CONCEIVE PLUS

K131355 · Sasmar, Inc. · PEB · Nov 7, 2013 · Obstetrics/Gynecology

Device Facts

• Record ID: K131355
• Device Name: CONCEIVE PLUS
• Applicant: Sasmar, Inc.
• Product Code: PEB · Obstetrics/Gynecology
• Decision Date: Nov 7, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Indications for Use

Conceive Plus® is a personal lubricant, for penile application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. Conceive Plus® is compatible with sperm, oocytes, and embryos and can be used by couples trying to conceive. This product can be used in fertility interventions to facilitate entry of diagnostic devices into the vaginal cavity. Conceive Plus® is compatible with natural rubber latex and polyurethane condoms. Conceive Plus® is not for use with synthetic polyisoprene condoms.

Device Story

CONCEIVE PLUS® is a non-sterile, water-based, isotonic personal lubricant and vaginal moisturizer. Formulated with calcium and magnesium ions to maintain a pH compatible with sperm survival and migration. Packaged in plastic tubes or pre-filled applicators for intra-vaginal or penile application. Used by couples trying to conceive or by clinicians during fertility interventions to facilitate device insertion. Supplements natural moisture; compatible with sperm, oocytes, and embryos. Does not hinder sperm motility, viability, or penetration into cervical mucus. Enhances comfort during sexual activity. Compatible with natural rubber latex and polyurethane condoms.

Clinical Evidence

Bench testing only. Studies included: human sperm survival assay (≥80% motility at 2 hours), mouse embryo assay (≥80% blastocysts at 96 hours), bovine cervical mucus penetration, and condom compatibility (ASTM D7661). Biocompatibility testing per ISO 10993 included acute systemic toxicity, cytotoxicity, delayed-type hypersensitivity, and vaginal irritation. All tests met acceptance criteria.

Technological Characteristics

Water-based, isotonic formulation containing deionized water, hypromellose, sodium phosphate, sodium dihydrogen phosphate, potassium chloride, sodium chloride, magnesium chloride, calcium chloride, glycerol, and methylparaben. pH 7.0-7.6; osmolarity 290-400 mOsm/KG. Delivered via tube or pre-filled applicator. Compatible with natural rubber latex and polyurethane condoms. Tested for microbial limits and endotoxin (≤ 0.5 EU/ml).

Indications for Use

Indicated for use by couples trying to conceive as a personal lubricant for penile and/or vaginal application to moisturize, lubricate, and enhance comfort during sexual activity. Also indicated for use in fertility interventions to facilitate the entry of diagnostic and therapeutic devices into the vaginal cavity. Compatible with natural rubber latex and polyurethane condoms; contraindicated for use with polyisoprene condoms.

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-Va Vaginal Lubricant (K072741)

Submission Summary (Full Text)

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510(k) Premarket Notification CONCEIVE PLUS®

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| | 510(K) SUMMARY |
|--|----------------|
|--|----------------|

| 510(k) | K131355 |
|----------------|-----------------------------------------------------------------------------------------------|
| SUBMITTER | SASMAR, INC.<br>155 North Wacker Drive<br>Chicago, IL 60606 |
| CONTACT PERSON | John-Michael Mancini<br>Chief Executive Officer<br>Tel: [phone]<br>Fax: [phone] |

NOV 07 2013

| MANUFACTURER | SASMAR SPRL<br>40-42 rue de l'Association<br>1000 Brussels Belgium<br>Tel [phone]<br>Fax [phone] |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| PREPARATION DATE | 6 November, 2013 |
| TRADE NAME | CONCEIVE PLUS® |
| CLASSIFICATION NAME | Personal Lubricant |
| CLASSIFICATION | Condom |
| PANEL | Class II (21 CFR 884.5300) |
| PRODUCT CODE | PEB<br>(lubricant, personal, gamete, fertilization, and embryo compatible) |
| PREDICATE DEVICE<br>(Primary) | Pre-Va Vaginal Lubricant (K072741) |
| DEVICE DESCRIPTION | CONCEIVE PLUS® is non-sterile water-based personal lubricant<br>and vaginal moisturizer that is isotonic. The device contains<br>calcium and magnesium ions and is formulated to meet a pH<br>range that is compatible with sperm survival and migration.<br>CONCEIVE PLUS® supplements the body's own natural moisture<br>and is compatible with sperm, oocytes and embryos and can be<br>used by couples trying to conceive. The device is packaged in a<br>plastic tube or a pre-filled applicator for intra-vaginal application. |

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PREMARKET NOTIFICATION SUMMARY, K131355

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510(k) Premarket Notification CONCEIVE PLUS®

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CONCEIVE PLUS® is formulated using Deionized Water, Hypromellose, Sodium Phosphate, Sodium dihydrogen Phosphate, Potassium Chloride, Sodium Chloride, Magnesium Chloride, Calcium Chloride, Glycerol and Methylparaben.

