(383 days)
Not Found
No
The 510(k) summary describes a personal lubricant and does not mention any AI or ML components or functionalities.
No.
A therapeutic device is typically used for the treatment or prevention of a disease, or to affect the structure or function of the body for medical purposes. A personal lubricant, while it enhances comfort and facilitates sexual activity, does not meet the typical definition of a therapeutic device designed for medical treatment or diagnosis.
No
The device is a personal lubricant intended to moisturize and lubricate for comfort during intimate sexual activity, not to diagnose any condition.
No
The device description clearly states it is a liquid personal lubricant, which is a physical substance, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. They are used outside of the body (in vitro) to diagnose, monitor, or screen for diseases or conditions.
- Device Description and Intended Use: The description and intended use of ONE® SILICONE Personal Lubricant clearly state that it is a personal lubricant for penile and/or vaginal application to enhance sexual activity. It is applied to the body, not used to test specimens from the body.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting specific analytes (like proteins, DNA, or chemicals).
- Providing diagnostic information about a disease or condition.
- Using reagents or test kits.
The information provided describes a Class II medical device intended for lubrication during sexual activity, which is a different category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
ONE® SILICONE Personal Lubricant is an over-the-counter personal lubricant.
ONE® SILICONE 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, polyisoprene, and polyurethane condoms.
Product codes (comma separated list FDA assigned to the subject device)
NUC
Device Description
ONE® SILICONE Personal Lubricant is a non-sterile, 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 nor does it contain any spermicidal component. Two forms of packaging are intended. The first primary packaging (having direct contact with product) consists of a plastic packaging. The second primary packaging is foil wrappers.
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
Not Found
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:
Biocompatibility testing was performed in accordance with ISO 10993-1.
| Testing Performed | Results |
|---|---|
| Cytotoxicity | Product is Non-toxic |
| ISO Guinea Pig Maximization Sensitization Test | Product does not elicit a sensitization response |
| Acute Systemic Toxicity | There is no evidence of system toxicity |
| Vaginal Irritation and Systemic Toxicity Study Following Repeated Exposure in Rabbits (The study utilizes FDA recommended alternate design that is a hybrid between ISO Vaginal Irritation test and ISO Acute Systemic Toxicity) | Product produced no macroscopic or microscopic evidence of systemic toxicity and is considered a nonirritant. |
Condom Compatibility:
Compatibility Testing was performed in accordance with ASTM D7661-10, 'Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms' on three marketed brands of Natural Rubber Latex condoms, one brand of Polyisoprene condoms, and one brand of Polyurethane condoms.
The results demonstrated that the condom compatibility testing of the silicone lubricant is compatible with commercially available male condoms made from natural rubber latex, polyurethane, and polyisoprene materials.
Shelf-Life:
ONE® SILICONE Personal Lubricant has a one-year shelf life based on the results of an accelerated aging study. The accelerated aging study evaluated both versions of packaging. The product met specifications.
A real-time aging study is 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
Abbreviated 510(k) Notification for ONE® Personal Lubricant (Silicone)
II. 510(k) Summary
MAR 2 8 2012
| 510(k) SUMMARY | |
|---|---|
| -- | ---------------- |
ONE® 12 Channel Street Boston, MA 02210
Contact Persons:
Submitted by:
Sharon Pietila Regulatory Affairs / Quality Assurance Manager Tel .: 617-946-2800 ext. 15 Fax: 617-946-3246 Email: sharon@globalprotection.com
Davin Wedel President Tel .: 617-946-2800 ext. 14 Fax: 617-946-3246 Email: davin@globalprotection.com
ONE® SILICONE Personal Lubricant
Date Prepared:
March 19, 2012
Personal Lubricant
Propriety Name:
Proposed Trade Name:
Common Name:
Classification Name:
Predicate Device:
Device Description:
Condom Class II (21 CFR §884.5300) NUC
ONE® Personal Lubricant
K-Y Brand Intrigue Personal Products Co. 510(k) No. K062796
ONE® SILICONE Personal Lubricant is a non-sterile, 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 nor does it contain any spermicidal component. Two forms of packaging are intended. The first primary packaging (having direct contact with product) consists of a plastic packaging. The second primary packaging is foil wrappers.
