(267 days)
Not Found
No
The device description and performance studies focus on the physical and chemical properties of the lubricants, with no mention of AI or ML.
No.
The intended use of the devices is to moisturize and lubricate for comfort during sexual activity and supplement natural lubrication, not to treat or prevent a medical condition.
No
The device is a personal lubricant and moisturizer, not intended for diagnosing medical conditions. Its purpose is to enhance comfort during sexual activity and supplement natural lubrication.
No
The device description clearly states the products are physical substances (lubricants and moisturizers) packaged in tubes and applicators, not software.
Based on the provided information, these devices are not In Vitro Diagnostics (IVDs).
Here's why:
- Intended Use: The intended use of these devices is for personal lubrication during sexual activity and to supplement natural lubrication. This is a physical function applied directly to the body.
- Device Description: The descriptions detail the composition and physical form of the lubricants.
- Performance Studies: The performance studies focus on biocompatibility, condom compatibility, shelf life, and microbial limits. These are all related to the safety and physical properties of the product when used on the body.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples taken from the body (like blood, urine, tissue).
- Providing information about a physiological state, disease, or condition.
- Using reagents or instruments to perform tests on samples.
IVDs are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. These personal lubricants do not fit that definition. They are topical medical devices intended for physical application and lubrication.
N/A
Intended Use / Indications for Use
YES® oil-based Personal Lubricant: A personal lubricant, for vaginal and penile application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. YES® oil-based Personal Lubricant is not compatible with natural rubber latex, polyurethane or polyisoprene condoms.
YES® water-based Personal Lubricant: A personal lubricant, for vaginal and penile application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. YES® water-based Personal Lubricant is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
YES® Vaginal Moisturizer: A personal lubricant, for vaginal and penile application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. YES® Vaginal Moisturizer is compatible with natural rubber latex and polvisoprene condoms. This product is not compatible with polyurethane condoms.
Product codes (comma separated list FDA assigned to the subject device)
NUC
Device Description
YES® oil-based Personal Lubricant: This non-sterile and oil-based personal lubricant consists primarily of Sunflower oil and Shea butter, and is not compatible with condoms. It is neither a contraceptive nor a spermicide. The formulation is a cream-colored thick paste that melts at body temperature. The product is packaged in a high density polyethylene (HDPE) tube with a flip-top cap.
YES® water-based Personal Lubricant: This non-sterile and water-based personal lubricant contains Aloe vera and other components, and is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms. It is neither a contraceptive nor a spermicide. The formulation is a lightly opaque, non-greasy liquid gel. The product is packaged in a HDPE tube with a flip-top cap, and a HDPE single-use applicator.
YES® Vaginal Moisturizer: This non-sterile and water-based personal lubricant contains Aloe vera and other components, and is compatible with natural rubber latex, and polyisoprene condoms. This product is not compatible with polyurethane condoms. It is neither a contraceptive nor a spermicide. The formulation is a lightly opaque, non-greasy liquid gel. The product is packaged in a HDPE tube with a flip-top cap, and a HDPE single-use applicator.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Vaginal and penile application
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)
Performance Testing:
- Biocompatibility: Testing was conducted to assess the biocompatibility of the YES® oil-based Personal Lubricant, YES® water-based Personal Lubricant and YES® Vaginal Moisturizer. Testing included assessments for Cytotoxicity (ISO 10993-5:2009(R)2014), Vaginal Irritation (ISO 10993-10:2010(R)2014), Sensitization (ISO 10993-10:2010(R)2014), and Acute Systemic Toxicity (ISO 10993-11:2006). The results of testing demonstrated that they are non-cytotoxic, non-irritating, non-sensitizing and non-systemically toxic.
- Condom Compatibility:
- YES® oil-based Personal Lubricant: Condom compatibility testing was performed for polyurethane condoms per ASTM D7661-10. The results indicate that the device is not compatible with polyurethane condoms. Additionally, compatibility testing was not performed for natural rubber latex or polyisoprene condoms; therefore, the device is not compatible with natural rubber latex or polyisoprene condoms.
