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.

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.

AI/ML Overview

This document is a 510(k) premarket notification for a personal lubricant, not a device that uses artificial intelligence or requires complex algorithms for analysis. Therefore, most of the requested information regarding acceptance criteria, study methodologies for AI/ML devices, ground truth establishment, expert adjudication, and comparative effectiveness studies are not applicable.

However, I can extract the relevant information regarding the performance testing conducted to demonstrate substantial equivalence for this specific medical device.

Key Information from the Document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with numerical targets for each test, as might be seen for an AI/ML device. Instead, it lists the standards against which testing was performed and states that the device was found to be in compliance. The "reported device performance" is implicitly that the device met the requirements of these standards.

Test Category	Relevant Standard / Criteria	Reported Performance (Implied)
Biocompatibility	ISO 10993-5 (Cytotoxicity)	Compliant (Implied by "were conducted on the device ... in compliance")
	ISO 10993-10 (Irritation & Sensitization)	Compliant
	ISO 10993-11 (Systemic Toxicity)	Compliant
	USP <88> (Biological Reactivity, In Vivo)	Compliant
Microbiology	USP <51> (Antimicrobial Effectiveness)	Compliant
	USP <61> (Microbial Enumeration)	Compliant
	USP <62> (Specified Microorganisms)	Compliant
Condom Compatibility	ASTM D7661-10 (Natural Rubber Latex & Polyisoprene Condoms)	Compliant
Shelf Life	ICH Q1A(R2) Guidelines	10-month shelf life initially, with intent to extend to 2-3 years after real-time testing.
Shipping Testing	ISTA 3A	Compliant

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated in terms of number of units tested for each standard. The document only mentions "testing were conducted on the device." For a physical product, this typically refers to a statistically significant number of units or batches tested per standard.
Data Provenance: The document states that testing was "conducted on the device by outside laboratories." The country of origin of the data is not specified, but the applicant (Guy & O'Neill, Inc.) is located in Fredonia, WI, USA. The studies are prospective in the sense that they were performed specifically for this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This concept is not applicable here. Ground truth, in the context of an AI/ML device, refers to expert-validated diagnoses or labels. For a personal lubricant, the "ground truth" is determined by established scientific and regulatory standards (e.g., ISO, USP, ASTM) and the results of laboratory tests run against those standards. The expertise lies in the accredited laboratories and their personnel performing the tests according to the standards, rather than a panel of clinical experts establishing diagnostic "ground truth."

4. Adjudication Method for the Test Set

Not applicable. There is no subjective interpretation or diagnostic labeling requiring adjudication. The outcome of the tests (e.g., cytotoxicity, microbial count, condom integrity) is objectively measured against the specified standard.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is a study design used to evaluate the impact of an AI algorithm on human reader performance for diagnostic tasks.

6. Standalone Performance (i.e., algorithm only without human-in-the-loop performance)

Not applicable. This device does not involve an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device is the successful fulfillment of the criteria outlined in the referenced consensus standards (ASTM, ISO, USP, ISTA, ICH). These standards provide objective, measurable parameters for safety (biocompatibility, microbiology) and compatibility (condom compatibility, shelf-life, shipping integrity).

8. The Sample Size for the Training Set

Not applicable. There is no training set as this is not an AI/ML device.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no training set and thus no ground truth to establish for it.

Summary

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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

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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,

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

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Indications for Use

510(k) Number (if known) K160717

Device Name ally® Warming Liquid Personal Lubricant

Indications for Use (Describe)

Type of Use ( Select one or both, as applicable )
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| Prescription Use (Part 21 CFR 801 Subpart D)

|X Over-The-Counter Use (21 CFR 801 Subpart C)

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Traditional 510(k) Summary

1.	Date Prepared:	June 11, 2016
2.	Applicant Name& Address:	Guy & O'Neill, Inc.200 Industrial DriveFredonia, WI 53021, USA
3.	SubmissionCorrespondent:	John F. ZiobroPrincipal ConsultantSpectraMedEx, LLC3215 Golf Road, #149Delafield. WI 53018262.719.8922
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:

12. Device Description:

INGREDIANTS: Glycerin, propanediol

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1. Technological Characteristics:
  This product is a glycerin-based personal lubricant, and its ingredients and physical parameters are comparable to the predicate device.
1. 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:
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 <88>: Biological Reactivity Tests, In Vivo
. USP <51> Antimicrobial Effectiveness Testing
USP <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration . Tests
USP <62> 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.

Regulation Number and Section

§ 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.