(21 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's stated primary use is for comfort during sexual activity and other lubrication needs, rather than to treat or prevent a disease or condition. Its function is primarily mechanical lubrication.
No
The device description states that Lubriglide is a personal lubricant for reducing discomfort and lubricating various items, not for diagnosing any medical condition.
No
The device description clearly indicates that Lubriglide is a physical product (a water-based lubricant) and not a software application. The 510(k) summary focuses on the physical properties and performance of the lubricant.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of Lubriglide is for personal lubrication during sexual activity and for lubricating medical devices used externally or rectally (thermometers, tampons, douches, enemas). This is a physical function, not a diagnostic one.
- Device Description: The description focuses on the physical properties of the lubricant (water-based, non-irritating, etc.) and its function as a lubricant.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue, etc.) to provide information about a disease or condition.
- Performance Studies: The performance studies focus on stability, preservative effectiveness, and comparison to a predicate personal lubricant, not on diagnostic accuracy or performance.
IVD devices are specifically designed to perform tests on samples taken from the body to diagnose, monitor, or screen for diseases or conditions. Lubriglide's function is purely physical lubrication.
N/A
Intended Use / Indications for Use
Lubriglide is a non-sterile personal lubricant for over-the-counter use. Its primary use is to apply the product to the genital area to reduce the discomfort associated with sexual activity. Lubriglide can also be used to lubricate rectal thermometers, tampons, douches, and enemas.
Product codes
KMJ
Device Description
Lubriglide is a water-based, water-soluble personal lubricant designed to imitate the body's own lubricating fluids. It is nonirritating, non-staining, and won't dry out or leave behind any solid residues. Lubriglide is non-toxic and is easily removed with water.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Genital area, rectal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-the-counter use, personal use.
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)
Non-clinical studies:
- Stability: Lubriglide successfully passed the requirements of the Qualis, Inc., accelerated stability protocol and has been assigned a two-year expiration period.
- Preservative Effectiveness: Lubriglide successfully passed the requirements of the Qualis, Inc., antimicrobial preservative challenge.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.6375 Patient lubricant.
(a)
Identification. A patient lubricant is a device intended for medical purposes that is used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.(b)
Classification. Class I (general controls). Except when the device is a vaginal patient lubricant or an oral lubricant, it is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
0
Image /page/0/Picture/0 description: The image shows a sequence of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the numbers 9, 7, 3, 5, 5, and 7. The numbers are written in a simple, slightly irregular style, giving them a casual appearance. The handwriting is clear enough to easily distinguish each character.
OCT . 0 1997
510 (k) Summary of Information Respecting Safety and Effectiveness 9.
-
A. Legally Marketed Device.
Qualis claims substantial equivalence to Astroglide (K935299), currently in commercial distribution by Bio Film, Inc. -
B. Device Description.
Lubriglide is a water-based, water-soluble personal lubricant designed to imitate the body's own lubricating fluids. It is nonirritating, non-staining, and won't dry out or leave behind any solid residues. Lubriglide is non-toxic and is easily removed with water. -
C. Intended Use.
Lubriglide is a non-sterile personal lubricant for over-the-counter use. It can also be used to lubricate rectal thermometers, tampons, douches, and enemas. -
D. Comparison with Predicate Device.
A summary comparison of the features of Lubriglide and the Predicate Device (Astroglide) is provided in Table 1. -
E. Performance Data.
Non-clinical studies. -
- Stability.
Lubriglide successfully passed the requirements of the Qualis, Inc., accelerated stability protocol and has been assigned a two-year expiration period.
- Stability.
-
- Preservative Effectiveness.
Lubriglide successfully passed the requirements of the Qualis, Inc., antimicrobial preservative challenge.
- Preservative Effectiveness.
1
- Comparison with Predicate Device. 3.
i
Lubriglide was compared to Astroglide on the basis of perceptual qualities, physical and chemical properties, ingredients list review, label claims, and packaging. The result of this review was a "Satisfactory" comparison.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES • USA
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
Mary Finn, Ph.D. Director of Regulatory Affairs Qualis, Incorporated 4600 Park Avenue 50321 Des Moines, Iowa
OCT 10 1997
K973557 Re : Lubriglide Trade Name: Requlatory Class: I Product Code: KMJ Auqust 25, 1997 Dated: September 19, 1997 Received:
Dear Dr. Finn:
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 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual reqistration, listing of devices, qood 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
3
Page 2 - Dr. Finn
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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 regulation 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/dsmamain.html".
Sincerely yours,
Susan Turner
imothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
5 10(k) Number (if known): K973557
Device Name:
Lubriglide
Indications For Usc:
Lubriglide is a non-sterile personal lubricant for over-the-counter use. Its primary use is to apply the product to the genital area to reduce the discomfort associated with sexual activity. Lubriglide can also be used to lubricate rectal thermometers, tampons, douches, and enemas.
(PLEASE DO NOT VRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concilitence of CDRH, Office of Device Evaluation (ODE)
Patricia Ciccole
(Division Sign-Off) Division of Dental, Infaction Control, and General Hospital I 510(k) Number
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use /
(Optional Formal 1-2-96)