PRE-VA VAGINAL LUBRICANT

K072741 · Ingfertility, LLC · PEB · Jul 16, 2008 · Obstetrics/Gynecology

Device Facts

• Record ID: K072741
• Device Name: PRE-VA VAGINAL LUBRICANT
• Applicant: Ingfertility, LLC
• Product Code: PEB · Obstetrics/Gynecology
• Decision Date: Jul 16, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Indications for Use

To lubricate vaginal tissues to facilitate entry of diagnostic or therapeutic devices including those used in fertility interventions. Pre~Va may be applied directly to the device or may be deposited intravaginally using the applicator, prior to the insertion of diagnostic or therapeutic devices used in fertility interventions. As a personal lubricant Pre-Va supplements the body's own natural lubricating fluids, to moisturize, relieve friction and to enhance the ease and comfort of intimate sexual activity. Pre~Va is safe for use by couples who are trying to conceive and may be applied to vaginal or penile tissues for lubrication and moisturization purposes. It is compatible with latex and polyurethane condoms.

Device Story

Pre~Va is a non-sterile, water-based personal lubricant; formulated to supplement natural lubricating fluids; pH and osmolarity balanced to fertile cervical mucus and semen; non-spermicidal. Used in clinical settings to facilitate insertion of diagnostic/therapeutic devices (e.g., fertility interventions) and in home settings as a personal lubricant. Applied directly to devices, vaginal tissues, or penile tissues. Enhances comfort; facilitates device entry; supports conception efforts. Compatible with latex and polyurethane condoms.

Clinical Evidence

No clinical data provided; substantial equivalence based on identical technological characteristics and formulation to the predicate device.

Technological Characteristics

Water-based lubricant; ingredients include Hydroxyethylcellulose (NF), Pluronic 127 (NF), Sodium Chloride (USP), Arabinogalactan, Sodium Phosphate, Carbopol 934P (NF), Methyl Paraben (USP), Sodium Hydroxide (NF), and Potassium Phosphate. Non-sterile; compatible with latex and polyurethane condoms.

Indications for Use

Indicated for individuals requiring vaginal lubrication for diagnostic/therapeutic device insertion (including fertility interventions) or as a personal lubricant to relieve friction and enhance comfort during sexual activity. Safe for use by couples attempting to conceive.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Pre' Vaginal Lubricant

Submission Summary (Full Text)

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### 510(k) Summary Pre~Va Vaginal Lubricant

JUL 1 6 2008

### l. General Information on Submitter

| Address: | INGfertility, LLC (Subsidiary of Bio-Origyn, LLC)<br>17206 S. Spangle Creek Rd.<br>Valleyford, WA 99036 USA |
|-----------------|-------------------------------------------------------------------------------------------------------------|
| Telephone: | 509.443.0149 |
| Fax: | 509.471.9638 |
| Email: | [e-mail] |
| Contact Person: | G. Dennis Clifton, Pharm.D. |
| Date Prepared: | March 18, 2008 |

### II. General Information on Device

| Proprietary Name: | Pre~Va Vaginal Lubricant |
|----------------------|--------------------------------------------------------------------------------------|
| Classification Name: | lubricant, patient, vaginal, latex compatible (21 CFR<br>884.5300, Product Code NUC) |

### III. Predicate Devices

| START | AREARY |
|----------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Section of Allen August of Control Commens and Commens and Call All All of Concelle<br>Carol<br>1. DE RE | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |

### IV. Description of Device

This product is a non-sterile, water-based personal lubricant formulated to supplement the body's own natural lubricating fluids. Pre~Va is used to lubricate vaginal tissues to facilitate entry of diagnostic or therapeutic devices including those used in fertility interventions. It is also used as a personal lubricant to supplement the body's own natural lubricating fluids and to enhance the comfort of intimate sexual activity. The formulation does not harm sperm function and has a pH and osmolarity that are physiologic ("balanced") to that of fertile cervical mucus and semen. The product is compatible with latex and polyurethane condoms. Following is the ingredient list for Pre~Va Vaginal Lubricant:

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

1

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### V. Intended Use

- . To lubricate vaginal tissues to facilitate entry of diagnostic or therapeutic devices including those used in fertility interventions. Pre~Va may be applied directly to the device or may be deposited intravaginally using the applicator, prior to the insertion of diagnostic or therapeutic devices used in fertility interventions
- As a personal lubricant Pre-Va supplements the body's own natural . lubricating fluids, to moisturize, relieve friction and to enhance the ease and comfort of intimate sexual activity. Pre~Va is safe for use by couples who are trying to conceive and may be applied to vaginal or penile tissues for lubrication and moisturization purposes. It is compatible with latex and polyurethane condoms.

# VI. Technological Characteristics of Device Compared to Predicate Device

All of the technological characteristics of Pre~Va are identical to the predicate device.

### VII. Summary of Performance Data

The performance data of Pre~Va are identical to the predicate.

### VIII. Conclusion

Pre~Va Vaginal Lubricant is safe for its intended use and substantially equivalent to the predicate device 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 consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized symbol that resembles an abstract caduceus or a bird-like figure, composed of three curved lines.

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

February 27, 2014

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

Re: K072741

Trade/Device Name: Pre-Va Vaginal Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: PEB Dated (Date on orig SE Itr): July 1, 2008 Received (Date on orig SE Itr): July 8, 2008

Dear Dennis Clifton,

This letter corrects our substantially equivalent letter of July 16, 2008.

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.

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

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Page 2 - Dennis Clifton, Pharm.D.

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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# 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): K072741

Device Name: Pro-Va Vaginal Lubricant

Indications for Use:

- > To lubricate vaginal tissues to facilitate entry of diagnostic or therapeutic devices including those used in fertility interventions. Pre~Va may be applied directly to the device or may be deposited intravaginally using the applicator, prior to the insertion of diagnostic or therapeutic devices used in fertility interventions.
- > As a personal lubricant Pre-Va supplements the body's own natural Tutoricaling Thuids, To moisturize, relieve Triction and To enthance The ease and comfort of intimate sexual activity. Pre~Va is safe for use by couples who are trying to conceive and may be applied to vaginal or penile tissues for lubrication and moisturization purposes. It is 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)

Hales Turner

Division Sig Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number.

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