(266 days)
Astroglide® Organix® Liquid 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 and polyisoprene condoms. This product is not compatible with polyurethane condoms.
Astroglide® Organix® Liquid is a non-sterile, colorless to slight yellow, water-based personal lubricant intended for penile and vaginal application 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 and is not compatible with polyurethane condoms. This product is for over-the-counter (OTC) use. Astroglide® Organix® Liquid's formulation consists of water, glycerin, xanthan gum, aloe barbabensis powder, chamomilla recutita (matricaria) flower extract, calendula officinalis flower extract, vaccinium macrocarpon (cranberry) fruit extract, passiflora incarnata flower extract, sodium benzoate, potassium sorbate, and citric acid. It is packaged in 2.5 oz polyethylene terephthalate bottles with a polypropylene flip-top cap. Bottles are secondarily packaged in cardboard cartons. This product is also provided in 2.5 ml foil packs.
The document describes the Astroglide® Organix® Liquid personal lubricant and its substantial equivalence to a predicate device, Astroglide® Natural. The provided text outlines non-clinical performance testing conducted to support its safety and effectiveness.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document provides a table of device specifications (acceptance criteria) and the reported performance for the Astroglide® Organix® Liquid.
| Parameter | Acceptance Criteria / Specification (Subject Device) | Reported Device Performance (Implied by meeting specifications) |
|---|---|---|
| Appearance | Hazy liquid | Hazy liquid |
| Color | Colorless to slightly yellow | Colorless to slightly yellow |
| Odor | Odorless | Odorless |
| pH (per USP<791>) | 3.5-5.5 | Within 3.5-5.5 |
| Osmolality (per USP<785>) | 500-800 mOsm/kg (1:5 dilution) | Within 500-800 mOsm/kg (1:5 dilution) |
| Viscosity (per USP<912>) | 250-310 cps | Within 250-310 cps |
| Total aerobic microbial count (per USP<61>) | <100 cfu/g | <100 cfu/g |
| Total yeast/mold count (per USP<61>) | <10 cfu/g | <10 cfu/g |
| Antimicrobial effectiveness (per USP<51>) | Category 2, bacteria should show not less than 2.0 log reduction at 14 days and no increase from 14-day count at the 28-day count. Yeast and molds should show no increase from the initial calculated count at 14 and 28 days | Met Category 2 criteria |
| Absence of pathogenic organisms ( Staphylococcus aureus, Pseudomonas aeruginosa, and Candida albicans - per USP<62>) | Absent | Absent |
| Biocompatibility | Non-cytotoxic, non-sensitizing, non-irritating, and not acutely-systemically toxic (per ISO 10993-5, 10993-10 alternative, 10993-11) | Demonstrated non-cytotoxic, non-sensitizing, non-irritating, and not acutely-systematically toxic |
| Condom Compatibility | Compatible with natural rubber latex and polyisoprene condoms; not compatible with polyurethane condoms (per ASTM D7661-10) | Compatible with natural rubber latex and polyisoprene condoms; not compatible with polyurethane condoms (results showed compatibility with natural rubber latex and polyisoprene condoms) |
| Shelf-life | Maintain device specifications (as shown in Section IV) over 17 months in 2.5 oz bottles and 9 months in foil packs | Devices maintained specifications over 17 months (bottles) and 9 months (foil packs) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not explicitly state the sample sizes for the individual tests (biocompatibility, condom compatibility, shelf-life, or other device specifications). It also does not specify the country of origin for the data or whether the studies were retrospective or prospective. The testing was conducted in accordance with recognized international standards (ISO, USP, ASTM), which implies a specific methodology, but sample sizes are not reported.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not applicable to this type of device and study. The testing for this personal lubricant involves objective physical, chemical, and biological evaluations according to established standards (e.g., pH, viscosity, microbial counts, biocompatibility assays, condom compatibility tests). Ground truth is established by the results of these standardized tests, not by expert consensus or interpretation of images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable as it pertains to subjective assessments or diagnostic interpretations, which are not relevant for a personal lubricant's performance 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:
This information is not applicable. An MRMC study is relevant for medical imaging or diagnostic AI devices where human readers interpret cases. This document describes the testing of a personal lubricant, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not applicable. This refers to AI algorithm performance studies, which are not relevant to this product.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth for the performance criteria is established by objective measurements and standardized test results as defined by the USP, ISO, and ASTM standards. For example:
- pH: Measured directly against the specified range.
- Microbial counts: Counted according to USP<61> and compared to the acceptable limits.
- Biocompatibility: Determined by the specific outcomes of ISO 10993 tests (e.g., cell viability for cytotoxicity, skin reaction for irritation/sensitization).
