(263 days)
Not Found
No
The device is a personal lubricant and the description focuses on its physical properties, ingredients, and compatibility, with no mention of AI or ML.
No.
The device is intended to moisturize and lubricate to enhance the ease and comfort of intimate sexual activity and supplement natural lubrication, which are not considered therapeutic effects.
No
The device is a personal lubricant intended to moisturize and lubricate for comfort during sexual activity, not to diagnose any condition.
No
The device is a personal lubricant gel, which is a physical substance intended for topical application. The description details its chemical composition, packaging, and physical properties, indicating it is a hardware/substance-based medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of Onetouch™ Non-paraben Lubricant Gel is for personal lubrication during sexual activity. This is a physical function, not a diagnostic one.
- Device Description: The description details a lubricant for topical application, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies focus on biocompatibility, shelf-life, and condom compatibility, which are relevant to a personal lubricant, not an IVD. IVD performance studies would typically involve evaluating the accuracy and reliability of a test to detect a specific condition or substance.
IVD devices are used to perform tests on samples taken from the human body (like blood, urine, tissue) to diagnose diseases, monitor health conditions, or screen for specific markers. This lubricant does not perform any such diagnostic function.
N/A
Intended Use / Indications for Use
Onetouch™ Non-paraben Lubricant Gel is a personal lubricant, for penile, vaginal and/or anal application, intended to moisturize and lubricate, 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 (comma separated list FDA assigned to the subject device)
NUC
Device Description
Onetouch™ Non-paraben Lubricant Gel is a non-sterile, water-based, over-the-counter use personal lubricant that is intended for penile, vaginal and/or anal application, to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. Onetouch™ Nonparaben Lubricant Gel is compatible with natural rubber latex and polyisoprene condoms. The product is not compatible with polyurethane condoms.
Onetouch™ Non-paraben Lubricant Gel has the following eight flavor and color versions:
-
- Natural Color, No Flavor
-
- Natural Color, Cucumber Flavor
-
- Natural Color, Mixfruit Flavor
- Pink Color, Strawberry Flavor 4.
-
- Natural Color, Strawberry Flavor
-
- Natural Color, Vanilla Flavor
-
- Natural Color, Mentha Piperita (Peppermint) Flavor
- Natural Color, Aloe Vera Flavor 8.
The formulations of all versions consist of purified water, hydroxyethyl cellulose, refined glycerin, propane-1,3-diol, sodium benzoate, and PEG-40 hydrogenated castor oil. Specific versions of the device include flavors or a pink colorant, as shown in the list above.
Onetouch™ Non-paraben Lubricant Gel is packaged in 75ml LDPE plastic tubes or 5 ml PE layered aluminum foil sachets. Sachets and tubes are secondarily packaged in cartons.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
penile, vaginal and/or anal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility testing was performed in accordance with the 2020 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." The following testing was conducted:
- Cytotoxicity (ISO 10993-5:2009)
- Guinea Pig Maximization Sensitization (ISO 10993-10:2010)
- Vaginal Irritation (ISO 10993-10:2010)
- Acute Systemic Toxicity (ISO 10993-11:2017)
The results of this testing demonstrate that the subject lubricant is non-cytotoxic, non-irritating, and not systemically toxic.
The subject device has a shelf-life of 12 months based on the results of real-time and accelerated aging testing. All specifications for the subject lubricant listed in Table 1 were met throughout the shelf-life study in lubricant packaged in tubes and sachets.
The compatibility of Onetouch™ Non-paraben Lubricant Gel with condoms was evaluated in accordance with ASTM D7661-10(R) 2017 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. The results of testing showed compatibility of the lubricant with natural rubber latex and polyisoprene condoms. The results also showed that the device is not compatible with polyurethane condoms.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 884.5300 Condom.
