(60 days)
Astroglide® Glycerin & Paraben Free is a personal lubricant for penile, and/or anal 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 and polyisoprene condoms. This product is not compatible with polyurethane condoms.
Astroglide® Glycerin & Paraben Free is a non-sterile, water-based liquid personal lubricant for penile, anal, and/or vaginal application. This product is not a spermicide or contraceptive. It is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms. The subject device is sold as an overthe-counter (OTC) product in a 2.5 oz. clear PETE bottle with a screw on polypropylene flip-top cap. The bottle is labeled front and back and then packaged in a cardboard carton which constitutes the final packaging. This device is composed of water, butylene glycol, propylene glycol, xylitol, methyl gluceth-20, polyquarternium-7, hydroxyethyl cellulose, potassium sorbate, sodium benzoate, citric acid.
The provided document is a 510(k) Premarket Notification from the FDA for a personal lubricant called Astroglide® Glycerin & Paraben Free. It primarily focuses on demonstrating substantial equivalence to a previously marketed predicate device, rather than providing details on a study of a device's performance against specific clinical acceptance criteria for diagnostic or AI-driven devices.
Therefore, much of the requested information (sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone AI performance, training set details) is not applicable to this type of regulatory submission for a personal lubricant.
However, I can extract information related to the acceptance criteria for the product's physical and chemical properties, as well as its biocompatibility and condom compatibility.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Test Method) | Reported Device Performance |
|---|---|---|
| Color | Clear to slight golden | Not explicitly stated as "reported performance," but the device is described as having this specification. |
| Clarity | Clear | Not explicitly stated as "reported performance," but the device is described as having this specification. |
| Odor | Slight sweet odor | Not explicitly stated as "reported performance," but the device is described as having this specification. |
| Absence of particulate matter | Absent | Not explicitly stated as "reported performance," but the device is described as having this specification. |
| Viscosity | 1000-2800 cP | Not explicitly stated as "reported performance," but the device is described as having this specification. |
| pH | 3.5-5.5 | Not explicitly stated as "reported performance," but the device is described as having this specification. |
| Osmolality | 230-300 mOsm/kg, 1:5 dilution factor | Not explicitly stated as "reported performance," but the device is described as having this specification. |
| Total yeast/mold count (TYMC) | <10 cfu/mL (USP <61>) | Not explicitly stated as "reported performance," but the device is described as having met this specification. |
| Total aerobic microbial count (TAMC) | <100 cfu/mL (USP <61>) | Not explicitly stated as "reported performance," but the device is described as having met this specification. |
| Presence of Pathogenic Organisms | Absent (USP <62>) (Staphylococcus aureus, Pseudomonas aeruginosa, and Candida albicans) | Not explicitly stated as "reported performance," but the device is described as having met this specification. |
| Antimicrobial effectiveness | Meets USP <51> acceptance criteria for Category 2 products. | Not explicitly stated as "reported performance," but the device is described as having met this specification. |
| Biocompatibility (Cytotoxicity) | Non-cytotoxic (per ISO 10993-5:2009/(R)2014) | Demonstrated non-cytotoxic |
| Biocompatibility (Sensitization) | Non-sensitizing (per Human Repeat Insult Patch Testing (HRIPT) per ASTM D6355) | Demonstrated non-sensitizing |
| Biocompatibility (Irritation) | Non-irritating (per Human Repeat Insult Patch Testing (HRIPT) per ASTM D6355) | Demonstrated non-irritating |
| Biocompatibility (Systemic Toxicity) | Not systemically toxic (per ISO 10993-11:2017) | Demonstrated not systemically toxic |
| Shelf Life (Device Specifications) | Met specifications in Table 1 across shelf-life | Met specifications at all time points over 22 months |
| Condom Compatibility (Natural rubber latex) | Compatible (per ASTM D7661-18) | Compatible |
| Condom Compatibility (Polyisoprene) | Compatible (per ASTM D7661-18) | Compatible |
| Condom Compatibility (Polyurethane) | Not Compatible (per ASTM D7661-18) | Not Compatible |
2. Sample size used for the test set and the data provenance
- For physical/chemical specifications: The document refers to standard test methods (e.g., USP <61>, USP <62>) but does not specify the sample size for these tests. The data provenance is implied to be from BioFilm, Inc.'s internal testing, likely from the U.S.