- Condom Compatibility: Determined by physical tests on condoms as per ASTM D7661-10.
- Shelf-life: Determined by maintaining all device specifications (as defined in Section IV) over the specified time period under controlled conditions.
8. The sample size for the training set:
This information is not applicable. This document describes the performance testing of a physical product (personal lubricant), not the development or validation of an AI algorithm that would require a training set.
9. How the ground truth for the training set was established:
This information is not applicable for the same reason as point 8.
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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.
October 13, 2020
BioFilm, Inc. Richard Hines Regulatory Affairs Manager 3225 Executive Ridge Vista, CA 92081
Re: K200114 Trade/Device Name: Astroglide® Organix® Liquid Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: September 10, 2020 Received: September 11, 2020
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. 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 Actinclude 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-devices/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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) K200114
Device Name Astroglide® Organix® Liquid
Indications for Use (Describe)
Astroglide® Organix® Liquid 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 and polyisoprene condoms. The product is not compatible with polyurethane condoms.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Production Use (Part 21 CFR 321, Subpart B) | Own-Use Testing (21 CFR 321, Subpart C) |
|---|---|
| --------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------- |
__ 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 K200114 Astroqlide® Organix® Liquid
l. Submitter Information
| 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: | October 9, 2020 |
| II. Device Information |
| Trade Name: | Astroglide® Organix® Liquid |
|---|---|
| Common Name: | Personal Lubricant |
| Regulation Number: | 21 CFR 884.5300 |
| Regulation Name: | Condom |
| Product Code: | NUC (Lubricant, Personal) |
| Regulatory Class: | II |
III. Predicate Device
| Predicate Device | 510(k) Number |
|---|---|
| Astroglide® NaturalApplicant: BioFilm Inc. | K141581 |
The predicate device has not been subject to a device-related recall.
IV. Description of Device
Astroglide® Organix® Liquid is a non-sterile, colorless to slight yellow, water-based personal lubricant intended for penile and vaginal application 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 and is not compatible with polyurethane condoms. This product is for over-the-counter (OTC) use.
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Astroglide® Organix® Liquid's formulation consists of water, glycerin, xanthan gum, aloe barbabensis powder, chamomilla recutita (matricaria) flower extract, calendula officinalis flower extract, vaccinium macrocarpon (cranberry) fruit extract, passiflora incarnata flower extract, sodium benzoate, potassium sorbate, and citric acid. It is packaged in 2.5 oz polyethylene terephthalate bottles with a polypropylene flip-top cap. Bottles are secondarily packaged in cardboard cartons. This product is also provided in 2.5 ml foil packs.
Device specifications are listed in the table below:
| Parameter | Specification |
|---|---|
| Appearance | Hazy liquid |
| Color | Colorless to slightly yellow |
| Odor | Odorless |
| pH (per USP<791>) | 3.5-5.5 |
| Osmolality (per USP<785>) | 500-800 mOsm/kg (1:5 dilution) |
| Viscosity (per USP<912>) | 250-310 cps |
| Total aerobic microbial count (perUSP<61>) | <100 cfu/g |
| Total yeast/mold count (perUSP<61>) | <10 cfu/g |
| Antimicrobial effectiveness (perUSP<51) | Category 2, bacteria should show not less than2.0 log reduction at 14 days and no increasefrom 14-day count at the 28-day count. Yeastand molds should show no increase from theinitial calculated count at 14 and 28 days |
| Absence of pathogenic organisms( Staphylococcus aureus ,Pseudomonas aeruginosa , andCandida albicans - per USP<62>) | Absent |
V. Indications for Use
Astroglide® Organix® Liquid 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 and polyisoprene condoms. This product is not compatible with polyurethane condoms.
