Astroglide® TTC 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. Astroglide TTC is compatible with sperm, oocytes, and embryos and can be used by couples trying to conceive. Astroglide® TTC is compatible with natural rubber latex, polyisoprene and polyurethane condoms.

Device Description

Astroglide® TTC Fertility Friendly Personal Lubricant is a non-sterile, clear, and water-based personal lubricant for penile and/or vaginal application. Astroglide® TTC has a pH and osmolarity that is compatible with sperm survival and migration. The device is packaged in pre-filled tube applicators which may be used for single use intra-vaginal application or applied directly to penis or vagina. Astroglide® TTC is formulated using water, propylene glycol, hydroxyethylcellulose, fructose, methylparaben, sodium phosphate, potassium phosphate, propyl paraben, galactose, and sodium hydroxide. This device is batch lot tested for appearance, color, viscosity, pH, microbial count, osmolality, endotoxin, mouse embryo assay and human sperm survival assay.

AI/ML Overview

The provided text discusses the premarket notification for Astroglide TTC Fertility Friendly Personal Lubricant, detailing its characteristics and comparison to a predicate device. It includes a summary of performance data to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and the studies mentioned:

1. Table of Acceptance Criteria and Reported Device Performance

Attribute	Acceptance Criteria (from Predicate)	Reported Device Performance (Astroglide TTC)
pH	7.20-7.45	7.2-7.6
Osmolarity	260 to 370 mOsm/kg	220-400 mOsm/kg
Endotoxin by LAL methodology	≤ 0.7 EU/mL	≤ 0.7 EU/mL
Mouse Embryo Assay (MEA)	Using 1-cell MEA exposed to 5% solution for 30 minutes, > 80% expanded blastocysts at 96 hrs.	Using 1-cell MEA exposed to 10% solution for 30 minutes, > 80% expanded blastocysts at 96 hrs.
Human Sperm Survival Assay (HSSA)	After exposure to 10% Pre-Va for 30 min, ≥ 80% of the control.	After exposure to 10% TTC for 2 hours, ≥ 80% of the control.
Condom Compatibility	Compatible with latex and polyurethane condoms.	Compatible with latex, polyurethane, and polyisoprene condoms.
Cytotoxicity (Formula)	Not explicitly stated, likely "not considered cytotoxic."	Not considered to have a cytotoxic effect.
Sensitization (Formula)	Not explicitly stated, likely "did not elicit sensitization."	Did not elicit sensitization reactions.
Vaginal Irritation (Formula)	Not explicitly stated, likely "non-irritating."	Considered non-irritating to the vaginal mucosa in New Zealand White Rabbits.
Systemic Toxicity (Formula)	Not explicitly stated, likely "met requirements."	Met the requirements of ISO 10993-11. No test animals exhibited any biological reactivity.
Cytotoxicity (Applicator)	Not explicitly stated, likely "not considered cytotoxic."	Not considered to have a cytotoxic effect.
Sensitization (Applicator)	Not explicitly stated, likely "did not elicit sensitization."	Did not elicit sensitization reactions.
Vaginal Irritation (Applicator)	Not explicitly stated, likely "non-irritating."	Minimally irritating when extracted in saline; non-irritating when extracted in cottonseed oil.
Shelf-life Stability	(Implied by predicate) Effective over shelf-life.	Met acceptance criteria for 8-month shelf-life.
Antimicrobial Effectiveness	(Implied by predicate) Preservative system effective.	Preservative system is effective.

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

The document does not specify exact sample sizes for the test sets (e.g., number of mouse embryos, human sperm samples, or animals for biocompatibility). The studies performed are laboratory-based and animal studies (New Zealand White Rabbits for irritation, Guinea Pig for sensitization, mice for embryo assay). The data provenance is not explicitly stated as "country of origin" but implies controlled laboratory settings, which are typically retrospective in terms of analyzing the results from a pre-defined experiment.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not mention the use of experts to establish a "ground truth" for the test set in the traditional sense of medical image analysis or diagnostic studies. The ground truth for these types of in vitro and in vivo studies is established by the experimental protocols themselves, with results interpreted against scientific and regulatory standards (e.g., ISO standards for biocompatibility).

4. Adjudication Method for the Test Set

Not applicable. The studies described are laboratory, animal, and in vitro tests, not clinical trials requiring adjudication of observer interpretations.

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

Not applicable. This is a medical device (personal lubricant) and the studies do not involve AI or human readers for diagnostic interpretation. Therefore, an MRMC study and effect size in human reader improvement are not relevant.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is not an algorithm or AI.

7. The Type of Ground Truth Used

The ground truth used in these studies is primarily:

Experimental Results against predefined thresholds/standards: For pH, osmolarity, endotoxin, MEA, HSSA, and condom compatibility, the "ground truth" is whether the measured values or observed outcomes meet the established scientific and regulatory criteria (e.g., >80% expanded blastocysts, ≥80% sperm survival).
Biocompatibility Standards: For cytotoxicity, sensitization, irritation, and systemic toxicity, the ground truth is whether the device passes the requirements of specific ISO 10993 standards.
Functional Assays: For sperm function (penetration, motility, DNA integrity) and IVF, the ground truth is the scientific demonstration that the device does not impede or harm these biological processes.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable. There is no training set for this type of device.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 9, 2015

Biofilm, Inc. Sherry Castello Regulatory Affairs and Quality Assurance Associate 3225 Executive Ridge Vista, CA 92081

K141132 Trade/Device Name: Astroglide TTC Fertility Friendly Personal Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: Class II Product Code: PEB Dated: November 24, 2014 Received: November 25, 2014

Dear Sherry Castello,

Re:

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. 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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Herbert P. Lerner -S

for

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K141132

Device Name

Astroglide TTC Fertility Friendly Personal Lubricant

Indications for Use (Describe)

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 Astroglide TTC Fertility Friendly Personal Lubricant

General Information on Submitter i.

Applicant:	BioFilm, Inc.
Address:	3225 Executive RidgeVista, CA 92081 USA
Telephone:	760-727-9030
Fax:	760-727-8080
Contact Person:	Sherry Castello
Email:	sherry@biofilm.com
Date Prepared:	November 24, 2014
Establishment Registration:	2025771

ii.	General Information on Device
	Proprietary Name:	Astroglide® TTC Fertility Friendly Personal Lubricant
	510(k) Number:	K141132
	Common Name:	Personal Lubricant
	Classification Name:	Lubricant, Personal, Gamete, Fertilization, and EmbryoCompatible (21 CFR 884.5300, Condom), product code:PEB

iii. Predicate Device

Pre-Va Vaginal Lubricant, K072741, manufactured by INGFertility, LLC

Description of Device iv.

Astroglide® TTC is formulated using water, propylene glycol, hydroxyethylcellulose, fructose, methylparaben, sodium phosphate, potassium phosphate, propyl paraben, galactose, and sodium hydroxide.

This device is batch lot tested for appearance, color, viscosity, pH, microbial count, osmolality, endotoxin, mouse embryo assay and human sperm survival assay.

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Image /page/4/Picture/0 description: The image shows the logo for Biofilm, Inc. The logo is purple and features the company name in a bold, sans-serif font. Underneath the name is a curved line, also in purple, that adds a visual element to the logo. The registered trademark symbol is present next to the "C" in "INC."

Indications for Use V.

vi. Technological Characteristics of Astroglide® TTC Compared to Predicate

Technological Characteristics of Astroglide TTC and the predicate are very similar. Any minor technological differences noted do not affect the safety or effectiveness of the device.

Attribute	TTC, Fertility FriendlyPersonal Lubricant	Predicate: Pre-Va VaginalLubricant
510(k)	K141132	K072741
Indications for use	Astroglide® TTC is apersonal lubricant for penileand/or vaginal application,intended to moisturize andlubricate, to enhance the easeand comfort of intimatesexual activity andsupplement the body'snatural lubrication.Astroglide TTC iscompatible with sperm,oocytes, and embryos andcan be used by couples tryingto conceive. Astroglide®TTC is compatible withnatural rubber latex,polyisoprene andpolyurethane condoms.	● To lubricate vaginaltissues to facilitate entry ofdiagnostic or therapeuticdevices including thoseused in fertilityinterventions. Pre-Va maybe applied directly to thedevice or may bedeposited intravaginallyusing the applicator priorto the insertion ofdiagnostic or therapeuticdevices used in fertilityinterventions.● As a personal lubricantPre-Va supplements thebody's own naturallubrication fluids, tomoisturize, relieve frictionand to enhance the easeand comfort of intimatesexual activity. Pre-Va issafe for use by coupleswho are trying to conceiveand may be applied tovaginal or penile tissuesfor lubrication and

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Attribute	TTC, Fertility FriendlyPersonal Lubricant	Predicate: Pre-Va VaginalLubricant
Ingredients	Water, Propylene Glycol,Hydroxyethylcellulose, Fructose,Methylparaben, SodiumPhosphate, Potassium Phosphate,Propyl Paraben, Galactose,Sodium Hydroxide	Water, Hydroxyethylcellulose,Pluronic 127, Sodium Chloride,Arabinogalactan, SodiumPhosphate, Carbopol 934P,Methyl Paraben, SodiumHydroxide, Potassium Phosphate
Method ofApplication	Directly by hand or intra-vaginally with pre-filled tubeapplicator	Directly from tube or withseparate disposable applicator
Storage Instruction	36°F to 86°F	36°F to 86°F
pH	7.2-7.6	7.20-7.45
Osmolarity	220-400 mOsm/kg	260 to 370 mOsm/kg
Endotoxin by LALmethodology	$≤$ 0.7 EU/mL	$≤$ 0.7 EU/mL
Mouse EmbryoAssay (MEA)	Using 1-cell MEA exposed to10% solution for 30 minutes$>$ 80% expanded blastocysts at 96hrs.	Using 1-cell MEA exposed to 5%solution for 30 minutes, $>$ 80%expanded blastocysts at 96 hrs.
Human SpermSurvival Assay(HSSA)	After exposure to 10% TTC for 2hours, $≥$ 80% of the control.	After exposure to 10% Pre-Va for30 min, $≥$ 80% of the control.
CondomCompatibility	Compatible with latex,polyurethane, and polyisoprenecondoms	Compatible with latex andpolyurethane condoms.

Summary of Performance Data vii.

Lubricant barrier assays performed on Astroglide® TTC demonstrated that the properties of the device do not impede sperm penetration into the lubricant. Mouse In vitro fertilization assays in combination with Mouse embryo assays (IVF-MEA) demonstrated normal fertilization and embryo development with no suggestion of toxicity. Mucosal penetration studies using a hyaluronic acid (that mimics cervical mucus) indicate that the "swim-up" ability of sperm exposed to Astroglide TTC is not affected. Computer Assisted Sperm Analysis demonstrates the progressive motility of sperm is not harmed by Astroglide TTC. DNA integrity testing after exposure to Astroglide TTC demonstrated the device does not harm human sperm chromatin (DNA). Sperm penetration assays (hamster zona-free ovum tests) demonstrated that the presence of Astroglide TTC did not affect the penetration of hamster ova by human sperm.

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Condom compatibility studies indicate that TTC is safe to use with natural rubber latex, polyisoprene, and polyurethane condoms.

Biocompatibility tests and results are shown in the table below:

Biocompatibility Testing	Astroglide TTC Result
Cytotoxicity, Direct Contact, ISO 10993-5,formula	The test article was not considered to have acytotoxic effect.
Guinea Pig Maximization, ISO 10993-10,formula	The test article did not elicit sensitizationreactions.
Vaginal Irritation, ISO 10993-10, formula	The test article was considered non-irritatingto the vaginal mucosa in New Zealand WhiteRabbits.
Systemic Toxicity, ISO 10993-11, formula	Test article met the requirements of ISO10993-11. No test animals exhibited anybiological reactivity.
Cytotoxicity, MEM Elution, ISO 10993-5,applicator tube	The test article was not considered to have acytotoxic effect.
Guinea Pig Maximization, ISO 10993-10,applicator tube	The test article did not elicit sensitizationreactions.
Vaginal Irritation, ISO 10993-10, applicatortube	In New Zealand White Rabbits, the testarticle when extracted in saline wasconsidered minimally irritating. The testarticle when extracted in cottonseed oil wasconsidered non-irritating.

On-going stability studies show the device has met acceptance criteria for appearance, color, clarity, odor, viscosity, pH, microbial count, osmolality, endotoxin, mouse embryo assay, and human sperm survival assay for an 8 month shelf-life. Antimicrobial effectiveness testing has been performed and the preservative system is effective.

The performance data concludes that Astroglide® TTC is substantially equivalent to the predicate device Pre-Va Vaginal Lubricant. Astroglide® TTC does not harm sperm, oocytes, or embryos and is safe for use by couples trying to conceive.

viii. Conclusion

The proposed and predicate indication statements do not represent a new intended use. Astroglide TTC personal lubricant has the same intended use as PreVa for use in a nonclinical environment. The technological characteristics of Astroglide TTC and the predicate are very similar. Any minor technological differences noted do not affect the safety or efficacy of the device. Performance testing demonstrates that Astroglide TTC does not harm sperm, oocytes, or embryos and is safe to use by couples trying to conceive.

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.