- YES® Vaginal Moisturizer and YES® water-based Personal Lubricant: Condom compatibility testing was performed per ASTM D7661-10. The results indicated that the devices are compatible with natural rubber latex and polyisoprene condoms, but are not compatible with polyurethane condoms.
- Shelf Life and Microbial Limits: YES® oil-based Personal Lubricant, YES® water-based Personal Lubricant, and YES® Vaginal Moisturizer have a 9-month shelf life. The results of shelf-life testing demonstrated that the subject lubricants met all device specifications as shown in the Device Description section for the duration of the 9-month shelf-life.
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.
K124044 Aloe Cadabra Personal Lubricant (Seven Oaks Ranch, Inc.), K122477 Lifestyles Luxe Premium Personal Lubricant (Ansell Healthcare Products LLC)
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/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name in a circular arrangement around a stylized emblem. The emblem consists of three human profiles facing right, stacked on top of each other, with flowing lines extending from the bottom profile.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 9, 2017
Biotech Lubricants Ltd % Karen Cornelius Senior Associate Maetrics BioCity Nottingham, Pennyfoot Street Nottingham, NG1 1GF United Kingdom
K162569 Re:
Trade/Device Name: YES® oil-based Personal Lubricant, YES® water-based Personal Lubricant, YES® Vaginal Moisturizer Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: May 9, 2017 Received: May 11, 2017
Dear Karen Cornelius:
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.
1
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 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 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,
Benjamin R. Fisher -S
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K162569
Device Name
YES® oil-based Personal Lubricant, YES® water-based Personal Lubricant, YES® Vaginal Moisturizer
Indications for Use (Describe) Device Name: YES® oil-based Personal Lubricant
Indications for Use:
A personal lubricant, for vaginal and penile application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. YES® oil-based Personal Lubricant is not compatible with natural rubber latex, polyurethane or polyisoprene condoms.
Device Name: YES® water-based Personal Lubricant
Indications for Use:
A personal lubricant, for vaginal and penile application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. YES® water-based Personal Lubricant is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
Device Name: YES® Vaginal Moisturizer
Indications for Use:
A personal lubricant, for vaginal and penile application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. YES® Vaginal Moisturizer is compatible with natural rubber latex and polvisoprene condoms. This product is not compatible with 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
510(k) Summary
| Submitter: | Biotech Lubricants Limited
Ramshill
Petersfield
GU31 4AT
United Kingdom
Phone: +44 (0) 3450 94 11 41
Email: sarah@biotechlubricants.com |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Correspondent: | Karen Cornelius
Maetrics
BioCity Nottingham, Pennyfoot Street
Nottingham, NG1 1GF
United Kingdom
Phone: +44 (115) 921 6200
Email: kcornelius@maetrics.com |
| Date Prepared: | June 9, 2017 |
| Device Proprietary Names: | YES® oil-based Personal Lubricant
YES® water-based Personal Lubricant
YES® Vaginal Moisturizer |
| Device Common Name: | Personal Lubricant |
| Classification: | Condom (21 CFR 884.5300) |
| Regulatory Class: | II |
| Product Code: | NUC (lubricant, personal) |
| Predicate Device: | K124044 Aloe Cadabra Personal Lubricant (Seven Oaks Ranch, Inc.)
K122477 Lifestyles Luxe Premium Personal Lubricant (Ansell Healthcare Products LLC) |
The predicate devices have not been subject to a design-related recall.
