Astroglide® Diamond Silicone Gel Personal Lubricant 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, polyurethane, and polyisoprene condoms.

Device Description

Astroglide® Diamond Silicone Gel Personal Lubricant is non-sterile, clear, odorless, and silicone-based lubricant. This product is not a spermicide or contraceptive. It is compatible with natural rubber latex, polyurethane, and polyisoprene condoms.

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

AI/ML Overview

The provided text is a 510(k) Summary for a medical device (Astroglide® Diamond Silicone Gel Personal Lubricant), seeking to demonstrate substantial equivalence to a predicate device. It primarily focuses on the device's physical properties, biocompatibility, and compatibility with condoms.

This document does not contain information about an AI/Algorithm-based medical device, a multi-reader multi-case (MRMC) study, or any details related to establishing ground truth for a training or test set using experts, as would be expected for an AI/ML device.

Therefore, I cannot extract the information required to answer your questions about acceptance criteria, study details, sample sizes, expert involvement, or adjudication methods for an AI/ML device. The document describes a traditional medical device's non-clinical performance testing.

The information I can provide based on the document is:

Device Performance Reported: The document describes the performance of the personal lubricant in relation to its physical specifications and safety testing.
- Color: Colorless
- Clarity: Clear
- Odor: Odorless
- Absence of particulate matter: Absent
- Viscosity: 12,000-22,000 cP
- Total yeast/mold count: <10 cfu/mL
- Total aerobic microbial count: <100 cfu/mL
- Pathogens (Staphylococcus aureus, Pseudomonas aeruginosa, and Candida albicans): Absent
- Biocompatibility: Non-cytotoxic, non-sensitizing, non-irritating (vaginal), non-systematically toxic.
- Condom Compatibility: Compatible with natural rubber latex, polyurethane, and polyisoprene condoms.
- Shelf life: 2 years (based on 8 months accelerated aging).
Nature of Study: Non-clinical performance testing (biocompatibility, condom compatibility, shelf-life verification) for a personal lubricant seeking 510(k) clearance based on substantial equivalence.

To answer your specific questions, I would need a different type of document, specifically one detailing the validation of an AI/ML medical device.

Summary

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

February 10, 2017

BioFilm, Inc. Richard Hines Regulatory Affairs Manager 3225 Executive Ridge Vista, CA 92081

Re: K163395

Trade/Device Name: Astroglide® Diamond Silicone Gel Personal Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: December 1, 2016 Received: December 5, 2016

Dear Richard Hines:

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.

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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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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.

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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) K163395

Device Name

Astroglide® Diamond Silicone Gel 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 – K163395 Astroglide® Diamond Silicone Gel 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:	Richard Hines
Contact Title:	Regulatory Affairs Manager
Email:	richard@biofilm.com
Date Prepared:	February 9, 2017
Establishment Registration:	2025771

ii. General Information on Device

Proprietary Name:	Astroglide® Diamond Silicone Gel PersonalLubricant
Common Name:	Personal Lubricant
Classification Name:	Condom (21 CFR 884.5300)
Regulatory Class:	II
Product Code:	NUC (lubricant, personal)

iii. Predicate Device

Predicate Device	510(k) Number
ONE® SILICONE Personal LubricantOriginal Applicant: ONE®	K110690

This predicate device has never been the subject of a device recall.

iv. Description of Device

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

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

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Parameter	Specification (Test Method)
Color	Colorless
Clarity	Clear
Odor	Odorless
Absence of particulate matter	Absent
Viscosity	12,000-22,000 cP
Total yeast/mold count	<10 cfu/mL (USP <61>)
Total aerobic microbial count	<100 cfu/mL (USP <61>)
Staphylococcus aureus, Pseudomonas aeruginosa, and Candida albicans	Absent (USP <62>)

Predicate Device Comparison V.

