Astroglide® O Oil Personal Lubricant & Massage Oil 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 not compatible with condoms.

Device Description

Astroglide® O Oil Personal Lubricant & Massage Oil is non-sterile, light yellow, lightly coconut and ylang-ylang scented, and oil-based lubricant. All oils used in the subject formulation are certified organic, and the subject lubricant is a USDA certified organic final product. This product is not a spermicide or contraceptive. It is NOT compatible with natural rubber latex, polyurethane, or polyisoprene condoms.

This product primary packaging is a PETE amber bottle with a screw on polypropylene flip-top cap. The bottle and cap constitute the device are labeled front and back and then packaged in a cardboard carton which constitutes the final packaging.

AI/ML Overview

The provided text is a 510(k) summary for the Astroglide® O Oil Personal Lubricant & Massage Oil. It details the device, its intended use, and its comparison to a predicate device. However, it does not describe a study involving an AI-powered device or software. Therefore, I cannot extract the information requested about acceptance criteria, study details, ground truth, or MRMC studies for an AI device from this document.

The document focuses on non-clinical performance testing for a personal lubricant to demonstrate its safety and effectiveness, which is a different type of evaluation than what would be conducted for an AI/ML medical device.

If the request was intended to ask about the non-clinical performance testing detailed in the document, here is a summary of that information:

1. A table of acceptance criteria and the reported device performance for Astroglide® O Oil Personal Lubricant & Massage Oil (non-AI device):

Parameter	Specification (Acceptance Criteria)	Reported Device Performance
Color	Light yellow	Light yellow (as described)
Clarity	Clear	Clear (as described)
Odor	Coconut and ylang-ylang	Coconut and ylang-ylang (as described)
Absence of particulate matter	Absent	Absent (as described)
Viscosity	60-120 cP	Within the specified range of 60-120 cP
Total yeast/mold count	<10 cfu/mL (USP <61>)	<10 cfu/mL
Total aerobic microbial count	<100 cfu/mL (USP <61>)	<100 cfu/mL
Staphylococcus aureus, Pseudomonas aeruginosa, and Candida albicans	Absent (USP <62>)	Absent
Biocompatibility - Cytotoxicity	Non-cytotoxic (ISO 10993-5: 2009/(R)2014)	Found to be non-cytotoxic
Biocompatibility - Sensitization	Non-sensitizing (ISO 10993-10: 2010/(R)2014)	Found to be non-sensitizing
Biocompatibility - Vaginal Irritation	Non-irritating (ISO 10993-10: 2010/(R)2014)	Found to be non-irritating
Biocompatibility - Systemic Toxicity	Non-systematically toxic (ISO 10993-11: 2006/(R)2010)	Found to be non-systematically toxic
Condom Compatibility (Natural rubber latex, polyisoprene, polyurethane)	Compatible (ASTM D7661-10 - implied predicate compatibility)	NOT Compatible (This is a key difference and limitation)
Shelf Life	Maintained specifications over 18-month shelf-life (ASTM F1980-07)	Maintained specifications over the duration of its shelf life

Regarding the other points (#2-9), this information is not applicable to an AI device and is not contained in the document for this non-AI product.

Sample size for test set and data provenance: N/A for an AI device. For the lubricant, samples were tested per the specified ASTM and USP methods.
Number of experts and qualifications: N/A for an AI device. Testing was conducted according to standardized laboratory methods.
Adjudication method: N/A for an AI device.
MRMC comparative effectiveness study: N/A as this is not an AI device.
Standalone performance: N/A as this is not an AI device. Its performance is evaluated through material and biological testing.
Type of ground truth used: N/A for an AI device. The ground truth for this product is based on established scientific standards and analytical test results for chemical and biological properties.
Sample size for training set: N/A as this is not an AI device.
How ground truth for training set was established: N/A as this is not an AI device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three faces in profile, stacked on top of each other.

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

August 30, 2017

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

Re: K171985

Trade/Device Name: Astroglide® O Oil Personal Lubricant & Massage Oil Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: June 30, 2017 Received: July 3, 2017

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.

{1}------------------------------------------------

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.

Charles Viviano -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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known)

K171985

Device Name

Astroglide® O Oil Personal Lubricant & Massage Oil

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(K) Summary - K171985 Astroglide® O Oil Personal Lubricant & Massage Oil

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:	August 29, 2017
Establishment Registration:	2025771

ii. General Information on Device

Proprietary Name:	Astroglide® O Oil Personal Lubricant & Massage Oil
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
O Glide Personal LubricantOriginal Applicant: Grafenberg Labs	K142726

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

iv. Description of Device

{4}------------------------------------------------

The specifications for Astroglide® O Oil Personal Lubricant & Massage Oil are described in the following table.

Parameter	Specification (Test Method)
Color	Light yellow
Clarity	Clear
Odor	Coconut and ylang-ylang
Absence of particulate matter	Absent
Viscosity	60-120 cP
Total yeast/mold count	<10 cfu/mL (USP <61>)
Total aerobic microbial count	<100 cfu/mL (USP <61>)
Staphylococcus aureus, Pseudomonasaeruginosa, and Candida albicans	Absent (USP <62>)

v. Indication for Use

Astroglide O Oil Personal Lubricant & Massage Oil 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 not compatible with condoms.

Predicate Device Comparison vi.

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

Characteristic /Feature	®Astroglide O OilPersonal Lubricant &Massage Oil (subjectdevice)	O Glide PersonalLubricant (predicatedevice) - K142726	Comparison
Indication for use	®Astroglide O Oil PersonalLubricant & Massage Oil 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.This product is not compatiblewith condoms.	O Glide Personal Lubricantis a personal lubricant forpenile and/or vaginalapplication, intended tomoisturize and lubricate, toenhance the ease andcomfort of intimate sexualactivity and supplement thebody's natural lubrication.This product is notcompatible with condoms.	Same: The subject andpredicate devices have thesame indication for use, andtherefore have the sameintended use.
Oil-BasedLubricant	Yes	Yes	Same
Over the Counter	Yes	Yes	Same
Odorless	No	No	Same
Not acontraceptive orSpermicide	Yes	Yes	Same
Non-sterile	Yes	Yes	Same
PrimaryIngredients	Helianthus Annuus(Sunflower) Seed Oil, RicinusCommunis (Castor) Seed Oil,Cocos Nucifera (Coconut)Oil, Prunus Amygdalus Dulcis(Sweet Almond) Oil,Simmondsia Chinesis (Jojoba)Seed Oil , Argania SpinosaKernel (Argan Tree Nut) Oil,Tocopherol, Cananga Odorata(Ylang Ylang) Flower Oil**Indicates Organic	Olus (vegetable) oil,Olea Europeaea (olive)Fruit Oil, ArganiaSpinosa Kernel Oil,Pichia / ResveratrolFerment Extract	Different: The ingredientsof the predicate deviceare different; however,differences in deviceingredients do not raisedifferent questions ofSafety & Effectiveness (S& E) (e.g.,biocompatibility)
Microbial Limits	• Total mold/yeast count<10 cfu/mL• Total aerobic microbialcount <100 cfu/mL• Absence of pathogens(Candida albicans,Pseudomonas aeruginosa,Staphylococcus aureus)	• Total mold/yeast count<10 cfu/mL• Total aerobic microbialcount <100 cfu/mL• Absence of pathogens(Candida albicans,Pseudomonas aeruginosa,Staphylococcus aureus)	Same
Viscosity	60-120 cP	Unknown	Different: the viscosityof the predicatedevice is unknown;however, this doesnot raise differentquestions of Safety &Effectiveness (e.g.,viscosity specificationwithin the acceptedrange for these typesof devices).
Osmolality	N/A - Oil-based, non-polarformula	N/A - Oil-based, non-polarformula	Same
pH	N/A - Oil-based, non-polarformula	N/A - Oil-based, non-polarformula	Same

{5}------------------------------------------------

As noted in the table above, the subject and predicate device are similar in that they are both clear, non-sterile, non-aqueous based lubricants. However, differences do exist in the formulation and viscosity. The differences identified do not raise new questions of safety and effectiveness.

{6}------------------------------------------------

vii. Summary of Non-Clinical Performance Testing

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 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® O Oil Personal Lubricant & Massage Oil 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® O Oil Personal Lubricant & Massage Oil is NOT compatible with natural rubber latex, polyurethane, and polyisoprene condoms.

Shelf life

Astroglide® O Oil Personal Lubricant & Massage Oil has a shelf-life of 18 months based on 6 months of accelerated aging testing results per ASTM F1980-07, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices. The accelerated aging study demonstrated that the subject device maintained its specifications over the duration of its shelf life.

viii. Substantial Equivalence

The results of the testing described above provide reasonable assurance that the Astroqlide® O Oil Personal Lubricant & Massage Oil 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.