This device is batch lot tested for appearance, color, odor, viscosity, osmolarity, specific gravity, pH, microbial limits, endotoxin, mouse embryo assay, and human sperm survival assay.

#### INDICATION FOR USE CONCEIVE PLUS® is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication.

CONCEIVE PLUS® is compatible with sperm, oocytes and embryos and can be used by couples trying to conceive. This product can be used in fertility interventions to facilitate entry of diagnostic and therapeutic devices into the vaginal cavity.

CONCEIVE PLUS® is compatible with natural rubber latex and polyurethane condoms. CONCEIVE PLUS® is not for use with polyisoprene condoms.

# TECHNOLOGICAL CHARACTERISTICS

CONCEIVE PLUS® is a patent pending and proprietary formulation. The device has similar ingredients, similar composition and intended use to the predicate device.

Any minor differences in technological characteristics between CONCEIVE PLUS® and the predicate device do not raise new issues of safety or efficacy.

PREMARKET NOTIFICATION SUMMARY, K131355

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| Technological Characteristics of CONCEIVE PLUS® | Compared to Predicate. | |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Attribute | CONCEIVE PLUS® | |
| 510(k) | K131355 | K072741 |
| Indications for use | CONCEIVE PLUS® is a<br>personal lubricant, for penile<br>and/or vaginal application,<br>intended to moisturize and<br>lubricate, to enhance the ease<br>and comfort of intimate sexual<br>activity and supplement the<br>body's natural lubrication.<br><br>CONCEIVE PLUS® is<br>compatible with sperm,<br>oocytes and embryos and can<br>be used by couples trying to<br>conceive. This product can be<br>used in fertility interventions to<br>facilitate entry of diagnostic<br>and therapeutic devices into<br>the vaginal cavity.<br><br>CONCEIVE PLUS® is<br>compatible with natural rubber<br>latex and polyurethane<br>condoms. CONCEIVE PLUS®<br>is not for use with<br>polyisoprene condoms. | Currently marketed,<br>previously FDA cleared<br>device. Pre-Va Vaginal<br>Lubricant<br><br>To lubricate vaginal tissues to<br>facilitate entry of a diagnostic<br>or therapeutic devices<br>including those used in fertility<br>interventions. Pre-Va may be<br>applied directly to the device or<br>may be deposited<br>intravaginally using the<br>applicator, prior to the insertion<br>of diagnostic or therapeutic<br>devices used in fertility<br>interventions.<br>As a personal lubricant Pre-Va<br>supplements the body's own<br>natural lubricating fluids, to<br>moisturize, relieve friction and<br>to enhance the ease and<br>comfort of intimate sexual<br>activity. Pre-Va is safe for use<br>by couples who are trying to<br>conceive and may be applied<br>to vaginal or penile tissues for<br>lubrication and moisturization<br>purposes. It is compatible with<br>latex and polyurethane<br>condoms. |
| Method of application | Tube / Pre-filled applicator | Tube / disposable applicator |
| Storage instruction | 36°F - 86°F | 36°F - 86°F |
| Shelf life | 2 years | 2 years |
| Osmolarity | 290 - 400 mOsm/KG | 260 - 370 mOsm/KG |
| pH | 7.0 - 7.6 | 7.0 - 7.4 |
| Endotoxin (LAL) | ≤ 0.5 EU/ml | ≤ 0.7 EU/ml |
| Mouse Embryo Assay<br>(MEA) | 1-Cell MEA exposed to 10%<br>solution for 1 hour ≥ 80%<br>Blastocysts at 96 hours | 1-Cell MEA exposed to 5%<br>solution for 30 mins ≥ 80%<br>Blastocysts at 96 hours |
| Human Sperm Survival<br>Assay (HSSA) | Sperm motility at 2 hours<br>exposure to 10% solution<br>≥ 80% control | Sperm motility at 30 min<br>exposure to 10% solution<br>≥ 80% control |
| Ingredients | Deionized Water,<br>Hypromellose, Sodium<br>Phosphate, Sodium<br>dihydrogen Phosphate,<br>Potassium Chloride, Sodium<br>Chloride, Magnesium<br>Chloride, Calcium Chloride, | Purified water,<br>Hydroxyethylcellulose,<br>Pluronic, Sodium Chloride,<br>Sodium Phosphate, Carbomer<br>Methylparaben, Sodium<br>Hydroxide, Arabinogalactan,<br>Potassium Phosphate, |

