Natureplex Warm Touch Warming Jelly 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 condoms. This product is not compatible with polyisoprene or polyurethane condoms

Device Description

Warm Touch Warming Jelly is a non-sterile, clear, colorless, viscous jelly for use as a personal lubricant. The device is designed to supplement the body's own natural lubrication fluids and is compatible for use with natural rubber latex condoms during intimate sexual activity. The device is not compatible with polyurethane or polyisoprene condoms. The primary packaging for the product is a low-density polyethylene (LDPE) tube with a cap, and peel seal for safety. Each tube is secondarily packaged in a cardboard carton.

AI/ML Overview

This document is a 510(k) Pre-Market Notification from the FDA regarding the "Natureplex Warm Touch Warming Jelly." It details the device's characteristics and its comparison to a predicate device to establish substantial equivalence.

Based on the provided text, here is an analysis of the acceptance criteria and study information:

1. A table of acceptance criteria and the reported device performance

Parameter	Acceptance Criteria (Specification)	Reported Device Performance (Natureplex Warm Touch Warming Jelly)
Appearance	Smooth clear gel	Smooth clear gel
Odor	None to slight wax scent	None to slight wax scent
pH	4.0-6.0	4.0-6.0
Viscosity	60,000-155,000 cP	60,000-155,000 cP
Total Aerobic Microbial Count (TAMC) per USP <61>	<10 cfu/g	<10 cfu/g
Total Yeast and Mold Count (TYMC) per USP <61>	<10 cfu/g	<10 cfu/g
Water Activity per USP <1112D>	≤0.023 aw	≤0.023 aw
Absence of Pathogenic Organisms (S. aureus, P. aeruginosa, C. albicans)	Absent	Absent
Biocompatibility (Cytotoxicity)	Biocompatible	Biocompatible
Biocompatibility (Sensitization)	Biocompatible	Biocompatible
Biocompatibility (Vaginal Irritation)	Biocompatible	Biocompatible
Biocompatibility (Acute Systemic Toxicity)	Biocompatible	Biocompatible
Condom Compatibility (Natural Rubber Latex)	Compatible	Compatible
Shelf-Life	2 years	2 years

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes used for the various tests (biocompatibility, condom compatibility, shelf-life).
The data provenance (country of origin, retrospective/prospective) is not mentioned for any of the studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as the device is a personal lubricant, not an AI or diagnostic device that requires expert ground truth for interpretation. The ground truth for performance criteria is based on established laboratory testing standards.

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

This information is not applicable for this type of device and testing. Test results are typically objective measurements against defined specifications.

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

This information is not applicable as this is not an AI-assisted diagnostic device.

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

This information is not applicable as this is not an AI/algorithm-based device. The device itself (the lubricant) is the standalone entity being evaluated.

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

The "ground truth" for the performance criteria is derived from:

Laboratory testing standards: For pH, viscosity, microbial counts, water activity, and absence of pathogenic organisms, the "ground truth" is measured values compared against established specifications (e.g., USP <61>, USP <1112D>).
International Standards: Biocompatibility testing was performed in accordance with ISO 10993-1, ISO 10993-5, ISO 10993-10, and ISO 10993-11. Condom compatibility testing was performed in accordance with ASTM D7661-10. These standards define the methods and acceptance criteria for establishing compatibility and safety.
Real-time stability studies: For shelf-life, the "ground truth" is the observed maintenance of specifications over the duration of the shelf-life.

8. The sample size for the training set

This information is not applicable as there is no training set for an AI/machine learning model. The device is a physical product subject to physical and chemical testing.

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

This information is not applicable as there is no training set.

Summary

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December 20, 2018

Natureplex, LLC Felicia Irons Director of Quality 11085 Airport Road Olive Branch, Mississippi 38654

Re: K180828

Trade/Device Name: Natureplex Warm Touch Warming Jelly Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: Class II Product Code: NUC Dated: November 21, 2018 Received: November 23, 2018

Dear Felicia Irons:

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 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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael T. Bailey -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) K180828

Device Name Natureplex Warm Touch Warming Jelly

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary-K180828

Company Name:	Natureplex, LLC
Company Address:	11085 Airport Road Olive Branch, MS 38654-0221
Contact Person:	Felicia Irons 901-825-8556
Summary Preparation Date:	December 17, 2018
Device Trade Name:	Natureplex Warm Touch Warming Jelly
Common Name:	Personal Lubricant
Regulation Number:	21 CFR 884.5300
Regulation Name:	Condom
Product Code:	NUC (Lubricant, Personal)
Device Class:	Class II
Predicate Device:	Sheffield's Warming LubriGel Personal Lubricant K052162

The predicate device has not been subject to a design-related recall.

