(177 days)
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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.
The product is a personal lubricant intended to moisturize and lubricate for comfort during intimacy, not to treat or cure a medical condition.
No
Explanation: The device is 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 "viscous liquid" and describes physical and chemical properties, indicating it is a physical product, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that Sylk Personal Lubricant is 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 is a direct application to the body for a physical effect (lubrication and comfort).
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro (outside the body) for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description: The device description focuses on the physical properties of the lubricant (non-sterile, non-greasy, etc.) and its composition, not on analyzing biological samples.
- Performance Studies: The performance studies are related to biocompatibility and shelf life, which are relevant for a device applied to the body, not for diagnostic accuracy.
The information provided clearly indicates that Sylk Personal Lubricant is a topical medical device intended for physical lubrication, not for analyzing biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
NUC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility studies including Acute System Toxicity, Vaginal Irritation Testing, Cytotoxicity, and Guinea Pig Maximization Test (GPMT) were performed according to ISO 10993 standards.
Cytotoxicity: The Minimal Essential Media (MEM) Elution test was designed to determine the cytotoxicity of extractable substances. 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: The Irritant Rank Score was 0. The test article was classified as a non-irritant.
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): The Irritant Rank Score was 0. 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. Sylk Personal Lubricant was found to be compatible with Natural Rubber Latex, Polyisoprene and Polyurethane condoms.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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 features a stylized depiction of an eagle or bird-like figure with three heads, representing the department's focus on health, human services, and the well-being of the population. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
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
1
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, LLC |
| 7272 East Indian School Road, Suite 540, | |
| Scottsdale, Arizona 85251 | |
| Contact: | Jeff Morgan, Senior Consultant |
| QPC Services | |
| Phone: 253.208.3430 | |
| Email: 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, CA |
- |
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.