Astroglide Sensual Strawberry 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. This product is compatible with natural rubber latex, polyisoprene, and polyurethane condoms.

Device Description

Astroglide Sensual Strawberry personal lubricant is non-sterile, clear. colorless, and water based. It has a subtle flavor and fragrance of strawberry. Astroglide Sensual Strawberry is a proprietary blend consisting mainly of water soluble ingredients similar to the predicate device and other personal lubricant devices currently on the market. This product is not a spermicide or contraceptive. The product is provided in a clear bottle or a tube with flip top cap and it is compatible with natural rubber latex, polyisoprene and polyurethane condoms.

AI/ML Overview

The provided text is a 510(k) Summary for the medical device "Astroglide Sensual Strawberry." This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. This type of submission does not typically involve the rigorous clinical studies or complex AI performance metrics that your request implies.

Therefore, many of the requested categories (e.g., sample size for test and training sets, number of experts for ground truth, adjudication method, MRMC studies, standalone algorithm performance) are not applicable to this type of device and submission.

However, I can extract information related to the acceptance criteria and the studies performed to demonstrate equivalence and safety.

Here's a summary based on the provided text, focusing on the relevant criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Specification	Reported Device Performance	Study / Test Method
Biocompatibility:
Non-cytotoxic	Results show the product is non-cytotoxic.	ISO 10993-5 (Cytotoxicity)
No irritation or sensitization	The product did not elicit any irritation or sensitization reactions.	ISO 10993-10 (Guinea Pig Maximization)
Non-irritating to vaginal mucosa	The product was considered non-irritating to the vaginal mucosa in New Zealand White Rabbits.	ISO 10993-10 (Vaginal Irritation)
Meets ISO 10993-11 requirements, no biological reactivity	The product met the requirements of ISO 10993-11. No test animals exhibited any biological reactivity.	ISO 10993-11 (Acute Systemic Toxicity)
Lot Release Specifications:	(Maintained throughout shelf-life)
Color	Specifications maintained	In-house specifications
Clarity	Specifications maintained	In-house specifications
Odor	Specifications maintained	In-house specifications
Absence of particulate matter	Specifications maintained	In-house specifications
pH	Specifications maintained	In-house specifications
Viscosity	Specifications maintained	In-house specifications
Total yeast/mold count	Specifications maintained	In-house specifications
Total aerobic microbial count	Specifications maintained	In-house specifications
Absence of pathogens (Staphylococcus aureus, Pseudomonas aeruginosa, Candida albicans)	Specifications maintained	In-house specifications
Shelf Life:
2-year shelf-life	Demonstrated a shelf-life of 2 years.	8-month accelerated stability study and ongoing real-time stability study with preservative effectiveness testing.
Condom Compatibility:
Compatible with natural rubber latex, polyisoprene, and polyurethane condoms	Results show Astroglide Sensual Strawberry is compatible with latex, polyisoprene, and polyurethane condoms.	ASTM D7661-10 (Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms)

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

Biocompatibility Studies (ISO 10993 series): Numbers of animals used for these tests are generally small, as per standard test protocols (e.g., typically 3 animals for acute systemic toxicity, 5 for guinea pig maximization, a specified number for vaginal irritation). The document does not specify the exact number of animals for each test but indicates the tests were performed "in accordance with ISO 10993." These are controlled laboratory experiments, not field data.
Stability Studies: The stability studies involved product samples tested at various time points across an 8-month accelerated study and an ongoing real-time study. The exact number of samples tested at each time point is not specified.
Condom Compatibility Study (ASTM D7661-10): This standard typically requires testing a specific number of condom samples (e.g., 30 condoms per lubricant-condom combination for certain tensile property tests). The document does not specify the exact number of condoms tested.
Data Provenance: Laboratory studies conducted according to international standards (ISO, ASTM). The location of the testing labs or the specific country of origin for the data is not mentioned, but it's typically performed by certified contract research organizations. These are prospective experimental studies.

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

Not Applicable. This device is a personal lubricant, and its efficacy and safety are assessed through physicochemical properties, biocompatibility, and material compatibility tests, not through expert-reviewed "ground truth" labels in a clinical diagnostic context. The "ground truth" for these tests is defined by the standardized methodologies themselves (e.g., non-cytotoxic if cell viability is >70% compared to control).

4. Adjudication Method for the Test Set

Not Applicable. As above, this type of product assessment does not involve human adjudication in the traditional sense. Test results are interpreted against predefined passing criteria in the respective ISO and ASTM standards.

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 not an AI-powered diagnostic device, and therefore no MRMC study or AI-related comparative effectiveness was conducted.

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

Not Applicable. This is not an AI algorithm. Its performance is intrinsic to the product's chemical and physical characteristics.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is based on:
- Standardized Test Results: Adherence to defined endpoints (e.g., cell viability, irritation scores, tensile strength of condoms) established by recognized international standards (ISO, ASTM).
- Physicochemical Measurements: Direct measurement of properties like pH, viscosity, and microbial counts against internal specifications.
- Stability Performance: Evaluation of product characteristics over time under controlled conditions to ensure specifications are maintained.

