Glycerin and Paraben Free Astroglide® 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.

Device Description

Glycerin & Paraben Free Astroglide® is a non-sterile, clear, non-greasy, high viscosity liquid used as a personal lubricant. Glycerin & Paraben Free Astroglide® is not a contraceptive or spermicide. It is compatible with latex condoms as demonstrated in Condom Compatibility Testing conducted according the standards defined by ASTM D 3492.

AI/ML Overview

This document is a 510(k) summary for a personal lubricant, Glycerin & Paraben Free Astroglide®. It describes the device, its intended use, and the studies conducted to demonstrate its substantial equivalence to predicate devices and its safety. Since this is a submission for a personal lubricant and not an AI/ML powered medical device, the questions regarding AI/ML device performance metrics (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable in this context.

Here's an analysis of the provided text in relation to the acceptance criteria and study information, with an emphasis that many of the requested AI-specific points are not relevant for this type of device:

1. A table of acceptance criteria and the reported device performance

For a personal lubricant, acceptance criteria typically involve biocompatibility, compatibility with condoms, and performance related to its intended use (lubrication, moisturizing). The studies performed address these aspects.

Acceptance Criteria / Test	Reported Device Performance
Condom Compatibility	Compatible with latex condoms as demonstrated in Condom Compatibility Testing conducted according to ASTM D 3492.
Dermal Sensitization (ISO 10993-10)	Considered to be a Grade I (weak) sensitizer in guinea pigs. (Note: While "Grade I" implies some sensitization, the submission likely aims to show it's within acceptable safety limits for its intended use, or that this level of sensitization is common/not clinically significant for topical products. Further interpretation of "acceptable" is not provided but inferred by FDA clearance.)
Rabbit Penile Irritation (ISO 10993-10)	Considered to be a minimal irritant as compared to control (0.9% NaCl). (Again, "minimal" implies within acceptable safety range.)
Rabbit Vaginal Irritation (ISO 10993-10)	Considered to be a nonirritant as compared to control (0.9% NaCl).
Mouse Systemic Injection (ISO 10993-11)	Did not cause mortality and was not associated with systemic toxicity.
Human Repeat Insult Patch Test (RIPPT)	May be considered as a Non-Primary Irritant and Non-Primary Sensitizer (in 50 human subjects). This is a strong indicator of low irritation and sensitization potential in humans.
Cytotoxicity (ISO 10993-5, MEM Elution Test)	Satisfied the requirements of an ISO MEM Elution Test and passed the test at a dilution of 1:4 or greater.
Substantial Equivalence to Predicate Devices	Shown to be substantially equivalent to Good Lubrications Personal Lubricant (K020586) and Astroglide Personal Lubricant (K935299) based on same intended use and similar formulation. (This is the primary regulatory pathway for 510(k) clearance, demonstrating that the new device is as safe and effective as a legally marketed device).

Regarding AI-specific questions (2-9):

The device in question, Glycerin & Paraben Free Astroglide®, is a personal lubricant, which is a physical product and not an AI/ML powered medical device. Therefore, the following points are not applicable (N/A) to this 510(k) submission.

2. Sample size used for the test set and the data provenance: N/A (not an AI/ML device)
* For biocompatibility: Guinea pigs, rabbits, mice were used for animal studies. 50 human subjects were used for the Repeat Insult Patch Test. Data provenance is implied by the testing being conducted by "outside laboratories, in compliance with Good Laboratory Practices (GLP's)".

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (not an AI/ML device)
* For the non-AI tests, "ground truth" is established by laboratory measurements and observations in controlled animal and human studies, interpreted by qualified laboratory personnel and clinicians.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A (not an AI/ML device)

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: N/A (not an AI/ML device)

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A (not an AI/ML device)

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): N/A (not an AI/ML device)
* The "ground truth" for this product is derived from direct biological response in controlled experiments (e.g., irritation, sensitization, toxicity, condom compatibility).

8. The sample size for the training set: N/A (not an AI/ML device)

9. How the ground truth for the training set was established: N/A (not an AI/ML device)

Summary

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510(k) SUMMARY

K072647

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Applicant	BioFilm, Inc.3225 Executive RidgeVista, CA 92081
Contact Person	Robert L. De ArmondV.P. Operations / Regulatory Affairs(760)727-9030 Phone(760)477-2424 Fax
Date Prepared	September 11, 2007
Proprietary Name	Glycerin & Paraben Free Astroglide®
Common Name	Personal Lubricant
Classification Name	HIS - Condom, (21 CFR 884.5300)MMS - Patient Lubricant (21 CFR 880.6375)
Predicate Device	Good Lubrications Personal Lubricant (K020586)

Description of Device

Indications for Use

This product is compatible with latex condoms.

Technological Characteristics

Glycerin & Paraben Free Astroglide® formula is proprietary. The product however has no exceptional technological characteristics consisting mainly of water soluble ingredients similar to other lubricants currently on the market.

Substantial Equivalence

This product has been shown in laboratory testing to be substantially equivalent to the currently marketed Good Lubrications Personal Lubricant (K020586) and Astroglide Personal Lubricant (K935299). Both devices have the same intended use and similar formulation.

Rev. 1 January 25, 2008

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510(k) SUMMARY

Product Testing per ISO 10993

Biocompatibility studies on Glycerin & Paraben Free Astroglide® conducted by outside laboratories, in compliance with Good Laboratory Practices (GLP's) demonstrated:

. in a Dermal Sensitization Study that the product was considered to be a Grade I (weak) sensitizer in guinea pigs. (ISO 10993-10)
. in a 5-Day Rabbit Penile Irritation Study that the product was considered to be a minimal irritant as compared to the control article, 0.9% NaCL. (ISO 10993-10)
. in a 5-Day Rabbit Vaginal Irritation Study that the product was considered to be a nonirritant as compared to the control article, 0.9% NaCL. (ISO 10993-10)
in a Mouse Systemic Injection Study that the product did not cause mortality and was not . associated with systemic toxicity. (ISO 10993-11)
. in a 50 human subject Repeat Insult Patch Test that the product may be considered as a Non-Primary Irritant and Non-Primary Sensitizer.
in a test for Cytotoxicity at a dilution of 1:4 or greater that the product satisfied the . requirements of a ISO MEM Elution Test and passed the test. (ISO 10993-5)

Rev. 1 January 25, 2008

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.

2 5 2008 JAN

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Mr. Robert L. De Armond Vice President Operations/Regulatory Affairs BioFilm, Inc. 3225 Executive Ridge VISTA CA 92081

Re: K072647

Trade/Device Name: Glycerin & Paraben Free Astroglide Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: December 4, 2007 Received: December 10, 2007

Dear Mr. De Armond:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.

Image /page/2/Picture/10 description: The image shows a circular logo with the text "1906-2006" at the top. Below the text is the acronym "FDA" in a stylized font. The word "Centennial" is written in cursive below the acronym. There are three stars at the bottom of the logo. The logo is surrounded by a dotted circle.

Protesting and Promoting Public Health

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Page 2

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); good manufacturing practice requirements as set forth in 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.

Sincerely yours.

Nancy C. Brogdon

Nancy C. Brogdon Director. Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known): K072647

Device Name: Glycerin & Paraben Free Astroglide®

Indications For Use:

Glycerin and Paraben Free Astroglide® is a personal lubricant, for penile, anal, or vaginal application, intended to moisturize and fubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication.

This product is compatible with latex condoms.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The Counter Use _ X (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number	K072647

Page 1 of 1

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.