(245 days)
Not Found
No
The device description lists chemical ingredients and a plastic bottle, with no mention of software, algorithms, or data processing. The intended use is purely for lubrication.
No.
The intended uses are for lubrication, moisturizing, and enhancing condom use and intimate activity, none of which are considered therapeutic.
No
The intended use describes lubrication for personal comfort, to facilitate entry of other devices, and to enhance intimate activity. It does not mention diagnosing any condition.
No
The device description clearly states it is a physical product (lubricant) in a plastic bottle, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are for personal lubrication, facilitating entry of devices, moisturizing vaginal dryness, and enhancing intimate activity. None of these involve testing samples taken from the human body to diagnose a condition or provide information about a physiological state.
- Device Description: The description details the composition and packaging of a lubricant. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD-specific information: The document lacks information typically found in submissions for IVD devices, such as details about sample types, analytical methods, performance characteristics related to diagnostic accuracy (sensitivity, specificity, etc.), or training/test sets for algorithms (which are not present anyway).
Therefore, "CVS Personal Lubricant" falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Personal lubrication and lubrication of a body orifice to facilitate entry of a diagnostic or therapeutic device, as a moisturizer for vaginal dryness, and to enhance condom use and the ease of intimate activity.
Product codes (comma separated list FDA assigned to the subject device)
85 HIS
Device Description
"CVS Personal Lubricant" is a clear , colorless and odorless personal lubricant, which is composed of the following ingredients; Purified Water, Glycerin, Propylene Glycol, Polyquaternium #5, Methyparaben and Propylparaben. The "CVS Personal Lubricant" bottle is composed of high density polyethylene plastic.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Not Found
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
K9832
Page 1 of 3
Laboratories Inc
MAY 17 1999
MANUFACTURING . PRODUCT DEVELOPMENT CONTRACT FILLING . CREATIVE PACKAGING
ELS . LOTIONS UCTS . SHAMPOOS
ABBREVIATED 501(k)-SUMMARY
SUBMITTER'S NAME: San-Mar Laboratories, Inc.
ADDRESS: 4 Warehouse Lane Elmsford, New York 10523
TELEPHONE: (914) 592-3130
FAX: (914) 592-2586
CONTACT PERSON: Irwin Silverberg Vice President
DATE PREPARED: September 1, 1998
NAME OF DEVICE
PROPRIETARY NAME: CVS PERSONAL LUBRICANT
COMMON/USUAL NAME: Personal Lubricant
CLASSIFICATION NAME: Patient Lubricant-Class I
PREDICATE DEVICE: Astroglide Personal Lubricant, K935291
DESCRIPTION OF DEVICE: "CVS Personal Lubricant" is a clear , colorless and odorless personal lubricant, which is composed of the following ingredients; Purified Water, Glycerin, Propylene Glycol, Polyquaternium #5, Methyparaben and Propylparaben. The "CVS Personal Lubricant" bottle is composed of high density polyethylene plastic.
INTENDED USE: Personal lubrication and lubrication of a body orifice to facilitate entry of a diagnostic or therapeutic device, as a moisturizer for vaginal dryness, and to enhance condom use and and the ease of intimate activity.
1
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS: Astroglide Personal Lubricant and "CVS Personal Lubricant" consist of a water and glycerin base, with the addition of thickening and preservative ingredients.
SUBSTANTIAL EQUIVALENCE: The ingredients used in the manufacture of "CVS Personal Lubricant" are substantially the same as those used to manufacture Astroglide Personal Lubricant.
While the actual percentage of each ingredient may vary slightly, it is likely, given the nature of the ingredients and the usual quantities found in such formulations, that such variation is not significant.
Therefore, "CVS Personal Lubricant" is substantially equivalent to Astroglide Personal Lubricant, manufactured by BioFilm, Inc., Vista, CA 92083.
- STATEMENT: San-Mar Laboratories, Inc. believes that all information submitted herewith is truthful and accurate and that no material facts have been omitted.
(2)
2
fair. 3 of 3
(3)
DOCUMENTATION REFERENCES:
21 Code of Federal Regulations, April 1, 1997-Parts 800, 801, 803, 804, 807, 814, 820, 821, 860, 880.
21 CFR Part 820 Medical Devices: Qualiy System Regulation; Current Good Manufacturing Practice; Final Rule, October 7, 1996.
Federal Food, Drug, and Cosmetic Act, As Amended July 1993, Chapter V, Sec. 501, 502, 503, and 513.
Federal Medical Device Quality System Final Rule, October 7, 1996, 21 CFR Parts 808, 812, 820.
The New 501(k) Paradigm-Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications-Final Guidance, March 20, 1998.
FDA Modernization Act of 1997-Guidance for the Device Industry on Implementation of Highest Priority Provisions, February 6, 1998.
Guidance Addendum: How to Submit a Premarket Notification [501(k)], March, 1995.
3
Image /page/3/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the circle is a stylized image of three overlapping lines that resemble a bird in flight. The lines are thick and black, and they create a sense of movement and energy.
MAY 1 7 1999
Mr. Irwin Silverberg Vice-President San-Mar Laboratories. Inc. 4 Warehouse Lane Elmsford, New York 10523 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Re: K983216 CVS Personal Lubricant Dated: March 26, 4 1999 Received: April 1, 1999 Requlatory Class: II 21 CFR 884.5300/Procode: 85 HIS
Dear Mr. Silverberg:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 III (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing maior requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Recister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled. "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
CONFIDENTIAL
K983216 510 (k) Number (if known) :
Device Name: CVS PersonalLubricant Liquid
、『
1
Indications For Use:
Personal lubrication and lubrication of a body orifice to facilitate entry of a diagnostic or therapeutic device, as a moisturizer for vaginal dryness, and to enhance condom use and the ease of intimate activity.
1
Page
I
of
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NESDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_ (Per 21 CFR 801.109) OR
Over-The-Counter Use
. 11:1
f
y
(Optional Format 1-2-96)
. .
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number. K983216/5002