(223 days)
Not Found
No
The document describes a personal lubricant and its physical and chemical properties, with no mention of AI or ML technology.
No
The device is a personal lubricant intended to enhance comfort during sexual activity and supplement natural lubrication. While it can be used to facilitate the use of diagnostic and therapeutic devices, it is not itself a therapeutic device.
No.
The device's primary purpose is to moisturize and lubricate; it does not diagnose medical conditions or states. While it can facilitate the use of diagnostic devices, it is not one itself.
No
The device description clearly states it is a "non-sterile, water-based personal lubricant" and is packaged in a tube with applicators, indicating it is a physical product, not software.
Based on the provided text, Pre-Seed™ Fertility Lubricant is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The primary intended use is as a personal lubricant for penile and/or vaginal application to enhance comfort during sexual activity and supplement natural lubrication. While it mentions compatibility with sperm and oocytes and use during fertility interventions, its core function is lubrication, not diagnosis.
- Device Description: The description focuses on the physical properties and packaging of a lubricant.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (like blood, urine, or tissue) to provide diagnostic information about a person's health or condition.
- Performance Studies: The performance studies focus on biocompatibility, sperm compatibility, condom compatibility, and shelf-life – all related to its function as a lubricant and its safety for use in the reproductive tract. There are no studies related to diagnostic accuracy or performance.
While it can be used in the context of fertility interventions, its role is to facilitate the use of other devices or processes, not to provide a diagnosis itself.
N/A
Intended Use / Indications for Use
Pre-Seed™ Fertility Lubricant 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. Pre-Seed™ Fertility Lubricant is compatible with sperm, oocytes, and can be used by trying to conceive couples. It is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms.
Pre-Seed™ Fertility Lubricant can be used to lubricate genital tissues and devices to facilitate use of diagnostic and therapeutic devices during fertility interventions and reproductive medicine.
Product codes (comma separated list FDA assigned to the subject device)
PEB
Device Description
Pre-Seed™ Fertility Lubricant is a non-sterile, water-based personal lubricant formulated to supplement the body's own natural lubrication. The product is also compatible with sperm, oocytes, and embryos, can be used by trying to conceive couples, and can also be used to lubricate diagnostic and therapeutic devices during fertility interventions and reproductive medicine.
Pre-Seed™ Fertility Lubricant is packaged in a High-Density Polyethylene tube with a Polypropylene closure. A foil seal is present over the tube opening under the cap closure. The provided with single-use, piston type, Low Density Polyethylene applicators for delivering the product to the vagina.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
penile and/or vaginal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
-
Biocompatibility:
- Study Type: Biocompatibility testing per ISO 10993-5:2009 (cytotoxicity), ISO 10993-10:2010 (vaginal irritation, guinea pig maximization sensitization), and ISO 10993-11:2006 (acute systemic toxicity).
- Key Results: The testing demonstrated that the Pre-Seed™ Fertility Lubricant is biocompatible.
-
Non-clinical Performance Testing:
- Study Type: Human sperm survival assay (HSSA), and lubricant barrier assay.
- Key Results: Indicates that Pre-Seed™ Fertility Lubricant is compatible with sperm and does not inhibit sperm motility.
-
Condom Compatibility:
- Study Type: Testing per ASTM D7661-10: Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms.
- Key Results: The results indicate that Pre-Seed™ Fertility Lubricant is compatible with natural rubber latex and polyisoprene condoms. Pre-Seed™ Fertility Lubricant is not compatible with polyurethane condoms.
-
Shelf-Life:
- Study Type: Accelerated and real-time stability testing.
- Key Results: Pre-Seed™ Fertility Lubricant has a 22-month shelf-life. The results demonstrated that Pre-Seed™ Fertility Lubricant maintains its specifications for appearance/color, odor, pH, osmolality, viscosity. TAMC, TYMC, absence of pathogenic organisms, antimicrobial effectiveness, endotoxins, HSSA, and lubricant barrier testing over the duration of its proposed shelf-life of 22 months.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- pH: 7.0-7.4
- Osmolality: 260-370 mOsm/kg
- Viscosity: 2800-11500 cps
- Total Aerobic Microbial Count (TAMC):
§ 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.
0
Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
July 23, 2020
Church & Dwight Co., Inc. Joelle Reinson Senior Regulatory Affairs Specialist 500 Charles Ewing Boulevard Ewing, NJ 08628
Re: K193450
Trade/Device Name: Pre-Seed™ Fertility Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: PEB Dated: June 25, 2020 Received: June 26, 2020
Dear Joelle Reinson:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Monica D. Garcia, Ph.D. Acting Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K193450
Device Name Pre-Seed™ Fertility Lubricant
Indications for Use (Describe)
Pre-Seed™ Fertility Lubricant 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. Pre-Seed™ Fertility Lubricant is compatible with sperm, oocytes, and can be used by trying to conceive couples. It is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms.
