PERSONAL LUBRICATING LIQUID by QUALIS, INC.

The provided 510(k) summary for K973780, "Personal Lubricating Liquid," describes a comparison study against a predicate device, KY Liquid (K790087). However, it does not provide acceptance criteria in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy), nor does it detail a study that would typically be associated with such criteria for a diagnostic or AI device.

This submission is for a medical device that is a personal lubricant, not an AI or diagnostic device. Therefore, the questions related to clinical performance, ground truth, experts, and AI-specific metrics are not applicable to the information provided.

Based on the document:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Explicitly Stated)	Reported Device Performance
Stability: Successfully pass accelerated stability protocol requirements.	Passed: Successfully met the requirements of Qualis, Inc., accelerated stability protocol, assigned a two-year expiration period.
Preservative Effectiveness: Successfully pass antimicrobial preservative challenge.	Passed: Successfully met the requirements of Qualis, Inc., antimicrobial preservative challenge.
Comparison with Predicate Device (Perceptual Qualities, Physical/Chemical Properties, Ingredients, Label Claims, Packaging): Result in a "Good" comparison.	Achieved: "Good" comparison with KY Liquid based on the specified criteria.

2. Sample size used for the test set and the data provenance: Not applicable. The study involved a comparison of properties and qualities, not a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth was established through laboratory testing and comparative analysis of product attributes.

4. Adjudication method for the test set: Not applicable. No test set requiring adjudication was described.

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: Not applicable. This is not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm.

7. The type of ground truth used: For stability and preservative effectiveness, the ground truth was based on established laboratory protocols and industry standards for product quality and safety. For the comparison with the predicate device, it was based on an assessment of perceptual qualities, physical and chemical properties, ingredient list review, label claims, and packaging of both products.

8. The sample size for the training set: Not applicable. There is no concept of a "training set" for this type of device submission.

9. How the ground truth for the training set was established: Not applicable.

Summary

{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.
1. Stability.
  Personal Lubricating Liquid successfully passed the requirements of the Qualis, Inc., accelerated stability protocol and has been assigned a two-year expiration period.
1. Preservative Effectiveness.
  Liquid successfully passed Personal Lubricating the requirements of the Qualis, Inc., antimicrobial preservative challenge.

{1}------------------------------------------------

K973780
PL692

1. 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.

{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:

Over-The-Counter Use

(Optional Formal 1-2-96)

Regulation Number and Section

§ 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.