(95 days)
Personal Warming Lubricant is designed to enhance the ease and comfort of intimate activity and is compatible with latex condoms
Personal Warming Lubricant is a non-sterile, clear, nonstaining, non-greasy, high viscosity liquid gel used as a personal lubricant. This product is highly lubricous and may be used with or without a latex condom during intimate sexual activity.
The provided document is a 510(k) Premarket Notification for a Personal Warming Lubricant. The information primarily focuses on establishing substantial equivalence to a predicate device rather than presenting detailed acceptance criteria and a study proving performance against those criteria in the way a medical diagnostic or AI device submission might.
Based on the provided text, here's a breakdown of the requested information, adapted to the nature of this submission:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device (personal lubricant), the "acceptance criteria" are primarily related to safety, physical/chemical properties, and performance relative to the predicate device, rather than diagnostic accuracy metrics.
| Acceptance Criteria Category | Specific Criteria (Implicit or Explicit in Document) | Reported Device Performance |
|---|---|---|
| Stability | Successful completion of accelerated stability testing. | "Personal Warming Lubricant has successfully passed 90 day accelerated stability." |
| Preservative Effectiveness | Meeting requirements of Qualis, Inc. anti-microbial preservative challenge. | "Personal Warming Lubricant successfully passed the requirements of the Qualis, Inc., anti-microbial preservative challenge." (Reference to "Attachment D for the Preservative Effectiveness Study Report") |
| Comparison to Predicate Device | Perceptual qualities, physical and chemical properties, ingredients list, label claims, and packaging are acceptably comparable to the predicate device (K-Y Brand Warming Liquid Personal Lubricant). | "Personal Warming Lubricant was compared to K-Y Brand Warming Liquid Personal Lubricant on the basis of perceptual qualities, physical and chemical properties, ingredients list review, label claims, and packaging. The result of this review was an acceptable comparison." (Reference to "Attachment B for the ACTS comparison Report.") |
| Intended Use Compatibility | Designed to enhance ease and comfort of intimate activity and compatible with latex condoms. | Stated in "Indications For Use" section: "Personal Warming Lubricant is designed to enhance the ease and comfort of intimate activity and is compatible with latex condoms." Compatibility with latex condoms is a key aspect, implying some form of testing or ingredient analysis to confirm non-degradation of latex. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a numerical "sample size" for a traditional test set in the context of device performance testing for diagnostic accuracy. The studies mentioned (Stability, Preservative Effectiveness, Comparison to Predicate Device) would have involved samples of the product itself rather than human subjects or data sets in the way an AI/diagnostic device would. For the "Comparison with Predicate Device," the "test set" would implicitly be the new device and the predicate device being compared.
- Data Provenance: Not applicable in the traditional sense. The studies were non-clinical, involving the product itself.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This information is not provided in the document. For non-clinical product testing like stability or preservative effectiveness, "experts" might be laboratory technicians or chemists, but their number and specific qualifications are not detailed here. For the "perceptual qualities" comparison, it's possible human evaluators were used, but no details are given.
4. Adjudication Method for the Test Set
- This information is not provided and is generally not applicable for this type of non-clinical product submission. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical image or data interpretation studies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of cases, often with and without AI assistance, to measure changes in human reader performance. This personal lubricant submission does not involve such a scenario.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No, a standalone study was not done. This concept is specific to AI algorithms. This submission is for a physical product, not an algorithm.
7. The Type of Ground Truth Used
- For Stability: The "ground truth" is adherence to predefined physical/chemical specifications over time.
- For Preservative Effectiveness: The "ground truth" is successful inhibition of microbial growth according to established challenge test criteria.
- For Comparison to Predicate Device: The "ground truth" for "acceptable comparison" would be a qualitative and quantitative assessment of physical, chemical, and perceptual attributes aligning closely with the predicate device, as determined by laboratory analysis and potentially human sensory evaluation according to an internal protocol.
8. The Sample Size for the Training Set
- This information is not applicable. There is no "training set" for this type of product submission, as it does not involve machine learning or AI algorithms. Product development might involve various formulation iterations and testing, but these are not considered "training sets" in the AI context.
9. How the Ground Truth for the Training Set was Established
- This information is not applicable as there is no training set mentioned or implied in the context of an AI/ML device.
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APR 2 0 2004
510(k) Premarket Notification Personal Warming Lubricant
Page 1 of 2
510 (k) Summary of Information Respecting Safety and 9. Effectiveness
-
Legally Marketed Device. A.
Qualis Claims substantial equivalence to K-Y Brand Warming Liquid Personal Lubricant (K021492), currently in commercial distribution by Personal Products Company Division of McNeil-PPC inc.. -
Device Description. B.
Personal Warming Lubricant is a non-sterile, clear, nonstaining, non-greasy, high viscosity liquid gel used as a personal lubricant. This product is highly lubricous and may be used with or without a latex condom during intimate sexual activity. -
C. Intended Use.
Personal Warming Lubricant is designed to enhance the case and comfort of intimate activity and is compatible with latex condoms. -
Comparison with Predicate Device. D.
A summary comparison of the features of Personal Warming Lubricant and the Predicate Device K-Y Brand Warming Liquid Personal Lubricant is provided in Table 1. -
Performance Data E.
Non-Clinical Studies. -
- Stability.
Personal Warming Lubricant has successfully passed 90 day accelcrated stability.
- Stability.
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510(k) Premarket Notification Qualis, Inc. Personal Warming Lubricant
Кочов85
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Preservative Effectiveness. 2.
Personal Warming Lubricant successfully passed the requirements of the Qualis, Inc., anti-microbial preservative challenge. See Attachment D for the Preservative Effectiveness Study Report -
Comparison with Predicate Device. 3.
Personal Warming Lubricant was compared to K-Y Brand Warming Liquid Personal Lubricant on the basis of perceptual qualities, physical and chemical properties, ingredients list review, label claims, and packaging. The result of this review was an acceptable comparison. See Attachment B for the ACTS comparison Report.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 0 2004
Mr. Mike Peterson Quality Assurance Manager Qualis, Inc. 4600 Park Avenue DES MOINES IA 50321
Re: K040085
Trade/Device Name: Personal Warming Lubricant Regulation Number: 21 CFR §880.6375 Regulation Name: Patient Lubricant Product Code: 80 MMS Regulation Number: 21 CFR §884.5300 Regulation Name: Condom Product Code: 85 HIS Regulatory Class: II Dated: January 15, 2004 Received: January 23, 2004
Dear Mr. Peterson:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encroours) is the enactment date of the Medical Device Amendments, or to conimered provises that have been reclassified in accordance with the Federal Food, Drug, devices that have been receasined require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, therefore, mains of the Act include requirements for annual registration, listing of general controls provision practice, labeling, and prohibitions against misbranding and adulteration.
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 i Toast to advised that I Dr overan that your device complies with other requirements of the Act that I Dr Han made a and regulations administered by other Federal agencies. You must of any I edotal battatoo use as a requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set (21 CFR Part 007), faceming (25) regulation (21 CFR Part 820); and if applicable, the electronic rorni in the quinty of trol 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 allow you to begin marketing your antini equivalence of your device to a legally premarket notification. The PDA miding of succemand equivalias on 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 advice for your device on our last ling of your bers, based on the regulation number at the top of the letter.
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions on the promotion on the regulation entitled, "Masbranding
Office of Compliance at (301) 594-4639. Internation one one Othce of Compliance at (301) 554-4057. Tably processor.97) you may obtain. Othics general by reference to premarket notification (210) It it it is a be obtained from the Division of Small information on your responsionalism uncer the reach its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-drively and consem Manufacturers, International and Collisamer institution in the market in the manain. html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
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Indications for Use
・・・
510(k) Number (if known): K040085
Device Name: Personal Warming Lubricant
Indications For Use; Personal Warming Lubricant is designed to enhance the ease and comfort of intimate activity and is compatible with latex condoms
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel A. Denman
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number .
Page 1 of 1
§ 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.