(263 days)
Not Found
No
The device description and performance studies focus on the chemical composition and physical properties of a personal lubricant and its applicator. There is no mention of any computational or data-driven components that would suggest the use of AI or ML.
No
Explanation: The device is a personal lubricant intended to moisturize and lubricate, which are not considered therapeutic actions. It is indicated to supplement natural lubrication and enhance comfort during sexual activity, rather than to treat a disease or condition. The provided information also mentions biocompatibility and condom compatibility testing, which are not typically associated with therapeutic devices. Additionally, the predicate device is a vaginal moisturizer, further indicating its non-therapeutic nature.
No.
The document explicitly states that Satisfaite™ is a personal lubricant intended to moisturize and lubricate to enhance comfort during sexual activity, not to diagnose any condition.
No
The device description explicitly states it consists of a "polypropylene plastic applicator pre-filled with the lubricant," indicating it is a physical medical device with hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a personal lubricant for vaginal application to moisturize, lubricate, and enhance sexual activity. This is a physical function, not a diagnostic one.
- Device Description: The description details a topical lubricant and applicator for direct application to the vaginal mucosa. It does not involve testing a sample of bodily fluid or tissue in vitro (outside the body) to diagnose a condition.
- Lack of Diagnostic Function: There is no mention of the device being used to detect, measure, or analyze any biological markers or substances to provide diagnostic information.
- Performance Studies: The performance studies focus on physical properties (condom compatibility), biocompatibility (safety for the body), and microbial testing (product purity), not on diagnostic accuracy or performance.
- Predicate Device: The predicate device is also a vaginal moisturizer, further supporting the classification as a non-diagnostic device.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not perform such a function.
N/A
Intended Use / Indications for Use
Satisfaite™ is a personal lubricant, for vaginal application, intended to moisturize and lubricate, to supplement the body's natural lubrication, and to enhance the ease and comfort of intimate sexual activity. This product is compatible with natural rubber, latex, and polyisoprene condoms; and is not compatible with polyurethane condoms.
Product codes
NUC
Device Description
Satisfaite™ is a topically applied, water-based personal lubricant for vaginal application, intended to moisturize and lubricate, and to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. Satisfaite™ is self-administered to the user via a prefilled unit dose applicator for intravaginal administration. The device consists of the polypropylene plastic applicator pre-filled with the lubricant. The three main ingredients of the lubricant by percent weight are purified water, glycerin and propylene glycol. Each pre-filled applicator holds 1 gram of lubricant and is for a single use in a home environment. Each pre-filled applicator is individually over-wrapped with a disposable polypropylene sleeve and packaged 10 units to a cardboard box. The lubricant makes direct patient contact with the vaginal mucosa and has a contact duration of ), Total Combined Yeast/Mold Count (USP ), Antimicrobial Effectiveness (USP ), Absence of Pathogenic Organism (USP 61/62)) met the requirements of the standards and demonstrated the device met specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 13, 2019
FemmePharma Consumer Healthcare, LLC % Stuart Goldman Sr. Consultant, RA/OA Emergo by UL 2500 Bee Cave Road, Bldg. 1, Suite 300 Austin, TX 78746
Re: K190752
Trade/Device Name: Satisfaite Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: November 14, 2019 Received: November 15, 2019
Dear Stuart Goldman:
We have reviewed vour 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/cfpmp/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
1
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 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-regulatory-information/postmarketing-safety-reportingcombination-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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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 Sharon M. Andrews 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) K190752
Device Name Satisfaite™M
Indications for Use (Describe)
Satisfaite™ is a personal lubricant, for vaginal application, intended to moisturize and lubricate, to supplement the body's natural lubrication, and to enhance the ease and comfort of intimate sexual activity. This product is compatible with natural rubber, latex, and polyisoprene condoms; and is not compatible with polyurethane condoms.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
|X | 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 Satisfaite™
1. Submission Sponsor
FemmePharma Consumer Healthcare, LLC 175 Strafford Ave. Bldg. 4, Suite 275 Wayne, PA 19087 USA Phone: (610) 995-0801 Contact: Gerianne DiPiano Title: Chief Executive Officer Email: gerianne@femmepharma.com
2. Submission Correspondent
Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 USA Phone: (512) 327-9997 Contact: Stuart R. Goldman Title: Sr. Consultant RA/QA Email: Stuart.Goldman@UL.com
3. Date Prepared
December 12, 2019
4. Device Identification
Trade/Proprietary Name: Satisfaite™ Common/Usual Name: Personal Lubricant Classification Name: Condom Regulation Number: 21 CFR 884.5300 Product Code: NUC Class: II Classification Panel: Obstetrics/Gynecology
5. Predicate Device Identification
Replens™ Long-Lasting Vaginal Moisturizer (in 35g Tube with Reusable Applicator) – K101098. The predicate device has not been subject to a design related recall.