Description of Device

The primary packaging for the product is a low-density polyethylene (LDPE) tube with a cap, and peel seal for safety. Each tube is secondarily packaged in a cardboard carton.

The device specifications are listed in the table below:

Parameter	Specification
Appearance	Smooth clear gel
Odor	None to slight wax scent

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pH	4.0-6.0
Viscosity	60,000-155,000 cps
Total Aerobic MicrobialCount (TAMC) per USP<61>	<10 cfu/g
Total Yeast and Mold Count(TYMC) per USP<61>	<10 cfu/g
Water Activity per USP<1112D>	[le]0.023 aw
Absence of PathogenicOrganisms (S. aureus, P.aeruginosa, and C.albicans) per USP<62>	Absent

Indications for Use

Feature	K1800828Warm TouchWarming JellySubject Device	K052162Sheffield'sWarming LubriGelPersonal LubricantPredicate Device
Indication for Use	Natureplex Warm TouchWarming Jelly is apersonal lubricant, forpenile and/or vaginalapplication, intended tomoisturize and lubricateto enhance the ease andcomfort of intimatesexual activity andsupplement the body'snatural lubrication. Thisproduct is compatiblewith natural rubber latexcondoms. This product isnot compatible withpolyisoprene orpolyurethane condoms	Personal lubricant forpenile and vaginal useonly (compatible withlatex condoms)

Predicate Device Comparison

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Formulation	Propylene glycol, polyethyleneglycol, hydroxypropylcellulose, lactic acid	Propylenecol,polyethylene glycol,hydroxypropyl cellulose,lactic acid
Condom Compatibility	Natural rubber latexcondoms	Natural rubber latexcondoms
pH	4.0-6.0	Not known
Viscosity	60000-155000 cPs	Not known
Total Microbial	<10 cfu/g (USP <61>)	Not known
Fungal/Yeast/Mold	<10 cfu/g(USP <61>)	Not known
Absence ofPathogenicOrganisms (S.aureus, P.aeruginosa,and C.albicans)	Absent	Not known
Shelf-Life	2 years	Not known

The subject and predicate devices have different indications for use statements; however, their intended uses are the same, i.e., lubrication during intimate sexual activity and compatibility with natural rubber latex condoms.

The subject and predicate devices have similar technological characteristics (e.g., condom compatibility, formulation ingredients, etc.); however, differences in specifications and concentrations of specific chemicals in the formulation exist.

The differences in technological characteristics described above between the subject and predicate devices do not raise different questions of safety and effectiveness. In addition, the specifications for the subject device are comparable to other devices of this type.

Performance Data

Biocompatibility:

Biocompatibility studies were performed in accordance with the 2016 FDA guidance document "Use of International Standard ISO 10993-1, Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process" and ISO 10993- 1:2009 as follows:

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

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The results of this testing demonstrated that the subject lubricants are biocompatible.

Condom Compatibility:

Condom Compatibility testing was performed in accordance with ASTM D7661-10

"Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms." The results based on the recognized standard demonstrate that the product is compatible with natural rubber latex condoms. No testing was performed on polyisoprene or polyurethane condoms. Therefore, the Warm Touch Warming Jelly is labeled as not compatible with polyisoprene and polyurethane condoms.

Shelf-Life:

The shelf-life of Warm Touch Warming Jelly is 24 months from the date of production. This is based on the results of real-time stability studies that demonstrated the device can maintain its specifications over the duration of its shelf-life.

Substantial Equivalence:

The results of the performance testing described above demonstrate that the Warm Touch Warming Jelly is as safe and effective as the predicate device and supports a determination of substantial equivalence.

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.