Device Description:
YES® oil-based Personal Lubricant: This non-sterile and oil-based personal lubricant consists primarily of Sunflower oil and Shea butter, and is not compatible with condoms. It is neither a contraceptive nor a spermicide. The formulation is a cream-colored thick paste that melts at body temperature. The product is packaged in a high density polyethylene (HDPE) tube with a flip-top cap. The specifications for the YES® oil-based Personal Lubricant are shown below:
| Parameter | Specification |
|---|---|
| Color | Opaque paste |
| Odor | Slight beeswax and/or cocoa odor |
| Viscosity | N/A: measuring viscosity is not feasible, since changes in phase during measurement lead to differences in viscosity readings |
| Total yeast/mold count | ) |
| Total aerobic mesophilic count | ) |
| Absence of Pathogenic bacteria: | |
| Staphylococcus aureus, Candida | Absent in 1g (USP) |
4
| albicans, and gram negative bacteria | |
|---|---|
| (e.g., Pseudomonas aeruginosa) |
YES® water-based Personal Lubricant: This non-sterile and water-based personal lubricant contains Aloe vera and other components, and is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms. It is neither a contraceptive nor a spermicide. The formulation is a lightly opaque, non-greasy liquid gel. The product is packaged in a HDPE tube with a flip-top cap, and a HDPE single-use applicator. The specifications for the YES® water-based Personal Lubricant are shown below:
| Parameter | Specification |
|---|---|
| Color | Opaque gel |
| Odor | Slight-mild, delicate linseed / leather note |
| Viscosity | 2,000 - 20,000 cP |
| pH | 3.70 - 4.50 |
| Osmolality | 100 - 400 mOsm/kg |
| Antimicrobial Effectiveness | At least 2.0 log reduction from the initial count at 14 days; no increase from the 14 days count at 28 days; no increase from the initial calculated count at 14 and 28 days (USP ) |
| Total yeast/mold count | ) |
| Total aerobic mesophilic count | ) |
| Absence of Pathogenic bacteria: | |
| Staphylococcus aureus, Candida albicans, and gram negative bacteria (e.g., Pseudomonas aeruginosa) | Absent in 1g (USP) |
YES® Vaginal Moisturizer: This non-sterile and water-based personal lubricant contains Aloe vera and other components, and is compatible with natural rubber latex, and polyisoprene condoms. This product is not compatible with polyurethane condoms. It is neither a contraceptive nor a spermicide. The formulation is a lightly opaque, non-greasy liquid gel. The product is packaged in a HDPE tube with a flip-top cap, and a HDPE single-use applicator. The specifications for the YES® Vaginal Moisturizer are shown below:
| Parameter | Specification |
|---|---|
| Color | Opaque gel |
| Odor | Slight-mild, delicate linseed / leather |
| Viscosity | 2,000 – 20,000 cP |
| pH | 3.50–4.50 |
| Osmolality | 250-400 mOsm/kg |
| Antimicrobial Effectiveness | At least 2.0 log reduction from the initial count at 14 days; no increase from the 14 days count at 28 days; no increase from the initial calculated count at 14 and 28 days (USP ) |
| Total yeast/mold count | ) |
| Total aerobic mesophilic count | ) |
| Absence of Pathogenic bacteria: | Absent in 1g (USP) |
5
| Staphylococcus aureus, Candida
albicans, and gram negative
bacteria (e.g., Pseudomonas
| aeruginosa) | |
|---|---|
| ------------------------------------------------------------------------------------------------------------- | -- |
Indications for Use:
YES® oil-based Personal Lubricant: A personal lubricant, for vaginal and penile application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. YES® oil-based Personal Lubricant is not compatible with natural rubber latex, polyurethane or polyisoprene condoms.
YES® water-based Personal Lubricant: A personal lubricant, for vaginal and penile application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. YES® water-based Personal Lubricant is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
YES® Vaginal Moisturizer: A personal lubricant, for vaginal and penile application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. YES® Vaginal Moisturizer is compatible with natural rubber latex, and polyisoprene condoms. This product is not compatible with polyurethane condoms.