VI. Summary of Intended Use and Technological Characteristics of the Subject Device in Comparison to the Predicate Device
The following table compares the Intended Use and technological characteristics of the subject and predicate device:
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| Characteristic /Feature | Astroglide® Organix®LiquidK200114Subject Device | Astroglide® Natural - K141581Predicate Device) | Comparison |
|---|---|---|---|
| Indication for use | Astroglide® Organix®Liquid is a personallubricant for penile and/orvaginal application, intendedto moisturize and lubricate,to enhance the ease andcomfort of intimate sexualactivity and supplement thebody's natural lubrication.This product is compatiblewith natural rubber latex andpolyisoprene condoms.This product is notcompatible withpolyurethane condoms. | Astroglide® Natural 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 only compatible withnatural rubber latex andpolyisoprene condoms. | Same: The indicationsfor use are the same,with the exception thatthe subject indicationsfor use specificallystates that it is notcompatible withpolyurethane condoms.Therefore, the subjectand predicate deviceshave the sameintended use (provideslubrication duringintimate sexualactivity). |
| Water-BasedLubricant | Yes | Yes | Same |
| Over theCounter | Yes | Yes | Same |
| PrimaryIngredients | Water, Glycerin, XanthanGum, Aloe BarbabensisPowder, ChamomillaRecutita (Matricaria) FlowerExtract, CalendulaOfficinalis Flower Extract,Vaccinium Macrocarpon(Cranberry) Fruit Extract,Passiflora Incarnata FlowerExtract, Sodium Benzoate,Potassium Sorbate, CitricAcid | Water, Xylitol,Hydroxyethylcellulose,Phenoxyethanol, AloeBarbadensis Leaf Juice Extract,Chamomilla Recutita (Matricaria)Flower Extract, Pectin,Potassium Ascorbyl TocopherylPhosphate, Lactic Acid | Different: The subjectand predicate devicehave differences informulation. Thesedifferences do not raisedifferent questions ofsafety andeffectiveness (S&E). |
| Non-sterile | Yes | Yes | Same |
| Odorless | Yes | Yes | Same |
| Viscosity | 250-310 cps | 2200-3400 cps | Different: Theviscosity is lower for thesubject device. Thisdifference does notraise different |
| pH | 3.5-5.5 | 4.0-7.0 | questions of S&E.Different: The subjectdevice has a lower pHthanthe predicate. Thisdifference does notraise differentquestions of S&E. |
| Osmolality | 500-800 mOsm/kg (1:5dilution) | 769 mOsm/kg | Different: Theosmolality specification |
| for the subject device isdifferent than thepredicate device.Differences inosmolalityspecifications do notraise differentquestionsof S&E. | |||
| Microbial Limits | Total mold/yeast count <10cfu/gTotal aerobic microbialcount <100 cfu/gAbsence of pathogenicorganisms ( Candida albicans, Pseudomonas aeruginosa,Staphylococcus aureus ) | Total mold/yeast count <10cfu/mLTotal aerobic microbial count<100 cfu/mlAbsence of pathogenicorganisms ( Candida albicans,Pseudomonas aeruginosa,Staphylococcus aureus ) | Same |
| AntimicrobialEffectivenessTesting(USP<51>Category 2) | Yes | Yes | Same |
| CondomCompatibility | Compatible with naturalrubber latex andpolyisoprene condoms only. | Compatible with natural rubberlatex and polyisoprene condomsonly. | Same |
| Packaging | PETE bottle and foil | PETE bottle | Different: Bothdevices are packagedin PETE bottles. Thesubject device is alsopackaged in a foil pack.These differences donot raise differentquestions of S&E. |
| Shelf-Life | Bottles: 17 monthsFoil: nine months | Three years | Different: The subjectdevices have a shortershelf-life than thepredicate device. Thisdifference does notraise differentquestions of S&E |
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The subject and predicate device indications for use are not identical, as the predicate device indications for use does not specifically state that it is not compatible with polyurethane condoms. However, the intended use of the subject and predicate devices is the same (i.e., provides lubrication during intimate sexual activity).
In addition, the subject and predicate devices have different technological characteristics as shown in the table above. The differences in technological characteristics between the subject and predicate devices do not raise different questions of safety and effectiveness.
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VII. Summary of Non-Clinical Performance Testing
Biocompatibility
Astroglide® Organix® Liquid has undergone biocompatibility testing 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." Testing included:
- Cytotoxicity per ISO 10993-5: 2009
- Sensitization and Irritation testing using the human repeat insult patch testing, an alternative test method to ISO 10993-10:2010
- Acute systemic toxicity testing per ISO 10993-11:2017. ●
The testing demonstrated that Astroglide® Organix® Liquid is non-cytotoxic, nonsensitizing, non-irritating, and not acutely-systemically toxic.
Condom Compatibility
Astroglide® Organix® Liquid was tested in accordance with ASTM D7661-10 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms." Results showed that Astroglide® Organix® Liquid is compatible with natural rubber latex and polyisoprene condoms. Astroglide® Organix® Liquid is not compatible with polyurethane condoms.
Shelf life
Astroglide® Organix® Liquid has a shelf-life of 17 months in 2.5 oz bottles and 9 months in foils packs. Results from testing demonstrated that the device can maintain its specifications (as shown in Section IV) over the duration of its shelf-life in both packaging forms.
VIII. Substantial Equivalence
The results of the performance testing described above demonstrate that Astroglide® Organix® Liquid 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.