(251 days)
Not Found
No
The 510(k) summary describes a personal lubricant and does not mention any AI or ML technology in its intended use, device description, or performance studies.
No
The device is a personal lubricant intended to enhance comfort during sexual activity, not to treat or prevent a disease or condition.
No
The device is described as a personal lubricant intended to moisturize and lubricate for enhancing sexual activity. It does not mention any function for diagnosis or detection of a disease or condition.
No
The device description clearly states it is a silicone-based personal lubricant, which is a physical substance, not software. The performance studies also focus on biocompatibility and condom compatibility, which are relevant to a physical product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a personal lubricant for penile and/or vaginal application to enhance sexual activity and supplement natural lubrication. This is a topical application for physical comfort and function, not for diagnosing, monitoring, or treating a disease or condition by examining samples from the human body.
- Device Description: The description details a silicone-based personal lubricant. There is no mention of it being used with biological samples (blood, urine, tissue, etc.) or for any diagnostic purpose.
- Performance Studies: The performance studies focus on biocompatibility (cytotoxicity, sensitization, irritation), condom compatibility, and shelf life. These are relevant to a topical personal lubricant, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
In summary, the device's purpose and characteristics align with a personal lubricant, which is a medical device but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
ID® Millennium® 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.
ID® Moments® Silicone 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
ID® Millennium® is non-sterile, an over-the-counter silicone based personal lubricant, formulated to be clear, non-irritating, non-greasy natural and odorless. This device is silicone soluble liquid for use as a personal lubricant. ID® Millennium® Personal Lubricant contains a blend of silicone fluid ingredients similar to ingredients found in the predicate device. ID® Millennium® Personal Lubricant is neither a contraceptive nor a spermicide.
The device is available in the following variant personal lubricant formulas: ID® Millennium® and ID Moments® Silicone.
ID® Millennium® Personal Lubricant is provided in plastic/PET bottles with screw-on cap, flip top closure, pump dispensers, and foils.
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: Testing for cytotoxicity, vaginal irritation, sensitization, and systemic toxicity demonstrate that the device is biocompatible.
- Cytotoxicity (Agar Overlay): The device is not cytotoxic (ISO 10993-5:2009)
- ISO Guinea Pig Maximization Sensitization: The device is non-sensitizing (ISO 10993-10:2010)
- Vaginal Irritation and Systemic Toxicity Study Following Repeated Exposure in Rabbits: The device is not an irritant and not systemically toxic (ISO 10993-10:2010, ISO 10993-11:2006)
Condom Compatibility: Condom Compatibility Testing was performed in accordance with ASTM 7661-10 on major brand name latex, polyurethane, and polyisoprene condoms. The condom compatibility testing demonstrate that ID® Millennium® lubricants are compatible with commercially available male condoms made from natural rubber latex, polyurethane, and polyisoprene materials.
Shelf Life Testing: ID® Millennium Personal Lubricant has three year shelf-life. Retains were obtained and tested per Westridge Laboratories, Inc. specifications.
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 Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three abstract human profiles facing to the right, stacked one behind the other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 9, 2015
Westridge Laboratories, Inc. Albert Rego, Ph.D. Regulatory Consultant 27001 La Paz Road, Suite 312 Mission Vieio. CA 92691
Re: K141767
Trade/Device Name: ID® Millennium®, ID® Moments® Silicone Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: Class II Product Code: NUC Dated: February 21, 2015 Received: February 23, 2015
Dear Albert Rego,
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
Page 2 - Albert Rego, Ph.D.
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
Indications for Use
510(k) Number (if known) K141767
Device Name ID® Millennium® . ID® Moments® Silicone
Indications for Use (Describe)
ID® Millennium® 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.
ID® Moments® Silicone 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.
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)
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3
510(K) Summary
| Submitted by: | Westridge Laboratories, Inc.
