(273 days)
I-D Glide lubricant is intended enhance the comfort and ease of intimate activity and is compatible with latex and polyurethane condoms.
Personal lubricant for penile and vaginal use only. Compatible with latex and polyurethane condoms.
I-D Glide Personal lubricant is a water-based non-sterile personal lubricant containing purified water, glycerin, propylene glycol, cellulose polymer, PEG 90m, Carbomer 981, various antifungal preservatives, pH adjuster, and chelating agent.
This document is a 510(k) summary for the I-D Glide Lubricant, indicating it is a premarket notification to the FDA to demonstrate substantial equivalence to legally marketed predicate devices. The document does not describe a study with acceptance criteria and device performance in the way typically associated with medical imaging or diagnostic AI. Instead, it demonstrates equivalence through a comparison of product characteristics and intended use.
Here's an analysis based on the provided text, addressing the points where information is available and noting where it's not:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative performance metric sense (e.g., sensitivity, specificity, AUC). Instead, the "acceptance criteria" can be inferred as satisfying the characteristics of the predicate devices. The "reported device performance" is the device's characteristics aligning with those of the predicates.
| Characteristic | "Acceptance Criteria" (Predicate Devices) | Reported Device Performance (I-D Glide) |
|---|---|---|
| Common Name: Lubricant | Yes (for both predicates) | Yes |
| Product Code: 80 MMS | Yes (for both predicates) | Yes |
| Intended Use: Enhance ease and comfort of intimate activity, compatible with latex condoms | Yes (for both predicates) | Yes |
| Over the Counter Use | Yes (for both predicates) | Yes |
| Water-soluble | Yes (for both predicates) | Yes |
| Contains purified water | Yes (for both predicates) | Yes |
| Contains Preservatives | Yes (for both predicates) | Yes |
| Biocompatibility Tested | Yes (for both predicates) | Yes |
| Antimicrobial Tested | Yes (for Instead Intimate) / No (for Personal Lubricating Gel) | Yes |
Note: The I-D Glide exceeds one predicate (Qualis, Inc.'s Personal Lubricating Gel) by being "Antimicrobial Tested" while still being substantially equivalent to the other predicate (Instead, Inc's Instead Intimate Lubricant) which is also antimicrobial tested.
2. Sample size used for the test set and the data provenance
This is not applicable as this is a comparison to predicate devices based on product characteristics and general testing (biocompatibility, antimicrobial), not a clinical study with a "test set" in the context of an AI device's performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable. The "ground truth" here is the established characteristics and testing performed on the predicate devices and the new device, not expert interpretation of data.
4. Adjudication method for the test set
This is not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. This document pertains to a personal lubricant, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as this is not an algorithm or AI device.
7. The type of ground truth used
The "ground truth" used for this submission is based on the characteristics and testing performed on the device itself (I-D Glide) and the established characteristics and testing of the predicate devices (Instead Intimate Lubricant and Qualis Personal Lubricating Gel). This includes:
- Intended Use: As defined by the manufacturer and accepted by the FDA for similar products.
- Compositional Analysis: Listing of ingredients.
- Physical Properties: Water-solubility.
- Safety Testing: Biocompatibility testing, antimicrobial testing.
8. The sample size for the training set
This is not applicable. There is no AI model or "training set" for a personal lubricant.
9. How the ground truth for the training set was established
This is not applicable.
Summary of Device Meeting Acceptance Criteria:
The device, I-D Glide Lubricant, meets the inferred acceptance criteria by demonstrating substantial equivalence to two legally marketed predicate devices (Instead, Inc.'s Instead Intimate Lubricant and Qualis, Inc.'s Personal Lubricating Gel). This is "proven" by a detailed comparison table showing that I-D Glide shares the same common name, product code, intended use, over-the-counter status, water-solubility, presence of purified water and preservatives, and has undergone biocompatibility testing, just like the predicate devices. Furthermore, I-D Glide also underwent antimicrobial testing, aligning with one predicate and exceeding the other, thus not raising new questions of safety or effectiveness. The FDA's 510(k) clearance letter (K051295) confirms that the FDA reviewed the submission and determined the device is substantially equivalent to the predicates for its stated indications for use.
