Astroglide Ultra Gentle Gel 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 and polyisoprene condoms. This product is not compatible with polyurethane condoms.

Device Description

Astroglide Ultra Gentle Gel is a non-sterile, clear, odorless, and water based personal lubricant. This product is not a spermicide or contraceptive. It is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms. The device is composed of water, propylene glycol, hydroxyethylcellulose, polyquaternium 7, potassium sorbate, sodium benzoate and citric acid. The product primary packaging is a white LDPE 3-ounce tube with a screw on cap. The tube and cap constitute the device final packaging.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and the supporting study, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (Specification)	Reported Device Performance (Met/Not Met/Not Applicable)
Color	Clear to golden	Met (Implied, as testing "met specifications")
Clarity	Clear	Met (Implied, as testing "met specifications")
Odor	Odorless	Met (Implied, as testing "met specifications")
Absence of particulate matter	No particles	Met (Implied, as testing "met specifications")
Viscosity	10,000-25,000 cP	Met (Implied, as testing "met specifications")
pH	3.5-5.5	Met (Implied, as testing "met specifications")
Osmolality	200-300 mOsm/kg, 1:5 dilution factor	Met (Implied, as testing "met specifications")
Total yeast/mold count (TYMC)	<10 cfu/mL (USP <61>)	Met (Implied, as testing "met specifications")
Total aerobic microbial count (TAMC)	<100 cfu/mL (USP <61>)	Met (Implied, as testing "met specifications")
Presence of Pathogenic Organisms (Staphylococcus aureus, Pseudomonas aeruginosa, Candida albicans)	Absent (USP <62>)	Met (Implied, as testing "met specifications")
Antimicrobial effectiveness	Meets USP <51> acceptance criteria for Category 2 products	Met (Implied, as testing "met specifications")
Cytotoxicity	Non-cytotoxic (per ISO 10993-5:2009/(R)2014)	Met
Sensitization/Irritation	Non-sensitizing, Non-irritating (per ASTM D6355)	Met
Systemic Toxicity	Not systemically toxic (per ISO 10993-11:2017)	Met
Shelf Life (24 months)	Maintain all specifications listed in Table 1	Met (Confirmed by accelerated aging study)
Compatibility with Natural Rubber Latex Condoms	Compatible (per ASTM D7661-18)	Compatible
Compatibility with Polyisoprene Condoms	Compatible (per ASTM D7661-18)	Compatible
Compatibility with Polyurethane Condoms	Not Compatible (per ASTM D7661-18)	Not Compatible (This is a reported finding, not a failure of a positive criterion)

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

The document does not specify the exact sample sizes for each test in the "Summary of Non-Clinical Performance Testing" section. For the Shelf Life study, it mentions an "accelerated aging study, conducted for 8 months at 40°C," but doesn't detail the number of samples or batches tested. The provenance of the data is internal to BioFilm, Inc., as these are non-clinical performance tests conducted for device clearance. There is no information regarding country of origin or whether it's retrospective or prospective beyond the description of the tests themselves.

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

This information is not applicable to this type of device and study. The testing described (biocompatibility, shelf life, condom compatibility) are laboratory-based, objective performance tests conducted against established international or national standards (e.g., ISO, ASTM, USP). Ground truth is established by the test method's specified criteria, not by expert consensus in the way a clinical diagnostic device would require.

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

This is not applicable as the tests are objective laboratory performance tests, not subjective interpretations requiring adjudication among experts.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for AI-driven diagnostic or screening devices involving human interpretation, not for a personal lubricant.

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

This is not applicable. The device is a personal lubricant, not an AI algorithm. The performance tests are directly on the physical product.

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

The ground truth for the acceptance criteria for most of the parameters (Color, Clarity, Odor, Absence of particulate matter, Viscosity, pH, Osmolality, Microbial Limits, Antimicrobial effectiveness) is based on pre-defined quantifiable specifications and standard laboratory test methods (USP <61>, USP <62>, USP <51>).

For Biocompatibility, the ground truth is established by the pass/fail criteria defined in international standards like ISO 10993-1, ISO 10993-5, ISO 10993-11, and ASTM D6355.

For Condom Compatibility, the ground truth is established by the pass/fail criteria defined in ASTM D7661-18.

