To lubricate vaginal tissues to facilitate entry of a diagnostic or therapeutic a devices including fertility interventions.
As a personal lubricant to supplement the body's own natural lubricating As a personal labriount to cappion and to enhance the ease and comfort nfinate sexual activity. This lubricant may be safely applied to vaginal or penile tissues for lubrication and moisturization purposes. It is also compatible with latex and polyurethane condoms.

Device Description

This product is a non-sterile, water-based personal lubricant formulated to supplement the body's own natural lubricating fluids. This product may be used to facilitate entry of diagnostic or therapeutic devices, enhance the comfort of intimate sexual activity, or provide personal lubrication when vaginal dryness causes discomfort. The formulation does not harm sperm function and is pH balanced to match fertile cervical mucus. The product is compatible with latex and polyurethane condoms.

AI/ML Overview

This document describes a 510(k) submission for a vaginal lubricant, not an AI-powered medical device. Therefore, many of the requested categories are not applicable. I will provide the information directly relevant to the submission and note when a category is not applicable for this type of device.

1. A table of acceptance criteria and the reported device performance

This product is a Class II medical device (vaginal lubricant) seeking substantial equivalence to a predicate device (K-Y Brand Ultra Gel, K020827). For such devices, acceptance criteria are typically met by demonstrating that the new device has "technological characteristics" and "preclinical/clinical performance data" that are substantially equivalent to the predicate device, especially regarding safety and effectiveness for its intended use.

Acceptance Criteria (Demonstrated Substantial Equivalence to K-Y Brand Ultra Gel)	Reported Device Performance (Pre' Vaginal Lubricant)
Technological Characteristics:
- Highly lubricious	Shares this characteristic
- Medium viscosity	Shares this characteristic
- Water-based	Shares this characteristic
- Clear	Shares this characteristic
- Non-irritating	Preclinical biocompatibility studies in rabbits revealed no penile or vaginal irritation. Slug Mucosal Irritation Test demonstrated no potential for vaginal mucosal irritation. Biocompatibility studies in humans found no evidence of skin irritation or sensitization.
- Non-sterile	Shares this characteristic
- Condom compatible	Formulation is compatible with latex and polyurethane condoms.
Specific Performance for Intended Use:
- Does not harm sperm function (for fertility interventions)	No detrimental effects on human sperm motility parameters, sperm viability, or sperm chromatin.
- pH balanced to match fertile cervical mucus	Formulated to be pH balanced to match fertile cervical mucus.
- Non-toxic to embryos	Mouse Embryo Assay (MEA) studies demonstrated normal embryo development with no suggestion of toxicity. No detrimental effects on the ability to fertilize bovine embryos in vivo.
- Stable formulation	Stability confirmed in accordance with FDA and ICH guidelines.
- Effective as a personal lubricant	Focus groups and consumer-use testing demonstrated it is "very effective as a personal lubricant."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set:
- Preclinical Animal Studies: Not explicitly stated, but "studies in rabbits" and "Mouse Embryo Assay (MEA) studies" are mentioned, implying multiple animals were used. "No detrimental effects on the ability to fertilize bovine embryos in vivo" suggests a study involving bovine subjects.
- Human Biocompatibility: Not explicitly stated, but "Biocompatibility studies found no evidence of skin irritation or sensitization in humans" implies a cohort of human subjects.
- Focus Groups & Consumer-Use Testing: Not explicitly stated, but "Focus groups and consumer-use testing" implies a group of participants.
- In vitro studies: Tests on human sperm and material compatibility (latex/polyurethane condoms) were conducted, but specific sample sizes of sperm or condom units are not provided.
Data Provenance: Not explicitly stated for specific studies. Given the applicant is in the USA (Washington), it's reasonable to infer studies were conducted in the USA or under internationally recognized standards (e.g., ICH guidelines). The studies appear to be prospective for the purpose of this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is a medical device (lubricant) submission, not an AI model requiring "ground truth" established by experts in the context of image interpretation or diagnosis. The evaluation relies on standardized biological, chemical, and physical tests, and performance assessments.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is a medical device (lubricant) submission. Adjudication methods like 2+1 or 3+1 are typically used in clinical trials involving expert interpretation of medical images or outcomes where discrepancies need resolution. For this device, standard laboratory and clinical study protocols would be followed, and results are typically analyzed statistically or qualitatively based on predefined endpoints.

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. MRMC studies are for evaluating diagnostic performance (e.g., radiologists reading images). This is a lubricant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a lubricant, not an algorithm or AI system. Its performance is evaluated through laboratory and preclinical/clinical studies.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable in the AI sense. The "ground truth" or reference standards for evaluating this device were based on:

Established biological and chemical standards: For pH, osmolarity, sperm viability, embryo development, material compatibility.
Preclinical irritation assessments: Observation of animal tissues, validated irritation tests (e.g., Slug Mucosal Irritation Test).
Human irritation/sensitization clinical observations: Direct observation and potentially patient reporting.
Consumer feedback: For effectiveness as a personal lubricant through focus groups and consumer-use testing.

