(131 days)
Not Found
No
The device description and performance studies focus on the chemical composition and physical properties of a personal lubricant, with no mention of AI or ML technology.
No.
The lubricant's intended use is to moisturize, lubricate, and enhance comfort during sexual activity, not to treat or prevent a disease or condition.
No
The device is a personal lubricant intended to moisturize and lubricate for comfort during intimate sexual activity, not to diagnose any condition.
No
The device is a personal lubricant, described as a liquid composed of chemical ingredients and packaged in a bottle. It is a physical product, not software.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication." This describes a topical product for physical application, not a test performed on samples taken from the body to diagnose or monitor a condition.
- Device Description: The description details a "water soluble, clear, colorless, viscous liquid" composed of various chemical ingredients. This is consistent with a personal lubricant, not a diagnostic test kit or instrument.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
- Over-The-Counter Use: IVDs are typically used in clinical settings or require specific instructions for home use related to diagnosis or monitoring. This product is sold over-the-counter for personal use during sexual activity.
In summary, the description clearly indicates that Poise Personal Lubricant is a personal care product intended for physical lubrication, not a diagnostic device.
N/A
Intended Use / Indications for Use
Poise Personal Lubricant is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is not compatible with natural rubber latex condoms but is compatible with polyisoprene and polyurethane condoms.
Product codes (comma separated list FDA assigned to the subject device)
NUC
Device Description
Poise Personal Lubricant is a water soluble, clear, colorless, viscous liquid composed of purified water, hydroxyethyl cellulose (Natrosol 250), propylene glycol, benzoic acid and sodium hydroxide. Poise Personal Lubricant is presented as a non-sterile product. It is neither a contraceptive nor a spermicide and is sold over-the-counter. The product is packaged in a seventy-four ml plastic, cylindrical pump bottle placed inside a display carton. The outside of the display carton contains a tamper evident seal. Poise Personal Lubricant is a non-greasy and fragrance-free formulation which contains only United States Pharmacopeia (USP) or National Formulary (NF) ingredients.
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
Over-The-Counter
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)
Preclinical toxicology (biocompatibility) tests were conducted for cytotoxicity, sensitization, vaginal irritation, subacute toxicity, genotoxicity (In vitro Bacterial Reverse Mutation, In vitro Chromosome Aberration, In Vivo Mouse Micronucleus), and ocular irritation, with results indicating non-cytotoxic, non-sensitizing, non-irritating, non-systemically toxic, and non-genotoxic properties. Oral toxicity assessment concluded the product as Non-Toxic. Preclinical Microbiological Testing on three process validation lots met USP criteria for microbial limits. These studies supported the conclusion of safety and effectiveness equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Cytotoxicity: Non-cytotoxic ≤ 3.13%
Sensitization: Non-sensitizing
Vaginal Irritation: Non-irritating
Subacute Toxicity: Non-systemically toxic
Genotoxicity: Non-genotoxic for all three study types
Ocular Irritation: Non-irritating
Microbial Limits Test: ≤ 100 cfu (colony forming unit)/ml and no objectionable organisms.
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
දිගු Kimberly-Clark Corporation
.
Traditional 510(k) for Kimberly-Clark Poise® Personal Lubricant
JUL 1 1 2012
·
,
.
Section 5. 510(K) Summary
·
Summary of Safety and Effectiveness Information
| Submitter's Name: | Kimberly-Clark Corporation |
|---|---|
| Submitter's Address: | 2100 Winchester Road |
| Neenah, WI 54956 |
Mailing address for regulatory correspondence:
1400 Holcomb Bridge Road
Roswell, GA 30076-2199
Contact Person: Swarna Mukund Ph. D. |
| Submitter's Phone No: | 770-587-8083 |
| Submitter's Fax No. | 920-225-3632 |
| Date of Preparation: | February 29, 2012 |
| Trade Name: | Poise® Personal Lubricant |
| Device Common Name: | Personal Lubricant |
| Classification Name: | Condom |
| Classification Product Code: | NUC (Lubricant, Vaginal, Patient, Latex Compatible) |
| Regulation Number: | 21CFR884.5300 |
| Regulatory Class: | Class II |
| Legally marketed device to which equivalency is claimed: | Durex® Play™ Lubricant (K032124) (Marketed as Durex® Play™ More) |
| Intended Use: | Poise Personal Lubricant is a personal lubricant, for penile
and/or vaginal application, intended to moisturize and lubricate,
enhance the ease and comfort of intimate sexual activity and
supplement the body's natural lubrication. This product is not
compatible with natural rubber latex condoms but is compatible
with polyisoprene and polyurethane condoms. |
1
Kimberly-Clark Corporation
Traditional 510(k) for Kimberly-Clark Poise® Personal Lubricant
Description of the device:
Poise Personal Lubricant is a water soluble, clear, colorless, viscous liquid composed of purified water, hydroxyethyl cellulose (Natrosol 250), propylene glycol, benzoic acid and sodium hydroxide. Poise Personal Lubricant is presented as a non-sterile product. It is neither a contraceptive nor a spermicide and is sold over-the-counter. The product is packaged in a seventy-four ml plastic, cylindrical pump bottle placed inside a display carton. The outside of the display carton contains a tamper evident seal. Poise Personal Lubricant is a non-greasy and fragrance-free formulation which contains only United States Pharmacopeia (USP) or National Formulary (NF) ingredients.
