(73 days)
K-Y® Brand SENSUAL MIST™ is intended as a personal lubricant (for penile and vaginal application) compatible with latex condom.
This device is a condom compatible personal lubricant that has been specifically developed to be delivered via a non-aerosol spray pump.
The provided text describes a 510(k) Special Device Modification for the K-Y® Brand SENSUAL MIST™ Personal Lubricant. The filing emphasizes the device's substantial equivalence to predicate devices, particularly K-Y® Brand Liquid. However, the document does not contain explicit acceptance criteria or a study designed to prove the device meets specific performance criteria in the way one might expect for a new, high-risk medical device.
Instead, the submission focuses on demonstrating substantial equivalence to an existing, legally marketed predicate device (K-Y® Brand Liquid). This means the primary "acceptance criterion" is that the modified device performs equivalently to the predicate and is safe and effective for its intended use.
Here's an analysis of the provided information, framed to answer your questions where possible:
1. Table of Acceptance Criteria and Reported Device Performance
As explicit quantitative "acceptance criteria" and their corresponding device performance values are not detailed in the provided text (like sensitivity, specificity, accuracy, etc.), I will extrapolate the information based on the nature of a 510(k) substantial equivalence submission for a personal lubricant.
| Acceptance Criteria (Inferred from 510(k) Submission) | Reported Device Performance |
|---|---|
| 1. Condom Compatibility: Compatible with leading commercial brands of latex condoms. | "Laboratory test results demonstrated that the proposed device is compatible with the leading commercial brands of latex condoms." |
| 2. Lubricity: Comparable lubricity to the predicate device. | "Lubricity of the proposed device is comparable to the lubricity of predicate device." |
| 3. Ingredient Safety: Ingredients are generally recognized as safe (GRAS) for use in personal lubricant products. | "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." |
| 4. Inhalation Safety (Particle Size): Not likely to reach deep lung (alveolar region) upon inhalation. | "The particle size analysis data suggest that any inhalation of the product is not likely to reach the deep lung (i.e., alveolar region)." |
| 5. Non-sensitizing: Does not cause skin sensitization. | "The human RIPT shows that the proposed device is non-sensitizing." |
| 6. Overall Equivalence: Substantially equivalent to currently marketed products in technology, intended use, safety, and suitability. | "The proposed device is substantially equivalent to the currently marketed products in technology, intended use, safety, and suitability characteristics." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated in terms of a specific number of instances. The document mentions "leading commercial brands of latex condoms" for compatibility testing, but not the number of condoms tested. For the "human RIPT," it doesn't specify the number of human participants.
- Data Provenance: The studies mentioned ("laboratory testing," "pre-clinical evaluations," and "human RIPT") appear to be prospective studies conducted specifically for this device modification. The country of origin of the data is not specified, but given the submitter's location (Skillman, NJ, USA) and the FDA submission, it's presumed to be conducted or overseen within the US or to standards acceptable for US regulatory submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This information is not provided in the document. The studies described are more focused on direct physical/chemical properties (condom compatibility, lubricity, particle size) and biological responses (RIPT) rather than expert-based "ground truth" establishment for diagnosis or interpretation.
4. Adjudication Method for the Test Set
- This information is not applicable/not provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where multiple human readers interpret data (e.g., medical images) and their disagreements need to be resolved to establish a ground truth. The studies for this lubricant are laboratory and pre-clinical in nature.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or is not described. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., radiology AI). The K-Y® Brand SENSUAL MIST™ is a personal lubricant, and its evaluation does not involve human readers interpreting "cases."
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
- Applicable in a different context: While not an "algorithm" in the AI sense, the performance data presented (condom compatibility, lubricity, particle size analysis, RIPT) can be considered "standalone" performance evaluations of the device itself, without human intervention in its efficacy assessment in the way a human-in-the-loop study would assess an AI. The device's properties were tested objectively.
7. Type of Ground Truth Used
- The "ground truth" in this context is established through a combination of:
- Laboratory measurements: For condom compatibility, lubricity (presumably measured by standardized methods), and particle size analysis.
- Pre-clinical evaluations: For ingredient safety.
- Human RIPT (Repeat Insult Patch Test): For skin sensitization, where the "ground truth" is the observed biological reaction (or lack thereof) in human participants.
- Regulatory standards/guidelines: Underlying the expectation for GRAS ingredients and the design of the RIPT.
8. Sample Size for the Training Set
- Not applicable/not provided. The concept of a "training set" is relevant for machine learning algorithms. This submission is for a physical medical device (personal lubricant), not an AI/ML algorithm.
9. How Ground Truth for the Training Set Was Established
- Not applicable/not provided. As there is no training set for an AI/ML model, the establishment of ground truth for such a set is not relevant to this submission.
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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]
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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 withlatex condom. |
|---|---|
| Indicationsstatement | This device and predicate devices have similar indications, by being appliedto the vaginal area or condom in order to enhance comfort and ease ofintimate activity. |
| Technologicalcharacteristics | The device has the same technological characteristics as the currentlymarketed condom compatible personal lubricants. |
| Performancedata | The results from laboratory testing, pre-clinical evaluations, and human RIPTshow that the proposed device performs equivalently to the predicate device.Laboratory test results demonstrated that the proposed device is compatiblewith the leading commercial brands of latex condoms. Lubricity of theproposed device is comparable to the lubricity of predicate device. |
| The ingredients used in the formulation of the proposed device are generallyrecognized as safe (GRAS) and the pre-clinical evaluation of the ingredientshas determined that they are safe for use in personal lubricant products.The particle size analysis data suggest that any inhalation of the product is notlikely to reach the deep lung (i.e., alveolar region). The alveolar regionrepresents the region of the respiratory tract where the most potentiallyserious health consequences may occur. The human RIPT shows that theproposed device is non-sensitizing. | |
| Conclusion | The proposed device is substantially equivalent to the currently marketedproducts in technology, intended use, safety, and suitability characteristics. |
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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.
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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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(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|
§ 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.