(151 days)
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.
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.
This document describes the OFNat Lubricant (L15) device, a personal lubricant. It primarily focuses on demonstrating substantial equivalence to a predicate device, as required for 510(k) clearance by the FDA. The information provided is characteristic of a regulatory submission rather than a clinical study report. Therefore, some of the requested data points (like expert qualifications, adjudication methods, MRMC studies, or training set details) are not typically included in such documents and are absent here.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are described as "Specifications" in "Table 1: Device Specifications for OFNat Lubricant (L15)". The reported device performance is indicated by the statement that "the device maintains its specifications (as shown in Table 1) over the duration of its shelf-life" based on accelerated aging results.
| Property | Acceptance Criteria (Specification) | Reported Device Performance |
|---|---|---|
| Appearance | Semi-Viscous liquid | Maintained specification (implied by shelf-life study) |
| Color | Clear | Maintained specification (implied by shelf-life study) |
| Odor | Odorless | Maintained specification (implied by shelf-life study) |
| Viscosity (per USP<911>) | 2,200 – 3,500 cps | Maintained specification (implied by shelf-life study) |
| pH (per USP<791>) | 3.8 – 4.5 | Maintained specification (implied by shelf-life study) |
| Osmolality (per USP<785>) | 3,100 – 4,100 mOsm/kg | Maintained specification (implied by shelf-life study) |
| Total Aerobic Microbial Count (TAMC, per USP <61>) | <100 cfu/g | Maintained specification (implied by shelf-life study) |
| Total Yeast and Mold Count (TYMC, per USP <61>) | <10 cfu/g | Maintained specification (implied by shelf-life study) |
| Presence of Pathogens (per USP <62>): | ||
| Pseudomonas aeruginosa | Absent | Maintained specification (implied by shelf-life study) |
| Staphylococcus aureus | Absent | Maintained specification (implied by shelf-life study) |
| Candida albicans | Absent | Maintained specification (implied by shelf-life study) |
| Escherichia coli | Absent | Maintained specification (implied by shelf-life study) |
| Salmonella spp. | Absent | Maintained specification (implied by shelf-life study) |
| Clostridia spp | Absent | Maintained specification (implied by shelf-life study) |
| Antimicrobial Effectiveness Testing (per USP <51>): | ||
| Bacteria | Meets USP <51> 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 | Maintained specification (implied by shelf-life study) |
| Yeast and Molds | No increase from the initial calculated count at 14 and 28 days | Maintained specification (implied by shelf-life study) |
| Biocompatibility | Meets ISO 10993 standards (Cytotoxicity, Sensitization, Vaginal Irritation, Acute Systemic Toxicity) | Supports the biocompatibility of the device materials (conclusion of testing) |
| 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 (conclusion of testing per ASTM D7661-10(R) 2017) |
| Shelf-Life | 17 months, maintaining all specifications in Table 1. | Achieved 17 months, maintaining specifications through accelerated aging. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify exact sample sizes for each test (e.g., how many batches were tested for viscosity, how many animals for biocompatibility). The studies are non-clinical (laboratory and in-vitro, with some in-vivo for biocompatibility) and relate to product quality and safety, not clinical efficacy in humans.
- Test Set Sample Size: Not explicitly stated for individual tests.
- Data Provenance: The testing appears to be conducted by the manufacturer as part of their regulatory submission. The country of origin for the data (where the tests were physically performed) is not specified, but the applicant (Suretex Limited) is in Thailand. The testing is prospective in the sense that it was conducted specifically to support this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided. For non-clinical tests like those described (e.g., viscosity, pH, microbial counts, biocompatibility), the "ground truth" is typically established by validated laboratory methods and adherence to international standards rather than expert consensus on interpretations of complex medical images or diagnoses.
4. Adjudication Method for the Test Set
Not applicable. This device is a personal lubricant, and the testing involves laboratory measurements and standard biological assays rather than human interpretation or adjudication of results in the way one might for diagnostic AI.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. Such studies are typically for diagnostic devices, especially those involving human interpretation of imaging, to assess reader performance with and without an AI aid. This device is not a diagnostic AI.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
Not applicable. This device is a physical product (personal lubricant), not an algorithm or AI. All performance tests are considered "standalone" in the sense that they evaluate the product itself against set specifications.