| YES® oil-based Personal Lubricant | Comparison | ||
|---|---|---|---|
| 510(k) # | K162569 | K122477 | |
| Device Name | YES® oil-based personal | ||
| lubricant | LifeStyles Luxe Premium | ||
| Personal Lubricant | |||
| Manufacturer | Bio-tech Lubricants Ltd | Ansell Healthcare Products, | |
| LLC | |||
| Classification | 884.5300 | 884.5300 | |
| Product code | NUC | NUC | |
| Description | Personal Lubricant | Personal Lubricant | Same |
| Indications for use | A personal lubricant, for | ||
| vaginal and penile | |||
| 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 not | |||
| compatible with natural | |||
| rubber latex, polyurethane | |||
| or polyisoprene condoms. | LifeStyles Luxe Premium | ||
| Personal Lubricant 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, polyurethane, | |||
| and polyisoprene condoms. | Different: The subject and | ||
| predicate devices indication | |||
| for use statements differ in | |||
| regards to compatibility | |||
| with condoms. Differences | |||
| noted do not represent a | |||
| new intended use. | |||
| Oil-based lubricant | YES | YES | Same: the subject and |
| predicate devices are both | |||
| oil-based lubricants; | |||
| however, the specific oils in | |||
| the formulation are |
Comparison of Intended Use and Technological Characteristics of Subject and Predicate Devices:
6
| YES® oil-based Personal Lubricant | Comparison | ||
|---|---|---|---|
| Ingredients | Sunflower seed oil, Shea | ||
| butter, Sweet almond oil, | |||
| Bees wax, Cocoa seed | |||
| butter, Vitamin E | Not known | Different: The difference in | |
| ingredients do not raise | |||
| different questions of S & | |||
| E. | |||
| Biocompatible | YES | YES | Same |
| Non-sterile | YES | YES | Same |
| Contains | |||
| preservatives | NO | NO | Same |
| Microbial limits | |||
| (TAMC, TYMC, and | |||
| absence of | |||
| pathogenic bacteria) | See product specifications | ||
| table | |||
| (USP & ) | Meets the requirements of | ||
| USP & | Different: the microbial | ||
| limits of the predicate are | |||
| not known; however this | |||
| does not raise different | |||
| questions of S & E as the | |||
| microbial limits | |||
| specifications are within the | |||
| accepted ranges for these | |||
| types of devices. | |||
| Condom | |||
| Compatibility | Not compatible with natural | ||
| rubber latex, polyurethane, | |||
| or polyisoprene condoms. | Compatible with natural | ||
| rubber latex, polyurethane, | |||
| and polyisoprene condoms. | Different: The condom | ||
| compatibility for the subject | |||
| and predicate devices are | |||
| different; However, this | |||
| difference does not | |||
| represent a new intended | |||
| use. |
As noted in the table above the subject and predicate devices indications are similar in that they are both used to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. However, they do differ in regards to condom compatibility as the subject device is not compatible with condoms, while the predicate is condom compatible. Differences in condom compatibility between the subject and predicate devices do not represent a new intended use. In regards to technology, the subject and predicate devices are similar in that they are both non-sterile and are oil-based. Differences do exist as described in the table above (e.g., product formulations, specifications for microbial limits, condom compatibility, etc.). The differences identified do not raise different questions of safety and effectiveness as discussed in the table above
| YES® water-based Personal Lubricant | Comparison | ||
|---|---|---|---|
| 510(k) # | K162569 | K124044 | |
| Device name | YES® water-based | ||
| Personal Lubricant | Aloe Cadabra Personal | ||
| lubricant | |||
| Manufacturer | Bio-tech Lubricants Ltd | Seven Oaks Ranch, Inc. | |
| Classification | 884.5300 | 884.5300 | |
| Product code | NUC | NUC | |
| Description | Personal Lubricant | Personal Lubricant | Same |
| Indications for use | A personal lubricant, for | ||
| vaginal and penile | |||
| application, intended to | |||
| moisturize and lubricate, to | Aloe Cadabra Lubricant and | ||
| Aloe Cadabra | |||
| Flavored/Scented Lubricants | |||
| are personal lubricants for | Same: The subject and | ||
| predicate devices have the | |||
| same indication for use, | |||
| and therefore have the. | |||
| YES® water-based Personal Lubricant | Comparison | ||
| Water-based | |||
| lubricant | enhance the ease and | ||