For Shelf Life, the ground truth is that the device must continue to meet all the physical, chemical, and microbiological specifications after accelerated aging, following ASTM F1980-16.

8. The sample size for the training set

This is not applicable as the device is not an AI/ML algorithm. There is no "training set" for a physical personal lubricant.

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

This is not applicable as there is no training set for this device.

Summary

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May 26, 2022

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

Re: K220355 Trade/Device Name: Astroglide Ultra Gentle Gel Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: April 7, 2022 Received: April 27, 2022

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.

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov

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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, 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) K220355

Device Name Astroglide Ultra Gentle Gel

Indications for Use (Describe)

Astroglide Ultra Gentle Gel is a personal lubricant for penile, 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 and polyisoprene condoms. This product is not compatible with polyurethane condoms.

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

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 – K220355 Astroglide Ultra Gentle Gel

l. 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:	May 24, 2022

II. General Information on Device

Proprietary Name:	Astroglide Ultra Gentle Gel
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
Glycerin & Paraben Free Astroglide	K072647

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

IV. Description of Device

The product primary packaging is a white LDPE 3-ounce tube with a screw on cap. The tube and cap constitute the device final packaging.

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The specifications for Astroglide Ultra Gentle Gel Personal Lubricant are described in Table 1.

Parameter	Specification (Test Method)
Color	Clear to golden
Clarity	Clear
Odor	Odorless
Absence of particulate matter	No particles
Viscosity	10,000-25,000 cP
pH	3.5-5.5
Osmolality	200-300 mOsm/kg, 1:5 dilution factor
Total yeast/mold count (TYMC)	<10 cfu/mL (USP <61>)
Total aerobic microbial count (TAMC)	<100 cfu/mL (USP <61>)
Presence of Pathogenic Organisms( Staphylococcus aureus, Pseudomonasaeruginosa, and Candida albicans )	Absent (USP <62>)
Antimicrobial effectiveness	Meets USP <51> acceptance criteriafor Category 2 products.

Table 1. Device Specifications

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:

Characteristic /Feature	Astroglide Ultra GentleGel Personal Lubricant(subject device)	Glycerin & Paraben FreeAstroglide (predicatedevice) - K072647	Comparison
	Indication for use	Astroglide Ultra Gentle Gel 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 and polyisoprene condoms. This product is not compatible with polyurethane condoms.	Glycerin & Paraben FreeAstroglide is a personal lubricant for penile, anal 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 latex condoms.	Similar: The subject and predicate devices have similar indications for use, with the exception of the condom compatibility statement, and they have the same intended use.
Water-BasedLubricant		Yes	Yes	Same
Over the Counter		Yes	Yes	Same
Not acontraceptive orSpermicide		Yes	Yes	Same
Non-sterile		Yes	Yes	Same
PrimaryIngredients		Water, Propylene glycol,Hydroxyethylcellulose,Polyquaternium 7, Potassiumsorbate, Sodium benzoate,Citric Acid	Not publicly available	Different: The ingredients of the predicate device are different; the ingredients do not raise different 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)	Not publicly available	N/A
Viscosity		10,000 - 25,000 cP	Not publicly available	N/A
Osmolality		200-300 mOsm/kg,1:5 dilution factor	Not publicly available	N/A
pH		3.5-5.5	Not publicly available	N/A

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The subject and predicate devices have similar 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.

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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 (per ISO 10993-5:2009/(R)2014) ●
Human Repeat Insult Patch Testing (HRIPT) per ASTM D6355 to address ● sensitization and irritation
. Systemic Toxicity (per 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 packaged in a 3 oz. bottle with a 24-month shelf-life in accordance with the results of an accelerated aging study, conducted for 8 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

Astroglide Ultra Gentle Gel Personal Lubricant was tested for compatibility with natural rubber latex, polyisoprene, and polyurethane condoms using ASTM D7661-18, Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. The results show that Astroglide Ultra Gentle Gel Personal Lubricant is compatible with natural rubber latex and polyisoprene condoms. Astroglide Ultra Gentle Gel Personal Lubricant is not compatible with polyurethane condoms.

VIII. Conclusion

The results of the testing described above demonstrate that the Astroglide Ultra Gentle Gel 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.