(177 days)
Sylk Personal Lubricant is intended for 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 and polyurethane condoms.
Sylk Personal Lubricant is intended 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.
Sylk Personal Lubricant is formulated to be a non-sterile, non-greasy, non-sticky, non-staining, viscous liquid. The device is not a contraceptive and does not contain a spermicide. This device is packaged in 3 ounce tubes. The specifications for the Sylk Personal Lubricant include appearance, odor, pH, viscosity, osmolality, antimicrobial effectiveness, total microbial count, total yeast and mold count, and absence of pathogenic organisms.
The document provided describes the Sylk Personal Lubricant, a device regulated under 21 CFR 884.5300 as a Class II product with the classification name "Condom" and product code NUC. The device is intended for vaginal application to moisturize and lubricate, enhancing the ease and comfort of intimate sexual activity and supplementing natural lubrication. It is also compatible with natural rubber latex, polyisoprene, and polyurethane condoms.
The document does not describe an AI/ML-driven device or a study involving human readers or comparative effectiveness for an AI system. It details the performance testing for a personal lubricant to demonstrate its safety and effectiveness, and substantial equivalence to a predicate device (K124044 - Aloe Cadabra® Personal Lubricant). Therefore, many of the requested elements for an AI study (such as MRMC studies, training set details, expert ground truth establishment, etc.) are not applicable to this document.
However, based on the information provided, here's a breakdown of the acceptance criteria and the studies performed for the Sylk Personal Lubricant:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is not an AI/ML device, the "acceptance criteria" here refer to the successful completion of specific biocompatibility and compatibility tests according to established standards. The "reported device performance" refers to the results of these tests confirming the device meets those standards.
| Acceptance Criterion (Standard Met) | Reported Device Performance |
|---|---|
| Biocompatibility - Cytotoxicity (ISO 10993-5: 2009, MEM Elution Test) | All test method acceptance criteria were met. All results passed from full strength to 1:16 dilution. The product did not demonstrate cytotoxicity. |
| Biocompatibility - Vaginal Irritation (ISO 10993-10: 2010) | None of the control animals had a total score higher than 4 (indicating a valid test). The Irritant Rank Score was 0. Conclusion: Test article classified as a non-irritant. |
| Biocompatibility - Acute Systemic Toxicity (ISO 10993-11: 2010) | The polar extracts did not induce any toxic reaction in investigated mice within an observation period of 72 hours. The apolar extracts did not induce any toxic reaction in investigated mice within an observation period of 72 hours. |
| Biocompatibility - Sensitization (Guinea Pig Maximization Test - GPMT) (ISO 10993-10: 2010) | None of the control animals had a total score higher than 4 (indicating a valid test). The Irritant Rank Score was 0. Conclusion: Test article classified as a non-irritant. |
| Condom Compatibility (ASTM D7661-10: Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms) | Results: Sylk Personal Lubricant was found to be compatible with Natural Rubber Latex, Polyisoprene, and Polyurethane condoms. The specific acceptance criteria within ASTM D7661-10 are not detailed, but the affirmative statement of compatibility implies successful adherence to the standard's requirements (e.g., no degradation of condom material beyond specified limits). |
| Shelf Life | The device maintains its specifications over the duration of its shelf life. Reported Shelf Life: 11 months. |
| Device Specifications (Appearance, odor, pH, viscosity, osmolality, antimicrobial effectiveness, total microbial count, total yeast and mold count, absence of pathogenic organisms) | The document states these specifications include these parameters, and implies they were met, as it concludes the device is safe and effective. However, the specific acceptance ranges/limits and exact performance values for these parameters are not explicitly provided in the summary. |
2. Sample Size Used for the Test Set and Data Provenance
- Cytotoxicity (ISO 10993-5): Not explicitly stated, but typically involves cell monolayers in culture which are tested with extracts.
- Vaginal Irritation (ISO 10993-10): "Control animals" are mentioned, suggesting an animal model. The exact number is not explicitly stated, but common protocols involve a specific number of animals (e.g., rabbits for irritation tests).
- Acute Systemic Toxicity (ISO 10993-11): "Investigated mice" are mentioned. The exact number is not stated, but typically involves groups of mice assigned to control and test articles.
- Guinea Pig Maximization Test (GPMT) (ISO 10993-10): "Control animals" are mentioned, implying a group of guinea pigs. The exact number is not explicitly stated.
- Condom Compatibility (ASTM D7661-10): This standard typically requires a minimum number of condoms to be tested for various properties (e.g., burst pressure, volume). The exact sample size used is not specified in the document.
- Shelf Life: "Real time aging studies" were performed. The sample size or exact protocol detail is not provided.
- Data Provenance: The studies are described as performance data to support a 510(k) submission to the FDA. They were conducted according to ISO (International Organization for Standardization) and ASTM (American Society for Testing and Materials) standards. These are typically prospective studies performed in a controlled laboratory setting. The country of origin for the data is not specified, but given the US FDA submission, it is likely that the testing was performed by accredited labs, potentially in the US or internationally.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable for this type of device and study. The "ground truth" for these performance tests is established by adhering to standardized international test protocols (ISO, ASTM) and observing physical/biological responses, not through expert consensus on images or diagnostic outcomes.