- For biocompatibility: No specific sample sizes for human subjects or animal models are provided for the HRIPT or systemic toxicity tests. For cytotoxicity, it's generally in vitro testing. Data provenance is implied to be from BioFilm, Inc.'s testing.
- For condom compatibility: No specific sample size (i.e., number of condoms tested) is explicitly mentioned, but the testing was conducted according to ASTM D7661-18. Data provenance is implied to be from BioFilm, Inc.'s testing.
- For shelf life: The study was an accelerated aging study conducted for 8 months at 40°C, per ASTM F1980-16. No sample sizes (number of devices) are given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not a study requiring expert clinical review or ground truth establishment for diagnostic accuracy. The ground truth for the physical/chemical properties, biocompatibility, and condom compatibility are defined by the standardized test methods themselves.
4. Adjudication method for the test set
Not applicable. There is no subjective assessment requiring adjudication in this type of testing.
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 personal lubricant device, not an AI-driven diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a personal lubricant device, not an algorithm.
7. The type of ground truth used
The "ground truth" for the various acceptance criteria were established by:
- Standardized laboratory methods/specifications: For color, clarity, odor, particulate matter, viscosity, pH, osmolality, microbial counts (TYMC, TAMC, pathogens), and antimicrobial effectiveness, the ground truth is defined by specified ranges, limits, or absence/presence criteria according to recognized pharmacopeial (USP) or internal standards.
- International Standards (ISO) and ASTM Standards:
- Biocompatibility: ISO 10993-5 (cytotoxicity), ASTM D6355 (sensitization/irritation), ISO 10993-11 (systemic toxicity).
- Shelf Life: ASTM F1980-16 (accelerated aging for medical devices).
- Condom Compatibility: ASTM D7661-18.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI-driven device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 6, 2022
BioFilm, Inc. Kevin Jamil Regulatory Affairs 3225 Executive Ridge Vista, CA 92081
Re: K220653
Trade/Device Name: Astroglide® Glycerin & Paraben Free Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: February 27, 2022 Received: March 7, 2022
Dear Kevin Jamil:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Monica D. Garcia, Ph.D. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K220653
Device Name Astroglide® Glycerin & Paraben Free
Indications for Use (Describe)
Astroglide® Glycerin & Paraben Free is a personal lubricant for penile, and/or anal 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 and polyisoprene condoms. This product is not compatible with polyurethane condoms.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) Summary - K220653 Astroglide® Glycerin & Paraben Free
l. General Information on Submitter
| Applicant: | BioFilm, Inc. |
|---|---|
| Address: | 3225 Executive RidgeVista, CA 92081 USA |
| Telephone: | 760-727-9030 |
| Fax: | 760-727-8080 |
| Contact Person: | Kevin Jamil |
| Contact Title: | Regulatory Affairs |
| Email: | kevin@biofilm.com |
| Date Prepared: | May 6, 2022 |
II. General Information on Device
| Proprietary Name: | Astroglide® Glycerin & Paraben Free |
|---|---|
| Common Name: | Personal Lubricant |
| Regulation Name: | Condom |
| Regulation Number: | 21 CFR 884.5300 |
| Regulatory Class: | II |
| Product Code: | NUC (Lubricant, Personal) |
lll. Predicate Device
| Predicate Device | 510(k) Number |
|---|---|
| Astroglide® Glycerin & Paraben Free | K072647 |
This predicate device has not been subject to a design-related recall.
IV. Description of Device
Astroglide® Glycerin & Paraben Free is a non-sterile, water-based liquid personal lubricant for penile, anal, and/or vaginal application. This product is not a spermicide or contraceptive. It is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms. The subject device is sold as an overthe-counter (OTC) product in a 2.5 oz. clear PETE bottle with a screw on polypropylene flip-top cap. The bottle is labeled front and back and then packaged in a cardboard carton which constitutes the final packaging.
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This device is composed of water, butylene glycol, propylene glycol, xylitol, methyl gluceth-20, polyquarternium-7, hydroxyethyl cellulose, potassium sorbate, sodium benzoate, citric acid.
