HydraDose Vaginal Suppositories are a personal lubricant, for 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 not compatible with natural rubber latex, polyurethane, and polyisoprene condoms.

Device Description

HydraDose Vaginal Suppositories is a glyceride-based personal lubricant for over-thecounter use. The subject device is a non-sterile solid preparation containing hyaluronic acid, cocoa butter, triglycerides, and cera alba. The subject device is packaged in sets of five a polyvinyl chloride (PVC)/polyethylene (PE) blister pack. The lubricant is not compatible with natural rubber latex, polyisoprene condoms, and polyurethane condoms.

AI/ML Overview

I am sorry, but the provided text does not contain information about the acceptance criteria and the study that proves a device meets acceptance criteria in the context of an AI-powered medical device or diagnostic.

The document is an FDA 510(k) premarket notification clearance letter for a medical device called "HydraDose Vaginal Suppositories," which is a personal lubricant. It discusses the substantial equivalence of this product to a predicate device based on its indications for use, technological characteristics, and non-clinical performance testing (biocompatibility, shelf life, condom compatibility).

The request asks for details specific to the development and validation of an AI model, such as:

A table of acceptance criteria and reported device performance (for an AI-powered device)
Sample size and data provenance for a test set
Number and qualifications of experts for ground truth establishment
Adjudication method for test set ground truth
MRMC comparative effectiveness study details (human reader improvement with AI)
Standalone AI performance details
Type of ground truth used
Sample size for the training set
How training set ground truth was established

None of these elements are present in the provided text as the device under review is a physical, chemical-based personal lubricant, not an AI or software-based medical device.

Summary

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June 23, 2023

MD Labs, LLC % Louie Goryoka Sr. RA/QA Consultant Med-Device Consulting, Inc. 5804 Rainbow Hill Road Agoura Hills, CA 91301

Re: K230518

Trade/Device Name: HydraDose Vaginal Suppositories Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: May 19, 2023 Received: May 22, 2023

Dear Louie Goryoka:

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.

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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-regulatoryinformation/postmarketing-safety-reporting-combination-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 mediation-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 -S

Monica D. Garcia, Ph.D. 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) K230518

Device Name HydraDose Vaginal Suppositories

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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510(K) Summary – K230518 HydraDose Vaginal Suppositories

l. General Information on Submitter

Applicant:	MD Labs LLC
Address:	780 Lakefield Road, Suite HWestlake Village, California,91361-2628
Telephone:	818-585-7488
Contact Person:	Louie Goryoka
Contact Title:	Sr. Regulatory and QualityConsultantMed-Device Consulting, Inc
Email:	mdci@m-dci.us
Date Prepared:	June 21, 2023

II. General Information on Device

Proprietary Name:	HydraDose Vaginal Suppositories
Common Name:	Personal Lubricant
Regulation Name:	Condom
Regulation Number:	21 CFR 884.5300
Regulatory Class:	II
Product Code:	NUC (Lubricant, Personal)

lll. Predicate Device

Predicate Device	510(k) Number
Revaree Plus Vaginal Suppositories	K213220

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

IV. Description of Device

The subject device is packaged in sets of five a polyvinyl chloride (PVC)/polyethylene (PE) blister pack. The lubricant is not compatible with natural rubber latex, polyisoprene condoms, and polyurethane condoms.

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The specifications for HydraDose Vaginal Suppositories are described in Table 1.

Parameter	Test Method	Specification
Appearance	Visual	Solid; yellowish to white color
Odor	Olfactory	None
pH	N/A	N/A
Viscosity	N/A	N/A
Osmolality	N/A	N/A
AntimicrobialEffectiveness	USP <51>	Meets USP <51> acceptancecriteria for Category 2products. Category 2,bacteria should show not lessthan 2.0 log reduction at 14days and no increase fromthe 14-day count to the 28-day count. Yeast and moldsshould show no increasefrom the initial calculatedcount at 14 and 28 days
Total Microbial Count	USP <61> and<1111>	<100 cfu/g
Fungal/Yeast/MoldLimits	USP <61> and<1111>	<10 cfu/g
Absence of PathogenicOrganisms(StaphylococcusAureus, PseudomonasAeruginosa, CandidaAlbicans)	USP <62>	Absent
Content of hyaluronicacid	Spectrophotometric	0.25 - 2%
Disintegration time	USP <701> and<2040>	12 minutes 21 seconds;37.5°C
Average weight	Analytical balance	2g

