(181 days)
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.
CONCEIVE PLUS® is non-sterile water-based personal lubricant and vaginal moisturizer that is isotonic. The device contains calcium and magnesium ions and is formulated to meet a pH range that is compatible with sperm survival and migration. CONCEIVE PLUS® supplements the body's own natural moisture and is compatible with sperm, oocytes and embryos and can be used by couples trying to conceive. The device is packaged in a plastic tube or a pre-filled applicator for intra-vaginal application.
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.
This document describes acceptance criteria and performance data for CONCEIVE PLUS®, a personal lubricant. It is a 510(k) premarket notification (K131355) for a Class II medical device.
1. Table of Acceptance Criteria and Reported Device Performance
| Attribute | Acceptance Criteria (CONCEIVE PLUS®) | Reported Device Performance (CONCEIVE PLUS®) | Predicate Device (Pre-Va Vaginal Lubricant - K072741) |
|---|---|---|---|
| Osmolarity | 290 - 400 mOsm/KG | Met acceptance criteria throughout two-year shelf life. | 260 - 370 mOsm/KG |
| pH | 7.0 - 7.6 | Met acceptance criteria throughout two-year shelf life. | 7.0 - 7.4 |
| Endotoxin (LAL) | ≤ 0.5 EU/ml | Met acceptance criteria throughout two-year shelf life. | ≤ 0.7 EU/ml |
| Mouse Embryo Assay (MEA) | 1-Cell MEA exposed to 10% solution for 1 hour ≥ 80% Blastocysts at 96 hours | Demonstrated normal fertilization and embryo development with no suggestion of toxicity. Met acceptance criteria throughout two-year shelf life. | 1-Cell MEA exposed to 5% solution for 30 mins ≥ 80% Blastocysts at 96 hours |
| Human Sperm Survival Assay (HSSA) | Sperm motility at 2 hours exposure to 10% solution ≥ 80% control | Poses no barrier for sperm penetration or movement and does not harm motility or viability of human sperm. Confirmed not to harm human sperm chromatin (DNA). Met acceptance criteria throughout two-year shelf life. | Sperm motility at 30 min exposure to 10% solution ≥ 80% control |
| Condom Compatibility | Compatible with natural rubber latex and polyurethane condoms. Not for use with polyisoprene condoms. | Confirmed device is compatible with natural latex and polyurethane condoms according to ASTM D7661. (Explicitly states "not for use with polyisoprene condoms" in indications for use). | Compatible with latex and polyurethane condoms. |
| Bovine Cervical Mucus Studies | No hindrance to sperm penetration or migration into cervical mucus. | Confirmed that the device does not hinder the ability of sperm to penetrate and migrate into cervical mucus. | Not explicitly mentioned for predicate in this summary. |
| Biocompatibility - Acute Systemic Toxicity | Not systemically toxic for external communicating devices with limited contact duration. | The device is not systemically toxic (ISO 10993-11:2006). | Not explicitly mentioned for predicate in this summary. |
| Biocompatibility - Cytotoxicity | No cytotoxic effect (mild reactivity). | The device does not have a Cytotoxic effect (mild reactivity) (ANSI/AAMI/ISO 10993-5:2009). | Not explicitly mentioned for predicate in this summary. |
| Biocompatibility - Maximization Test For Delayed-Type Hypersensitivity | Does not elicit sensitization reactions. | The device does not elicit sensitization reactions (ISO 1993-5:2010). | Not explicitly mentioned for predicate in this summary. |
| Biocompatibility - Vaginal Irritation Test | Non-Irritating. | The device is Non-Irritating (ISO 1993-10:2010). | Not explicitly mentioned for predicate in this summary. |
| Appearance, Color, Odor, Viscosity, Specific Gravity, Microbial Limits | Met acceptance criteria (no specific numerical values provided in document). | 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. | Not explicitly mentioned for predicate in this summary beyond general statement of being "currently marketed." |
| Antimicrobial Effectiveness | Preservative system shown to be effective. | Antimicrobial effectiveness testing has been conducted and the preservative system is shown to be effective. | Not explicitly mentioned for predicate in this summary. |
2. Sample Sizes and Data Provenance
Due to the nature of medical device premarket notifications for lubricants, specific numerical sample sizes for each test are not detailed in this summary. The studies involve laboratory-based assays rather than human clinical trials with 'test sets' in the typical sense of AI/image analysis.
- Data Provenance: The origin of the data is from in vitro (Mouse Embryo Assay, Human Sperm Survival Assay, Bovine Cervical Mucus Studies, Biocompatibility tests) and in situ (Condom Compatibility testing) laboratory testing of the CONCEIVE PLUS® product itself. Given the context of a European manufacturer (SASMAR SPRL, Brussels, Belgium) seeking FDA clearance, these tests would have been performed in compliance with international standards (ISO, ASTM) and likely in designated testing facilities.
- Retrospective or Prospective: All tests would have been prospective, as they were conducted specifically to demonstrate the safety and effectiveness of CONCEIVE PLUS® for its 510(k) submission.
3. Number of Experts and Qualifications
This document does not specify the number or qualifications of experts used to establish ground truth. For these types of laboratory tests, "ground truth" is established by the validated methodologies of the tests themselves (e.g., ISO standards for biocompatibility, established protocols for MEA/HSSA). The expertise lies in the certified laboratories and trained personnel conducting these assays according to recognized standards.
