Astroglide® X Silicone 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 and polyurethane condoms.

Device Description

Astroglide® X Silicone Personal Lubricant is non-sterile, clear, odorless, and siliconebased lubricant. This product is not a spermicide or contraceptive. Astroglide® X Silicone Personal Lubricant is compatible with natural rubber latex condoms. Astroglide® X Silicone Personal Lubricant is not compatible with polyurethane, or polyisoprene condoms. This product's primary packaging is a PETE clear bottle with a screw on polypropylene flip-top cap. The bottle is packaged in a cardboard carton which constitutes the final packaging.

AI/ML Overview

The provided text describes the acceptance criteria and a study for the Astroglide® X Silicone Personal Lubricant.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (Specification)	Reported Device Performance
Appearance	Clear	Clear
Odor	Characteristic	Odorless
Viscosity	225 to 350 centipoise	225 to 350 centipoise
Total yeast/mold count (USP <61>)	<10 cfu/mL	<10 cfu/mL
Total aerobic microbial count (USP <61>)	<100 cfu/mL	<100 cfu/mL
Absence of Pathogenic Organisms (Staphylococcus aureus, Pseudomonas aeruginosa, and Candida albicans) (USP <62>)	Absent	Absent
Water activity (USP<1112>)	< 0.3 Aw	< 0.3 Aw
Condom Compatibility	Compatible with natural rubber latex condoms	Compatible with natural rubber latex condoms only
Shelf-Life	3 years	3 years
Biocompatibility (Cytotoxicity)	Non-cytotoxic	Non-cytotoxic
Biocompatibility (Sensitization)	Non-sensitizing	Non-sensitizing
Biocompatibility (Irritation)	Non-irritating	Non-irritating
Biocompatibility (Systemic Toxicity)	Not systemically toxic	Not systemically toxic

Note: The "Reported Device Performance" column reflects that the device met the stated specifications/criteria, as confirmed by the "Summary of Non-Clinical Performance Testing" section.

2. Sample size used for the test set and the data provenance

The document does not specify a distinct "test set" in the context of a clinical trial or a specific number of samples for each non-clinical test. The testing described is non-clinical performance testing.

Sample Size: Not explicitly stated for each test. The document refers to "the subject lubricant" being tested.
Data Provenance: Not explicitly stated. The tests are non-clinical (laboratory-based) and conducted according to international standards (ISO, ASTM, USP). There's no mention of country of origin for data or if it's retrospective/prospective in a clinical sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This section is not applicable. The evaluations are based on internationally recognized laboratory test methods (ISO, ASTM, USP), not expert consensus on individual cases or ground truth derived from clinical experts.

4. Adjudication method for the test set

This section is not applicable. The evaluations are based on objective laboratory test results against defined specifications, not on human interpretation requiring adjudication.

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 section is not applicable. This document pertains to the regulatory submission of a personal lubricant, not an AI-powered diagnostic device, so an MRMC comparative effectiveness study is irrelevant.

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

This section is not applicable. This document pertains to the regulatory submission of a personal lubricant, not an AI-powered algorithm.

7. The type of ground truth used

The "ground truth" for the device's performance is established by objective measurements against predetermined specifications and international standards. This includes:

Physical property measurements (viscosity, appearance, odor, water activity).
Microbiological testing (total yeast/mold count, aerobic microbial count, absence of specific pathogens).
Biocompatibility testing results (cytotoxicity, irritation, sensitization, systemic toxicity) as per ISO 10993.
Condom compatibility testing results as per ASTM D7661-10.
Shelf-life testing results as per ASTM F1980-16.

8. The sample size for the training set

This section is not applicable. There is no "training set" as this is a physical medical device (personal lubricant) undergoing non-clinical performance testing, not a machine learning model.

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

This section is not applicable, as there is no training set for this type of device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 28, 2021

BioFilm, Inc. Kevin Jamil Regulatory Affairs 3225 Executive Ridge Vista, CA 92081

Re: K210242

Trade/Device Name: Astroglide® X Silicone Personal Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: January 27, 2021 Received: January 29, 2021

Dear Kevin Jamil:

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 and Part 809); 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/cdrl-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. 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) K210242

Device Name Astroglide® X Silicone 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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510(k) Summary - K210242 Astroglide® X Silicone Personal Lubricant

i. General Information on Submitter

Applicant:	BioFilm, Inc.
Address:	3225 Executive RidgeVista, CA 92081 USA
Telephone:	760-727-9030
Fax:	760-727-8080
Contact Person:	Kevin Jamil
Contact Title:	Regulatory Affairs
Email:	kevin@biofilm.com
Date Prepared:	4/27/2021
Establishment Registration:	2025771

ii. General Information on Device

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

iii. Predicate Device

Predicate Device	510(k) Number
pjur® Backdoor Anal Glide and pjur®Analyse Me!	K141913

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

iv. Description of Device

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The specifications for Astroglide® X Silicone Personal Lubricant are described in the following table.

