Aloe Glide Lubricant 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

Aloe Glide Lubricant is a personal lubricant that is non-sterile, waterbased, and provides lubrication during intimate sexual activity. This device is compatible with natural rubber latex and polyisoprene condoms, and is not compatible with polyurethane condoms. Its formulation consists of water, xanthan gum, licorice and marshmallow extract, aloe barbadensis leaf extract, potassium sorbate, citric acid, and natapres. Aloe Glide is packaged in 2, 4, and 8 fl. oz bottles composed of polyethylene terephthalate (PET). Aloe Glide lubricant is a personal lubricant for over-the-counter (OTC) use.

AI/ML Overview

This looks like a 510(k) summary for a medical device called "Aloe Glide Lubricant." The document states that the device 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. It is compatible with natural rubber latex and polyisoprene condoms but not with polyurethane condoms.

The document is a US FDA 510(k) clearance letter, which means the device has been found to be substantially equivalent to a legally marketed predicate device. This is primarily a regulatory submission for market clearance, not typically a clinical study demonstrating performance against specific clinical efficacy or diagnostic accuracy acceptance criteria in the same way an AI/ML device would.

Therefore, the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, expert adjudication, and MRMC studies, does not apply to this type of device and submission. The "study" here refers to the performance testing to demonstrate substantial equivalence, focusing on safety and technical characteristics rather than clinical performance or diagnostic accuracy.

Here's a breakdown of the provided information, framed as closely as possible to your request, but highlighting where your specific questions are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for a personal lubricant, in the context of a 510(k) submission, are primarily defined by the specifications to demonstrate safety and functional equivalency to a predicate device. These are detailed in Table 1 (Device Specifications) and through performance testing results.

Property	Acceptance Criteria (Specification)	Reported Device Performance
Appearance	Clear and transparent	Demonstrated to meet this specification.
Odor	Characteristic	Demonstrated to meet this specification.
Viscosity	10,000 - 15,000 cps	Demonstrated to meet this specification.
Osmolality	300 – 400 mOsm/kg	Demonstrated to meet this specification.
pH at 25 °C	4.5 – 5.8	Demonstrated to meet this specification.
Total Aerobic Microbial Count (USP <61>)	<100 cfu/g	Demonstrated to meet this specification.
Total Yeast & Mold Count (USP <61>)	<10 cfu/g	Demonstrated to meet this specification.
Absence of Pathogenic Organisms (USP <62>)	Pseudomonas aeruginosa: Absent; Staphylococcus aureus: Absent; Candida albicans: Absent; Escherichia coli, Salmonella, Clostridium Species: Absent	Demonstrated to meet these specifications.
Antimicrobial Effectiveness (USP <51>)	E. coli, P. aeruginosa, S. aureus: NLT 2.0 log reduction from initial count at 14 days and no increase from 14-day count at 28 days.	Demonstrated to meet these specifications.
	C. albicans, A. niger: No increase from initial calculated count at 14 and 28 days.	Demonstrated to meet these specifications.
Biocompatibility	Non-cytotoxic, non-sensitizing, non-irritating, non-systemically toxic	Reported: Non-cytotoxic (based on alternate testing comparable to ISO 10993-5:2009), non-sensitizing (human repeat insult patch testing), non-irritating (human repeat insult patch testing), and non-systemically toxic (acute systemic toxicity testing per ISO 10993-11:2017).
Condom Compatibility	Compatible with natural rubber latex and polyisoprene condoms; Not compatible with polyurethane condoms	Reported: Compatible with natural rubber latex and polyisoprene condoms; Not compatible with polyurethane condoms (evaluated per ASTM D7661-10).
Shelf Life (1-year accelerated aging study)	Maintain specifications (Table 1) over duration of shelf life	Reported: Device can maintain its specifications over the duration of its shelf life.

