Good Clean Love Personal Lubricant Almost Naked and Natural Cinnamon Vanilla are personal lubricants 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, polyisoprene, and polyurethane condoms.

Device Description

Good Clean Love Personal Lubricants Almost Naked and Natural Cinnamon Vanilla contain water-solvent organic materials. The primary ingredient is aloe vera (95%). The products are provided in tube containers and have a gel consistency. They include aromatics of cinnamon, vanilla, and lemon. The lubricants are not a spermicide or contraceptive. They are compatible with natural rubber latex, polyisoprene, and polyurethane condoms.

AI/ML Overview

The provided document describes the 510(k) premarket notification for "Good Clean Love Personal Lubricants Almost Naked and Natural Cinnamon Vanilla". This documentation is for a medical device (personal lubricant) and as such, the acceptance criteria and supporting studies are focused on its physical and chemical properties, biocompatibility, and compatibility with condoms, rather than performance metrics typically associated with AI/ML-based diagnostic devices.

Therefore, many of the requested points (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC comparative effectiveness study, standalone algorithm performance, training set sample size, ground truth for training set) are not applicable to this type of device submission.

Here's a breakdown of the available information based on your request:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Test	Reported Device Performance/Conclusion
Physical/Chemical Specs	Appearance	Met specifications
	Odor	Met specifications
	pH	Met specifications
	Viscosity	Met specifications
	Osmolality	Met specifications
Microbiological Specs	Antimicrobial effectiveness	Met specifications
	Total microbial count	Met specifications
	Fungal/yeast/mold limits	Met specifications
	Absence of pathogenic organisms	Met specifications
Shelf-Life	Established shelf-life	One-year shelf-life established
Condom Compatibility	Compatibility with natural rubber latex, polyisoprene, and polyurethane condoms (following ASTM D7661-10)	Concluded to be compatible with natural rubber latex, polyisoprene, and polyurethane condoms.
Biocompatibility	Vaginal Mucosa Irritation (ISO 10993-10:2010)	Accepted results
	Acute Systemic Toxicity (ISO 10993-11:2006)	Accepted results
	Maximization Test for Delayed Hypersensitivity (ISO-10993-10:2010)	Accepted results
	Cytotoxicity (MatTek EpiVaginal Tissue Model)	Accepted results
Substantial Equivalence	Performance as well as the legally marketed predicate device, Aloe Cadabra (K124044), for intended use and technological characteristics.	The non-clinical tests and predicate comparison demonstrate that the subject device performs as well as the legally marketed device and is substantially equivalent to the cited predicate device for intended use and technological characteristics. Both products consist of 95% organic aloe vera, are compatible with natural rubber latex and polyisoprene condoms, and are biocompatible.

Non-AI/ML Specific Information (as per document):

Sample size used for the test set and the data provenance: Not applicable in the context of typical AI/ML test sets. The tests performed are laboratory-based, chemical, physical, and biological assessments. "Test set" refers to samples of the product itself for analytical and biological evaluation. The data provenance is internal laboratory testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for these types of tests is established by adherence to established international standards (e.g., ISO, ASTM) and validated laboratory methods, not by expert consensus in the diagnostic sense.
Adjudication method: Not applicable. Lab testing results are objective measurements against defined specifications.
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: Not applicable. This is not an AI/ML diagnostic device involving human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical and chemical product, not an algorithm.
The type of ground truth used: Ground truth for this device's performance is established by objective laboratory measurements against predefined specifications and internationally recognized standards (e.g., pH, viscosity, microbial counts, compatibility according to ASTM, biocompatibility according to ISO standards).
The sample size for the training set: Not applicable. This device does not involve a "training set" in the AI/ML context. Its development and verification involve formulation and testing.
How the ground truth for the training set was established: Not applicable.

Summary

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November 21, 2019

Good Clean Love, Inc. % Steven Chernoff Vice President Drug & Device Development Co., Inc. P.O. Box 3515 Redmont. WA 98073

Re: K150094

Trade/Device Name: Good Clean Love Personal Lubricants Almost Naked and Natural Cinnamon Vanilla Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: Class II Product Code: NUC Dated: September 30, 2015 Received: October 2, 2015

Dear Steven Chernoff:

This letter corrects our substantially equivalent letter of November 19, 2015.

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Monica D. Garcia, Ph.D. Acting Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal. ObGyn. General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K150094

Device Name

Good Clean Love Personal Lubricants Almost Naked and Natural Cinnamon Vanilla

Indications for Use (Describe)

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)

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510(k) Summary (21 CFR 807.92) Section 5.

Date prepared: Nov. 19. 2015

Submitter:

Good Clean Love, Inc. 207 West 5th Avenue Eugene, OR 97401 Contact Person: Wendy Strgar Ph: 541-344-4483 Fax: 541-685-1335

Proprietary name:

Good Clean Love Personal Lubricants Almost Naked and Natural Cinnamon Vanilla Common name:

Personal Lubricant

Classified name:

Condom

CFR 884.5300 Class II Product code NUC

Intended use:

Good Clean Love Personal Lubricant Almost Naked and Natural Cinnamon Vanilla are personal lubricants 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, polyisoprene, and polyurethane condoms.

Predicate device:

The Good Clean Love personal lubricants are substantially equivalent to Aloe Cadabra personal lubricants (K124044).

Description of device:

Summary of technological characteristics compared to predicate devices:

Both the Good Clean Love products and its predicate device, Aloe Cadabra, consist of 95% organic aloe vera. Both products are compatible with natural rubber latex and polyisoprene condoms and are biocompatible.

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Non-clinical testing:

Testing has established that lubricants met specifications for appearance, odor, pH, viscosity, osmolality, antimicrobial effectiveness, total microbial count, fungal/yeast/mold limits, and absence of pathogenic organisms. Shelf-life has been established at one-year.

Condom compatibility testing following ASTM D7661-10 concluded that the lubricants are compatible with natural rubber latex, polyisoprene, and polyurethane condoms.

Biocompatibility testing for Vaginal Mucosa Irritation (ISO 10993-10:2010), Acute Systemic Toxicity (ISO 10993-11:2006), Maximization Test for Delayed Hypersensitivity (ISO-10993-10:2010), and Cytotoxicity (MatTek EpiVaginal Tissue Model) all had acceptable results.

Conclusion:

The conclusions drawn from the non-clinical tests and predicate comparison demonstrate that the subject device performs as well as the legally marketed device and the Good Clean Love's personal lubricants are substantially equivalent to the cited predicate device for intended use and technological characteristics.

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.