(270 days)
Not Found
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 device is described as a personal lubricant intended to moisturize and lubricate to enhance the ease and comfort of intimate sexual activity, not to treat or prevent a disease or condition.
No
Explanation: The device is a personal lubricant intended to moisturize and lubricate for comfort during intimate sexual activity. Its function is not to diagnose any condition or disease.
No
The device description clearly indicates the product is a physical substance (lubricant) packaged in bottles and sachets, with specifications related to physical and chemical properties. There is no mention of software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Swiss Navy Premium Lubricants are "personal lubricants 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 describes a device used on the body for physical lubrication, not a device used in vitro (outside the body) to examine specimens for diagnostic purposes.
- Device Description: The description details the physical properties and packaging of the lubricants. It does not mention any components or functions related to analyzing biological samples or providing diagnostic information.
- Performance Studies: The performance studies focus on biocompatibility (cytotoxicity, sensitization, irritation) and condom compatibility, which are relevant to a personal lubricant used on the body. There are no studies related to diagnostic accuracy, sensitivity, specificity, or other metrics typically associated with IVDs.
- Predicate Devices: The predicate devices listed are also personal lubricants (Pjur Original Silicone Lubricant and ID Glide Water-Based Personal Lubricant), further indicating that this device falls within the category of personal lubricants, not IVDs.
IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to diagnose diseases or other conditions. This device's function is entirely external and related to physical lubrication during sexual activity.
N/A
Intended Use / Indications for Use
This 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.
Product codes (comma separated list FDA assigned to the subject device)
NUC
Device Description
Swiss Navy® Premium Silicone Lubricant is a non-sterile, silicone-based personal lubricant for use with or without a condom. It is specifically formulated to be a clear, non-irritating, non-greasy and odorless liquid. This device is not a contraceptive, not does it contain any spermicidal components. Swiss Navy Premium Silicone Lubricant comes packaged in the following configurations: 20 ml square PET mini bottle with an aluminized Mylar seal, 2ounce, 4-ounce, 16-ounce, and 32-ounce PET bottles with a pump. All have the cap or pump shrink-wrapped. The 32-ounce PET size contains a travel cap with an aluminized Mylar induction seal. A pump is included with this size. This product also is packaged in 5-ml foil sachets.
The specifications for this device include color, odor, viscosity, water activity level, total aerobic microbial count, total yeast and mold count, absence of pathogenic organisms, and specific gravity.
Swiss Navy® Premium Water-Based Lubricant is a non-sterile water-based personal lubricant for use with or without a condom. It is clear, non-irritating and non-greasy. It is not a contraceptive, nor does it contain any spermicidal components. Swiss Navy® Premium Water Based into the following configurations: 20 ml square PET mini bottle with ascrew-on cap fitted with an aluminized Mylar seal, 2-ounce, 8-ounce, 16-ounce, and 32-ounce PET bottles with a pump. All have the cap or pump shrink-wrapped. The 32-ounce PET size contains a travel cap with an aluminized Mylar induction seal. A pump is included with this size. This product also is packaged in 5-ml foil sachets.
The specifications for this device include pH, osmolality, color, viscosity, water activity level, total aerobic microbial count, total yeast and mold count, absence of pathogenic organisms, and specific gravity.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
penile and / or vaginal
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 testing was performed on each of this 510(k) in accordance with FDA recognized ISO 10993-1 by independent third-party laboratories.
Testing Performed: Cytotoxicity, Results: Swiss Navy Premium Lubricants were not considered to have a cytotoxic effect based on grading criteria in ISO 10993-5: 2009
Testing Performed: Maximization & Sensitization, Results: Swiss Navy Premium Lubricants do not elicit a sensitization response in guinea pigs according to methods detailed in ISO 10-993-10: 2010
Testing Performed: Acute Systemic Toxicity, Results: There is no evidence of systemic toxicity in mice after being injected with the Swiss Navy Premium Lubricants. This test was performed according to ISO 10993-11: 2006 standards.
Testing Performed: Vaginal Irritation, Results: Results of the testing show that Swiss Navy Premium Lubricants were non-irritating to the vaginal mucosa in female New Zealand White Rabbits utilizing ISO 10993-10 methods
Condom Compatibility:
Testing was performed in accordance with ATM D7661-10, Standard Test Method for Determining Compatibility of Swiss Navy Premium Lubricants with Natural Rubber Latex Condoms" on three marketed brands of Natural Rubber Latex Condoms and one brand of Polyisoprene condoms.
The results of condom compatibility testing demonstrated the Swiss Navy Premium lubricants are compatible with commercially available male condoms made from natural rubber latex and polysoprene materials. This product is not compatible with polyurethane materials.
Shelf Life:
Swiss Navy Premium Lubricants have a 1-year shelf life based on the results of an accelerated aging study. A real-time aging study is presently being conducted to confirm results of the accelerated aging study.
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.