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# Technological Characteristics of CONCEIVE PLUS® Compared to Predicate.

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## PERFORMANCE DATA

Fertility studies performed on CONCEIVE PLUS® demonstrate that the device poses no barrier for sperm penetration or movement and does not harm motility or viability of human sperm. Bovine cervical mucus studies confirmed that the device does not hinder the ability of sperm to penetrate and migrate into cervical mucus.

Mouse Embryo Assay studies with CONCEIVE PLUS® demonstrated normal fertilization and embryo development with no suggestion of toxicity. Testing confirmed the device does not harm human sperm chromatin (DNA). Condom compatibility testing in accordance with ASTM D7661 confirmed the device is com;patible with natural latex and polyurethane condoms.

Testing confirmed that the device in both tube and applicator met all acceptance criteria for appearance, color, odor, viscosity, osmolarity, specific gravity, pH, microbial limits, endotoxin, mouse embryo assay, and human sperm survival assay throughout the entire proposed two year shelf life. Antimicrobial effectiveness testing has been conducted and the preservative system is shown to be effective.

The results of the following ISO biocompatibility tests support a determination of substantial equivalence. No adverse effects have been encountered. The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as the predicate device.

The data concludes that CONCEIVE PLUS® is substantially equivalent to its primary predicate device Pre-Va Vaginal Lubricant and is safe for use by individuals and couples trying to conceive.

| Biocompatibility Test | CONCEIVE PLUS® Result |
|-------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| Acute Systemic Toxicity<br>(ISO 10993-11:2006) | The device is <i>not</i> systemically toxic |
| Cytotoxicity (ANSI/AAMI/ISO<br>10993-5:2009) | The device does <i>not</i> have a Cytotoxic<br>effect (mild reactivity). |
| Maximization Test For Delayed-<br>Type Hypersensitivity (ISO 1993-<br>5:2010) | The device does <i>not</i> elicit sensitization<br>reactions. |
| Vaginal Irritation Test (ISO 1993-<br>10:2010) | The device is <i>Non-Irritating</i> |

#### SUMMARY

CONCEIVE PLUS® has the same intended use and basic technological characteristics as the predicate device. This lubricant is as safe and effective as the predicate and can be used by couples trying to conceive.

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Image /page/4/Picture/1 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 outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird.

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

November 7, 2013

Sasmar, Inc. % John-Michael Mancini Chief Executive Officer 155 North Wacker Drive, Suite 4250 Chicago, IL 60606

Re: K131355 Trade/Device Name: CONCEIVE PLUS® Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: PEB Dated: October 7, 2013 Received: October 8, 2013

Dear John-Michael Mancini,

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.

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Page 2 - John-Michael Mancini

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm 1 15809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Benjamin R. Fisher -S

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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known)

K131355

# Device Name

CONCEIVE PLUS®

Indications for Use (Describe)

Conceive Plus® is a personal lubricant, for ponilo application, intended to moisturize and lubricato, to enhance the oase and comfort of Intimate soxual activity and supploment the body's natural lubrication. Conceive Pluse is compatible with sporm, oocytes, and embryos and can be used by couples trying to conceive. This product can be used in fertility interventions to fecilitate antry of diagnostic devices into the vaginal cavity. Conceive Plus® is compatible with natural rubber latex and polyurethano condoms. Concolvo Plus® is not for use with synthetic polysoprene condoms.

Type of Use (Select one or both, as applicable)

Prescription Use (Parl 21 CFR 801 Subpart D)

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

. . . .

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY .

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

# Benjamin R. Fisher -S 2013.11.07 16:48:00 -05'00'

FORM FDA 3881 (9/13)

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