| comfort of intimate sexual | |||
| activity and supplement | |||
| the body's natural | |||
| lubrication. YES® water- | |||
| based Personal Lubricant | |||
| is compatible with natural | |||
| rubber latex and | |||
| polyisoprene condoms. | |||
| This product is not | |||
| compatible with | |||
| polyurethane condoms. | 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. | same intended use. | ||
| Ingredients | Water, Aloe vera, Flax | ||
| seed extract, Guar gum, | |||
| Locust bean gum, Xanthan | |||
| gum, Sodium chloride, | |||
| Potassium sorbate, Citric | |||
| acid, Phenoxyethanol | Aloe vera | Different: The difference | |
| in ingredients do not raise | |||
| different questions of S & | |||
| E. | |||
| Biocompatible | YES | YES | Same |
| Non-sterile | YES | YES | Same |
| Contains | |||
| preservatives | YES | YES | Same |
| Microbial limits | |||
| (TAMC, TYMC, | |||
| and absence of | |||
| pathogenic | |||
| bacteria) | See product specifications | ||
| table | |||
| (USP & ) | Not known | Different: the microbial | |
| limits of the predicate are | |||
| not known; however this | |||
| does not raise different | |||
| questions of S & E as these | |||
| specifications are within | |||
| the accepted range for | |||
| these types of devices. | |||
| Viscosity | 2,000 - 20,000 cP | Not known | Different: the viscosity of |
| the predicate is not known. | |||
| This does not raise | |||
| different questions of S & | |||
| E as the viscosity | |||
| specification is within the | |||
| accepted range for these | |||
| types of devices. | |||
| pH | 3.70 - 4.50 | Not known | Different: the pH of the |
| predicate is not known. | |||
| This does not raise | |||
| different questions of S & | |||
| E as the pH specification is | |||
| within the accepted range | |||
| for these types of devices. | |||
| Osmolality | 100 - 400 mOsm/kg | Not known | Different: the osmolality of |
| the predicate is not known. | |||
| This does not raise | |||
| different questions of S & | |||
| E as the osmolality | |||
| specification is within the | |||
| accepted range for these | |||
| types of devices. | |||
| YES® water-based Personal Lubricant | Comparison | ||
| Condom | |||
| Compatibility | Compatible with natural | ||
| rubber latex and | |||
| polyisoprene condoms. | |||
| Not compatible with | |||
| polyurethane condoms. | Compatible with natural | ||
| rubber latex and | |||
| polyisoprene condoms. Not | |||
| compatible with | |||
| polyurethane condoms. | Same |
7
8
As noted in the table above the subject and predicate devices have indication for use and intended use. In addition, the subject and predicate devices are similar in that they are both non-sterile, compatible with the same types of contain Aloe vera, and are water-based. Differences do exist as described in the table above (e.g., product formulations, specifications for microbial limits, viscosity, etc.). The differences identified do not raise different questions of safety and effectiveness as discussed in the table above.
| YES® Vaginal Moisturizer | Comparison | ||
|---|---|---|---|
| 510(k) # | K162569 | K124044 | |
| Device Name | YES® VM (Vaginal | ||
| Moisturizer) | Aloe Cadabra Personal | ||
| lubricant | |||
| Manufacturer | Bio-tech Lubricants Ltd | Seven Oaks Ranch, Inc. | |
| Classification | 884.5300 | 884.5300 | |
| Product code | NUC | NUC | |
| Description | Personal Lubricant | Personal Lubricant | Same |
| Indications for use | A personal lubricant, for | ||
| vaginal and penile | |||
| application, intended to | |||
| moisturize and lubricate, to | |||
| enhance the ease and | |||
| comfort of intimate sexual | |||
| activity and supplement the | |||
| body's natural lubrication. | |||
| YES® Vaginal Moisturizer | |||
| is compatible with natural | |||
| rubber latex and | |||
| polyisoprene condoms. This | |||
| product is not compatible | |||
| with polyurethane condoms. | Aloe Cadabra Lubricant and | ||
| Aloe Cadabra | |||
| Flavored/Scented Lubricants | |||
| are personal lubricants 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. | Same: The subject and | ||
| predicate devices have the | |||
| same indication for use, and | |||
| therefore have the same | |||
| intended use. | |||
| Water-based | |||
| lubricant | YES | YES | Same |
| Ingredients | Water, Aloe vera, Flax seed | ||
| extract, Guar gum, Locust | |||
| bean gum, Xanthan gum, | |||
| Sodium chloride, Potassium | |||
| sorbate, Citric acid, | |||
