(54 days)
Not Found
No
The device is a personal lubricant and the summary describes its physical properties, intended use, and biocompatibility testing, with no mention of AI or ML.
No
A therapeutic device is used to treat or cure a disease or condition. This device is intended to moisturize and lubricate to enhance comfort during sexual activity, which is not a therapeutic function.
No
The intended use of Astroglide Natural is to moisturize and lubricate for comfort during sexual activity, not to diagnose any medical condition.
No
The device description clearly states it is a physical product (personal lubricant) packaged in a bottle and carton, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for personal lubrication during sexual activity, applied to the body (penile and/or vaginal).
- Device Description: The description details a personal lubricant, not a device used to examine specimens derived from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting substances, or providing diagnostic information based on in vitro testing. The performance studies focus on biocompatibility and shelf life, not diagnostic accuracy.
IVD devices are specifically designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
NUC
Device Description
Astroglide Natural personal lubricant is non-sterile, clear and water based. Astroglide® Natural is a proprietary blend consisting mainly of water soluble ingredients similar to other lubricants currently on the market. 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. This product primary packaging is a clear PET bottle with a screw on flip top cap comprised of polypropylene. Each bottle is packaged into a cardboard carton, which constitutes the device outer packaging.
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
Not Found
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 testing was performed in accordance with ISO 10993, Biological Evaluation of Medical Devices.
- Cytotoxicity: Passed Test - Non-cytotoxic
- Guinea Pig Maximization, ISO 10993-10: Passed test - The test article did not elicit any reactions
- Vaginal Irritation, ISO 10993-10: The test article was considered non- irritating to the vaginal mucosa in New Zealand White Rabbits as compared to the control article.
- Penile Irritation, ISO 10993-10: The test article was considered non- irritating to the penile tissue in New Zealand White Rabbits as compared to the control article.
- Systemic Toxicity, ISO 10993-11: All extracts of the test article met the requirements of ISO 10993-11. No test animals exhibited any biological reactivity.
Shelf Life: Astroglide Natural shows a shelf-life of 3 years based on a 3-year real-time stability study and a 1 year accelerated aging study. Preservative effectiveness was demonstrated at critical time-points throughout the stability testing.
Condom Compatibility: Astroglide® Natural 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® Natural is compatible with latex and polyisoprene condoms but not compatible with polyurethane condoms.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which consists of a stylized human figure with three faces in profile, representing health and well-being. The emblem is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 6, 2014
BioFilm. Inc. Sherry Castello Regulatory Affairs and Ouality Assurance Associate 3225 Executive Ridge Vista, CA 92081
Re: K141581 Trade/Device Name: Astroglide® Natural Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: June 10, 2014 Received: June 13, 2014
Dear Sherry Castello,
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 yours.
Joyce M. Whang -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
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Indications for Use
510(k) Number (if known) K141581
Device Name Astroglide Natural
Indications for Use (Describe)
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.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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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:
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510(k) Summary Astroglide® Natural
General Information on Submitter
Applicant: Address:
- Telephone: Fax: Contact Person: Email:
Date Prepared: Establishment Registration:
BioFilm, Inc. 3225 Executive Ridge Vista, CA 92081 USA 760-727-9030 760-727-8080 Sherry Castello Regulatory Affairs Associate sherry@biofilm.com Aug 5, 2014 2025771
General Information on Device
Proprietary Name: Common Name: Classification Name: Astroqlide® Natural
Personal Lubricant Lubricant, Personal, 21 CFR 884.5300 Condom, Product Code: NUC
Predicate Device
| Predicate Device | 510(k) Number | |
|---|---|---|
| Glycerin and Paraben Free Astroglide | K072647 | |
| Original Applicant: BioFilm, Inc. |
Description of Device
Astroglide Natural personal lubricant is non-sterile, clear and water based. Astroglide® Natural is a proprietary blend consisting mainly of water soluble ingredients similar to other lubricants currently on the market. 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. This product primary packaging is a clear PET bottle with a screw on flip top cap comprised of polypropylene. Each bottle is packaged into a cardboard carton, which constitutes the device outer packaging.
Indications for Use
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.
4
Technological Characteristics
There are no fundamental differences in Astroglide® Natural as compared to the predicate device Glycerin and Paraben Free Astroglide. Both lubricants are clear, water based lubricants formulated without glycerin and paraben. Both formulas use Xylitol as a humectant, thickener, and preservative aid.
| Attribute | Astroglide® Natural
Lubricant | Predicate: Glycerine and
Paraben Free Astroglide |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | To Be Determined | K072647 |
| Indications for use | 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. | Glycerin and Paraben
Free Astroglide® is a
personal lubricant for
penile, anal, 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 latex condoms. |
| Ingredients | Water, Xylitol ,
Hydroxyethylcellulose,
Phenoxyethanol, Aloe
Barbadensis Leaf Juice
Extract, Chamomilla Recutita
(Matricaria) Flower Extract,
Pectin, Potassium Ascorbyl
Tocopheryl Phosphate, Lactic
Acid | Water, Butylene Glycol, Xylitol,
Propylene Glycol,
Polyquaternium-15 |
| Storage
Instruction | Room Temperature | Room Temperature |
| pH | 4.0 - 7.0 | 3.5 - 6.0 |
| Osmolarity | 769 mOsm/kg | 727 mOsm/kg |
| Viscosity | 2200-3400 cP | 1100 - 1500 cP |
| Condom
compatibility | Natural rubber latex and
polyisoprene | Latex |
Table 5-1. Technological Characteristics Comparison
Biocompatibility
Biocompatibility testing was performed in accordance with ISO 10993, Biological Evaluation of Medical Devices.
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Table 5-2. Biocompatibility of Astroglide® Natural
| Biocompatibility Testing | Astroglide Natural Results |
|---|---|
| Cytotoxicity | Passed Test - Non-cytotoxic |
| Guinea Pig Maximization, ISO 10993-10 | Passed test - The test article did not |
| elicit any reactions | |
| Vaginal Irritation, ISO 10993-10 | The test article was considered non- |
| irritating to the vaginal mucosa in New | |
| Zealand White Rabbits as compared to | |
| the control article. | |
| Penile Irritation, ISO 10993-10 | The test article was considered non- |
| irritating to the penile tissue in New | |
| Zealand White Rabbits as compared to | |
| the control article. | |
| Systemic Toxicity, ISO 10993-11 | All extracts of the test article met the |
| requirements of ISO 10993-11. No test | |
| animals exhibited any biological | |
| reactivity. |
Specifications
Astroglide Natural has the following lot release specifications: color, clarity, odor, absence of particulate matter, pH, viscosity, total yeast/mold count, total aerobic microbial count, and absence of pathogens including Staphylococcus aureus, Pseudomonal aeruginosa, and Candida albicans.
Shelf Life
Astroglide Natural shows a shelf-life of 3 years based on a 3-year real-time stability study and a 1 year accelerated aging study. Preservative effectiveness was demonstrated at critical time-points throughout the stability testing.
Condom Compatibility
Astroglide® Natural 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® Natural is compatible with latex and polyisoprene condoms but not compatible with polyurethane condoms.
Substantial Equivalence
Astroglide® Natural personal lubricant has the same intended use and basic technological characteristics as the predicate device. Astroglide® Natural performed well in biocompatibility and performance bench testing proving it is as safe and effective as the predicate device.