(307 days)
Not Found
No
The device description and performance studies focus on the chemical composition, physical properties, and compatibility of a personal lubricant, with no mention of AI or ML technology.
No.
The device is a personal lubricant intended to enhance comfort during intimate sexual activity, not to treat or cure a medical condition.
No
Explanation: A diagnostic device is used to detect, diagnose, or monitor a medical condition. The provided text clearly states that OneTouch™ Lubricant Gel is a personal lubricant intended to moisturize and lubricate to enhance comfort during sexual activity, and it does not mention any diagnostic capabilities.
No
The device description clearly states it is a gel, which is a physical substance, not software. The performance studies also focus on physical properties and compatibility, not software validation.
Based on the provided information, 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 penile and/or vaginal areas. This is a direct application to the body for a physical purpose, not for testing or analyzing samples taken from the body.
- Device Description: The description confirms its function as a personal lubricant with specific ingredients for lubrication and preservation. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
- Using reagents or assays for testing
The testing performed (biocompatibility, condom compatibility, microbial counts, etc.) are relevant to the safety and performance of a topical personal lubricant, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
OneTouch™ Lubricant Gel is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
Product codes
NUC
Device Description
One Touch™ Lubricant Gels by Thai Nippon Rubber Industry Company, Ltd. ("TNR") are a line of 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. These lubricants are compatible with natural rubber latex and polyisoprene condoms, and are not a contraceptive and do not contain a spermicide. One Touch™ Lubricant Gels are made available in three (3) different versions: One Touch™ Plain, One Touch™ Flavored and One Touch™ Colored, and come packaged in either single-use disposable application film/foil sachets, or in multiple application polyethylene tubes with a flip-top closure. OneTouch™ Lubricant Gels use hydroxyethyl cellulose and refined glycerin as the lubricating agent, with the methyl paraben, propyl paraben and cremophor acting as the antiseptic and preservative additives.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
penile and/or vaginal 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
Non-Clinical Performance Data: TNR completed a number of tests on their device to prove safety and effectiveness and substantial equivalence. OneTouch™ Lubricant Gel passed all the testing in accordance with national and international standards shown below to support substantial equivalence to the predicate devices.
- Biocompatibility Testing (Per ISO 10993-1)
- Condom Compatibility Testing (Per ASTM D7661)
- Total Aerobic Microbial Counts (Per USP 37 /)
- Total Combined Yeast and Mold Counts (Per USP 37 /)
- Package Shelf-Life (Per ASTM F1980)
- Device Risk Analysis (Per ISO 14971)
Clinical Performance Data: There was no human clinical testing required to support OneTouch™ Lubricant Gel as the indications for use is equivalent to the predicate devices. These types of devices, including the predicate devices, have been on the market for many years with a proven safety and efficacy for the intended use of the device. The non-clinical testing detailed in this submission supports the substantial equivalence of OneTouch™ Lubricant Gel to the predicate devices.
Key Metrics
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.
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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" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a series of human profiles facing right, rendered in a dark color.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 30, 2015
Thai Nippon Rubber Industry Co., Ltd. % Stuart Goldman Senior Consultant Emergo Group 816 Congress Avenue Suite 1400 Austin, Texas 78701
Re: K142790
Trade/Device Name: OneTouch Lubricant Gel Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: Class II Product Code: NUC Dated: June 30, 2015 Received: July 1, 2015
Dear Stuart Goldman,
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 device
1
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 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,
Joyce M. Whang -S
for Benjamin 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) K142790
Device Name OneTouch™ Lubricant Gel
Indications for Use (Describe)
OneTouch™ Lubricant Gel is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
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)
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:
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"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
for
OneTouch™ Lubricant Gel
1. Submission Sponsor
Thai Nippon Rubber Industry Company, Ltd. ("TNR") 789/139 Pinthong Industrial Estate, Nongkham Sriracha, Chonburi, 20110 Thailand Phone: + 66 38 317 999 Fax: + 66 38 317 950 Contact: Mr. Pisut Chanwatarungkull, Quality Management System Manager Email: pisut c@tnrcondom.com; tnrfact@tnrcondom.com
2. Submission Correspondent
Emergo Group 816 Congress Avenue, Suite 1400 Austin, TX 78701, USA Office Phone: 512.327.9997 Fax: 512.327.9998 Contact: Stuart R. Goldman, Senior Consultant, RA/QA Email: project.management@emergogroup.com
3. Date Prepared
July 30, 2015
4. Device Identification
| Trade/Proprietary Name: | OneTouch™ Lubricant Gel |
|---|---|
| Common/Usual Name: | Lubricant, Personal |
| Classification Name: | Condom |
| Classification Regulation: | §884.5300 |
| Product Code: | NUC |
| Device Class: | Class II |
| Classification Panel: | Obstetrics/Gynecology |
5. Legally Marketed Predicate Device(s)
Global Protection Corp. [ONE® Oasis (K110691)] Ansell Healthcare Products [LifeStyles® Smooth™ 2-in-I Massage & Lubricant (K122476)]
6. Device Description
One Touch™ Lubricant Gels by Thai Nippon Rubber Industry Company, Ltd. ("TNR") are a line of 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. These lubricants are compatible with natural rubber latex and
4
polyisoprene condoms, and are not a contraceptive and do not contain a spermicide. One Touch™ Lubricant Gels are made available in three (3) different versions: One Touch™ Plain, One Touch™ Flavored and One Touch™ Colored, and come packaged in either single-use disposable application film/foil sachets, or in multiple application polyethylene tubes with a flip-top closure. OneTouch™ Lubricant Gels use hydroxyethyl cellulose and refined glycerin as the lubricating agent, with the methyl paraben, propyl paraben and cremophor acting as the antiseptic and preservative additives.
7. Indication for Use Statement
OneTouch™ Lubricant Gel is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
8. Substantial Equivalence Discussion
TNR has chosen two predicate devices in the 510(k) submission for their OneTouch™ Lubricant Gel, those being ONE® Oasis by Global Protection Corp. (K110691) and LifeStyles® Smooth™ 2-in-1 Massage & Lubricant by Ansell Healthcare Products (K122476).
The following table 5-1 compares OneTouch™ Lubricant Gels to the predicate devices with respect to intended use, technological characteristics and principles of operation, thus providing more detailed information regarding the basis for the determination of substantial equivalence in this 510(k) submission.
| Device | OneTouch™
Lubricant Gel | ONE® Oasis | LifeStyles®
Smooth™
2-in-1 Massage
& Lubricant | Differences |
|-------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k): | Pending | K110691 | K122476 | - |
| Manufacturer: | Thai Nippon
Rubber Industry
Company, Ltd. | Global
Protection Corp. | Ansell Healthcare
Products | - |
| Product Code: | NUC | NUC | NUC | Same. The subject
and predicate
devices share the
same FDA product
code. |
| Regulation: | §884.5300 | §884.5300 | §884.5300 | Same. The subject
and predicate
devices share the
same FDA
regulation number. |
| Class: | II | II | II | Same. The subject
and predicate
devices share the
same FDA device
classification. |
| Prescription or
OTC Use: | OTC | OTC | OTC | Same. The subject
and predicate |
| | | | | devices are sold
OTC. |
| Intended Use: | OTC personal
lubricant. | OTC personal
lubricant. | OTC personal
lubricant. | Same. The subject
and predicate
devices are sold
OTC and intended
be used as a
personal lubricant. |
| Indications for
Use: | OneTouch™
Lubricant Gel 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
lubricant. This
product is
compatible with
natural rubber
latex, polyisoprene,
and polyurethane
condoms. | ONE® Oasis 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,
polyisoprene, and
polyurethane
condoms. | Indications for Use:
LifeStyles®
Smooth™ 2-in-l
Massage &
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. | Similar. The subject
and predicate
devices have
virtually the same
indications for use;
any minor wording
differences
between them are
insignificant to
their intended use
and do not affect
the safety or
efficacy. |
| Mode of
Operation
(Lubricating
Agent): | hydroxyethyl
cellulose | hydroxyethyl
cellulose | hydroxyethyl
cellulose | Similar. The subject
and predicate
devices use
hydroxyethyl
cellulose as the
main lubricating
agent in their
product
formulation; overall
ingredient % may
vary. |
| Water Based
Lubricant: | Yes | Yes | Yes | Same. The subject
and predicate
devices are water-
based personal
lubricants. |
| Sterile: | No | No | No | Same. The subject
and predicate
devices are not
provided sterile or |
| | | | | intended to be
sterilized by the
user. |
| Body Location
Target Area: | for penile and/or
vaginal application | for penile and/or
vaginal application | for penile and/or
vaginal application | Same. The subject
and predicate
devices are for
penile and/or
vaginal application. |
| Single Use: | Yes | Yes | Yes | Same. The subject
and predicate
devices are applied,
as needed, to the
target area. |
| Packaging: | Single use film/foil
sachets and
multiple use tubes. | Multiple use tubes. | Multiple use
plastic pump
dispenser. | Similar. The subject
and predicate
devices use
somewhat different
sizes and shapes for
their OTC
packaging, but
these differences
are minor and have
no impact on the
safety or efficacy of
the personal
lubricant. |
| Shelf-life: | 3 years | 1 year | 3 years | Similar. The subject
and predicate
devices have the
same or similar
shelf-life for their
OTC packaging, but
these differences
are minor and have
no impact on the
safety or efficacy of
the personal
lubricant. |
| Biocompatibility
Testing
Performed: | Yes
ISO 10993-1
(-5, -10, -11) | Yes
ISO 10993-1
(-5, -10, -11) | Yes
ISO 10993-1
(-5, -10, -11) | Same. The subject
and predicate
devices have
undergone
biocompatibility in
accordance with
the applicable parts
of ISO 10993-1. |
| Condom
Compatibility
Testing
Performed: | Yes
ASTM D7661-10 | Yes
ASTM D7661-10 | Yes
ASTM D7661-10 | Same. The subject
and predicate
devices have been
tested for condom
compatibility in
accordance with
ASTM D7661-10. |
| Microbiological | Yes | Not known | Yes | Same. The subject |
| Examination of
Non-sterile
Products
Testing: | USP 37
(/) | USP | and one of the
predicate devices
(K122476) have
been tested for
microorganism
contamination in
accordance with
the applicable parts
of the USP. | |
Table 5-1 OneTouch™ Lubricant Gels vs. Predicate Devices - Similarities and Differences
5
6
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9. Non-Clinical Performance Data
As part of demonstrating the safety and effectiveness of OneTouch™ Lubricant Gel and in showing substantial equivalence to the predicate devices, TNR completed a number of tests on their device to prove this. OneTouch™ Lubricant Gel meets all the requirements for overall design, biocompatibility, condom compatibility, microbial contamination, package shelf-life and device risk, which confirms that the outputs meets the design inputs and specifications for the device.
OneTouch™ Lubricant Gel passed all the testing in accordance with national and international standards shown below to support substantial equivalence to the predicate devices.
- Biocompatibility Testing (Per ISO 10993-1) ●
- Condom Compatibility Testing (Per ASTM D7661)
- Total Aerobic Microbial Counts (Per USP 37 /)
- Total Combined Yeast and Mold Counts (Per USP 37 /)
- Package Shelf-Life (Per ASTM F1980)
- Device Risk Analysis (Per ISO 14971) ●
10. Clinical Performance Data
There was no human clinical testing required to support OneTouch™ Lubricant Gel as the indications for use is equivalent to the predicate devices. These types of devices, including the predicate devices, have been on the market for many years with a proven safety and efficacy for the intended use of the device. The non-clinical testing detailed in this submission supports the substantial equivalence of OneTouch™ Lubricant Gel to the predicate devices.
11. Statement of Substantial Equivalence
By definition, a device is substantially equivalent to a predicate device when the subject device has the same intended use and the same technological characteristics as the previously cleared device, or has the same intended use and different technological characteristics, but it can be demonstrated that the new device is substantially equivalent to the predicate device, and that the new device does not raise any questions regarding its safety and effectiveness when compared to the predicate device.
OneTouch™ Lubricant Gel and the predicate devices that are the subject of this 510(k) submission, all function as 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 to supplement the body's natural lubricant, and are all compatible with natural
8
rubber latex, polyisoprene, and polyurethane condoms, but are not a contraceptive and do not contain a spermicide.
Therefore, based on the substantial equivalence analysis described above, OneTouch™ Lubricant Gel, as designed, developed, manufactured, packaged and tested by TNR, is determined to be substantially equivalent to ONE® Oasis (K110691) and LifeStyles® Smooth™ 2-in-1 Massage & Lubricant (K122476) personal lubricants regulated by the FDA as a Class II medical device under Product Code NUC and §884.5300.