Pre-Seed™ Fertility Lubricant can be used to lubricate genital tissues and devices to facilitate use of diagnostic and therapeutic devices during fertility interventions and reproductive medicine.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| -------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary - K193450
| Submitter Name: | Church & Dwight Co., Inc. |
|---|---|
| Submitter Address: | 500 Charles Ewing Boulevard |
| Ewing, NJ 08628 | |
| Contact Person: | Joelle Reinson |
| Senior Regulatory Affairs Specialist | |
| Church & Dwight Co., Inc. | |
| 469 North Harrison Street | |
| Princeton, NJ 08543 | |
| Tel: (609) 806.1671 | |
| Fax: (609) 403.7415 | |
| Date Prepared: | July 23, 2020 |
| Device Trade Name: | Pre-Seed™ Fertility Lubricant |
| Device Common Name: | Personal Lubricant |
| Regulation Number: | 21 CFR 884.5300 |
| Regulation Name: | Condom |
| Product Code: | PEB (lubricant, personal, gamete, fertilization, and embryo compatible) |
| Predicate Device: | K072741: Pre~Va Vaginal Lubricant |
The predicate device has not been subject to a design-related recall.
Description of Device:
Pre-Seed™ Fertility Lubricant is a non-sterile, water-based personal lubricant formulated to supplement the body's own natural lubrication. The product is also compatible with sperm, oocytes, and embryos, can be used by trying to conceive couples, and can also be used to lubricate diagnostic and therapeutic devices during fertility interventions and reproductive medicine.
Pre-Seed™ Fertility Lubricant is packaged in a High-Density Polyethylene tube with a Polypropylene closure. A foil seal is present over the tube opening under the cap closure. The provided with single-use, piston type, Low Density Polyethylene applicators for delivering the product to the vagina.
| Table 1: Specifications for Pre-Seed™ Fertility Lubricant | |||
|---|---|---|---|
| ----------------------------------------------------------- | -- | -- | -- |
| Specification | Recommended Acceptance Criteria |
|---|---|
| Appearance/Color | Hazy, colorless to slightly yellow, viscous |
| liquid | |
| Odor | Characteristic, no off odor |
| (25 °C ± 2) |
4
| pH | 7.0-7.4 |
|---|---|
| Osmolality | 260-370 mOsm/kg |
| Viscosity | 2800-11500 cps |
| Total Aerobic Microbial Count (TAMC)- | |
| USP and | and |
| Antimicrobial Effectiveness | |
| USP | Bacteria- Not less than 2.0 log reduction from the initial count at 14 days. No increase from 14 days count to 28 days. |
| Yeast & Mold- not increase from the initial calculated count at 14 and 28 days. | |
| Endotoxin | and |
| log reduction from the | |
| initial count at 14 days. No | |
| increase from 14 days' | |
| count 28 days. | |
| Yeast & Mold: No increase | |
| from the initial calculated | |
| count at 14 and 28 days. | Bacteria: Not less than |
| 2.0 log reduction from | |
| the initial count at 14 | |
| days. No increase | |
| from 14 days' count | |
| 28 days. | |
| Yeast & Mold: No | |
| increase from the | |
| initial calculated count | |
| at 14 and 28 days. | Same |
| Endotoxin | 80% |
| of sperm motility in | |
| control medium | Same |
| Shelf-life | 22 months |
| OTC use | Yes |
5
6
The subject and predicate devices do not have identical indications for use statements; however, these differences do not alter the intended use of the subject device, which is identical to the predicate device.
As noted in the table, the subject and predicate device have different technological characteristics, including different formulations, condom compatibility, specifications (e.g., endotoxin, appearance, odor, pH, viscosity, etc.). The differences in technological characteristics between the subject and predicate device do not raise different questions of safety and effectiveness.
Performance Data:
As part of demonstrating substantial equivalence to the predicate device, the following non-clinical performance tests were conducted:
7
Biocompatibility:
Pre-Seed™ Fertility Lubricant underwent biocompatibility testing including cytotoxicity per ISO 10993-5:2009, vaginal irritation per ISO 10993-10:2010, guinea pig maximization sensitization per ISO 10993-10:2010 and acute systemic toxicity per ISO 10993-11:2006. The testing demonstrated that the Pre-Seed™ Fertility Lubricant is biocompatible.
Non-clinical Performance Testing.
Human sperm survival assay (HSSA), and lubricant barrier assay testing was conducted and indicates that Pre-Seed™ Fertility Lubricant is compatible with sperm and does not inhibit sperm motility.
Condom Compatibility:
Pre-Seed™ Fertility Lubricant was tested for condom compatibility per ASTM D7661-10: Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. The results of this test indicate that Pre-Seed™ Fertility Lubricant is compatible with natural rubber latex and polyisoprene condoms. Pre-Seed™ Fertility Lubricant is not compatible with polyurethane condoms.
Shelf-Life:
Pre-Seed™ Fertility Lubricant has a 22-month shelf-life based on the results from accelerated and real-time stability testing. The results of accelerated aging shelf-life testing demonstrated that Pre-Seed IM Fertility Lubricant maintains its specifications for appearance/color, odor, pH, osmolality, viscosity. TAMC, TYMC, absence of pathogenic organisms, antimicrobial effectiveness, endotoxins, HSSA, and lubricant barrier testing over the duration of its proposed shelf-life of 22 months.
Substantial Equivalence:
The results of performance testing described above demonstrate that the Pre-Seed™ Fertility Lubricant is as safe and effective as the predicate device and supports a determination of substantial equivalence.