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FEB 1 5 2006
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
The assigned 510(k) number is: KO5/295
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- Submitter's Identification:
Westridge Laboratories, Inc. 1671 Saint Andrew Place Santa Ana, CA 92705 Telephone: (714) 259-9400 Fax: (714) 259-9401
- Submitter's Identification:
Contact Person: Gregg Haskell, President
Date of Summary: May 12, 2005
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- Device Name: I-D Glide
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- Classification Name: Lubricant
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- Substantial Equivalence Statement: This product is similar in design, intended use and function to many other lubricants on the market. Section 5 contains a comparison of I-D Glide Personal Lubricant with Instead, Inc's Instead Intimate Lubricant and Qualis, Inc.'s Personal Lubricating Gel.
| Company | Product | 510(k) # |
|---|---|---|
| Instead, Inc. | Instead Intimate Lubricant | K033776 |
| Qualis, Inc. | Personal Lubricating Gel | K041129 |
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- Intended Use: I-D Glide lubricant is intended enhance the comfort and ease of intimate activity and is compatible with latex and polyurethane condoms.
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- Device Description: I-D Glide Personal lubricant is a water-based non-sterile personal lubricant containing purified water, glycerin, propylene glycol, cellulose polymer, PEG 90m, Carbomer 981, various antifungal preservatives, pH adjuster, and chelating agent.
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- Predicate Product Comparison:
| WestridgeLaboratories, Inc.I-D Glide | Instead, IncInstead IntimateLubricant | Qualis, Inc.PersonalLubricating Gel | |
|---|---|---|---|
| Common Name | Lubricant | Lubricant | Lubricant |
| Product Code | 80 MMS | 80 MMS | 80 MMS |
| Intended Use | PersonalLubricating Gel isdesigned to enhancethe ease andcomfort of intimateactivity and iscompatible withlatex condoms. | PersonalLubricating Gel isdesigned to enhancethe ease andcomfort of intimateactivity and iscompatible withlatex condoms. | PersonalLubricating Gel isdesigned to enhancethe ease andcomfort of intimateactivity and iscompatible withlatex condoms. |
| Over the Counter Use | YES | YES | YES |
| Water-soluble | YES | YES | YES |
| Contains purifiedwater | YES | YES | YES |
| ContainsPreservatives | YES | YES | YES |
| BiocompatibilityTested | YES | YES | YES |
| Antimicrobial Tested | YES | YES | NO |
Product comparison chart shows that the Westridge Laboratories, Inc.'s I -D Giide is Product comparison chart shows that the 1. Instead Intimate Lubricant and Qualis equivatent to the I rodicate Products (instituted use and design. Westridge Laboratories, Inc.
Inc., Personal Lubricating Gel) in intended use and designed of Sating associa Inc, Fersonal Eubricating Oor) in mendous as oncerns of safety and effectiveness.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. 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 image of an eagle with three lines representing its wings and body. The eagle is facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 5 2006
Westridge Laboratories, Inc. % Albert Rego, Ph.D. Scientific Consultant 27001 La Paz Road, Suite 314 MISSION VIEJO CA 92691
Re: K051295
Trade/Device Name: I-D Glide I ubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: January 20, 2006 Received: January 20, 2006
Dear Dr. 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 the enerobate) to regary ment date of the Medical Device Amendments, or to devices that have been rear 20, 1978, ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . do not require approval of a premarket approval application (PMA). You may, therefore, market the do not require upproval on a 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket 11 your ab, it may be subject to such additional controls. Existing major regulations affecting your Applorary, It also be rederal 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 docs 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 r odvards and regulirements, including, but not limited to registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.
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This letter will allow you to begin marketing your device as described in your Section 510(k) i his letter will anow you to ocgin hanceing your antial equivalence of your device to a legally premarket nothication: "The PDA mainly of backannal vour device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire spective advice for your device on our laboring - based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to promatics that from the Also, please note the regulation chitted, "Thisotananages on your responsibilities under the Act from the 190 807.97). You may obtain other general information on your copy and its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Nancy C. Higdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K051295
Device Name: I-D Glide Lubricant
Indications For Use: Personal lubricant for penile and vaginal use only. Compatible with latex and polyurethane condoms.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ X _____________________________________________________________________________________________________________________________________________________ (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)
Nancy C. Brogdon
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device
510(k) Number K051295
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
§ 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.