(25 days)
PDI Sterile Lube Jelly is intended for use to lubricant a body orifice of a patient in order to facilitate the entry of a diagnostic or therapeutic medical device (such as a catheter, enema tip, or endoscope). The device is intended for use on order of a physician.
Not Found
I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a sterile lubricating jelly. It primarily discusses the regulatory approval of the device and its intended use.
This document does not contain information about:
- Acceptance criteria and reported device performance from a study.
- Sample sizes, data provenance, or details about test sets.
- The number of experts or their qualifications for establishing ground truth.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance studies.
- The type of ground truth used.
- Sample size for the training set or how its ground truth was established.
Therefore, I cannot fulfill your request to describe the acceptance criteria and study proving device performance based on the provided text.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 16 1998
Mr. Gary Vance Director of Research & Packaging Development Nice-Pak Products, Incorporated Two Nice-Pak Park Orangeburg, New York 10962-1376
Re: K974768 PDI Sterile Lubricating Jelly Trade Name: Requlatory Class: I KMJ Product Code: Dated: December 10, 1997 Received: December 22, 1997
Dear Mr. Vance:
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 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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਉ substantially equivalent determination assumes compliance with --the current Good Manufacturing Practice requirement, 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 In addition, FDA may publish further announcements action. 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
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through 542 of the Act for devices under the Electronic enroduct Radiation Control provisions, or other Federal laws or requlations.
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) 594-4618. 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" (21 CFR 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/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timothy A Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510k INDICATION FOR USE STATEMENT
510(k) Number (if known):
| Device Name: | PDI Sterile Lubricating Jelly |
|---|---|
| --------------------- | -------------------------------------- |
Applicant Name: Professional Disposables Inc., division of Nice-Pak Products Inc.
Indications for Use: PDI Sterile Lube Jelly is intended for use to lubricant a body orifice of a patient in order to facilitate the entry of a diagnostic or therapeutic medical device (such as a catheter, enema tip, or endoscope). The device is intended for use on order of a physician.
PDI/Nice-Pak Signature:
Gary Vance
Date: 12-30-97
Gary Vance Director of Research & Packaging Development
Pabaux Crescent
(Division Sign-Off) Division of Dental, Infection Contr and General Hospital Device
510(k) Number K974768
Image /page/2/Picture/12 description: The image contains the words "NON PRESCRIPTION use" written in a handwritten style. The word "NON" is written in all capital letters, followed by "PRESCRIPTION" and "use". There is a circle around the letters "Ty".
§ 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.