Astroglide® Sensual Strawberry Personal Lubricant is a personal lubricant for penile, vaginal, and/or anal 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

Astroglide® Sensual Strawberry Personal Lubricant is a non-sterile, clear, strawberry-scented and flavored, water-based personal lubricant intended for penile, anal, or vaginal application. This product is not a spermicide or contraceptive. Astroglide® Sensual Strawberry Personal Lubricant is compatible with natural rubber latex condoms. It is not compatible with polyisoprene and polyurethane condoms. This product's primary packaging is a PETE clear bottle with a screw on polypropylene flip-top cap. The bottle is then packaged in a cardboard carton which constitutes the final packaging.

AI/ML Overview

This document is a 510(k) Premarket Notification from BioFilm, Inc. to the FDA for their product, Astroglide® Sensual Strawberry Personal Lubricant. It aims to demonstrate substantial equivalence to a legally marketed predicate device (Glycerin & Paraben Free Astroglide, K072647).

Therefore, this document does not describe:

Acceptance criteria and device performance for an AI/ML medical device.
A study proving the performance of an AI/ML medical device.
Data provenance, sample sizes for test/training sets, expert qualifications, or adjudication methods related to AI/ML model development or validation.
Multi-reader multi-case (MRMC) comparative effectiveness studies or standalone AI performance.
Details about ground truth establishment for AI/ML models.

Instead, the document focuses on:

Device Description: A water-based personal lubricant, its physical characteristics, and specifications.
Predicate Device Comparison: Highlighting similarities (indications for use, over-the-counter status, base type, pH) and differences (ingredients, osmolality, viscosity, packaging, shelf-life). The document asserts that these differences do not raise new questions of safety and effectiveness.
Non-Clinical Performance Testing: This is the equivalent of "proof" in this context, demonstrating the device's safety and effectiveness through:
- Biocompatibility Testing: Cytotoxicity, sensitization, irritation, and acute systemic toxicity.
- Condom Compatibility Testing: Specifically with natural rubber latex condoms using ASTM D7661-10.
- Shelf-Life Testing: Using accelerated aging (ASTM F1980-16) to determine an 8.5-month shelf-life.

To answer your specific questions based on the provided document, which is NOT about an AI/ML device:

A table of acceptance criteria and the reported device performance:

Physical Specification Tests	Acceptance Criteria / Ranges/Specifications	Reported Device Performance (from text, implicitly met for approval)
Particulate matter	No particles	Met (implied by FDA clearance and statement: "All specifications for the subject lubricant... were met throughout the shelf-life study.")
Color	Clear to slight golden	Met (implied by FDA clearance and statement: "All specifications for the subject lubricant... were met throughout the shelf-life study.")
Clarity	Clear	Met (implied by FDA clearance and statement: "All specifications for the subject lubricant... were met throughout the shelf-life study.")
Odor	Strawberry scent	Met (implied by FDA clearance and statement: "All specifications for the subject lubricant... were met throughout the shelf-life study.")
pH (per USP <791>)	3.5-5.5	Met (implied by FDA clearance and statement: "All specifications for the subject lubricant... were met throughout the shelf-life study." Also stated in comparison table as "Same" to predicate.)
Viscosity (per USP <912>)	200 - 450 cps	Met (implied by FDA clearance and statement: "All specifications for the subject lubricant... were met throughout the shelf-life study." The value 200-450 cps is the reported device performance for this specific product, which is different from the predicate, but deemed acceptable by the FDA.)
Osmolality (per USP <785>)	200 - 450 mOsm/kg, dilution factor of 5	Met (implied by FDA clearance and statement: "All specifications for the subject lubricant... were met throughout the shelf-life study." The value 200-450 mOsm/kg is the reported device performance for this specific product, which is different from the predicate, but deemed acceptable by the FDA.)
Antimicrobial effectiveness (per USP <51>)	Category 2: bacteria show ≥2.0 log reduction at 14 days, no increase from 14-day count at 28-day count; yeast/molds show no increase from initial calculated count at 14 and 28 days.	Met (implied by FDA clearance and statement: "All specifications for the subject lubricant... were met throughout the shelf-life study." Also stated in comparison table as "Same" to predicate.)
Total yeast/mold count (per USP <61> & USP <62>)	< 10 cfu/mL	Met (implied by FDA clearance and statement: "All specifications for the subject lubricant... were met throughout the shelf-life study." Also stated in comparison table as "Same" to predicate.)
Total aerobic microbial count (per USP <61> & USP <62>)	< 100 cfu/mL	Met (implied by FDA clearance and statement: "All specifications for the subject lubricant... were met throughout the shelf-life study." Also stated in comparison table as "Same" to predicate.)
Absence of pathogenic organisms (Staphylococcus aureus, Pseudomonas aeruginosa, and Candida albicans - per USP <61> & USP <62>)	Absent	Met (implied by FDA clearance and statement: "All specifications for the subject lubricant... were met throughout the shelf-life study." Also stated in comparison table as "Same" to predicate.)
Biocompatibility	Non-cytotoxic, non-sensitizing, non-irritating, not systemically toxic	Demonstrated to be non-cytotoxic, non-sensitizing, non-irritating, and not systemically toxic.
Condom Compatibility (Natural Rubber Latex) (per ASTM D7661-10)	Compatible	Results show that Astroglide® Sensual Strawberry Personal Lubricant is compatible with natural rubber latex condoms.
Shelf-Life (per ASTM F1980-16)	All specifications from Section IV met throughout the study.	8.5 months shelf-life achieved; all specifications in Section IV were met throughout the shelf-life study.

Sample size used for the test set and the data provenance: This document describes non-clinical performance testing for a personal lubricant, not an AI/ML device using a "test set" in the machine learning sense. The tests are laboratory-based.
- Sample Size: Not explicitly stated for each test (e.g., number of lubricant samples tested for pH, viscosity, microbial counts). For biocompatibility, it's not specified how many samples/subjects were used for the in-vitro and in-vivo tests. For condom compatibility, ASTM D7661-10 would specify the number of condoms and lubricant samples, but this detail is not provided in the summary. For shelf-life, a sufficient number of product units would have been put on accelerated aging.
- Data Provenance: Not applicable in the geopolitical sense. The data comes from the results of laboratory testing conducted for the purpose of this 510(k) submission. These are not "retrospective or prospective" patient data sets.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a lubricant is established by laboratory measurements (e.g., pH meter for pH, viscometer for viscosity, microbial culture for counts, established protocols for biocompatibility and condom compatibility). There are no human "experts" establishing a "ground truth" for classification or detection tasks as would be the case for an AI/ML device.
Adjudication method: Not applicable. This is not a human-reader study where adjudication is needed.
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 document is not about an AI/ML device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document is not about an AI/ML device.
The type of ground truth used:
- Physical Specifications: Instrumental measurements (pH meters, viscometers, osmolality readers) and laboratory assays (microbial cultures, particulate inspection).
- Biocompatibility: In-vitro (cytotoxicity) and in-vivo (sensitization, irritation, acute systemic toxicity) testing according to ISO standards.
- Condom Compatibility: Standardized mechanical and material property testing (ASTM D7661-10).
- Shelf-Life: Stability testing over time under accelerated conditions according to ASTM F1980-16, measuring the physical specifications listed in the table.
The sample size for the training set: Not applicable. This is not an AI/ML device.
How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

Summary

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March 3, 2022

BioFilm, Inc. Jennifer Keller R&D Formulation Chemist II 3225 Executive Ridge Vista, CA 92081

Re: K213671

Trade/Device Name: Astroglide® Sensual Strawberry Personal Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: November 17, 2021 Received: November 22, 2021

Dear Jennifer Keller:

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,

For 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) K213671

Device Name Astroglide® Sensual Strawberry Personal Lubricant

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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K213671 Page 1 of 5

510(k) Summary K213671 Astroglide® Sensual Strawberry Personal Lubricant

I. Submitter Information

Applicant:	BioFilm, Inc.
Address:	3225 Executive RidgeVista, CA 92081 USA
Telephone:	760-727-9030
Fax:	760-727-8080
Contact Person:	Jennifer Keller
Contact Title:	Research & Development
Email:	Jennifer@biofilm.com
Date Prepared:	2/25/2022

II. General Information on Device

Proprietary Name:	Astroglide® Sensual Strawberry Personal
	Lubricant
Common Name:	Personal Lubricant
Regulation Number:	21 CFR 884.5300
Regulation Name:	Condom
Product Code:	NUC (Lubricant, Personal)
Regulatory Class:	II

III. Predicate Device

Predicate Device	510(k) Number
Glycerin & Paraben Free AstroglideApplicant: BioFilm, Inc.	K072647

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

IV. Description of Device

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with a screw on polypropylene flip-top cap. The bottle is then packaged in a cardboard carton which constitutes the final packaging.

The specifications for Astroglide® Sensual Strawberry Personal Lubricant are described in the following table.

Physical Specification Tests	Ranges/Specifications
Particulate matter	No particles
Color	Clear to slight golden
Clarity	Clear
Odor	Strawberry sent
pH (per USP <791>)	3.5-5.5
Viscosity (per USP <912>)	200 - 450 cps
Osmolality (per USP <785>)	200 - 450 mOsm/kg, dilution factor of 5
Antimicrobial effectiveness (perUSP <51>)	Category 2, bacteria should show not lessthan 2.0 log reduction at 14 days and noincrease from 14-day count at the 28-daycount. Yeast and molds should show noincrease from the initial calculated count at 14and 28 days
Total yeast/mold count (perUSP <61> & USP <62>)	< 10 cfu/mL
Total aerobic microbial count (perUSP <61> & USP <62>)	< 100 cfu/mL
Absence of pathogenic organisms( Staphylococcus aureus ,Pseudomonas aeruginosa , andCandida albicans - per USP <61> &USP <62>)	Absent

V. Indications for Use

VI. Predicate Device Comparison

The following table compares the intended use and key technological characteristics of the subject and predicate device:

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Product Name	Astroglide® SensualStrawberry PersonalLubricantK213671Subject Device	Glycerin & Paraben FreeAstroglideK072647Predicate Device	Comparison
Indications forUse	Astroglide® SensualStrawberry Personal Lubricantis a personal lubricant forpenile, vaginal, and/or analapplication intended tomoisturize and lubricate, toenhance the ease andcomfort of intimate sexualactivity and supplement thebody's natural lubrication.This product is compatiblewith natural rubber latexcondoms. This product is notcompatible with polyisopreneor polyurethane condoms.	Glycerin & Paraben FreePersonal LubricantAstroglide® is a personallubricant, for penile, anal, orvaginal application, intendedto moisturize and lubricate,to enhance the ease andcomfort of intimate sexualactivity and supplement thebody's natural lubrication.This product is compatiblewith latex condoms.	Same: Theindications for usefor the subject andpredicate device arethe same.Therefore, thesubject andpredicate devicehave the sameintended use.
Over-the-Counter Device	Yes	Yes	Same
Base Type	Water	Water	Same
Ingredients	Purified Water, Glycerin,Propylene Glycol, MethylGluceth-20, Natural & ArtificialStrawberry Flavor, ClearXanthan Gum,Hydroxyethylcellulose, SodiumGluconate, Sodium Saccharin,Sodium Benzoate, PotassiumSorbate, Citric Acid	Purified Water, ButyleneGlycol, Propylene Glycol,Xylitol, Polyquaternium-15	Different: Thesubject and predicatedevice havedifferences informulation. Thesedifferences do notraise differentquestions of safetyand effectiveness(S&E).
Condomcompatibility	Natural rubber latexcondoms.	Natural rubber latexcondoms.	Same
pH	3.5-5.5	3.5-5.5	Same
Osmolality	200 - 450 mOsm/kg, 1:5dilution factor	N/A	Different: Thesubject andpredicate devicehave differentosmolalityspecifications.Differences inosmolalityspecifications do notraise differentquestions of S&E.
Viscosity	200 - 450 cps,	1,100-1,500 cps	Different: Thesubject andpredicate devicehave differentviscosityspecifications.
Product Name	Astroglide® SensualStrawberry PersonalLubricantK213671Subject Device	Glycerin & Paraben FreeAstroglideK072647Predicate Device	Comparison
			viscosityspecifications do notraise differentquestions of S&E.
Microbial Limits	• Total mold/yeast count<10 cfu/mL• Total aerobic microbialcount <100 cfu/mL• Absence of pathogens(Candida albicans,Pseudomonasaeruginosa,Staphylococcus aureus)	• Total mold/yeast count<10 cfu/mL• Total aerobic microbialcount <100 cfu/mL• Absence of pathogens(Candida albicans,Pseudomonasaeruginosa,Staphylococcus aureus)	Same
Antimicrobialeffectiveness(per USP<51>)	Category 2, bacteria shouldshow not less than 2.0 logreduction at 14 days and noincrease from 14-day countat the 28-day count. Yeastand molds should show noincrease from the initialcalculated count at 14 and28 days	Category 2, bacteriashould show not less than2.0 log reduction at 14days and no increase from14-day count at the 28-day count. Yeast andmolds should show noincrease from the initialcalculated count at 14 and28 days	Same
Sterile	Non-sterile	Non-sterile	Same
Packaging	2.5 oz PETE bottlepolypropylene cap	2.5 oz PETE bottle withHDPE cap	Different: Thesubject andpredicate devicehave differentpackaging.Differences inpackaging do notraise differentquestions of S&E.
Shelf-life	8.5 months	2 years	Different: Thesubject andpredicate devicehave different shelf-life durations.Differences in shelf-life durations do notraise differentquestions of S&E.

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As noted in the table above, the subject and predicate device have the same indications for use and intended use (i.e., to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication). The subject and predicate device have differences in their technological characteristics.

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However, as stated in the table, the differences in technological characteristics do not raise different questions of safety and effectiveness.

VII. Summary of Non-Clinical Performance Testing

Biocompatibility

Biocompatibility testing on Astroglide® Sensual Strawberry Personal Lubricant was conducted in accordance with the 2020 FDA quidance document "Use of International Standard ISO 10993-1.Biological Evaluation of Medical Devices -Part 1: Evaluation and testing within a risk management process." Testing included the following assessments:

. Cytotoxicity per ISO 10993-5:2009
Sensitization and irritation testing using the human repeat insult patch test, an ● alternative test method to ISO 10993-10:2010
Acute systemic toxicity testing per ISO 10993-11:2017.

The testing demonstrated that Astroglide® Sensual Strawberry Personal Lubricant is non-cytotoxic, non-sensitizing, non-irritating, and not systemically toxic

Condom Compatibility

Astroglide® Sensual Strawberry Personal Lubricant was tested for compatibility with condoms using ASTM D7661-10, "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms." Results show that Astroglide® Sensual Strawberry Personal Lubricant is compatible with natural rubber latex condoms and not compatible with polyisoprene or polyurethane condoms.

Shelf-Life

Astroglide® Sensual Strawberry Personal Lubricant has a shelf-life of 8.5 months based on accelerated aging testing results per ASTM F1980-16, "Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices." All specifications for the subject lubricant, as stated in Section IV of the summary, were met throughout the shelf-life study.

VIII. Conclusion

The results of the testing described above demonstrate that the Astroglide® Sensual Strawberry Personal Lubricant 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.