(73 days)
K-Y® Brand Liquid
Not Found
No
The 510(k) summary describes a personal lubricant and its performance characteristics, with no mention of AI or ML technology in the intended use, device description, or performance studies.
No.
The document states the device is intended as a personal lubricant for penile and vaginal application, which is not considered a therapeutic use.
No
Explanation: The device is a personal lubricant, as stated in the 'Intended Use / Indications for Use' and 'Device Description' sections. Its purpose is to facilitate physical intimacy, not to diagnose any medical condition.
No
The device description clearly states it is a "condom compatible personal lubricant" delivered via a "non-aerosol spray pump," indicating it is a physical product (lubricant) and a hardware component (spray pump), 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 clearly stated as a "personal lubricant (for penile and vaginal application) compatible with latex condom." This is a topical application for lubrication during sexual activity.
- Device Description: The description reinforces its function as a "condom compatible personal lubricant."
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose, monitor, or treat any medical condition by examining samples from the human body (like blood, urine, tissue, etc.). IVDs are specifically designed for these types of analyses.
- Performance Studies: The performance studies focus on lubricity, condom compatibility, safety of ingredients, particle size (related to potential inhalation), and skin sensitization. These are all relevant to a personal lubricant, not a diagnostic test.
Therefore, the K-Y® Brand SENSUAL MIST™ is a personal lubricant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of this device is as a personal lubricant compatible with latex condom.
This device and predicate devices have similar indications, by being applied to the vaginal area or condom in order to enhance comfort and ease of intimate activity.
Product codes (comma separated list FDA assigned to the subject device)
NUC, MMS
Device Description
This device is a condom compatible personal lubricant that has been specifically developed to be delivered via a non-aerosol spray pump.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vaginal area
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)
The results from laboratory testing, pre-clinical evaluations, and human RIPT show that the proposed device performs equivalently to the predicate device. Laboratory test results demonstrated that the proposed device is compatible with the leading commercial brands of latex condoms. Lubricity of the proposed device is comparable to the lubricity of predicate device.
The ingredients used in the formulation of the proposed device are generally recognized as safe (GRAS) and the pre-clinical evaluation of the ingredients has determined that they are safe for use in personal lubricant products. The particle size analysis data suggest that any inhalation of the product is not likely to reach the deep lung (i.e., alveolar region). The alveolar region represents the region of the respiratory tract where the most potentially serious health consequences may occur. The human RIPT shows that the proposed device is non-sensitizing.
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.
K-Y® Brand Liquid
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
Personal Product Company Division of McNeil - PPC, Inc.
Special 510(k) Device Modification
(Appendix A) FEB 1 7 2006 510(k) Summary of Safety and Effectiveness -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------and the same of the same of the same of the same of the same of the same of the same of the same of the same of the seat of the seat of the seat of the seat of the seat of th Personal Products Company Submitter Division of McNeil - PPC, Inc. 199 Grandview Road Skillman, NJ 08558 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Nader Fotouhi, Ph.D. Contact Manager, Regulatory Affairs Personal Product Company Division of McNeil - PPC, Inc. 199 Grandview Road Skillman, NJ 08558 Phone: (908) 904-3730 Fax: (908) 904-3748 December 5, 2005 Date K-Y® Brand SENSUAL MIST™ Trade Name Personal Lubricant Common Name HIS - Condom (21CFR 884.5300) Classification MMS - Patient Lubricant (21CFR 880.6375) Name This modification of the device is substantially equivalent to currently Statement marketed predicate devices, K-Y® Brand Liquid. This device is a condom compatible personal lubricant that has been Device specifically developed to be delivered via a non-aerosol spray pump. description ート - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
[INFORMATION IN BRACKETS IS CONSIDERED CONFIDENTIAL]
Page 41
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Special 510(k) Device Modification
K053 397
510(k) Summary of Safety and Effectiveness (Continued)
| Intended use | The intended use of this device is as a personal lubricant compatible with
latex condom. |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
statement | This device and predicate devices have similar indications, by being applied
to the vaginal area or condom in order to enhance comfort and ease of
intimate activity. |
| Technological
characteristics | The device has the same technological characteristics as the currently
marketed condom compatible personal lubricants. |
| Performance
data | The results from laboratory testing, pre-clinical evaluations, and human RIPT
show that the proposed device performs equivalently to the predicate device.
Laboratory test results demonstrated that the proposed device is compatible
with the leading commercial brands of latex condoms. Lubricity of the
proposed device is comparable to the lubricity of predicate device. |
| | The ingredients used in the formulation of the proposed device are generally
recognized as safe (GRAS) and the pre-clinical evaluation of the ingredients
has determined that they are safe for use in personal lubricant products.
The particle size analysis data suggest that any inhalation of the product is not
likely to reach the deep lung (i.e., alveolar region). The alveolar region
represents the region of the respiratory tract where the most potentially
serious health consequences may occur. The human RIPT shows that the
proposed device is non-sensitizing. |
| Conclusion | The proposed device is substantially equivalent to the currently marketed
products in technology, intended use, safety, and suitability characteristics. |
2
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 7 2006
Nader Fotouhi, Ph.D. Manager, Regulatory Affairs Personal Products Company Division of McNeil-PPC, Inc. 199 Grandview Road SKILLMAN NJ 08558
Re: K053397
Trade/Device Name: K-Y® Brand SENSUAL MIST Regulation.Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: January 30, 2006 Received: February 2, 2006
Dear Dr. Fotouhi:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable. the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you'to obgh mationing of substantial equivalence of your device to a legally premaired nothoution: " Presults in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific active for your de received in the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, prease note the regulation entires, formation on your responsibilities under the Act from the 007.77). Tou may obtain other gamer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/industrv/support/index.html
Sincerely vours.
T. Nancy C. Brigdon
Naney C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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ーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーー
(Appendix C)
Indications for Use Statement
510(k) Number, if known
Device Name: K-Y® Brand SENSUAL MIST™
Indications for Use:
indications for USe:
K-Y® Brand SENSUAL MIST™ is intended as a personal lubricant (for penile and vaginal application) compatible with latex condom.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
OR Over-the-Counter Use Prescription Use_
Gaird A. Bergman
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _
IINFORMATION IN BRACKETS IS CONSIDERED CONFIDENTIAL|