Table 1. Device Specifications

V. Indications for Use

VI. Substantial Equivalence Discussion

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A comparison of the intended use and technological features of the subject and predicate devices is provided in Table 2 below:

Table 2. Intended Use and Technological Characteristics of Subject Device Compared to Predicate Device

Characteristic /Feature	HydraDose VaginalSuppositories (subjectdevice)	Revaree Plus VaginalSuppositories (predicatedevice) - K213220	Comparison
Indication for use	HydraDose VaginalSuppositories are a personallubricant, for vaginalapplication, intended tomoisturize and lubricate, toenhance the ease and comfortof intimate sexual activity andsupplement the body's naturallubrication. This product is notcompatible with natural rubberlatex, polyurethane, andpolyisoprene condoms.	Revaree plus vaginalsuppositories are a personallubricant for vaginalapplication, intended tomoisturize and lubricate, toenhance the ease and comfortof intimate sexual activity, andsupplement the body's naturallubrication. This product is notcompatible with natural rubberlatex, polyurethane, andpolyisoprene condoms.	Same
Percentage ofHyaluronic Acid	0.25-2%	0.5%	Different
Over the Counter	Yes	Yes	Same
Not acontraceptive orSpermicide	Yes	Yes	Same
Non-sterile	Yes	Yes	Same
PrimaryIngredients	Hyaluronic acid, cocoa butter,triglycerides, cera alba	Hyaluronic acid, glycerides,sweet almond oil	Different: The ingredients of thepredicate device are different;the ingredients do not raisedifferent questions of Safety &Effectiveness (S & E)
Microbial Limits	Total mold/yeast count <10cfu/mLTotal aerobic microbial count<100 cfu/mLAbsence of pathogens(Candida albicans,Pseudomonas aeruginosa,Staphylococcus aureus)	Total mold/yeast count <10cfu/mLTotal aerobic microbial count<100 cfu/mLAbsence of pathogens(Candida albicans,Pseudomonas aeruginosa,Staphylococcus aureus)	Same
CondomCompatibility	Not compatible with naturalrubber latex, polyisoprenecondoms, and polyurethanecondoms	Not compatible with naturalrubber latex, polyisoprenecondoms, and polyurethanecondoms	Same

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The subject and predicate devices have identical indications for use and have the same intended use - to provide lubrication during intimate sexual activity. The subject and predicate devices have different technological characteristics, including different formulations and device specifications. The different technological characteristics do not raise different types of safety and effectiveness questions.

VII. Summary of Non-Clinical Performance Testing

Biocompatibility

Biocompatibility testing on the subject lubricant was performed in accordance with the 2020 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/(R)2014) ●
Guinea Pig Maximization Sensitization Test (ISO 10993-10: 2010) ●
Vaqinal Irritation (ISO 10993-23: 2021) ●
Acute Systemic Toxicity (ISO 10993-11:2017) .

The results of this testing demonstrate that the subject lubricant is non-cytotoxic, nonirritating, non-sensitizing, and not systemically toxic.

Shelf Life

The subject device is a non-sterile personal lubricant weighing 2g and packaged in blister packs with an 8.5-month shelf-life in accordance with the results of an accelerated aging study, conducted for 3 months at 40°C per ASTM F1980-16. Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices. The device specifications listed in Table 1 were tested across the device shelf-life and the subject device met the specifications at all time points.

Condom Compatibility

Condom compatibility testing was not conducted for the subject device. Therefore, HydraDose Vaginal Suppositories is not compatible with natural rubber latex, polyisoprene, and polyurethane condoms

VIII. Conclusion

The results of the testing described above demonstrate that HydraDose Vaqinal Suppositories are 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.