(87 days)
A lubricant for non-sterile gynecological and hospital procedures. Not harmful to rubber appliances or medical instruments.
Recommended for personal lubrication when vaginal dryness causes discomfort. Lubrication for insertion of rectal thermometers, enemas, douches, and similar types of nozzles.
Not Found
I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA to BioFilm, Inc. regarding their Exam Room Astroglide and Target Lubricating Jelly devices.
This document is a regulatory approval letter and does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methods.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 9 2001
Mr. Robert L. De Armond Vice President, Quality Systems and Regulatory Compliance BioFilm, Inc. 3121 Scott Street VISTA CA 92083
Re: K003867
Exam Room Astroglide and Target Lubricating Jelly Dated: December 11, 2000 Received: December 12, 2000 Regulatory Class: I 21 CFR §880.6375/Procode: 85 MMS
Dear Mr. De Armond:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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, issues, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4639. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 yours,
Tirid h. byron
David A. Segerson Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure (s)
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Image /page/1/Picture/0 description: The image shows the logo for BioFilm, INC. The logo is black and white and features the company name in a bold, sans-serif font. Above and below the company name are black geometric shapes. Below the company name is the text "Manufacturer of Astroglide."
Applicant: BioFilm, Inc.
510(k) Number (if known): K003867
Device Name: Exam Room Astroglide
Indications For Use:
A lubricant for non-sterile gynecological and hospital procedures. Not harmful to rubber appliances or medical instruments.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Per 21 CFR 801.109)
| (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
|---|---|
| -- | -------------------------------------------------------------------------------------------------------------- |
| Over-the-Counter Use | |
|---|---|
| 510(k) Number | K003867 |
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Image /page/2/Picture/0 description: The image shows the logo for BioFilm, INC. The logo is black and white and features the company name in a bold, sans-serif font. Above and below the company name are black bars. Below the company name, it says "Manufacturer of Astroglide."
Applicant: BioFilm, Inc.
510(k) Number (if known): K003867
Device Name: Target Lubricating Jelly
Indications For Use:
Recommended for personal lubrication when vaginal dryness causes discomfort. Lubrication for insertion of rectal thermometers, enemas, douches, and similar types of nozzles.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Over-the-Counter Use,
(Per 21 CFR 801.109)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K003867
Arrid
3121 Scott Street VISTA, CALIFORNIA 92083 760.727.9030 FAX 760.727.8080
§ 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.