The following table compares the Indications for Use and key technological characteristics of the subject and predicate device:

Characteristic /Feature	Astroglide® DiamondSilicone Gel PersonalLubricant (subject)	One Silicone PersonalLubricant (predicatedevice) - K110690	Comparison
Indication for use	Astroglide® Diamond SiliconeGel Personal Lubricant is apersonal lubricant for penileand/or vaginal application,intended to moisturize andlubricate, to enhance the easeand comfort of intimate sexualactivity and supplement thebody's natural lubrication. Thisproduct is compatible withnatural rubber latex,polyurethane, andpolyisoprene condoms.	ONE® Silicone Personallubricant is a personallubricant for penile and/orvaginal application,intended to moisturize andlubricate, to enhance theease and comfort ofintimate sexual activity andsupplement the body'snatural lubrication. Thisproduct is compatible withnatural rubber latex,polyisoprene, andpolyurethane condoms.	Same: The subject andpredicate devices have thesame indication for use, andtherefore have the sameintended use.
Silicone-basedlubricant	Yes	Yes	Same
Over the Counter	Yes	Yes	Same
Non-greasy &odorless	Yes	Yes	Same
Not acontraceptive orSpermicide	Yes	Yes	Same
Non-sterile	Yes	Yes	Same

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PrimaryIngredients	Dimethicone, CyclomethiconeDimethicone / VinylDimethicone Crosspolymer,Cocos Nucifera (Coconut) Oil	Information is unknown	Different: The ingredientsin the predicate deviceare not known; however,differences in deviceingredients do not raisedifferent questions ofSafety & Effectiveness (S& E) (e.g.,biocompatibility, condomcompatibility)
Microbial Limits	• Total mold/yeast count<10 cfu/mL• Total aerobic microbialcount <100 cfu/mL• Absence of pathogens(Candida albicans,Pseudomonas aeruginosa,Staphylococcus aureus)	Information isunknown	Different: themicrobial limitsspecifications for thepredicate device arenot known; howeverthis does not raisedifferent questions ofS & E (e.g., microbialspecifications withinaccepted range forthese types ofdevices).
Viscosity	12,000-22,000 cP	Information isunknown	Different: the viscosityof the predicatedevice is not known;however this does notraise differentquestions of S & E(e.g., viscosityspecification withinthe accepted rangefor these types ofdevices).

As noted in the table above, the subject and predicate device are similar in that they are both clear, non-sterile, silicone-based lubricants, and are compatible with natural rubber latex, polyisoprene, and polyurethane condoms. However, differences do exist in the formulation and product specification for microbial limits and viscosity. The differences identified do not raise different questions of safety and effectiveness as discussed in the table above.

Summary of Non-clinical Performance Testing vi.

Biocompatibility

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

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Management Process.

Biocompatibility Testing	Astroglide® Diamond Silicone Gel PersonalLubricant Results
Cytotoxicity, ISO 10993-5: 2009/(R)2014	The test article was found to be non-cytotoxic.
Guinea Pig Maximization, ISO 10993-10:2010/(R)2014	The test article was found to be non-sensitizing.
Vaginal Irritation, ISO 10993-10: 2010/(R)2014	The test article was found to be non-irritating.
Systemic Toxicity, ISO 10993-11: 2006/(R)2010	The test article was found to be non-systematicallytoxic.

Condom Compatibility

Astroglide® Diamond Silicone Gel Personal Lubricant 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® Diamond Silicone Gel Personal Lubricant is compatible with natural rubber latex, polyurethane, and polyisoprene condoms.

Shelf life

Astroglide® Diamond Silicone Gel Personal Lubricant has a shelf-life of 2 years based on 8 months of accelerated aging testing results per ASTM F1980-07, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices. Preservative effectiveness per USP <51> was demonstrated at critical time-points throughout the stability testing including at the time zero (0) and eight-month (8) time points for the accelerated aging study. All specifications for the subject lubricant were met during the shelf-life study.

vii. Substantial Equivalence

The results of the testing described above provide reasonable assurance that the Astroglide® Diamond Silicone 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.