(218 days)
Not Found
No
The device is a personal lubricant and the description focuses on its physical properties, chemical composition, and biocompatibility testing. There is no mention of any computational or data processing capabilities, let alone AI/ML.
Yes.
A personal lubricant intended to moisturize and lubricate to enhance sexual activity and supplement natural lubrication, particularly for couples trying to conceive, fits the definition of a therapeutic device as it provides a physiological benefit.
No
The device is a personal lubricant intended to moisturize and lubricate for sexual activity, not to diagnose a medical condition.
No
The device is a personal lubricant, which is a physical substance applied to the body, not a software program. The description details its composition and physical properties.
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 sexual activity and supplement natural lubrication. While it mentions compatibility with sperm and oocytes for couples trying to conceive, its primary function is lubrication for sexual activity, not diagnosing a condition or providing information about a person's health status based on in vitro testing of samples.
- Device Description: The description details the physical properties and ingredients of a lubricant. There is no mention of components designed for testing biological samples outside of the body.
- Lack of IVD Characteristics: The document does not describe any process of analyzing biological samples (like blood, urine, tissue, etc.) in vitro to provide diagnostic information. The performance studies focus on biocompatibility, sperm compatibility, shelf-life, and condom compatibility, which are relevant to a personal lubricant, not an IVD.
In summary, the device functions as a personal lubricant applied to the body, not as a tool for performing diagnostic tests on samples taken from the body.
N/A
Intended Use / Indications for Use
JO Actively Trying Personal Lubricant is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of sexual activity and supplement the body's natural lubrication. This product is compatible with sperm, oocytes and can be used by couples trying to conceive. This product is compatible with natural rubber latex, polyurethane and polyisoprene condoms.
Product codes (comma separated list FDA assigned to the subject device)
PEB
Device Description
JO Actively Trying Personal Lubricant is a clear, semi-viscous personal lubricant that is compatible with condoms made of natural rubber latex, polyurethane and polyisoprene. This device is a non-sterile personal lubricant for penile and/or vaginal application, to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with sperm, oocytes and embryos and can be used by couples trying to conceive. This product is provided in clear, Polyethylene Terephthalate (PET) cylinder bottles are capped with silver disc top caps. The individual bottles are hermetically sealed during the production process. This device is composed of Water (Aqua), Propylene Glycol, Hydroxyethylcellose, Fructose, Arabinogalactan, Sodium Phosphate, Salt, Potassium Phosphate, Methylparaben.
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: Studies performed in accordance with the 2016 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. Tests included Cytotoxicity (ISO 10993-5:2009), Sensitization (ISO 10993-10:2010), Vaginal Irritation (ISO 10993-10:2010), Penile Irritation (ISO 10993-10:2010), and Acute Systemic Toxicity (ISO 10993-11:2006). Results demonstrated that the subject lubricant is biocompatible.
Additional biocompatibility testing performed: Human Sperm Survival, Limulus Amebocyte Lysate (LAL) Gel-Clot Method, and Lubricant Barrier Assay. The subject lubricant received passing scores for all these tests, indicating compatibility with sperm, oocytes and embryos.
Shelf-Life: Real time and accelerated aging study. The subject device met the device specifications at all time points (0, 1, and 2 years), supporting a two-year shelf-life.
Condom Compatibility: Evaluated in accordance with ASTM D7661-10 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. Results indicated that JO Actively Trying Personal Lubricant is compatible with natural rubber latex, polyurethane and polyisoprene condoms.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Viscosity (cps): 6,500 cps to 12,000 cps
- pH: 7.25 to 7.80
- Specific Gravity: 0.900 to 1.000
- Osmolality: 800 to 1,000 mOsm/kg
- Human Sperm Survival Assay (HSSA): After exposure to 10% JO Actively Trying for 30 minutes, ≥ 80% of the control.
- Limulus Amebocyte Lysate (LAL) Gel-Clot Method: : Meets US acceptance criteria for Category 2 products
- Total aerobic microbial count (TAMC) per USP and : Less than 10 cfu/g
- Total yeast and mold count (TYMC) per USP and : Less than 10 cfu/g
- Presence of Pathogens per USP
- Pseudomonas aeruginosa: Absent
- Staphylococcus aureus: Absent
- Salmonella/Shigella: Absent
- Escherichia coli: Absent
- Candida albicans: Absent
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.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
April 26, 2019
United Consortium Stephanie Morris Global Regulatory Specialist 29000 N. Hancock Pkwy. Valencia, CA 91355
Re: K182585
Trade/Device Name: JO Actively Trying Personal Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: PEB Dated: March 22, 2019 Received: March 25, 2019
Dear Stephanie Morris:
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.