4. Adjudication Method for the Test Set
Not applicable for these types of performance tests. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation or clinical endpoints subject to inter-observer variability. The biocompatibility and compatibility tests rely on objective measurements and observations against pre-defined criteria in the standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, this was not done. MRMC studies are relevant for imaging diagnostics or other clinical decision-making support systems, typically involving human readers. This document describes the performance testing of a physical product (personal lubricant).
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This device is not an algorithm or an AI system.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance in these studies is based on:
- Standardized Test Methods and Criteria: Adherence to established ISO (e.g., ISO 10993 for biocompatibility) and ASTM (e.g., ASTM D7661 for condom compatibility) standards.
- Objective Laboratory Observations and Measurements: Direct observation of cellular responses, animal reactions, or material properties (e.g., lack of cytotoxicity, absence of irritation, no toxic reactions, condom integrity).
- Real-time Aging Data: For shelf-life, the ground truth is derived from the actual performance of the device over time in controlled conditions.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/ML device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 10, 2016
Toro Management LLC DBA Sylk % Jeff Morgan Senior Consultant Opc Services P O Box 818 Ocean Shores, WA 98569
Re: K152646 Trade/Device Name: Sylk Personal Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: Class II Product Code: NUC Dated: February 1, 2016 Received: February 8, 2016
Dear Jeff Morgan,
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) 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,
Herbert P. Lerner -S
for
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
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Indications for Use
510(k) Number (if known) K152646
Device Name Sylk Personal Lubricant
Indications for Use (Describe)
Sylk Personal Lubricant is intended for 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 and 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
March 10, 2016
In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 5 10(k) Summary for the Sylk Personal Lubricant is provided below.
| Device Common Name: | Personal Lubricant |
|---|---|
| Device Proprietary Name: | Sylk Personal Lubricant |
| Submitter: | Toro Management, LLC7272 East Indian School Road, Suite 540,Scottsdale, Arizona 85251 |
| Contact: | Jeff Morgan, Senior ConsultantQPC ServicesPhone: 253.208.3430Email: jmorgan@gpcservices.com |
| Classification Regulation: | 884.5300 |
| Class | Class 2 |
| Classification Name: | Condom |
| Panel: | Obstetrics and Gynecology |
| Product Code: | NUC |
| Predicate Device: | K124044 - Aloe Cadabra® Personal Lubricant - Natural Aloe(Seven Oaks Ranch, Inc. 2658 Channel Drive, Ventura, CA93003) |
Indication for Use:
Sylk Personal Lubricant is intended 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.
Device Description:
Sylk Personal Lubricant is formulated to be a non-sterile, non-greasy, non-sticky, non-staining, viscous liquid. The device is not a contraceptive and does not contain a spermicide. This device is packaged in 3 ounce tubes. The specifications for the Sylk Personal Lubricant include appearance, odor, pH, viscosity, osmolality, antimicrobial effectiveness, total microbial count, total yeast and mold count, and absence of pathogenic organisms.
Performance Data:
Biocompatibility studies including Acute System Toxicity, Vaginal Irritation Testing, Cytotoxicity, and Guinea Pig Maximization Test (GPMT) were performed according to ISO 10993 standards. The test procedures described below were followed without deviation.
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Cytotoxicity:
ISO 10993-5: 2009
The Minimal Essential Media (MEM) Elution test was designed to determine the cytotoxicity of extractable substances. An extract of the test article was added to cell monolayers and incubated. The cell monolayers were examined and scored based on the degree of cellular destruction. All test method acceptance criteria were met. All results passed from full strength to 1:16 dilution. The product did not demonstrate cytotoxicity.
Vaginal Irritation Testing: ISO 10993-10: 2010
None of the control animals had a total score higher than 4, indicating a valid test. The Irritant Rank Score was 0. In conclusion, based on the requirements of this study, the test article was classified as a non-irritant.
ISO 10993-11: 2010 Acute Systemic Toxicity:
The polar extracts of the tested material did not induce any toxic reaction in the investigated mice within an observation period of 72 hours.
The apolar extracts of the tested material did not induce any toxic reaction in the investigated mice within an observation period of 72 hours.
Guinea Pig Maximization Test (GPMT): ISO 1099310: 2010
None of the control animals had a total score higher than 4, indicating a valid test. The Irritant Rank Score was 0. In conclusion, based on the requirements of this study, the test article was classified as a non-irritant.
Shelf Life:
The shelf life of Sylk Personal Lubricant is 11 months. This is based on the results of real time aging studies that demonstrated that the device maintains its specifications over the duration of its shelf life.
Condom Compatibility:
Condom Compatibility was performed using the FDA Recognized Consensus Standard ASTM D7661-10 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. RESULTS: Sylk Personal Lubricant was found to be compatible with Natural Rubber Latex, Polyisoprene and Polyurethane condoms.
Conclusions drawn from Testing Performed:
The device is substantially equivalent to the predicate device, Aloe Cadabra® Personal Lubricant - Natural Aloe and is as safe and effective as the predicate device.
§ 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.