8. The sample size for the training set

Not applicable. This is a lubricant, not an AI model that requires a training set.

9. How the ground truth for the training set was established

Not applicable. See point 8.

Summary

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K051436
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Image /page/0/Picture/1 description: The image shows the logo for INGferility. The tagline below the name reads "Naturally Enhancing Reproduction". The logo includes a stylized image of a plant.

510(k) Summary Pre' Vaginal Lubricant

OCT 1 3 2006

I. General Information on Submitten

Address:	INGfertility, LLC (Subsidiary of Bio-Origyn, LLC)17206 S. Spangle Creek Rd.Valleyford, WA 99036 USA
Telephone:	509.443.0149
Fax:	509.448.0601
Email:	dclifton@ingfertility.com
Contact Person:	G. Dennis Clifton, Pharm.D.
Date Prepared:	May 18, 2005

II. General Information on Device

Proprietary Name:	Pre' Vaginal Lubricant
Classification Name:	Lubricant, Vaginal, Patient (21 CFR 880.6375-Product Code MMS)

III. Predicate Devices

Predicate Device	510(k) control #
K-Y Brand Ultra Gel	K020827

IV. Description of Device

Ingredients
Water
Hydroxyethylcellulose, NF
Pluronic 127, NF
Sodium Chloride, USP
Arabinogalactan
Sodium Phosphate
Carbopol 934P, NF
Methyl Paraben, USP
Sodium Hydroxide, NF
Potassium Phosphate

The Makers of Pre-Seed® "Sperm Friendly" Intimate Moisturizer

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K051436
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V. Intended Use

Pre' has the following intended uses:

To lubricate vaginal tissues to facilitate entry of a diagnostic or therapeutic devices including fertility interventions.
As a personal lubricant to supplement the body's own natural lubricating fluids, to moisturize, relieve friction and to enhance the ease and comfort of intimate sexual activity. This lubricant may be safely applied to vaginal or penile tissues for lubrication and moisturization purposes. It is also compatible with latex and polyurethane condoms.

VI. Technological Characteristics of Device Compared to Predicate Device

Pre' shares the following technological characteristics with the predicate device: highly lubricious, medium viscosity, water based, clear, non-irritating, non-sterile, and condom compatible.

VII. Summary of Preclinical Performance Data

Preclinical biocompatibility studies in rabbits revealed no penile or vaginal irritation from Pre'. The Slug Mucosal Irritation Test of the formulation demonstrated no potential for vaginal mucosal irritation. Pre' had no detrimental effects on the ability to fertilize bovine embryos in vivo. Mouse Embryo Assay (MEA) studies with Pre' have demonstrated normal embryo development with no suggestion of toxicity. Pre' has no detrimental effects on human sperm motility parameters, sperm viability or sperm chromatin. Stability of Pre' was confirmed in accordance with FDA and International Conference on Harmonization (ICH) guidelines. The formulation is compatible with latex and polyurethane condoms.

VIII. Summary of Clinical Performance Data

Biocompatibility studies found no evidence of skin irritation or sensitization in humans. Focus groups and consumer-use testing demonstrates that Pre' is nonirritating and very effective as a personal lubricant.

IX. Conclusion

Laboratory, preclinical, and clinical testing conducted with Pre' Vaginal Lubricant has provided scientific evidence that this product is safe for its intended use and substantially equivalent to the predicate device KY® Brand Ultra Gel™

Section F 510(k) Summary Pre' Vaginal Lubricant

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like figure with flowing lines, representing movement or progress. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 10, 2014

INGfertility, LLC G. Dennis Clifton, Pharm.D. Vice President 17206 South Spangle Creek Road Valleyford, WA 99036

Re: K051436 Trade/Device Name: Pre' Vaginal Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: PEB Dated: September 14, 2006 Received: September 15, 2006

Dear Dennis Clifton,

This letter corrects our substantially equivalent letter of October 13, 2006.

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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Page 2 - G. Dennis Clifton, Pharm.D.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Herbert P. Lerner -S

for

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K05)436

Device Name: Pre' Vaginal Lubricant

Indications for Use:

To lubricate vaginal tissues to facilitate entry of a diagnostic or therapeutic a devices including fertility interventions.
As a personal lubricant to supplement the body's own natural lubricating As a personal labriount to cappion and to enhance the ease and comfort nfinate sexual activity. This lubricant may be safely applied to vaginal or penile tissues for lubrication and moisturization purposes. It is also compatible with latex and polyurethane condoms.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ X (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David R. Lepson

Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 510(k) Number

Page 15 of 49

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.