(91 days)
Not Found
No
The 510(k) summary describes a personal lubricant and does not mention any AI or ML components. The performance studies focus on biocompatibility, microbiology, and condom compatibility, not algorithmic performance.
No
The device is a personal lubricant intended to moisturize and lubricate for comfort during sexual activity, and it does not claim to treat or prevent a disease or condition.
No
The intended use of the device is to moisturize and lubricate for intimate sexual activity, not to diagnose a disease or condition.
No
The device is a liquid gel, which is a physical substance, not software. The description details its physical properties and ingredients.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a personal lubricant for penile and/or vaginal application to enhance comfort during intimate sexual activity. This is a topical application for lubrication, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is described as a liquid gel for external use.
- Lack of Diagnostic Purpose: There is no mention of the device being used to detect, measure, or analyze any substance or characteristic in a sample from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
- Performance Studies: The performance studies focus on biocompatibility, microbiology, condom compatibility, and stability, which are relevant for a personal lubricant, not an IVD.
IVD devices are typically used to test samples like blood, urine, tissue, etc., to provide diagnostic information. This device does not fit that description.
N/A
Intended Use / Indications for Use
ally® Warming Liquid is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, 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. This product is not compatible with polyurethane condoms.
Product codes
NUC
Device Description
The device is non-sterile, clear, non-staining, non-greasy, high viscosity liquid gel used as a personal lubricant. This product is highly lubricous and may be used with or without a natural rubber latex or polyisoprene condom during intimate sexual activity. This product is not a contraceptive or spermicide. The product is packaged in 2 to 8 ounce plastic bottles with tamperproof seals.
INGREDIANTS: Glycerin, propanediol
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, microbiology, condom compatibility and shipping testing were conducted on the device by outside laboratories, in compliance with the following recognized consensus standards:
- ASTM D7661-10, Standard Test Method for Determining Compatibility of Personal ● Lubricants with Natural Rubber Latex Condoms for compliance with latex and polyisoprene condoms.
- ISO 10993-5 Biological Evaluation of Medical Devices-Part 5: Tests for in vitro . cytotoxicity
- ISO 10993-10 Biological Evaluation of Medical Devices-Part 10: Tests for irritation and ● skin sensitization
- . ISO 10993-11 Biological Evaluation of Medical Devices-Part 11: Tests for systemic toxicity
- . United States Pharmacopeia, National Formulary General Chapter : Biological Reactivity Tests, In Vivo
- . USP Antimicrobial Effectiveness Testing
- USP Microbiological Examination of Nonsterile Products: Microbial Enumeration . Tests
- USP Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms
- ISTA 3A: Packaged-Products for Parcel Delivery System Shipment 70 Kg (150 lb) or Less ●
SHELF LIFE TESTING:
Both accelerated and real time stability studies were performed on the ally® Warming Liquid per ICH Q1A(R2) Guidelines. The device will be launched with a 10-month shelf life based on accelerated aging and then re-labeled with 2- and 3-year shelf life once the results of the real-time testing are completed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 14, 2016
Guy & O'Neill, Inc. % John Ziobro Principal Consultant SpectraMedEx, LLC 3215 Golf Road, #149 Delafield, WI 53018
Re: K160717
Trade/Device Name: ally® Warming Liquid Personal Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: Class II Product Code: NUC Dated: Mav 24, 2016 Received: May 26, 2016
Dear John Ziobro,
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,
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) K160717
Device Name ally® Warming Liquid Personal Lubricant
Indications for Use (Describe)
ally® Warming Liquid is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, 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. This product is not compatible with polyurethane condoms.
| Type of Use ( Select one or both, as applicable ) |
|---|
| ---------------------------------------------------------- |
| 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
Traditional 510(k) Summary
| 1. | Date Prepared: | June 11, 2016 |
|---|---|---|
| 2. | Applicant Name | |
| & Address: | Guy & O'Neill, Inc. | |
| 200 Industrial Drive | ||
| Fredonia, WI 53021, USA | ||
| 3. | Submission | |
| Correspondent: | John F. Ziobro | |
| Principal Consultant | ||
| SpectraMedEx, LLC | ||
| 3215 Golf Road, #149 | ||
| Delafield. WI 53018 | ||
| 262.719.8922 | ||
| 4. | Trade Name: | ally® Warming Liquid Personal Lubricant |
| 5. | Common Name: | Personal Lubricant |
| 6. | Regulation: | 21 CFR 884.5300 |
| 7. | Class: | II |
| 8. | Classification Name: | Condom |
| 9. | Product Code: | NUC |
| 10. | Predicate Device: | K-Y Brand Warming Liquid Personal Lubricant (K021492) |
- Indication for Use:
ally® Warming Liquid is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, 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. This product is not compatible with polyurethane condoms.
12. Device Description:
The device is non-sterile, clear, non-staining, non-greasy, high viscosity liquid gel used as a personal lubricant. This product is highly lubricous and may be used with or without a natural rubber latex or polyisoprene condom during intimate sexual activity. This product is not a contraceptive or spermicide. The product is packaged in 2 to 8 ounce plastic bottles with tamperproof seals.
INGREDIANTS: Glycerin, propanediol
4
-
- Technological Characteristics:
This product is a glycerin-based personal lubricant, and its ingredients and physical parameters are comparable to the predicate device.
- Technological Characteristics:
-
- Summary of Performance Data:
Biocompatibility, microbiology, condom compatibility and shipping testing were conducted on the device by outside laboratories, in compliance with the following recognized consensus standards:
- Summary of Performance Data:
-
ASTM D7661-10, Standard Test Method for Determining Compatibility of Personal ● Lubricants with Natural Rubber Latex Condoms for compliance with latex and polyisoprene condoms.
-
ISO 10993-5 Biological Evaluation of Medical Devices-Part 5: Tests for in vitro . cytotoxicity
-
ISO 10993-10 Biological Evaluation of Medical Devices-Part 10: Tests for irritation and ● skin sensitization
-
. ISO 10993-11 Biological Evaluation of Medical Devices-Part 11: Tests for systemic toxicity
-
. United States Pharmacopeia, National Formulary General Chapter : Biological Reactivity Tests, In Vivo
-
. USP Antimicrobial Effectiveness Testing
-
USP Microbiological Examination of Nonsterile Products: Microbial Enumeration . Tests
-
USP Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms
-
ISTA 3A: Packaged-Products for Parcel Delivery System Shipment 70 Kg (150 lb) or Less ●
SHELF LIFE TESTING:
Both accelerated and real time stability studies were performed on the ally® Warming Liquid per ICH Q1A(R2) Guidelines. The device will be launched with a 10-month shelf life based on accelerated aging and then re-labeled with 2- and 3-year shelf life once the results of the real-time testing are completed.
15. Conclusions
The proposed Ally ® Warming Liquid Personal Lubricant and the predicate device (K021492) have the same intended use and comparable technological characteristics. The differences in specific ingredients do not raise any different types of questions. Performance data demonstrated that the subject device is substantially equivalent to the predicate device in terms of safety and effectiveness.