Image /page/0/Picture/20 description: The image shows the word "ONE" in bold, white letters against a black rectangular background with rounded corners. The letters are large and fill most of the rectangle. The letter "E" is slightly stylized, with the horizontal bar in the middle being shorter than the top and bottom bars.
12 Channel Street Boston, MA 02210
1
Abbreviated 510(k) Notification for ONE® Personal Lubricant (Silicone) .
Intended Use:
Indications For Use:
ONE® SILICONE Personal Lubricant is an over-the-counter personal lubricant.
ONE® SILICONE 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, polyisoprene, and polyurethane condoms.
Technological Characteristics:
ONE® SILICONE Personal Lubricant contains a blend of silicone fluid ingredients similar to ingredients found in the predicate device.
Biocompatibility:
Biocompatibility testing was performed in accordance with ISO 10993-1.
| Testing Performed | Results |
|---|---|
| Cytotoxicity | Product is Non-toxic |
| ISO Guinea Pig Maximization Sensitization | |
| Test | Product does not elicit a |
| sensitization response | |
| Acute Systemic Toxicity | There is no evidence of system |
| toxicity | |
| Vaginal Irritation and Systemic Toxicity Study | |
| Following Repeated Exposure in Rabbits | |
| (The study utilizes FDA recommended alternate | |
| design that is a hybrid between ISO Vaginal | |
| Irritation test and ISO Acute Systemic Toxicity) | Product produced no macroscopic or |
| microscopic evidence of systemic | |
| toxicity and is considered a | |
| nonirritant. |
Condom Compatibility:
Compatibility Testing was performed in accordance with ASTM D7661-10, 'Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms' on three marketed brands of Natural Rubber Latex condoms, one brand of Polyisoprene condoms, and one brand of Polyurethane condoms.
The results demonstrated that the condom compatibility testing of the silicone lubricant is compatible with commercially available male condoms made from natural rubber latex, polyurethane, and polyisoprene materials.
Image /page/1/Picture/13 description: The image shows the word "ONE" in bold, white letters against a black, rounded rectangle. The letters are large and fill most of the rectangle's space. The overall design is simple and modern, with a focus on readability and contrast.
12 Channel Street Boston, MA 02210
2
Abbreviated 510(k) Notification for ONE® Personal Lubricant (Silicone)
Shelf-Life:
ONE® SILICONE Personal Lubricant has a one-year shelf life based on the results of an accelerated aging study. The accelerated aging study evaluated both versions of packaging. The product met specifications.
A real-time aging study is being conducted to confirm results of the accelerated aging study.
Image /page/2/Picture/4 description: The image shows the word "ONE" in white letters against a black background. The letters are bold and sans-serif. The black background is a rounded rectangle, and there is a small black dot in the lower right corner of the image.
12 Channel Street Boston, MA 02210
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or body. To the left of the graphic, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.
Public Health Service
MAR 2 8 2012
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Sharon Pietila Regulatory Affairs / Quality Assurance Manager ONE 12 Channel Street BOSTON MA 02210
Re: K110690
Trade/Device Name: ONE® SILICONE Personal Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: March 19, 2012 Received: March 20, 2012
Dear Ms. Pietila:
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
4
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Benjamin K. Eicher
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
5
VII. Indications for Use Statement
Indications for Use
| 510(k) Number: | |
|---|---|
| ---------------- | -- |
Device Name:
ONE® SILICONE Personal Lubricant
Indications For Use:
ONE® SILICONE 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, polyisoprene, and polyurethane condoms.
Prescription Use
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
2 Channel Street oston, MA 02210
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