(261 days)
Vielle™ personal lubricant is intended for personal lubrication, lubrication of a body orifice to facilitate use of diagnostic or therapeutic, to enhance condom use and for vaginal use.
Vielle™ is a clear, water-soluble, silicone based gel. No fragrances or petroleum-based chemicals are used in the formulation.
The provided text describes the 510(k) summary for a personal lubricant, Vielle™ Lubricant, and focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific quantitative acceptance criteria in a typical AI/software medical device context.
Therefore, many of the requested sections regarding AI/software studies (like sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, etc.) are not applicable to this type of device submission.
However, I can extract the relevant information regarding the device's characteristics and the non-clinical testing performed to establish its substantial equivalence.
Here's the breakdown of what is available in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
For this device, "acceptance criteria" are implied by the characteristics of the predicate devices and the non-clinical tests performed to demonstrate similar safety and effectiveness. There are no explicit numerical acceptance criteria for a lubricant's performance, but rather characteristics and test results showing its safety and compatibility.
| Characteristic / Test | Acceptance Criteria (Implied by Predicate & Standards) | Vielle™ Lubricant Reported Performance |
|---|---|---|
| Common Name | Lubricant | Lubricant |
| Product Code | 80 MMS | 80 MMS |
| Intended Use | Personal lubrication, diagnostic/therapeutic use, condom compatibility, vaginal use | Personal lubrication, diagnostic/therapeutic use, condom compatibility, vaginal use |
| Over the Counter Use | Yes | Yes |
| Water-soluble | Yes | Yes |
| Contains Preservatives | Not required if inert & cannot support microbial contamination | No - Product is inert & cannot support Microbial contamination |
| Latex compatible Tested | Yes (to show compatibility with condoms) | Yes |
| Biocompatibility Tested | Yes (irritation and sensitization) | Yes |
| Antimicrobial Tested | Yes | Yes |
| Sterile | No (for similar non-sterile personal lubricants) | No |
| Chemical Composition | Water-soluble, silicone-based gel, no fragrances or petroleum-based chemicals | Clear, water-soluble, silicone based gel. No fragrances or petroleum-based chemicals. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified for any of the non-clinical tests (e.g., how many condoms were tested for compatibility, or how many tests for biocompatibility).
- Data Provenance: Not explicitly stated, but the submission is from the UK (CST Medical Ltd, Antrobus House, Petersfield, Hants, GU31 4AD UK). The non-clinical testing was likely conducted in accordance with relevant standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This is a physical device (lubricant) and not an AI/software device that requires expert ground truth for interpretation or classification. The "ground truth" for its properties would be established via standard laboratory testing and compliance with relevant ASTM, ISO, or other recognized standards.
4. Adjudication Method for the Test Set
- Not Applicable. As above, this is for physical device testing, not for expert consensus or image interpretation.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
- No. This type of study is specifically for evaluating the effectiveness of a diagnostic or interpretive AI/software system with human readers. It is not relevant for a personal lubricant.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is for AI/software algorithms.
7. The Type of Ground Truth Used
- The "ground truth" for the device's properties (e.g., water-soluble, latex compatible, biocompatible) would have been established through laboratory testing according to recognized industry standards (e.g., ISO, ASTM for condom compatibility and biocompatibility) for physical and chemical properties.
8. The Sample Size for the Training Set
- Not Applicable. This refers to AI/machine learning models, which are not involved in this device submission.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As above.
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FEB 3 2006
510K Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92
- 1 . Submitters Identification: CST Medical Ltd Antrobus House 18 College Street Petersfield Hants GU31 4AD UK
Contact Person: John Adcock Regulatory Specialist
Date of Summary: May 5, 2005
- Device Name: Vielle™ Lubricant 2.
- Classification Name: Lubricant (21 CFR 884.5300) ని.
-
- Predicate Device: Instead, Inc. Instead Intimate Lubricant K033776 Personal Lubricating Gel Qualis, Inc. K04129
5. Intended Use: Vielle™ personal lubricant is intended for personal lubrication, lubrication of a body orifice to facilitate use of diagnostic or therapeutic, to enhance condom use and for vaginal use.
-
- Device Description/Comparison: Vielle™ is a clear, water-soluble, silicone based gel. No fragrances or petroleum-based chemicals are used in the formulation.
A comparison of technological characteristics of the CST lubricant with predicate devices substantiates the substantial equivalence of the Vielle™ Lubricant to the predicate devices.
- Device Description/Comparison: Vielle™ is a clear, water-soluble, silicone based gel. No fragrances or petroleum-based chemicals are used in the formulation.
| CST MedicalVielle™ Lubricant | Instead, IncInstead IntimateLubricant | Qualis, Inc.PersonalLubricating Gel | |
|---|---|---|---|
| Common Name | Lubricant | Lubricant | Lubricant |
| Product Code | 80 MMS | 80 MMS | 80 MMS |
| Intended Use | Personal | Personal | Personal |
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K051288
Page 2 of 2
| Lubricating Gel | Lubricating Gel | Lubricating Gel | |
|---|---|---|---|
| Indications for use | VielleTM personallubricant isintended forpersonallubrication,lubrication of abody orifice tofacilitate use ofdiagnostic ortherapeutic, toenhance condomuse and for vaginaluse.. | PersonalLubricating Gel isdesigned toenhance the easeand comfort ofintimate activityand is compatiblewith latexcondoms. | PersonalLubricating Gel isdesigned toenhance the easeand comfort ofintimate activityand is compatiblewith latexcondoms. |
| Over the Counter Use | YES | YES | YES |
| Water-soluble | YES | YES | YES |
| ContainsPreservatives | NO-Product is inert& cannot supportMicrobialcontamination. | YES | YES |
| Latex compatibleTested | YES | YES | YES |
| BiocompatibilityTested | YES | YES | YES |
| Antimicrobial Tested | YES | YES | YES |
| Sterile | NO | NO | NO |
Non-clinical testing of the Vielle™ Lubricant included compatibility
testing with condoms and biocompatibility testing for irritation and
sensitization.
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Image /page/2/Picture/1 description: The image shows a logo with a circular border containing text, and an abstract bird-like figure in the center. The text around the border is not clearly legible, but it appears to be part of an official seal or emblem. The bird figure is stylized with thick, curved lines, giving it a sense of motion or flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 3 2006
CST Medical Ltd. c/o Mr. E. J. Smith E.J. Smith Associates 1676 Village Green, Suite A CROFTON MD 21114
Re: K051288 Trade/Device Name: Vielle™ Lubricant Regulation Number: 21 CFR §884.5300 Regulation Name: Condom Product Code: HIS Regulation Number: 21 CFR §880.6375 Regulation Name: Patient lubricant Product Code: KMJ Regulatory Class: II
Dated: January 5, 2006 Received: January 9, 2006
Dear Mr. Smith:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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); 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) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your 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 contact the Office of Compliance at one of the following numbers, 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 premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
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):
Device Name: Vielle™ Lubricant
Classification Panel: 880.6375
Indications for Use:
Vielle™ personal lubricant is intended for personal lubrication, lubrication of a body orifice to facilitate use of diagnostic or therapeutic, to enhance condom use and for vaginal use.
Prescription Use (Part 21 CFR 801 Subpart D) And/Or
Over the Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy Brogdon
Page 1 of
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. K051288
§ 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.