(16 days)
The Art of Intimacy Response" ™ Liquid Personal lubricant is principally intended as personal lubricant to supplement the body's natural lubricating fluids, and to enhance the ease and comfort of intimate sexual activity with or without a latex condom.
The Art of Intimacy Response ™ is a homogenous blend of fluids. It is specifically formulated to be a clear, non-irritating, non-staining, non-greasy, medium viscosity liquid gel and is compatible for use with or without a latex condom during intimate sexual activity as evidenced by condom compatibility testing. The Art of Intimacy Response ™ is not a contraceptive or spermicide, nor does it contain any such component.
The provided text is a 510(k) summary for a personal lubricant, "The Art of Intimacy Response™ Personal Lubricant." It is a regulatory submission to the FDA and primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive study details in the way requested for a medical AI device.
Therefore, many of the requested categories for a rigorous AI device study analysis cannot be fulfilled from the provided document. The document primarily relies on conformity to industry standards and material safety, not a clinical trial comparing device performance against human experts or a gold standard using specific metrics.
Here's an attempt to extract and interpret information based on the provided text, highlighting what is available and what is missing:
Acceptance Criteria and Device Performance Study for "The Art of Intimacy Response™ Personal Lubricant"
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (from a regulatory/safety standpoint) | Reported Device Performance/Evidence |
|---|---|
| Condom Compatibility | Tested by independent laboratories; demonstrated "compatibility for use with or without a latex condom" (as evidenced by adherence to identified industry standards). |
| Biocompatibility | Tested by independent laboratories; results from identified industry standards. |
| Preservative Effectiveness | Tested by independent laboratories; results from identified industry standards. |
| Ingredient Safety (for Intended Use) | Contains ingredients "used in the manufacture of the predicate devices" and "meet specifications defined in the United State Pharmacopoeia (USP) or National Formulary (NF)" or "recognized as safe for their intended use." |
| Substantial Equivalence (overall) | Demonstrated through comparison of intended use, ingredients, and application to a legally marketed predicate device. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the document. The testing was conducted by "independent laboratories" using "identified industry standards." These standards likely define sample sizes for physical and chemical tests (e.g., condom integrity, cytotoxicity if applicable for biocompatibility).
- Data Provenance: The standard tests typically involve laboratory-controlled evaluations of the product itself, not human subjects or real-world usage data in the sense of a clinical trial for AI. No information on country of origin for specific test data is provided. The tests described are retrospective for the device's formulation, meaning they evaluate the final product's characteristics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This concept is not applicable to the evaluation of this personal lubricant as described. "Ground truth" in this context refers to established industry standards (e.g., ISO or ASTM standards for condom compatibility, USP/NF for ingredient purity). The "experts" would be the chemists, toxicologists, and engineers who developed and interpret these standards, as well as the laboratory personnel performing the tests according to these validated methods. No specific number or qualifications of individual experts are detailed.
4. Adjudication method for the test set
- Not applicable as described for AI studies. Performance is determined by whether the product meets the established scientific/engineering criteria outlined in the industry standards (e.g., tensile strength of condoms after lubricant exposure, growth inhibition in preservative effectiveness tests). There isn't an "adjudication" of expert opinions because the "truth" is defined by objective physical/chemical measurements against predefined thresholds.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is not an AI device, and therefore no MRMC study was conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI device. The described tests are evaluations of the product's physical and chemical properties in a standalone manner (the lubricant itself), not an algorithm.
7. The type of ground truth used
- The "ground truth" for this device's safety and effectiveness relies on adherence to established industry standards and pharmacopeial monographs. This includes:
- Standards for condom compatibility (e.g., ISO, ASTM standards for lubricants claiming condom compatibility).
- Standards for biocompatibility (e.g., ISO 10993 series relevant for topical applications, though not explicitly cited).
- Standards for preservative effectiveness (e.g., USP <51> Antimicrobial Effectiveness Testing).
- Chemical and purity specifications from United State Pharmacopoeia (USP) or National Formulary (NF) for ingredients.