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jason Roberts -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) K182585
Device Name JO Actively Trying Personal Lubricant
Indications for Use (Describe)
JO Actively Trying Personal Lubricant is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of sexual activity and supplement the body's natural lubrication. This product is compatible with sperm, oocytes and can be used by couples trying to conceive. This product is compatible with natural rubber latex, polyurethane and polyisoprene 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.qov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510 (k) Summary - K182585
1. Submitter Information
| Applicant: | United Consortium |
|---|---|
| Contact: | Stephanie Morris |
| Global Regulatory Specialist |
| Bruce Albert | |
|---|---|
| Head of Technical Services | |
| Address: | 29000 N. Hancock Parkway Valencia, CA |
| 91355 | |
| Phone: | (661) 295-1700, ext. 232 |
| Phone: | (661) 295-1700, ext. 231 |
| FAX: | (661) 295-1800 |
2. Correspondent Information
| Contact: | Stephanie Morris |
|---|---|
| Address: | 29000 N. Hancock Parkway Valencia, CA |
| 91355 | |
| Phone: | (661) 295-1700, ext. 232 |
| Fax: | (661) 295-1800 |
| Email: | smorris@systemjo.com |
3. Date prepared: April 24, 2019
4. Device Information
| Device Name: | JO Actively Trying Personal Lubricant |
|---|---|
| Common Name: | Personal Lubricant |
| Regulation Number: | 21 CFR 884.5300 |
| Regulation Name: | Condom |
| Regulatory Class: | Class II |
| Product Code: | PEB (lubricant, personal, gamete, fertilization and embryo compatible) |
5. Predicate Device Information
| Device Name: | Astroglide TTC Fertility Friendly Personal Lubricant |
|---|---|
| 510(k) Number: | K141132 |
| Manufacturer: | Biofilm, Inc. |
| Regulatory Class: | Class II |
| Product Code: | PEB (lubricant, personal, gamete, fertilization, and embryo compatible) |
The predicate device has not been subject to a design-related recall.
6. Device Description
JO Actively Trying Personal Lubricant is a clear, semi-viscous personal lubricant that is compatible with condoms made of natural rubber latex, polyurethane and polyisoprene. This device is a non-sterile personal lubricant for penile and/or vaginal application, to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with sperm, oocytes and embryos and can be used by couples trying to conceive.
4
This product is provided in clear, Polyethylene Terephthalate (PET) cylinder bottles are capped with silver disc top caps. The individual bottles are hermetically sealed during the production process. This device is composed of Water (Aqua), Propylene Glycol, Hydroxyethylcellose, Fructose, Arabinogalactan, Sodium Phosphate, Salt, Potassium Phosphate, Methylparaben. The device specifications are listed in the table below:
| Property | Specification |
|---|---|
| Appearance | Clear, semi-viscous liquid |
| Color | Clear |
| Odor | Odorless |
| Viscosity (cps) | 6,500 cps to 12,000 cps |
| pH | 7.25 to 7.80 |
| Specific Gravity | 0.900 to 1.000 |
| Osmolality | 800 to 1,000 mOsm/kg |
| Human Sperm Survival Assay (HSSA) | After exposure to 10% JO Actively Trying for |
| 30 minutes, ≥ 80% of the control. | |
| Limulus Amebocyte Lysate (LAL) Gel-Clot | |
| Method | |
| Category 2 products | |
| Total aerobic microbial count (TAMC) per | |
| USP and | Less than 10 cfu/g |
| Total yeast and mold count (TYMC) per | |
| USP and | Less than 10 cfu/g |
| Presence of Pathogens per USP | Specification |
| Pseudomonas aeruginosa | Absent |
| Staphylococcus aureus | Absent |
| Salmonella/Shigella | Absent |
| Escherichia coli | Absent |
| Candida albicans | Absent |
Table 1: Device Specifications for JO Actively Trving Personal Lubricant
7. Indications for Use
JO Actively Trying Personal Lubricant is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of sexual activity and supplement the body's natural lubrication. This product is compatible with sperm, oocytes and embryos and can be used by couples trying to conceive. This product is compatible with natural rubber latex, polyurethane and polyisoprene condoms.
8. Comparison of Intended Use and Technological Characteristics with the Predicate Device
The table below lists the comparative indications for use and technological characteristics of the subject and predicate device.
5
Table 2: Comparator Table for Subject Device – JO Actively Trying Personal Lubricant and Predicate Device Astroglide TTC Fertility Friendly Personal Lubricant
| Feature | JO Actively Trying
Personal Lubricant | Astroglide TTC Fertility
Friendly Personal
Lubricant (K141132) |
|------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Classification
Name | Lubricant, Personal, Gamete,
Fertilization, and Embryo
Compatible | Lubricant, Personal, Gamete,
Fertilization, and Embryo
Compatible |
| Product Code | PEB | PEB |
| Indications for Use | JO Actively Trying Personal
Lubricant is a personal
lubricant, for penile and/or
vaginal application, intended to
moisturize and lubricate, to
enhance the ease and comfort
of sexual activity and
supplement the body's natural
lubrication. This product is
compatible with sperm, oocytes
and embryos and can be used
by couples trying to conceive.
This product is compatible with
natural rubber latex,
polyurethane and polyisoprene
condoms. | 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. |
| Water soluble | Yes | Yes |
| Contains water | Yes | Yes |
| Primary ingredients | Water (Aqua), Propylene Glycol,
Hydroxyethylcellose, Fructose,
Arabinogalactan, Sodium
Phosphate, Salt, Potassium
Phosphate, Methylparaben,
Propylparaben | Water, Propylene Glycol,
Hydroxyethylcellulose,
Fructose, Methylparaben,
Sodium Phosphate, Potassium
Phosphate, Propyl Paraben,
Galactose, Sodium Hydroxide |
| pH | 7.25 - 7.80 | 7.2 - 7.6 |
| Osmolarity | 800 - 1000 mOsm/kg | 220 - 400 mOsm/kg |
| Human Sperm Survival
Assay (HSSA) | After exposure to 10% JO
Actively Trying for 30 minutes,
80% of the control. | After exposure to 10% TTC
for 2
hours, ≥80% of the control. |
| Limulus Amebocyte
Lysate (LAL) Gel-Clot
Method |