(253 days)
Not Found
No
The summary describes a personal lubricant and its testing, with no mention of AI or ML technologies.
No.
A therapeutic device is typically intended to treat or cure a disease or medical condition. This device is a personal lubricant used to enhance comfort and supplement natural lubrication during sexual activity, particularly for couples trying to conceive, without directly treating a medical condition.
No
Explanation: The device is a personal lubricant intended to facilitate sexual activity and aid conception, not to diagnose any medical condition.
No
The device description clearly states it is a "non-sterile, clear, and water-based personal lubricant" and is "packaged in pre-filled tube applicators," indicating it is a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to moisturize and lubricate for sexual activity and supplement natural lubrication, specifically for couples trying to conceive. While it's designed to be compatible with sperm, oocytes, and embryos, its primary function is lubrication, not diagnosing a condition or providing information about a patient's health status based on in vitro examination of specimens.
- Device Description: It's described as a personal lubricant for penile and/or vaginal application.
- Performance Studies: The performance studies focus on the lubricant's compatibility with sperm and its safety for use, not on its ability to diagnose or provide diagnostic information.
- Lack of Diagnostic Function: There is no mention of the device being used to test a sample (like blood, urine, or tissue) outside the body to diagnose a disease or condition.
IVD devices are typically used to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. Astroglide TTC does not fit this description.
N/A
Intended Use / Indications for Use
Astroglide® TTC 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. Astroglide TTC is compatible with sperm, oocytes, and embryos and can be used by couples trying to conceive. Astroglide® TTC is compatible with natural rubber latex, polyisoprene and polyurethane condoms.
Product codes
PEB
Device Description
Astroglide® TTC Fertility Friendly Personal Lubricant is a non-sterile, clear, and water-based personal lubricant for penile and/or vaginal application. Astroglide® TTC has a pH and osmolarity that is compatible with sperm survival and migration. The device is packaged in pre-filled tube applicators which may be used for single use intra-vaginal application or applied directly to penis or vagina.
Astroglide® TTC is formulated using water, propylene glycol, hydroxyethylcellulose, fructose, methylparaben, sodium phosphate, potassium phosphate, propyl paraben, galactose, and sodium hydroxide.
This device is batch lot tested for appearance, color, viscosity, pH, microbial count, osmolality, endotoxin, mouse embryo assay and human sperm survival assay.
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)
Lubricant barrier assays performed on Astroglide® TTC demonstrated that the properties of the device do not impede sperm penetration into the lubricant. Mouse In vitro fertilization assays in combination with Mouse embryo assays (IVF-MEA) demonstrated normal fertilization and embryo development with no suggestion of toxicity. Mucosal penetration studies using a hyaluronic acid (that mimics cervical mucus) indicate that the "swim-up" ability of sperm exposed to Astroglide TTC is not affected. Computer Assisted Sperm Analysis demonstrates the progressive motility of sperm is not harmed by Astroglide TTC. DNA integrity testing after exposure to Astroglide TTC demonstrated the device does not harm human sperm chromatin (DNA). Sperm penetration assays (hamster zona-free ovum tests) demonstrated that the presence of Astroglide TTC did not affect the penetration of hamster ova by human sperm.
Condom compatibility studies indicate that TTC is safe to use with natural rubber latex, polyisoprene, and polyurethane condoms.
Biocompatibility tests and results are shown in the table below:
| Biocompatibility Testing | Astroglide TTC Result |
|---|---|
| Cytotoxicity, Direct Contact, ISO 10993-5, formula | The test article was not considered to have a cytotoxic effect. |
| Guinea Pig Maximization, ISO 10993-10, formula | The test article did not elicit sensitization reactions. |
| Vaginal Irritation, ISO 10993-10, formula | The test article was considered non-irritating to the vaginal mucosa in New Zealand White Rabbits. |
| Systemic Toxicity, ISO 10993-11, formula | Test article met the requirements of ISO 10993-11. No test animals exhibited any biological reactivity. |
| Cytotoxicity, MEM Elution, ISO 10993-5, applicator tube | The test article was not considered to have a cytotoxic effect. |
| Guinea Pig Maximization, ISO 10993-10, applicator tube | The test article did not elicit sensitization reactions. |
| Vaginal Irritation, ISO 10993-10, applicator tube | In New Zealand White Rabbits, the test article when extracted in saline was considered minimally irritating. The test article when extracted in cottonseed oil was considered non-irritating. |
On-going stability studies show the device has met acceptance criteria for appearance, color, clarity, odor, viscosity, pH, microbial count, osmolality, endotoxin, mouse embryo assay, and human sperm survival assay for an 8 month shelf-life. Antimicrobial effectiveness testing has been performed and the preservative system is effective.
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 9, 2015
Biofilm, Inc. Sherry Castello Regulatory Affairs and Quality Assurance Associate 3225 Executive Ridge Vista, CA 92081
K141132 Trade/Device Name: Astroglide TTC Fertility Friendly Personal Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: Class II Product Code: PEB Dated: November 24, 2014 Received: November 25, 2014
Dear Sherry Castello,
Re:
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. 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 yours,
Herbert P. Lerner -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) K141132
Device Name
Astroglide TTC Fertility Friendly Personal Lubricant
Indications for Use (Describe)
Astroglide® TTC 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. Astroglide TTC is compatible with sperm, oocytes, and embryos and can be used by couples trying to conceive. Astroglide® TTC is compatible with natural rubber latex, polyisoprene and polyurethane condoms.
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)
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3
Image /page/3/Picture/0 description: The image shows the logo for Biofilm, Inc. The text "BIOFILM, INC." is in a bold, sans-serif font and is purple. Underneath the text is a curved line, also in purple, that resembles a wave.
510(k) Summary Astroglide TTC Fertility Friendly Personal Lubricant
- General Information on Submitter i.
| Applicant: | BioFilm, Inc. |
|---|---|
| Address: | 3225 Executive Ridge |
| Vista, CA 92081 USA | |
| Telephone: | 760-727-9030 |
| Fax: | 760-727-8080 |
| Contact Person: | Sherry Castello |
| Email: | sherry@biofilm.com |
| Date Prepared: | November 24, 2014 |
| Establishment Registration: | 2025771 |
| ii. | General Information on Device | ||
|---|---|---|---|
| Proprietary Name: | Astroglide® TTC Fertility Friendly Personal Lubricant | ||
| 510(k) Number: | K141132 | ||
| Common Name: | Personal Lubricant | ||
| Classification Name: | Lubricant, Personal, Gamete, Fertilization, and Embryo | ||
| Compatible (21 CFR 884.5300, Condom), product code: | |||
| PEB |
iii. Predicate Device
Pre-Va Vaginal Lubricant, K072741, manufactured by INGFertility, LLC
Description of Device iv.
Astroglide® TTC Fertility Friendly Personal Lubricant is a non-sterile, clear, and water-based personal lubricant for penile and/or vaginal application. Astroglide® TTC has a pH and osmolarity that is compatible with sperm survival and migration. The device is packaged in pre-filled tube applicators which may be used for single use intra-vaginal application or applied directly to penis or vagina.
Astroglide® TTC is formulated using water, propylene glycol, hydroxyethylcellulose, fructose, methylparaben, sodium phosphate, potassium phosphate, propyl paraben, galactose, and sodium hydroxide.
This device is batch lot tested for appearance, color, viscosity, pH, microbial count, osmolality, endotoxin, mouse embryo assay and human sperm survival assay.
4
Image /page/4/Picture/0 description: The image shows the logo for Biofilm, Inc. The logo is purple and features the company name in a bold, sans-serif font. Underneath the name is a curved line, also in purple, that adds a visual element to the logo. The registered trademark symbol is present next to the "C" in "INC."
Indications for Use V.
Astroglide® TTC 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. Astroglide TTC is compatible with sperm, oocytes, and embryos and can be used by couples trying to conceive. Astroglide® TTC is compatible with natural rubber latex, polyisoprene and polyurethane condoms.
vi. Technological Characteristics of Astroglide® TTC Compared to Predicate
Technological Characteristics of Astroglide TTC and the predicate are very similar. Any minor technological differences noted do not affect the safety or effectiveness of the device.
| Attribute | TTC, Fertility Friendly
Personal Lubricant | Predicate: Pre-Va Vaginal
Lubricant |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | K141132 | K072741 |
| Indications for use | Astroglide® TTC 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.
Astroglide TTC is
compatible with sperm,
oocytes, and embryos and
can be used by couples trying
to conceive. Astroglide®
TTC is compatible with
natural rubber latex,
polyisoprene and
polyurethane condoms. | ● To lubricate vaginal
tissues to facilitate entry of
diagnostic or therapeutic
devices including those
used in fertility
interventions. Pre-Va may
be applied directly to the
device or may be
deposited intravaginally
using the applicator prior
to the insertion of
diagnostic or therapeutic
devices used in fertility
interventions.
● As a personal lubricant
Pre-Va supplements the
body's own natural
lubrication fluids, to
moisturize, relieve friction
and to enhance the ease
and comfort of intimate
sexual activity. Pre-Va is
safe for use by couples
who are trying to conceive
and may be applied to
vaginal or penile tissues
for lubrication and |
5
| Attribute | TTC, Fertility Friendly
Personal Lubricant | Predicate: Pre-Va Vaginal
Lubricant |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Ingredients | Water, Propylene Glycol,
Hydroxyethylcellulose, Fructose,
Methylparaben, Sodium
Phosphate, Potassium Phosphate,
Propyl Paraben, Galactose,
Sodium Hydroxide | Water, Hydroxyethylcellulose,
Pluronic 127, Sodium Chloride,
Arabinogalactan, Sodium
Phosphate, Carbopol 934P,
Methyl Paraben, Sodium
Hydroxide, Potassium Phosphate |
| Method of
Application | Directly by hand or intra-
vaginally with pre-filled tube
applicator | Directly from tube or with
separate disposable applicator |
| Storage Instruction | 36°F to 86°F | 36°F to 86°F |
| pH | 7.2-7.6 | 7.20-7.45 |
| Osmolarity | 220-400 mOsm/kg | 260 to 370 mOsm/kg |
| Endotoxin by LAL
methodology | $≤$ 0.7 EU/mL | $≤$ 0.7 EU/mL |
| Mouse Embryo
Assay (MEA) | Using 1-cell MEA exposed to
10% solution for 30 minutes
$>$ 80% expanded blastocysts at 96
hrs. | Using 1-cell MEA exposed to 5%
solution for 30 minutes, $>$ 80%
expanded blastocysts at 96 hrs. |
| Human Sperm
Survival Assay
(HSSA) | After exposure to 10% TTC for 2
hours, $≥$ 80% of the control. | After exposure to 10% Pre-Va for
30 min, $≥$ 80% of the control. |
| Condom
Compatibility | Compatible with latex,
polyurethane, and polyisoprene
condoms | Compatible with latex and
polyurethane condoms. |
Summary of Performance Data vii.
Lubricant barrier assays performed on Astroglide® TTC demonstrated that the properties of the device do not impede sperm penetration into the lubricant. Mouse In vitro fertilization assays in combination with Mouse embryo assays (IVF-MEA) demonstrated normal fertilization and embryo development with no suggestion of toxicity. Mucosal penetration studies using a hyaluronic acid (that mimics cervical mucus) indicate that the "swim-up" ability of sperm exposed to Astroglide TTC is not affected. Computer Assisted Sperm Analysis demonstrates the progressive motility of sperm is not harmed by Astroglide TTC. DNA integrity testing after exposure to Astroglide TTC demonstrated the device does not harm human sperm chromatin (DNA). Sperm penetration assays (hamster zona-free ovum tests) demonstrated that the presence of Astroglide TTC did not affect the penetration of hamster ova by human sperm.
6
Image /page/6/Picture/0 description: The image shows the logo for Biofilm, Inc. The logo is purple and features the company name in bold, sans-serif font. A curved line is below the company name. The registered trademark symbol is to the right of the company name.
Condom compatibility studies indicate that TTC is safe to use with natural rubber latex, polyisoprene, and polyurethane condoms.
Biocompatibility tests and results are shown in the table below:
| Biocompatibility Testing | Astroglide TTC Result |
|---|---|
| Cytotoxicity, Direct Contact, ISO 10993-5, | |
| formula | The test article was not considered to have a |
| cytotoxic effect. | |
| Guinea Pig Maximization, ISO 10993-10, | |
| formula | The test article did not elicit sensitization |
| reactions. | |
| Vaginal Irritation, ISO 10993-10, formula | The test article was considered non-irritating |
| to the vaginal mucosa in New Zealand White | |
| Rabbits. | |
| Systemic Toxicity, ISO 10993-11, formula | Test article met the requirements of ISO |
| 10993-11. No test animals exhibited any | |
| biological reactivity. | |
| Cytotoxicity, MEM Elution, ISO 10993-5, | |
| applicator tube | The test article was not considered to have a |
| cytotoxic effect. | |
| Guinea Pig Maximization, ISO 10993-10, | |
| applicator tube | The test article did not elicit sensitization |
| reactions. | |
| Vaginal Irritation, ISO 10993-10, applicator | |
| tube | In New Zealand White Rabbits, the test |
| article when extracted in saline was | |
| considered minimally irritating. The test | |
| article when extracted in cottonseed oil was | |
| considered non-irritating. |
On-going stability studies show the device has met acceptance criteria for appearance, color, clarity, odor, viscosity, pH, microbial count, osmolality, endotoxin, mouse embryo assay, and human sperm survival assay for an 8 month shelf-life. Antimicrobial effectiveness testing has been performed and the preservative system is effective.
The performance data concludes that Astroglide® TTC is substantially equivalent to the predicate device Pre-Va Vaginal Lubricant. Astroglide® TTC does not harm sperm, oocytes, or embryos and is safe for use by couples trying to conceive.
viii. Conclusion
The proposed and predicate indication statements do not represent a new intended use. Astroglide TTC personal lubricant has the same intended use as PreVa for use in a nonclinical environment. The technological characteristics of Astroglide TTC and the predicate are very similar. Any minor technological differences noted do not affect the safety or efficacy of the device. Performance testing demonstrates that Astroglide TTC does not harm sperm, oocytes, or embryos and is safe to use by couples trying to conceive.