
The Chain Reaction™ Personal Lubricant is packaged in a polyethylene terephthalate (PET) bottle with a screw on, flip top polypropylene (PP) closure. An induction seal will be placed over the bottle for tamper resistance. One bottle is packed in a carton.
Intended Use Comparison:
The subject and predicate device have identical indications for use - for penile and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. Therefore, the intended use of the subject and predicate device are the same.
Technological Characteristics Comparison:
The following table compares the key technological characteristics of the subject and predicate device:
| Device & Predicate Device(s): | K161544 | K120706 |
|---|---|---|
| Condom Compatibility | Natural rubber latex | |
| and polyisoprene | Natural rubber latex | |
| and polyisoprene | ||
| Base Type | Silicone | Silicone |
| Primary Ingredients | Dimethicone | Dimethicone |
| Dimethiconol | Dimethiconol | |
| Sensate | Sensate | |
| Biocompatible | yes | yes |
| Appearance | Clear and colorless | Viscous liquid, clear |
| Odor | Characteristic odor – no | |
| malodor | Menthol | |
| Viscosity | 400 – 800 cps | 528 – 566 cp |
| Total Microbial Count | and , Total Yeast and Mold count (USP and ), and Absence of Pathogens (USP ). The results were satisfactory for all parameters. |
Substantial Equivalence:
The subject device is substantially equivalent to the predicate device. Both the subject and predicate device have identical intended uses and comparable technological characteristics. In addition, non-clinical performance data, biocompatibility testing, and shelf life testing further demonstrate that the subject device is substantially equivalent to the predicate device.