4
6. Device Description
Satisfaite™ is a topically applied, water-based personal lubricant for vaginal application, intended to moisturize and lubricate, and to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. Satisfaite™ is self-administered to the user via a prefilled unit dose applicator for intravaginal administration.
The following features, characteristics and properties are applicable to Satisfaite™:
- a. The device consists of the polypropylene plastic applicator pre-filled with the lubricant. The three main ingredients of the lubricant by percent weight are purified water, glycerin and propylene glycol. Each pre-filled applicator holds 1 gram of lubricant and is for a single use in a home environment.
- b. Each pre-filled applicator is individually over-wrapped with a disposable polypropylene sleeve and packaged 10 units to a cardboard box.
- c. The lubricant makes direct patient contact with the vaginal mucosa and has a contact duration of acceptance criteria for Category 2 products vii.
- viiii. total microbial count: for TAMC | Conforms with
USP | Similar |
| USP | Conforms with
USP for TYMC | Conforms with
USP | Similar |
| Antimicrobial
Effectiveness
USP | Conforms with
USP | Conforms with
USP | Similar |
| Biocompatibility
ISO 10993-1 | ISO 10993-5
ISO 10993-10
ISO 10993-11 | Conforms with
ISO 10993-1 and its
applicable parts. | Same |
| Condom
compatibility
ASTM D7661-10 | Compatible with natural rubber latex,
and polyisoprene condoms.
NOT compatible with polyurethane
condoms | Compatible with natural
rubber latex, polyisoprene,
and polyurethane
condoms. | The subject device is
not compatible with
polyurethane condoms,
while the predicate is
compatible. |
- viiii. total microbial count: for TAMC | Conforms with
Table 5-1 –Comparison of Satisfaite™ vs. Replens®
6
The differences in technological characteristics between Satisfaite™ and Replens™ do not raise different questions of safety and effectiveness.
9. Non-Clinical Performance Data
As part of demonstrating substantial equivalence of Satisfaite™ to Replens®, FemmePharma Consumer Healthcare submitted their device for testing in accordance with the applicable parts of the following voluntary standards. Results confirm that the design inputs and performance specifications for the device are met. Satisfaite™ passed all testing in accordance with the standards shown below, and therefore its substantial equivalence to the predicate devices:
- . Condom Compatibility (ASTM D7661-10)
- testing showed that Satisfaite™ is compatible with: o
- . natural rubber latex condoms
- polyisoprene condoms
- o testing showed that Satisfaite™ is not compatible with:
- . polyurethane condoms
- testing showed that Satisfaite™ is compatible with: o
- Biocompatibility studies, including Cytotoxicity, Sensitization, Vaginal Irritation, and Acute Systemic Toxicity Testing were performed in accordance with the 2016 FDA guidance document Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices –Part 1: Evaluation and testing within a risk management process" and ISO 10993-1:2009 as follows:
7
- Cytotoxicity (ISO 10993-5:2009) O
- o Sensitization (ISO 10993-10:2010)
- o Vaginal Irritation (ISO 10993-10:2010)
- o Acute Systemic Toxicity (ISO 10993-11:2017)
The results of this testing demonstrated that the subject lubricants are not cytotoxic, not sensitizing, not irritating and non-systemically toxic.
- . Microbial - Total Aerobic Microbial Count (USP ) testing met the requirements of the standard and demonstrated the device met specifications o
- . Microbial - Total Combined Yeast/Mold Count (USP )
- testing met the requirements of the standard and demonstrated the device met specifications o
- . Microbial - Antimicrobial Effectiveness (USP )
- testing met the requirements of the standard and demonstrated the device met specifications o
- . Microbial – Absence of Pathogenic Organism (USP 61/62)
- o testing met the requirements of the standard and demonstrated the device met specifications
10. Conclusion
The results of the non-clinical testing described above demonstrate that the subject device is as safe and effective as the predicate device and supports a determination of substantial equivalence.