(a)
Identification. A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). The device may also be used to collect semen to aid in the diagnosis of infertility.(b)
Classification. (1) Class II (special controls) for condoms made of materials other than natural rubber latex, including natural membrane (skin) or synthetic.(2) Class II (special controls) for natural rubber latex condoms. The guidance document entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300” will serve as the special control. See § 884.1(e) for the availability of this guidance document.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the acronym "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
October 21, 2022
Thai Nippon Rubber Industry Public Company Limited Tossaporn Nilkhamhang Chief Technical Officer 789/139 Pinthong Industrial Estate Nongkham Sriracha. Chonburi 20230 Thailand
Re: K220273
Trade/Device Name: OnetouchTM Non-paraben Lubricant Gel Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: September 5, 2022 Received: September 23, 2022
Dear Tossaporn Nilkhamhang:
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.
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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/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Monica D. Garcia, Ph.D. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K220273
Device Name OnetouchTM Non-paraben Lubricant Gel
Indications for Use (Describe)
Onetouch™ Non-paraben Lubricant Gel is a personal lubricant, for penile, vaginal and/or anal application, intended to moisturize and lubricate, 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)
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510(k) Summary Onetouch™ Non-paraben Lubricant Gel
1. Submitter Information
| Applicant: | Thai Nippon Rubber Industry Public Company Limited |
|---|---|
| Contact: | Tossaporn Nilkhamhang |
| Address: | 789/139 Moo 1 Pinthong Industrial Estate Nongkham |
| Sriracha Chonburi 20110 Thailand | |
| Phone: | (+66-38-317999) |
2. Correspondent Information
| Company: | Regulatory Insight |
|---|---|
| Contact: | Kevin Walls |
| Phone: | (720) 962-5412 |
| Email: | kevin@reginsight.com |
3. Device Information
| Device Name: | Onetouch™ Non-paraben Lubricant Gel |
|---|---|
| Common Name: | Personal Lubricant |
| Regulation Number: | 21 CFR 884.5300 |
| Regulation Name: | Condom |
| Product Code: | NUC (lubricant, personal) |
| Regulatory Class: | Class II |
4. Predicate Device Information
| Device Name: | OneTouch™ Lubricant Gel |
|---|---|
| 510(k) Number: | K142790 |
| Manufacturer: | Thai Nippon Rubber Industry Public Company Limited |
The predicate device has not been subject to a design-related recall.
5. Device Description
Onetouch™ Non-paraben Lubricant Gel is a non-sterile, water-based, over-the-counter use personal lubricant that is intended for penile, vaginal and/or anal application, to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. Onetouch™ Nonparaben Lubricant Gel is compatible with natural rubber latex and polyisoprene condoms. The product is not compatible with polyurethane condoms.
Onetouch™ Non-paraben Lubricant Gel has the following eight flavor and color versions:
-
- Natural Color, No Flavor
-
- Natural Color, Cucumber Flavor
-
- Natural Color, Mixfruit Flavor
- Pink Color, Strawberry Flavor 4.
-
- Natural Color, Strawberry Flavor
-
- Natural Color, Vanilla Flavor
-
- Natural Color, Mentha Piperita (Peppermint) Flavor
- Natural Color, Aloe Vera Flavor 8.
4
The formulations of all versions consist of purified water, hydroxyethyl cellulose, refined glycerin, propane-1,3-diol, sodium benzoate, and PEG-40 hydrogenated castor oil. Specific versions of the device include flavors or a pink colorant, as shown in the list above.
Onetouch™ Non-paraben Lubricant Gel is packaged in 75ml LDPE plastic tubes or 5 ml PE layered aluminum foil sachets. Sachets and tubes are secondarily packaged in cartons.