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

Test Set Sample Size: Not applicable. The "tests" here refer to chemical, physical, and biological performance evaluations of the lubricant itself, or compatibility tests with condoms. These are not clinical studies with patient test sets in the typical sense of diagnostic performance.
Data Provenance: Not applicable for a clinical test set. The data originates from laboratory performance testing performed by the manufacturer or contracted labs.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Number of Experts: Not applicable. Ground truth as typically defined in diagnostic studies (e.g., expert consensus on medical images) is not relevant for lubricant safety and performance testing.
Qualifications of Experts: Not applicable. The "ground truth" for the performance tests relies on established scientific methods and criteria for chemical, microbiological, and biocompatibility assessments, not clinical interpretation by expert readers.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. There is no "test set" requiring adjudication in the context of clinical or diagnostic performance. The results of the laboratory tests are factual measurements and observations against predefined specifications.

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

MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks involving interpretation of complex data (e.g., medical images). It is not applicable to a personal lubricant's safety and performance evaluation.
Effect Size: Not applicable as no MRMC study was performed.

6. Standalone (Algorithm Only) Performance Study

Standalone Performance Study: No, a standalone performance study (i.e., algorithm only without human-in-the-loop performance) was not done. This concept is relevant for AI/ML diagnostic tools. For this device, the "performance" is inherent in the product's physical and biological properties.

7. Type of Ground Truth Used

Type of Ground Truth: The "ground truth" is established by standardized laboratory test methods and scientific principles for assessing material properties, microbiological purity, biocompatibility, and condom compatibility. This is based on industry standards (e.g., USP, ISO 10993, ASTM D7661-10) rather than expert consensus on medical conditions, pathology, or clinical outcomes data.

8. Sample Size for the Training Set

Training Set Sample Size: Not applicable. This device is not an AI/ML algorithm that requires a training set. The formulation and manufacturing processes are developed through traditional pharmaceutical/cosmetic science and engineering, not machine learning.

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

Ground Truth Establishment for Training Set: Not applicable. As there is no AI/ML algorithm or training set, this question is not relevant.

Summary

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September 25, 2019

Desert Harvest, Inc % Abhishek Gurnani Partner Amin Talati Wasserman, LLP 100 S. Wacker Drive, Suite 2000 Chicago, IL 60606

Re: K190323 Trade/Device Name: Aloe Glide Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: August 23, 2019 Received: August 26, 2019

Dear Abhishek Gurnani:

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

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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,

Sharon M. Andrews 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) K190323

Device Name Aloe Glide Lubricant

Indications for Use (Describe)

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

Registration Use (Part 21 CFR 201.2 Select B)	On The Counter Use (21 CFR 201.2 Select C)
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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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510(k) Summary Aloe Glide Lubricant - K190323

This summary uses the format provided in 21 CFR 807.92:

(a)(1) Submitter/Owner:	Desert Harvest, Inc.P.O. Box 1412 Hillsborough,NC 27278 Phone: 919-245-1853
Preparer/Contact:	Abhishek K. GurnaniAmin Talati Wasserman, LLP100 South Wacker Drive, Suite 2000Chicago, IL 60606
	Phone: 312-327-3325
	Fax: 312-884-7352
	Email: Abhishek@AminTalati.com
Summary Prepared:	September 24, 2019
(a)(2) Trade Name:	Aloe Glide Lubricant
Common Name:	Personal Lubricant
Regulation Number:	21 CFR 884.5300
Regulatory Name:	Condom
Regulatory Class:	Class II
Product Code:	NUC (lubricant, personal)

(a)(3) Identification of Predicate Device: Aloe Cadabra Personal Lubricant (K124044).
The predicate device has not been subject to a design related recall.
(a)(4) Device Description: Aloe Glide Lubricant is a personal lubricant that is non-sterile, waterbased, and provides lubrication during intimate sexual activity. This device is compatible with natural rubber latex and polyisoprene condoms, and is not compatible with polyurethane condoms. Its formulation consists of water, xanthan gum, licorice and marshmallow extract, aloe barbadensis leaf extract, potassium sorbate, citric acid, and natapres. Aloe Glide is packaged in 2, 4, and 8 fl. oz bottles composed of polyethylene terephthalate (PET). Aloe Glide lubricant is a personal lubricant for over-the-counter (OTC) use.

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Device specifications are listed in Table 1 below.