1671 E. Saint Andrew Place
Santa Ana, CA 92705-4932 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Robert Grant
Quality & Regulatory Affairs Manager
Tel: (714) 259-9400 Ext. 230
Fax: (714) 259-9550
Email: bGrant@westridgelabs.com |
| Date Prepared: | |
| Propriety Name: | ID® Millennium Personal Lubricant |
| Proposed Trade Name: | ID® Millennium Personal Lubricant |
| Common Name: | Personal Lubricant |
| Classification Name: | Condoms
21 CFR 884.5300 Class II
NUC |
| Predicate Device: | Wet Platinum Premium Lubricant®
510(K) No. (K130012) |
| Device Description: | ID® Millennium® is non-sterile, an over-the-counter silicone based
personal lubricant, formulated to be clear, non-irritating, non-greasy
natural and odorless. This device is silicone soluble liquid for use as a
personal lubricant. ID® Millennium® Personal Lubricant contains a
blend of silicone fluid ingredients similar to ingredients found in the predicate device. ID® Millennium® Personal Lubricant is neither a contraceptive nor a spermicide.
The device is available in the following variant personal lubricant formulas:
ID® Millennium® and ID Moments® Silicone.
ID® Millennium® Personal Lubricant is provided in plastic/PET bottles with screw-on cap, flip top closure, pump dispensers, and foils. |
| Intended Use: | ID® Millennium® Personal Lubricant is non-sterile, over-the-counter
personal lubricant. This device is compatible with natural rubber latex,
polyisoprene, and polyurethane condoms. |
4
510(K) Summary
| Indications for Use: | ID® Millennium®:
ID® Millennium® 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. |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | ID® Moments® Silicone:
ID® Moments® Silicone 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. |
| | ID® Millennium® Personal Lubricant and predicate device have the same
Indications for Use Statement. |
| Technological
Characteristics: | There are no differences in the fundamental technological
characteristics of ID® Millennium ® Personal Lubricant and predicate
Wet Platinum Premium Lubricant®. ID® Millennium® Personal
Lubricant consists mainly of silicone; it contains a blend of silicone fluid
ingredients similar to other lubricants currently on the U.S. markets and
is substantially equivalent to the predicate device. ID® Millennium®
Personal Lubricant formula is neither a contraceptive nor a spermicide. |
BIOCOMPATIBILITY:
As with the predicate, testing for cytotoxicity, vaginal irritation, sensitization, and systemic toxicity demonstrate that the device is biocompatible.
| Testing Performed | Standard Reference # | Results |
|---|---|---|
| Cytotoxicity (Agar Overlay) | ISO 10993-5:2009 | The device is not cytotoxic |
| ISO Guinea Pig Maximization Sensitization | ISO 10993-10:2010 | The device is non-sensitizing |
| Vaginal Irritation and Systemic Toxicity | ||
| Study Following Repeated Exposure in | ||
| Rabbits (The study utilizes FDA | ||
| recommended hybrid ISO Irritation / Acute | ||
| Systemic Toxicity test) | ISO 10993-10:2010 | |
| ISO 10993-11:2006 | The device is not an irritant and not | |
| systemically toxic. |
5
510(K) Summary
| Specifications: | ID® Millennium line of products has the following specifications:
viscosity, specific gravity, appearance, color and odor, absence of
pathogenic organisms (Pseudomonas aeruginosa, Staphylococcus
aureus, and Candida albicans) per USP , total aerobic microbial
count, and total yeast and mold count per USP and , and
water activity test per USP . |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Condom
Compatibility: | Condom Compatibility Testing was performed in accordance with
ASTM 7661-10 on major brand name latex, polyurethane, and
polyisoprene condoms.
The condom compatibility testing demonstrate that ID® Millennium®
lubricants are compatible with commercially available male condoms
made from natural rubber latex, polyurethane, and polyisoprene
materials. |
| Shelf Life Testing: | ID® Millennium Personal Lubricant has three year shelf-life. Retains
were obtained and tested per Westridge Laboratories, Inc.
specifications. |
| Conclusion: | ID® Millennium® Personal Lubricant has the same intended use and
basic technological characteristics as the predicate device and is as safe
and effective as its predicate device. Therefore, ID® Millennium
Personal Lubricant is substantially equivalent to the predicate device. |