Device specifications are listed in Table 1 below:
| Property | Specification |
|---|---|
| Appearance | A clear medium viscous gel, free of foreign matter |
| Color | Colorless (all natural color versions) |
| Pink (Pink Color, Strawberry Flavor version) | |
| Odor | Odorless (Natural Color, No Flavor version) |
| Cucumber (Natural Color, Cucumber Flavor version) | |
| Mixfruit (Natural Color, Mixfruit Flavor version) | |
| Strawberry (Pink Color, Strawberry Flavor version) | |
| Strawberry (Natural Color, Strawberry Flavor version) | |
| Vanilla (Natural Color, Vanilla Flavor version) | |
| Mentha Piperita (Natural Color, Mentha Piperita | |
| (Peppermint) Flavor version) | |
| Aloe Vera (Natural Color, Aloe Vera Flavor version) | |
| Viscosity (USP) | 9,500 -16,000 cps |
| pH at 25°C (USP) | 5.5 - 6.5 |
| Osmolality (USP) | 300-600 mOsm/kg (1:8 dilution) |
| Antimicrobial Effectiveness | |
| (USP) | Bacteria: NLT 2.0 log reduction from the initial count at |
| 14 days, and no increase from 14 days 'count at 28 days; | |
| Yeasts/Molds: No increase from the initial calculated | |
| count at 14 and 28 days. | |
| Total Aerobic Microbial Count | |
| (TAMC, per USP ) | ) |
Table 1: Device Specifications for Onetouch™ Non-paraben Lubricant Gel
6. Indications for Use
Onetouch ™ Non-paraben Lubricant Gel is a personal lubricant, for penile, vaginal and/or anal application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity and supplement
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the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
7. Comparison of Intended Use and Technological Characteristics with the Predicate Device
The table below compares the intended use and technological characteristics of the subject and predicate device:
| Table 2: Comparator Table for Subject and Predicate Device | |||
|---|---|---|---|
| OnetouchTM | |||
| Non-paraben Lubricant Gel | |||
| Subject Device | OneTouch TM | ||
| Lubricant Gel | |||
| K142790 | |||
| Predicate Device | Comparison | ||
| Indications for Use | OnetouchTM Non-paraben Lubricant Gel is a personal lubricant, for penile, vaginal and/or anal application, intended to moisturize and lubricate, 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. | OneTouch TM 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. | The indications for use for the subject and predicate devices are not identical, as the subject device is for anal, vaginal, and penile use, while the predicate device is only for vaginal and penile use. The addition of anal use for the subject device does not represent a new intended use, which is the same for both the subject and predicate devices (e.g., to provide lubrication during intimate sexual activity). |
| Base type | Water-based | Water-based | Same |
| Not a contraceptive or Spermicide | Yes | Yes | Same |
| Primary ingredients | - Purified Water |
- Hydroxyethyl cellulose
- Refined Glycerin
- Propane-1,3-diol
- Sodium Benzoate
- PEG-40 Hydrogenated Castor Oil
- Flavor (specific to device versions)
- Pink colorant (specific to colored device version) | - Purified Water
- Hydroxyethyl cellulose
- Refined Glycerin
- Methyl 4-Hydroxybenzoate
- Propyl 4-Hydroxybenzoate
- PEG-40 Hydrogenated Castor Oil
- Flavor (specific to device versions)
- Pink colorant (specific to colored device version) | Different: The subject and predicate devices have different formulations. These differences do not raise different questions of safety and effectiveness (S&E) |
| Rx/OTC | OTC | OTC | |
| Sterile | No | No | Same |
| Appearance | Clear medium viscous gel, free of foreign matter, natural color or pink color depending on device version. | Clear medium viscous gel, free of foreign matter, natural color or pink color depending on device version. | Same |
| Odor | Dependent on version (odorless, cucumber, mixfruit, strawberry, vanilla, mentha piperita, or aloe vera) | Odorless | Different: The subject device includes versions with and without odors, while as versions of the predicate device are stated to be odorless. This difference does not raise different questions of S&E. |
| Flavored Versions | Yes - 7 versions | Yes - 1 version | Different: Both include flavored versions; however, the subject device includes more flavored versions. Differences in flavored versions does not raise different questions of S&E. |
| Viscosity | 9,500 -16,000 cps | 8,000 -20,000cps | Similar |
| Osmolality | 300-600 mOsm/kg (1:8 dilution) | ≤1,200 mOsm/kg | Different: The osmolality specification is not the same as the predicate device. This difference does not raise a different question of S&E. |
| pH | 5.5 - 6.5 | 5.5 - 6.5 | Same |
| Microbial Limits | Total aerobic microbial count: