(54 days)
Not Found
No
The summary describes a personal lubricating liquid and its performance studies, with no mention of AI or ML technology.
No.
The device is a personal lubricant used to enhance comfort during intimate activity, which falls under general wellness/comfort rather than treating or preventing a disease or condition.
No
Explanation: The "Intended Use / Indications for Use" section states that the device is "designed to enhance the ease and comfort of intimate activity," which describes a function related to personal comfort or facilitation rather than diagnosis of a condition. There is no mention of identifying, detecting, or monitoring any medical condition.
No
The device description clearly states it is a "Lubricating Liquid," which is a physical substance, not software. The performance studies also focus on the physical properties and stability of the liquid.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to enhance the ease and comfort of intimate activity." This is a physical function, not a diagnostic one.
- Device Description: The description focuses on the physical properties of the lubricant (water-based, nonsticky, nonstaining) and its compatibility with condoms and diaphragms. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of Diagnostic Elements: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition.
- Performance Studies: The performance studies described are related to stability, preservative effectiveness, and comparison of physical/perceptual qualities with a predicate device. These are not diagnostic performance studies.
Therefore, this device falls under the category of a personal lubricant, which is a medical device but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Personal Lubricating Liquid is designed to enhance the ease and comfort of intimate activity and is compatible with latex condoms.
Product codes
85 HIS
Device Description
Personal Lubricating Liquid is a water-based, nonsticky. Personal nonstaining personal lubricant that is compatible with condoms and diagrams.
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
Non-clinical studies:
- Stability: Personal Lubricating Liquid successfully passed the requirements of the Qualis, Inc., accelerated stability protocol and has been assigned a two-year expiration period.
- Preservative Effectiveness: Personal Lubricating Liquid successfully passed the requirements of the Qualis, Inc., antimicrobial preservative challenge.
- Comparison with Predicate Device: Personal Lubricating Liquid was compared to KY Liquid on the basis of perceptual qualities, physical and chemical properties, ingredients list review, label claims, and packaging. The result of this review was a "Good" comparison.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K973780
PI92
NOV 26 1997
510 (k) Summary of Information Respecting Safety and Effectiveness 9.
-
Legally Marketed Device. A.
Qualis claims substantial equivalence to KY Liquid (K790087), currently in commercial distribution by Ortho Pharmaceutical Corp. -
B. Device Description.
ﺴﺔ
Lubricating Liquid is a water-based, nonsticky. Personal nonstaining personal lubricant that is compatible with condoms and diagrams.
-
C. Intended Use.
Personal Lubricating Liquid is designed to enhance the ease and comfort of intimate activity and is compatible with latex condoms. -
D. Comparison with Predicate Device.
A summary comparison of the features of Personal Lubricating Liquid and the Predicate Device (KY Liquid) is provided in Table 1. -
E. Performance Data.
Non-clinical studies. -
- Stability.
Personal Lubricating Liquid successfully passed the requirements of the Qualis, Inc., accelerated stability protocol and has been assigned a two-year expiration period.
- Stability.
-
- Preservative Effectiveness.
Liquid successfully passed Personal Lubricating the requirements of the Qualis, Inc., antimicrobial preservative challenge.
- Preservative Effectiveness.
1
K973780
PL692
-
- Comparison with Predicate Device.
Personal Lubricating Liquid was compared to KY Liquid on the basis of perceptual qualities, physical and chemical properties, ingredients list review, label claims, and packaging. The result of this review was a "Good" comparison.
- Comparison with Predicate Device.
1
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 26 1997
Mary A. Finn, Ph.D. Director - Compliance and Regulatory Affairs QUALIS, Inc. 4600 Park Avenue Des Moines, Iowa 50321
Re: K973780 Personal Lubricating Liquid (Patient Lubricant) Dated: September 5, 1997 Received: October 3, 1997 Regulatory class: II 21 CFR §884.5300/Product code: 85 HIS
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 Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, subject to the general controls provisions of 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 (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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) 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 Register. Please note: this response to your premarket notification does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing 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 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,
William Yu
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page
K973780 510(k) Number (if known):
Device Name: Personal Lubricating Liquid
Indications For Use:
Personal Lubricating Liquid is designed to enhance the ease and comfort of Personal Lubricating Bigable with latex condoms.
(PLEASE DO NOT VRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dober R. Ratting/
(Division Sign Off)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number _K 973780
Prescription Use (Per 21 CFR 801.109)
page: 2017-02-22:
OR
Over-The-Counter Use
(Optional Formal 1-2-96)