Summary of technological characteristics compared to the predicate device:
Poise Personal Lubricant has been shown to be substantially equivalent to the predicate device Durex Play More in terms of technological characteristics such as being water-based and non-sterile, color/appearance/odor, pH, viscosity, specific gravity, osmolality and longlasting lubricity measured as coefficient of friction. Poise Personal Lubricant and Durex Play More contain identical formulation components. Stability studies conducted in accordance with ICH Q1a and Consumer Health Products Association (CHPA) stability guidelines confirm a shelf life of two years for the Poise Personal Lubricant product; the same as that for the predicate device, Durex Play More.
Durex Play More is labeled as condom compatible whereas the label for Poise Personal Lubricant says that the product is not compatible with natural rubber latex condoms but is compatible with polyisoprene and polyurethane condoms in condom compatibility testing conducted according to the standards defined by ASTM-D7661-10. No new questions of safety or effectiveness are presented.
Based on the comparisons above, nonclinical performance data, biocompatibility review and testing and safety data, we conclude that Poise Personal Lubricant and Durex Play More are substantially equivalent with regards to the general intended use, safety and efficacy.
Brief description of preclinical toxicology (biocompatibility) tests:
Table 5-1 provides the biocompatibility tests conducted and the results obtained for Poise Personal Lubricant.
2
23 Kimberly-Clark Corporation
| 20650
Traditional 510(k) for Kimberly-Clark Poise® Personal Lubricant
Biocompatibility Test Results of Poise Personal Lubricant Table 5-1:
| Endpoint of
Toxicological
| Concern | Study Type | Reference | Result |
|---|---|---|---|
| Cytotoxicity | In Vitro Cytotoxicity | 10993-05 | *Non-cytotoxic |
| $≤$ 3.13% | |||
| Sensitization | In Vivo - Guinea Pig Maximization | ||
| Assay | 10993-10 | Non-sensitizing | |
| Vaginal Irritation | Rabbit Vaginal Irritation | 10993-10 | Non-irritating |
| Subacute Toxicity | Two week, Rabbit Vaginal Exposure | 10993-11 | Non-systemically |
| toxic | |||
| Genotoxicity | In vitro Bacterial Reverse Mutation | 10993-03, | |
| OECD 471 | Non-genotoxic | ||
| In vitro Chromosome Aberration | 10993-03, | ||
| OECD 473 | Non-genotoxic | ||
| In Vivo Mouse Micronucleus | 10993-03, | ||
| OECD 474 | Non-genotoxic | ||
| Ocular Irritation | In Vitro, 3D Cell Culture (EpiOcular) | MatTek | |
| EpiOcular MTT | |||
| Viability Assay | Non-irritating |
*This formulation contains Propylene Glycol which in vitro has a moderate cytotoxic potential. Cytotoxicity is not demonstrated in vivo for propylene glycol or for Poise Personal Lubricant.
Oral Toxicity Assessment: The components of the Poise Personal Lubricant formulation have been individually assessed for oral toxicity. These components are Generally Recognized as safe (GRAS) with use levels significantly less than accepted ingestible amounts. Hence, the lubricant product is assessed as Non-Toxic with regards to oral toxicity.
Preclinical Microbiological Testing:
Microbial Limits Test was conducted on three process validation lots as per USP and . The product release specification for this test is ≤ 100 cfu (colony forming unit)/ml and no objectionable organisms to meet lot acceptance criteria. It was found that all three process validation lots met the specification for microbial limits testing by meeting the USP criteria.
3
Traditional 510(k) for Kimberly-Clark Poise® Personal Lubricant
Safety and Effectiveness Assessment:
The subject 510(k) device has undergone extensive biocompatibility, microbiological, stability, and nonclinical laboratory performance testing as described above and in subsequent sections. The results of these studies support the conclusion that the subject 510(k) device is equivalent and as safe and effective as the predicate device, Durex Play More.
Conclusions:
Based on the results of biocompatibility testing and nonclinical performance testing, Poise Personal Lubricant is safe for its intended use and is substantially equivalent to the predicate device, Durex Play More, in terms of general intended use, safety and effectiveness.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002
Swarna Mukund, Ph.D. Regulatory Affairs Technical Leader Kimberly-Clark Corporation 1400 Holcomb Bridge Road ROSWELL GA 30076
JUL 1 1 2012
Re: K120650
Trade/Device Name: Kimberly-Clark* Poise® Personal Lubricant Regulation Number: 21 CFR$ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: July 2, 2012 Received: July 3, 2012
Dear Dr. Mukund:
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 I ou may , and so visions 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 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
5
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set de vice-relation adverse events) (21 CER Part 820); and if applicable, the electronic forth in the quant) 2500 m (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 11 10 http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.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 I ou may 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,
Sincerely yours,
Benjamin R. Tucker
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
6
(Kimberly-Clark Corporation
INDICATIONS FOR USE
| Applicant: | Kimberly-Clark Corporation |
|---|---|
| 510(k) Number: | K120650 |
| Device Name: | Kimberly-Clark* Poise® Personal Lubricant |
| Indications for use: | Poise Personal Lubricant is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is not compatible with natural rubber latex condoms but is compatible with polyisoprene and polyurethane condoms. |
Prescription Use Per 21CFR 801.109 Subpart D Over-The-Counter X Per 21CFR 801.109 Subpart C
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH Office of Device Evaluation (ODE)
Hels Rumer
on Sidn-C of Reproductive, Gastro-Renal, and 510(k) Number