0
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 caduceus, which is a symbol often associated with healthcare. The caduceus is depicted with three intertwined snakes and a pair of wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 20, 2015
Package Solutions LLC Jack Scalisi Director Of Operations 2131 Blount Road Pompano Beach, Florida 33069
Re: K150153
Trade/Device Name: Swiss Navy Premium Silicone Lubricant; Swiss Navy Premium Water Based Lubricant
Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: Class II Product Code: NUC Dated: September 15, 2015 Received: September 16, 2015
Dear Jack Scalisi:
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 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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K150153
Device Name
SWISS NAVY® Premium Silicone Lubricant
Indications for Use (Describe)
This 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.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
3
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K150153
Device Name
SWISS NAVY® Premium Water-Based Lubricant
Indications for Use (Describe)
This 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.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
4
Image /page/4/Picture/0 description: The image is a logo for M.D. Science Lab LLC. The logo features the text "M.D. Science Lab" in a bold, blue font. To the right of the text is a blue caduceus symbol, which is a common symbol for medicine. The letters "LLC" are in the bottom right corner of the caduceus.
| Submitted By: | Package Solutions LLC
2131 Blount Road
Pompano Beach, FL 33069 |
|-----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jack Scalisi,
Director of Operations
Telephone: (954) 725-5502 ext 1312
Fax: (954) 725-6922
Email: jscalisi@mdsciencelab.com |
| Date Prepared: | January 20, 2015 |
| Proprietary Name: | Swiss Navy® Premium Silicone Lubricant
Swiss Navy® Premium Water-Based Lubricant |
| Common Name: | Personal Lubricant |
| Classification Name: | Condom |
| Regulation: | 21 CFR §884.5300 |
| Product Code: | NUC |
| Device Class: | Class II |
| Predicate Device:
Manufacturer
510(k) Number: | Pjur Original Silicone Lubricant (for Swiss Navy® Premium Silicone Lubricant)
Pjur Group, Luxembourg SA
K133233 |
| Predicate Device:
Manufacturer
510(k) Number: | ID Glide Water-Based Personal Lubricant (for Swiss Navy® Premium Water-Based Lubricant)
Westridge Laboratories, Inc
K051295 |
Indications For Use:
The Swiss Navy Premium Lubricants are personal lubricants 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. These products are compatible with natural rubber latex and polyisoprene condoms. These products are not compatible with polyurethane condoms.
Device Description:
Swiss Navy® Premium Silicone Lubricant is a non-sterile, silicone-based personal lubricant for use with or without a condom. It is specifically formulated to be a clear, non-irritating, non-greasy and odorless liquid. This device is not a contraceptive, not does it contain any spermicidal components. Swiss Navy Premium Silicone Lubricant comes packaged in the following configurations: 20 ml square PET mini bottle with an aluminized Mylar seal, 2ounce, 4-ounce, 16-ounce, and 32-ounce PET bottles with a pump. All have the cap or pump shrink-wrapped. The 32-ounce PET size contains a travel cap with an aluminized Mylar induction seal. A pump is included with this size. This product also is packaged in 5-ml foil sachets.
The specifications for this device include color, odor, viscosity, water activity level, total aerobic microbial count, total yeast and mold count, absence of pathogenic organisms, and specific gravity.
Swiss Navy® Premium Water-Based Lubricant is a non-sterile water-based personal lubricant for use with or without a condom. It is clear, non-irritating and non-greasy. It is not a contraceptive, nor does it contain any spermicidal components. Swiss Navy® Premium Water Based into the following configurations: 20 ml square PET mini bottle with ascrew-on cap fitted with an aluminized Mylar seal, 2-ounce, 8-ounce, 16-ounce, and 32-
5
ounce PET bottles with a pump. All have the cap or pump shrink-wrapped. The 32-ounce PET size contains a travel cap with an aluminized Mylar induction seal. A pump is included with this size. This product also is packaged in 5-ml foil sachets.
The specifications for this device include pH, osmolality, color, viscosity, water activity level, total aerobic microbial count, total yeast and mold count, absence of pathogenic organisms, and specific gravity.
Technoloqical Characteristics:
The Swiss Navy® Premium Lubricants have similar technological characteristics to their proposed predicate devices.
Biocompatibility:
Biocompatibility testing was performed on each of this 510(k) in accordance with FDA recognized ISO 10993-1 by independent third-party laboratories.
| Testing Performed | Results |
|---|---|
| Cytotoxicity | Swiss Navy Premium Lubricants were not considered to |
| have a cytotoxic effect based on grading criteria in ISO | |
| 10993-5: 2009 | |
| Maximization & Sensitization | Swiss Navy Premium Lubricants do not elicit a sensitization |
| response in guinea pigs according to methods detailed in ISO | |
| 10-993-10: 2010 | |
| Acute Systemic Toxicity | There is no evidence of systemic toxicity in mice after being |
| injected with the Swiss Navy Premium Lubricants. This test | |
| was performed according to ISO 10993-11: 2006 standards. | |
| Vaginal Irritation | Results of the testing show that Swiss Navy Premium |
| Lubricants were non-irritating to the vaginal mucosa in female | |
| New Zealand White Rabbits utilizing ISO 10993-10 methods |
Condom Compatibility:
Testing was performed in accordance with ATM D7661-10, Standard Test Method for Determining Compatibility of Swiss Navy Premium Lubricants with Natural Rubber Latex Condoms" on three marketed brands of Natural Rubber Latex Condoms and one brand of Polyisoprene condoms.
The results of condom compatibility testing demonstrated the Swiss Navy Premium lubricants are compatible with commercially available male condoms made from natural rubber latex and polysoprene materials. This product is not compatible with polyurethane materials.
Shelf Life:
Swiss Navy Premium Lubricants have a 1-year shelf life based on the results of an accelerated aging study. A real-time aging study is presently being conducted to confirm results of the accelerated aging study.
Conclusion:
Swiss Navy® Premium Lubricants have the same intended use and technological characteristics as the predicate devices. Swiss Navy® Premium Lubricants are substantially equivalent to its proposed predicate devices and are as safe and effective as the predicate devices.