| Phenoxyethanol | Aloe vera | Different: The difference in | |
| ingredients do not raise | |||
| different questions of S & E | |||
| Biocompatible | YES | YES | Same |
| Non-sterile | YES | YES | Same |
| Contains | |||
| preservatives | YES | YES | Same |
| Microbial Limits | See product specifications | Not known | Different: the microbial |
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| YES® Vaginal Moisturizer | Comparison | ||
|---|---|---|---|
| (TAMC, TYMC, and | |||
| absence of | |||
| pathogenic bacteria) | table | ||
| (USP & ) | limits of the predicate are | ||
| not known; however this | |||
| does not raise different | |||
| questions of S & E as these | |||
| specifications are within the | |||
| accepted range for these | |||
| types of devices. | |||
| Viscosity | 2,000 - 20,000 cP | Not known | Different: the viscosity of |
| the predicate is not known. | |||
| This does not raise different | |||
| questions of S & E as the | |||
| viscosity specification is | |||
| within the accepted range | |||
| for these types of devices | |||
| pH | 3.50-4.50 | Not known | Different: the pH of the |
| predicate is not known. This | |||
| does not raise different | |||
| questions of S & E as the pH | |||
| specification is within the | |||
| accepted range for these | |||
| types of devices. | |||
| Osmolality | 250-400 mOsm/kg | Not known | Different: the osmolality of |
| the predicate is not known. | |||
| This does not raise different | |||
| questions of S & E as the | |||
| osmolality specification is | |||
| within the accepted range | |||
| for these types of devices. | |||
| Condom | |||
| Compatibility | Compatible with natural | ||
| rubber latex and | |||
| polyisoprene condoms. Not | |||
| compatible with | |||
| polyurethane condoms. | Compatible with natural | ||
| rubber latex and polyisoprene | |||
| condoms. Not compatible | |||
| with polyurethane condoms. | Same |
As noted in the table above the subject and predicate devices have the same indication for use and intended use. In addition, the subject and predicate devices are similar in that they are both non-sterile, compatible with the same types of contain Aloe vera, and are water-based. Differences do exist as described in the table above (e.g., product formulations, specifications for microbial limits, viscosity, etc.). The differences identified do not raise different questions of safety and effectiveness as discussed in the table above.
Performance Testing:
Biocompatibility:
Testing was conducted to assess the biocompatibility of the YES® oil-based Personal Lubricant, YES® water-based Personal Lubricant and YES® Vaginal Moisturizer. Testing included assessments for Cytotoxicity (ISO 10993-5:2009(R)2014), Vaginal Irritation (ISO 10993-10:2010(R)2014), Sensitization (ISO 10993-10:2010(R)2014), and Acute Systemic Toxicity (ISO 10993-11:2006).
The results of testing demonstrated that they are non-cytotoxic, non-irritating, non-sensitizing and nonsystemically toxic.
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Condom Compatibility:
YES® oil-based Personal Lubricant: Condom compatibility testing was performed for polyurethane condoms per ASTM D7661-10. The results indicate that the device is not compatible with polyurethane condoms. Additionally, compatibility testing was not performed for natural rubber latex or polyisoprene condoms; therefore, the device is not compatible with natural rubber latex or polyisoprene condoms.
YES® Vaginal Moisturizer and YES® water-based Personal Lubricant: Condom compatibility testing was performed per ASTM D7661-10. The results indicated that the devices are compatible with natural rubber latex and polyisoprene condoms, but are not compatible with polyurethane condoms.
Shelf Life and Microbial Limits:
YES® oil-based Personal Lubricant, YES® water-based Personal Lubricant, and YES® Vaginal Moisturizer have a 9-month shelf life. The results of shelf-life testing demonstrated that the subject lubricants met all device specifications as shown in the Device Description section for the duration of the 9-month shelf-life.
Conclusion:
YES® oil-based Personal Lubricant, YES® water-based Personal Lubricant, and YES® Vaginal Moisturizer have the same intended use and similar technological characteristics as the predicate devices. The results of the performance testing conducted on the subject demonstrate that they are as safe and effective as the predicate devices and support substantial equivalence.