Property	Specification
Appearance	Clear and transparent
Odor	Characteristic
Viscosity	10,000 - 15,000 cps
Osmolality	300 – 400 mOsm/kg
pH at 25 °C	4.5 – 5.8
Total Aerobic Microbial Count (USP<61>)	<100 cfu/g

Total Yeast & Mold Count (USP <61>)	<10 cfu/g
	<100 cfu/g
Absence of Pathogenic Organisms (USP<62>)

Pseudomonas aeruginosa	Absent
Staphylococcus aureus	Absent
Candida albicans	Absent
Escherichia coli, Salmonella, ClostridiumSpecies	Absent
Antimicrobial Effectiveness (USP<51>)
Escherichia coli, Pseudomonasaeruginosa, Staphylococcus aureus,	NLT a 2.0 log reduction from initialcount at 14 days and no increase fromthe 14 day count at 28 days
Candida albicans, Aspergillus niger	No increase from the initial calculatedcount at 14 and 28 days

Table 1: Subject Device Specifications

(a)(5) Indications for Use Statement: Aloe Glide Lubricant 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.
The subject and predicate device have the same intended use.

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(a)(6) Comparison of Technological Characteristics

	K190323	K124044
	Subject Device	Predicate
Sponsor	Desert Harvest, Inc.	Seven Oaks Ranch, Inc.
Regulation NumberProduct CodeDevice Class	844.5300NUCII	844.5300NUCII
Indications for Use	Aloe Glide Lubricant is apersonal lubricant, for penileand/or vaginal application,intended to moisturize andlubricate, to enhance the easeand comfort of intimate sexualactivity and supplement thebody's natural lubrication. Thisproduct is compatible withnatural rubber latex andpolyisoprene condoms. Thisproduct is not compatible withpolyurethane condoms.	Aloe Cadabra® Lubricant andAloe Cadabra®Flavored/Scented Lubricantsare personallubricants, for penile and/orvaginal application, intended tomoisturize and lubricate, toenhancethe ease and comfort ofintimate sexual activity andsupplement the body's naturallubrication.This product is compatiblewith natural rubber latex andpolyisoprene condoms. Thisproduct isnot compatible withpolyurethane condoms.
Physical Features	Clear liquid	Not known
Water-based	Yes	No (Aloe-based)
PrimaryIngredients	WaterXanthan GumNatapres*	Aloe Extract
Sterile	No	No
CondomCompatibility	Natural Rubber LatexPolyisoprene	Natural Rubber LatexPolyisoprene
BiocompatibilityTested	Yes	Yes
AntimicrobialTested	Yes	Yes

Table 2. Technological Characteristics of Aloe Glide and Compared to the Predicate

*Natapres contains glycerin, leuconostoc/radish, root ferment filtrate, lonicera japonica (honeysuckle) flower extract, lonicera caprifolium (honeysuckle) extract, populus tremuloides bark extract, and gluconolactone

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The subject and predicate devices have the same indications for use statements. As noted in the table above, the subject and predicate device have different formulations. The differences in technological characteristics between the subject and predicate device do not raise different questions of safety and effectiveness.

(b) Summary of Performance Data

Biocompatibility: Aloe Glide has undergone biocompatibility testing including cytotoxicity based on alternate testing comparable to ISO 10993-5: 2009, human repeat insult patch testing (sensitization and irritation), and acute systemic toxicity testing per ISO 10993-11:2017. The testing found that Aloe Glide is non-cytotoxic, non-sensitizing, non-irritating, and non-systemically toxic.

Condom Compatibility: The compatibility of the subject devices with natural rubber latex. polyisoprene and polyurethane condoms was evaluated in accordance with ASTM D7661-10 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms" and was determined to be compatible with natural rubber latex and polyisoprene condoms. The subject device was determined not to be compatible with polyurethane condoms.

Shelf Life: Aloe Glide has a 1-year shelf life in accordance with the results of an accelerated aging stability study. Results from testing demonstrated that the device can maintain its specifications (as shown in Table 1) over the duration of its shelf life.

Conclusion: The results of the performance testing described above demonstrate that the Aloe Glide 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.