7. The Type of Ground Truth Used
The ground truth for the non-clinical tests is based on:
- Established laboratory measurement standards: e.g., USP <911> for Viscosity, USP <791> for pH, USP <785> for Osmolality, USP <61> for Microbial Counts, USP <62> for Pathogen Presence, USP <51> for Antimicrobial Effectiveness.
- International biocompatibility standards: ISO 10993 series for Cytotoxicity, Sensitization, Vaginal Irritation, and Acute Systemic Toxicity.
- Condom compatibility standard: ASTM D7661-10(R) 2017.
- Manufacturer's defined specifications: for properties like appearance, color, and odor, which are then verified through testing.
8. The Sample Size for the Training Set
Not applicable. There is no concept of a "training set" for this type of device (a physical personal lubricant). The manufacturing process and formulation development might involve iterative testing, but this is not analogous to training an AI algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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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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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.
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| Property | Specification |
|---|---|
| Appearance | Semi-Viscous liquid |
| Color | Clear |
| Odor | Odorless |
| Viscosity (per USP<911>) | 2,200 – 3,500 cps |
| pH (per USP<791>) | 3.8 – 4.5 |
| Osmolality (per USP<785>) | 3,100 – 4,100 mOsm/kg |
| Total Aerobic Microbial Count (TAMC, per USP <61>) | <100 cfu/g |
| Total Yeast and Mold Count (TYMC, per USP <61>) | <10 cfu/g |
| Presence of Pathogens (per USP <62>) | Specification |
| Pseudomonas aeruginosa | Absent |
| Staphylococcus aureus | Absent |
| Candida albicans | Absent |
| Escherichia coli | Absent |
| Salmonella spp. | Absent |
| Clostridia spp | Absent |
| Antimicrobial Effectiveness Testing (per USP <51>) | Specification |
| Bacteria | Meets USP <51> 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)K221243Subject Device | LifeStyles® Natural PersonalLubricantK122054Predicate Device | |
|---|---|---|
| Indications for Use | OFNat Lubricant (L15) is a personallubricant for vaginal and penileapplication, intended to moisturize andlubricate, to enhance the ease andcomfort of intimate sexual activity andsupplement the body's naturallubrication. This product is compatiblewith natural rubber latex andpolyisoprene condoms. This product isnot compatible with polyurethanecondoms. | Lifestyles(r) natural personal lubricantis a personal lubricant, for penileand/or vaginal application, intended tomoisturize and lubricate, to enhancethe ease and comfort of intimatesexual activity and supplement thebody's natural lubrication. Thisproduct is compatible with naturalrubber latex, polyurethane, andpolyisoprene condoms. |
| Base type | Water | Water |
| Primary ingredients | Water (Aqua), Propanediol, OkraExtract, Hydroxyethylcellulose, SodiumLactate, Benzoic Acid, Flaxseed Gum | Water (Aqua), Glycerin, XanthanGum, Sodium Hyaluronate, PotassiumSorbate, Sorbic Acid, SodiumChloride |
| 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 Microbialcount (TAMC) | <100 cfu/g | -- |
| Total Yeast and Mold Count(TYMC) | <10 cfu/g | -- |
| Absence of PathogenicOrganisms | Yes | Yes |
| Antimicrobial EffectivenessTested | Yes | Yes |
| Condom Compatibility | Compatible with natural rubber latex andpolyisoprene condoms | Compatible with natural rubber latex,polyisoprene, and polyurethanecondoms |
| Biocompatibility Tested | Yes | Yes |
| Shelf life | 17 months | 36 months |
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The subject and predicate device indications for use and intended use are the same. The subject and predicate device have different technological characteristics, including formulations, shelf-life, and condom compatibility. The differences in technological characteristics between the subject and predicate devices do not raise different questions of safety and effectiveness.
9. Summary of Non-Clinical Performance Testing
Biocompatibility
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)
- Sensitization (ISO 10993-10:2010) ●
- Vaginal Irritation (ISO 10993-10:2010) ●
- Acute Systemic Toxicity (ISO 10993-11:2017) ●
The results of testing support the biocompatibility of the device materials.
Shelf-Life
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
The compatibility of OFNat Lubricant (L15) 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 this test showed OFNat Lubricant (L15) to be compatible with natural rubber latex and polyisoprene condoms. OFNat Lubricant (L15) is not compatible with polvurethane condoms.
10. Conclusion
The results of the performance testing described above demonstrate that OFNat Lubricant (L15) is as safe and effective as the predicate device and supports a determination of substantial equivalence.
§ 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.