(151 days)
No
The device description and performance studies focus on the physical and chemical properties of a personal lubricant, with no mention of AI or ML technology.
No
A therapeutic device is used to treat, cure, mitigate, or prevent disease. This device is a personal lubricant intended to enhance sexual activity, not for medical treatment.
No
Explanation: The device is described as a personal lubricant intended to moisturize and lubricate for comfort during sexual activity, not to diagnose any condition.
No
The device description clearly states it is a physical product (a lubricant) with a specific formulation and packaging, not a software application.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of OFNat Lubricant (L15) is for personal lubrication during sexual activity. This is a physical function, not a diagnostic one.
- Device Description: The description focuses on its composition and physical properties as a lubricant.
- Lack of Diagnostic Function: There is no mention of the device being used to test a sample (like blood, urine, or tissue) to diagnose a condition, monitor a disease, or screen for a health issue.
- Performance Studies: The performance studies focus on biocompatibility, shelf-life, and condom compatibility, which are relevant to a personal lubricant, not a diagnostic test.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic purposes. OFNat Lubricant (L15) is applied in vivo (on the body) for a non-diagnostic purpose.
N/A
Intended Use / Indications for Use
OFNat Lubricant (L15) is 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 compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
Product codes
NUC
Device Description
OFNat Lubricant (L15) is a non-sterile, water-based personal lubricant for vaginal and penile application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This device is compatible with natural rubber latex and polyisoprene condoms and is not compatible with polyurethane condoms.
Its formulation consists of water (aqua), propanediol, okra extract, hydroxyethylcellulose, sodium lactate, benzoic acid, and flaxseed gum.
OFNat Lubricant (L15) is sold as an over-the-counter (OTC) product and is packaged in 80 ml black HDPE bottle and 5 ml sachet.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vaginal and penile
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:
- Study Type: Biocompatibility testing
- Key Results: 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." Tested for Cytotoxicity (ISO 10993-5:2009), Sensitization (ISO 10993-10:2010), Vaginal Irritation (ISO 10993-10:2010), and Acute Systemic Toxicity (ISO 10993-11:2017). The results of testing support the biocompatibility of the device materials.
Shelf-Life:
- Study Type: Shelf-life study
- Key Results: The subject device has a shelf-life of 17 months. Results from accelerated aging demonstrated that the device maintains its specifications (as shown in Table 1) over the duration of its shelf-life.
Condom Compatibility:
- Study Type: Condom compatibility testing
- Key Results: 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 showed OFNat Lubricant (L15) to be compatible with natural rubber latex and polyisoprene condoms. OFNat Lubricant (L15) is not compatible with polyurethane condoms.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Viscosity (per USP): 2,200 – 3,500 cps
- pH (per USP): 3.8 – 4.5
- Osmolality (per USP): 3,100 – 4,100 mOsm/kg
- Total Aerobic Microbial Count (TAMC, per USP ): ): ): Meets USP criteria for category 2. No less than 2.0 log reduction from initial count at 14 days and no increase from the 14-day count at 28 days for Bacteria. No increase from the initial calculated count at 14 and 28 days for Yeast and Molds.
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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September 30, 2022
Suretex Limited % Carole C. Carey Senior Consultant C3-Carey Consultants, LLC 9451 Ellsworth Court Fulton, MD 20759
Re: K221243 Trade/Device Name: OFNat Lubricant (L15) Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: August 31, 2022 Received: September 1, 2022
Dear Carole C. Carey:
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) K221243
Device Name OFNat Lubricant (L15)
Indications for Use (Describe)
OFNat Lubricant (L15) is 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 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)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary K221243 OFNat Lubricant (L15)
1. Submitter Information
Applicant: Suretex Limited Contact: KC Nguyen, Vice President, R&D, QA and RA Address: 31/1 Moo 4, Suratthani-Thakuapha Road Tambon Khao Hua Kwai, Amphur Phunphin Suratthani 84130 Thailand Phone: +66 77 277 400 Email: kc.nguyen@lifestyles.com
2. Correspondent Information
Correspondent firm: C3-Carey Consultants, LLC Contact: Carole Carey Address: 9451 Ellsworth Court, Fulton, MD 20759 USA Phone: (301) 395-2249 Email: carolecarey@mac.com
3. Date prepared: September 27, 2022
4. Subject Device Information
Device Trade Name: OFNat Lubricant (L15) Common Name: Personal Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Product Code: NUC (lubricant, personal) Device Class: Class II
5. Predicate Device Information
Device Name: Lifestyles Natural Personal Lubricant 510(k) Number: K122054 Manufacturer: Ansell Healthcare Products LLC
The predicate device has not been subject to a design-related recall.
6. Device Description
OFNat Lubricant (L15) is a non-sterile, water-based personal lubricant for vaginal and penile application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This device is compatible with natural rubber latex and polyisoprene condoms and is not compatible with polyurethane condoms.
Its formulation consists of water (aqua), propanediol, okra extract, hydroxyethylcellulose, sodium lactate, benzoic acid, and flaxseed gum.
OFNat Lubricant (L15) is sold as an over-the-counter (OTC) product and is packaged in 80 ml black HDPE bottle and 5 ml sachet.
Device specifications for the OFNat Lubricant (L15) are listed in Table 1.
4
| Property | Specification |
|---|---|
| Appearance | Semi-Viscous liquid |
| Color | Clear |
| Odor | Odorless |
| Viscosity (per USP) | 2,200 – 3,500 cps |
| pH (per USP) | 3.8 – 4.5 |
| Osmolality (per USP) | 3,100 – 4,100 mOsm/kg |
| Total Aerobic Microbial Count (TAMC, per USP ) | ) |
| Pseudomonas aeruginosa | Absent |
| Staphylococcus aureus | Absent |
| Candida albicans | Absent |
| Escherichia coli | Absent |
| Salmonella spp. | Absent |
| Clostridia spp | Absent |
| Antimicrobial Effectiveness Testing (per USP ) | Specification |
| Bacteria | Meets USP criteria for category 2. |
| No less than 2.0 log reduction from initial count at 14 days and no increase from the 14-day count at 28 days | |
| Yeast and Molds | No increase from the initial calculated count at 14 and 28 days |
Table 1: Device Specifications for OFNat Lubricant (L15)
7. Indications for Use
OFNat Lubricant (L15) is 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 compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
8. 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.
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Table 2: Intended Use and Technological Characteristics Comparison of the Subject and Predicate Device
| | OFNat Lubricant (L15)
K221243
Subject Device | LifeStyles® Natural Personal
Lubricant
K122054
Predicate Device |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | OFNat Lubricant (L15) is 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 compatible
with natural rubber latex and
polyisoprene condoms. This product is
not compatible with polyurethane
condoms. | Lifestyles(r) natural 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. |
| Base type | Water | Water |
| Primary ingredients | Water (Aqua), Propanediol, Okra
Extract, Hydroxyethylcellulose, Sodium
Lactate, Benzoic Acid, Flaxseed Gum | Water (Aqua), Glycerin, Xanthan
Gum, Sodium Hyaluronate, Potassium
Sorbate, Sorbic Acid, Sodium
Chloride |
| Rx/OTC | OTC | OTC |
| Sterile | No | No |
| Appearance | Semi-Viscous liquid | -- |
| Color | Clear | -- |
| Odor | Odorless | -- |
| Viscosity | 2,200 – 3,500 cps | -- |
| pH | 3.8 – 4.5 | -- |
| Osmolality | 3,100 – 4,100 mOsm/Kg | -- |
| Total Aerobic Microbial
count (TAMC) |