8. The Sample Size for the Training Set

Not Applicable. There is no "training set" in the context of this device. The development of the formulation and manufacturing processes is an iterative design process, but it doesn't involve a dataset in the way an AI model is trained.

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

Not Applicable. As there is no training set for an AI model, this question is not relevant. The "ground truth" for product development is established through formulation science, quality control, and adherence to relevant regulatory and safety standards.

Summary

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

October 30, 2014

BioFilm, Inc. Sherry Castello Regulatory Affairs Associate 3225 Executive Ridge Vista, CA 92081

Re: K140590 Trade/Device Name: Astroglide Sensual Strawberry Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: September 26, 2014 Received: October 1, 2014

Dear Sherry Castello,

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,

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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) K140590

Device Name Astroglide Sensual Strawberry

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)

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

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BIOFILM. INC.

510(k) Summary Astroglide Sensual Strawberry

General Information on Applicant:

Applicant: BioFilm, Inc. 3225 Executive Ridge Vista CA 92081 Phone: (760) 727-9030 Fax: (760) 727-8080

Contact Person: Sherry Castello, Regulatory Affairs Associate Email: sherry@biofilm.com Date Prepared: October 30, 2014 510(k) Number: K140590 Establishment Registration: 2025771

General Information on Device:

Proprietary Name:	Astroglide Sensual Strawberry
Common Name:	Personal Lubricant
Classification Name:	Condom (21 CFR 884.5300, Product code: NUC, Class II)

Predicate Device: 510(k) Number K122476, Lifestyles® Smooth™ 2-in-1 Massage and Lubricant, Ansell Healthcare Products, LLC; Class II, Product Code: NUC

Description of Device: Astroglide Sensual Strawberry personal lubricant is non-sterile, clear. colorless, and water based. It has a subtle flavor and fragrance of strawberry. Astroglide Sensual Strawberry is a proprietary blend consisting mainly of water soluble ingredients similar to the predicate device and other personal lubricant devices currently on the market. This product is not a spermicide or contraceptive. The product is provided in a clear bottle or a tube with flip top cap and it is compatible with natural rubber latex, polyisoprene and polyurethane condoms.

Indications for Use: Astroglide Sensual Strawberry 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. This product is compatible with natural rubber latex, polyisoprene, and polyurethane condoms.

Technological Characteristics: There are no fundamental technological differences in Astroglide Sensual Strawberry as compared to the predicate device Lifestyles® Smooth™ 2-in-1 Massage and Lubricant. Both lubricants are non-sterile, water based lubricants with Strawberry flavor and scent. The indications for use are identical and the ingredients are very similar.

3225 Executive Ridge Vista, CA 92081 Page 5-1 800.848.5900 760.727.9030 FAX: 760.727.8080

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BIOFILM. INC.

Biocompatibility: Biocompatibility testing was performed in accordance with ISO 10993, Biological Evaluation of Medical Devices.

Cytotoxicity, ISO 10993-5: Results show the product is non-cytotoxic .
Guinea Pig Maximization, ISO 10993-10: The product did not elicit any irritation or . sensitization reactions.
Vaginal Irritation, ISO 10993-10: The product was considered non-irritating to the . vaginal mucosa in New Zealand White Rabbits as compared to the control article.
Acute Systemic Toxicity, ISO 10993-11: The product met the requirements of ISO . 10993-11. No test animals exhibited any biological reactivity.

Specifications: Astroglide Sensual Strawberry has the following lot release specifications: color, clarity, odor, absence of particulate matter, pH, viscosity, total yeast/mold count, total aerobic microbial count, and absence of pathogens including Staphylococcus aureus, Pseudomonas aeruginosa, and Candida albicans.

Other: This product has been tested for osmolality.

Shelf Life: Astroglide Sensual Strawberry shows a shelf-life of 2 years based on an 8 month accelerated stability study and an ongoing real-time stability study. Preservative effectiveness was demonstrated at critical time-points throughout the stability testing. These studies demonstrated that the product specifications were maintained throughout the shelf-life period.

Condom Compatibility: Astroglide Sensual Strawberry was tested for compatibility with natural rubber latex, polyisoprene, and polyurethane 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 is compatible with latex, polyisoprene, and polyurethane condoms.

Substantial Equivalence: Astroglide Sensual Strawberry personal lubricant has the same indications for use, similar ingredients, and basic technological characteristics as the predicate device. Astroglide Sensual Strawberry performed well in biocompatibility and stability testing showing it is as safe and effective as the predicate device.

3225 Executive Ridge Vista, CA 92081 Page 5-2 800.848.5900 760.727.9030 FAX: 760.727.8080

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.