8. The sample size for the training set
- Not applicable. This is not an AI device. There is no concept of a "training set."
9. How the ground truth for the training set was established
- Not applicable. This is not an AI device. No ground truth for a training set was established.
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K05/668
Page 1 of 2
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS (21 CFR 807.92) [21 CFR 807.87(H)]
The Art of Intimacy Response ™ Personal Lubricant
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe In accordance with the Food and Drug Auministration new York, this information Medical Devices ACt of 1990 and in officitions with of Intimacy Response ™ Personal Lubricant
| Submitted By:Date:Contact Person: | Goodmark USA, Inc.March 8, 2005Boston TalbertProject Manager |
|---|---|
| Proprietary Name: | The Art of Intimacy Response ™ |
| Common Name: | Personal Lubricant |
| Classification Name: | The General Hospital and Personal Use Device section ofthe General Medical Devices Panel within the FDA'sCenter for Medical Device & Radiological Health considerspatient lubricants (21 CFR §880.6375, Class I) to beClass II devices when promoted as being compatible foruse with condoms (21 CFR §884.5300) |
| Intended Use: | The Art of Intimacy Response ™ Liquid Personal lubricantis principally intended as personal lubricant to supplementthe body's natural lubricating fluids, and to enhance theease and comfort of intimate sexual activity with or withouta latex condom. |
Device Description
Device Description The Art of millings of Rosponso - 16 a horners on fluids. It is specifically formulated to be a clear, supplement the body s own hatural lubriscosity liquid gel and is compatible for use with or non-intalling, non-starting, mgn-hectivity as evidenced by condom compatibility williout a latex condom daning intimate contraceptive or spermicide, nor does it contain any such component
Summary of Technological Characteristics
The Art of Intimacy Response ™ Liquid Personal lubricant contains ingredients that are The Art of Intimaty Acoponos - used in the manufacture of the predicate devices. The ingredients meet specifications defined in the United State Pharmacopoeia (USP) or National ingrediction most openized as safe for their intended use" (21 CFR 172.515).
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The product was tested by independent laboratories for condom compatibility, biocompatibility The product was tested by independent laboratorious for only the devices and preservative enectiveness. Thia results from the identified industry standards.
Substantial Equivalence Information:
Substantial Equivalence Information:
The intended use, ingredients, and application of the proposed device are substantially The intended use, ingledients, and application of the proposatial equivalence, the Art of equivalent to those of the predicate device. "In acteming as ally marketed device to which the Sponsor claims substantial equivalence.
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Image /page/2/Picture/1 description: The image shows a black and white logo. The logo features a stylized bird in flight, with three curved lines representing its body and wings. The word "DEPARTMENT" is written vertically along the left side of the logo, following the curve of the bird's wing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL = 8 2005
Goodmark USA, Inc. c/o Mr. Mark Job Regulatory Technology Services, Inc. 1394 25th Street, NW BUFFALO MN 55313
Re: K051668
Trade/Device Name: The Art of Intimacy Response™ Personal Lubricant Regulation Number: 21 CFR §884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: June 18, 2005 ري جي جي Received: June 22, 2005
Dear Mr. Job:
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 electronic 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) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results 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 contact the Office of Compliance at one of 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 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy 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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510(k) Premarket Notification The Art of Intimacy Response ™ Liquid Personal Lubricant
Indications For Use
Page _________________________________________________________________________________________________________________________________________________________________________ of 1 510(k) Number (if known):
Device Name: The Art of Intimacy Response™ Personal Lubricant
Indications for Use:
"The Art of Intimacy Response" ™ Liquid Personal lubricant is principally intended as personal lubricant to supplement the body's natural lubricating fluids, and to enhance the ease and comfort of intimate sexual activity with or without a latex condom.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) Over-The Counter Use
(Optional Format 1-2-96)
David W. Lynn
(Division Sign-Off)
Division of Reproductive, Abdomi
and Radiological Devices
510(k) Number
Ko
§ 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.