The specifications for Astroglide® Glycerin & Paraben Free are described in Table 1.
| Parameter | Specification (Test Method) |
|---|---|
| Color | Clear to slight golden |
| Clarity | Clear |
| Odor | Slight sweet odor |
| Absence of particulate matter | Absent |
| Viscosity | 1000-2800 cP |
| pH | 3.5-5.5 |
| Osmolality | 230-300 mOsm/kg, 1:5 dilution factor |
| Total yeast/mold count (TYMC) | <10 cfu/mL (USP <61>) |
| Total aerobic microbial count (TAMC) | <100 cfu/mL (USP <61>) |
| Presence of Pathogenic Organisms(Staphylococcus aureus, Pseudomonasaeruginosa, and Candida albicans) | Absent (USP <62>) |
| Antimicrobial effectiveness | Meets USP <51> acceptance criteriafor Category 2 products. |
Table 1. Device Specifications
V. Indications for Use
Astroglide® Glycerin & Paraben Free is a personal lubricant for penile, vaginal, and/or anal 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 and polyisoprene condoms. This product is not compatible with polyurethane condoms.
VI. Substantial Equivalence Discussion
The following table compares the intended use and key technological characteristics of the subject and predicate device:
| Characteristic /Feature | Astroglide® Glycerin &Paraben Free (subjectdevice) | Astroglide® Glycerin &Paraben Free PersonalLubricant (predicatedevice) — K072647 | Comparison |
|---|---|---|---|
| Indication for use | Astroglide® Glycerin & ParabenFree is a personal lubricant forpenile, vaginal, and/or analapplication intended tomoisturize and lubricate, toenhance the ease and comfortof intimate sexual activity andsupplement the body's naturallubrication. This product iscompatible with natural rubberlatex and polyisoprenecondoms. This product is notcompatible with polyurethanecondoms. | Glycerin & Paraben FreeAstroglide® is a personallubricant for penile, anal orvaginal application, intended tomoisturize and lubricate, toenhance the ease and comfortof intimate sexual activity andsupplement the body's naturallubrication.This product is compatible withlatex condoms. | Similar: The subject andpredicate devices have similarindications for use, with theexception of the condomcompatibility statement, andthey have the same intendeduse. |
| Water-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 | Purified Water, Xylitol, ButyleneGlycol, Methyl Gluceth-20,Propylene Glycol,Polyquaternium-7,Hydroxyethylcellulose,Potassium Sorbate, SodiumBenzoate, Citric Acid | Not publicly available | Different: The ingredients of thepredicate device are different;the ingredients do not raisedifferent questions of Safety &Effectiveness (S & E) |
| Microbial Limits | Total mold/yeast count <10cfu/mLTotal aerobic microbial count<100 cfu/mLAbsence of pathogens(Candida albicans,Pseudomonas aeruginosa,Staphylococcus aureus) | Not publicly available | N/A |
| Viscosity | 1000-2800 cP | Not publicly available | N/A |
| Osmolality | 230-300 mOsm/kg,1:5 dilution factor | Not publicly available | N/A |
| pH | 3.5-5.5 | Not publicly available | N/A |
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The subject and predicate devices have similar indications for use and have the same intended use – to provide lubrication during intimate sexual activity. The subject and predicate devices have different technological characteristics, including different
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formulations and device specifications. The different technological characteristics do not raise different types of safety and effectiveness questions.
Summary of Non-Clinical Performance Testing VII.
Biocompatibility
Biocompatibility testing on the subject lubricant was performed in accordance with the 2020 FDA guidance document Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process" and ISO 10993-1:2009 as follows:
- Cytotoxicity (per ISO 10993-5:2009/(R)2014)
- Human Repeat Insult Patch Testing (HRIPT) per ASTM D6355 to address ● sensitization and irritation
- . Systemic Toxicity (per ISO 10993-11:2017)
The results of this testing demonstrate that the subject lubricant is non-cytotoxic, nonirritating, non-sensitizing, and not systemically toxic.
Shelf Life
The subject device is a non-sterile personal lubricant packaged in a 2.5 oz. bottle with a 22-month shelf-life in accordance with the results of an accelerated aging study. conducted for 8 months at 40°C per ASTM F1980-16, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices. The device specifications listed in Table 1 were tested across the device shelf-life and the subject device met the specifications at all time points.
Condom Compatibility
Astroglide® Glycerin & Paraben Free was tested for compatibility with natural rubber latex, polyisoprene, and polyurethane condoms using ASTM D7661-18, Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. The results show that Astroglide® Glycerin & Paraben Free is compatible with natural rubber latex and polyisoprene condoms. Astroglide® Glycerin & Paraben Free is not compatible with polvurethane condoms.
VIII. Conclusion
The results of the testing described above demonstrate that the Astroglide® Glycerin & Paraben Free is as safe and effective as the predicate device and supports a determination of substantial equivalence.
§ 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.