Parameter	Specification (Test Method)
Appearance	Clear
Odor	Characteristic
Viscosity	225 to 350 centipoise
Total yeast/mold count (USP <61>)	<10 cfu/mL
Total aerobic microbial count (USP <61>)	<100 cfu/mL
Absence of Pathogenic Organisms,Staphylococcus aureus, Pseudomonasaeruginosa, and Candida albicans(USP <62>)	Absent
Water activity (USP<1112>)	0.3 Aw

Table 1. Physical Specifications of Astroglide® X Silicone Personal Lubricant

V. Indications for Use

vi. Substantial Equivalence Discussion

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

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Characteristic /Feature	Astroglide® X SiliconePersonal Lubricant(Subject Device)	pjur® Backdoor AnalGlide and pjur® AnalyseMe! (Predicate device)	Comparison
Indications for use	Astroglide® X SiliconePersonal Lubricant is apersonal lubricant for penile,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 polyisopreneand polyurethane condoms.	pjur® Backdoor Anal Glideis a personal lubricant forpenile, vaginal, and/or analapplication intended tomoisturize and lubricate, toenhance the ease andcomfort of intimate sexualactivity and supplementthe body's naturallubrication. This product iscompatible with naturalrubber latex, syntheticpolyisoprene, andpolyurethane condoms.	The subject and predicatedevices have the sameindications for use exceptfor a difference in condomcompatibilities.
CondomCompatibility	This product is compatiblewith natural rubber latexcondoms. This product is notcompatible with polyisopreneand polyurethane condoms.	This product iscompatible with naturalrubber latex, syntheticpolyurethane, andpolyisoprene condoms.	The condom compatibilityof the predicate device isdifferent, but it does notraise different questionsof safety andeffectiveness.
Silicone-BasedLubricant	Yes	Yes	Same
Over the Counter	Yes	Yes	Same
Appearance	Clear	Clear	Same
Not acontraceptive orSpermicide	Yes	Yes	Same
Non-sterile	Yes	Yes	Same
PrimaryIngredients	CyclopentasiloxaneDimethiconeCyclohexasiloxane	cyclopentasiloxane,dimethicone,dimethiconol,Simmondsia Chinensis(Jojoba) Seed Oil	The ingredients of thepredicate device aredifferent; however,differences in deviceingredients do not raisedifferent questions ofsafety & effectiveness
Characteristic /Feature	Astroglide® X SiliconePersonal Lubricant(Subject Device)	pjur® Backdoor AnalGlide and pjur® AnalyseMe! (Predicate device)	Comparison
Microbial Limits	- Total mold/yeast count<10 cfu/mL- Total aerobic microbialcount <100 cfu/mL- Absence of pathogens(Candida albicans,Pseudomonas aeruginosa,Staphylococcus aureus)	- Total mold/yeast count<10 cfu/mL- Total aerobic microbialcount <100 cfu/mL- Absence of pathogens(Candida albicans,Pseudomonas aeruginosa,Staphylococcus aureus)	Same
Viscosity	225 - 350 centipoise	600 - 1,000 centipoise	The viscosities of thesubject and predicatedevices are different;however, differencesin viscosities do notraise differentquestions of safetyand effectiveness.
Water Activity	< 0.3 Aw	< 0.3 Aw	Same
Shelf-Life	3 years	3 years	Same

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As noted in the table above, the subject and predicate device have similar indications for use statements nad have the same intended use – to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. The subject and predicate device have difference technological characteristics, including different formulations, specifications, and condom compatibilities. The different technological characteristics identified do not raise different questions of safety and.

Summary of Non-Clinical Performance Testing vii.

Biocompatibility

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Biocompatibility testing on the subject lubricant was performed in accordance with ISO 10993-1: 2009/(R)2013, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing Within a Risk Management Process.

Table 3. Biocompatibility of Astroglide® X Silicone Personal Lubricant

Test Performed
Cytotoxicity per ISO 10993-5: 2009/(R)2014
Human Repeat Insult Patch Testing (HRIPT) per ASTM D6355to address sensitization and irritation
Acute Systemic Toxicity per ISO 10993-11: 2017

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

Condom Compatibility

Astroglide® X Silicone Personal Lubricant was tested for compatibility with natural rubber latex condoms using ASTM D7661-10. Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. Results show that Astroglide® X Silicone Personal Lubricant is compatible with natural rubber latex condoms only.

Shelf Life

Astroglide® X Silicone Personal Lubricant has a shelf-life of 3 years based on 12 months of accelerated aging testing results per ASTM F1980-16, Standard Guide for Accelerated Aqing of Sterile Barrier Systems for Medical Devices. All specifications for the subject lubricant listed in Table 1 were met throughout the shelf-life study.

viiii. Substantial Equivalence

The results of the testing described above demonstrate that the Astroglide® X Silicone 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.