Mano and Mano Personal Lubricant is a water-based 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 not compatible with natural rubber latex, polyurethane, and polyisoprene condoms.

Device Description

Mano and Mano Personal Lubricant (additionally branded as Nooky, Hello Sailor, or Lulu) is a clear, colorless, water-based personal lubricant composed of purified water, propylene glycol, hydroxethyl cellulose, sodium pyrrolidone carboxylic acid, potassium sorbate and citric acid.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device: "Mano and Mano Personal Lubricant". It focuses on establishing substantial equivalence to a predicate device through bench testing and biocompatibility.

Based on the document, here's an analysis against your requested information:

This document does NOT describe the type of study where an AI/algorithm's performance is tested against established ground truths, involving human experts, and a multi-reader, multi-case study. The device is a personal lubricant, not an AI or diagnostic imaging device. Therefore, many of your requested points are not applicable to this type of medical device submission.

However, I can extract information related to the performance data and "acceptance criteria" presented for this specific product.

Acceptance Criteria and Reported Device Performance (Bench Testing & Biocompatibility)

The "Performance Data" section details several bench tests and biocompatibility tests. For these, the "acceptance criteria" are the "Specifications" listed in the table and the "passed" declarations for biocompatibility.

1. A Table of Acceptance Criteria and the Reported Device Performance

Criteria	Specifications (Acceptance Criteria)	Reported Device Performance
Appearance	Not explicitly stated in the table, but described as "clear, colorless" for both subject and predicate device. Implied to be met.	Met (implied, as "the subject device met the physical specifications (appearance...)")
pH	Not explicitly stated in the table, but considered a "physical specification."	Met (implied, as "the subject device met the physical specifications (ph...)")
Viscosity	Not explicitly stated in the table, but considered a "physical specification."	Met (implied, as "the subject device met the physical specifications (viscosity...)")
Osmolality	Not explicitly stated in the table, but considered a "physical specification."	Met (implied, as "the subject device met the physical specifications (osmolality...)")
Total Aerobic Microbial Count	≤100 cfu/g	Met (Implied, as "demonstrated that the subject device met...microbiology specifications")
Total Yeast and Mold Count	≤10 cfu/g	Met (Implied, as "demonstrated that the subject device met...microbiology specifications")
Absence of Pathogenic Organisms	Absence of pseudomonas aeruginosa, staphylococcus aureus, and candida albicans	Met (Implied, as "demonstrated that the subject device met...microbiology specifications")
Antimicrobial Effectiveness	At least 2.0 log reduction from the initial count at 14 days; no increase from the 14 days count at 28 days; no increase from the initial calculated count at 14 and 28 days	Met (Implied, as "demonstrated that the subject device met...microbiology specifications")
Shelf-life (stability)	Maintenance of all physical and microbiology specifications at the end of the shelf-life period. (Initial shelf-life of 10 months, to be extended later).	Met ("Shelf-life (stability) testing...demonstrated that the subject device maintained all physical and microbiology specifications at the end of shelf-life period.")
Biocompatibility: Cytotoxicity	Compliance with ISO 10993-5:2009 standards (specific criteria not detailed in this summary, but implied by "passed")	Passed ("The subject device has passed the following biocompatibility testing...")
Biocompatibility: Sensitization	Compliance with ISO 10993-10:2010 standards (specific criteria not detailed in this summary, but implied by "passed")	Passed ("The subject device has passed the following biocompatibility testing...")
Biocompatibility: Irritation	Compliance with ISO 10993-10:2010 standards (specific criteria not detailed in this summary, but implied by "passed")	Passed ("The subject device has passed the following biocompatibility testing...")
Biocompatibility: Acute Systemic Toxicity	Compliance with ISO 10993-11:2006 standards (specific criteria not detailed in this summary, but implied by "passed")	Passed ("The subject device has passed the following biocompatibility testing...")

Regarding the AI/Algorithm specific questions (most are Not Applicable to this device):

2. Sample sized used for the test set and the data provenance:

For physical and microbiology tests: The sample size is not explicitly stated in this summary. It would be typical for these tests to use a number of batches or samples as per the test methodologies (USP and ISO standards).
Data Provenance: Not specified, but generally refers to in-house or third-party laboratory testing. The document states "Shelf-life (stability) testing conducted by a third-party laboratory".

