(266 days)
Not Found
No
The device description and performance studies focus on the chemical composition, biocompatibility, and condom compatibility of a personal lubricant, with no mention of AI or ML technology.
No.
A therapeutic device is intended to treat, mitigate, or cure a disease or condition. This device is a personal lubricant intended to enhance sexual activity and supplement natural lubrication, not treat a medical condition.
No
The intended use of the device is to moisturize and lubricate during sexual activity, not to diagnose any condition.
No
The device description clearly indicates a physical product (liquid lubricant) packaged in bottles and foil packs, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a personal lubricant for penile and/or vaginal application to enhance the ease and comfort of intimate sexual activity and supplement natural lubrication. This is a physical function, not a diagnostic one.
- Device Description: The description details the physical properties and ingredients of a lubricant. There is no mention of analyzing samples from the human body to provide diagnostic information.
- Performance Studies: The performance studies focus on biocompatibility, condom compatibility, and shelf life – all related to the physical properties and safety of a lubricant for its intended use. There are no studies related to diagnostic accuracy or performance.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing any kind of diagnostic result.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that definition.
N/A
Intended Use / 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. The product is not compatible with polyurethane condoms.
Product codes
NUC
Device Description
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.
Device specifications:
- Appearance: Hazy liquid
- Color: Colorless to slightly yellow
- Odor: Odorless
- pH (per USP): 3.5-5.5
- Osmolality (per USP): 500-800 mOsm/kg (1:5 dilution)
- Viscosity (per USP): 250-310 cps
- Total aerobic microbial count (per USP): ): ): Absent
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
penile and/or vaginal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility: Astroglide® Organix® Liquid underwent 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, non-sensitizing, 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
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 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
2
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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3
510(K) Summary K200114 Astroqlide® Organix® Liquid
l. Submitter Information
| Applicant: | BioFilm, Inc. |
|---|---|
| Address: | 3225 Executive Ridge |
| Vista, 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® Natural | |
| Applicant: 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.
4
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) | 3.5-5.5 |
| Osmolality (per USP) | 500-800 mOsm/kg (1:5 dilution) |
| Viscosity (per USP) | 250-310 cps |
| Total aerobic microbial count (per | |
| USP) | ) |
| Pseudomonas aeruginosa , and | |
| Candida albicans - per USP) | 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:
5
| Characteristic /
Feature | Astroglide® Organix®
Liquid
K200114
Subject Device | Astroglide® Natural - K141581
Predicate Device) | Comparison |
|----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication 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. | Astroglide® Natural 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 only compatible with
natural rubber latex and
polyisoprene condoms. | Same: The indications
for use are the same,
with the exception that
the subject indications
for use specifically
states that it is not
compatible with
polyurethane condoms.
Therefore, the subject
and predicate devices
have the same
intended use (provides
lubrication during
intimate sexual
activity). |
| Water-Based
Lubricant | Yes | Yes | Same |
| Over the
Counter | Yes | Yes | Same |
| Primary
Ingredients | 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, Citric
Acid | Water, Xylitol,
Hydroxyethylcellulose,
Phenoxyethanol, Aloe
Barbadensis Leaf Juice Extract,
Chamomilla Recutita (Matricaria)
Flower Extract, Pectin,
Potassium Ascorbyl Tocopheryl
Phosphate, Lactic Acid | Different: The subject
and predicate device
have differences in
formulation. These
differences do not raise
different questions of
safety and
effectiveness (S&E). |
| Non-sterile | Yes | Yes | Same |
| Odorless | Yes | Yes | Same |
| Viscosity | 250-310 cps | 2200-3400 cps | Different: The
viscosity is lower for the
subject device. This
difference does not
raise different |
| pH | 3.5-5.5 | 4.0-7.0 | questions of S&E.
Different: The subject
device has a lower pH
than
the predicate. This
difference does not
raise different
questions of S&E. |
| Osmolality | 500-800 mOsm/kg (1:5
dilution) | 769 mOsm/kg | Different: The
osmolality specification |
| | | | for the subject device is
different than the
predicate device.
Differences in
osmolality
specifications do not
raise different
questions
of S&E. |
| Microbial Limits | Total mold/yeast count Candida albicans, Pseudomonas aeruginosa,
Staphylococcus aureus ) | Total mold/yeast count Candida albicans,
Pseudomonas aeruginosa,
Staphylococcus aureus ) | Same |
| Antimicrobial
Effectiveness
Testing
(USP
Category 2) | Yes | Yes | Same |
| Condom
Compatibility | Compatible with natural
rubber latex and
polyisoprene condoms only. | Compatible with natural rubber
latex and polyisoprene condoms
only. | Same |
| Packaging | PETE bottle and foil | PETE bottle | Different: Both
devices are packaged
in PETE bottles. The
subject device is also
packaged in a foil pack.
These differences do
not raise different
questions of S&E. |
| Shelf-Life | Bottles: 17 months
Foil: nine months | Three years | Different: The subject
devices have a shorter
shelf-life than the
predicate device. This
difference does not
raise different
questions of S&E |
6
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.
7
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.