4. Adjudication Method
Not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used for clinical studies involving interpretation of data (e.g., medical images) by multiple human readers. The tests performed for this lubricant are laboratory-based assays with objective endpoints.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not a study involving human readers or AI in an assistive capacity for diagnostic tasks.
6. Standalone (Algorithm Only) Performance
Not applicable. This product is a personal lubricant, not an algorithm or AI device. The "performance" refers to its physical and biological compatibility characteristics.
7. Type of Ground Truth Used
The ground truth used for performance evaluation is based on established scientific and regulatory standards for safety and compatibility in laboratory settings:
- Laboratory Assay Results: Objective measurements from tests like osmolarity, pH, endotoxin levels, and direct observation of biological effects (sperm motility, embryo development, cellular response in biocompatibility tests).
- Standardized Test Protocols: Adherence to international standards (e.g., ISO 10993 for biocompatibility, ASTM D7661 for condom compatibility) which define acceptable ranges and methodologies.
8. Sample Size for the Training Set
Not applicable. This device is not an AI/ML product and does not involve a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable.
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510(k) Premarket Notification CONCEIVE PLUS®
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| 510(K) SUMMARY | |
|---|---|
| -- | ---------------- |
| 510(k) | K131355 |
|---|---|
| SUBMITTER | SASMAR, INC.155 North Wacker DriveChicago, IL 60606 |
| CONTACT PERSON | John-Michael ManciniChief Executive OfficerTel: (773) 942 0030Fax: (773) 337 9148 |
NOV 07 2013
| MANUFACTURER | SASMAR SPRL40-42 rue de l'Association1000 Brussels BelgiumTel +32 2 880 8220Fax +32 2 880 8221 |
|---|---|
| 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(lubricant, personal, gamete, fertilization, and embryo compatible) |
| PREDICATE DEVICE(Primary) | Pre-Va Vaginal Lubricant (K072741) |
| DEVICE DESCRIPTION | CONCEIVE PLUS® is non-sterile water-based personal lubricantand vaginal moisturizer that is isotonic. The device containscalcium and magnesium ions and is formulated to meet a pHrange that is compatible with sperm survival and migration.CONCEIVE PLUS® supplements the body's own natural moistureand is compatible with sperm, oocytes and embryos and can beused by couples trying to conceive. The device is packaged in aplastic 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 apersonal lubricant, for penileand/or vaginal application,intended to moisturize andlubricate, to enhance the easeand comfort of intimate sexualactivity and supplement thebody's natural lubrication.CONCEIVE PLUS® iscompatible with sperm,oocytes and embryos and canbe used by couples trying toconceive. This product can beused in fertility interventions tofacilitate entry of diagnosticand therapeutic devices intothe vaginal cavity.CONCEIVE PLUS® iscompatible with natural rubberlatex and polyurethanecondoms. CONCEIVE PLUS®is not for use withpolyisoprene condoms. | Currently marketed,previously FDA cleareddevice. Pre-Va VaginalLubricantTo lubricate vaginal tissues tofacilitate entry of a diagnosticor therapeutic devicesincluding those used in fertilityinterventions. Pre-Va may beapplied directly to the device ormay be depositedintravaginally using theapplicator, prior to the insertionof diagnostic or therapeuticdevices used in fertilityinterventions.As a personal lubricant Pre-Vasupplements the body's ownnatural lubricating fluids, tomoisturize, relieve friction andto enhance the ease andcomfort of intimate sexualactivity. Pre-Va is safe for useby couples who are trying toconceive and may be appliedto vaginal or penile tissues forlubrication and moisturizationpurposes. It is compatible withlatex and polyurethanecondoms. |
| 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(MEA) | 1-Cell MEA exposed to 10%solution for 1 hour ≥ 80%Blastocysts at 96 hours | 1-Cell MEA exposed to 5%solution for 30 mins ≥ 80%Blastocysts at 96 hours |
| Human Sperm SurvivalAssay (HSSA) | Sperm motility at 2 hoursexposure to 10% solution≥ 80% control | Sperm motility at 30 minexposure to 10% solution≥ 80% control |
| Ingredients | Deionized Water,Hypromellose, SodiumPhosphate, Sodiumdihydrogen Phosphate,Potassium Chloride, SodiumChloride, MagnesiumChloride, Calcium Chloride, | Purified water,Hydroxyethylcellulose,Pluronic, Sodium Chloride,Sodium Phosphate, CarbomerMethylparaben, SodiumHydroxide, Arabinogalactan,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(ISO 10993-11:2006) | The device is not systemically toxic |
| Cytotoxicity (ANSI/AAMI/ISO10993-5:2009) | The device does not have a Cytotoxiceffect (mild reactivity). |
| Maximization Test For Delayed-Type Hypersensitivity (ISO 1993-5:2010) | The device does not elicit sensitizationreactions. |
| Vaginal Irritation Test (ISO 1993-10:2010) | The device is Non-Irritating |
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 (800) 638-2041 or (301) 796-7100 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)
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)
PSC Publishing Services ( 1011 013-6740
§ 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.