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

N/A. This applies to expert-driven evaluations, such as reading medical images. For a personal lubricant, "ground truth" is established by laboratory measurements against defined standards (e.g., USP monographs, ISO standards). The "experts" are the lab technicians and chemists performing and interpreting these standardized tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

N/A. This refers to consensus building among human readers for diagnostic studies. Lab tests follow pre-defined analytical methods, not adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

N/A. This is irrelevant for a personal lubricant. It pertains to AI-assisted diagnostic tools.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

N/A. This does not apply to this product. Standalone performance refers to AI algorithms.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Laboratory Standards and Measurements: For this device, the "ground truth" for its performance is derived from quantitative measurements and qualitative observations made according to established United States Pharmacopeia (USP) monographs and International Organization for Standardization (ISO) standards for microbiological, chemical, and biocompatibility properties.

8. The sample size for the training set:

N/A. There is no "training set" in the context of this device. This concept applies to machine learning models.

9. How the ground truth for the training set was established:

N/A. Not applicable, as there is no training set for this device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, and three human profiles facing right.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 6, 2016

Mano and Mano Proprietary Limited % Gary Mocnik Regulatory Consultant ClinReg Consulting Services, Inc. 733 Bolsana Drive Laguna Beach, CA 92651

Re: K161585

Trade/Device Name: Mano and Mano Personal Lubricant (also branded as Nooky, Hello Sailor, or Lulu) Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: Class II Product Code: NUC Dated: June 6, 2016 Received: June 8, 2016

Dear Gary Mocnik:

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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (OS) 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/Resourcesfor You/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,

Joyce M. Whang -S

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

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Indications for Use

510(k) Number (if known) K161585

Device Name

Mano and Mano Personal Lubricant (additionally branded as Nooky, Hello Sailor, or Lulu)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
[Checkbox 1] [Checkbox 2]

| | Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary (K161585)

Applicant:	Mano and Mano Proprietary Limited286 Chesterville RdMoorabbin, Victoria 3189Australia
Contact:	Gary MocnikClinReg Consulting Services, Inc.733 Bolsana DriveLaguna Beach, CA 92651Phone: 949-433-0413E-mail: gmocnik@cox.net)
Date Prepared:	August 16, 2016
Proprietary Name:	Mano and Mano Personal Lubricant (also branded as Nooky, Hello Sailor, orLulu)
Common Name:	Personal Lubricant
Regulation Number:	21 CFR 884.5300
Regulatory Class:	Class II
Product Code:	NUC
Predicate Device:	Poise Personal Lubricant (K120650)

Device Description:

This product has an initial shelf-life of 10 months. The shelf-life will be extended pending completion of further study.

Indications for Use:

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Substantial Equivalence Discussion

The subject and predicate devices have the same indications. They both are clear, colorless, waterbased personal lubricants. Although there are differences in pH, osmolality, viscosity and formulation of these devices, the differences do not represent a new technology as they do not raise different questions of safety and effectiveness.

Performance Data

Bench testing demonstrated that the subject device met the physical specifications (appearance, pH, viscosity and, osmolality) and the following microbiology specifications:

Criteria	Specifications	Methods
Total Aerobic Microbial Count	≤100 cfu/g	USP <61>
Total Yeast and Mold Count	≤10 cfu/g	USP <61>
Absence of PathogenicOrganisms	Absence of pseudomonas aeruginosa, staphylococcusaureus, and candida albicans	USP <62>
Antimicrobial Effectiveness	At least 2.0 log reduction from the initial count at 14days; no increase from the 14 days count at 28 days; noincrease from the initial calculated count at 14 and 28days	USP<51>

Shelf-life (stability) testing conducted by a third-party laboratory demonstrated that the subject device maintained all physical and microbiology specifications at the end of shelf-life period.

The subject device has passed the following biocompatibility testing in accordance with relevant ISO standards:

Cytotoxicity (ISO 10993-5:2009) ●
Sensitization (ISO 10993-10:2010) ●
Irritation (ISO 10993-10:2010) ●
Acute Systemic Toxicity (ISO 10993-11:2006) ●

Conclusion:

The subject and predicate devices have the same indications and fundamental technological characteristics. The differences in technological characteristics do not raise different types of questions and can be assessed by bench and biocompatibility testing. Performance data demonstrates 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.