(336 days)
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Not Found
No
The summary describes a personal lubricant and does not mention any AI or ML capabilities.
No
The device is a lubricant intended to facilitate the entry of a diagnostic or therapeutic device, but it is not a therapeutic device itself. Its primary function is lubrication for sexual activity and to assist other devices, not to treat a condition.
No
Explanation: The device is a lubricant intended to facilitate the entry of diagnostic or therapeutic devices, or to enhance sexual activity, but it does not perform any diagnostic function itself.
No
The device description clearly states "Good Lubrications Personal Lubricant," which is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a lubricant for facilitating entry of diagnostic or therapeutic devices into a body orifice, and as a personal lubricant for intimate activities. This involves direct interaction with the body and its orifices, not the examination of samples taken from the body (which is the core of IVD).
- Device Description: The device is described as a "Personal Lubricant." This aligns with its intended use as a topical or internal lubricant, not a diagnostic test.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting specific substances or markers
- Providing diagnostic information about a disease or condition
Therefore, based on the provided text, Good Lubrications Personal Lubricant is a medical device, but it falls under a different classification than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Good Lubrications patient lubricant is a medical device intended for medical purposes to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.
Good Lubrications is recommended as a personal lubricant to enhance intimate activities. It is designed to help enhance the sexual experience by providing supplemental vaginal lubrication during sexual intercourse.
Good lubrications may be used with condoms.
Product codes
79 KMJ, 85 HIS
Device Description
Good Lubrications Personal Lubricant
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
body orifice, vaginal
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Not Found
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).
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§ 880.6375 Patient lubricant.
(a)
Identification. A patient lubricant is a device intended for medical purposes that is used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.(b)
Classification. Class I (general controls). Except when the device is a vaginal patient lubricant or an oral lubricant, it is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. In the center of the seal is an abstract image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 4 2003
Mr. Robert L. De Armond Vice President RA/QA BioFilm, Inc. 3121 Scott Street VISTA CA 92083
Re: K020586
Trade/Device Name: Good Lubrications Regulation Number: 21 CFR 880.6375 Regulation Name: Patient Lubricant Regulatory Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: 79 KMJ and 85 HIS Dated: November 19, 2002 Received: November 20, 2002
Dear Mr. De Armond:
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 (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); 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 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 Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.
Sincerely vours.
Nancy C. Brogdon
Nancv 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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Applicant: BioFilm, Inc.
510(k) Number (if known): K020586
Device Name: Good Lubrications Personal Lubricant
Indications For Use:
Good Lubrications patient lubricant is a medical device intended for medical purposes to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.
Good Lubrications is recommended as a personal lubricant to enhance intimate activities. It is designed to help enhance the sexual experience by providing supplemental vaginal lubrication during sexual intercourse.
Good lubrications may be used with condoms.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Nancy Brogdon | (Per 21 CFR 801.109) |
|---|---|
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K020586 |
| Over-the-Counter Use | |
|---|---|
| ---------------------- | -- |